Informed Consent

INFORMED CONSENT—FOCUS ON THE PROCESS

Not quite a year ago, we posted an entry on this blog addressing consent forms. Informed consent is, of course, in the front of our minds every day at Aspire, and we’d like to revisit it. This month, we focus on the process of informed consent. Next month, we will speak again about the consent form itself.

It is Aspire IRB’s policy that each trial site provides its process for obtaining informed consent. Aspire must be able to determine that the process conforms to federal regulations found in 21 CFR 50, Subpart B and 45 CFR 46. Informed consent must be obtained from each subject or the subject’s legally authorized representative, and be properly documented, unless a waiver of some elements has been approved by the IRB.

Some descriptions we see of an informed consent process are, to put it bluntly, too sparse to be sufficient. Some descriptions amount to, “We give the subject the consent form, place him (or her) in a private room, and when they come out, they sign it.” We’d like to hear more, to be sure that each site is paying attention to the process of consent.

The informed consent begins when a prospective subject is first approached about a trial, continuing throughout that subject’s participation. Personal, face-to-face, ongoing contact between the study subject and the investigators or study staff, continuing throughout the study, are essential to ensure that each subject has sufficient information and understanding to provide voluntary consent to participate in the study. The process must cover the required elements of informed consent (21 CFR 50.25 and 45 CFR 46.116), which must also be embodied in the consent form, but simply handing a written list to the subject is not a complete process.

Sessions on informed consent at the December, 2011 Public Responsibility in Medicine and Research (PRIM&R) conference yielded a few points of note, including:
• Longer, more complex consent forms do not enhance the subject’s decision-making process and may in fact impair it (about which more next month);
• Multimedia approaches (e.g., using DVDs) do not necessarily improve subject understanding;
• 7 out of 8 American adults cannot correctly interpret and act on even basic medical information;
• Attempts to measure subject understanding, such as quizzes about the form, may measure test-taking ability but not understanding;
• Long consent forms look like legal contracts, making them, among other things, intimidating.

In other words, subjects need more handholding. In fact, the moderators of one session at PRIM&R said that subjects want pre-consent information, a peer mentor, tools to understand the study, a mid-study chance to revisit information and ask new questions, and an exit interview. Clearly, not all of these will apply in the same way for all studies, but it’s equally clear that a comprehensive consent form does not a consent process make.

Aspire will soon make available a “template” consent process, that it finds minimally acceptable, to sites that do not have a consent SOP or detailed process in place. If you do have one, send it with your application and we will review it. If you don’t, we can help you—you won’t have to try to guess what we are thinking.