toring should be central elements of the system as a whole and, hence, also of any accreditation process intended to improve that system.

Accreditation Versus Certification

The committee uses the term “accreditation” to refer to a process described in Chapter 2 and Chapter 3. That process is centered on an organization rather than individuals. The committee uses the term “certification” to refer to an individual. The National Association of IRB Managers, for example, has offered a certification examination since 1995, and the Applied Research Ethics National Association recently has launched a certification program for individuals who staff or chair IRBs (National Association of IRB Managers, 2001; PRIM&R, 2001a).

Certification is offered only to those with demonstrated experience and entails passing a test of knowledge about protection of human research participants. Certification has been discussed for investigators who conduct research involving human participants. For example, the government of the United Kingdom licenses those doing animal research and research on in vitro fertilization and embryo research. In the United States, however, no structure to carry out national certification of U.S. investigators exists. NIH and several universities (e.g., Case Western Reserve University and the University of Rochester), for example, have recently adopted requirements that investigators take a World Wide Web-based interactive test that demonstrates knowledge of human research protections before they can seek IRB approval of a protocol (Case Western Reserve University, 2001; Chadwick and Liders, 2000; Office of Human Subjects Research, National Institutes of Health, 2001). A national certification requirement for investigators, however, would be a major step entailing the development of a substantial infrastructure. For this reason, the committee does not consider the issue of certification in this report.



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