reports have been issued,3 accreditation programs have been launched,4 privacy regulations have been promulgated and revised,5 Congressional hearings have been held,6 and legislation has been drafted.7 This committee has endeavored, however, to formulate recommendations that reflect the current state of policy development, the present regulatory framework, and the efforts undertaken by others.

In contrast to other reports on these issues, this committee focused on the roles and responsibilities of the individual HRPPP, with the majority of recommendations directed toward improving the protection of the individual research participant through HRPPP policy and procedural enhancements.


As recently detailed by the National Bioethics Advisory Commission (NBAC), many highly regarded groups have assessed the strengths and weaknesses of the national system for ensuring the ethical protection of volunteer research participants.8 Proposals for reform have been presented to the public, the Executive Branch of the federal government, and Congress. However, a fact that has repeatedly confounded this committee’s deliberations is the lack of data regarding the scope and scale of current protection activities. This absence of information seriously handicaps an objective assessment of protection program performance and needs and the development of useful policy directions. Nonetheless, the evidence is abundant regarding the significant strains and weaknesses of the current system, and this committee has reached the conclusion that major reforms are in order.


AAMC, 2001; AAU, 2001; GAO, 2001; NBAC, 2001a,b; NIH COPR, 2001.


Both the National Committee for Quality Assurance (NCQA) and the Association for the Accreditation of Human Research Protection Programs (AAHRPP) launched accreditation programs for human protection programs in 2001.


The Health Insurance Portability and Accountability Act of 1996 regulations were modified in March 2002 and finalized in August 2002 (DHHS, 2002).


The Senate Committee on Health, Education, Labor, and Pensions held a hearing on protecting research participants on April 23, 2002. The House Committee on Veterans Affairs held a hearing on VA research and nonprofit research corporations and educational foundations on May 16, 2002.


Representatives DeGette and Greenwood have proposed legislation in the House of Representatives [A Bill to Amend the Public Health Service Act with Respect to the Protection of Human Subjects in Research. H.R. 4697. 107th Congress, 2nd Sess. (2002)]. Subsequent to the public release of this report, Senator Kennedy introduced the Research Revitalization Act [Research Revitalization Act of 2002. S. 3060. 107th Congress, 2nd Sess. (2002)].


NBAC, the DHHS Office of Inspector General, the General Accounting Office, the Advisory Committee on Human Radiation Experiments, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

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