Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1 (1994) / Chapter Skim
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Appendix D: Compensation Systems for Research Injuries
Appendix D: Compensation Systems for Research Injuries
Pages 243-252
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From page 243... ...
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.
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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, 19931. Pharmaceutical manufacturers typically have in-house compensation schemes that pay for medical expenses of injuries directly resulting from drug trials.
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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~.
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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, 1 993b)
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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.
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EXAMPLES OF COMPENSATION SYSTEMS IN 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.
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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.
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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.
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Monograph prepared for NIH Office of Protection from Research Risks. HEW Secretary's Task Force on the Compensation of Injured Research Subjects.
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LeRoy B Walters, Chair, Recombinant DNA Advisory Committee, to Dr.
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