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Originally Published MX July/August 2002

GOVERNMENTAL & LEGAL AFFAIRS

Human-Subject Protection in Congress Today

The safety of human research subjects is getting congressional attention again, with both houses considering the tightening of existing protections.

On April 23, 2002, the Senate Committee on Health, Education, Labor, and Pensions held a hearing entitled "Protecting Human Subjects in Research: Are Current Safeguards Adequate?" Witnesses suggested many potential improvements to the systems in place, including:

  • Preempting state and local human-subject protections by a single, uniform federal standard.
  • Requiring investigators to fully disclose financial and other conflicts of interest to IRBs and prospective study subjects.
  • Imposing higher standards of accountability on IRBs, and stronger requirements for certification.
  • Considering a new framework for research review based on the risk of the research.
  • Centralizing responsibility for the federal oversight of human-subject protection in a single independent office.

The House of Representatives is moving on the issue by reviving a legislative proposal first considered in 2000. The new bill, called the Human Research Subject Protections Act of 2002, was introduced on May 9. Cosponsored by Representatives Diana DeGette (D–CO) and James Greenwood (R–PA), it includes many of the recommendations heard by the Senate committee in April, as well as some made in a report on IRB effectiveness delivered by the inspector general of the Department of Health and Human Services in 2000. Provisions in the House bill:

  • Authorize the functions and enforcement authority of the Office for Human Research Protections, giving it legal status.
  • Apply the "Common Rule" (45 CFR 46, Subpart A) to all public and private research.
  • Support voluntary, rather than mandatory, IRB accreditation.
  • Earmark portions of government research grants to cover IRB overhead costs.
  • Mandate better harmonization of existing human-subject protection regulations.

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