Anonymous

Commentary On

Sherry confronts a number of dilemmas in this case study. She faces the choice of doing what she thinks is right from her viewpoint and that of her co-workers. She also makes a few ethically questionable moves. This case study is designed to present a person to whom most people can relate, someone who sometimes thinks of herself first, not an unrealistically virtuous person. I want to introduce some so-called gray areas for discussion using a few issues that have come up in my own graduate career as well as some that I considered thought-provoking.

At the end of each section, conclusions can be drawn that will end the story, and I intended the reader to be able to do this, as indicated by the possible conclusion paragraph after the first set of questions. As the story continues, additional ethical issues arise. When the story ends, there is a wide avenue for discussion of what Sherry did and what she should or should not have done. The reader has a broad spectrum of issues for an animated class discussion.

Questions 1-3

The question here is whether Norman has been dishonest in his dealings with Sherry's work. Since Norman is also listed as an author, he should be able to revise work if he wishes. But did he really fabricate the data? Could he have been revising her work? It is a possibility that he did the experiment himself and got the correct conclusions. What Sherry should have done is to ask him in the beginning about the manuscript, or ask to help edit it.

If Sherry decides that Norman is falsifying data, should she tell anyone? The truth is that she probably would be blacklisted in her field, or at least make some serious enemies. She could be saying good-bye to any chance for success. Is it really worth all that?

All of these issues aside, Sherry should never have looked at papers on Norman's desk. Her action is a clear invasion of privacy.

Questions 4-5

Part 2 attempts to display a gray area for discussion. It brings up the question of responsibility or accountability for a publication. Sherry's decision not to "blow the whistle" this time is solely based on her self-interest, not on any sense of loyalty to anyone else in the lab. Is this decision any more or less justifiable than her earlier decisions, which took into account the fate of her co-workers?

Questions 6-8

In Part 3, I want the reader to think of what Sherry should do after discovering that others have shared her experience with Norman. Obviously, none of them have reported Norman, even though they knew what he was doing, and had discussed his actions among themselves. Should Sherry now sacrifice her career to prevent his jeopardizing the newer students? Her predecessors never warned her. Should she too turn a blind eye? After all, she is about to leave, and no one would ever know what happened.

Should Sherry also be accused of misconduct? She knew of an unethical situation (or one she thought was unethical) and did nothing about it. My point here is for the discussion participants to find out their own institutions' policy on reporting unethical behavior. At some institutions, she would be held accountable; at others, not. Most institutions have no set policy for ownership of data and reporting misconduct because it is impossible to know the minute details and circumstances of every case. Misconduct is handled on a case-by-case basis, although each institution may have a highly structured procedure for handling such cases.

References

Beabout, G. R., and Wenneman, D. J. Applied Professional Ethics: A Developmental Approach for Use with Case Studies. Lanham, Md.: University Press of America, Inc., 1994. National Academy of Sciences,
National Academy of Engineering and Institute of Medicine. Responsible Science: Ensuring the Integrity of the Research Process, Volume 1. Washington, D.C.: National Academy Press, 1994.
Sigma Xi., Honor in Science. Research Triangle Park, N.C.: The Scientific Research Society, Inc., 1994, pp. 29-32.

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Commentary On

Scientific Research and the Autonomy of Indigenous Peoples: The Case of the Kennewick Man

The case of the Kennewick Man, and NAGPRA in general, raise many difficult questions. The specific questions listed in the case are discussed below. Additional relevant issues are then raised. Finally, precedents and analogous situations are considered.

1. Are there values that are more important than the value of scientific research?

Clearly, some values are more important than scientific research. For example, it is generally accepted that research on human subjects cannot be conducted without consent of the patient or study subject. The Nuremberg Code, established in 1947, specifies that consent in research experiments must be voluntary. It also requires that experiments be conducted in such a manner as to avoid unnecessary harm, both physical and mental (Nuremberg Military Tribunals 1947). The American Anthropological Society's guidelines state that research should be conducted in a manner that does not harm the subject. (American Anthropological Association 1995) These examples suggest that the well-being of the subject is a more important value than scientific research in and of itself. Thus, we already recognize instances when other values are considered more important than scientific research.

2. Is cultural autonomy one such value?

In the United States, arguments for cultural autonomy in the practice of science could be based on arguments for religious freedom. The free exercise of religion occasionally conflicts with the practice of science. For example, a patient has the right to refuse medical treatment on religious grounds. Religious autonomy may be considered a form of cultural autonomy, implying that it is acceptable and legal for different groups to practice science in different ways or not at all.

Globally, recognition of the value of cultural autonomy has increased with a greater sensitivity toward colonial attitudes and with growing political movements to recognize the rights of indigenous peoples throughout the globe. Colonial practices extended beyond politics; they included economic, social and even scientific systems. Scientific colonialism has been defined as "that process whereby the centre of gravity for the acquisition of knowledge about the nation is located outside the nation itself." (Galtung 1967:13) Using this definition, archaeological and physical anthropological research into past Native American societies can be considered a form of scientific colonialism. Research is conducted outside the Native American nations, by outside scientists. The physical remains are curated on the outside, and the knowledge gained through the study of these remains is generally disseminated outside Native American nations. After realizing the potential for research on Native Americans to be conducted in a colonial manner, archaeologists and physical anthropologists have the challenging tasks of forming more balanced relationships with the descendants of the Native American nations they are studying.

Does the political independence of groups necessarily entail independence from other cultural, social, intellectual and scientific practices? At the very least, political independence implies that autonomous groups have the right to regulate the practices of science within their community. However, in keeping with accepted conventions of scientific research, autonomous regulation should not permit the practice of science so that it harms persons outside the community.

Could it be argued that the scientific study of the remains of indigenous peoples should not be permitted because it is not an accepted practice within most indigenous communities? Alternately, could it be argued that the archaeologists, physical anthropologists and the public body of knowledge are harmed by repatriation practices? If the harm is not physical or financial, how can it be measured? If both sides are harmed, should the deciding criteria be which side suffers the most harm? This reasoning would imply that the decision rests on benefit to the greater good. Accordingly, it could be argued that the study of remains benefits the larger society while cessation of study would benefit only a minority of the population. Such an argument would likely result in a ruling favorable to study rather than repatriation. This type of ruling would also imply that the rights of minority groups do not receive special protection, an idea that is still being debated in our society. Recent political action in California and in the U.S. Congress demonstrates that the American public is divided in its opinion of special programs and protection for minority groups.

3. Is NAGPRA a suitable means for addressing the problem of the disposition of Native American remains?

NAGPRA was designed to prevent continued ethical abuses in the study of human remains. One objection to NAGPRA is that it attempts to legislate ethics and morals, which may not be the appropriate domain for federal law. However, federal legislation can be considered appropriate in this case for the following reasons:

The federal government has acted to protect certain values (such as free speech) in the interest of the American public.
The federal government has also acted to protect the rights of minority groups.
The federal government has traditionally been the authority to enact laws regarding Native American tribes.
Federal laws are an effective means for establishing national standards for certain behaviors.
Existing federal laws already protect cemeteries and burials.
National (and international) laws that protect cultural property already exist in the United States and other countries.

When considered in the context of these precedents, a federal law to protect Native American graves and grave goods seems appropriate. However, NAGPRA is vague enough to permit differing opinions of what constitutes a legitimate claim. Furthermore, the legislation does not reconcile the differing interests of the parties involved in repatriation. It also leaves open the means for handling claims, so that some institutions may recognize an affiliation that other institutions do not.

For institutions or researchers who disagree with NAGPRA and feel protective or proprietary about their collections, mild forms of noncompliance (such as foot-dragging or shoddy cataloging) may be a temptation. However, this response can only create further hostility. It reinforces the impression that archaeologists and museums hoard their collections and are unwilling to share them with other interested parties. Focusing on the problems with NAGPRA and its implementation only diverts attention from the central issue -- the appropriate way to study human remains. Instead of disputing the validity of the law, archaeologist and institutions should focus their energies on developing revisions that are generally acceptable to all parties. For example, some sources used to support repatriation claims are now known to contain erroneous information that leads to claims on unaffiliated materials. Standards of proof, implementation procedures and accepted affiliations could be developed as addenda to the law in order to make it more explicit and fair.

Problems with the law do not necessarily imply that the law is unjust but rather that the law isn't perfect and that revisions are necessary. Those who are concerned about potential pitfalls might choose to compile lists of suggested revisions through a committee of archaeologists, physical anthropologists, Native Americans and members of Congress. They may press for legislative revisions, for clarifications from the court systems and for the adoption of the revisions through other means than legislation.

4. Are there moral or ethical considerations that are more important than following the letter of the law? If so, what implications does that have for limitations to scientific research, not just in archaeology, but in all disciplines?

NAGPRA was written to address ethical obligations. Like many laws, it can be interpreted narrowly or broadly. A narrow reading of the law, which gave more weight to the biological and historical data, would result in a decision that the skeleton does not meet the requirements for reclamation. With a narrow reading, scientific research would be permitted to continue. However, a broad interpretation of the law, which gives equal weight to oral history, would find that the skeleton does meet the requirements for repatriation. Since NAGPRA can be interpreted in different ways, should sympathy for the concerns of the Native Americans or for the concerns of the archaeologists weigh more heavily? Should a moral obligation to respect the dead influence the reading of the law? What about a perceived ethical obligation to compensate for the wrongdoing of the past? Is the integrity of the scientific research process less important than humanistic concerns? As Galtung (1967:13) argues, "knowledge is known as a good thing, but in human affairs it is not immaterial how that knowledge was acquired." That implies that archaeologists, physical anthropologists and all other researchers whose subjects are human beings must be certain that their research methods are justifiable in humanistic and scientific terms.

5. Should science defer to the wishes of indigenous people?

In this case study, this question is the primary issue directly confronting scientific research. The case challenges both the autonomy of the scientific research process and the scientific method itself. First, the right to autonomy in scientific research is challenged by the right to cultural autonomy. Should scientific research (provided it is not violating human rights or other laws) be restricted by political concerns? If the archaeologists and physical anthropologists are not harming their subjects, what would be the implications for the practice of science if their research were forbidden? Is there a potential to set dangerous precedents here? Does it matter that the subject of the study is a rare find? Does it matter that the information that could be gained from the study would be extremely valuable, since very little data on the subject exists to date? (NAGPRA legislation does provide exemptions for cases where the study of the remains results in a major benefit to the United States.) Or is this case a clear-cut example of scientific colonialism, where the study would not produce information of major benefit?

Is it responsible conduct to stop a research project that has already begun? If the study were stopped, it would be impossible to attain complete, valid or reliable results. Should the limited data that were already collected be used? Without enough time to complete the study, it would be difficult to attain any results beyond basic measurements. Without assurance that the study results are valid, should the partial results be used? If the study subject is deemed "off limits" for further study, how can reliable results be assured? Should data from a study that has been stopped mid-stream be published, published with caveats, or remain unpublished?

6. Are there times when the importance of scientific information outweighs the wishes of indigenous people?

In addition to the problem of assuring the integrity of the scientific research process, this case also raises the issue of what knowledge should be included in the public domain. Does the tribe's interest in reburying the skeleton outweigh the interest of contributing to scientific knowledge about migration to the New World and the history of the United States? Should we accept the oral history of the tribe as the source of information rather than scientific data? By extension, should we then adopt indigenous theories on any topic rather than exploring them through science? If that were the case, it is possible that the recent outbreak of the Ebola virus would not have been stopped, or stopped as quickly, because indigenous theories of the disease were not preventing its spread. Clearly, in this case, Western scientific research that investigated how Ebola was spread did benefit indigenous peoples.

NAGPRA legislation does provide exceptions to repatriation when the remains are a necessary part of a scientific study that would contribute significantly to the United States. If the material is repatriated, it is returned only after study is complete. Thus, the legislation itself seems to recognize exceptions to repatriation procedures. Is this a recognition of the value of information and/or the interests of the larger public? The law is vague in this regard.

7. Are archaeologists and physical anthropologists facing a legitimate threat to research?

It appears that some research is threatened. However, much research (i.e., research on nonfederal or nontribal property) is unaffected by NAGPRA legislation as it currently stands. With federal laws that also require the constant assessment of cultural resources in developing areas, it is unlikely that archaeology as a profession will disappear entirely. However, NAGPRA legislation may mean that archaeologists must find a new modus operandi -- one that involves consultation with native peoples in order to develop mutually satisfying research projects. To this end, some archaeologists have already developed research programs founded on collaboration with Native Americans.

8. If so, how can archaeologists and physical anthropologists continue to conduct research while operating within the restrictions required by law?

As discussed above, archaeologists and physical anthropologists are faced with the prospect of doing their work in a new way. Some lines of research may not be permitted, and research must be designed so that legally and ethically compromising situations are avoided. Preventive measures that ensure compliance may become necessary. Although they may eliminate some potentially exciting research projects, compliance and respect will be necessary to forge stronger relations with Native Americans. The end result may be that, after archaeologists and physical anthropologists demonstrate respect for and develop research programs in collaboration with Native Americans, feelings of distrust, alienation and powerlessness may be relieved, and currently forbidden areas of research may be reopened.

9. How can archaeologists and physical anthropologists continue to conduct research while abiding by the spirit of the law?

In situations such as the Kennewick case, research is begun for salvage purposes and/or the discovery of remains is unintentional. What starts as an accepted line of research may become ethically compromised. Again, it seems that the best way to avoid such a situation is to plan ahead. If human remains, either prehistoric or historic, are encountered, how should one proceed? On federal property or tribal lands, NAGPRA is explicit in the proper procedures. However, it does not outline proper procedure on nonfederal or nontribal property, although there may be state guidelines. If full excavation is not possible, are there acceptable means of documenting the remains without removing them from the ground? If a sacred object is encountered, what should happen?

These kinds of situations often arise unexpectedly. When faced with an unexpected situation, the archaeologist will usually choose to proceed according to his or her training (which encourages study through careful documentation and removal to the lab). Most archaeologists are required to call the State Historic Preservation Office (SHPO) for an official opinion how to proceed. Emergency phone calls to the SHPO may remain necessary because of unexpected finds, but an archaeologist should not begin field work until he or she is sure of SHPO policy and Native American concerns. In addition, frequent contact with a representative of local or interested Native American groups would also be advisable. Although this approach may initially lead to headaches and unwanted research restrictions, inclusion is an important means of demonstrating the desire to work with Native Americans. It also prevents the spread of rumors and the suspicions that are generated by "closed" research.

Further Considerations

Several ulterior motives can lie behind repatriation claims and arguments against repatriation. Below, three examples of these motives are raised and then discussed.

If it were found that a group was claiming skeleton in an attempt to strengthen their land claims and thus gain power over other Native American groups, would that change the strength of the group's argument for repatriation?
If the group that receives skeletons or grave goods also received money with which to rebury the materials, should a profit-making motive be considered in the decision?

In some cases, ulterior motives may play a role in repatriation claims or dispute. NAGPRA may be open for abuse just as other laws are. However, NAGPRA does not contain provisions that allow for exceptions when ulterior motives are suspected (or even proven). In cases where ulterior motives are suspected but repatriation is permitted anyway, follow-up may be necessary to make sure that the proper reburial procedures are being followed and the intent of the law is thereby upheld. Revisions to the law, including provisions for follow-up and assessment of penalties for noncompliance with reburial guidelines, may prevent ulterior motives from overriding the intent of the law.

What if the study of the skeleton were fueled by other considerations, such as a desire for fame, or for the grant money that can be obtained to study skeletal remains and grave goods, especially for ancient skeletons like the Kennewick Man? Should these factors play a role in determining the validity of the archaeologists' arguments against repatriation?

Desire for fame and funding may play a role in the tenacity with which an archaeologist or physical anthropologist disputes a repatriation claim. Again, NAGPRA does not contain clauses that permit consideration of these matters in repatriation rulings. The primary means of preventing economic factors and/or vanity from entering the arbitration process is the necessity to prove that a study will result in major benefits to the United States. However, proving that the study is important is a different matter than completing, publishing and widely disseminating the results of the study. These requirements and penalties for noncompliance might be added to the law to prevent archaeologists and physical anthropologists from using important remains primarily for personal gain.

The biggest problem that archaeology faces is not repatriation, but the looting of sites and the buying and selling of artifacts, which creates the market for looted or forged materials. The relation of looting and forged artifacts to NAGPRA are considered below.

If the reputation of the archaeologist involved in the study, or if the nature of the archaeological find were suspect, how should the repatriation claim be handled? Can the reputation of the contesting parties be included in decisions about repatriation?
What if it appeared that the material was looted or faked? In such cases, it may require archaeological study to prove that the materials are genuine. If such research is prohibited, should potentially forged artifacts be repatriated?

In the above scenarios, it would be of interest to all parties that the artifacts and remains be thoroughly investigated and that the reports of the investigation be reviewed by an outside evaluator before any rulings are made. Native Americans probably don't care to claim forged materials, and archaeologists and physical anthropologists wouldn't want to invest their energies and resources in a dispute over repatriation when the materials are not authentic. NAGPRA was not written for remains that aren't culturally affiliated or to artifacts that are not part of a tribe's cultural heritage, past or present. However, the law does not currently require authentication. Authenticity should be included in the definition of indigenous human remains, funerary objects (both associated and unassociated), sacred objects and objects of cultural patrimony.

Precedents

Two possible sources may be used on a comparative basis in reviewing this case. The first source involves informed consent; the second involves research on subjects who have traditionally been subject to prejudicial treatment.

Informed consent. Because the subject of the study cannot provide consent, and because there is no recognized legal guardian, policies regarding informed consent can only be loosely applied to this case. However, there are provisions for cases where the generalizable knowledge that is vital to the understanding of a condition can provide the basis for conducting research that may pose more than minimal risk to a subject. This exception may be used to argue that, at least in this case, study of the remains should go forward.

Prejudicial treatment. Even science has not lacked examples of prejudicial treatment. (Jones 1993) Prejudice should be considered in this case, too. Would archaeologists be so interested in the remains if they belonged to a white settler from the nineteenth century? If not, is it because the research potential is less, or is it because there is a reluctance to do similar research on subjects who share the same ancestry? A positive answer to the latter question would indicate the prejudices are playing a role in the research process.

Conclusion

The case of the Kennewick Man appears to fall under NAGPRA provisions that permit study followed by repatriation in situations where the results would be of major benefit. With multiple claimants, however, the situation also requires decision by mutual agreement or arbitration. The case is now in court; no ruling had been issued as of November 1, 1997.

Although this case deals with an archaeological problem, it involves issues of concern to scientific research. NAGPRA and repatriation claims challenge the integrity of the research process and the scientific method. In cases where scientific research conflicts with cultural values, which should take priority? This question can be argued from a philosophical, legal and ethical point of view. The answer is not clear, and any attempt at a solution is likely to be hotly contested. Situations such as this repatriation claim probably will be evaluated on a case-by-case basis. Consequently, a case such as this one may not be used to generalize a solution for instances when scientific research conflicts with other cultural systems. However, the case does point out some of the ethical issues that will require sensitivity as researchers conduct research or review research proposals outside a traditional Western setting.

References

American Anthropological Association. Final Report of the Commission to Review the AAA Statement of Ethics. Washington, D. C.: American Anthropological Association, 1995.
Galtung, J. "Scientific Colonialism: The Lessons of Project Camelot." Transition 5-6 (30): 11- 15.
Jones, J. H. Bad Blood: The Tuskegee Syphilis Experiment. New York: The Free Press, 1993.
Nuremberg Military Tribunals. The Nuremberg Code. Nuremberg: Nuremberg Military Tribunals, 1947.
U. S. Department of the Interior. Native American Graves Protection and Repatriation Act Regulations. 43 CFR Part 10. Federal Register 62 (148).

Whistle-blowing

Questions 1, 2 and 3 were written to promote discussion of whistle-blowing by exploring Thomas's options. Whistle-blowers, in the world of science, are individuals who bring soundly based charges of misconduct to the attention of academic/research institutions or government agencies. A panel assembled by the National Academy of Sciences in 1993 defined misconduct in science as: "fabrication, falsification, or plagiarism, in proposing, performing, or reporting research. Misconduct in science does not include errors of judgment; errors in the recording, selection or analysis of data; differences in opinions involving the interpretation of data; or misconduct unrelated to the research process." (National Academy of Sciences, 1992, p. 5)

By definition, Dr. Woodward is not guilty of misconduct; rather, the National Academy of Sciences would describe his actions as "questionable research practices" or "actions that violate traditional values of the research enterprise and may be detrimental to the research process." (National Academy of Sciences, 1992, p. 5) Based on this criterion, should Thomas act on his knowledge of the situation?

Certainly, the easiest thing for Thomas to do would be to sit on the information and do nothing. After all, he is nearly finished at State University; becoming involved in this situation could delay the completion of his degree. Furthermore, raising questions about the research practices of a senior faculty member serving on his committee would hardly serve to advance his career The reality is that young scientists rely heavily on positive recommendations from senior faculty members; getting involved could tarnish Thomas's reputation, and thus his career. Even though the National Science Foundation and Public Health Service require institutions receiving public funds to have regulations in place to protect whistle-blowers, discrimination against these individuals is not uncommon. In fact, reprisals against whistle-blowers have been well documented, even in situations where the whistle-blower was proven correct. (Rossiter, 1992)

Aside from Thomas's fears regarding his career, he is also experiencing a conflict between his loyalty to Dr. Woodward and his responsibility to do what is right. The case makes it clear that Dr. Woodward has been helpful to Thomas. Because of this relationship, it would be unpleasant for Thomas to report these allegations to the institution, especially during the midst of a precarious tenure process. At the same time, Thomas is convinced that Dr. Woodward's actions were improper. Although this case does not involve misconduct in the strictest sense, Thomas believes that Marilyn and Shawn could be harmed by the medication. Given this piece of information alone, Thomas has the responsibility to act on his knowledge. But what type of action should he take, and when?

The case implies that Thomas and Dr. Woodward have a favorable relationship, so perhaps, rather than reporting this information to the institution, Thomas should directly confront Dr. Woodward with his concerns. It is unclear from the description of the case whether Dr. Woodward's actions represent a pattern of irresponsible behavior or just a lapse in judgment. If the case were modified so that Dr. Woodward's actions reflected a pattern of behavior, rather than this isolated case, Thomas might need to take his story to a higher authority. However, given the information at hand, confronting Dr. Woodward may offer the best solution for all parties involved. If Thomas does choose this option, the timing should not affect the tenure process; he should approach Dr. Woodward with his concerns as soon as possible.

The intent of Question 2 was to explore whether the consequences of Dr. Woodward's actions should influence Thomas's decision. In other words, should the fact that Marilyn and Shawn were not harmed by the beta-blockers have any bearing on Thomas's responsibility to act? When considering this issue, it is important to note that this specific case states that the students suffered no ill effects in the short term. In all likelihood, the students will not suffer any chronic effects either, but Thomas cannot know that for certain. Likewise, fabricating data seldom leads to immediate problems, but these actions can ultimately result in untold damage and expense if not exposed. Therefore, caution should be exercised in basing our decisions on consequences alone.

Question 3 was written to promote discussion on the case if the dynamics were changed so that Dr. Woodward were a M.D./Ph.D. While this modification would alter the legalities of the situation, some problems remain. Unless Marilyn and Shawn were under Woodward's direct medical care, it would not be proper for him to prescribe beta-blockers to the students as described. Another issue is that of diverting for personal use supplies that had been purchased for the conduct of experiments. Regardless of Dr. Woodward's degree, he has used materials purchased with federal or private funding for applications that were not stated in his grant protocol.

Student-Mentor Relationship

Questions 4 and 5 were written to foster a discourse on the relationship between Dr. Woodward and the students. The case indicates that Dr. Woodward has been generous in providing assistance to Thomas throughout his graduate studies, so one could reasonably conclude that Dr. Woodward is genuinely trying to help Marilyn and Shawn. However, from a cynical standpoint, Dr. Woodward could be exploiting the situation to recruit the students into his laboratory. It is not uncommon for would-be mentors to pursue graduate students by befriending them in the early stages of their academic careers. Unfortunately, there are instances in which faculty use empty promises of publications or even guarantee the student will complete a dissertation within a set time to persuade students into their laboratories. (Krulwich and Friedman, 1993) In this instance, the case does not indicate what motivates Dr. Woodward's behavior, but regardless of his intentions, he has placed the students into a difficult situation. As first-year students who are struggling to make their grades, they are vulnerable to an authority figure with an apparent quick-fix solution to their problems. It would be admirable for Marilyn and Shawn to politely decline Dr. Woodward's invitation, but realistically, new graduate students are generally eager to please and are likely to accept a faculty member's suggestion.

A final aspect of the case to be examined concerns the fairness of Dr. Woodward's actions. Certainly, other students in the Gross Anatomy class performed poorly on the exam, yet Dr. Woodward offered beta-blockers only to Marilyn and Shawn. This preferential treatment could be even more troubling if Dr. Woodward were involved in teaching this course. It might be worthwhile to consider how Dr. Woodward's actions in this case would differ from a situation in which a professor provides a test review only to selected students rather than the class as a whole. In both instances, the faculty member has violated the student-mentor relationship by giving certain students an advantage over others.

References

Krulwich, T.A., and Friedman, P.J. "Integrity in the Education of Researchers." Academic Medicine 68 (9, 1993): S14-S18.
National Academy of Sciences. Responsible Science: Ensuring the Integrity of the Research Process. Washington D.C.: National Academy Press, 1992.
Rossiter, E.J.R. "Reflections of a Whistle-Blower." Nature 357 (1992): 434-436.

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Commentary On

Protection from Proposal Idea Scooping?

Question 1

At least two levels of analysis are possible here -- legal and ethical. Legally, principal investigators and co-principal investigators must sign the following statement: "I certify to the best of my knowledge that the statements herein (excluding any scientific hypotheses and scientific opinions) are true and complete. . . . I understand that the willful provision of false information or any other communication submitted to NSF is a criminal offense." Thus, despite a possible reaction that Ness's action may be a "small murder," which is bad only in that it will lead to worse actions if it succeeds, the introduction of the error is in itself a legally prosecutable offense.

However, Ness was not caught in this deliberate act. Even if she were caught, it would be difficult to prove her guilt, due to the burden of proving intent and lack of negligence and providing expert witnesses.

That leaves open the question of whether the introduction of the error was ethical. Ness has a responsibility to herself and her co-principal investigator, Black, to be truthful so that her proposal can fairly evaluated. She also has an ethical obligation to other proposers and the NSF peer review process. By being untruthful, Ness has jeopardized her own career and Black's career, penalized the careers of other proposers and corrupted the review process. That may seem like a strong indictment, but the entire system is built upon truth. Violations cannot be taken lightly because they bring into question the entire system.

Does it matter that Ness introduced an error in the method and not a fudging of data? An argument can be made that they differ in severity, but both are misconduct.

Do you think Ness can later claim she made an honest mistake in the method and is thus innocent of misconduct? This possibility will require a convincing explanation that is hard to express unless one is completely truthful.

Mention must also be made about the division of labor in writing the proposal. Although it is common practice to divide writing the parts of the proposal, ultimately all coauthors are responsible for the entire proposal; coauthorship of proposals is similar to coauthorship of a paper. Thus Ness and Black should have ensured that each of them completely understand the other's written contribution; specifically, Black should have understand and caught Ness's deliberate error. Black can be faulted for failing to ask Ness to explain her methods until he understood; Ness can be faulted for not giving an explanation or giving an unclear or misleading explanation.

Question 2

Ness may or may not have good reasons to support her beliefs, but she has the right to her own opinion. I do see a problem, however, in Ness acting on her belief that the NSF peer review process is corrupt. By introducing an error in the proposal, Ness is actually contributing to corruption of the process. She may be inaccurate in her belief and the NSF peer review process may be of the highest integrity; by her actions, she is creating a self-fulfilling prophecy. If Ness is accurate in her belief, a common response may be that anything is justified in a corrupt process -- anything you can get away with, that is, and Ness has gotten away with an error that has protected her research ideas (or at least that is what she thinks). Ness knows herself what she has done, and her deception will likely manifest itself sometime. What would Ness think if she were a future proposal peer reviewer who had detected such a deliberate error?

I state in the discussion of Question 7 that Ness has an obligation to fix any problems she encounters and not just point the finger while acting unethical herself.

Question 3

The first thing that jumps out is that this new material or the process to create the new material may be patentable, protected under intellectual property law. There are many ways to apply for a patent (these procedures are changing rapidly), and the best advice is to consult a specialty lawyer. State University will surely have a claim (legitimate or not), and the State University legal department may be one place to start, although the counsel there will be acting on behalf of the University and not on Ness's behalf. Laboratory notebooks and other documentation become very important in patent applications. World patent law is moving toward a global "first-to file" standard (as opposed to the traditional U.S. first-to-invent standard), so time is of the essence.

Patenting the new material or the process to make the new material may conflict with Ness's desire to submit a proposal to NSF and/or publicly present her preliminary results. She may be forced to decide whether it is in her interest to patent or publish; these options may be mutually exclusive.

The best way to avoid a situation in which the researcher feels vulnerable to being "scooped" is to publish research, to build a body of work that can stand for itself. If it is good work, others will notice and possibly pursue some of the ideas. Researchers should be honored when others follow their work. Most papers are not referenced and are read only by their authors and close colleagues. Problems of proper acknowledgement of intellectual contributions may arise, but science is a self-contained community; most problems will not only be noticed and remedied but the perpetrator's reputation will suffer severely. To a large extent, Ness has been forced into this fear of being scooped because she has not published.

One suggestion is that Ness only sketch her methods and state that the complete methodology is available upon request, but what happens if many people make requests? Ness can also be vague in her description and omit information about her methodology, but that will cause two problems: 1) It may hurt her evaluations if peer reviewers realize that she may not have a completely workable experiment. 2) It also causes ethical concerns if Ness strays close to untruthfulness (e.g., omitting vital information). A last suggestion is that Ness can use specific jargon that is truthful but cryptic and undecipherable. Using specific jargon will probably harm her chances for funding. Unfortunately, many researchers write in jargon not to protect information but because they cannot express themselves clearly in written communications.

Question 4

The peer review process is handled differently by different organizations. One common practice is to distribute proposals under consideration to researchers at universities and other institutions so that their feedback can be incorporated in the selection process. An explicit statement of confidentiality stating that the prohibits sharing of proposal contents. Unfortunately, professors commonly discuss the proposals with students, possibly even involving students in creating the proposal feedback to be sent back as peer review. After the peer review process concludes, the funding organization notifies all reviewers that the proposals they have in their possession should be destroyed. Unfortunately, many reviewers hold proposals for later reference. Because students who are given proposals by their professors are often unaware of the context of the research material they have been provided, the scenario depicted in this case is not that far-fetched.

Other problems from student involvement in the peer review process include: 1) feedback to the proposer(s) and possibly even award selections may be partially based on student review and not peer review; 2) when students become aware of their covert involvement in the peer review process, they may come to doubt the entire proposal process, perhaps rationalizing unethical actions on the belief that peer review cannot be trusted. On a final note, there should be an assumption of innocence until all the facts become clear. The graduate student in this case appears to be an innocent party, and the person(s) who provided him with the confidential NSF proposal appear to be guilty, but we do not know all the facts.

Question 5

Ness can either admit her actions to the student or continue to cover-up. her actions. If she continues to try to cover up, the coverup may actually become as significant or even eclipse her original deceit. Of course, any admission will need to be complete, exhaustive and reciprocal, since Ness needs to know how the student came upon her proposal.

Question 6

Does wrongdoing by another party ever justify wrongdoing by a researcher? In this case, does it really matter whether the NSF peer review process actually leaked confidential information? Specifically, is it introduction of the error unacceptable if the NSF peer review process has integrity and acceptable if the NSF peer review process lacks integrity? Ness must examine her own actions independent of the actions of others. A researcher cannot control the actions of others and should concentrate on her own ethical behavior. To do otherwise brings ethical behavior to the lowest common denominator.

Question 7

I see at least two other major ethical obligations:

Ness has an obligation to admit to NSF that she introduced the original error into the proposal. Although it appears that the error is moot (because the proposal has concluded, the error may or may not have had any relevance to the award and the correct method has been published), the error is still significant. The story of this error may be contained to a single graduate student, but chances are that it will have a life of its own. Ness will actually be contributing to her own belief that the NSF peer review process lacks integrity, a self-fulfilling prophecy that is simply hypocritical. As for the ramifications of coming forth with such information, there may be legal actions and severe career repercussions but there also may be support for honesty. In any case, it is better for Ness to disclose her deceit earlier rather than later (i.e.., in an admission in court).
Ness has an ethical obligation to find out specifically how her confidential proposal was compromised and ultimately an obligation to help fix any confidentiality problem she finds in the peer review process. She cannot be divorced from the NSF peer review process. By her very participation, and subsequent selection and support, Ness must take responsibility to ensure the integrity of the NSF peer review process for herself and others.

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Commentary On

Ownership of Knowledge and Graduate Education

This case raises three primary ethical issues: 1) ownership of ideas in the scientific process; 2) understanding professional obligations toward others and oneself; and 3) power differentials between these roles that can easily be exploited. What exacerbates the ethical concerns in this case is the lack of clear communication among those involved.

In Part 1, several incidents of miscommunication or lack of communication led to each person's perceptions. Moss feels that her ideas are not receiving proper credit, that Reynolds is taking advantage of her and that Abrams is not willing to champion her cause. These feelings arise from expectations that Moss may have had before entering the laboratory. She believes that her ideas should receive personal credit and that her research mentor should protect her when conflicts arise in the lab. Abrams' mentoring style cannot accommodate Moss's wishes. However, even if Abrams' mentoring style were made explicit to Moss, unexpected situations may arise in one's career. Continued communication between Moss and Abrams seems to be lacking. Both Moss and Abrams should strive to improve communication to resolve conflicts.

Reynolds is trying to write research grants, which is of paramount importance to a post-doc. He included Moss by asking her to read the proposal, which may have been his way of respecting Moss's ideas. His responsibility to Moss is somewhat ambiguous because although he is including her, she believes that she deserves more credit The issue here is whether Reynolds is taking credit for Moss's idea, and that is not clear from the case study. It could be argued that Reynolds is the most ethical of the three because he is trying to keep the laboratory funded, he appreciated Moss's ideas enough to include them in a grant proposal, and he suggested that Moss stay involved with the project. But that ignores Moss's concerns that she is being exploited by Reynolds. Abrams is a busy researcher in a competitive field. Professors with active research programs have many demands on their time. Resolving conflicts between people in the lab may not be a high priority, especially since graduate students and post-doctoral fellows are expected to behave like responsible adults. The real issue, then, is how to create policies in the laboratory to prevent unreasonable expectations, and, when new situations arise that cause conflict, to resolve these issues. One alternative is to discuss the situation with someone outside the lab. That could lend a fresh analysis of the situation and perhaps a swift resolution of the problem. Another, more feasible, option is to have regular, individual conversations between the lab director and the employees to try to avoid confrontations.

The ownership of ideas in scientific research is an ambiguous ethical issue. The scientific community is debating whether conceptualization of an experiment constitutes work that should receive credit and, in some cases, authorship. In Part 2 of the case, both Reynolds and Abrams agree that ideas are cheap, but results are priceless. Moss feels that she deserves credit for her ideas and first shot at the bench work. Reynolds and Abrams agree that she can do the experiments, but they refuse to credit her ideas. In this particular case, Moss will get credit if she completes the experiments. If she does not do the experiments, however, will she still be acknowledged? Or more importantly, should she be acknowledged? Because the ideas belong to the laboratory, someone else may do the experiments before Moss has a chance. Unless Abrams and Reynolds agree to let Moss have the first attempt, Moss may again feel exploited. At that point, the issues of power differentials would have to be addressed.

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Commentary On

New Technology - Who Is the Designer?

Support for Fabio's Perspective

Support for Edgar's Position

Legal and Ethical Considerations

Initial Discussion

Additional Discussion

Ethical Milestones and Judgment

Technology has become more than ever a collaborative product at all levels. With so much emphasis in academic research on the concept of intellectual property, this case illustrates a commonly blurred area between the right to ownership of one's ideas and the "right to exclude others from making, using, or selling" an invention. The primary ethical dilemma concerns the patenting of the sampling device; a secondary issue concerns authorship requirements. People in different positions view patents and authorship differently; that is where much of the conflict originates. From a contemporary academic perspective, Edgar is clearly the person with the good idea that was developed into a new technology, and he may deserve credit. In fact, it may appear difficult to make the case for Fabio's position. However, the concept of intellectual property in the business world often relies on the axiom that "possession is nine-tenths of the law." Furthermore, the patent is more a mechanism to protect initial market position for an invention than a means for providing credit or recognition.

It may be worth noting that technology can be a rather nebulous term, involving an overall approach rather than just an instrument or device. The patent discussed in this case applies to the sampling system built by Fabio (which is only part of Edgar's idea), rather than to the overall sampling approach. In some cases, such as chemical manufacturing, a production process can be patented, but the intent in this case is not to characterize Edgar's concept for sampling as this kind of production process.

Patents require that competitors obtain direct permission from the patent holder if they wish to manufacture or market a product, invention or process covered by the patent. A patent prevents someone from "reverse engineering" Fabio's design with the intention of marketing it independently. According to law, only the inventor may apply for a patent (except in particular situations, such as when the inventor is dead). More than one person can be an inventor, but a person providing financial support to the development is not considered a joint inventor. Application for a patent requires: 1) a written document that comprises a specification and an oath that the inventor believes him/herself to be the original inventor; 2) a drawing (when necessary); and 3) the filing fees. (U. S. Department of Commerce, 1992)

However, the concept of intellectual property introduces some important questions. In science, intellectual property is primarily an issue of credit and recognition rather than the marketing or production issues addressed by a patent. The research community acknowledges the potential conflict between openness and competition for discovery. Research institutions, academic journals and federal funding sources (such as the National Science Foundation) have set standards protecting individuals with good ideas by ensuring that they receive credit for their contributions. (National Academy of Science, National Academy of Engineering, Institutes of Medicine, 1993)

Support for Fabio's Perspective

We begin by making the case for Fabio to support an extended discussion with those more familiar with the intellectual property arguments. In this case, Fabio prepared all technical drawings and defined explicit specifications for the sampling machine. While these documents were inspired by a rough sketch and statement of needs that Edgar had defined, the initial concept was hardly a design. Analogously, many people had the idea of human flight long before the first successful design. Edgar's concept of an improved sampler may not have contained the detail required for patent until Fabio invented the specific design to solve Edgar's problem. Furthermore, Edgar entered into a financial contract with Fabio that compensated Fabio for his design. While Edgar did review the designs occasionally, there is no evidence in the case (as written) supporting Edgar as a collaborative inventor. To Fabio, Edgar's contribution could have been design review milestones in developing a customized vendor product. In fact, Fabio based much of his design on a hand-operated sampling machine that he clearly invented without Edgar. These arguments are all consistent with patent guidance supporting Fabio as the inventor.

Support for Edgar's Position

It appears clear that Edgar saw the application of this new technology as his idea, his intellectual property. After all, he recognized the need to improve current sampling methods and took all the necessary steps to implement his idea. He sketched out a concept that became the basis for the design or at least inspired it. Edgar approached Doris to secure half the development funds and hired Fabio to fabricate - not invent - the design concept. Edgar provided more than the initial design concept; he suggested to Fabio other technologies to be integrated into a system design. Fabio accepted these additional ideas as part of the collaborative effort that included joint review and development of the drawings and specifications. Simply put, without Edgar this design would not have existed in its current form. And Edgar is not claiming to be the sole inventor, he just wants to be named on the patent.

Legal and Ethical Considerations

From a legal point of view, Fabio may have more evidence that he designed the system. He holds all detailed specifications and drawings. Edgar never used his professional engineering license to stamp or approve the design. (In fact, Edgar may have been outside his practice area if he had because the device is a mechanical system, not a civil engineering design.) The case can be made that Edgar's contributions to the project were financial rather than design. Edgar can certainly contest these arguments, but he has less evidence in hand. By putting his design ideas into loose files instead of his project notebook, he may have weakened his position. However, Edgar does hold some legal ground. That loose file can be offered as evidence despite the legal preference for bound research notes. He can show the contract with Fabio as defining the design concepts and argue that he is a co-inventor. Edgar can claim that the design reviews with Fabio were not simply contractual milestones between vendor and client, but important collaborative discussions on the system design. He has Doris (at least), whose early approval he sought to pursue this idea further, although in her press releases she identified the design as Fabio's. These legal claims have never been made in this case.

Ethically, the characters in this case did not identify any problem until the patent issue arose. Edgar seemed more interested in the intellectual insights that improved sampling would provide, and he was proud to publish articles discussing the sampling protocol he pioneered (which used the technology built by Fabio). He was not particularly interested in the legal benefits of a patent, namely the right to license the design to competing vendors or exclude them from using the design. As a leading vendor in the field, Fabio has a clear interest in improving his product line and competitive position in the market. He benefited from the articles published by Edgar, even without being an author, because Fabio could cite current research claims as testimonials that his design was high quality and cost effective. If Fabio had not applied for a patent, would this case raise any ethical issues at all?

Initial Discussion

The initial questions for discussion try to clarify some of these issues. Many researchers do not consider vendors or technicians to be colleagues involved in innovations; they are rarely included as authors. Discussing Edgar's role in meeting with Fabio to review the drawings and specifications may identify underlying bias in the participants. (This case was specifically designed so that Fabio was an outside vendor, perhaps not covered by the intellectual property policies of Edgar's research institution.)

Whether or not Edgar should have included Fabio as an author may be discussed within the context of the Academies' standards and/or by using some journals' actual authorship guidelines. The primary issue is whether each named author made a significant intellectual contribution to the paper. Depending on the focus of Edgar's papers, Fabio could have made a significant contribution to the design of the sampling protocol by building the sampling machine. Alternatively, Edgar could have focused on field development and testing in such a way that Fabio's contribution was less significant. Consensus on this point may be more difficult than it appears.

Some guidelines for authorship may include:

Conception and design of the experiment;
Execution of the experiment and collection and storage of the supporting data;
Analysis and interpretation of the primary data; and
Preparation and revision of the manuscript. (National Academy of Science, National Academy of Engineering, Institutes of Medicine, 1993, p. 52)

The question of including Edgar on the patent may be ethically clearer, if not legally so. Fabio may have a business concern about including Edgar on the patent, because as a patent holder Edgar could participate in licensing the technology to Fabio's competitors. General Information Concerning Patents states, "Any joint owner of a patent, no matter how small the part interest, may make, use, and sell the invention for his or her own profit, without regard to the other owner." (U. S. Department of Commerce, 1992, p. 27) This right includes selling one's interest or granting licenses to others without consulting the other joint owner, unless the joint owners of the patent agree to other conditions independent of the patent. Edgar's desire for recognition as an inventor could be legitimate ethically. With some better negotiation, Edgar and Fabio may have found conditions that met both of their objectives. For example, Fabio could retain all licensing rights and a majority ownership of the patent. Edgar could be named on the patent, but his share of royalties or licensing fees could be limited. This kind of agreement is common within corporations.

Mac may also have some claim to the patent if his contribution in field development resulted in significant design elements in the patent; his contribution is unclear, however. It appears that Doris has no claim as an inventor since she provided only financial support. By publicizing the technology in company literature, she may have added to the motivations for Fabio to seek patent protection. Doris's role, as presented in the commentary and to some extent in the case, does not clearly indicate sufficient contribution to warrant co-authorship. Perhaps she was invited to be a co-author by Edgar as a courtesy for her support. This question could be briefly discussed as another ethical issue related to this study.

Additional Discussion

The additional information included in the case attempts to further clarify the legal and ethical analysis. By weakening Edgar's legal case somewhat, the discussion necessarily focuses on the ethical dimensions. Some participants may follow the weakening legal position and conclude that Fabio is the sole designer of the technology; others who are more secure in the academic concept of intellectual property may continue to defend Edgar's position. One can introduce additional scenarios where Edgar might have included some intellectual property agreement into his initial contract with Fabio. If this happens, it may be valuable to adopt Fabio's perspective again and challenge the fairness of this agreement regarding patent ownership.

The question about Fabio's education relative to Edgar's is designed to expose for discussion any underlying preference in academic research for the intellectual authority. This concern is also relevant in corporate research. There are many cases where ideas that were developed by the technicians or junior engineers/researchers were adopted by their supervisors without credit. Despite the potential for these abuses, this may be more of a confounding question than necessary, and could be quickly put aside in discussion if no debate occurs.

When we change the contractual relationship between Edgar and Fabio from client/vendor to fellow employees - and, moreover, to supervisor and subordinate - the assessment may change. First, it becomes constrained by any applicable prior agreements within the institution. (This point could provide a good opportunity to review the research facility's policies on ownership of ideas.) Second, the responsibility for work products such as a new design may be less clearly defined. Edgar is the principal investigator and may be considered in responsible charge of all the products of this research. His authority may improve his claim to the design and patent, although it should not displace Fabio from the patent.

Ethical Milestones and Judgment

We can identify many places where Edgar could have acted to clarify his claim to the intellectual property and as co-inventor. Some suggested opportunities include:

Conception: Edgar could have used his field notebook, or another personal notebook, to document his design concept better.
Initial contract with Fabio: Edgar could have discussed the implications of the idea with Fabio initially, perhaps documenting some agreement about final disposition of the technology. At a minimum, they might have agreed to explicitly discuss the topic during design review intervals.
Publishing results: Edgar could have included Fabio as a coauthor, using these opportunities to share credit with Fabio. These were opportunities to begin (or reopen) discussion about the potential patent. In this regard, Edgar seems to have ignored the value of a patent until Fabio's patent application.
Following patent application: Edgar could have retained a patent attorney to review the evidence. The case may be strong enough to contest, or at least strong enough to reopen discussion with Fabio about joint ownership. There are mechanisms to add a name to a patent after filing when another inventor should be included. This could be the least effective strategy for Edgar and it may be the most costly.

In assessing the ultimate fairness of the outcome, two perspectives may be useful. One takes the initial motivations of each of the characters into account. From this perspective, it can be argued that all achieved their initial objectives. Sampling at Doris's site benefited from improved sampling protocols and from positive public relations. Mac received good field experience and co-authorship in journal publications. Edgar achieved all of the objectives he had for the research, published well-respected articles and received promotion. Edgar's intellectual property claims to the research results were never contested. Fabio expanded his product line to include a new system for sampling, improving his reputation as a vendor, and protected his product design from competition by patenting the technology.

The other perspective is whether the design idea was collaborative. If so, then it may be most ethical for Fabio to include Edgar on the patent. However, Fabio has an interest in negotiating with Edgar limited authority to sell or license the technology to Fabio's competitors. Edgar might have some ethical obligation to share authorship with Fabio as well. This perspective would require more negotiation between the two characters to achieve a satisfactory result. The meanings we attach to the terms concurrent engineering, team development, etc., have important implications for both intellectual property and patent protection.

Certainly, the opportunities to resolve the concerns raised here were most available early on. With the increased complexity of technology and interdisciplinary teams in research, this point becomes the central lesson to draw from the case.

References

U. S. Department of Commerce, General Information Concerning Patents. Washington, D.C.: U.S. Government Printing Office, 1992.
National Academy of Science, National Academy of Engineering, Institute of Medicine. Responsible Science: Ensuring the Integrity of the Research Process, vol 1. Washington, D. C.: National Academy Press, 1993.
Martin, M. W., and Schinzinger, R. Ethics in Engineering. New York: McGraw-Hill, Inc., York, 1983.
Harris, C. E.; Pritchard, M. S.; and Rabins, M. J. Engineering Ethics: Concepts and Cases. New York: Wadsworth Publishing Company, 1995.

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Commentary On

Jack Fry's Interview

This case raises two primary issues: data sharing and recognition of the contributions of others. The first issue concerns when it is appropriate to share the work of one's colleagues. Jack has procured Bob's work, integrated it with his own material, and presented it as one cohesive unit. Whether that is appropriate depends on the standards within Hill's lab as well as on the standards throughout the scientific community, in particular the standards that the interviewers expect their job candidates to adhere to. If the standards for sharing the work of a colleague are not explicitly stated, the door is open for abuse. It could be argued that Hill has an obligation to set explicit standards within his lab for data sharing to prevent problems such as the one that has arisen in Jack Fry's case.

Another point to consider is the power disparity between Jack and Bob. Jack is a post-doctoral fellow, and Bob is a graduate student. Because Jack is in many ways Bob's superior, Bob may have felt he had to comply with Jack's request for his materials. If Bob didn't comply, he may have been ostracized by other members of the lab as disloyal, and, ultimately, his career prospects could have been jeopardized. It is unethical for Jack to impose the arrangement on Bob if Bob was complying simply because he felt he had to show his loyalty to the lab. Again, it is worth pointing out that if Hill had explicit rules for sharing work amongst colleagues within his lab, these problems could have been avoided. It is particularly important to establish such criteria in a highly interdisciplinary lab such as Hill's, where every project is conducted with the help of several people.

The lack of explicit rules for sharing data, both in Hill's lab and throughout the profession in general, raises another interesting question: What are the expectations of Jack's interviewers? They are from a chemical engineering department where interdisciplinary work is probably much less common. Are they aware of how Hill's lab is run? Are they aware that each project is the work of several people, or do they expect Jack to present only his own work, unless otherwise explicitly stated? In the absence of explicit standards for data sharing, Jack has an obligation to the interviewers, Bob and the other candidates for the job, to clearly define his contributions and the contributions of others to the work he presented. In addition, the interviewers have an obligation to Jack, Bob, the department, the university and the other candidates for the job, to determine Jack's contribution to the work presented in his talk.

If Jack does not explicitly declare Bob's contribution, he is deceiving the interviewers. If his deception is found out, Jack risks a marred reputation and a loss of his colleagues' trust. Even if he is not found out, he will have to live with himself as a deceiver, which may erode his sense of integrity and self-confidence. Alternatively, he may decide that his behavior was acceptable, and may repeat his deception later or extend it to more serious breaches of integrity. He may spread his tactics throughout the engineering profession by training his students to adopt the same strategy in their presentations.

If the interviewers fail to determine the degree of Jack's contribution to the work he presented, they may hire Jack and not a more capable candidate who did not embellish his talk with the work of others. This would rob future students, the university and the scientific community of the best possible professor and researcher for their money. To clarify this point, suppose the interviewers only really liked the mathematical model portion of the talk, or suppose the department only had the resources for mathematical modeling and not for biological studies. In this case, they would have hired Jack specifically for work he had no direct role in producing.

The other issue raised by this case is proper recognition. Again, if explicit norms existed, problems would be less likely to occur. Recognition requires both permission and citation. Jack apparently had permission, since Bob helped him prepare for the talk and loaned Jack his slides. It is possible, however, that Bob was coerced into providing Jack with permission, in light of his vulnerable position as a graduate student in Hill's lab.

The question of permission aside, did Jack properly recognize Bob's contribution? One way of answering this question is to consider whether Bob would have been satisfied with Jack's acknowledgment slide if he had been in the audience during Jack's presentation.

Added insight into this case can be gleaned by considering various paradigm cases. First, consider the level of Bob's permission. If Bob were in a higher power position than Jack and had given Jack permission to use his materials, Jack's use of the materials could be considered completely ethical. Alternatively, if Jack had taken Bob's materials without his knowledge (for example while Bob was on vacation), then Jack would have been using the material without Bob's permission and therefore would have been acting unethically.

A second set of paradigm cases concerns the level of Jack's contribution to Bob's mathematical model. If Jack was so involved in deriving the mathematical model that he was a co-author of the paper, then his use of the mathematical model in his talk would be ethical, because much of the work would have been his own. Alternatively, if Jack had never helped Bob with the mathematical model, then Jack's use of the mathematical model would be unethical, unless he clearly stated that he had not been involved in its development.

Finally, it is useful to consider the adequacy of Jacks recognition of Bob's contribution to the mathematical model. If Jack clearly stated that Bob derived the mathematical model when the first slide discussing the mathematical model was brought up, than Jack would have acted ethically. If Jack did not acknowledge Bob's contribution at all, even in a final acknowledgment slide, than Jack would have acted unethically.

Considering the arguments and comments above, a creative solution to Jack's problem can be offered. Jack clearly wishes to come across to his interviewers as a competent engineer. He has already established his competence in his graduate studies, in which he had extensive mathematical modeling experience. If he desires, Jack could provide the interviewers with copies of his graduate school work to demonstrate his mathematical modeling capabilities. Jack should use Bob's mathematical model to illustrate the application of engineering principles to the DDS problem. Jack should explicitly state that Bob developed the mathematical model. By demonstrating his fluency with modeling, Jack will show his capabilities as an engineer and demonstrate how engineering can be applied to the DDS problem. Most important, he can emphasize his ability to work with others in a multidisciplinary environment to provide a complete understanding of a complex problem, by conducting both mathematical and experimental analyses. By being forthright and honest in his representation of his skills and accomplishments, Jack can satisfy his obligations to himself for career advancement, to Bob for proper recognition of his work, and to his interviewers and the other candidates for the faculty position.

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Commentary On

Informed Consent for Use of Stored Specimens

This case concerns the appropriate use of stored biological specimens from research with human subjects. Parts 1 and 2 describe a scenario in which the investigators have finished their originally planned analyses on the stored samples and now wish to conduct further analyses that were not described when they obtained consent from the participants in the study. This scenario may happen more often today because of the development of new technologies for analyzing biological specimens that were not anticipated when samples were first collected.

In Part 1, Smith's desire to pursue this research area, which could be beneficial to her career, and society's interest in increasing knowledge about the causes of preterm birth are conflicting with the right of the participants to make informed decisions concerning the types of research activities in which they participate. Smith wants to take advantage of a unique opportunity to conduct important research with little additional effort or funding. She fears that a requirement to obtain permission from the participants to do additional analyses of their specimens will make it impossible to conduct the research at all.

The women who participated in the study probably assumed that the biological specimens they provided would not be used for any purposes other than those specified on the consent form. The informed consent process should allow prospective participants in a study to make informed decisions about whether or not to participate in research activities, based on knowledge of the nature and purpose of the study and of its risks and benefits. Some women may not have agreed to participate in the study if they knew it would contribute to knowledge of genetic causes of adverse pregnancy outcomes. They may feel that this type of research could lead to discrimination against groups of people or to less attention to prevention programs if preterm birth is perceived as primarily a genetic problem rather than the result of modifiable factors.

If Smith proceeds with the genetic analysis, she will presumably contribute to knowledge of causes of preterm birth, and she may expect that her reputation as a researcher will be enhanced. However, she may have doubts about whether her decision was ethical. There is a risk that results of the genetic analysis could be linked to the participants individually and threaten their ability to get or maintain health insurance or employment if it is discovered that they are genetically susceptible to preterm delivery. Also, there are possible adverse consequences for Smith's relationships with women who agreed to participate in the original study. If the women find out that their specimens were used for such a purpose without their permission, some of them may feel betrayed by the researchers and may develop a mistrust of scientists and the scientific process. Other members of the public who learn the details of the consent process may also become less trusting of the scientific enterprise, thus jeopardizing public support for science.

Smith has an obligation to fully disclose to women who agreed to be in her study what she intends to do with the samples she collected from them. She should respect the women's rights to make informed decisions regarding their participation in research studies. However, she might argue that the need for informed consent is not the same for research on stored samples as it is for research that more personally involves the participants. In Part 2, Smith raises the possibility of avoiding the need to obtain consent for the genetic analyses by destroying identifiers. Making the specimens anonymous would alleviate many of the concerns about confidentiality. However, even if the specimens are "anonymized," as long as each specimen is linked to other information obtained from the women (for example, age, race and date and site of recruitment), the danger of deductive disclosure remains. When specimens are currently linked to names, the issue also arises of whether it is appropriate to pass up the opportunity to obtain informed consent (by destroying the links). Additionally, as Jones points out, making the specimens anonymous means that the investigators will be unable to provide specific information on the results of the genetic analysis to individual women in the study, or to obtain more information about the women for use in follow-up research.

Several points must be considered regarding whether the investigators should inform women of their individual results. First, it is important to consider the accuracy of a genetic test and how predictive a genetic marker is. In other words, how likely is it that a woman who is determined to have increased susceptibility to preterm delivery will actually deliver prematurely if she becomes pregnant? The women should be asked, preferably before they agree to participate in the research, whether they would want to receive their specific results. Some women may prefer not to know. If results are shared with the women, counseling would be important. In the specific case of studies on preterm delivery, any specific individual results will not be particularly relevant to women who are past reproductive age or who do not plan to have more children. However, this information may be relevant if the women's children are likely to be at higher risk of preterm delivery.

In Part 3, the scenario is changed to suppose that the investigators anticipated the desire to do genetic research and included a statement in the consent form to that effect. Although this statement is technically accurate, it is quite vague, and it is likely that most participants will not understand that their samples may be used eventually for genetic research. Even if the consent form had informed the participants that the investigators would "look at genes," this phrase may still be inadequate without further explanation of the potential consequences of genetic research. It may be desirable to ask participants whether they agree to have the links between their names and the identification numbers preserved, and, if links are kept, whether they would want to know any specific results concerning genetic analyses. Alternatively, if the specimens were made anonymous, it may be appropriate to ask participants if they agree to have the links destroyed and to inform them that in that case it would not be possible to provide them with specific results.

References

American College of Medical Genetics Storage of Genetics Materials Committee. ACMG Statement. Statement on Storage and Use of Genetic Materials. American Journal of Human Genetics 57 (1995): 1499-1500.
Clayton, E.W.; Steinberg, K. K.; Khoury, M. J.; et al. "Informed Consent for Genetic Research on Stored Tissue Samples." Journal of the American Medical Association 274 (1995): 1786-92.
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Screening and Counseling for Genetic Conditions. Washington, D.C.: U.S. Government Printing Office, 1983.

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Commentary On

Informed Consent and the Collection of Biological Samples from Indigenous Populations

Background

Questions 1-3

References

Background

Depending upon one's point of view, this case study might be viewed as either an exciting foray into new ethical territory or a marginally interesting development of issues only obliquely related to the more important core issues involving the notion of informed consent. I think both interpretations are hasty: While the case does highlight some newer elements, I believe it also illuminates issues central to a complete discussion of informed consent, and, what's more, does so in a way that provides a fresh perspective on some of those core issues themselves.

Contemporary events are, effectively, forcing more indigenous populations into working relationships with scientists. The supply of basic medical care, the HIV pandemic, drug testing and global projects such as the Human Genome Diversity Initiative (which seeks to catalog extant human genetic diversity) are all contributing to the greater rapport (or lack thereof) between western science and indigenous populations.

This case study was inspired by a controversy involving the patenting of an indigenous human cell line. An anthropologist working with the Hagahai of Papua New Guinea jointly filed a patent claim with the NIH in order to (ironically enough) ensure fair compensation for the Hagahai in case the unique characteristics of their blood turned out to be profitable. The response was a general outcry about "patenting life" and scientific "biocolonialism." While these are timely issues in need of discussion, what struck me was the relationship between the Hagahai and their western contact. In particular, it struck me that the "informed consent" of the Hagahai was based almost entirely on trust -- they trusted "their anthropologist" to represent their interests to the NIH and the local government; they trusted that they would not be exploited; and they trusted her word on what it meant for the NIH to "[find] a virus in our blood and make a map of it." (Cultural Survival Quarterly, p. 33) This level of trust and the concomitant level of personal integrity and responsibility that go along with it are a lot to ask of anyone. Given the increased competition for funding in science, the pressure placed upon neophyte scientists, and the increasingly complex context of scientific research, how can the scientific community, Institutional Review Boards (IRBs), and funding agencies work toward safeguarding the integrity of the relationship between investigator and indigenous human subject? And what can a careful consideration of this question teach us about "informed consent" in more traditional contexts?

Questions 1-3

Question 1. It is generally agreed that any scientific research involving human subjects should strive to obtain "informed consent" of each individual participant. As a beginning point, we might define this concept as follows:

Consent is informed when it is given by a person who understands the purpose and nature of the study, what participation in the study requires the person to do and to risk, and what benefits are intended to result from this study. (CIOMS, 1991, p. 11)

This definition focuses on the adequate disclosure of information by the investigator to the prospective participants. But two additional components need elaboration: comprehension and voluntariness. (Belmont Report, p. 6)

Comprehension is implied in the above definition by the word "understands," but its significance needs to be stated more explicitly. In particular, the criterion of adequate comprehension requires the investigator to accomplish two things: 1) to provide requisite information in an appropriate manner (for example, free of jargon or specialized concepts) (Belmont Report, p. 6) and 2) to be aware that adequate comprehension cannot simply be assumed to be the responsibility of the participants -- i.e., the burden of ensuring adequate comprehension lies with the investigator.

Voluntariness distinguishes between mere agreement to participate and voluntary assent. Thus this component of informed consent forbids the use of coercion, undue influence, or any other means by which prospective participants might be pressured into agreement (Belmont Report, p. 6). As defined in the Belmont Report, "coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance" [Belmont Report, p. 6] and "undue influence. . . occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance." [Belmont Report, p. 6]

Informed consent, then, comprises three elements: providing prospective participants with adequate information, ensuring their adequate comprehension of that information, and refraining from actions that might compromise their ability to freely choose to participate. This notion of informed consent is meant to apply to a wide range of scientific activities and contexts. With respect to the present case study, however, the third component, voluntariness, proves the most relevant for evaluating Tiptree's actions.

Question 2. Informed consent is most often associated with individual participants in a given study. But indigenous populations present a unique situation, in that investigators will need to deal with both governmental authorities of foreign countries as well as more local authorities with special cultural significance. Two issues arise in this context. First, must an investigator secure permission of both national and local authorities? It is very likely that some sort of official permission from the national government (or its science agencies) will be needed. But that "official" governmental permission may have little or no value with the local group exercising authority for an indigenous population -- especially given the frequently "strained" relationships between national governments and their indigenous populations.For example, in their statement concerning the patenting controversy noted above, Yokotam Ibeji and Korowai Gane, members of the Hagahai people, write: "Part of (this money) does not belong to the PNG [Papua New Guinea] government, no way. Why (should they get the money) when they get money and do not think about us, the Hagahai? No way. . . . They (the government) just think about themselves." (Cultural Survival Quarterly, p. 33) The different roles and interests of both groups may need to be considered. And in cases where an indigenous population is or has been exploited or oppressed by its national government, the issue of voluntary choice may stand in need of especially careful evaluation.

Second, investigators may have to comply with additional ethical guidelines or specific formulations of concepts and rules that will replace their American counterparts.Cf. DHHS and NIH Code of Federal Regulations, part 46 (Protection of Human Subjects), Section 46.101, paragraphs (b)(6)(g) and (b)(6)(h)]. This requirement reflects the fact that there are no universally accepted ethical guidelines for experimentation involving humans and no internationally recognized body for the ethical review of research involving human subjects.Cf. Law, Medicine, and Health Care, p. 160, which suggests establishing such an international committee.

The first issue is relevant to Tiptree's circumvention of the Yuchi council of elders. In particular, it points to a consideration of the status of the council of elders and their authority relative to their constituency and the local government officials. Insofar as the council is a locally recognized source of authority, its decisions ought to be respected. By ignoring the council's denial of permission to collect samples, Tiptree essentially violates the right to self-determination and autonomy of the Yuchi people. Even if the people themselves were completely open to giving blood, but the council opposed it, the council's decision would have to be respected. This conclusion follows because, presumably, the council has been chosen and empowered to represent the interests and well-being of the community. As such, it is the council that must bear the burden of deciding, in certain cases, what course of action would best serve Yuchi interests and well-being. If all the people disagree with the council's decision, then that is a matter for the group as a whole to work out -- it certainly doesn't license Tiptree to collect his samples.

The case study implicates the local government officials as the impetus for Tiptree's actions. As implied above, however, national governments may actually have interests and agendas that stand to benefit from undermining the authority of local bodies of authority, such as the Yuchi council. In this interpretation, Tiptree could be seen as a naive pawn in a political struggle. However, for the reasons set out in the last paragraph, his actions would still be deemed unethical.

Question 3. Now we are asked to assume that the council does sanction the collection of blood samples, but requires Tiptree to obtain consent of family heads and family members. In this way, we can scrutinize Tiptree's three strategies in light of the discussion of informed consent in Question 1.

My intention in providing three strategies was to form a continuum from least objectionable to most objectionable. Let me briefly discuss each strategy.

Strategy 1: All other things being equal, I believe this strategy is unobjectionable. Tiptree attempts to provide adequate information to prospective participants while at the same time discussing the potential benefits of his work. Assuming the details are provided in an appropriate manner and that there is adequate comprehension, this strategy would serve as a prelude to voluntary assent.
Strategy 2: This strategy is, at best, borderline. By offering poor families "incentives" or "compensation" in the form of valuable items or cash, this strategy verges on undue influence. That is, the form of the compensation Tiptree is offering might be "excessive, unwarranted, inappropriate or improper" (see above). Because the families are in a compromised position, their compliance might not be voluntary. The distinction here might be expressed as that between "buying consent" versus "reasonable compensation" for participation.
Strategy 3: This strategy is clearly wrong. By arguing that the families "owe" something to Professor Kroeber and then "intimating" that future help would be withheld, Tiptree is basically threatening the families. This sort of coercion forces compliance at the price of voluntary assent. By abusing his position of authority and privilege, Tiptree sets a particularly poor example for others and jeopardizes the long-term prospects of other researchers hoping to work with indigenous populations.

Therefore, given the details of the case study, even if Tiptree did have the full consent of the council to proceed with blood sampling, the manner in which he obtained consent was clearly improper and blameworthy.

References

The Council for International Organizations of Medical Sciences (CIOMS). International Guidelines for Ethical Review of Epidemiological Studies. Geneva: CIOMS, 1991.
Cultural Survival Quarterly 20 (No. 2, Summer 1996) [Special issue on "Genes, People, and Property"].
Department of Health and Human Services (DHHS) and National Institutes of Health (NIH). Code of Federal Regulations, Part 46--Protection of Human Subjects. 1991.
Law, Medicine, and Health Care 19 (Nos. 3-4, 1991) [Special issue on "Research on Human Populations: National and International Ethical Guidelines"].
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. OPRR Reports, April 18, 1978.
North American Regional Committee--Human Genome Diversity Project. Model Ethical Protocol for Collecting DNA Samples. 1997. Available at: http://www.stanford.edu/group/morrinst/hgdp/protocol.html.

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Commentary On

Ethical Issues in Longitudinal Research with At-Risk Children and Adolescents

Researcher Obligations
The Role of Informed Consent
Developmental Factors
Options for Action
What should Judy do?

Although many considerations are involved in this case, four broad areas deserve comment: researcher obligations, the role of informed consent, developmental factors; and options of action available to researchers who discover that minors may be in jeopardy.

1. Researcher Obligations

Who are the interested parties? What are Judy's responsibilities to each? How might each conflict?

The interested parties include the students, parents, Ms. Rosen and Judy's funders. She holds different responsibilities to each party, which, at times, conflict. For example, Judy promises the students that she will keep their responses secret and will not disclose their information to anyone. The students trust Judy not to violate that promise.

On the other hand, parents give permission for their children to participate in research with the understanding that Judy will act to maximize potential benefits and will not cause harm to the children, in accordance with the principles of beneficence and nonmaleficence (National Commission, 1979). In designing her research protocol and consent procedures, it is imperative that Judy consider parental expectations. Parents of at-risk youth may view any contact with professionals as a means of gaining assistance for their children and may erroneously assume that benefit will come from participation; that assumption may influence parental consent (Fisher, 1993; Thompson, 1992). In addition, parents may believe that the researcher's responsibility to act in the interests of the youth requires the researcher to disclose information that suggests that a student is in jeopardy; however, research protocols do not always correspond to this belief. Although Judy is obligated to keep the participants in her study from foreseeable harm, the parents may also feel that she is obligated to inform them of potential dangers to the students (i.e., excessive engagement in risky behavior).

Ms. Rosen, as a principal or school administrator, seeks information that will help the school as a whole and assist her in making administrative decisions. She seeks some disclosure of information; however, unlike the parents, she does not require unique identifiers or student names.

Judy is obligated by her sense of scientific integrity to conduct sound research. However, Judy's proposal is supported by grants; she is obligated by more than scientific virtue to conduct the best study possible. Her grant sources require her to conduct a thorough, scientifically valid study that, ideally, finds significant results.

It is apparent that Judy's obligations to these parties conflict. In sum, Judy is obligated to protect confidentiality, as she promised the students, as well as to protect them from harm. Appropriately, parents trust her to act in the best interests of the youth and may expect good, or at least no harm, to come from the interaction. Parents may also assume that information pertinent to youths' welfare will be fully disclosed; here, Judy's responsibilities to parents may conflict with her promise to her participants. In addition, Judy's relationship with funders obligates her to obtain meaningful, valid results. Providing a referral or intervention for a child or teen in jeopardy may damage the validity of Judy's study, compromising her obligation to her funders.

2. The Role of Informed Consent

What is informed consent?

The requirement of informed consent for participation in research was first iterated in the Nuremberg Code (1949), following the Nazi atrocities in World War II. Informed consent is a means of protecting participant autonomy and providing protection for those with diminished autonomy, an extension of the ethical principle of respect for persons (National Commission, 1979). The provision of consent to participate in research implies that an individual has made a voluntary and informed decision to participate. That is, the decision to participate must be made by a person with the rational as well legal capacity to decide; the person must be adequately informed; and the decision must not be coerced.

The following information must be disclosed to the participant: an explanation of the purpose of the research, anticipated duration of involvement; the procedures involved; potential risks, discomforts, benefits, alternatives; assurances of confidentiality; and identification of whom to contact with questions (ß46.116; Department of Health and Human Services [DHHS], 1991). In addition, participants must understand that participation is voluntary and that refusal will not penalize them in any way and will not result in a loss of benefits (ß46.116). In research on minors, parents' or guardians' permission is required, as well as the child's assent. In other words, both parent and child must be informed of the voluntariness, risks and benefits of participation in a way that is appropriate to the individual's developmental and educational level (ß46.408). Although parents must provide permission, minors have absolute veto power (Tymchuk, 1992).

When is informed consent required, and how may it be sought?

Federal guidelines (ß46.101; DHHS, 1991) stipulate that all research involving human subjects requires informed consent from participants. The exception is research examining normal educational practices such as a comparison of the effectiveness of instructional methods or curriculum techniques. As Judy's research does not fall under the umbrella of educational research, she is not exempt from consent requirements.

Parental consent for minors' participation in research may be sought either actively, whereby parents and guardians are informed of the proposed research procedures and must respond in order for their child to participate, or passively, whereby parents are sent letters describing the research and are to respond only if they do not want their child to participate. It has been argued that passive consent does not respect parental autonomy in that the researcher can never be certain that the parent received the information or that failure to respond reflects an informed agreement to allow the child to participate (Fisher, 1993). Parental permission may be differentiated from child assent, which refers to the child's agreement to participate and protects his or her developing autonomy (Tymchuk, 1992); both permission and assent are necessary in research with minors.

How may the rights of parents and minors conflict?

As the principle of respect for persons requires autonomous decisions about whether to engage in treatment (National Commission, 1979), the requirement of parental permission until age 18 presumes that youth need parental protection because they are not autonomous, or able to make rational decisions on their own. Youths' lack of autonomy may be challenged on two grounds: 1) parents do not always act in the best interests of their children, as is evident in cases of child abuse; and 2) many adolescents are cognitively able to make reasoned decisions (Brooks-Gunn and Rotheram-Borus, 1994). The developmental literature provides a wealth of information about the cognitive capacities of adolescents to consent. Minors below the age of 11 generally do not have the intellectual ability and volition to give informed, voluntary and rational consent; by mid-adolescence, however, teens are able to consider treatment alternatives, risks and benefits, and provide rational and voluntary consent comparable to that of adults (Grisso and Vierling, 1978; Weithorn, 1983; Weithorn and Campbell, 1982).

4. Developmental Factors

How important are developmental factors in decision making? Does Judy's responsibility vary with the age of the participants?

The developmental status of the participants must be carefully considered at least twice in the research plan: first, when planning research and weighing minor vulnerabilities with proposed research protocols; and second, when making decisions about reporting and referring minors who may be in need of assistance. When planning research with children and youth, an investigator's assumptions about development and vulnerability are crucial to the decision-making process. Children do not become less vulnerable in a linear fashion over the course of development; Thompson (1992) has argued that vulnerability differs by domain, and not merely developmental status. In other words, the risks and benefits associated with different domains of research risk must be evaluated according to the age of the child, as children of different ages may not be equally vulnerable to certain risks.

As the process of weighing protocol risks with developmental factors can be quite complex, Thompson (1992) has offered a few developmental guidelines. With increasing age, the self-concept becomes more coherent and integrated. Therefore, threats to self-concept become more stressful; however, the range of coping skills increases as well, permitting greater adaptive functioning in the face of adversity. These developments suggest that although participation in some types of psychological research may be more stressful for teens than children, they may also have developed coping resources to adapt. As children grow older, they are increasingly able to infer the attitudes and motives of others and develop a greater understanding of individual rights, which serves to balance their views of authority, thus making them less susceptible to coercion. With increasing age, youth are able to take a greater responsibility for their own participation in research, suggesting that perhaps they should be afforded a greater role in consent procedures and decisions regarding reporting and referring.

Second, developmental knowledge must be used to assist investigators in making decisions outside the original protocol, as when a researcher discovers that a participant is in jeopardy. Consider Judy's case: Her data are based on surveys and interviews, therefore she is not manipulating variables with the potential to harm children. However, she may learn that a child is in jeopardy. Should her reaction vary depending upon the age of the child? Some experimentation and risk is developmentally appropriate for teenagers, but what about fourth and sixth graders? It is imperative that Judy be aware of the developmental literature and use this literature to make decisions. For example, we know that by age 16, 50-60 percent of youth have engaged in sexual intercourse; the exact percentage varies by sex and ethnicity (Hofferth and Hayes, 1987). If a participant substantially younger (e.g., aged 11-13) reports sexual activity, that may signal special needs and difficulties, which Judy must attend to. If Judy believes that the child may need treatment or intervention, how should she decide what to do?

5. Options for Action

At least four options are available to Judy and other researchers confronted with similar decisions about how to handle minor participants in danger: maintaining confidentiality, reporting, directly intervening and referring the participant to outside sources of assistance (Fisher, Higgins, Rau, Kuther and Belanger, in press).

Maintain confidentiality -- take no action.

When scientists discover that participants are in potential jeopardy, a no-action stance is common. This response reflects a concern for confidentiality as well as a commitment to scientific validity, which may be threatened by humanitarian actions (Fisher et al., in press; Fisher 1993). Taking no action is supported by ethical guidelines that stress maintaining confidentiality of information derived from research in order to protect participants' right to privacy (APA, 1992; DHHS, 1991; National Commission, 1979). Sharing information about minor participants with parents may, at times, have adverse consequences, especially if the parents react to the disclosure with punitive measures. In addition, acting to assist the participant may threaten the internal validity of a study and jeopardize the trust and participation of other participants.

This tension between the investigator's commitment to scientifically valid designs and the humanitarian obligation to protect participant welfare has been referred to as the "scientist-citizen dilemma" (Veatch, 1987). It has been argued that the interests of researchers and participants diverge, as researchers seek to produce scientifically generalizable knowledge rather than participants' well-being (Scott-Jones, 1994). Many investigators do not acknowledge a humanitarian obligation to their participants outside the provision of informed consent.

Reporting

Unlike the guidelines articulated by the federal government (DHHS, 1991) or American Psychological Association (1992), the Society for Research in Child Development (SRCD)'s Ethical Standards for Research with Children support taking action when a researcher encounters information suggesting that a minor is in danger:

When, in the course of research, information comes to the investigator's attention that may jeopardize the child's well-being, the investigator has a responsibility to discuss the information with the parents or guardians and with those expert in the field in order that they may arrange the necessary assistance for the child (SRCD, 1993, p. 339).

In applied research contexts such as Judy's case, where information suggests delinquent behavior, substance abuse or sexual promiscuity on the part of minors, SRCD's professional guidelines (1993) could be interpreted as encouraging Judy to report the problem to adults who could assist the youths. (Fisher et al., in press) In some cases, the investigator's obligation to protect the immediate welfare of participants may outweigh his or her obligation to produce scientifically valid results, thus supporting the reporting of information obtained in research. In addition, federal, state and local laws must be considered in weighing the decision to report information obtained in research, especially in the case of child abuse, where researchers may be mandated reporters. (See Liss, 1994.)

The decision to report information obtained in research must be carefully considered, especially if error is possible. Reporting may have a negative impact upon the youth and his or her family. For example, child abuse carries a negative social stigma and legal consequences (Scott-Jones, 1994). Investigators must recognize that reporting and referring practices may be affected by their own assumptions about participants, especially if participants are members of vulnerable populations, such as low-income minority youth. In fact, increased surveillance rather than a higher rate of occurrence may promote greater reporting in groups considered to be of low status (e.g., low income, minority and single parent families; Scott-Jones, 1994). Without carefully considering the evidence and potential consequences of reporting information, researchers are in danger of over-reporting suspected problems.

Investigator competence is at the forefront of issues to consider in decisions about whether to report research-derived information. In many cases, investigators are trained in research methodology and may not be clinically trained or equipped to assess the extent of participant problems such as child abuse, substance abuse and depression, or to determine whether treatment is necessary. Although the scientists may recognize that their opinions must be taken with the proverbial grain of salt, as they are not clinicians, their reports are likely to be taken quite seriously (Scott-Jones, 1994). Therefore, they should exercise restraint in reporting suspected problems, and in fact, SRCD's ethical principles recognize this danger: "Because the investigator's words many carry unintended weight with parents and children, caution should be exercised on reporting results, making evaluative statements, or giving advice" (SCRD, 1993, p. 339).

In addition, reporting can violate confidentiality, which has long been regarded as the cornerstone of ethical research. If there is potential for reporting , consent and assent procedures must be modified to include this possibility; the obligation to report changes the nature of informed consent and voluntary participation (Scott-Jones, 1994). For example, if the investigator plans to report abuse, then informed consent and assent require a statement to that effect, so that parents and participants are forewarned. This requirement applies to high risk behavior with minor participants as well.

Intervention

Intervention is an option that may be considered by researchers in Judy's position. In this case, Judy would teach the students coping skills relevant to their particular vulnerabilities. For example, students having difficulties with violence would learn skills such as anger management and conflict mediation. There are two problems with this option: 1) This intervention is not appropriate for every problem encountered (e.g., what skills would be taught in cases of sexual promiscuity?); and 2) intervention would create a dual relationship between Judy and the participants. The ethical guidelines of the American Psychological Association (1992) suggest that professionals refrain from entering into multiple relationships, which may impede objectivity and interfere with a professional's duty. If she intervened, Judy would be entering into a therapeutic relationship with her participants, perhaps creating conflicting roles.

Referral

Referrals may be appropriate in cases where an investigator obtains information suggesting that an adolescent research participant would benefit from medical, social or psychological services, but not from the reporting of the risk status to parents or guardians (Fisher et al., in press). The provision of referral information is an attempt to balance the teen's right to confidentiality with his or her need for treatment. In school-based research, students may be referred to sources within the school, such as the school psychologist or counselor, without violating promises to parents, as these sources of assistance are available to all who attend the school. Provision of a blanket referral could be standard procedure in school-based research; for example, all participants could be provided with a list of local sources of help for common problems such as anxiety, substance abuse and risk of pregnancy. Referral information could be provided for services that adolescents can obtain in normal circumstances without parental consent (i.e., contraception and family planning at a local clinic). However, the provision of referral information is sometimes not enough to protect the participant; the researcher's obligations may be extended depending upon the law, the situation at hand and what the he or she deems appropriate.

6. What should Judy do?

Should Judy suspect that an adolescent research participant is having difficulties, she should first consider whether the difficulties are within the range of normative developmental phenomena for the participant's age. In addition, she should interview the youth to see whether concern is warranted. This step is especially important when the information is derived from survey techniques such as depression, anxiety or risk questionnaire inventories. Such indices usually offer a cut-off score to indicate risk. High scores are indicative of risk, but they are not proof, as identification is not perfect (Brooks-Gunn and Rotheram-Borus, 1994). Because the teen has provided assent and the parent consent, Judy should contact the teen directly to determine whether her suspicions have merit.

If Judy's suspicions are confirmed, the teen must be referred for clinical services. Depending upon the problem, that may or may not require disclosure to parents and their consent. Disclosure to parents violates confidentiality, but failure to provide clinical intervention may not be in the child's best interests (Brooks-Gunn and Rotheram-Borus, 1994). For example, a referral without parental disclosure would be appropriate when services are available to teens without parental permission. For example, referral would be appropriate when a teen has a sexually transmitted disease and can obtain services from a local clinic, unless the teen is engaging in abnormally early sexual activity. However, if a teen has a serious or life-threatening problem such as HIV, the parents must be notified regardless of the participant's wishes. Here, the researcher must assist the youth in obtaining treatment because early treatment increases the length of life and must disclose the information to parents in order to facilitate the pursuit of treatment, which is expensive and often requires hospitalization (Brooks-Gunn and Rotheram-Borus, 1994).

Ideally, the researcher should anticipate the need for treatment or intervention and should make provisions for reporting and referring in the initial protocol. In the consent/assent forms, Judy could have included a statement explaining the possibility of discussing any medical or psychological condition with a parent. If such a statement was not included in the consent/assent form, as in Judy's case, then the researcher must discuss the problem and potential solutions with the teen, as well as the advisability of discussing the problem with parents. The investigator is responsible for working with the participant on a plan for seeking treatment. Depending upon the problem, if the teen refuses to tell his or her parents, the researcher must disclose out of her clinical responsibility to ensure participant welfare, unless there is reason to believe that the parent would not act in the teen's best interest.

Other strategies for protecting participants' privacy could be implemented at the assent or data collection stages. For example, the consent form could include a statement that if problems are identified the researcher would contact the teen and discuss it further (Brooks-Gunn and Rotheram-Borus, 1994). At this time, blanket referrals could be made, providing the participant with information about a variety of available services, as indicated earlier. Another possibility is to ask participants directly, during data collection, if they want to talk with someone about a particular problem or current issue (Brooks-Gunn and Rotheram-Borus, 1994). Participants can be informed that parents will not be told of this desire, and then can be referred to resources within the school such as the school counselor or psychologist, who is better equipped to make decisions about the students' welfare. Finally, should a researcher make a decision that is not in the initial protocol, he or she must seek approval from the institutional review board before taking action.

References

American Psychological Association. "Ethical Principles of Psychologists and Code of Conduct." American Psychologist 47 (1992): 1597-1611.
Brooks-Gunn, J., and Rotheram-Borus, M. J. "Rights to Privacy in Research: Adolescents versus Parents." Ethics and Behavior 4 (2; 1994): 109-121.
Department of Health and Human Services (1991). "Protection of Human Subjects." Code of Federal Regulations, Title 45, Part 46, revised 1991.
Fisher, C. B. "Integrating Science and Ethics in Research with High-risk Children and Youth." Society for Research in Child Development: Social Policy Report 7 (4, Winter 1993): 1-26.
Fisher, C. B.; Higgins, A.; Rau, J. M. B.; Kuther, T. L.; and Belanger, S. "Reporting and Referring Research Participants at Risk: Views from Urban Adolescents." Child Development (in press).
Gisso, T. and Vierling, L. "Minors' Consent to Treatment: A Developmental Perspective." Professional Psychology 9 (1978): 412-427.
Hufferth, S. L., and Hayes, C. D. Risking the Future: Adolescent Sexuality, Pregnancy and Child-bearing. Washington, D. C.: National Academy Press, 1987.
Liss, M. B. (1994). "Child Abuse: Is There a Mandate for Researchers to Report?" Ethics and Behavior 4 (2, 1994): 133-146.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects Research." Washington, D. C.: Government Printing Office., 1979.
Nuremberg Code. Journal of the American Medical Association 132 (1949): 1090.
Scott-Jones, D. "Ethical Issues in Reporting and Referring in Research with Low-income Minority Children." Ethics and Behavior 4 (2, 1994): 97-108.
Society for Research in Child Development. "Ethical Standards for Research with Children." In Directory of Members. Ann Arbor: Society for Research in Child Development, 1993, pp. 337-339.
Thompson, R. A. "Developmental Changes in Research Risk and Benefit: A Changing Calculus of Concerns." In B. Stanley and J. E. Sieber , eds. Social Research on Children and Adolescents: Ethical Issues. Newbury Park, Calif.: Sage, 1992, pp. 31-64.
Tymchuk, A. J. "Assent Processes." In B. Stanley and J. E. Sieber, eds. Social Research on Children and Adolescents: Ethical Issues. Newbury Park, Calif.: Sage, 1992, pp. 109-127.
Veatch, R. M. The Patient as Partner. Bloomington: Indiana University Press, 1987.
Weithorn, L. "Children's Capacities to Decide to Participate in Research." IRB: A Review of Human Subjects Research 5 (2, 1983): 1-5.
Weithorn, L. A., and Campbell, S. B. "The Competency of Children and Adolescents to Make Informed Treatment Decisions." Child Development 53 (1982): 1589-159.

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Commentary On

Crashing into Law

Two issues arise in this case. The first is how models should be used. Sven argues that in this case, his model is not being used properly and that it is poor science for Oleson to use the model's output to prove the lawyer's points. The second issue is how an expert witness should present scientific information.

There has been a lot of discussion on what makes a good experiment, including a good experimental design, appropriate use of statistical tools, and honesty in the manner in which data are included or excluded. However, there has not been much discussion of how models should be used. Models are used more and more frequently in engineering and science to examine problems that cannot be examined by direct experimentation. For instance, in this case, it would be impractical to examine crash damage in aircraft by crashing planes of every type in each kind of terrain. This strategy would be prohibitively expensive and dangerous. However, it is important to know how an airplane might come apart in a crash in order to design safer aircraft.

What rules should govern the use of models? How might one go about protecting the interests of science and the public through judicious use of models? Here are few guidelines that I believe most modelers would agree on.

The first guideline is that a model makes appropriate use of underlying scientific principles and works within the limitations of the tools it uses. In mathematical modeling, models that are made up of lots of variables instead of a few underlying principles are sometimes described as able to "fit an elephant." That means that such models can fit every data point but might also be able to fit any other data, such as the shape of an elephant. In modeling, it isn't enough for a model to fit all available data; it should also make sense scientifically. Without scientific validity, one cannot extend a model beyond where it has been tested.

The second guideline is that a model should be validated by experiment. It is not enough that a model has a basis in some scientific principle. It should also be validated by comparing the model's predictions with experimentally measured data. These data should not be the data used as input in designing the model. This guideline can be problematic, since models are generally created to deal with problems that cannot easily be investigated experimentally. However, the more one can prove a model works, the more confidence can be placed in it.

The final guideline is the admission of the limitations of the model. Everyone who creates or uses a model should be aware of its limitations. They should have an understanding of the scientific principles and tools on which the model is based. Without such an awareness, even a good, well-validated model can be used inappropriately.

This case study calls the final guideline into question. Sven believes the limitations of his model make it inappropriate for Oleson's purposes. Sven believes that the model is being used outside its range of applicability. However, in Part 2, Oleson believes in his use of the model. This conflict makes the ethics of the case less obvious. We want to believe that modeling is science, but an element of faith is also involved. Each of the proposed guidelines enhances confidence in a model, but models inevitably contain a degree of uncertainty. In Part 2, the issue is who has a better understanding of the model. It becomes a question of whom we believe -- Sven or Oleson? Did Oleson try to convince himself the model was valid because he wanted it to be valid? Because he had already promised the lawyers that he could deliver, Sven might not have been able to persuade him to reconsider. On the other hand, Sven has less experience in the field and may not understand the limitations of the model as well as his professor.

The second issue in this case is that of the expert witness. In Engineering Ethics, Harris, Pritchard and Rabin present five guidelines for expert testimony:

There should be adequate time for a thorough investigation.
A witness should not accept a case if testimony cannot be presented in good conscience. (He or she should be able to testify honestly, without withholding information.)
The witness should consult extensively with the lawyer to ensure the lawyer is familiar with the technical aspects of the case.
The witness should maintain an objective and unbiased demeanor on the witness stand.
The witness should always be open to new information, even during the course of the trial. (Harris, Pritchard and Rabins, 1995, pp. 203-204)

Guidelines 2 and 5 are called into question in this case. In Part 1, Oleson evidently plans to withhold information on the limitations of the model. Along with the ethical issue of dishonesty, he may be acting foolishly. If the lawyers learn of the inadequacy of the model and question him in court, Oleson may be embarrassed and his professional reputation may be damaged.

In Part 2, Oleson may encounter a problem with Guideline 5. He does not seem to be open to Sven's criticism of the model. Oleson has a possible bias because he wants to keep his commitment to the lawyer that the model could find the source of the damage.

The case also raises the question of Sven's options for expressing his concerns. One option would be to include his assessment of the model's limitations, along with an analysis of its uncertainty, in any writeup. Although a writeup would still be filtered by Oleson, such a report generally goes to lawyers on both sides of a suit and would allow communication of the model's limitations to the lawyers.

This case study raises two separate issues. First is the issue of how a model should be used. Second is the issue of an expert witness's obligation to report the whole truth.

This case can provide an opener into discussing the broader question of scientists' or engineers' obligations in reporting their work, particularly modeling work, to the general public. The discussion can be expanded to include not only the role of expert witnesses, but also the roles of public policy consultants to government agencies or sources in a newspaper article or a TV news program.

References

Harris, C. E., Jr.; Pritchard, M.S.; and Rabins, M.J. Engineering Ethics. Belmont, Calif.: Wadsworth Publishing Co., 1995.

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Commentary On

Counting Sheep: Ethical Protocols in Animal Research

Background: The concept of proper and ethical treatment of research animals

Rules and regulations for animal research are derived from various laws, including the Animal Welfare Act (CFR 1985) (enforced by the Animal and Plant Health Inspection Service, a branch of the USDA); the Public Health Service's Policy on Humane Care and Use of Laboratory Animals (PHS 1996); and any state and local laws that may apply. Guidelines for research protocols are taken from the Guide for the Care and Use of Laboratory Animals, commonly known as "the Guide" (National Research Council 1996). The Guide is a collaborative effort between the Institute of Laboratory Animal Resources, the Commission on Life Sciences and the National Research Council. Institutional committees typically use the Guide as a reference when reviewing research protocols that involve animal use.

An animal care and use protocol (ACUP) is a document that gives the working details and justification for a research project. These details might include the number of animals involved, techniques used during surgical procedures, the names of the people who will be performing procedures, what medications will be administered (i.e., anesthetics, experimental drugs, analgesics), and what form of euthanasia (if appropriate) will be used. In order for a project to proceed, the ACUP must be reviewed and approved by the institutional animal care and use committee (IACUC). Only those approved items listed in the ACUP are allowed, and any changes to the protocol must be authorized before they can be instituted. (National Research Council 1996, pp.10-11)

The investigators, the animal care personnel and the attending veterinarian are encouraged to work together to avoid and deal with problems as they arise. However, allegations of noncompliance with established animal care and use rules at an institution if serious, can warrant an investigation by an IACUC-established Investigative Committee. Anyone can report to the IACUC. The Investigative Committee's response after investigation will depend on the findings of the inquiry and legal and institutional policy that the IACUC is bound by. The IACUC can suspend research, and if the research was supported by PHS funding, the suspension must be reported to the PHS. (National Institutes of Health 1992, D-1 -- D-3)

In recent years, there has been increasing public awareness of animal use in research. This area of the field of bioethics has therefore become more prominent (Baker and Mellor 1993, pp. i-iii) As a consequence, researchers using animal subjects are held to stricter standards today than were common in the past. This increasing accountability of scientists for their actions regarding animal subjects has been achieved in a number of different ways. Reputable research institutions have formed committees that are responsible for overseeing the approval of research protocols (i.e. the IACUC mentioned above). Other factors that have helped improve the lot of research animals include accreditation of animal facilities in order to have common standards of care and housing. Ideally, these changes should have decreased redundancy in animal use (less "waste" of animals). (Novak and Hitleberg 1989, p.14) They also delineated limits on the number and type of procedures that can be performed and called for better standards of living for the subjects. In practice, of course, the ideal is not always realized.

In reviewing bioethics cases, one should keep in mind the difference between what could be considered cases involving basic ethical flaws and those cases in which there may be violations in what would otherwise be thought of as useful, justifiable research. For example, the former could be a situation in which research is not justifiable in terms of its results and has the potential to abuse the animals used. In such cases the basic foundation of the project is flawed. In the case presented here, the research has already been approved; therefore we can assume that the review committee felt that the research was justifiable and the use of the sheep model appropriate. Thus, initially at least, the reader is not asked to make a decision regarding the ethical appropriateness of the research but whether certain ethical issues arise in the course of the research.

The foremost issue that this particular case will raise for most readers involves the ethics of using animals in biomedical research. While this case was not written with the intention of focusing on this aspect of bioethics, it is an important concept and should be addressed. Research on animals is usually conducted under the assumption that pain and suffering in subject animals should be avoided, but that there will be certain cases in which the information that can be gathered from the research will have great positive impact on future directions in human medicine. In these cases most people consider that the research must still take place.

In this case, Mariel is a junior graduate student working on a collaborative project that involves detailed animal surgery. Since she is not a veterinarian, she cannot do the procedures herself; instead, she relies on Jorge Beliz, collaborator and fellow graduate student.

As the case develops, it becomes apparent that Mariel is being placed in a situation in which she will have to choose a course of action. Her primary conflict regards whether she has witnessed a violation of the ACUP by Jorge during the second round of surgeries. The issue is a complicated one that brings up many questions whose answers may not be immediately apparent from the facts presented in the case. Was Jorge in fact responsible for the loss of the sheep? Was the health of the animals before surgery an issue (as Jorge argues)? Was it a combination of Jorge's technique and the condition of the sheep that led to the eventual outcome? Faced with all these points, the reader is asked in the discussion questions to come up with some suggestions for what actions Mariel should take.

The validity of this case rests on the existence of a consensus between the reader and Mariel that there is indeed an issue to be raised about the animal care and use protocol. There is no question that a violation in an ACUP should be brought to the attention of the proper authorities; however, one may rightly ask at what point do you draw the line between a minor incident and a potential ACUP infraction? If Mariel had seen the animal care technician giving the animals a feed intended for goats and not sheep, she would undoubtedly not have been bothered to the extent that she was in this case. Since the differences in the feed type will most likely have few lasting ramifications in the long term, the problem with the feed could be resolved easily, with a note in the animal records and a word to the technicians to be more careful during feeding.

In an ideal world, it may be possible to say that either no infractions in an ACUP would occur, or, if they did, they would all be reported no matter how small. However, we and Mariel live in the real world, where issues such as this one are compounded by the fact that humans have emotions, opinions, preconceived notions and other concerns that affect how we view a scenario. While we are not aware of all the factors that could affect Mariel's course of action, we can consider how she might be affected by such things as desire to be loyal to her colleague, fear of reprisal if she were to blow the whistle on him, the consequences for her project if she were to jeopardize her relationship with Jorge, and the fear that she will be ridiculed for speaking out, given that she is only a beginning graduate student. For this case to be seen as realistic I feel justified in putting forth the notion that there are no cut and dried resolutions to this case (i.e. one might conceivably think that all that Mariel had to do about her problem was to talk to her adviser, but I feel that this is too simplistic a view).

The question then comes back to what actions should Mariel take? Mariel could choose to do nothing and ignore her concerns in the hopes that it was all an isolated incident that will not be repeated. If nothing did happen, then she will be justified. If, however, it should turn out later that she deliberately kept quiet after being witness to something that should have been reported, Mariel could find herself becoming party to the whole incident without meaning to.

Animals have died after the second round of surgery, when none died after the same procedures in the first round. The animals' deaths and the effect this will have on her project upset Mariel. Since she is convinced that she saw something unusual during surgery, Mariel is probably right in deciding that she needs to say something to someone about the whole incident.

Whom should she address first? The logical choice is Jorge, since he is the one directly involved. What happens next may depend on whether Mariel and Jorge can come to an agreement as to what happened during surgery.

Jorge denies that he is responsible for the sheep's deaths; he has come to the conclusion that the sheep were not well enough to survive the surgery because of their cancers. At this point Mariel could ask Jorge why he did not put forth this issue to the group at the time the ACUP was written. Surely it would have been an important point to bring up then. Certainly Jorge as veterinarian in charge was responsible for these types of concerns. Had the group been aware of his concerns then, they might have hesitated to put the ACUP up for approval by the IACUC. Is Jorge telling the truth? Why did no sheep die in the first round of surgeries? Does Jorge have an explanation for the discrepancy between the first and second round of procedures?

Suppose that Jorge thinks about what Mariel has said, and then acknowledges that perhaps it was simply because he was tired and rushed during the second round that he did not follow his meticulous technique used in the first round. At this point, the two students have reached an accord, and resolution can follow. They can go and talk to Carroll together about what happened and discuss how to prevent it from happening again. Carroll may know what steps to take next, how to report to the IACUC if necessary, or bring in another surgeon, or even find some other way to lessen Jorge's load so that he is not so tired and busy. The case as it stands in this scenario is resolved in a fairly simple manner.

Consider an alternate situation, in which Jorge is adamant that he is not at fault. Mariel suspects that Jorge did not in fact follow the same techniques in the first and second rounds. She feels that it was these differences that affected the survival of the second group of sheep and not the fact that they had cancer. Here she and Jorge cannot reach a consensus, and it is her word against his. In this case Mariel will probably need to discuss the issue with Carroll alone. She will need to point out her concerns that the ACUP was not followed, and that Jorge may be jeopardizing her project by his actions. Carroll is in a better position than Mariel to take the situation in hand, having the advantage of seniority, and probably more experience with this type of situation.

In Part 3, the reader is asked to consider how the situation changes if the affected sheep do not in fact die, but appear to be exhibiting signs of distress and discomfort after surgery. While no animals have died, potential animal suffering is a very serious issue. At this point, Mariel should really defer to the attending veterinarian, who should examine the animals to see whether the cause of discomfort can be ascertained. If the veterinarian feels that the animals are exhibiting symptoms of post-operative distress within the range of what is to be expected after the major surgery they have had, then administration of analgesics is probably the first course of action. Use of analgesia is an appropriate and important part of a research protocol and at the time the ACUP was written, the drugs of choice should have been stipulated (note that in special circumstances, the IACUC could grant an exemption to a research project in which the analgesics would interfere with the outcome of the study). After receiving the medication, the sheep should be watched carefully to see whether their condition improves. If the sheep recover, the project can probably continue, provided that the events were properly recorded. The researchers may want to address this issue and see if it can be avoided in the future. They may wish to examine matters such as their pre-operative care or surgical technique in an effort to reduce the chances of causing suffering in the animals after surgery.

If, on the other hand, some or all of the sheep do not improve after the administration of analgesics, then the research team may choose to have more diagnostics run on the animals to see whether further treatments could be administered to help the animals. If additional veterinary care fails to relieve the distress, then the team may have to consider euthanasia for the sheep. While the decision to euthanize the animals may be a troubling one, in the sense that in a research project such as this one the death of one animal can mean tremendous loss of data, it is unreasonable to keep the animals alive if they cannot at least be comfortable. Again, on occasion, certain research is exempted from this premise if it can be justified. Unless the team's ACUP was approved for such an exemption by the IACUC, then euthanasia is probably the only humane recourse left. While Mariel may attempt to weigh the issues of animal well-being versus the importance of the information the animal(s) can provide, it would be inappropriate for the final decision to be left to her. These types of decisions are left to the IACUC. It is up to the reviewers to determine what is justifiable and what is not. In reality, an ACUP would probably need to include information relevant to a situation such as the one described (i.e. what endpoints are reasonable, under what circumstances the animals would be euthanized, what means of euthanasia would be used).

A final point to ponder when faced with the euthanasia option is to consider how much useful data the animals can realistically be expected to provide the research team given that they are in discomfort. The distress is a manifestation of the animal(s) altered physiology, which could mean that any data collected from animals in this state might not be a true reflection of the condition the researchers are studying. In the long-term ignoring this point could lead to publication of inaccurate data, which could in turn have serious ramifications for future research in disease treatment and pharmaceutics.

When Mariel has taken action leading to one of these resolutions, we can discuss some of the subsidiary issues in more detail. Take the issue of collaboration. Jorge, Mariel and Carroll are collaborators who all stand to gain from this project. All have a responsibility to make this effort successful. How seriously should they take this responsibility? In the case presented here, it is apparent that Jorge's research can continue even in the event of the sheep's deaths since he only needs tissue samples. On the other hand, Mariel's work requires not only that the animals survive but also that the surgery be done correctly.

If Jorge truly is being negligent, then he is being a poor scientist in many ways. He is violating an ACUP as well as being a selfish collaborator who places his work and career above those of others. This is unethical conduct for someone who should be setting a positive example for his junior colleague. The final issue returns to the point that Jorge makes about the sheep being unfit to survive surgery. If this is something that he only realized after operating on the sheep, then he cannot be blamed for not mentioning it during the writing of the ACUP. However, at this point he should be making provisions for submitting a change in protocol to the IACUC. It is unacceptable to continue doing surgery in the knowledge that the animals will suffer and die as a result so that the only information the surgeries will provide is data that could be derived in other ways less harmful to the animals such as biopsies. Carroll and Mariel should support these changes, even if the project will be delayed or the scope of the research narrowed as a result. The ACUPs were written to make researchers more responsible for their actions, and should be seen not as a hindrance but an advance in scientific integrity.

References

Baker, R.M.; Jenkin, G.; and Mellor, D.J. Mellor, eds. Improving the Well-being of Animals in the Research Environment. Conference Proceedings, Sydney, October, 1993. Glen Osmond, SA, Australia: ANZCCART, 1994.
CFR (Code of Federal Regulations). Title 9 (Animals and Animal Products), Subchapter A (Animal Welfare). Washington, D.C.: Office of the Federal Register, 1985.
National Institutes of Health. Institutional Animal Care and Use Committee Guidebook. NIH Publication No. 92-3415., 1992.
National Research Council. Guide for the Care and Use of Laboratory Animals, 7th ed. Washington D.C.: National Academic Press, 1996.
Novak, G. R., and Hitleberg, R., eds. Principles of Proper Laboratory Animal Use in Research. Silver Springs, Md.: MTM Associcates, Inc., 1989.
Public Health Service. Policy on Humane Care and Use of Laboratory Animals. Washington, D.C.: U.S. Department of Health and Human Services, 1996.

References

American Nurses' Association, Code for Nurses With Interpretive Statements. Kansas City, Mo.: American Nurses' Association, 1985.
Lennane, J. K. "Whistleblowing: A Health Issue." British Medical Journal 307 (1993): 667-70.
Whistleblowing. Video production through the University of Illinois at Chicago, College of Nursing, 1988.
Witt, P. Personal communication, May 26 and June 1, 1996.
Witt, P. "Notes of a Whistleblower." American Journal of Nursing 83 (1983): 1649-1651.
Zorn, E. "Whistle-blower Saved Lives, Lost Everything Else." Chicago Tribune, June 21, 1987, pp. 1, 2.

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Commentary On

Beyond Expertise: One Person's Science, Another Person's Policy

Reams is faced with the decision of whether or not to participate in a regulatory decision-making process. In Part 1, she is invited to participate but refuses to move beyond her role as researcher. However, she is drawn into the controversy because 1) the regulatory decisions are justified based on her research and 2) she is dissatisfied with the final outcome of the decision and feels that the new regulations do not accurately represent her experimental results.

It is important to ask why Reams is wary of stepping outside of her role as researcher. This question attempts to probe ideas about the perceived role of a scientist. She claims that her knowledge is limited and insufficient for the nature of the decision required. Yet, her knowledge of the chemistry of jeckylhydium is likely to be greater than that of any of the EPA's decision makers. Perhaps she is reacting to the idea that it is unprofessional or even unethical to be both a provider of knowledge and an advocate of how to apply it, especially in a situation where one cannot predict with certainty the outcome of various hypothetical scenarios. While science is fundamentally descriptive and necessary in order to define the ethical issues, ethics is prescriptive (Brown, 1987). To engage politically is to exert power, while the objective of scientific research is to pursue knowledge or truth. As a provider of descriptive knowledge, Reams has met her responsibilities as well as may be expected in her role as researcher.

Does Reams have a responsibility to represent her experimental work as it applies to regulatory problems? Her wariness about participation in drafting regulations may stem from the idea that the strength of scientific inquiry comes from its objectivity and a "value-free" context. As a scientist, Reams is trained to apply strict standards for drawing inferences from facts. However, regulatory and public policy decisions often require decision making without the luxury of complete or conclusive data. If a researcher takes a political stand on a scientifically based issue, there may be the appearance of compromised objectivity. And for a scientist, objectivity is closely related to integrity. Yet Reams is studying the fundamental behavior of a metal that has economic and environmental impacts. In fact, the importance of jeckylhydium may be the reason for the availability of funding for the research. Her interest in this metal is not entirely distinct from its significance.

Who is Reams working for? If her research is funded by governmental agencies then perhaps she does have responsibility to participate in solving the broader regulatory problem. She has succeeded in obtaining research support by suggesting that results from her research may be used to address problems of jeckylhydium pollution and remediation strategies. Her experimental work is implicitly applied research even if it is not explicitly defined as such. In a sense, her discovery of jeckylhydium transformations pushed her basic research efforts into the context of applied research because of the urgency for application. Reams may have to step back and ask a more philosophical question, i.e., who is this science for? If she does scientific research with the hope and intent of making some kind of social contribution, then perhaps she should honor that desire and make a commitment to contributing at the policy level.

In Part 2, Reams agrees to participate in the regulatory decision-making process, but despite her input in the process, she is not satisfied with the results. She is not happy with the final decision to regulate total jeckylhydium in an all or nothing fashion. Dotterer (1929) drew a distinction between a "world-view" and a "life-view," which makes a nice analogy for the use of scientific information in making regulatory policy for jeckylhydium. He defined "world-view" as a description of the facts of a situation and "life-view" or "life-plan" as a blueprint or a plan of action. He argued that the best chance for an effective or successful life-plan comes from adherence to the most accurate world-view. These ideas are metaphors for science and for the application of science to policy. Reams is dissatisfied with the life-plan or regulatory policy for jeckylhydium because the world-view or scientific foundation is based on simplistic assumptions and incomplete knowledge. In the realm of scientific research, generalizations and simplifications are inaccuracies that weaken the foundations of understanding. However, is that also true when science is incorporated into policy? Is simplification necessarily a form of error? And since the regulations are motivated by the need to reduce risk to innocent people, is a less stringent standard appropriate?

According to Brown (1987), research analysts tend to look at problems from within their own discipline. For example, those who study nuclear power look at risk of failure, not at issues of proliferation, theft, sabotage, routine emission, etc. It is important to ask whether Reams is limited by thinking solely from within the confines of her discipline. She may not be seeing the other factors that press into the decision calculus. On the other hand, Reams may be witnessing a compromise of scientific integrity that will ultimately weaken the life-plan of the regulatory policy itself.

Reams has shared her knowledge as a participant in the policy forum, but she remains dissatisfied with the outcome. She is a jeckylhydium expert, a citizen, and a scientist upholding the values of "good science." And now she decide whether to take further action to promote what she sees as more accurate and appropriate use of her research. Reams's motives would be questionable if insisting on rigorous standards of "good science" resulted in policy that did not serve to protect innocent people from risk. However, it appears that she is trying to optimize both good science and good policy -- not one or the other. Perhaps this situation is drawing her into a new role as "applied scientist." That is a significant departure from basic research and probably more akin to engineering.

References

Brown, D. A. "Ethics, Science, and Environmental Regulation." Environmental Ethics 9 (1987): 331-350.
Dotterer, R. H. Philosophy By Way of the Sciences. New York: MacMillan, 1929.

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Commentary On

Barking Up the Wrong Tree? Industry Funding of Academic Research

The underlying issue in this case study is the conflict of interest that arises from the impact of private industry funding on Katz's behavior as an academic researcher. The basis for this conflict of interest, as described by Pritchard (1996), is the influence that one position (affiliation with private industry) has on another position (a scientist's behavior and judgment). This case is presented from the perspective of a graduate student to illustrate some of the problems conflict of interest can create for students and to generate discussion about some of the less commonly considered aspects of conflict of interest.

Discussions of conflict of interest typically address issues of data falsification or bias and financial gain rather than influences on experimental design or, in this case, selection of experiments. Whereas falsification or bias of data can be discovered by duplication of experiments, it is more difficult to detect the influence conflict of interest may have on experimental design.

Some university researchers have turned to private industry as a funding source because availability of funds from many government sources has decreased and competition for remaining funds has correspondingly increased. Industry stands to benefit from such funding arrangements in that research conducted by academic institutions is generally perceived by the public as more objective than similar work performed by consultants or done in-house. It may also be less expensive for industry to fund universities than to hire consultants. Whether or not industry expects recipients of funds to have the allegiance expected of hired consultants, a researcher's perception of such expectations could affect his or her objectivity.

Conflict of interest is not obvious in this case. Had it not been for Katz's comment to the post-doc, it would appear that Nellie's proposed work would deviate from that of the lab and possibly from Katz's area of expertise. Thus, the primary problem would arise from Nellie's work being inappropriate for Katz's lab. However, in addition to his comment to the post-doc, Katz's conflict of interest is made apparent by his suggestion that Nellie evaluate effects of water temperature in addition to those of TTT (Scenario 1). By including elevated water temperature (a potential problem not associated with the chemical industry) and excluding DPP (which is associated with the chemical industry) from Nellie's study, Katz shows a bias in favor of the study of factors that could vindicate (or at least not implicate) the chemical industry in the decline of fish species. If indeed funding has been designated solely for research involving TTT, Katz could be considered to have misused funds by having Nellie evaluate the effects of water temperature (Scenario 1) and having other students work on compounds other than TTT (Scenario 2). Thus, rather than misusing funds for research involving compounds or factors other than TTT, Katz's choice of what to study appears to be influenced by his concern for the interests of the chemical consortium. Concerns of this nature would be expected of consultants hired by the chemical consortium, but they are not generally expected of university-based researchers.

None of the information provided in this case indicates that the chemical consortium expects the research conducted by Katz's lab to be less than totally objective. However, because the lab's primary source of funding is the chemical consortium and funding is renewed annually, Katz's concern about continued funding is understandable. Perhaps he can justify denying Nellie funding to evaluate DPP because he has been able to support the majority of his lab's research without any such conflicts. Thus, one could rationalize that much more good than bad has resulted from the chemical consortium funding.

The funding arrangement with the chemical consortium is lucrative, as indicated by Katz's well-equipped lab, which can make it difficult for Katz to be objective about the potential for conflicts of interest. Because of the financial advantages offered by industrial funding, it's important for academic institutions to establish an external (nondepartmental) review system to evaluate appropriateness of funding. Requiring longer-term funding arrangements (perhaps three to five years) would also provide increased financial stability and perhaps lessen perceived pressures.

Secondary issues in this case include Katz's responsibilities to his student Nellie and her responsibilities to Katz, as well as the general responsibilities of scientists. As this case is written, Katz has allowed Nellie to get into a difficult situation. Regardless of what she does, she loses either her enjoyment of science, her integrity or her funding. Perhaps by restricting her choice of dissertation topics, Katz could have avoided many of the problems presented in this case. However, it seems inevitable that at some point, a seemingly uncontroversial topic would take on a direction that could be perceived as being potentially deleterious to members of the chemical consortium.

In addition to being contrary to basic principles of science, a significant concern, particularly over the long term, is the potential effect of Katz's biased behavior on public perception of science. Blumenthal (1996) describes the importance of public trust to the scientific enterprise. Similarly, Frankel (1996) writes that the public perceives and characterizes present-day science as objective and disinterested. Actions of scientists that undermine these principles and perceptions could result in loss of public trust and ultimately diminished government funding.

Environmental concerns are another issue in this case. The potential loss of species is a significant concern, perhaps a greater concern than obtaining a degree or renewed funding. If indeed DPP is adversely affecting native fish, and based on information in the case, it is incumbent on Nellie (as well as upon Katz) to express her concerns about DPP to someone who can (or will) do the necessary research.

Environmental concerns could well take precedence over any others. Nellie could change schools or live her life without an advanced degree; Katz could find other funding if the chemical consortium opted to discontinue his funding; and lab employees could find other jobs. Once gone, however, a species cannot be recreated.

References

Blumenthal, D. "Ethics Issues in Academic-Industry Relationships in the Life Sciences: The Continuing Debate." Academic Medicine 71 (1996; 12): 1291-1296.
Frankel, M. "Perception, Reality, and the Political Context of Conflict of Interest in University-Industry Relationships." Academic Medicine 71 (1996; 12): 1297-1304.
Pritchard, M. S. "Conflicts of Interest: Conceptual and Normative Issues." Academic Medicine 71 (12; 1996): 1305-1313.

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Commentary On

Bad Chemistry

Disciplinary Action

Criteria for Authorship

Favoritism and Prejudice Regarding Career Goals

Faculty Members' Responsibilities

This case is intended to foster discussion of some important ethical (and procedural) issues that affect the workings of a graduate research group. As such, it is intended primarily for use in discussions with graduate students or post-docs and their supervisors/professors. The main issues it attempts to present include disciplinary action within a research group, criteria for authorship, favoritism and prejudices regarding career goals, and finally, faculty members' responsibilities to state clear expectations and to foster collegiality among the members of their working groups.

Disciplinary Action

The first question is intended simply to begin a discussion as much as to raise the issue of disciplinary action. Most (if not all) students in research groups have encountered situations in which an explicit or implied rule has been violated or some other perceived "wrong" has been committed. In these situations, the immediate authority is obviously the professor in charge of the research group. What can a research adviser do in a case like this one? The leader of a discussion might ask the participants for two extremes in level of response appropriate for Imhof. The most severe extreme will probably involve something along the lines of kicking Jones out of his research group, or even expulsion from the university. While this action might be appropriate for some infractions (fabrication of data, sabotage, etc.), it would seem to be quite severe for this case. The other extreme would, of course, have Imhof taking no action at all.

It is made clear in the story that Jones is the person Michaels wants to see punished. An interesting question that may come up in discussion concerns Perry's level of wrongdoing. He may seem less guilty than Jones, if only because he is the "new guy" and might not understand the norms of group research. However, he has contributed in a very real way to the situation that has angered Michaels.

Criteria for Authorship

This topic is frequently discussed in research ethics and is not intended to be the centerpiece of discussion in this case. However, it is an issue that will face almost every participant in scientific research at some time and as such is an appropriate lead-in to other points in this case study.

Criteria for authorship, at least within the scientific community, are not spelled out by any universal governing body such as the American Chemical Society. Questions that are often considered when determining authorship include, but are not limited to, who actually writes the manuscript, who performs the experiments and who conceives the idea or makes significant intellectual contributions toward its fruition.

In the present case, Michaels originally conceived the idea in question. Therein lies his claim to authorship and the basis for his complaint against Jones. During discussion of the case, Michaels' request for authorship will be addressed. Since Michaels has not yet performed any actual experiments related to his idea, it is unlikely that all participants in the discussion will entirely agree with his position. However, most will probably feel that he has some right to credit for his idea. How much credit is really the question. Again here, asking participants in the discussion to propose two extremes in the amount of credit Michaels should receive might be helpful to the discussion. The extremes would range from sole authorship of the paper to no credit at all. Between these extremes, a consensus might be found; such a consensus may involve including Michaels as a co-author or mentioning him in the acknowledgments section of the paper.

A slightly more subtle point that stems from this discussion concerns the ways in which credit for intellectual contributions to group projects might be rewarded, other than by co-authorship on a paper. One possibility is the all-important letter of recommendation a professor writes for a student or post-doc at the completion of his or her time in the group. In this case, Imhof clearly does not think a lot of Michaels as a researcher. Thus, this avenue for receiving credit is not likely to be available to him. The reasons this situation has come about relate directly to the fundamental issues this case study is intended to address.

Favoritism and Prejudice Regarding Career Goals

The problem of favoritism by professors who head research groups, either real or imagined, is common enough that most graduate students will be exposed to it, either personally or by hearing someone else complain about it. Favoritism can occur for many reasons, and it is usually quite destructive to the group atmosphere. This case spotlights one common source of favoritism in the academic research setting.

Students choose to attend graduate school with various career goals in mind. These goals can include industrial employment, employment as a professor at an academic institution emphasizing research, or professorship at a (usually smaller) teaching-centered college or university. It is unfortunately common for professors at graduate institutions, who have achieved their stature in large part by dogged pursuit of research results, to think less of graduate students who wish to gain a Ph.D. under their direction but ultimately seek careers that emphasize teaching rather than research.

The third discussion question is intended to begin a discussion on this topic. Clearly, Imhof regards teaching as much less important than research, as seen in his response to Michaels at the end of the narrative. Michaels will end up angry, probably bitter, and without his name on a paper describing his idea in large part because of Imhof's attitude and, apparently, the fact that he allows his personal attitudes to affect his treatment of his students.

This part of the discussion is intended to move toward a professor's ethical responsibility to treat all the members of his or her group without prejudice, and the basic right held by members of a research group to be treated fairly and equally as long as they follow group rules and behave in a collegial fashion.

Faculty Members' Responsibilities

The final discussion question regarding what Professor Imhof could have done differently is intended to bring the discussion around to the main point of this case study; that is, the responsibilities of professors who head research groups. One likely response to the question will involve Imhof's failure to foster cooperation and collegiality among members of the group. The animosity between Jones and Michaels is clear in the story. This level of animosity poisons the work environment. Suggestions as to ways Imhof could have avoided this situation might include holding closed-door meetings with the "warring factions," conflict mediation and the like. Collegiality is expected within the scientific community. Major professors in science are ethically responsible for educating student under their direction in such basic principles. It is a vital part of the training to which graduate students are entitled.

The question might arise of whether Professor Imhof was even aware of the animosity. That is a good question, and in fact points to another common problem in research groups: ignorance on the part of a major professor regarding relations and personal difficulties between members of his or her research group. When the new student, Perry, is effectively assigned to a project not by Imhof but rather by another student, Jones, that suggests that Imhof is not adequately involved in the day-to-day functioning of his group.

It is hoped that the discussion will also consider the topic of rules and standards within a research group. One way to lead the discussion in this direction might be to ask the questions, "How will the students in the group know which names should go on the paper?" and "Why is there a conflict here?" If Imhof were to set forth clear guidelines for authorship, the answer to the first part of this question would be clear.

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Confidentiality Concerns

This case raises important issues dealing primarily with confidentiality and the student-mentor relationship. Maxwell has obviously abused his position by breaking the code of confidentiality imposed both by the department's stated guidelines and by the unstated expectations of a mentor. In addition, Maxwell involved Bernhard in an ethical dilemma. Maxwell's position as faculty member and mentor gives him considerable power over Schmidt and Bernhard, power he has abused. Beyond Maxwell's obviously wrong actions, the course of action to be taken by Bernhard, Schmidt and Schmidt's adviser is not as clear. All three are faced with the competing demands of loyalty and the need to stop Maxwell's inappropriate behavior.

Question 1 addresses a faculty member's responsibility to mentor graduate students. In this case, Maxwell breaches the responsibility of trust and respect for Schmidt. Maxwell's history of passing along confidential information is setting a bad example for Bernhard and the other graduate students in the department.

Question 2 investigates Bernhard's responsibilities in this case. Bernhard is pulled between his loyalty for Maxwell and his friendship with Schmidt. If Maxwell often tells Bernhard confidential departmental information, Bernhard has three reasonable choices: 1) He can keep the information to himself. 2) He can tell Maxwell that he isn't comfortable hearing the information and ask him to quit confiding in him. 3) He can report Maxwell's behavior to the department head or someone else in the department. Because of the power disparity and the control that Maxwell has over Bernhard's passing or failing the exam, Bernhard is placed in a difficult situation. Choices 2 and 3 may hurt his standing as a graduate student in the department; however, if Bernhard keeps quiet, Maxwell could go on mistreating other graduate students. Based on principle alone, Bernhard should choose either Choice 2 or 3. The potential of the information to cause harm would have to be the deciding factor between Choices 2 and 3. Had Bernhard chosen Choice 1 and refrained from passing on any information that he heard from Maxwell, he could have avoided putting himself into this dilemma, but he would not have been fulfilling his responsibilities to future graduate students. However, Bernhard didn't make any of these choices; therefore, he made a bad decision.

Question 3 focuses on Schmidt's conflict between her promise to Bernhard and her feeling of anger about the confidentiality breach. Schmidt must worry not only about possible consequences to her own graduate career but to Bernhard's career as well. She could be putting Bernhard into a bad situation with Maxwell, as Question 2 explores. She faces the same choices as Bernhard in that she has the ability to prevent further breaches of confidentiality. An interesting question here is whether Schmidt should tell her adviser before or after the exam results are announced. If Schmidt tells him before the announcement, she could potentially place the adviser in a situation where the appearance of conflict of interest occurs. Obviously, the adviser would like Schmidt to pass the exam; any interference on his part with Maxwell could be construed as trying to influence the exam results.

Once Schmidt has told Campbell, he must decide what to do. In the case, he chooses to dismiss the incident entirely. He might choose this course of action for several reasons: He may not see anything wrong with what Maxwell has done, or he may be worried about stirring up animosity before Maxwell decides to pass Schmidt. If the latter is the case, then he should explain his reasoning to Schmidt, and they should decide together whether they should take action after the exam results are announced. If Schmidt has asked him not to tell anyone, he will need to be creative to come up with a solution. He might bring up the issue of confidentiality in general at a faculty meeting or during the next year's exams. Or he may wait until both Schmidt and Bernhard have graduated to mention the issue to Maxwell. If he confronts Maxwell, Maxwell may deny the incident.

While it may be in the best interests of Bernhard and Schmidt to let the whole incident blow over, the integrity of the departmental exam process is at stake. Schmidt's adviser must try to find a way to address this issue without hurting the graduate students' interests if they choose to remain anonymous.

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Questions 1-3

Questions 4-5

Questions 6-8

References

Further Considerations

Precedents

Conclusion

References

Suggested Readings

Whistle-blowing

Student-Mentor Relationship

References

Question 1

Question 2

Question 3

Question 4

Question 5

Question 6

Question 7

Support for Fabio's Perspective

Support for Edgar's Position

Legal and Ethical Considerations

Initial Discussion

Additional Discussion

Ethical Milestones and Judgment

References

References

Background

Questions 1-3

References

1. Researcher Obligations

Who are the interested parties? What are Judy's responsibilities to each? How might each conflict?

2. The Role of Informed Consent

What is informed consent?

When is informed consent required, and how may it be sought?

How may the rights of parents and minors conflict?

4. Developmental Factors

How important are developmental factors in decision making? Does Judy's responsibility vary with the age of the participants?

5. Options for Action

Maintain confidentiality -- take no action.

Reporting

Intervention

Referral

6. What should Judy do?

References

References

Background: The concept of proper and ethical treatment of research animals

References

Suggested Reading

References

References

References

Disciplinary Action

Criteria for Authorship

Favoritism and Prejudice Regarding Career Goals

Faculty Members' Responsibilities