D
Compensation Systems for Research Injuries

This appendix provides information about compensation systems for research injuries, including: (1) an account of existing compensation systems; (2) the history of past efforts to enact a national system; (3) the issues to be considered when setting up such a system; and (4) lessons to be learned from the experiences of existing compensation systems in the area of medical malpractice.

EXISTING COMPENSATION SYSTEMS

There is no comprehensive compensation program to cover injuries resulting from privately and publicly funded research. Current federal policy, which applies to federally funded research with "more than minimal risk" to participants, requires that institutions that maintain a compensation system must inform participants of its existence as part of the informed consent process (45 C.F.R. 46.116(a)(6)).

Some institutions have set up their own compensation systems, but many others lack formal policies on compensation but provide acute care for research injuries as a matter of practice. No agency within DHHS, including NIH, currently has a formal compensation policy for injuries resulting from extramural or intramural research. For intramural research, acute care for injuries is routinely provided.

Beyond acute care, however, an injured research participant's only recourse is legal action under the Federal Tort Claims Act (FTCA) (F.W.



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--> D Compensation Systems for Research Injuries This appendix provides information about compensation systems for research injuries, including: (1) an account of existing compensation systems; (2) the history of past efforts to enact a national system; (3) the issues to be considered when setting up such a system; and (4) lessons to be learned from the experiences of existing compensation systems in the area of medical malpractice. EXISTING COMPENSATION SYSTEMS There is no comprehensive compensation program to cover injuries resulting from privately and publicly funded research. Current federal policy, which applies to federally funded research with "more than minimal risk" to participants, requires that institutions that maintain a compensation system must inform participants of its existence as part of the informed consent process (45 C.F.R. 46.116(a)(6)). Some institutions have set up their own compensation systems, but many others lack formal policies on compensation but provide acute care for research injuries as a matter of practice. No agency within DHHS, including NIH, currently has a formal compensation policy for injuries resulting from extramural or intramural research. For intramural research, acute care for injuries is routinely provided. Beyond acute care, however, an injured research participant's only recourse is legal action under the Federal Tort Claims Act (FTCA) (F.W.

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--> Dommel, Office for Protection from Research Risks, personal communication, July 1993). For extramural research, the institutions conducting the research may formulate their own policies regarding compensation, including the option to offer none at all. Most provide acute care for research injuries, but the Office of Protection from Research Risks at NIH knows of no institutions that offer long-term care (F.W. Dommel, Office for Protection from Research Risks, personal communication, July 1993). Despite the lack of federal guidance in this area, some institutions and pharmaceutical manufacturers have set up compensation systems for research injuries. For example, the University of Washington, the public institution receiving the largest amount of federal biomedical research dollars, has had a liability insurance program that would extend to research injuries in place since 1976.1 But the University of Washington's program appears to be unique. Most research institutions require participants, as part of the informed consent process, to attest to private insurance coverage of medical costs resulting from research injuries (Kolberg, 1993). Pharmaceutical manufacturers typically have in-house compensation schemes that pay for medical expenses of injuries directly resulting from drug trials. Pharmaceutical companies also carry liability insurance that would probably reimburse them for loss if a participant brings a successful tort action against them. EFFORTS TO DEVELOP A NATIONAL SYSTEM There has been an ongoing debate since the 1970s about the merits of establishing a compensation system for all participants injured in research (Mariner, 1994). The Public Health Service (PHS) has examined the issue of establishing a compensation system for research injuries over a number of years. In the 1970s, NIH submitted three proposals to the secretary of the Department of Health, Education, and Welfare (HEW)2 that would have authorized the federal government to indemnify participants in research sponsored in whole or in part by federal funds for any medical and other expenses resulting from research injuries. None of the proposals was accepted.3 In 1973 an ad hoc panel of the assistant secretary for health (HEW), reviewing the Tuskegee Syphilis Study, recommended a no-fault compensation system (Mariner, 1994). Although no such system was established, HEW reached settlement agreements with all survivors and with some heirs of participants in the Tuskegee study. In 1975 HEW created a task force to look at compensation for research injuries resulting from federally funded, conducted, and regulated research. The task force recommended that human subjects who suffer physical, psychological, or social injury in the course of research supported by PHS should be compensated if the injury was caused by the research and "the

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--> injury on balance exceeds that reasonably associated with such illness from which the subject may be suffering, as well as with treatment usually associated with such illness at the time the subject began participation in research" (HEW, 1977:11-2). The task force recommended that participants in intramural research be covered by expanding the Federal Employee's Compensation Act (FECA)4 to include research participants. For extramural research directly supported by PHS, the task force proposed that institutions be required to offer assurance of compensation to each participant, with the compensation to be no less than that provided under FECA. If upon further inquiry the secretary found that it would not be possible for institutions to assure compensation for injured research participants, the task force suggested that FECA be expanded to cover compensation for these participants as well. For research that was regulated but not financially supported by PHS, the task force recommended that the FDA consider legislation that would enable them to require that compensation be made available to injured research participants (HEW, 1977). Drafts of legislation to amend FECA to include participants in research were sent to HEW Secretary Joseph Califano, and proposed regulations to implement the task force's recommendations were also prepared. The same week in August 1979 that Califano was scheduled to sign the proposed rules and forward legislation to the Congress, he was fired by President Carter (Kolberg, 1993). The issue was not picked up by his successor. After the task force released its report in 1977, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research endorsed the recommendations but, without further study, recommended only that subjects be told in the informed consent process whether or not compensation was available (Mariner, 1994).5 The secretary of HEW then asked the department's Ethics Advisory Board to look into the recommendations, but the board was dissolved before it could complete the task. Before its termination, the board requested that the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research continue to consider the issue of compensation. The commission concluded in 1982 that compensation for research injuries was ethically desirable, and suggested that HEW (by now, DHHS) conduct a trial of different forms of compensation systems. Several institutions were to receive federal money over a period of 3-5 years to cover the costs of providing some form of no-fault compensation to injured research subjects (President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1982). Although DHHS considered such experiments, it concluded that they were not feasible and decided not to initiate the trials (C. McCarthy, former director of OPRR, personal communication, July 1993).

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--> Recently there have been more efforts to investigate the possibility of compensation for injured research participants. In January 1993, the Recombinant DNA Advisory Committee (RAC) sent a letter to NIH Director Bernadine Healy, asking her to form a panel to look at covering medical costs of research-related, nonnegligent injuries. The letter stated that it was "unfair to expect individuals, their families, or their insurers to absorb unpredictable and potentially substantial medical costs arising out of these individuals' participation as research subjects" (Walters, 1993a). In a subsequent letter, the RAC appealed to Dr. Healy to ask the health care reform task force to address the issue of providing health care coverage for persons who are injured as a result of participating in clinical research (Walters, 1993b). The effort to investigate compensation for research injuries is not limited to the United States. Although countries with national health care systems generally do not face the same pressures to create a separate compensation system for research injuries (President's Commission, 1982), nevertheless two major international health organizations developed compensation recommendations. The same year the commission released its report, the World Health Organization (WHO) and the Council for International Organizations of Medical Sciences (CIOMS) issued their guidelines for human subjects research, which declared that volunteer subjects are entitled to full compensation for temporary or permanent disability or death. These guidelines also recommended that pharmaceutical manufacturers assume responsibility for injuries resulting from research they sponsor. A recently revised version of these guidelines (1993) states that every subject is entitled to equitable compensation, except for expected adverse reactions from investigational interventions to diagnose or prevent disease (Mariner, 1994). ISSUES IN DEVELOPING A NATIONAL COMPENSATION SYSTEM Professor Mariner, in her paper published in Volume 2 of this report, discusses a variety of compensation systems for research injuries and their advantages and disadvantages. Advantages of a federal compensation program include the ability of injured parties to get benefits more easily, because they are not required to go into court and prove fault; usually, they need only show plausible evidence that their injuries were research-related. Other advantages include a higher percentage of injured participants and offspring receiving compensation, as well as a higher percentage of each compensation award going directly to the injured party. In addition, the costs to administer the system are far less than those of litigation. These costs may be spread over all who benefit from the research

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--> enterprise, particularly if the program is funded through general tax revenues (Mariner, 1994). Disadvantages to a compensation system include the difficulty that some claimants may have showing the causal relationship between their injuries and the research. This would be particularly relevant in the case of offspring injuries, where causation is often nearly impossible to prove. In addition, the existence of a compensation system may result in more people making claims under the system than would have otherwise pursued recovery through the courts. This may indicate a real need for the program; but it may also result in an unjustifiable rise in program costs, because people can misjudge the cause of their injuries (Mariner, 1994). The issues to be considered in developing a compensation system are numerous and complex. One crucial issue that must be resolved is determining who and what gets compensated (Mariner, 1994). For example, should the compensation system be available to all research participants, or only those participating in research for which they receive no health benefits? The issues are arguably more complex if offspring injured by a parent's participation in a clinical trial are to be included in the system. For example, if the parent consented to research after being adequately informed, is an offspring injury still eligible for compensation? Would the system cover injuries to offspring in protocols where the parent agreed to use contraception, and subsequently used inadequate contraception or none at all? Once it is determined who is to be compensated, the next question is: what injuries will be eligible for compensation? The resolution of this issue is particularly important for offspring injuries, because their injuries are often discovered many years after the research protocol is complete. The section below discusses three specific examples of compensation systems set up to alleviate medical malpractice concerns, and it demonstrates the relative advantages and disadvantages between setting up a system with a broad base of compensable events and restricting the system to specific types of injuries. Another important feature of any compensation system is the extent of the benefits available to eligible participants. The current tort system provides the most generous compensation available, with benefits ranging from recompense for physical injuries and lost wages to pain and suffering and, occasionally, punitive damages (Abraham, 1988). But since a compensation system offers some benefit to the participant in the rapid recovery of damages with administratively easy procedures, the participant is in turn asked to forego full recovery. The resolution of the question of benefits requires a compromise between the desire to be fair to the participant and the need to create a system that will remain fiscally solvent over time. Any compensation system necessarily limits recovery relative to what a plaintiff could gain pursuing a claim through the tort system, which creates some question

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--> of horizontal justice: persons suffering injury from other causes can recover full tort damages, whereas those injured through research are entitled to limited recovery (Abraham, 1988). This concern would be alleviated, however, by allowing injured research participants to elect the system in which to pursue recovery. In addition, a decision must be made about whether the system will be applied retroactively or only to prospective participants (Mariner, 1994). A related issue to the scope of benefits is the payment mechanism. Built into any compensation system is a structure for paying out benefits. Under a third-party insurance scheme, groups and individuals involved in the conduct of research would be required to obtain private insurance to cover research injuries. If a system requires first-party insurance, the participant is required to purchase insurance before entering a clinical study. Under a social insurance system, the government would insure or reinsure individuals or groups conducting research against the costs of research injuries. Finally, patient compensation funds could serve as the available pool of money for compensating research injuries, for which contributions may be exacted from the various groups involved in the conduct of research (Abraham, 1988). How the system would be administered is also a critical consideration. To some extent it will be governed by the payment mechanism selected. For example, a third- or first-party insurance-based system will likely be administered by an insurance company. If the system is government-sponsored, an agency will need to be set up to handle the claims. Within issues of administration are concerns about the participants' right to appeal any decisions not to compensate (Mariner, 1994). Although in theory the creation of a compensation system for research injuries appears to be a worthwhile endeavor, it is by no means an uncomplicated solution. As demonstrated above, the complexities involved in setting up a compensation system are numerous, and decisions made in structuring the system have direct implications for how fairly the compensation system will meet the burden of research injuries. EXAMPLES OF COMPENSATION SYSTEMSIN THE AREA OF MEDICAL MALPRACTICE The debate about tort reform in the area of medical malpractice has been an active one for more than a decade. Given the similarity in legal issues between medical malpractice and liability for research injuries, examples of medical malpractice reform efforts may be particularly instructive to any consideration of a compensation system for research injuries. This section discusses the advantages and disadvantages of three examples:

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--> the birth injury compensation systems in Virginia and Florida, and the National Vaccine Injury Compensation Act. Virginia and Florida During the late 1980s, legislatures in Virginia and Florida enacted narrowly circumscribed no-fault compensation schemes to alleviate insurer concern about particularly high damage awards in cases where infants sustained severe, disabling neurological injury during the delivery process. Under the Virginia Birth-Related Neurological Injury Compensation Act (Va. Code §§ 38.2-5000 et seq. [1990 Real. Vol.]), an infant sustaining ''birth-related neurological injury," as defined in the act, is entitled to payment for medical, rehabilitative, and residential expenses not recoverable from any governmental program or private insurance. The infant also receives reasonable expenses of filing a claim and a scheduled amount for loss of earnings between ages 18 and 65. Eligibility for compensation also depends on whether a child was delivered by a "participating physician" or in a "participating hospital." Damages are not recoverable for pain and suffering. In circumstances where the act applies, the remedies it provides are exclusive, supplanting the tort system. One distinguishing element to Virginia's system is its very limited applicability. Even after an amendment that broadened the act's original definition of "birth-related neurological injury," it remains very limited in scope. In addition, the act requires that the disability must cause the infant to be "permanently in need of assistance in all activities of daily living." As a result of the narrow scope of coverage, by mid-1993 only four claims had been paid under the Virginia Act. The Virginia scheme is financed through annually assessing physicians and hospitals, with possible surcharges against insurers should that become necessary. Currently every physician in the state is assessed $250 annually.6 "Participating physicians" pay $5,000 and "participating hospitals" pay according to the number of live births in their facility during the previous year. Florida's no-fault compensation scheme was modeled largely on the Virginia law. Its definition of "injury" is different, however, and far more claims have been paid under Florida's act, even though it has been in operation for less time. This may well be not only because of the somewhat less restrictive definition but also because Florida provides for a lump-sum payment of as much as $100,000. All hospitals are required participants under the Florida act.

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--> National Childhood Vaccine Injury Act The National Childhood Vaccine Injury Act (42 U.S.C.A. § 300aa-1 to -33 [1989]) was enacted by Congress to provide payments to children suffering harm through vaccine-related accidents on a "no-fault" basis. The ostensible purpose was to assure that vaccine production would continue. Before passage of the act, the costs of liability for vaccine-related injuries were grossly out of proportion to the profits manufacturers derived from the sale of vaccines. Under the act, an injured party must first file a claim with the Department of Health and Human Services. The injuries eligible for compensation are strictly prescribed, and the likelihood of receiving compensation depends on whether the injury appears in the Vaccine Injury Table. The major advantage of the act is that once a claimant demonstrates an injury from the Vaccine Injury Table, he or she is eligible to receive compensation for damages; there is no need to show that anyone was negligent. The damages are limited, however, including only actual costs of treatment not covered by public or private insurance and attorneys' fees, with caps on damages for pain and suffering (Clayton and Hickson, 1990). Children whose injuries do not appear in the table must show that the vaccine actually caused their injuries, which can be difficult to prove. If a compensation award is offered and the family accepts it, they may not pursue a legal action in tort against the vaccine manufacturer or the physician. If the family chooses not to accept the award (or if the claim is rejected as ineligible for compensation), the family may pursue recovery through the tort system (Clayton and Hickson, 1990). The advantages of the act include the guarantee of some measure of recovery for eligible children, without the delays and often prohibitive requirements of the tort system—for example, the need to prove negligence. Because of the choice to limit the compensable injuries, however, there may be injured children who receive no compensation. In addition, the Congressional Budget Office estimates that 220 vaccine-related injuries occur each year (Clayton and Hickson, 1990, citing H. Rep. No. 100-391, 100th Cong., 1st Sess. 693-4 [1987]). But there is a limit of 150 awards a year, which means that the act will lapse unless Congress steps in to provide more funds (Clayton and Hickson, 1990). Thus, there is reason to be concerned that the system could collapse under the weight of eligible claims. NOTES 1.   The coverage, provided on a no-fault basis, has an upper limit of $10,000, is limited to expenses from physical injuries, and applies only to injuries to healthy, normal participants (H. McGough, Human Subjects Di-

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-->     vision, University of Washington, personal communication, June 1993). As a condition of accepting reimbursement for physical injuries, the participant waives the right to seek legal action in tort against the university. In the past five years there have only been three or four claims for compensation, and the university has paid less than $2,000 in compensation for injuries (E. Cherry, Risk Management Office, University of Washington, personal communication, June 1993). 2.    The health and welfare components of HEW are now the Department of Health and Human Services (DHHS). 3.   The proposals were rejected for one or more of the following reasons: the social and fiscal implications of the proposal had not been adequately investigated, alternatives to a federal compensation program had not been examined, and the extent of the problem had not been fully defined (HEW, 1977). 4.   FECA is the statute that specifies limited levels of compensation for federal employees who are injured in the course of their work. 5.   This recommendation was incorporated into the federal regulations governing human subjects research (45 C.F.R. section 46.116(a)(6)). 6.   There are exceptions for retired physicians and others working in free clinics. See Va. Code section 38.2-5020.D (Cum. Sup. 1992). REFERENCES Abraham, K.S. 1988. Medical liability reform: A conceptual framework. Journal of the American Medical Association 260(1):68-72. Cherry, E. 1993. Conversation of D. McGraw with E. Cherry, head of risk management office, University of Washington. June 1993. Clayton, E.W., Hickson, G.B. 1990. Compensation under the National Childhood Vaccine Injury Act. The Journal of Pediatrics 116(4):508-513. Dommel, W. 1993. Conversation of D. McGraw with William Dommel of NIH on compensation for research injuries (July 6). Edwards, L.D. 1992. Design and Conduct of Research in Women: To Include or Exclude: A Pharmaceutical Industry Physician's Perspective. Monograph prepared for NIH Office of Protection from Research Risks. HEW Secretary's Task Force on the Compensation of Injured Research Subjects. 1977. Washington, D.C. U.S. Department of Health, Education and Welfare (HEW). Kolberg, R. 1993. RAC asks, who should pay for research injuries? The Journal of NIH Research 5(February):36-38. Mariner, W.K. 1994. Compensation for research injuries. In: Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, A. Mastroianni, R. Faden, and D. Federman, eds., Washington, D.C.: National Academy Press. McCarthy, C. 1993. Personal communication by D. McGraw with C. McCarthy, former director, Office of Protection from Research Risks (July). McGough, H. 1993. Conversation of D. McGraw with H. McGough, Human Subjects Division, University of Washington (June). President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. 1982. Compensating for Research Injuries: A Report on the Ethical

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--> and Legal Implications of Programs to Redress Injuries Caused by Biomedical and Behavioral Research. Volume 1. Washington, D.C.: Government Printing Office. Walters, L.B. 1993a. Letter from Dr. LeRoy B. Walters, Chair, Recombinant DNA Advisory Committee, to Dr. Bernadine Healy, Director, National Institutes of Health. January 6, 1993. Walters, L.B. 1993b. Letter from Dr. LeRoy B. Walters, Chair, Recombinant DNA Advisory Committee, to Dr. Bernadine Healy, Director, National Institutes of Health. June 28, 1993. STATUTORY AND REGULATORY REFERENCES 42 USCA §300aa-1 to -33 (1989) 45 C.F.R. 46.116(a)(b) Va. Code Sections 38.2-5000 et seq. [1990 Real. Vol.]