Posted 12 years and 12 months ago
Brian Schrag Association for Practical and Professional Ethics
This case raises a host of ethical issues, including a researcher's responsibility to ensure good design in human subjects research, particularly for topics that are politically sensitive. The case ... Read More
This case raises a host of ethical issues, including a researcher's responsibility to ensure good design in human subjects research, particularly for topics that are politically sensitive. The case presents issues of truth telling and deception in the reporting of findings and of the relative strength of obligations to report findings honestly as weighed against harms those findings might cause to others. Finally, it raises issues of the degree to which researchers have a responsibility to ensure their findings are not misreported or misused.
In this case, there are a number of stakeholders, and Lang may have moral obligations to most of them. Stakeholders include the general public, which relies on solid scientific information for making sound health policy and promoting pubic health; the scientific community; the needle exchange activists; the needle exchange participants, the opponents of needle exchange; the funders for Lang's research. Lang might also consider her own self-interest.
One can start with the observation that all stakeholders are ultimately best served if Lang is doing good science. One of the scientist's primary obligations is to design studies that have potential to provide useful results. One issue raised by this case is whether Lang has done that and consequently, whether she has results worth reporting.
Whether Lang has fulfilled this obligation depends in part on the study's objective. The point of needle exchange programs (NEP) is to reduce the spread of HIV by reducing needle sharing by injection drug users. Lang "designed a study that would provide data about the seroprevalence of HIV injection users in Capitol City. . . and track seroprevalence over time in a population that used needle exchanges and a group that did not." The significance of that data depends on the precise objective of her study. 1) One could do a study to determine NEPs' effectiveness in reducing HIV transmission. Answering that question would presumably require a randomized, controlled clinical study. As described, Lang's is not such a study but rather an observational study. So presumably her objective is not to determine NEPs' effectiveness in reducing HIV transmission. 2) Lang may be trying to simply a) measure the level of seroprevalence among NEP participants and b) monitor that level of seroprevalence over time compared to some other group; this objective could be achieved by an observational study. Lang appears to be doing the latter, but her objective is still not clear.
Surely she is not simply interested in measuring the initial level and continuing levels of seroprevalence among NEP participants, simpliciter, but rather those levels compared to some other group. One must have some context in which to make sense of the significance of measured levels of seroprevalence. For example, one could compare levels of seroprevalence among NEP participants to nondrug users, to the general population, to drug users who are not participants in NEP programs, or to drug users who are not participants in NEPs but who are otherwise relevantly similar to NEP participants.
Even if this is an observational study and not a clinical trial, the nonparticipant group can be used to provide some context for interpreting the significance of the findings. In the design of a study, one always makes judgments about the criteria of relevant similarity of the observational and control groups. The very choice of the control group is always a decision about the criterion of relevant similarity of the control group to the study group.
Thus, one could compare the seroprevalence levels of NEP participants to a group of NEP nonparticipants whose only relevant similarity is that they are intravenous drug participants. They may vary completely with regard to other risk factors for HIV. Or, one could compare the seroprevalence levels of NEP participants to a matched group of NEP nonparticipants who are also relevantly similar with regard to other risk factors such as likeliness to engage in prostitution, "inject frequently, borrow injection equipment, frequent shooting galleries, share equipment with HIV positive injection drug users."1 If the researcher ignores such well-established risk factors in the criteria for selection of nonparticipants, what has one learned by such a study? If the seroprevalence levels of the NEP participants are compared to nonparticipants, the significance of the comparison is not clear. This measurement may be an instance of garbage in, garbage out. Since the comparison is between NEP participants and nonparticipants, and since needle exchange is such a controversial issue, one can predict in advance that activists on one side or the other are likely to use the results, whatever they may be, to bolster their positions. Thus, one should at least be sure that there is a possibility of useful results. The worst outcome is to generate scientifically useless data that is still used for political agendas.
Given the case description, it appears that Lang may have failed to pay sufficient attention to selection of the nonparticipant group. The candidates for the nonparticipant group were surveyed for risk behavior at the beginning of the study. At that point, Lang could have screened the nonparticipant group to include only those who matched the study group in terms of risk behavior. For whatever reason, she did not. There are several possibilities here, regarding her moral responsibility for what follows.
First, suppose there is, in fact, a clear and significant difference between the nonparticipant group and the participant group regarding these risk factors and that that difference could have been anticipated and eliminated by careful study design. In that case, Dr. Lang has just done bad science, and there is no reason to suppose any results she may obtain from her study could tell us anything about the significance of the seroprevalence data for injection drug users in Capitol City and the tracking of seroprevalence over time in a population that used needle exchanges compared to one that did not.
If that is the case, Lang has certainly acted irresponsibly as a scientist and with respect to her funding agency by using the funds for a poorly designed study. In addition, if her study produces unreliable evidence, which somehow gets publicity and is then used to undermine the work of the activists and the welfare of drug users who cooperated with her, she has harmed them as well. Finally, her unreliable results may be used to shape public policy in a way that harms the public good. All of these moral harms could have been avoided if she had taken care in the original design. Sometime scientists need to practice "preventive ethics," avoiding moral difficulties in the first place rather than having to resolve ethical issues afterward.
It may be the case that there is in fact a clear and significant difference between the nonparticipant group and the participant group but for some reason, Lang was not able to identify that difference during the study's design. Perhaps the nonparticipant group misled her about their habits; perhaps some changed their behavior over the course of the three years. She may not be culpable for negligence in designing the study, but the study's results are no less suspect. We still have no reason to believe that the results tell us anything. It is still the case that if her unreliable evidence somehow gets publicity and is then used to undermine the work of the activists and welfare of drug users who cooperated with her, they may be harmed, and her results may be used to shape public policy in a way that harms the public good. Thus, harms may result from the study although not necessarily because she did poor science. The harms may result from her efforts to publicize her results, however.
A third possibility is that some, but not all, of the NEP nonparticipant group did not share needles and some, but not all, engaged in less risky behavior than the NEP participant group and that these variations between the groups became clear only at the end of the experiment. At this point, Lang must try to determine whether the variations between the NEP participant and nonparticipant groups are sufficiently small to allow reliable conclusions to be drawn from the results.
In this last scenario, perhaps the results are indeed significant and that, for some reason, seroprevalence is higher among the study group than a relevantly similar nonparticipant group. If so, she has discharged her responsibilities as a scientist to design a good study that permits some confidence in the results. If those results run counter to the preponderance of studies, then perhaps she has identified some important factor overlooked by other studies. Consequently, our understanding of the epidemiology of the disease may be advanced.
As a scientist, Lang has an obligation to share those results with scientific community. The results, if published, may indeed be used in ways that work to the detriment of the activists and NEP participants. Unlike Scenarios 1 and 2, here Lang is not morally culpable for that harm either because of bad design or publicizing unreliable results. Neither is she culpable for the use of her results by others to mislead public policy deliberations simply because she publicized credible results that run counter to other results.
Some might say she is culpable for causing harm to the activists and NEP participants if she seeks to publish the results rather than to suppress them. She could refuse to publish the results. That criticism presumes that the results of the preponderance of studies are correct and that her results do not identify a factor that could improve the programs. However, if her results point to some significant factor overlooked by the other studies, suppression of the results would harm the addicts by depriving them of suitably modified programs.
There are additional moral issues regarding publicity about the results. Whether Scenario 1, 2 or 3 describes the situation, Lang is under pressure to publish for prudential reasons. Failure to publish may mean the current grant will not be renewed or future grants will not be forthcoming and her research career may be at an end.
In Scenarios 2 and 3, if she makes clear that the composition of the nonparticipant group is flawed, it is not clear that any journal would accept the paper. That may tempt her to omit the information or falsify information on the nonparticipant group in order to get published and to further or at least preserve her career in an important area of research. Lang has an obligation to the scientific community to include a full report of what she knows of the design flaws in her experiment or else not submit her paper for publication. Falsification or suppression of information regarding the nonparticipant group would not be justified by the need to publish. Deliberate suppression of information about the nonparticipant group would undermine the practice of science, undermine work in this field and undermine her own integrity. Even if she stands to gain as an individual by such an act, that is outweighed by the other considerations and is a morally unacceptable alternative.2
In Scenario 3, if she is satisfied that the match between the participant and nonparticipant groups is sufficient to produce reliable results, then she has an obligation as a scientist to publish the results, even though she is concerned that others may misuse those results for political purposes. If researchers are to engage in research in areas that are politically sensitive, they must be prepared to let the chips fall where they may in terms of honestly reporting findings. Otherwise, why bother to do the science? The fact that some harm could come from honestly reporting her results does not necessarily justify falsifying results or suppressing results. She owes the truth about her findings to all stakeholders, including those who oppose needle exchange programs.
One consideration is the particular good and harm that publication of these results may do to various stakeholders (e.g., pro-NEP activists, anti-NEP activists, NEP participants and Lang's credibility and her future access to these populations). But an equally legitimate concern is whether one can justify a practice of deciding to report or publish scientific findings on the basis of the impact of the findings on some ongoing political debate. It is not clear that such a practice could be morally justified in scientific research.
One can also consider the researcher's responsibilities to ensure fair and responsible reporting, interpretation and use of the researcher's findings. The researcher has these responsibilities both qua researcher and qua citizen.
At one level, the researcher cannot be held morally responsible for others' irresponsible use of the researcher's findings. If a journalist is too lazy or ignorant to do responsible reporting, that behavior is beyond the researcher's control. If politicians or activists willfully misuse findings to support a political agenda, they must be held morally accountable for that. However, if the researcher is in the best position to anticipate that her findings will be misused or to recognize they are being misused, then she has some obligation as a scientist with a commitment to the truth and as a citizen with a commitment to honest civic deliberation to take whatever steps she can reasonably take to prevent that abuse or to set the record straight.3
In Scenario 3, for example, perhaps she can alert her colleagues before publication so they are aware of the problems her findings may create in the public sphere and so they can be prepared to respond. Perhaps she could meet with journalists prior to release of the results to ensure they can place the results in the context of other research in the field.
From: Graduate Research Ethics: Cases and Commentaries - Volume 3, 1999 edited by Brian Schrag
Posted 12 years and 11 months ago
In this case, it appears that the research is valuable and can be done only with the involvement of patients who are schizophrenic as research subjects. The research procedure involves having subjects "listen to auditory stimuli presented over headphones while their brain waves are recorded using noninvasive electroencephalographic (EEG) techniques." The participants are drawn from a pool that includes persons with a variety of mental disorders. Experi-mental subjects (patients with schizophrenia) and the control group (patients with dementia, bipolar disorder, and depression with psychotic features) will all undergo the same research procedures.The research is described as a nontherapeutic experiment with minimum risk.1
Does this experiment indeed entail minimum risk? The criterion of minimum risk is itself contested. According to the Federal Policy for the Protection of Human Subjects, also known as the"Common Rule," a study involves minimal risk if "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves that those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests."2 However, as the National Bioethics Advisory Committee notes, "The need for sensitivity in the application of risk categories is especially great when persons with mental disorders are among the potential subjects of a study. For some persons with mental disorders, their limited ability to understand the rationale for a specific intervention could cause them more distress than it would someone who fully understood the intervention."3 NBAC continues, "What may be a small inconvenience to ordinary persons may be highly disturbing to those with decisional impairments. Thus, for example, a diversion in routine can, for some dementia patients 'constitute real threats to needed order and stability, contribute to already high levels of frustration and confusion or result in a variety of health complications.'"4
Is it so clear that the activity of listening to auditory stimuli over headphones for six hours while being wired up to EEG equipment "so researchers could read their thoughts" would not provoke some psychotic reaction in some subjects who are also patients? The case states the "procedure has not been reported to exacerbate participants' symptomatology." It is not clear whether this statement refers only to patients with schizophrenia or to patients with the entire range of disorders that might be represented in subjects.
The diagnostic interview itself may not be so harmless. The National Commission noted that subjects who are institutionalized with mental disorders may "react more severely than normal persons 'to routine medical or psychological exams.'"5 One cannot be sure, but it is worth asking if it really is clear that being subjected to these procedures carries a minimal risk of provoking an adverse reaction in some of these subjects. That may depend on whether one accepts the Common Rule definition of risk as adequate for those with mental disorders.
Although this experiment is nontherapeutic, it may offer a benefit to the subjects. The case suggests that the diagnostic procedure administered by the researcher is likely to produce a more accurate diagnosis than the hospital's preliminary diagnosis, given the hospital staff's limited time resources for diagnosis. If so, then the one benefit subjects could gain from participation is a more accurate diagnosis of their condition, particularly if there is a possibility of conflict with the treatment team's diagnosis.
A central issue in this case is obtaining informed consent to participate in a non-therapeutic experiment, from patients in a psychiatric ward. The issue of informed consent in this case is of special interest for several reasons. 1) The possible disorders of this population include dementia, schizophrenia, bipolar disorder, and depression with psychotic features. All of these disorders are recognized as placing a subject's decisional capacities at risk.6 2) The target population for the study is patients with schizophrenia, who are at even higher risk for impairment of decision-making capacity that others in this population. They also have the compounding effect of fluctuating capacity for decision making. 2) Many patients in this environment may be recently institutionalized, which is an experience also recognized as sometimes impairing decision-making capacity. 3) Duncan will have access to these patients as subjects for a fairly short time since some may be processed and sent on to institutional settings. This limited access may create some pressure to abbreviate the consent process. The short time frame also reduces the option of waiting until temporary forms of impairment pass. 4) Duncan appears to be under pressure to collect as much data as possible, which again may create pressure to abbreviate the consent process. 5) All his potential subjects are under the influence of anti-psychotic drugs at some point. It is unclear whether they all receive medication before Duncan undertakes the informed consent procedure with them, although that is the case with Miriana. Presumably the impact of the anti-psychotic drug would be to increase their decision-making capacity, but that is not clear. 6) This study is nontherapeutic. Research in which the subjects receive s no benefit or are at higher risk or when the researcher has a conflict of interest are all situations that, morally speaking, may require even more stringent consent procedures, such as the use of an independent professional to assess subjects' capacity to make decisions, an auditor to administer the consent procedure, plans for reconsent procedures for subjects with fluctuating capacity and involvement of a friend or family member of the subject in the disclosure and consent process.7
Given his subject population, Duncan has strong reason to take special care and use a more sophisticated assessment procedure in the consent process than one might use with other populations. This population is at higher risk for impaired decision-making capacities when he approaches them. It is not clear that Duncan has made an effort to assess the degree to which his potential subjects demonstrate of each of four relevant decision-making capacities (capacity to express choice, understand relevant information, appreciate the situation and its consequences, and reason) and the degree to which they can apply those capacities during his consent process. As the researcher - and one under pressure to produce data - as well as the one who assesses potential subjects' capacities, Duncan has a conflict of interest. Since the issue of whether this population is at risk might be debatable, perhaps he should follow the NBAC's recommendation that he use an independent professional to assess potential subjects' decision-making capacities.8
When he first seeks her informed consent, Duncan does not know, based on his own assessment, Miriana's diagnosis or that of the other subjects from whom he obtains informed voluntary consent. Both the"experimental" group and the "controls" go through the entire procedure including the data collection as well as the two-hour diagnostic examination. It is possible, perhaps even likely, that a number of patients with schizophrenia as well as others would exhibit variable decisional capacity during the period of the procedure. Given the population with which he is dealing, it would appear prudent to have in place a procedure for dealing with those in either group whose decisional capacities, although at an acceptable level in the beginning, diminish during the research. Duncan apparently has not planned for that contingency since he is uncertain what to do when he encounters that situation. That procedure, whatever it is, should be addressed in the consent session and consent obtained if that event occurs.
Duncan should build into the consent procedure his plan for dealing with patients if they exhibit a decline or fluctuation in decision-making capacities. This plan may include an indication in the informed consent process of what is to be done if the subject experiences fluctuating capacity during the procedure. Possible responses might include the subjects' designating someone to serve as a surrogate decision maker or an indication that should such a situation develop, the researcher would suspend the research activity with the subject until he or she is competent to reconsent.9
Finally, it might involve indicating that if decision-making capacities declined or fluctuated, the subject would be suspended from the program.
Because of potential subjects' risk of decisional incapacity and fluctuating decision-making capacity, it may be wise in this experiment to routinely seek to have the potential subject's family, friend or legal advocate sit in on the consent and informational procedures and, with the patient's agreement, serve as a representative or an advocate for the patient/subject during the research.10 One can imagine a patient/subject or more likely a patient advocate being concerned that the research process might trigger a psychotic event in the patient /subject. It would be natural for them to want to consult with their physician before consenting to participate in the study. Suppose the subject or his or her representative requests that the patient's treatment team be present at the consent process and assist in making the decision on subject participation in the experiment. Should the researcher be open to that request? Should that practice be incorporated into the consent procedure? One difficulty for the researcher is that such a procedure may blur the line between research and treatment activity in the mind of the patient/subject or that of the advocate.
Some might argue that since this research appears to be low risk, such precautions in the consent process are not warranted. However, it is a mistake to assume that only the threat of risk in research justifies or requires attention to proper informed voluntary consent. Subjects can be wronged, even if not harmed, by failure to treat them with the respect due autonomous beings. Involving them in a nontherapeutic study without gaining their informed, voluntary consent falls in that category.
Not only is there an issue of how the informed consent procedure is conducted and obtained, there is also a question of what the potential subjects are told about the study. Everyone who consents is subjected to a two-hour diagnostic interview to allow the researcher to arrive at an accurate diagnosis of the subject's illness. Is that made clear to the subjects? It would be hard to imagine a thorough explanation of the research activity during the experiment that failed to explain that two of the eight hours are devoted to diagnosis. Would it also be made clear that the diagnostic assessment is done because the hospital preliminary diagnosis is judged insufficiently accurate for the purposes of research? There is a reference in the case to Miriana's hospital charts. Duncan apparently has access to Miriana's records and is aware of her preliminary diagnosis. If that is so, are the patients aware that Duncan has access to their records?
Once the potential subjects are aware that part of the research activity is a diagnosis of their illness, it would certainly be natural for them or their representatives to ask that that diagnosis be shared with them. It is not clear from the case if they are told that the results of this diagnosis will be shared with them. If the diagnosis is to be shared with subjects, then one would think it might also be shared with the attending physician. If so, will the subjects be told that the diagnosis will be shared with the attending physician? (More below about whether the diagnosis should be shared with subjects or their physician.)
Presumably there will also be thorough discussion of the purposes of the six-hour experimental activity. If Miriana can be confused by the presence of a tape recorder, what mistaken conceptions might other psychotic subjects acquire regarding the activity of listening to headphones for six hours?
The information process should also make clear to the potential subjects and their advocates that there is no implicit quid pro quo in which subjects ought to participate in the experiment carried out on the ward in exchange for treatment given in the ward.11
Should the researcher acknowledge in the informed consent process that subjects will be given a diagnostic assessment as part of the procedure? It is hard to believe that subjects or their advocates would not want to know this information or could give informed consent without it. The subjects or their advocates would want to know about the administration of the assessment not only because of its possible effect on the subject; they may also want to know the actual diagnosis, if indeed it is a more accurate diagnosis than that of the hospital. An accurate diagnosis may well appear to be a benefit for the patient, particularly if it conflicts with the hospital's diagnosis.
It is difficult to see how subjects or their advocates can be adequately informed without being told that part of the process is a diagnosis of their illness. The subjects in this case are also patients. Once they know that a diagnostic assessment will be conducted, it will be difficult for subjects/advocates to separate their concerns as subjects from their concerns as patients. It may be hard to avoid discussing with the subjects/advocates why another diagnosis is needed in addition to the hospital's diagnosis. It will be difficult to avoid the question of sharing diagnostic findings with subjects/patients or advocates. Many patients who have a mental illness or their advocates may want all the diagnostic information they can gather. If the diagnosis is shared, it could have adverse implications for the dynamics of between the patient and the treatment team, particularly if the hospital's and researcher's diagnoses are inconsistent. It could be especially difficult if physicians are unaware that a diagnosis has been shared or that it differs from their own.
Suppose that, as in this case, the informed consent agreement includes the provision that the diagnosis remains confidential and is not shared with the hospital without the subject's written permission. This provision places patients with possibly impaired judgment in the position of deciding to withhold potentially important information from the persons charged with their treatment or care. A decisional capacity sufficient to agree to a nontherapeutic experiment is not necessarily the same as a capacity sufficient to make decisions that could affect treatment.
The case indicates that in the consent process, Duncan assures potential subjects the diagnosis will be kept confidential and not shared "with the attending physician unless the patient gives written consent to do so." A reassurance about confidentiality could be essential to ensuring the accuracy of the researcher's data. As the other commentator notes, subjects may tell the researcher things they do not want the treatment team to know. Some patients, particularly patients with schizophrenia, may have an adversarial relationship with their treatment teams. If subjects know that the information given the researcher will be shared with physicians with or without their consent, they may have an incentive to downplay their symptoms or use of drugs since that information could affect decisions made about them in the treatment program.
If patients have the right to decide whether to release the diagnosis, that allows the possibility that they can manipulate the treatment team by releasing only "good" diagnoses. It may also give subjects an incentive to manipulate the researcher's diagnosis by selective sharing of facts with the researcher. Obviously, all that could affect the accuracy of the researcher's diagnosis as well interpretation of the experimental data.
If, in general, the researcher's diagnosis proved to be more accurate than the hospital's, the hospital may have an incentive to encourage patients to enroll in the program, which raises obvious issues of whether the researcher can obtain voluntary consent.
The treatment team could hardly consider it desirable for patients to be informed of a diagnostic assessment of their illness by someone other than patients' caregivers, particularly if that diagnosis conflicts with that of the treatment team. From their perspective, it would surely be even worse for the patient or the patient's representative to receive such a diagnosis without the treatment team's knowledge. Unknown to them, the patient and/or the patient's representative is now aware that there are conflicting diagnoses. This situation could create all kinds of difficulties in patient-physician relations and treatment. The treatment team may not place confidence in the researcher's diagnosis, in which case they may not be willing to accept it or alter treatment on the basis of that diagnosis; they may find it frustrating to have to defend their diagnosis against that of the researcher; and they may perceive sharing that diagnosis with their patient as undermining patient confidence. If they do accept the diagnosis, then the patient may benefit from an improved diagnosis. In this case, the treatment (using antipsychotic drugs) may be the same whatever the diagnosis. It might be difficult for the patient or advocate to understand that the diagnosis is really irrelevant as far as treatment is concerned.
There may be no good resolution of this issue. The option of failing to inform the subject that part of the procedure is a diagnostic assessment does not satisfy the requirements of informed consent. The option of sharing the results with the hospital without informing the patient would also violate voluntary consent and subjects' confidentiality. A third option would to be to inform subjects of the assessment but indicate that they will not be told the researcher's diagnosis. If that keeps subjects from joining the study, so be it. That would mean that they would not receive the benefit of a free diagnosis. A fourth option would be to inform the subjects/patients of the diagnosis and let the subject choose whether it is to be released to the treatment team. That alternative would be somewhat analogous to a patient seeking a second opinion.
From: Graduate Research Ethics: Cases and Commentaries - Volume 4, 2000 edited by Brian Schrag
Should Clarisse continue this experiment? The central moral issue in considering that question is whether the birds' interests should be taken into account in evaluating whether or how to conduct the ... Read More
Should Clarisse continue this experiment? The central moral issue in considering that question is whether the birds' interests should be taken into account in evaluating whether or how to conduct the experiment. If the answer is "No, their interests should not be taken into account," then, assuming the experiment is well designed and likely to yield useful results and hence is a good use of resources, there is no reason not to have undertaken it in the first place or continue the experiment If the answer is "Yes, the birds' interests should be taken into account," then one must determine what their interests are and what bearing consideration of their interests should have on a decision to undertake the experiment, modify it or continue the experiment.
To ask about the moral relevance of their interests is to ask about the moral status of birds. Are they the sort of entities that have moral standing, that is, entities that at least have interests of some moral importance and perhaps moral rights, or are they rather like rocks, which have no interests, no moral status?1 Relevant to the question of the birds' status is whether birds can feel pain or suffering. If they cannot experience pain or suffering, then one central objection to this experiment is removed. The birds cannot be harmed in this sense, so perhaps there is nothing wrong with the experiment. Historically some (the philosopher Descartes, for example) have held that birds (and other animals) do not experience pain. That view is not widely held in the scientific community, although there may be debate on the extent of pain and kind of suffering such animals experience. I will not focus on this view.
Even if one grants that the birds in this case experience pain and suffering during the experiment or later as a result of the experiment, one might take the position that such a fact is morally irrelevant to whether or not to conduct the experiment. One might hold, as did the philosopher Kant, that "animals are to be regarded as man's instruments, as means to [man's] ends.2 One can admit that the birds experience some forms of pain and suffering, but argue that their pain is of no moral relevance whatsoever to the question of whether the experiment is morally permissible. Some in the scientific community may hold this position. The fact that we have and observe the Animal Welfare Act, however, indicates that most people agree that research animals' pain and suffering is somehow a relevant factor. Although this position raises important ethical and philosophical issues, since the locus of disagreement tends to be elsewhere, I will not focus on this view, either.
At the other end of the spectrum, some hold that both humans and other animals (at least animals with a sufficiently rich psychological life) have inherent value, that is, they have "morally significant value in themselves, apart from their possible usefulness to others and independently of the. . . overall status of their mental life."3 This view, developed by Tom Regan and called "inherentism" holds that at least some animals have the same moral status as humans provided they are capable of having beliefs and desires and acting intentionally.4 Consequently, they are not to be used merely as means for human ends. If this view is correct, there is no justification for using these sorts of animals in any scientific research. If birds fall in the category of animals with inherent value, there ought to be no balancing the interests of the birds against those of humans. Clarisse should not have undertaken the experiment and should discontinue it immediately. As Regan himself admits, however, there are difficulties in determining which animals are psychologically rich enough to fall in this category.5
Even if one does not accept the inherentist position, a more common position holds that birds and other animals have some sort of moral status because they are sentient creatures, capable of experiencing pain and suffering. Sentience is the feature relevant to determining moral status. Humans have at least a prima facie duty not to cause any sentient being pain. The pain of any sentient creature counts, and the pain or pleasure of humans does not automatically override that of other animals. That is the utilitarians' view.
If one accepts this position on sentient beings, one still might argue that although the birds in this experiment experience pain, suffering, and death, those facts are irrelevant to determining what to do in this particular case. That is not because the birds' pain, suffering or death is morally irrelevant but rather because their pain and suffering was not causally connected to the experiment. Gladiator sparrows are aggressive. They attack and perhaps kill each other in the wild. If the same aggressive wounding and killing goes on in the wild at the same level as Clarisse observed in her cage, then one might argue that she had here a kind of natural laboratory. She was simply passively observing, in a convenient forum, what would have happened to these birds in the wild.
Indeed, Clarisse belatedly discovers from researchers and early reports in the literature that gladiator sparrows exhibit the intensity of aggression in the wild that she observes in her cage. If she were able to determine by literature search and field observation that the birds exhibited a level of aggression and outcomes that closely match what she later observed with her caged birds, then one might argue that she is simply a passive observer and that the experiment contributes nothing to the pain and suffering of the birds. Suppose she were able to determine by field observation in advance of the experiment that for every 30 birds in the wild, six to twelve would be killed and a number seriously injured during the first few weeks of the mating season. One might argue that her intervention had caused no harm and thus it would be acceptable to carry out and continue the experiment. On the other hand, if the aggression observed in the wild matches that in the cage but may not result in such serious injury or death because the birds under attack are not imprisoned with no chance for escape, then of course Clarisse's experiment has contributed to the pain and suffering of the animals.
Even if the levels of the birds'injuries and deaths in the wild match the outcomes in the cage, there are other considerations. The notion of the animal's "suffering" in this context typically includes tension, anxiety, stress, exhaustion, and fear. Do the acts of aggression in the cage create more of this sort of suffering since the birds under attack cannot escape? Do all the caged birds experience suffering in the capture process or when they discover they are trapped in an enclosure? If the aggression is learned behavior, will birds released from the cage have learned a higher level of aggression than their wild counterparts, and will they pass that on to the wild population, thereby raising the level of pain and suffering in the wild population? If any of these outcomes occur, then Clarisse's experiment has increased the birds' pain and suffering and her experiment is not merely a natural lab in which their pain and suffering is morally irrelevant.
One can of course debate whether birds are capable of emotions such as fear and anxiety or capable in general of experiencing the emotional pain of the events in this case. Some would argue that the basis for attribution of emotions in animals is as good as the basis for the attribution of pain.6 Some would argue that we are as certain that some animals have emotions as we are that other people have emotions. "We are as sure that a bear is angry as that a spouse is angry."7
Even if we grant, as it may be reasonable to assume, that the birds in this case experience pain and suffering in the cage that they would not have experienced in the wild, some might argue that, nevertheless, the experiment was morally justified in principle. The birds' pain and distress, although morally relevant, nevertheless, is somehow outweighed by the benefits of the experiment.
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The benefits of conducting the experiment may include the value of the knowledge we expect to gain as well as benefits to other stakeholders. Assume for the moment that the experiment is well designed and executed so that we gain maximal knowledge. It appears that the objective is to try to determine whether gladiator sparrows' aggressive behavior is largely innate or if significant environmental factors influence the development of aggressive behavior in the species. It is not clear if it is expected that the findings of such a study could be generalized to aggressive behavior in all nonhuman animals or to aggressiveness in humans. One might argue that the more general the implications of the findings, the more valuable the knowledge gained in the experiment.
Suppose that the experiment indeed gives us some additional understanding of whether gladiator sparrows' aggression is largely innate or learned. What is the benefit of that knowledge? 1) This knowledge will not have any direct instrumental benefit to the welfare of birds in the study. It is not on the order of a therapeutic experiment to help those specific birds in the study. Given that there are no benefits to the subjects of the experiments, it is clear that the benefit to the birds does not outweigh the pain they experience. 2) It may have instrumental value for the promoting the welfare of the population or species if we learn something about their behavior that could be used in conservation strategies to protect this species. It is not at all clear that is an expected outcome of the experiment, hence it is not clear that one could argue that these birds' suffering is for the greater good of their population or species. From the birds' perspective, their burdens certainly outweigh the experiment's benefits for them individually or for the species. 3) Serious human interests are not at stake in this experiment in the sense that animal experimentation designed to find a cure for a human disease might be considered a serious interest. 4) The experiment appears to have some value in yielding information intrinsically interesting to humans; it satisfies our desire to know and understand the world around us. Clarisse assumes the experiment will have relevance beyond the question of whether aggression is innate in this particular species. She is challenging a prevailing view that aggression is innate in animals. If she is correct, that finding could be significant for our understanding of the issue. This experiment might contribute to our understanding of aggression in humans, although one must always ask whether bird behavior would be close enough to human behavior to be relevant.
The intellectual benefits to humans lie in the broad advancement of scientific understanding of aggression in animals. Aside from any knowledge we may gain, what are the experiment's other benefits? It provides a research project for a graduate student. It may be part of a grant project that generates income for the department. It may provide a research program or career opportunities for the graduate student and her professors. In this experiment, the humans assume all the benefit; the birds assume all the burdens.
Do such considerations justify continuing this experiment? We recognize that it is at least prima facie wrong to inflict pain and death on these birds. It would be wrong to kill them for our amusement or for trivial reasons. 1) That is why it would be wrong to wound and kill them in an experiment so badly designed that it yielded no benefits of knowledge. 2) That is why it would be wrong to kill and wound them in an experiment that yielded only trivial results. (Presumably the other personal benefits to researchers in conditions 1) and 2) would not outweigh the harm to the birds.) 3) That is why it would be wrong to kill or wound them in an experiment that could be alternately designed to substitute models or other means to obtain the same results. 4) That is why it would be wrong to use more than the minimum number of birds statistically required.
Even if all such considerations have been answered in this case (and, as the other commentator notes, it is not clear that all such considerations have been answered), should the study continue? The decision still comes down to weighing the knowledge gained against the birds' pain, suffering, and death that would not have occurred absent this experiment.
This call is perhaps closer than one might think at first. If considerations 1-4 are justifiable reasons for not conducting the experiment, it is not at all obvious that any significant knowledge automatically justifies conducting or continuing the experiment. Once one allows the moral significance of the birds' pain and suffering, one allows for the possibility that their pain and suffering could count for more than the value of the scientific knowledge gained by the experiment. There may be times when we might justifiably argue that some knowledge ought to be forgone or lost rather than inflict on animals the pain and suffering required by the experiment. Some ethologists have made that judgment in other experiments.8
It is important to recognize that we are weighing the birds' highest interests in not suffering or dying against humans' less pressing interests in extending their knowledge. The difficulty is in weighing this tradeoff and, of course, humans are doing the weighing. In this case, it does seem to be a very close call.
It is not clear from this case if findings from field observations before the experiment or from the experimental results at the end of Year 1 would be adequate to allow Clarisse to design models that could be used to test subjects' behavior without harming them or to identify reliable indicators of aggression while permitting intervention before actual aggression occurs. If the experiment could be carried on without the actual pain and suffering of aggressive attacks, then perhaps the suffering due to capture, captivity, and threat of aggression might reasonably be judged to be outweighed by the knowledge gained. The experiment or its continuation as so modified might be justified.
To Clarisse's credit, she did do the literature research required, although perhaps not sufficient. She did attempt to match the habitat setting. She did get the animal use committee's approval. She did intervene to protect injured birds. She did reassess the experiment before the end of the year in an effort to reassure herself that it was a "natural lab." She did consider a modified program for Year 2.
It is worth noting that the Institutional Animal Care and Use Committee approved the experiment. It is not clear whether they required or considered a detailed ethical justification for the use of these birds or gave that question the same level of consideration they gave to the study's design or theoretical importance. The burden for such considerations ought not to lie solely with Clarisse. That fact has implications for the training and sophistication in ethical thinking one ought to expect from such committees as well as universities' responsibility to ensure appropriate levels of ethical training for such committees.
Brian Schrag Indiana University
It is not clear from the case description whether this project was initially designed as a longitudinal study with expected follow-up research (or at least data collection) or whether it simply intended to allow for the possibility of follow-up, perhaps to clarify information or to do further research. What does seem clear, given the fact that the ... Read More
It is not clear from the case description whether this project was initially designed as a longitudinal study with expected follow-up research (or at least data collection) or whether it simply intended to allow for the possibility of follow-up, perhaps to clarify information or to do further research. What does seem clear, given the fact that the initial consent form mentioned the possibility of re-contact, is that the follow-up contact was not simply someone's afterthought several years after the study was completed. It appears that a clear decision to do this particular follow-up seems to have been made years after the end of the study.
It is also not clear if this study was therapeutic or nontherapeutic. If it was a therapeutic study, there might be reasons to follow up with subjects for their benefit. I shall assume for the purposes of the discussion that it was a nontherapeutic study and hence the re-contact of subjects was not for their welfare.
The case raises a number of issues. Is the mere contacting of subjects years after a study is completed an ethical issue, does such an action require obtaining informed consent? Is the means of relocating subjects of a study years after the study is complete an ethical issue, and does that activity require informed consent? Should such issues have been addressed in the original study protocol? Having failed to address such issues adequately in the initial protocol, what ought to be done at later stages?
What we do know in this case is that the attempt to re-contact former subjects did have consequences for them. Some of the participants were contacted without their knowledge of the process or consent. Some participants may have been re-contacted against their wishes and without their consent. Some experienced an invasion of their privacy. Information on subjects' credit ratings was apparently obtained by the study manager and perhaps shared with others. A smaller group may have had their credit ratings harmed without their knowledge or consent. Merely participating in the original study made them vulnerable to harms inflicted by the researcher that had nothing to do with the content of the study.
Is the mere contacting of study participants years after the study has been completed an ethical issue? Some subjects may know from the outset that they do not wish to be contacted after the end of a study. Mere participation in a study does not mean one has surrendered any rights to be left alone or to have one's privacy respected in subsequent years. Much can happen to subjects in the interval after a study is completed. Depending on the study, there may be a variety of reasons subjects may wish not to be contacted. For example, they may not want their current intimate contacts to know they had participated in the study. They may simply prefer to not be disturbed, and that itself is a moral reason for them not to be contacted. For these considerations, researchers are morally required to obtain informed consent from such subjects for future contact.
Is the means of locating persons, even those who have given consent to be recontacted, an ethical issue? Clearly it is. Would anyone consent to allow a researcher to use a credit bureau to track one down, particularly if that negatively affects one's credit rating? Surely not. It would not occur to most of us that was a possibility. But the possibility does underline the fact that there are limits to what we would agree to in terms of procedures used to track us down, even if we give consent to be re-contacted.
Without knowledge of the nature of the study, the need for follow up or any therapeutic value to the participants, it is difficult to fully assess the moral seriousness of the actions in this case or to suggest what actions ought to be taken at later stages of the case. However, it is sometimes better to exercise preventive ethics, to take steps to avoid the ethical issues from arising rather that trying to solve the ethical problems after the fact. Adequate informed consent procedures established during the study could have gone a long way toward avoiding the ethical issues raised in this case.
Since the possibility of re-contacting subjects was anticipated from the beginning of the study, the investigators should have proposed a much more carefully thought out informed consent procedure to ensure that participants clearly gave their informed consent to be re-contacted.
Although the form mentioned the possibility of re-contact, it is not clear how explicit the request for permission to re-contact was, nor whether there was a blurring of the distinction between 1) consent to participate in this study and 2) consent to be contacted in the indefinite future for some unspecified purpose. It may well be that consent to participate in the study ought to be separated from consent to be re-contacted sometime in the indefinite future for some unspecified purpose. Participants may have been willing to participate but not willing to consent to re-contact. Some did not provide contact information, and it is not clear whether that should be interpreted as agreeing to participate in the current study but refusing to be re-contacted.
If re-contact is (less likely) actually the initiation of a new study, then it is not clear that it is appropriate to combine the informed consent to participate in the original study with consent to participate sometime in the future in a study of unspecified nature. The informed consent information presumably supplied details only for this study and, even if adequate to obtain informed consent for this study, could not be adequate for consent to an unspecified later study. Given these uncertainties, it is not at all clear that the informed consent for future contact was actually adequate for any of the subjects. It is even less clear that it was adequate for those who gave no future contact information.
If we assume the protocol should have included obtaining a clear and independent informed consent to re-contact, what would be reasonable for the researchers to say, regarding the method of contact, in order for the consent to be informed?
If one is contemplating the task of contacting subjects three years after completion of the original study, it should be obvious to the researchers from the start that some systematic procedure to locate subjects will need to be followed. (If the size of the pool is such that data would be useful only if virtually everyone in the study can be contacted, then it may not be wise to plan on re-contact unless an ethical means of successfully contacting all subjects is possible.) Obviously, the method outlined in the protocol was inadequate: Asking participants to list next of kin or other contacts did not produce a complete initial list of contacts.
One possibility would be to institute a tracking system to update contact information on a regular basis - every six months, for example. Each update would include and constitute a renewed permission to maintain contact.
However it is to be done, if the researchers expected to get informed consent for re-contacting subjects, they had an obligation to anticipate the difficulty of locating subjects and design a protocol accordingly. It does not take a rocket scientist to recognize there are acceptable and ethical ways of locating people and unethical and unacceptable ways of locating people. Obviously, technology is changing rapidly, and there may be possibilities of violating privacy in order to find contact information that were not thought of at the original point of consent. Nevertheless, the informed consent should include some assurances that the means used to find participants will stop short of violating their privacy or other interests.
Given all this, the researchers had an obligation to devise an informed consent form that would inform subjects of the purposes of re-contacting them in the future and the procedures that would be used to locate them. If the researchers failed to provide that in the protocol, the IRB had an obligation to raise the issue. Neither of them did so in this case.
Having failed to obtain an adequate informed consent for re-contact at the time of the study, what, if anything, should be done three years later when the researcher decides to do a follow-up study?
The researchers might use the contact information provided by subjects in the first place. There is, in the original consent form, at least a fig leaf of informed consent to be recontacted. If that strategy does not yield enough subjects for the study, the researchers should return to the IRB with a proposal for locating subjects for whom contact has been lost. It is the researchers' responsibility to obtain that approval from the IRB. It is the obligation of the IRB to see that the methods proposed to locate subject do not violate their interests. The researchers are also responsible for overseeing the actions of the study manager. It is clearly not the responsibility of the study manager to devise procedures on his own.
If no ethical means can be developed for locating subjects, then the study using these subjects should be abandoned. It may be that failure to find and contact the subjects means this study cannot go forward, and some useful or important information may be lost. It is not the case that the importance of the work automatically outweighs the means used to find the subjects merely because the technological means of locating the subjects are at hand. Poor initial planning and design by the PI are the reasons for the lost knowledge. That cannot be an excuse for the later unethical treatment of subjects.
From: Graduate Research Ethics: Cases and Commentaries - Volume 5, 2001 edited by Brian Schrag
The debate over the use of animals in scientific research, particularly when pain is inflicted, proceeds at both a general level and at the level of particular cases. (For discussions of some of the broader moral considerations in the use of animals in research see "The Gladiator Sparrow: Ethical Issues in Behavioral Research on Captive Populations of Wild Animals,"pp ... Read More
The debate over the use of animals in scientific research, particularly when pain is inflicted, proceeds at both a general level and at the level of particular cases. (For discussions of some of the broader moral considerations in the use of animals in research see "The Gladiator Sparrow: Ethical Issues in Behavioral Research on Captive Populations of Wild Animals,"pp 32-44; "Counting Sheep: Ethical Problems in Animal Research" pp. 82-96, and Changing the Subject," pp. 97-106, in Graduate Research Ethics: Cases and Commentaries, Volume 2 ).
Even if all were to agree that research on animals is sometimes justified, that would not settle the question of whether it would be justified in this case. We all recognize that there is no moral ground for gratuitously inflicting pain on animals. Thus in research experiments that involve inflicting pain on animals, the burden of proof must be on those proposing the experiment to show that the animals' suffering is somehow outweighed by the benefits of the experiment. A written scientific justification for any painful or distressing procedure to animals that cannot be relieved or minimized must be included in the Animal Study Protocol submitted to the Institutional Animal Care and Use Committee (IACUC).
In these comments, I will focus on this particular case, which raises a number of ethical issues. 1) Should the experiments have been done at all? What are the relative merits of the researcher's viewpoint and that of someone from the nonscientific community? 2) Even if the experiment is initially justified, is there a point at which it ought to be terminated, and if so, at what point? Related to this question is the issue of whether standards of certainty should be lowered when the cost of achieving involves infliction of pain on animals. 3) Should the protocol approved by the IACUC include points that trigger an evaluation of the decision to continue the experiment?
Aside from the experiment itself, the case raises issues about the researcher's interaction with his graduate student. 5) Is there adequate dialogue about experimentation on the animals and an atmosphere that encourages open dialogue? Should a lab that routinely experiments on animals have substantive introductory discussions with all entering graduate students on the ethical issues of research on animals in order to create an environment of ongoing dialogue in which students are free to raise issues?
Should the IACUC have approved this experiment? Eric wants to test a drug that might have potential therapeutic efficacy for humans, for example, to relieve pain in inflammatory bowel disease. Thus, the research appears to be on a topic of significance to human welfare. What is at issue is whether that significance outweighs the suffering of the animals in the experiment.
However significant the problem being investigated, one issue that is always relevant in research that inflicts pain on animals is whether or not a particular experiment is likely to yield useful information. It is troubling in this case that, after the experiment is approved, Eric's graduate student Michael does further research and finds data (of which Eric is apparently unaware) that suggest this drug "would not be an effective therapeutic agent against visceral pain and inflammation using the rodent model." Did Eric do an adequate literature search before proposing this experiment? Would the IACUC have approved this proposal had they been aware of Michael's findings? It is possible that the data Michael found were inconclusive and that in Eric's considered opinion, the data were not sufficient to discount the value of the investigation. Nevertheless, it appears that Eric was unaware of the data going into the experiment, and he ought to have a reason for discounting the data. Absent that, it does seem to weaken the case for doing the experiment.
It is also troubling that Michael finds an "alternate model of visceral no inception that is much less painful to the animal" (which again is something of which Eric is unaware or at least did not consider in developing his original protocol). Eric contemplates using the new model, but he decides to use the original model since the alternate is not widely accepted. Eric's judgment may be right, but it does raise questions about how thoroughly he researched the issue before designing the experiment and presenting his protocol to the IACUC.
Finally, the protocol specifies an intra-animal study where the same animals are used repeatedly as opposed to a between-animal study, which uses each animal only once, hence minimizing pain to any one animal but using more animals. One advantage of the former design is a reduction in the amount of variability in results since fewer animals are used. It may be that Eric is justified in using a model that gives results less subject to variability. This model may increase the certainty of the results, but at the cost of more pain to individual animals.
Suppose one grants that Eric's original design was justified. As the testing progresses, Michael gets inconclusive results. Eric assumes there is a procedural error in the experiment and asks for a repeat of the experiment. Michael again finds inconclusive results. Eric asks for the experiment to be repeated again.
Eric seems to be in denial about the findings of the experiment. One wonders how long he will continue to repeat the experiment if the results continue to be inconclusive. All science must deal with levels of certainty of results. In principle, the more one repeats an experiment, the more confidence one can have in the results. But at what cost should that certainty be purchased? There is a difference between the cost of increasing levels of certainty gained by repeating an experiment in inorganic chemistry, for example, and the cost of increasing levels of certainty when the experiment involves causing considerable pain to animals. The burden of proof is higher for justifying the value of incremental increases in levels of certainty of results when pain to animals is involved.
It is important to realize that the justification for a protocol of an experiment involving pain to animals at the beginning of an experiment may weaken as the results of the experiment come in. When one combines the literature results, which suggest this drug may not be efficacious, with the results of the first two trials, the justification for continuing the experiment may be weaker than the initial justification for the experiment. In an experiment involving infliction of pain on animals, it would be preferable to have some guidelines to indicate when it is no longer appropriate to continue the experiment.
Michael's obvious discomfort with the experiment and Eric's interaction with him suggests other concerns. If Eric is requesting a repeat of the experiment because he suspects Michael is not correctly performing the experiment, then, in light of the animal suffering involved, he has a responsibility to review procedures with Michael and to monitor Michael's work to ensure yet a third trial is not required because of errors on Michael's part. If there is nothing wrong with Michael's execution, then Eric's request for repeated work appears to be inappropriate pressure on Michael to get positive results. Michael may need some vehicle to raise the issue with Eric, and, if that fails, access to someone else to discuss the issue.
If this is a lab that routinely engages in experimentation with animals, it may be desirable to have initial faculty-graduate student discussions as graduate students join the laboratory, regarding the moral issues involved in research on animals as well as reporting new research on models for animal research and guidelines for research on animals. This setting would be appropriate for informing students of the proper procedures to follow if they have questions about the justification of particular experiments or experimental procedures involving animals. This forum would allow issues to be raised in a setting conducive to open discussion and not in the more threatening context of a professor's particular experiment. In this case, Michael would have had an opportunity to understand and evaluate the justification of various animal models before engaging in this specific research. Such a practice may also open lines of communication when students have a particular concern with a professor's experiment; in this case, that may have made it more comfortable for Michael to raise the issues with Eric. It may also open lines of communication when students have a particular concern with a professor's experiment.