How do we ensure that the signature on the document represents a truly informed study participant?  Verifying individuals are able to make an informed decision when deciding whether or not to enroll in a research study is a cornerstone of conducting ethical research.  Obtaining valid consent has been a concern since 1966 when Henry Beecher, wrote “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 sense… Nevertheless, it remains a goal toward which one must strive for sociological, ethical, and legal reasons” [1].

Now, nearly 50 years later, we are still concerned about the level of comprehension of a prospective research participant.  In September 2015, the Office of Human Research Protections (OHRP) released prosed new rules for human subject research. One of the proposed changes addresses issues surrounding informed consent, including:  The prospective subject or the representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. Hopefully the impact of this new language will not only improve the readability of the consent document but to also shift the focus to the manner in which consent in obtained.

A team comprised of researchers and Institutional Review Board (IRB) staff at Dartmouth created the VoICE (Valid Informed Consent Education) Program in an effort to provide a resource to research staff. The VoICE Program includes an overview of the elements of consent, a discussion of health literacy, and advocates the use of the teach back method [2]. The teach back technique has been used in clinical settings and has been shown to improve communication and patient comprehension. [3] In teach back, the prospective research participant is asked to ‘teach back’ to the individual obtaining consent each key element of the research study.  Using this method an opportunity for dialogue is created.  The researcher provides information then asks the potential subject to teach-back or explain the information to confirm understanding. “Asking that patients recall and restate what they have been told” is one of the 11 top patient safety practices based on the strength of scientific evidence.” [3] ”

An extremely important concept of this technique is that it is not a test of the prospective participant but rather a test of how well the researcher explained a concept. Using teach back rather than a test turns the tables by putting the responsibility of explaining on the research staff rather than solely the responsibility of the prospective subject.   The use of closed questions such as “Do you understand” or “Do you have any questions” will most likely be answered with a yes or no, do not encourage dialogue, and therefore are not recommended during the consent process. Rather the method of the researcher explaining a key concept, pausing, and using an open ended phrase such as “If you call your sister tonight, tell me how you would explain the purpose of this study to her” has shown to encourage dialogue. The teach back technique and the use of open ended phrases takes practice. Therefore, part of the VoICE education program includes time to consider what the key concepts of a particular research study may be and time to actually rehearse the teach back method with colleagues.

An important part of the VoICE education program is a discussion of health literacy. Research shows that patients remember and understand less than half of what clinicians explain to them and well-educated people may become functionally health illiterate when in pain or confronted with a serious disease or new diagnosis.[4]  During the education program we present a video which clearly demonstrates health literacy issues: Health literacy and patient safety: Help patients understand

We recommend the use of an education program to assist research team members in understanding the importance of obtaining valid informed consent. Information related to the VoICE program can be found here.

Author: Elizabeth Bankert

1) Henry K, Beecher M. Ethics and Clinical Research. N. Engl. J.Med. 274(24), 367-372 (1966)

2) Always use Teach-back.

3) AHQR 2001 Report, Making Health Care Safer;

4) Schillinger, Arch Inter Med/Vol 163 Jan 13, 2003 “Closing the Loop”