Bloomberg Law
Nov. 13, 2018, 7:06 PMUpdated: Nov. 14, 2018, 3:21 AM

FDA Aims to Ease Ethics Review for Low-Risk Studies (Corrected)

Jeannie Baumann
Jeannie Baumann

Drug and device companies will save time and money setting up low-risk clinical studies under a proposal by the FDA to relax consent requirements.

The proposed rule would allow for the first time ethics boards known as institutional review boards (IRBs) to waive the requirement for researchers to obtain informed consent from participants. IRBs could also alter the strict set of Food and Drug Administration requirements for research involving human volunteers (21 CFR parts 50 and 56).

Currently, IRBs can only waive informed consent requirements in life-threatening situations or for emergency research, when a patient population has no ...

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