108th Congress

Human Subjects Legislation

H.R. 3594

Background

In 1991, the core U.S. Department of Health and Human Services (DHHS) regulations (45 CFR Part 46, Subpart A) were formally adopted by more than a dozen other departments and agencies that conduct or fund research involving human subjects. Known as the Federal Policy for the Protection of Human Subjects, or “Common Rule,” these regulations require initial and continuing review by Institutional Review Boards (IRBs), which review both the scientific design of research protocols and informed consent documents and procedures.

Between 1998 and 2001, the DHHS Inspector General (IG), the General Accounting Office (GAO), and the Clinton Administration’s National Bioethics Advisory Commission (NBAC) conducted reviews of this system. These reviews, as well as publicity surrounding adverse events in several clinical trials at major academic health centers, led to various efforts to reform, restructure, and enhance the Governmentwide system for protecting human participants in biomedical research.

In June 2000, DHHS created a new office within the Office of the Secretary to oversee the protection of human subjects in research funded by DHHS. The Office of Human Research Protections (OHRP) replaced the former Office for Protection from Research Risks, which had been housed within the National Institutes of Health (NIH). During the 107th Congress, Representatives Diana L. DeGette (D-CO) and Jim Greenwood (R-PA) and Senator Edward M. Kennedy (D-MA) introduced legislation in an effort to revamp the Federal human subjects protection system in order to incorporate recommendations made by the GAO, DHHS IG, and NBAC. Although this legislation did not pass, it created an opportunity for continued dialog on Capitol Hill regarding (1) the effectiveness of the current IRB system, (2) ways to address conflicts of interest, and (3) the appropriate scope of coverage for the Federal requirements.

On November 21, 2003, Representative DeGette introduced H.R. 3594, the Protection for Participants in Research Act of 2003. The bill, a modified version of the bill introduced during the 107th Congress, would extend protections to all research, regardless of funding source; impose financial conflict of interest requirements for investigators; modify IRB membership to include more lay members and members unaffiliated with the institution; and expand OHRP’s enforcement mechanisms to address violations of the Common Rule.

Provisions of the Legislation/Impact on NIH

H.R. 3594—Protection for Participants in Research Act of 2003

H.R. 3594 contains the following significant provisions of interest to NIH:

• The bill would codify OHRP as an entity within the Office of the Secretary.
• The bill would extend Federal protections contained in 45 CFR Part 46 (including those that pertain specifically to certain vulnerable populations) to all human subjects research, regardless of funding source. This would require review by an IRB, as well as specified informed consent requirements.
• The bill would require the Secretary of Health and Human Services (HHS) to review the requirements of 45 CFR Part 46 and corresponding requirements of the Food and Drug Administration, 21 CFR Parts 50 and 56, to determine the extent to which such requirements could be harmonized.
• The bill would require the Secretary of HHS to review the Common Rule to consider changes regarding 1) the appropriateness of existing exemptions, 2) whether certain research should not be considered human subjects research, 3) whether certain expedited review procedures should be modified, 4) whether modified procedures should apply in cases where the research poses minimal risk to the subjects, and 5) whether IRBs should include sufficient numbers of minority individuals as Board members when reviewing proposals designed to involve a population of human subjects in which the majority are minority individuals.
• The bill would expand IRB membership to require that “not fewer than two members, or 20 percent of all members,” be nonscientific members and “not fewer than two members, or 20 percent of all members,” be individuals who are not affiliated with the institution. In addition, not fewer than 2 members or 25 percent of all members would be required to have scientific expertise. Current regulations require simply that each IRB include at least one scientific member, one nonscientific member, and one member who is not affiliated with the institution.
• The bill would require that all IRBs register with the Secretary of HHS. It would also provide for a system of voluntary accreditation of IRBs by an entity recognized by the Secretary.
• The bill would require investigators to disclose to the IRB any significant financial conflicts of interest or whether that investigator has been disqualified or restricted by any Federal entity in his or her ability to conduct human subjects research. Current regulations do not include this requirement.
• The bill would permit institutions to recover as direct costs those costs associated with compliance with human subjects protections.
• The bill would require that adverse events be reported to the IRB, the sponsor of the trial, and any other entities designated by the Secretary.
• The bill would give authority to OHRP to suspend any research protocol (regardless of funding source) if the entity involved is not in compliance with applicable requirements. The bill would also give OHRP (after notice and an opportunity for a hearing) the authority to suspend or debar principal investigators from receiving Federal funds or conducting human subjects research.
• The bill would require the Secretary of HHS to promulgate regulations to enhance the protection of people with diminished decisionmaking capacity with respect to their participation as subjects in human subjects research.

Status and Outlook

H.R. 3594 was introduced by Representative DeGette on November 21, 2003, and was referred to the House Committee on Energy and Commerce. On December 4, it was referred to the House Energy and Commerce Subcommittee on Health. The bill has no cosponsors. No further action has occurred on this legislation.