Before a patient or prospective research participant walks in the door, what are the policies and procedures that can create opportunities for more effective discussions with caregivers and optimize understanding among all parties involved?
Over the last five years, my organization has trained hundreds of oncology professionals on strategies to enhance their recruitment and accrual practices, with a strong focus on literacy and language. In the course of this training, we have found that the informed consent process in many institutions relies too heavily on the consent form itself, rather than on a meaningful discussion about risks and benefits, and researchers seldom assess understanding.
Since most consent forms exceed 20 pages and are written at a 12th-grade level or above, we cannot continue to rely on this document to ensure understanding. What does this have to do with institutional review boards (IRBs)? Four issues come to mind:
First, IRB professionals should work with investigators to address literacy levels in informed consent documents, which means not only looking at the language used, but also at the length of the document itself. In “Health literacy and cancer communication,” Davis and colleagues state: “IRBs are designed for patient protection; however, IRBs rarely take literacy into full account when reviewing consent documents.”
Second, IRB professionals need to understand the processes through which consent is given that optimize patient understanding- otherwise the consent form itself is meaningless. For example, does a member of the research staff read the form out loud to “consent” the participant? Do they assume the prospective participant has read the document himself or herself, because it was sent home ahead of time? Finally, how do research staff assess understanding? As a recent study pointed out, “strategies to increase patients’ knowledge need to be elaborated in order to improve the fulfillment of the requirements of informed consent in participants in cancer clinical trials.”
Third, IRB professionals should consider how well the consent process itself is explained to the public. Through our work in communities nationwide, we still see what Corbie-Smith and colleagues pointed out in their study of African Americans: “[Few understand] the concept of informed consent and [see] signing the document as relinquishing their autonomy and as a legal protection for physicians.”
Fourth, how can IRB professionals respond to the fact that more than 50 million US residents do not speak the same language as their physicians, i.e. how do we address the need of limited English proficiency (LEP) patients/prospective participants? Are translated informed consent documents and an available interpreter all that is needed? Is it legitimate for government-funded studies to exclude LEP populations?
What can we do to enhance the informed consent process? How can IRBs ensure that research staff or physicians discussing the trial optimize understanding for their patient?
I understand that these and related questions are addressed regularly at PRIM&R’s Advancing Ethical Research conferences, but I’d really like to take this opportunity to hear your thoughts, so please post a comment so that we can benefit from of our shared efforts in this complex area.
I’d like to end this post by returning to the question I posed at the outset: What’s the worst question you can ask during the consent process?
In my opinion, and the opinions of literacy and language experts, it’s relying on “do you understand?” to assess understanding. A prospective participant is very likely to answer “yes,” or nod, regardless of whether she/he actually does understand. The question shifts the burden to the prospective participant, when in fact it should lie with the researcher and the research staff. It’s our obligation to provide the information in a manner that promotes and ensures understanding. Furthermore, it’s our responsibility to ensure that understanding is achieved in an appropriate and interactive manner. Some excellent tips on doing so can be found in the American Medical Association video, “Health literacy and patient safety: Help patients understand”. A simple question such as “do you understand?” does not accomplish any of this and as a result just may qualify as the “the worst question.”
I welcome and encourage your questions and comments!