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By Gary Evans
A study asking readers to consent to a short form containing only the key information about the research resulted in suboptimal comprehension, suggesting participants only skimmed through it or skipped it outright.1
The lead author of the social science study is Evan Perrault, PhD, assistant professor of health communication at Purdue University. Perrault and co-authors recently published the findings in light of revisions to the Common Rule that call for “concise” consent documents that “facilitate comprehension.” The changes were enacted in part because informed consent documents have trended to lengthier forms that may leave participants consenting to something they do not completely understand.
The researchers developed a 71-word consent process for an online study, then tested participants’ comprehension of the information. Participants could either read the concise summary and proceed directly to the study, or get more information on the research to which they were consenting. All 429 participants bypassed this option and proceeded to the study, which was about preventing sexually transmitted diseases. The concise form included all the standard research parameters, but when questioned about their consent, “about one-third of participants did not know how long the study would take, 77% did not know who the primary investigator was, and 14% did not know that their responses would be anonymous,” according to researchers.
Participants indicated they liked the brief consent process, but many clearly did not comprehend the limited information or simply skipped over it. “If we want to continue referring to informed consent as informed, future research should be welcomed and supported by IRBs to seek ways to apply the newest Common Rule guidelines while increasing comprehension; otherwise, informed consent will likely always remain an oxymoron,” the authors concluded.
IRB Advisor asked Perrault to comment on the research in the following interview, which has been edited for length and clarity.
IRB Advisor: What are the implications of your study for IRBs, particularly as they try to address the call for more “concise” informed consent forms in the revised Common Rule?
Perrault: The study dealt only with an online study, so its conclusions cannot be generalized to all forms of research that IRBs oversee. However, at least for online, minimal-risk online studies, this study helps to showcase that still more work is needed to find ways to put the “informed” into “informed consent.” I would encourage local IRB managers across the U.S. to work with colleagues in the social sciences at their institutions to develop and test novel ways to ensure better information comprehension in their consent processes.
IRB Advisor: Does your study and the prior research you cite indicate that many research participants today do not really comprehend the research to which they have consented?
Perrault: I think the bigger question here relates to participants fully reading the forms. As researchers, we can’t expect participants to comprehend information if they’re not actually reading the forms. While our study did not assess whether participants read the concise consent form, a prior study of mine that also tested shorter forms (about 150-190 words) found that about 21% did not read the form at all, and about 69% skimmed the form. Future research should continue to focus on ways to encourage participants to fully read the content these forms contain. Only then can we expect comprehension to increase.
IRB Advisor: Can you elaborate on the finding that participants only comprehended about half the information in the short consent form?
Perrault: The short consent form provided to participants included many of the elements the revised Common Rule indicates are important to include in any consent form (the purpose of the study, the study duration, potential risks, contact information).
Questions to assess recall of these pieces of information were asked, with results revealing that greater than half of participants were unable to remember the primary investigator of the study (77%), the risks they many encounter in completing the study (83%), and the contact information of the university’s IRB (98%).
IRB Advisor: You make an interesting point about the impact of social media on the willingness of people to read a long consent form. Given that participants cannot, for ethical reasons, be forced to read a form, do you think this idea of informed choice may emerge as an alternative to informed consent?
Perrault: It is possible. As I stated in the paper, participants in the current study had the opportunity to learn more about the study beyond the 71-word form they received if they wanted to. No participants did. About 15% of participants indicated via an open-ended response that they appreciated that they were offered this choice as part of the informed consent process.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSBioethics, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, is a consultant for Ethicon USA and Mobile Instrument Service and Repair.