One of the key questions that will require more sophisticated research is the portion of participant illness and injury attributable to the research itself versus the underlying condition of the participant, and the ease with which such determinations can be made. These determinations pertain to the basic issue that must be addressed in any no-fault system—that of causation. Was the injury attributable to the research, or was it a manifestation of the participant’s underlying condition? If this cannot be easily resolved when claims are presented, the costs of resolving the dispute may escalate the costs of the compensation system itself. Making such determinations will require supplemental studies, and the committee recommends that these studies be commissioned as soon as possible in order to guide public policy decisions and accreditation standard development in this area.

Recommendation 6.8: Organizations conducting research should compensate any research participant who is injured as a direct result of participating in research, without regard to fault. Compensation should include at least the costs of medical care and rehabilitation, and accrediting bodies should include such compensation as a requirement of accreditation.

In light of the ongoing need to recognize and address the needs of those who have been harmed26 as a result of research, the committee believes that a fair compensation system should be established as soon as possible. Accordingly, the committee endorses the conclusion reached by NBAC that “a comprehensive system of oversight of human research should include a mechanism to compensate participants for medical and rehabilitative costs from research injuries” (2001b, p.123). Furthermore, this committee believes that, in principle, adequate compensation to those harmed as a result of research should be more generous than that recommended by NBAC and should include full recovery for economic loss, including work-related disability, and in appropriate cases, for lost earnings of a deceased participant. However, in light of the existing uncertainties concerning the number and severity of research-related injuries, the committee recognizes that this objective is attainable only in stages and therefore suggests a two-step approach.

The first step, which should be taken as soon as possible, would implement a compensation program along the lines recommended by NBAC as a requirement for HRPPP accreditation. Accredited research organizations would be expected to identify, characterize, and report research-related injuries and to cover costs of medical care and rehabilitation that are attributable to research-related injury. Meanwhile, voluntary efforts would be

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As discussed previously in this chapter, research harms are not limited to the physical domain, but also include harm to dignity, harm at the social level, and psychological harm.



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