by Jackie Tekiela, MS, CIP, Institutional Review Board (IRB) Administrator at Wheaton Franciscan Healthcare

“Most codes dealing with human experimentation start out with the bland assumption that consent is ours for the asking. This is a myth. The reality is that informed consent is often exceedingly difficult to obtain in any complete cense…Nevertheless, it remains a goal toward which on must strive for sociological, ethical, and legal reasons.”   

– Henry Beecher on informed consent in the article “Ethics and Clinical Research“

During the Consent: Processes, Criteria, and Considerations for Obtaining Informed Consent pre-conference program at the 2012 Advancing Ethical Research (AER) Conference, program faculty Moira Keane, MA, CIP, and Daniel K. Nelson, MSc, CIP, provided an overview of the informed consent process and issues IRBs should consider.

As you can image, a lot of great material was covered during this day-long session; far too much to include here. Topics ranged from the history of informed consent, regulatory requirements of the consent process, and documentation of consent, to waivers of and exemptions to informed consent; from special considerations for informed consent in vulnerable populations, to certificates of confidentiality and HIPAA rules and conflict of interest language. I’ve tried to sum up some main points and ideas that I found interesting.

I expected the history portion to begin with the Nuremburg Code, which, of course, is the document resulting from the 1947 trial of Nazi doctors for human experiments conducted during World War II. Even before the Nuremburg Code, however, as early as 1900, there were standards of consent in human research being developed in both Germany and in the US.

The main focus of the program was the discussion of the consent process, the consent document, and the regulatory requirements for each. Informed consent is obtained through a process—the communication and interaction between researchers and subjects—and is recorded using the consent document. In the federal regulations, the general requirements for the informed consent process (outlined at 45 CFR 46.116 and 21 CFR 50.25) are described first. The process is covered in greater length than the required documentation of informed consent (at 45 CFR 46.117 and 21 CFR 50.27).

There was interesting discussion around the IRB consideration of the elements of informed consent and, specifically, the qualifiers in the regulations (such as “when appropriate” and “if any”). Not all elements are applicable for all studies. It may even be appropriate for IRBs to waive a required element (45 CFR 46.116(d)) when it makes sense.

Other points from the session:

• Words matter during the consent process and in the consent form. For example, subjects believe “medical studies” are safer and offer better outcomes than “medical experiments” (Sugarman, et. al.).
• There are no one “size fits all” answers for the consent process or form. Refer to the regulations and apply them to each situation.
• There is no exact formula for consent form quality or format to ensure comprehension; be sure to consider your population.
• IRBs should ask about and review the informed consent process, not only the consent document.
• IRBs may observe, or have someone observe, the consent process.