An Overhaul for Human Research?

Proposed rules would streamline human research and strengthen protections for study subjects, according to the US government.

Tia Ghose
Jul 26, 2011

Vaccine trialFLICKR, US ARMY AFRICA

The US government is proposing a major overhaul of the rules that govern human subjects research, hoping to strengthen protections while eliminating red tape.

One proposed change would require any study conducted at an institution receiving government funding to abide by the human subject guidelines—even if an outside source such as a drug company pays for the study, The New York Times reports. Another measure would require consent from patients before their DNA or tissue is used in follow-up studies. Right now, tissue samples that aren’t linked to a person’s identity may be used without consent for later studies.

Other changes, such as allowing a single institutional review board to approve studies for multiple sites, are intended to reduce unnecessary regulatory delays. Currently, each site enrolling patients must go through a laborious approval process. The guidelines also suggest streamlining lengthy, confusing informed consent...

The current guidelines haven’t been updated since 1991. The public has 60 days to comment on the proposed rules.

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