Anonymous

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.

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.

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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.

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. 

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.

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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).

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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?

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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.

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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.

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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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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:

1. There should be adequate time for a thorough investigation.
2. 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.)
3. The witness should consult extensively with the lawyer to ensure the lawyer is familiar with the technical aspects of the case.
4. The witness should maintain an objective and unbiased demeanor on the witness stand.
5. 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.

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References

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

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.

Suggested Reading

• Francione, G. L. Animals, Property and the Law. Philadelphia: Temple University Press, 199
• Hecker, J. F. The Sheep as an Experimental Animal. London: Academic Press, 1983.
• IACUCs and the Ethics of Animal Research: A Conference on Institutional Animal Care and Use Committees. Boston: Responsibility in Medicine and Research, 1985.
• Mitruka, B. M.; Raunsley, H. M.; Vadehra, D. V., eds. Animals for Medical Research: Models for the Study of Human Disease. New York: Wiley & Sons, 1976.
• Mukerjee, M. Profile: Jan Moor-Jankowski, a Whistle-blower's Wars. Scientific American 277(1997; 3): 32-33. (Recent case concerning violations of the Animal Welfare Act).
• Penslar, R. L., ed. Research Ethics: Cases and Materials. Bloomington: Indiana University Press, 1995.

For the purposes of this case, "whistleblower" refers to any employee who reports unethical, illegal or incompetent acts to appropriate agencies outside the employer's facility. On the basis of this definition, the decision to blow the whistle to external authorities is a potentially risky endeavor fraught with moral conflicts and professional and personal risks. In reflecting upon when and how to report violations, many questions arise: Will the potential benefit outweigh the possible harms? Who can be trusted? Will confidentiality be maintained so that the whistleblower is protected against retaliation? What is the likelihood that change will occur if the person goes public? Will professional associations stand behind whistleblowers when they follow through on their professional obligations to exhaust all internal mechanisms before blowing the whistle?

As Jan's situation and other whistleblowing cases demonstrate, there are no definitive answers to whether a given act results in the desired outcome until the consequences of the action can be evaluated. Hindsight is often credited with 20-20 vision, but in reality it may or may not provide the insights necessary to protect the public welfare or future whistleblowers from retaliation. I will argue that the nursing profession (and other so-called helping professions) must re-evaluate the paradigm that currently underlies the profession's goals, values and ethics. I suggest that unless the paradigm shifts to include the care giver as a recipient of the same ethic of care, then current codes of professional ethics and statutory protections for the whistleblower will fail to provide the comprehensive protection needed for professionals and the clients they serve.

Jan did deliberate on the correct ethical and legal questions and opted to act upon her professional obligations -- obligations that are grounded in the Nurse Practice Act, standards of care and the profession's code of ethics. The Code for Nurses (American Nurses' Association 1985) explicates the values and goals of the profession and provides a framework to guide the nurse's ethical deliberations and actions. The notion that the nurse acts as a client advocate is a pervasive theme throughout the code and is a core element of nursing education. According to the code, nurses as client advocates act "to safeguard the client and the public when health care and safety are affected by incompetent, unethical, or illegal practices by any person." (ANA 1985, p. 6) The ANA expands on this guideline to include specific recommendations for appropriate action:

1. Express concerns about inappropriate or questionable practices to the person carrying out the practice and attention called to the detrimental effect such practices have on client welfare.
2. When factors in the health care delivery systems threaten the welfare of the client, similar action should be directed to the responsible administrative person. If indicated, the practice should then be reported to the appropriate authority within the institution, agency or larger system.
3. There should be an established process for reporting and handling of incompetent, unethical or illegal practice within the employment setting so that such reporting can go through official channels without causing fear of reprisal.
4. Written documentation of the observed practices or behaviors must be available to the appropriate authorities.
5. State nurses associations should be prepared to provide assistance and support in the development and evaluation of such processes and in reporting procedures.
6. When incompetent, unethical or illegal practice on the part of anyone concerned with the client's care is not corrected within the employment setting and continues to jeopardize the client's welfare and safety, the problem should be reported to other appropriate authorities such as practice committees of the pertinent professional organizations or the legally constituted bodies concerned with licensing of specific categories of health workers or professional practitioners. Some situations may warrant the concern and involvement of all such groups. (ANA, 1985, 6).

The code specifies that if internal mechanisms are followed and change does not occur, then the nurse may need to go outside the institution to protect the welfare and safety of clients.

Jan followed the ethical and legal guidelines of her profession. So what went wrong? The same thing that went wrong when the Thiokol engineers blew the whistle on the Challenger explosion. The same thing that can go wrong when any professional who follows their codes of ethics. If the organization views whistleblowers as trouble makers who should be punished for violating organizational norms of silence, then no professional code of ethics is adequate to protect whistleblower from retaliation. Furthermore, even the most comprehensive legislation is inadequate to protect whistleblower from personal and professional risks if the ethical milieu of the organization does not assist and reward employees for reporting unethical or illegal behavior. Even when structural mechanisms are in place (e.g., ethics committees, misconduct committees, IRBs), the political structure and power dynamics of corrupt organizations may find a way around these safeguards.

Jan's case is an exemplar of the way altruistic professions, such as nursing, are caught in a Catch 22. Nurses are taught that it is their professional obligation to act as client advocates. An ethic of care is one of the profession's most cherished values, if not its highest moral ideal. It seems that something is fundamentally wrong when we teach students in health-related fields the value of caring for others but neglect to teach them how to care for themselves as professionals. It is a no-win situation for the client and the nurse. Within the current system, a nurse who is committed to maintaining her professional integrity within an organization that refuses to change its unethical or illegal behaviors has limited options, most of which entail high stakes for the nurse, both personally and professionally.

Lennane (1993) conducted a survey of whistleblowers from various occupations who had exposed corruption or danger to the public. All subjects (N=35) in this nonrandom sample suffered adverse consequences. For 20 of the subjects, victimization started after the first internal complaint. Retaliation took many forms including dismissal, demotion, resignation or early retirement due to illnesses associated with victimization. Twenty-nine subjects had stress-related symptoms, 15 were started on long-term treatment with medication, 17 considered suicide, 30 reported adverse effects on their children, and almost half subjects reported reductions in income of 75 percent. One could raise questions about the generalizability of these findings. However, when one reviews the literature on whistleblowers and attends to the actual stories of whistleblowers, Lennane's observations and conclusions are, more often than not, supported. Lennane concludes, "Although whistleblowing is important in protecting society, the typical organizational response, causes severe and long lasting health, financial, and personal problems for whistleblowers and their families." (Lennane 1993, 667)

Ethical decision making among professionals in health care and the scientific community is about ethical principles and scientific integrity as much as it is about politics and power. Ethical theory and professional codes of ethics will remain abstract entities unrelated to real-life situations until we acknowledge that inequities of power and status in the hierarchy of systems have a profound impact on individuals who witness misconduct and not only want to protect the public, but deserve to be protected from professional and personal retaliation.

The nursing profession is particularly vulnerable to retaliation if misconduct is reported. In a predominantly female profession, employed primarily in hospital settings where they are paid by the institution, nurses have a variety of potentially conflicting loyalties: to the patient, the physician, the institution, to society at large, and (let us not forget) to self. When unethical or illegal conduct is reported through appropriate channels and nothing is done, the nurse is forced to choose between ignoring the situation and doing nothing, or ultimately finding it necessary to hire an attorney for legal representation. How many nurses are willing to take this risk, given their economic situation? Jan ended up having to act in isolation because she could not rally any of her nursing colleagues to stand with her.

Nothing less than a paradigm shift is needed to protect the public welfare and safety, as well as the welfare and safety of nurse professionals. The preparation and socialization of health care personnel must allow them to maintain their professional and moral integrity and also enable them to report colleagues' unethical, illegal or incompetent behavior. The public has entrusted its faith and its economic resources in health care professionals, who should be able to act in the best interests of the public without fear of retaliation.

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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.

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.

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. 

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.

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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.

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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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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.