We all know that designing a mechanism for obtaining valid informed consent is a perennial challenge, but it seems to be receiving special and renewed interest lately.
The United States Food and Drug Administration (FDA) recently released a draft guidance, Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors, for public comment. The draft is intended to replace the FDA’s previous, and much briefer, guidance on informed consent, which dates from 1998. Throughout the new draft guidance, the FDA emphasizes that informed consent involves more than a form, and encourages investigators, IRBs, and sponsors to think of informed consent as a dynamic process that can be adapted to reflect the unique needs of potential subjects, as well as local context.
The introduction to the FDA draft states it plainly:
To many, the term informed consent is mistakenly viewed as synonymous with obtaining a subject’s signature on the consent form. FDA believes that obtaining a subject’s oral or written informed consent is only part of the consent process. 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. To be effective, the process must provide sufficient opportunity for the subject to consider whether to participate.
PRIM&R has long championed this approach to thinking about informed consent, and we commend the FDA for recognizing that this guidance document can be used to foster improved understanding of the purpose and goals of informed consent. PRIM&R will submit comments to the FDA on the draft guidance, and I encourage you to share your thoughts and comments on the guidance, along with those on other topics, at the end of this post.
Additionally, the Secretary's Advisory Committee on Human Research Protections (SACHRP), the body charged with making recommendations to the Secretary of Health and Human Services regarding human subjects protections issues, devoted a full quarter of its July 2014 meeting agenda to a discussion of the informed consent process, in a session aptly titled, Informing Informed Consent: Defining and Validating Comprehension.
There is a common thread between these two examples—a renewed emphasis on the role and importance of subject understanding in the consent process.
The FDA draft guidance focuses on the importance of consent documents being written in language understandable to subjects, and includes expanded sections on informed consent with respect to non-English speakers. The SACHRP session concentrated on barriers to subject comprehension, including the fact that therapeutic misconception persists despite increasingly well-informed efforts to educate potential subjects about the purposes of research.
These points are well taken: empirical research dating back to the 1980s consistently shows that research subjects have limited understanding of study information (Falagas et al., 2009; King and Heubi, 2014), and that consent forms are often to blame. Long, dense, and technically written consent documents do a better job of legally protecting research institutions than enabling potential subjects to make informed decisions about research participation. And while legal protection is important for both the subject and the institution housing the research, the focus on avoiding future litigation puts the interests of the institution above the interests of individuals who are being asked to take on sometimes significant risks for the sake of, at least primarily, generating scientific knowledge. Without subject comprehension, consent can’t meet its intended goal: to afford potential research subjects the opportunity to autonomously agree to participate in a research study, with full and well-considered knowledge of all that participation entails.
None of this is news, of course. And valiant efforts are being made to offer empirically grounded recommendations about how to improve both consent forms and processes, precisely to increase subject comprehension (Nishimura et al., 2013; Koyfman et al., 2009; Stunkel et al., 2010; Kass et al., 2011). But attending the SACHRP meeting and then shortly afterward working on PRIM&R’s comments on the FDA guidance, got me thinking about the tenacity of the problems around subject comprehension in informed consent. This led me to reflect on another practice around consent I’ve noticed and always objected to: the use of “consenting” as a transitive verb – as in, “we consented the subject into the study….” This may seem like a minor detail; in fact you hear it all the time. But I think this way of speaking reflects the same general attitude toward consent that results in overly lengthy, poorly constructed consent forms: that it’s something done to subjects so that research can get started.
Thinking this way does real violence to the very idea of what consent is supposed to do: respect, acknowledge, and invoke the agency of potential research subjects as they think about and knowledgeably decide whether they want to participate in research. Again, the phrasing may seem like a small detail, but words matter. They convey an attitude. In this case, it’s an attitude reflective of a more general corruption of the spirit of informed consent, namely, that in practice, on the ground, there is not enough regard for its role as our primary mechanism for respecting the autonomous, informed choices of individuals to participate in this important endeavor we call research.
What do you think? Is this an issue of mere semantics, or a point requiring a culture change? What are your reactions to the FDA’s draft guidance? And what are some best practices you’ve seen or used to foster subject comprehension during the informed consent process?