A new draft guidance document issued by the US Food and Drug Administration (FDA) is meant to eventually replace a 16-year-old guide outlining the regulator's views on informed consent.

Informed Consent: The Basics

As FDA explains in the draft guidance, Informed Consent Information Sheet, when most people think about the process of obtaining consent, they think of it as obtaining written consent from the subject to participate in a medical study. But FDA says this understanding—while technically correct—is not complete.

"Informed consent involves providing a potential subject with adequate information to allow for an informed decision about participation in the clinical investigation, facilitating the potential subject’s comprehension of the information, providing adequate opportunity for the potential subject to ask questions and to consider whether to participate, obtaining the potential subject’s voluntary agreement to participate, and continuing to provide information as the clinical investigation progresses or as the subject or situation requires," FDA explained in its guidance.

In other words, it's not just about obtaining a signature on a piece of paper, but should instead be about allowing a subject to consider the opportunities and risks inherent in participating in a trial, and whether participation is appropriate for that particular subject.

Even after the informed consent document is signed, the consent process may still continue, FDA added. "Depending on the clinical investigation, additional information may need to be given to the subject, and the subject may need additional opportunities to ask questions and receive answers throughout the clinical investigation."

Guidance: New Sections

The guidance itself is fairly straightforward, and contains concepts that should mostly be familiar—if not basic—to professionals who have extensive experience conducting clinical trials.

However, there are several updates relative to FDA's 1998 guide on informed consent.

For example, the draft guidance now contains a section on non-English-speaking clinical trial participants. All information given to a patient "must be in language understandable to the potential subject or legally authorized representative." While this means that the information must be in a language the subject can understand, it also means that it must be written in terms the subject can understand as well. FDA cited data indicating that one-third of US adults have basic or worse health literacy, while one-half of US adults have difficulty understanding numbers and data.

The guidance also introduces a new section on dealing with patients with impaired consent capacity, which can range from minor or temporary impairments to complete impairment. Forms to enroll impaired trial participants may require modification, or a process to allow a legal representative to enroll the subject on their behalf. Institutional review boards (IRBs) and investigators should consider if the inclusion of the cognitively impaired or mentally disabled is "ethically appropriate and scientifically necessary," FDA said.

FDA's guidance also includes an extensive section on the inclusion of children in clinical trials, in which FDA asks that, in addition to the permission of the child's parent or legal guardian, investigators obtain the child's "assent" to participate in the research. FDA notes that "assent" means an "affirmative agreements to take part in a clinical investigation, not just the failure to object."

Other new additions include sections on reviewing patient records, subjects participating in more than one clinical trial, and study suspension/termination.

FDA notes that the draft comes just as federal regulators are considering updates to the Department of Health and Human Services' (DHHS) human research protections, better known as the "Common Rule." FDA said it will work with "other relevant Federal Agencies to facilitate consistency across policies" in the event of an "intersect" between the revised rule and the new draft guidance.

Comments on the draft guidance are due to FDA by 15 September 2014.

Informed Consent Information Sheet (FR)