RECOMMENDATIONS

Recommendation 5-1. Institutions whose IRBs or other review boards review HSR should ensure adequate administrative support and funding for review bodies and should incorporate improving review operations into overall institutional strategic planning, and organizations that sponsor HSR should also support designating adequate funds for such review.

The committee corroborated previous reports that questioned whether IRBs have the resources to carry out their mission. The committee noted especially the April 2000 update report of the DHHS Office of the Inspector General, (OIG). This report, Protecting Human Research Subjects: Status of Recommendations, concluded that the resource problems identified in the OIG's 1998 report, Institutional Review Boards: A Time for Reform, still exist. The committee heard that many IRBs already have a heavy workload of proposals for review and that most members serve in a voluntary capacity. Additional resources will be required to implement the best practices described in Chapter 3 and Chapter 4.

The committee found that IRBs (or any other review boards) need adequate funding specifically to review HSR.

As just mentioned, previous reports have documented the need for adequate funding of IRBs. The committee heard corroborating evidence that resources continue to be a problem for IRBs. A recent committee at the University of California at San Francisco, an institution conducting a great deal of research involving human subjects, recommended that high priority be given to adequate IRB staff support, increased use of computerized information systems, and increased funding for training investigators about IRB function (see also Appendix B).

In addition to adequate resources for staff and committee members, IRBs or other review boards need additional funding for new activities that could make their work more effective and efficient. With regard to HSR, for example, review committees need access to more expertise in information technology, such as how investigators can reduce the likelihood that subjects will be identified through the use of coding and encryption and through defining variables in ways that eliminate data cells having a small number of subjects with an unusual set of characteristics. Furthermore, human subjects protection programs will require additional resources to put into place the kinds of computer decision support systems that would enhance the effectiveness and efficiency of reviews of HSR studies and better ensure that these studies have in place appropriate safeguards for confidentiality.

The committee also heard a number of proposals for how to provide the resources that human subjects protection committees would need to carry out their missions adequately. Dr. James Kahn, IRB chair at the University of California in San Francisco, proposed that IRB review be added as a line item in grants,



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