Tuesday, September 9, 2014

Consent and the Autonomy of Human Subjects

by Elisa A. Hurley, PhD, Executive Director

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The United States Food and Drug Administration (FDA) recently released a draft guidance, Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors, for public comment.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 Throughout the new draft guidance, the FDA emphasizes that informed consent involves more than a form, and encourages investigators, IRBs, and sponsors to think of informed consent as a dynamic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 PRIM&R will submit comments to the FDA on the draft guidance, and I encourage you to share your thoughts and comments on the guidance, along with those on other topics, at the end of this post.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?


  1. Thank you Dr. Hurley for your heads-up with your observation on the use of the phrase "we consented the subject into the study". I think this phrase may partly be a result of busy research staff, who are otherwise conscientious of HSRP issues, simply communicating to get things done. Still, we need a continued awareness of the real intentions underlying informed consent; stated well here in Dr. Hurley’s article, as well as in the FDA's draft guidance. Without this awareness, busy research professionals might slip into a “corruption of the spirit of informed consent” Dr. Hurley refers to. I observed this behavior years ago in the related area of monitoring research data integrity.

    On the issue of semantics, Elizabeth asks: what are some of the best practices used for subject comprehension of the clinical study process? I continue to notice how often some professionals in the Human Subjects Protection field use the term “patients” when referring to subjects participating in clinical research studies. This certainly may contribute to any therapeutic misconception a subject may have, especially when research staff with frequent contact with subjects, use the term. It is almost a relief to read PRIM&R’s communications, such as this Ampersand article, in which appropriate terminology is used and reinforced.

    Of course, this necessary and ongoing awareness of the bioethical details inherent in clinical research is why we keep reading Ampersand. And why we will meet at AER 2014 in Baltimore in a few months.

    David R. Van Houten (@DavidRVH)
    Closter, NJ

  2. Thank you for your comments, David. Your point that use of “consent” as a transitive verb may often simply be a matter of mere convenience is well taken. My concern is about what it expresses about – but also to – those who agree to take part in research, and also about how it may play a role in that larger, general corruption of informed consent I mention – however unintentionally it is used.

    Regarding your point about use of the term “patients” to refer to research subjects, I absolutely agree that this seems likely to contribute to the therapeutic misconception. To make a parallel point to yours about the objectionable use of “consent,” I suspect that this is due more to the dual roles many clinical researchers plan, than to any intentional attempt to mislead subjects. But again, and I think you and I are in agreement on this point, vigilance about language used really matters in this realm. I look forward to our continued conversation on this topic.

    Finally, I’m pleased you find value in Ampersand and other PRIM&R resources, and I look forward to seeing you in Baltimore in December.

    Elisa Hurley


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