the research community,20 providing reasonable compensation for legitimate instances of research harm is critical to restoring credibility.

Although some activities in this area are ongoing, and international experience is available for guidance, determining the portion of participant illness and injury that is attributable to the research itself is a key area that will require de novo research. To guide public policy and accreditation standard development in this area and to help establish the potential magnitude of such claims, DHHS should assemble data on the incidence of research injuries and conduct economic analyses of their costs (see Recommendation 6.7).

It is the committee’s impression that many research organizations conducting clinical trials agree to provide at least short-term medical care for those who suffer research-related injuries (DoD, 2002; IOM, 1994a; NIH CC, 2000; 38 CFR 17.85), but that few research organizations cover other relevant costs. These observations refer only to harm resulting from research properly conducted in accordance with the protocol; harm due to negligence or malfeasance in science can and does end up in the tort system. However, a no-fault system could allow injured parties speedier claims resolution while permitting (as now) the pursuit of tort remedies for product defects or for negligent design or execution of studies.

The responsibility for no-fault compensation programs should fall initially on the institution or organization accountable for conducting the research, and its terms should be specified in the documentation accompanying the participant’s agreement to participate. The committee supports the findings of the many reports addressing this topic—that a comprehensive research participant protection system should include a compensation mechanism for medical and rehabilitative costs (ACHRE, 1995; DHEW, 1977; NBAC, 2001a,b; President’s Commission, 1982a). The committee further believes that the next step in this process should be to pilot test mechanisms to provide remuneration for lost work time.

Recommendation: 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. (Recommendation 6.8)

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This assertion is based upon increased media attention to research issues including recent adverse events and financial conflicts of interest, increased attention given by regulatory agencies to institutional noncompliance, and the growing pressures on the research system.



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