FDA Updates 16-Year Old Policy On Informed Consent In Clinical Trials

The Food and Drug Administration (FDA) has updated its 16-year old guidance on informed consent for clinical trial patients. The new draft guidance expands the agency’s view on informed consent, which it says is more than just asking for permission to treat in the beginning of the trial. The guidance will enhance patient protection and reduce the drug sponsor’s regulatory burden. The FDA is accepting comments on the policy until September 15, 2014. If the Department of Health and Human Services (DHHS) and other relevant Federal Agencies issue their own guidance, the FDA says it will “facilitate consistency across policies.”  

The new informed consent guidance provides information to clinical investigators, institutional review boards (IRBs), and drug sponsors. The last time the federal agency issued guidance was September 1998 and the agency has been working since then to harmonize the agencies' regulatory requirements. The most notable point the FDA makes is that informed consent is misunderstood. The guidance states that investigators should provide opportunities for the subject to ask questions and should provide information to the patient throughout the course of the trial.

New in this guidance is information on subjects that may need assistance in understanding informed consent, such as non-English-speaking patients, impaired patients, and children.

The FDA states that when investigators explain the trial to prospective patients, they should provide a clear and balanced description of the expected benefits, not just for the sake of the patient, but because it also benefits future patients with the same condition. An overly optimistic explanation may constitute an FDA violation. Additionally, investigators should explain that any clinical trial financial remuneration is for expenses and inconveniences, not a payment benefit.

Informed consent also means that investigators present alternate treatment plans to the patient, including the advantages and disadvantages of alternate treatments. If appropriate, the FDA expects investigators to refer patients to a healthcare professional in order to adequately assess alternate treatments before entering a trial.

If a patient wants to participate in more than one trial, the FDA believes that decisions must be made on a case-by-case basis. Investigators should discuss this issue in person, preferably with the patient’s physician, rather than waiting until it is time to sign the informed consent document, as “the sequence in which a subject may participate in the protocols may be important.”