Counting Sheep: Ethical Protocols in Animal Research

Parts 1 and 2

Preventive Ethics

Dealing With the Actual Situation

Part 3

Parts 1 and 2

Mariel and Jorge are graduate student research colleagues. Paid on the same grant, they share the same animal subjects for their research work, but they are working on different research projects. It is important to note the unequal relationship between Mariel and Jorge: Mariel is a first year graduate student with no advanced degrees while Jorge, already a veterinarian, is nearing the end of his Ph.D. program. Thus, the two students differ in graduate experience as well as recognized expertise in veterinary surgery. A dependency relation is evident here as well. Since Mariel is not a veterinarian, she is dependent upon Jorge to do the surgery she needs for her research. The differential in credentials is significant. Although Mariel has four years of experience as a veterinary surgical technician, and may be very well qualified to recognize deviations from surgery protocol, she lacks the credentials to challenge Jorge should their assessments differ on deviations from surgery protocol.

Furthermore, Mariel and Jorge have potentially conflicting interests in carrying out this protocol. After a first round of surgery, it becomes clear that the surgery protocol will take much longer than they anticipated and hence much more time will be required to process all the animals they need for their research. Jorge is on a tighter time schedule. He is considering a job offer and wants to graduate on time; thus, he has an incentive to rush the work. Since Jorge's research requires only tissue samples obtained during surgery, it will be unaffected if the sheep die a result of rushed work. Mariel's research will be severely affected, however, if the sheep die shortly after surgery.

At the completion of the second round of surgery, three facts are undisputed: 1) Following surgery, several of the sheep show signs of increased agitation and discomfort. This outcome is a departure from the first round of surgery. 2) Three of five sheep die within a day of surgery; no deaths occurred after the first round. 3) An autopsy of the three animals shows signs of tissue damage and bleeding at the site of the insertion of the sampling tubes. Presumably this result did not occur after the first round of surgery.

All the researchers in this case are expected to comply with U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training.For a definitive guide to care and use of laboratory animals, see Institute of Animal Resources Commission on Life Sciences, Guide for the Care and Use of Laboratory Animals (Washington, D.C.: National Academy Press, 1996). The U. S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training are included in Appendix D. For an overview of regulations and requirements in the care and use of animals in research, see B. T. Bennett, M. J. Brown and J. C. Schofield, eds., Essentials for Animal Research: A Primer for Research Personnel (Beltsville, Md.: National Agriculture Library, 19994), pp. 1 - 7. Reprinted in Deni Elliott and Judy Stern, eds., Research Ethics: A Reader (Hanover, N.H.: University Press of New England, 1997). One of the nine principles in that document (Principle IV) states an obligation to ensure "Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practice." Principle III states, "The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results." Animals should not die needlessly. The researchers also are expected to comply with the "Guide for the Care and Use of Laboratory Animals," which spells out procedures to ensure that these principles are observed.

Mariel believes that she observed Jorge rushing through surgery, paying less attention to surgical details (e.g. careful tissue handling and proper suturing during the cannulation procedure). Suppose that Mariel is right and that Jorge did deviate from the surgery protocol, which led to distress in the animals and caused their deaths. If nothing changes, one can assume that the same outcomes will be encountered in varying degrees in future surgeries. Sheep will suffer needlessly and will die needlessly; both outcomes are violations of the guidelines.

This situation presents a potential moral problem for Mariel. She has an obligation to observe the research principles for animal use and protect the animals from needless pain, suffering and death. What is her moral obligation to act if she has reason to believe that Jorge is violating those principles? At a practical level, she has another problem. If she does nothing, she may lose a substantial numbers of the sheep, and her project may be significantly delayed.

As the least senior and, in some senses, the most vulnerable member of the research team, Mariel is forced to pit her expertise against Jorge's in challenging his surgical techniques as well as his possible violation of surgery protocols. In the second scenario, Mariel and Jorge differ on the facts in this case: whether Jorge deviated from the surgery protocol and what caused the animals' deaths. Because, as a veterinarian, Jorge can claim more expertise in these matters, Mariel may have difficulty in making her case, even if she is right. In addition, she runs the risk of losing the cooperation of the person she is dependent upon to finish her research.

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Preventive Ethics

Sometimes it is easier to prevent an ethical problem rather than try to determine what to do after it arises. Mariel's "problem" is due, in part, to the failure of other members of the team to meet their ethical responsibilities. Jorge has a responsibility to show collegial regard for the effect of his actions on Mariel's research, and Carroll has a responsibility to oversee the research to minimize the likelihood that such problems will develop. A wise adviser might recognize the potential for problems, given the conflicting interests and the unequal power relationship between Mariel and Jorge. She could set up the protocol to prevent or minimize the chances that Mariel will be forced to decide whether to "blow the whistle" on Jorge.

One technique used in other organizational settings is making the reporting of bad news mandatory, not optional, thus relieving the most vulnerable persons of decision-making pressure. This strategy helps to eliminate concerns about disloyalty to a colleague or fear of reprisal.

In this instance Carroll, Jorge and Mariel all collaborate in developing the animal use protocol, which includes the surgery protocol. What Carroll could do is to specify in the surgery protocol that, after each round of surgery, any deviations from expected outcomes of surgery must routinely be reported to her, including evidence of post-surgical suffering or death of sheep. In the unexpected death of a sheep, an autopsy would be done automatically and the reports forwarded to her. Carroll could then decide whether the information warrants investigating to determine if the protocol needs to be changed for reasons that could not be or were not anticipated or whether any violations of protocol have occurred. This approach would also make Carroll aware of the unacceptable implications of high death rates of the sheep for Mariel's research project.

Recommendations in the Guidelines regarding surgery and the monitoring of post-surgical pain and stress in animal subjects suggest preventive measures that could be taken in the planning of the protocol.

1. In developing the surgery protocol, Carroll could ensure that pre surgery planning includes a careful preoperative animal health assessment to be sure the animals are healthy enough to withstand surgery.Institute of Animal Resources Commission on Life Sciences, Guide, p. 61. That judgment could be made by the supervising veterinarian rather than by Jorge. If sheep have been so certified any post-surgical deaths should trigger a review of surgical procedures.
2. The development of the surgery protocol would be an appropriate point at which to estimate the amount of time required to properly carry out the surgery protocol on each sheep and the implications of that time frame on Jorge's research program. If an honest assessment indicates that they will only be able to do, for example, five sheep per day, that provides an opportunity to discuss alternate ways of meeting the protocol requirements. The pressure on Jorge to rush the surgery could be thus anticipated and dealt with. Carroll could build into the protocol a requirement that significant deviations from the anticipated time required for surgery be reported to her after the first round.
3. Carroll should ensure that it is clear who is responsible for monitoring and keeping records of evidence of post-surgical stress and pain in the sheep. She could require that such evidence must be reported to her.Ibid., pp. 63 - 64

If such provisions were in place, then it would be Carroll, not Mariel, who would confront Jorge about the post-surgical suffering and death of the sheep. Carroll could ask Mariel for her observations of the surgical procedures, rather than leaving it up to Mariel to volunteer them. These measures should help to preserve a working relation between Mariel and Jorge and also provide an occasion for Carroll to have a frank talk with Jorge and Mariel about expectations of mutual collegial responsibility. If Jorge's actions are interfering with Mariel's research, that problem needs to be addressed. Carroll could take action at the earliest instant to get Mariel's research back on track.

If Jorge were to deny that his surgical technique caused the sheep's suffering and deaths, arguing instead that the diseased state of the sheep caused the problem, then that claim could be tested by referring to the pre-surgery certification of the health of the animals. It is possible that Jorge is correct. That may indicate the need to radically redesign the protocol or perhaps the need for a more refined certification procedures to identify diseased sheep that are sufficiently healthy to withstand the surgery.

If Jorge's technique is the culprit, that problem can be addressed and corrected more quickly than is likely if Mariel is carrying the whole burden of correcting the situation. The net result of involving Carroll is that the research is more likely to go smoothly and to be completed sooner with the research animals experiencing less suffering and pain.

These provisions allow Carroll to do at a lower level what the IACUC has formal responsibility to do. More importantly, it shields the most vulnerable member of the research team and gives Carroll an opportunity to nip a problem in the bud. At minimum, this strategy prevents wasted time in her research program.

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Dealing With the Actual Situation

Suppose, however, that Carroll has not had the foresight to build in these preventive measures and Mariel must deal with the situation. What should she do?

Given the animals' suffering and distress and the number that have died, Mariel cannot justifiably choose to do nothing. She must at least begin to address the cause of their suffering and death and whether anything can be done to alleviate it. If something can be done and she fails to do it, she has not exhibited proper care for the animals.

Since she suspects Jorge's surgery procedures, it will probably be least threatening to Jorge if she goes directly to him, rather than to Carroll or the IACUC. She needs to approach him in a collegial manner, point out the post surgery results and the autopsy findings, and ask if he thinks he rushed the surgery in the second round. He may be willing to concede that he rushed the work and try to take more care on the next round. If so, that may solve the problem.

Suppose Jorge denies that he is responsible and blames the poor outcomes on the diseased state of the sheep. He may be right. Perhaps he did not violate protocol. The sheep may have experienced discomfort and died because of their weakened condition. This possibility raises a question of whether the animal protocol is adequate. Mariel is now put in the position of having to press her case, increasingly alienating Jorge and /or watching her research go down the tubes because she loses his cooperation as well as a significant number of sheep.

As a next step, with or without Jorge's cooperation, she can ask the supervising veterinarian to review the necropsy reports of the sheep who died in the current round and to certify the preoperative health of the next set of sheep. If the problem persists in the sheep after the third round of surgery, she will have stronger evidence and the expertise of the supervising veterinarian to buttress her claims that Jorge's technique is causing the problem. She may convince Jorge and win his cooperation. If so, the delay, loss of time and sheep may be justified by the need to secure his cooperation. If not, she has little alternative but to go to Carroll or report the situation to the IACUC in order to correct the problem.

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Part 3

Suppose the sheep do not die but show signs of pain and discomfort during the recovery period. If the sheep are in distress for any significant length of time, should Mariel keep them alive and suffering and continue to collect research data or should she euthanize them and thus lose the possibility of data collection?

Recall that the first round of surgeries produced no signs of suffering or distress in the animals during the recovery period. That suggests that it is possible to perform this surgery without the undesirable side effects. Hence, it is reasonable to expect that the protocol, if followed, will not cause post-surgical distress in the animals.

This scenario suggests several possible outcomes from surgery. 1) Some of the animals exhibit distress for a short recovery period (perhaps 1-2 days). 2) Some of the animals exhibit distress for a longer period after surgery (several days). 3) Some of the animals experience chronic pain induced by the surgery that lasts for the entire month of the experiment.

Mariel's team's first obligation is to see if the sheep's pain can be relieved. If it can, it should be done. If not, then she will have to consider euthanizing this batch of sheep.

Her second obligation is to determine the cause of suffering and whether it can be prevented. If it is the result of a deviation from protocol, then that needs to be addressed before the next batch of sheep are subjected to surgery.

Suppose, however, the sheep's suffering is not the result of deviation from protocol but is, as Jorge suggests, the inevitable result of the weakened state of some of the diseased sheep. There are several possibilities here: 1) The pain occurs only in sheep in which the disease is too advanced. Furthermore, these sheep can be detected in a pre-surgical screening and eliminated from the group. The result is that the remaining sheep will not experience post-operative distress. If that is the situation, then the team should revise the protocol to ensure proper screening. 2) The pain is the result of the weakened condition of some of the sheep that cannot be detected by pre-operative screening. In that case, it is likely that some animals will experience post-operative distress.

It now becomes crucial to know whether the post-operative distress can be eliminated or controlled by analgesia or other means. If it can, then the IACUC must decide whether to permit the experiment with the proviso that the anticipated suffering can be alleviated for the duration of the animals' post operative discomfort. The ethical and practical issues for the IACUC may be especially difficult if pain control were to be required for the entire month of the experiment.

Finally, it may be the case that the pain (apparently) inevitably induced by the surgery in some of the diseased sheep cannot be alleviated for any length of time. This possibility puts in starkest terms, the trade off between the animals' discomfort and the knowledge gained by Mariel's experiment. It is now clear that the price of Mariel's research will be that some of the animals may experience stress, pain and discomfort for some length of time. This issue must be brought to the IACUC for review, and the IACUC will now need to decide whether that suffering can be justified.For a beginning discussion of some of the relevant moral issues in the use of animals in research, see Deni Elliott and Marilyn Brown, "Animal Experimentation and Ethics" and Richard P. Vance, "An Introduction to the Philosophical Presuppositions of the Animal Liberation/Rights Movement," both in Elliott and Stern, Research Ethics. For a discussion of pain in vertebrate animals, see Fred. W. Quimbly, "Pain in Animals and Humans: An Introduction" and Francis J. Keefe, Roger B. Fillingim and David A. Williams, "Behavioral Assessment of Pain: Nonverbal Measures in Animals and Humans," both in ILAR News 33 (1-2, Winter/Spring 1991). For a discussion of the moral relevance of animal pain, see P. Harrison, "Do Animals Feel Pain?" Philosophy 66 (1991): 25-40; Ian House, "Harrison on Animal Pain," Philosophy 66 (1991): 376-379; and Gordon M. Burghardt, "Heeding the Cry" in Hastings Center Report 21 (2, March-April 1991): 48-50.

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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.