The NPRM proposed a new §___.116(h) requiring a final version of the ICF for a trial conducted or sponsored by a federal department or agency to be posted on a publicly-available federal website within 60 days after the trial closes to further recruitment. Of all the proposed changes to the Common Rule, this offering may be the most universally disliked by stakeholders. Many argued that the requirement added a significant administrative burden (1) on researchers to upload ICFs, (2) on hospitals to implement compliance oversight procedures, (3) on IRBs to report investigator non-compliance, and (4) on agencies to develop this yet-to-be-established website. Stakeholders expressed concern that such burdens would not be offset by any real protection to patients.
Other commenters maintained that posted ICFs are likely to become even more lengthy and legalistic with sponsors and institutions attempting to protect themselves from post hoc scrutiny by federal regulators and plaintiffs’ attorneys. Additionally, because informed consent is a process, the public posting of ICFs does not capture many of the interpersonal interactions between investigators and subjects when discussing the research. As such, these commenters contend that a posted ICF may provide an incomplete and potentially misleading snapshot into a subject’s consent.
Stakeholders also queried how the public would use these ICFs as HHS provided no examples of proper versus improper documents. Again, without context, any potential scrutiny may be unfounded and likely too late to affect enrollees. Finally, commenters expressed worry that the industry may conduct studies in foreign markets to avoid this obligation. Because many ICFs contain confidential study designs, proprietary drug or device information, pre-market safety and efficacy information, or other commercialization strategies, commenters contend the risk of loss may not be worth the headache and drug and device manufacturers may seek friendlier regulatory pastures overseas.