Some recent legal filings have sought to name as defendants, among others, members of Research ERBs (Gelsinger v. University of Pennsylvania; Robertson, et al. v. McGee, et al.). Although no such lawsuits have yet prevailed, they may exert a chilling effect on both the willingness of individuals to become board members and on the independence of their decision making. Indemnification, which appears to be a common practice among larger research universities,27 remains important in the present litigation climate. Given the desirability of recruiting and appointing external members to review boards, it is especially important to insulate them from personal liability concerns. Organizations should indemnify both internal and external board members to prevent them from being unduly influenced by the personal risks of potential litigation, a protection that should be extended to individuals of other boards, such as DSMB/DMCs, Scientific Review Boards, and ethics and research expert consultants used by Research ERBs and other review bodies.

SUMMARY

An effective protection program should have QA and QI measures in place in order to continuously assess its strengths and weaknesses and to redress those weaknesses. DHHS should facilitate the activities of those studying the effectiveness of the collective system by gathering baseline data about the current system in order to assess improvements. Research sponsors should take on a similar responsibility by funding original research that would enhance the practice of QI.

There is also a need for data about the prevalence, nature, and costs of research-related injuries. Organizations conducting research with human participants should compensate any participant who is injured as a direct result of participation in the research; this compensation should include that for direct medical care, rehabilitative costs, and after appropriate study, lost work time. Accrediting bodies should include this requirement within their accreditation standards.

Accreditation by design is intended to encourage organizations to strive for a high standard of performance. Current accreditation efforts in the field of research involving human participants are nascent and merit review after a sufficient period of pilot testing (likely five years or so). Because of the significance of the task, DHHS should arrange for such a review through a credible, independent entity. Accreditation organizations should also fos-

27  

Lydia Villa Komaroff, personal communication, April 22, 2002.



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