The FDA has issued the first revisions to its guidance for informed consent since 1998. The revisions are currently in draft form and awaiting public comment until September 15.

The FDA has issued an Informed Consent Information Sheet, a draft guidance document intended to supersede the guidance it issued in 1998. Released in July, the Information Sheet provides guidance for institutional review boards, clinical investigators, and sponsors about how to obtain consent from patients enrolling in a clinical trial. The updates provide additional details regarding the recommended consent process in the context of the FDA's existing Code of Federal Regulations.

For example, regulations require “disclosures of appropriate alternative procedures or courses of treatment that may be advantageous to the subject.” The draft guidance elaborates, describing the types of alternative therapies that are appropriate for disclosure. According to the guidance, alternative therapies should include a description of the current standard of care, as well as “approved therapies for the patient's condition, other forms of therapy (e.g., surgical), and when appropriate, supportive care with no disease-directed therapy.”

The guidance defines standard of care as regimens recognized by a professional medical society or with supporting evidence in peer-reviewed publications and also states that it may include off-label uses of treatment regimens or medical devices. Because drugs and medical devices may be accessible to patients who do not enter a trial, this information allows patients to consider all of their options prior to providing consent.

Further, the FDA discourages the enrollment of subjects in more than one trial simultaneously because of concerns about the safety of combining multiple experimental interventions.

The updated guidance also suggests that participants in clinical trials be informed of the results of the trial. Specifically, the document states, “aggregate research results should be returned to subjects in a clear and comprehensible manner.”

Non–English-speaking participants in clinical trials are considered in a new section, with recommendations that information be provided in a language they or a legal representative can understand. Also added are sections regarding patient records, patients participating in multiple trials, and study termination.

Gaps remain, however, including a clear definition of who may act as a legal representative for patients who cannot give consent themselves, such as children and those who are unconscious or have dementia or mental illness.

The deadline for comments on the draft guidance is September 15, 2014. Comments may be submitted electronically at www.regulations.gov, docket number FDA-2006-D-0031. An index of all U.S. Health and Human Services' Office for Human Research Protections policy and guidance documents is available at www.hhs.gov/ohrp/policy/index/index.html.