InSites: New FDA Guidance on Informed Consent

InSites is a recurring commentary dedicated to clinical trial sites – including hospitals and academic medical centers – and their interaction with industry.

On July 16th, FDA released its: Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and SponsorsWhen finalized it will replace the 14-year-old, A Guide to Informed Consent. At 42 pages, it is as long as some informed consent forms (ICFs).

In fact, FDA advises sponsors and sites to avoid lengthy ICFs, because they can difficult to understand. It recommends that the ICF contain a chart summarizing investigational procedures, and provide an addendum to the ICF describing them in detail, if doing so will improve readability. However, the Guidance elsewhere requires actions that can substantially lengthen the ICF.  For example, the disclosure must include a description of the current medically-recognized standard of care as an alternative to research participation. The Guidance states: …FDA believes a description of any reasonably foreseeable risks or discomforts and potential benefits associated with these alternatives must be disclosed. Where such descriptions or disclosures can contain quantified comparative estimates of risks and benefits (e.g., from the clinical literature), they should do so. If included in the ICF (rather than during the interview), this will erase whatever length reductions are achieved with the addendum.

The Guidance recommends a specific order in which information should be presented in the ICF. Notably, a description of current  standard-of-care procedures (including risks & discomforts) should come before the description of research procedures, to aid the candidate’s decision-making.

FDA has done a commendable job noting that informed consent is a process that continues long after the ICF is signed. At various points, the Guidance suggests that key information can be presented in interviews, rather than in the ICF. For example, alternative procedures can be discussed with a healthcare professional, but such conversations must occur prior to signing and dating the ICF. Similarly, the Guidance notes that costs to the patient are difficult to predict because of the complexities of health insurance, and that a discussion with a financial counselor may be appropriate (prior to signing the ICF).

What the Guidance does not yet address is how information technology can influence informed consent, despite the emergence of electronic and tablet-based ICFs. Similarly, although the Guidance notes that patients should not simultaneously participate in multiple clinical investigations, it does not address the use of available technology that can avoid this problem. Hopefully, the final Guidance will address these, and provide more clarity as to when information must be included in the ICF.

InSites is a monthly column written by TIRS Editorial Board member Stuart Horowitz, PhD, MBA. Dr. Horowitz is President, Institutions & Institutional Services at WIRB-Copernicus Group.


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