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AAMC Submits Comment Letters to FDA and OHRP on Electronic Informed Consent Draft Guidance

May 8, 2015—The AAMC May 7 submitted a comment letter, to the Food and Drug Administration (FDA) and a comment letter to Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) regarding draft guidance for industry, clinical investigators, and institutional review boards, on the use of electronic informed consent in clinical investigations. The draft document from the FDA is described in the March 9 Federal Register (80 FR 12496), and a concurrent notice from OHRP (80 FR 12497) solicits public comment on the potential adoption of the proposed recommendations by OHRP and issuance of a joint document from FDA and OHRP when a final guidance is developed.

In the letters the AAMC acknowledges the necessity of developing a guidance on the use of electronic formats and processes to obtain informed consent, particularly in the context of a changed research enterprise which increasingly involves electronic methods of data collection. AAMC additionally states that the use of interactive web sites, graphics, videos, and other electronic communication methods may potentially allow for a more conducive environment for a subject to consider their participation in a study, increase participant engagement and comprehension, and facilitate a consent process which continues for the duration of a research study.

AAMC has long been supportive of efforts to harmonize research-related guidance and streamline federal research oversight. However, the association urges that any joint guidance released by OHRP and FDA on electronic informed consent should include specific sections for FDA-regulated clinical investigations that are not subject to the HHS protection of human subjects regulations (45 C.F.R. Part 46).

Finally, AAMC notes the timeline for reviewing and revising the guidance document is concurrent with the active discussions regarding the revisions to 45 C.F.R. Part 46, and questions whether proposed modifications to the rule might change the analysis if new regulations are finalized.


Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926


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