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Life Sciences

Agencies Issue Proposal Overhauling Regulations on Human Subject Research Protections


The Department of Health and Human Services (HHS) and 15 other agencies issued proposed revisions September 2 to the regulations for protection of human research subjects, known as the “common rule.”

The agencies last published an advance notice of proposed rule making in July 2011 to overhaul the regulations that were first issued in 1991.

The proposed changes are intended to “better protect research subjects and help build public trust" in the rules relating to informed consent, HHS said in a summary of the rule.

One of the major changes wrought by the proposal would be to streamline consent forms, which “would no longer be able to be unduly long documents,” the summary said.

In addition, informed consent generally would be required for secondary research with a biospecimen (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable her to identify whose biospecimen it is, according to the summary.

Consent would not need to be obtained for each specific research use of the biospecimen under the proposal, but rather could be obtained using a “broad” consent form in which a person would give consent to future unspecified research uses.

Another guiding principle of the revisions is that research that poses greater risk to subjects should receive more oversight and deliberation than less risky research. “Cumbersome and outdated regulatory standards overwhelm and distract institutions, [Institutional Review Boards (IRBs)], and investigators in ways that stymie efforts to appropriately address the real risks and benefits of research,” the rule summary said.

One result of the changes if they are implemented is that some studies that currently require IRB review would become exempt.

The rule also would add more categories of exempt research “to accommodate changes in the scientific landscape and to better calibrate the level of review to the level of risk involved in the research,” the summary said. And a new process would allow studies to be exempted without requiring administrative or IRB review.

In addition, the rule would mandate that U.S. institutions engaged in cooperative research rely on a single IRB for that portion of the research that takes place within the United States, with certain exceptions, and would extend oversight policy to cover all clinical trials, regardless of funding source, conducted at a U.S. institution that receives federal funding for non-exempt human subjects research.

New data security and information protection standards that would reduce the potential for violations of privacy and confidentiality also are included in the proposal.

The NPRM is slated to be published in the Federal Register on September 8 and comments will be accepted for 90 days after publication. 
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