Concerns on U.S. Proposal on Human Research Subjects

May 10, 2016

An Obama administration proposal to rewrite federal regulations governing the use of human subjects (and human genetic material) in research would hamper academic studies by overly restricting the use of biospecimens, a higher education association asserts in a new analysis.

The report, which was produced by the Council on Governmental Relations, analyzes more than 2,000 comments that were submitted in response to a proposal by the Department of Health and Human Services to update the so-called common rule, which is the government's main policy governing the use of human research subjects. (Note: This article has been updated from an earlier version to clarify who produced the report.)

Many of the comments submitted by researchers, university administrators and others regarded proposed new guidelines related to biological material known as biospecimens, and the sense that the guidelines would "reduce the number and diversity of biospecimens available for disease research; potentially place significant limitations on research using existing identified biospecimens for which consent has been obtained; and dramatically increase the cost of conducting research, effectively reducing research funding without providing additional protections for research participants," according to the groups' analysis.

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