are maintained by the Public Access Records Office, 2101 Constitution Avenue, NAS 171, Washington, DC 20418; tel: (202) 334-3543.

In order to conduct a thorough review, the committee conducted multiple literature searches and read numerous articles, books, policies, and reports concerning the protection of human participants in research. The committee maintained information about the materials in a database that allowed the committee to search for items by keywords or other criteria.

The materials provided to the committee addressed a large variety of topics including information about IRBs; informed consent procedures; federal regulations and compliance problems; the roles of industry, contract research organizations, participants, and other stakeholders in the research enterprise; the problems within the current protection system; the ethics of research involving humans; conflicts of interest; accreditation; regulatory costs; safety monitoring; multisite research; and a number of other topics.