Dramatic changes could be coming for researchers who use human subjects. According to Dianne Bourque of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, the U.S. Department of Health and Human Services, along with 15 other federal department and agencies, propose to update policies for the protection of human subjects. “The changes recognize that the volume and landscape of research involving human subjects has changed considerably since 1991,” says Bourque, referring to the date the laws were first enacted. Here are some highlights of the proposal:
• Restrictions on the use of stored biospecimens: Leftover blood and tissue samples used for secondary research now require consent. It would be obtained via broad consent forms, with clauses considering the future use for unspecified research studies, says Bourque.
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