Compensation for Research Injuries
Wendy K. Mariner
I have been asked to discuss the advantages and disadvantages of alternative ways to (1) limit liability for sponsors of research and (2) compensate research subjects, when women are used as subjects of research. This definition of the subject seems loaded with assumptions: first, that liability is interfering with important research that will benefit women; and second, that women research subjects, or their future children, will suffer great harm as a result of research.
These two assumptions do not coexist comfortably. If liability is preventing sponsors from doing research that will produce an important benefit for women, then the presumption is that liability is not justified and that the research does not pose great risks to women or their children. In that case, there should be little, if any, need to compensate injuries because there will not be any. On the other hand, if women and children suffer great harm that warrants compensation, then the research must be dangerous. If the research is dangerous, then one must ask whether it is really sufficiently beneficial to justify its being done at all.
A compensation system is sometimes seen as a substitute for tort liability. If people want to avoid liability for injury, they may propose a compensation system to take the place of individual liability. Of course, tort liability is itself one kind of compensation system. So the threshold question is whether any compensation is warranted for particular injuries.
REASONS FOR COMPENSATION
Reasons for compensating injured research subjects tend to fall into three categories: economic, ethical, and political.
The economic reason derives from the concept of risk-spreading and the economic theory that the costs of injury should be borne by the person who can best and most efficiently afford them.1 When injuries occur, there are only two choices: (1) to leave the losses where they lie—with the injured person; or (2) to shift the financial losses to another person—the person who caused the injury, if any, or society as a whole. In most instances, economic theory would favor shifting the losses to a research sponsor or institution2 because these ordinarily have greater resources than an individual research subject and they can recoup the losses by means of increased prices or other revenue-generating mechanisms. However, given the rarity of research injuries, it is possible that the administrative costs could exceed the efficiency gains of loss shifting.
In practice, economic theory rarely controls policy choices concerning the allocation of losses. Rather, social conceptions of moral rights and duties influence who should bear the financial consequences of different types of injury. This brings us to the second reason for compensating research subjects—ethical principles.
Since the 1960s, individual commentators,3and national commissions have agreed that the ethical principles of justice and virtue support, if not require, compensating research subjects who are harmed as a result of participating in research. The ad hoc panel created by the federal government's Department of Health, Education, and Welfare (HEW) to review the Tuskegee Syphilis Study recommended a no-fault compensation system in 1973.4 The HEW Task Force on the Compensation of Injured Research Subjects recommended compensating injured subjects of research conducted or supported by the Public Health Service in 1977.5 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, created in 1974, generally endorsed the Task Force's recommendations, but, without studying the issue, recommended only that subjects be told whether or not compensation was available.6
In 1982, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research found that compensation is appropriate and desirable, but, given the small number of serious injuries arising
out of research, could not determine whether there was a need for it.7 The Commission recommended conducting an experiment to evaluate different compensation systems in pilot settings to see whether their transaction costs and vulnerability to abuse would outweigh their benefits. Unfortunately, no such experiment has been conducted and we have little more information today than the Commission obtained in 1982.
Later in 1982, the World Health Organization and the Council for International Organizations of Medical Sciences issued their Proposed International Guidelines for Biomedical Research Involving Human Subjects based on the World Medical Association's Declaration of Helsinki.8 The brief Declaration of Helsinki, adopted in 1964, and revised most recently in 1989, has never required compensation for research injuries. The 1982 Proposed Guidelines, however, provided that volunteer subjects are entitled to financial or other assistance to compensate them fully for temporary or permanent disability or death; and endorsed compensation for all research subjects, noting that pharmaceutical manufacturers should assume responsibility for injuries resulting from research they sponsor. A revised version of the Guidelines issued in 1993 states that every subject is entitled to equitable compensation.9 It does make an exception for expected adverse reactions from "investigational therapies or other procedures performed to diagnose or prevent disease." Presumably, this absolves research sponsors of a duty to compensate foreseen adverse reactions in so-called "therapeutic research."
In the United States, no law requires special compensation for research injuries, apart from general tort law principles that apply to everyone. But this could change. In December 1992, for example, Recombinant DNA Advisory Committee of the National Institutes of Health requested the NIH Director to convene a study of how research related nonnegligent injuries should be compensated.10
There appear to be three points of view on the issue:
That compensation is morally required and not providing it is unjust.
That compensation is morally desirable as a charitable act, but not required.
That special compensation is not morally required and may even be unjust.
Which point of view one takes depends upon one's conception of research and research subjects. Swazey and Glantz argue that society's conception of its ethical obligation to research subjects may vary depending upon whether subjects are seen as altruistic heros, giftgivers, victims, or willing contractors who assume the risks of research.11 Heroes volunteer and assume risks for someone else's sake. Since heroes are not supposed to seek any reward, society has no
obligation to compensate heroic research subjects. It may wish to reward them, however. Similarly, research subjects can be seen as giving a gift to society. Although such donors may not be morally entitled to compensation, society may desire to return the favor by compensating their injuries. Victims appear more entitled to assistance, since the idea of victim connotes someone who has been misused without his consent, such as the Tuskegee Syphilis Study subjects.12 Victims have a strong moral claim to compensation, especially where society has facilitated the research or benefitted by it. A contractor conjures up the image of a businessman making a bargain, but this suggests that a contractor is entitled to no more than what he or she bargained for, as long as the bargaining process is fair.
These different images lead to two different conceptions of society's obligation. Under the first, which focuses on principles of distributive justice, society has a strong obligation to compensate injured research subjects and not doing so is unjust. Under the second, which focuses on respect for persons and autonomous choices, society has at best a privilege to compensate and not doing so is merely uncharitable, not unjust.
The principle of distributive justice requires that those who take the risks of research should receive the benefits. But the successful product of a research study rarely reaches all the subjects. Compensation is a means of redressing the imbalance between the risks undertaken by research subjects and the benefits that others enjoy as a result. Since most legitimate research is intended to benefit society as a whole, the subject assumes risks for society's sake (some would say making a gift to society). Therefore, society has a moral obligation to make the injured subject whole by compensating those who took the risks and suffered thereby. In addition, it may be argued that where society conducts, supports, or sponsors research, it voluntarily assumes an obligation to compensate those who are injured in its enterprise.
The second conception denies any social obligation to compensate injured research subjects. This view, based on respect for autonomous choices, argues that a research subject who voluntarily participates in research has agreed to assume the risks of research and that providing compensation would be wrong because it does not respect the subject's choice. Insistence on the voluntary consent of the research subject therefore undercuts the subject's claim to compensation. The consent form can be seen as a contract, whereby the subject voluntarily gives up any claim to compensation. Indeed, this is the way in which many consent forms are treated in law.
Women have sometimes pressed their demands to participate in research on the grounds that they are autonomous agents who are morally entitled to make their own decisions about the risks they will assume, especially when they believe they might obtain some benefit thereby. This insistence on autonomy can be turned against women. If the subject assumes the risk, she may forfeit any
moral claim to assistance if the risk materializes.
There are two problems with this view, one theoretical, and one empirical. First, it may not be fair to presume that by consenting to participate in research, a subject has assumed the financial risks of injury in addition to the physical or medical risks. Moreover, it may be unfair even to ask a subject to assume the financial risks. There are some things, like slavery, that no one is permitted to agree to. The fact that some research may potentially benefit individual subjects does not alter this conclusion. The nature of potential benefits—both to individual subjects and to general knowledge—is relevant to determining whether the research itself is justifiable. But the mere fact that the research is justified because the potential benefits outweigh the potential risks does not dispose of the question whether the subjects must automatically assume the financial consequences of risks they suffer. Potential benefits of research are not a form of compensation for injury.
The empirical problem is that the ideal of perfectly informed, understanding, voluntary consent to participate in research is rarely achieved in practice. Pressure—and sometimes coercion—to participate, the complexity of research, and difficulty in making it understandable work against achieving the ideal. We also do not know whether subjects would consent to waive compensation for injury since they are rarely given the choice. Finally, one can only assume risks of which one has knowledge, so that it seems wrong to presume that anyone would assume financial responsibility for risks that were unknown or unknowable at the time the research began. Although most research consent forms point out that unknown risks are possible, it is unlikely that research subjects really believe that serious injury from unforeseen causes could occur to them.
For these reasons, the view that society has a moral obligation to compensate injured subjects is more persuasive than the view that society has no such duty. Moreover, even if there is no moral duty, society is entitled to choose to provide compensation if it believes it to be beneficial.
The third category of reasons for providing compensation is political. This is the idea that liability for injuries somehow prevents someone from conducting important research that should be done. A compensation system is frequently proposed to relieve research sponsors of the responsibility for providing compensation, thereby eliminating an obstacle to research. It is thus a policy solution to a possible policy problem. However, the reality of the problem is rarely tested.
Liability for research injuries is a problem only if research organizations are
ready, willing, and able to conduct socially beneficial research, but for the costs of liability litigation and awards. In the absence of adequate data on liability claims experience from research sponsors, it is impossible to determine whether liability for injuries is a prohibitive financial drain. What few data exist suggest that the current situation differs little from that found by the President's Commission in 1982:9
The incidence of serious injury and the absolute numbers of people seriously injured are small.
Most injuries are trivial in nature and require no medical intervention.
Of those injuries that require intervention, most are only temporarily disabling.
Patient-subjects in therapeutic research are more likely than normal subjects in nontherapeutic research to suffer injury.
In view of the rarity of research injuries, it is pertinent to ask whether there is any need either to limit liability or to assure special compensation to women research subjects. Answering that question requires answering the following two questions: What might research sponsors be held responsible for, and what have research sponsors been held liable for?
Research sponsors might be held liable for injuries resulting to either women subjects or their later—born children. There appears to be little concern about potential claims by women who are injured as a result of participation in research.13 There is no reason to believe that women are more likely to be injured in research than are men. To the extent that women become a larger proportion of research subjects and make any claims for injury, their claims will merely replace claims that would have been made by men. The small number of such claims suggests that this has not posed a problem for research institutions to date.
Liability for injuries to the children of women research subjects appears to raise fears of substantial financial exposure in some research sponsors.14 Although tort law has changed over the past 30 years to permit children to sue for some prenatal injuries, the causes of action available to children remain limited.15,16
Most involve cases of malpractice by a physician or laboratory actively involved in treating a woman patient, and have no application to research sponsors. Although few drugs have been tested in pregnant women, many drugs have been prescribed for women, both pregnant and not pregnant, and one would expect to find a sampling of adverse reactions to such drugs, perhaps even more than to drugs that had been tested in pregnant women before marketing. However, there are few reported product liability cases alleging injury to a fetus and these are largely confined to intrauterine devices and three drugs:
thalidomide, DES, and bendectin. In some of these cases, like DES, it is hard to argue that there should be no liability. Moreover, these cases involve drugs that were intended to preserve pregnancy and fetal health, so that the fetus can be seen as an intended beneficiary of the drug and a foreseeable victim of injury.
The dual concerns about liability and compensation seem to arise out of the idea that people who are injured as a result of research (or anything else, for that matter) deserve compensation, but that the sponsors of research should not be responsible for all of the injuries or compensation. This is because many adverse reactions suffered by research subjects are unforeseeable even with the best scientific knowledge and preclinical testing. In such cases, it seems unfair to blame research sponsors for not preventing what they could not reasonably predict. Yet it also seems unfair to leave the entire financial burden (as well as the physical one) on someone who would not have been injured but for participating in the research. In such circumstances, it is reasonable to create a system apart from liability in tort to provide compensation. It also means, however, that research sponsors should only be protected against liability for nonnegligent conduct; they should remain liable for negligent conduct that causes injury. This is because negligence is, by definition, deviation from acceptable standards of conduct. Because negligence is not an intended part of any research, it is not an inherent risk of participating in research. People cannot consent to negligent treatment and research sponsors, like everyone else, remain responsible for injury caused by their own negligence.
TYPES OF COMPENSATION SYSTEMS
There are many ways to provide compensation for research injuries. Choosing among them depends upon the goal sought to be achieved. Following is a summary of the basic policy options (which can be varied to suit specific objectives), what they are designed to accomplish, and their major advantages and disadvantages. They are grouped into three categories: tort liability; mandatory compensation programs; and voluntary or contractual compensation systems.
Tort law functions, among other things, as one type of compensation system—an indemnity system that makes an individual company or institution responsible for the losses incurred by particular individuals. Historically, it has tied financial responsibility to moral responsibility for injury.17 More recently, however, liability has also been justified by economic considerations, imposing financial responsibility upon the entity that benefits from an injury-producing
enterprise or the entity that can avoid accidents most cheaply.18
Limiting liability is not a compensation mechanism, but a cost control measure for research sponsors. Its purpose is to reduce or eliminate financial responsibility for injury in instances in which it is believed that imposing liability on someone is either unjust or unfairly costly. There are three general ways to limit liability for research injuries. The first and broadest is to change tort law to eliminate liability for (nonnegligent) injuries resulting from research. This seems unwarranted in the absence of evidence that research in general gives rise to excessively costly litigation.
If the goal is to reduce the cost of claims from fetuses harmed as a result of research using women subjects, then an alternative would be to change tort law to eliminate specific liability for (nonnegligent) injuries only to such fetuses. Both alternatives guarantee reducing the cost of research, although the absolute amount of savings may be quite small. In both cases, however, it is difficult to justify withdrawing the tort remedy from one class of injured people (those harmed by research) while it is preserved for other classes. (This problem of horizontal justice or equity obtains for most policy options directed at one group.)
A third option is to have the law explicitly recognize that a woman's voluntary, understanding consent to participate in research precludes any claim on behalf of her later-born children that the research harmed them. Where the research is intended to benefit women (as opposed to fetuses or children), there is a good argument that a pregnant woman should be entitled to participate without regard to its effects on the fetus, and that the fetus should not interpose a claim that would discourage the woman from acting in her own best interest. It is also consistent with the idea that women should be free to participate in research regardless of the risk to future children. It is more difficult to ethically justify precluding a cause of action to the fetus, however, where the research is intended to benefit fetuses, as in investigational fetal surgery. As with the first two options, this alternative would probably require state legislation since tort rules are a matter of state law.19 This raises the practical problem of ensuring consistent laws in all 50 states, the District of Columbia, and the territories. Finally, the major disadvantage of these options is that none offers any assistance to the injured party.
Mandatory Compensation Systems
The term ''compensation system'' is more often associated with a public program established by state or federal government, such as workers' compensation programs, the federal Black Lung Benefits Act,20 or the National Vaccine Injury Compensation Program (NVICP).21 The Federal Employees' Compensation Act (FECA) is the federal equivalent of state workers'
compensation programs, and provides compensation for federal civilian employees who are injured in the performance of their employment.22 It has been extended to apply to other persons who have some connection with the federal government but are not employees, such as Peace Corps and VISTA volunteers and Job Corps participants. The National Institutes of health has considered the possibility of federal legislation to allow FECA to cover pregnant women research subjects and their later-born children.
Most of these programs offer compensation for injuries resulting from specific causes on a no-fault basis. As long as the injury is demonstrated to result from the specified cause (employment, in the case of workers' compensation; listed vaccines, in the case of the NVICP; and black lung disease in coal miners, in the case of the Black Lung Benefits Act), there is no need to prove negligence or fault in order to recover the available compensation.
No-fault compensation programs offer several advantages over tort litigation. A larger proportion of injuries receive compensation. The costs of administering the system are often less than those of litigation, and a larger percentage of the funds go to the injured parties. There are no "defendants," so parties that might otherwise be liable for injury need not participate in the claims determination process. Finally, the costs are often spread over society, rather than falling randomly on a few institutions. The program can be funded from general tax revenues, as is most appropriate when society as a whole benefits from the activity being protected. Or, where it is important to retain some financial penalty for risk creation, those who create the risks (such as research sponsors) may finance all or part of the system by special taxes.
Compensation programs have disadvantages, however. Any cause-based system raises questions of horizontal justice. As more compensation systems are devised for injuries resulting from particular activities, it becomes more difficult to defend excluding the remaining population of injured people. Those who feel left out may seek to fit their injuries within the definition of compensable harms of special programs. The existence of a compensation program also may attract more claimants than would otherwise seek compensation for their injuries. This may mean that there is a real need for the program. It may mean, however, that people are misattributing accidental injuries to their research experience, and it may raise costs unacceptably high.
Finally, no cause-based system can avoid disputes over the cause of injuries.23 Determining the cause of injury to a research subject may be even more difficult than finding the cause of other injuries. Most serious research injuries happen to patients who are subjects of therapeutic research, and distinguishing research-related harm from disease-related injury is likely to be especially problematic. Thus, a compensation system for research injuries may offer little savings in time or complexity over litigation.
A fault-based system has the same advantages and disadvantages as a no-fault system, plus an additional disadvantage: the requirement that a claimant
prove that someone was negligent or otherwise legally responsible for the injury. In effect, a special compensation system based on fault or negligence, such as the American Medical Association's proposal for malpractice, transfers the litigation process to a more congenial and possibly more efficient and less expensive forum.
It should be remembered that compensation programs only compensate injuries after they occur. They are not risk prevention or quality assurance mechanisms. If risk prevention is an important goal of research, as it should be, then some other mechanism must be in place to assure that subjects are not placed at any unnecessary risk.
If a compensation system is an appropriate policy option, then the following programmatic issues must be resolved:
Eligibility: Whether to compensate all subjects or only those in "nontherapeutic" research (and whether the therapeutic/nontherapeutic distinction is meaningful for this purpose). Whether to establish geographic or other limits on the characteristics of eligible subjects.
Covered injuries: Whether to provide compensation for all injuries or only for "serious" injuries (however defined) or injuries producing a minimal financial loss. Whether to cover latent injuries arising in the distant future.
Benefits: Whether to reimburse (in addition to medical expenses) actual and estimated losses (e.g., a percentage of individual's wages) or provide a standardized payment (e.g., a percentage of average nonfarm wages) regardless of individual resources. Whether to offer compensation for pain and suffering, and for attorneys' fees incurred.
Payment mechanism: Whether to pay compensation in a lump sum award, in periodic payments, or by means of an annuity (all necessitating estimating future needs) or by means of enrolling the injured party in a medical or disability insurance system.
Administration: What institution should be authorized to make decisions about eligibility for compensation and the amount of awards (e.g., an administrative review board or a court-based procedure).
Review and appeal: Whether claimants should have a right of appeal to the court system or only administrative review of decisions.
Application: Whether the system should have only prospective application or should also apply retrospectively to cover claims of injuries before the effective date.
Ultimately, the fairest compensation system is one that covers all injuries, regardless of cause. This is the only system that avoids the claim of injustice that arises from preferring some injuries over others. It is also likely to be administratively less complex and less expensive than multiple cause-based
compensation programs. The more cause-based programs that are advocated, the stronger becomes the case for a universal disability assistance or insurance system. The proposed reform of the health care system promised by the Clinton administration suggests that medical care should become available to all in the future. This should obviate the need for special compensation for medical expenses. It should be noted, however, that the reformed health care system will not necessarily cover injuries resulting from research.
Voluntary and Contractual Systems
Another alternative system for compensating injury is the contract model. The best-known version is that advocated by Professor Jeffrey O'Connell.24 Applied to research, it would have the research sponsor contractually agree with each research subject, before enrollment, that the sponsor would pay for medical care and some specified losses (usually not including pain and suffering) in the event of a research-related injury. In return, the subject would agree to accept those payments as full compensation and waive any right to sue the sponsor in tort. Ordinarily, there is a time limit in which the sponsor must offer the specified compensation after being notified of a claim.
A contract has the advantage of letting subjects know what they are entitled to before they agree to enroll in a research study, and promises relatively prompt resolution of claims. It has reportedly worked reasonably well in some settings, like school football injuries. However, it is more difficult to predict how it would work with research-related injuries, especially where cause is an issue. Since the sponsor's offer is intended to be less than the complete compensation contemplated by tort law, it might prove less expensive than litigation. However, it is not clear whether research subjects can fully appreciate what they are gaining and giving up when asked to enter into such a contract, and therefore whether it is fair to ask them. While healthy volunteers may feel free to consent or refuse, subjects in therapeutic research may feel pressured to agree to anything.
Some institutions have voluntarily created a compensation system to assist injured research subjects, although not all have told the subjects about them. These may be funded out of the institution's own assets or by commercially purchased insurance. As long as only a few institutions offer such compensation, it may be uneconomic for insurance companies to sell coverage to individual institutions, unless they are very large, since the administrative costs could overwhelm actual payouts. An alternative would be for a group of institutions to create a pooled self-insurance scheme. This would both spread the risk and retain the advantages of self-insurance. Administrative costs should also be minimal.
These voluntary efforts are likely to produce the least expensive
compensation system because they substitute an insurance-claims type of procedure for litigation. The disadvantage is that the compensation available is likely to vary from institution to institution, raising questions of horizontal justice.
If a compensation system is desired, which one is chosen depends upon the goal to be achieved. If the goal is merely to avoid or reduce claims of liability against research sponsors, then the most effective response is not a compensation system at all, but elimination of that liability. This, however, requires a justification for excluding research subjects from a remedy to which everyone else is entitled. If the goal is to compensate all significant injuries resulting from research at the least cost, then the most cost-effective solution would probably be to have research sponsors provide voluntary compensation on a no-fault basis, possibly funded by a self-insurance pool. If the goal is to shift the responsibility for research injuries to society as a whole, regardless of cost, then a federal no-fault compensation program funded by tax revenues (including taxes on research institutions) would serve.
There is really only one reason to adopt a compensation program—recognition of society's ethical obligation to repay those who suffer harm by assuming the risks of socially beneficial research. If society does not feel an ethical obligation to compensate research subjects itself, it may conclude nonetheless that such compensation is the proper responsibility of those who benefit most directly from the research—the sponsors of the research. The cost of compensating injuries can be seen as an ordinary cost of conducting research.
What compensation is not is a panacea for fears about liability. Neither is it a guarantee that important research will be done. It would be a mistake to assume that important research to improve women's health will miraculously begin if a compensation program is adopted. Women who are anxious to participate in research should remember that research is not risk free. There are reasons why people worry about research injuries. Our recent experience has been rather positive, with few serious adverse reactions. But history is full of examples of abusing people in the name of research: the Nazi doctors' experiments, the Tuskegee Syphilis Study, the Willowbrook hepatitis B study, to name only a few. The risk of mistreating research subjects by involving them in experiments that should not have been done at all or involving them without their consent is far higher than the risk of injury in a justifiable study. Although the issue of compensating research subjects is important, it is secondary to the question of what research should be done.