Issue: Human Subject Protection 

**This issue has been archived, the information on this page has not been updated since 2005.**

In May of 1974 the federal government, through the Office of Human Subjects Research (OHSR) within the National Institutes of Health (NIH) at the Department of Health and Human Services (DHHS), issued regulations that govern the protections for human subjects who participate in federally supported research.

The regulation, known as the Federal Policy for the Protection of Human Subjects (Title 45 CFR Part 46), set the standard for human subject research and created Institutional Review Boards (IRBs), charged with reviewing and authorizing all research activities involving human subjects. The IRBs also are charged with implementing the regulation and promoting compliance. No human subjects research may be initiated, and no ongoing research may continue, in the absence of IRB approval.

Revisions to the Policy for the Protection of Human Subjects were made throughout the 1980s, 1990s and into the 21st century to reflect the growth in research with human subjects, as well as to address issues such as research abuse, conflict of interest, informed consent, and the aptitude of institutional review boards.

In response to growing allegations of conflict of interest charges between NIH researchers and the NIH body that governed the research, in June of 2000, the Office of Human Subject Research (OHSR) was changed to the Office of Human Research Protection (OHRP) and was moved from the NIH to the DHHS within the Office of the Secretary. Between the OHRP and the FDA, all federally sponsored research with human subjects and all FDA-bound research with human subjects is covered. Privately sponsored research that does not result in an FDA application is not regulated by any federal agency. In addition, the Policy for the Protection of Human Subjects governs only those departments under the DHHS. In 1991 the regulation adopted 16 additional federal agencies that had to comply with the rule. However, despite the increase in compliance, not all agencies are mandated to comply with the regulation.

Another source of conflict, not directly related to the NIH, is the conflict between researchers and patients. In response to growing allegations of conflict of interest charges involving researchers being paid to recruit for clinical trials, and allegations of abuse and wrongdoing, President Clinton in 1995 issued an Executive Order that created the National Bioethics Advisory Commission (NBAC). NBAC, which no longer exists, was a presidentially appointed committee established to advise the Clinton Administration on bioethics issues. NBAC issued reports on the protection of human subjects, which were used by President Clinton to revise the Federal Policy for the Protection of Human Subjects. Later, the National Human Research Protections Advisory Committee was created to provide expert advice and recommendations to the Secretary of HHS, Assistant Secretary for Health (ASH), the Director of the Office for Human Research Protections (OHRP), and other departmental officials on a broad range of issues and topics pertaining to or associated with the protection of human research subjects.

As a result of a NBAC recommendation, in January of 2001 President Clinton issued new regulations (Final Rule 66FR 3878) on the Protection of Human Research Subjects.

However, on May 18, 2001, the Bush Administration delayed the rule's effective date and offered three modifications to the Clinton Regulation. The modifications, which dealt with protections for pregnant women and human fetuses involved in research, were adopted on July 6, 2001. The most stringent modification requires paternal consent when a pregnant woman is involved in research that solely affects the fetus.

The final regulation, which reflects the modifications regarding pregnant women in clinical trials, was published in the Federal Register on November 13, 2001, with an effective date of December 13, 2001.

Although the Bush Administration has issued the final rule on Protection of Human Research Subjects, the debate over human subject protection remains contentious as many of the issues surrounding human subject protection remain unsettled.

In the 108th Congress, Representative Diana DeGette (D-CO) introduced the Protection for Participants in Research Act (H.R. 3594).   Under this bill, if enacted, all research would be under uniform federal oversight.

In January 2003, the Bush Administration appointed members of the Advisory Committee on Human Research Protection. The Administration also directed the committee to include embryos in its definition of human subjects for research protection purposes, a decision that caused some consternation in the medical research community.