The Food and Drug Administration (FDA) announced the issuance of the draft Guidance for IRBs, Clinical investigators and Sponsors about Informed Consent Information Sheet. In its efforts to improve study subject's protection and reduce regulatory burden, FDA reminds the industry that the informed consent process is intended to provide study subjects with adequate information to allow for an informed decision about their participation in a clinical trial study. As such, the process should not be viewed solely as a mechanism to obtain participant's signature on a consent form. The Guidance also highlights new considerations, for example, concerning non-English speaking participants, patients with physical or mental impairment, and children as study subjects. When finalized, the Guidance is intended to supersede the earlier guidance on the same subject issued in September 1998. Comments regarding the draft Guidance should be submitted by Sept. 15, 2014.
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