countable to several federal agencies, while commercial enterprises may be primarily accountable to FDA. Accreditation by one of the independent accrediting agencies, presuming that accreditation is found to be effective, may provide assurance that the organization is achieving a particular level of protection. However, the goal of any organization should be an ongoing commitment to improve participant protections, not simply to comply with regulations. As stated in the committee’s first report, regulatory compliance should be the floor below which organizations do not fall; in no way should it represent the ceiling (IOM, 2001a).

Resources

Recommendation 2.3: Research sponsors and research organizations— public and private—should provide the necessary financial support to meet their joint obligation to ensure that Human Research Participant Protection Programs have adequate resources to provide robust protection to research participants.

No research study involving human participants should be allowed to proceed without ensuring adequate financial support for the proper functioning of the relevant HRPPPs. Providing the resources needed to establish and maintain the infrastructure for a robust protection program is the joint responsibility of the institution (or other organization) conducting the research and the research sponsor. Necessary resources for the HRPPP would include adequate space, equipment, and personnel, as well as a sufficient annual budget.

Assumption of the responsibility to pay for participant protection has been an issue of dispute within the funder/researcher alliance for some time. Although both sponsors and investigators agree that funds must be allocated to pay investigators and staff and to cover the out-of-pocket costs of research,6 no satisfactory agreement has been reached regarding how the increasing costs of protecting participants should be distributed. Not surprisingly, and as the recent tragedies and citations for administrative infractions at various academic medical centers demonstrate, the responsibility for protecting research participants ostensibly was not sufficiently funded at otherwise prestigious institutions (OHRP, 2000, 2001; Zieve, 2002). Agreements with OHRP that permitted the centers in question to continue federally funded research required significant increases in institutional support, in terms of both finances and personnel (McNeilly and Carome, 2001; NBAC, 2001b).

6  

45 CFR 46.103(b)(2) requires that the IRBs must have sufficient meeting space and staff.



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