Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies: Volume 2: Workshop and Commissioned Papers (1994) / Chapter Skim
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15 Compensation for Research Injuries
15 Compensation for Research Injuries
Pages 113-126
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From page 113... ...
limit liability for sponsors of research and (23 compensate research subjects, when women are used as subjects of research. This definition of the subject seems loaded win 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.
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From page 114... ...
Ethical Reasons Since the 1960s, individual commentators,3 and national commissions have agreed that the ethical principles of justice and virtue support, if not require, compensating research subjects who are banned as a result of participating in research. The ad hoc panel created by the federal government's Department of Health, Education, and Welfare MEWS 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
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From page 115... ...
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 smcalled "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.
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From page 116... ...
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.
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From page 117... ...
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.
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From page 118... ...
Liability for injuries to the children of women research subjects appears to raise fears of substantial financial exposure in some research sponsors.~4 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.~5 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.
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From page 119... ...
They are grouped into three categories: tort liability; mandatory compensation programs; and voluntary or contractual compensation systems. Tort Liability 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.
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From page 120... ...
Mandatory Compensation Systems The tenn "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) .2~ The Federal Employees' Compensation Act PECAN is the federal equivalent of state workers'
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From page 122... ...
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 injures after they occur.
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From page 123... ...
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 suffenog) in the event of a research-related injury.
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From page 124... ...
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 nofault compensation program funded by tax revenues (including taxes on research institutions)
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From page 125... ...
Proposed International Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland: CIOMS, 1982.
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From page 126... ...
167 (1987) (Michigan Statute prohibiting minor child from disaffirming arbitration agreements executed by parent on child's behalf held to bind child born after parental consent to arbitration)
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