Proposed changes to the Common Rule include a strong focus on the need to simplify informed consent. Some approaches include the following:
- having staff review the consent forms orally and in writing with research participants,
- using “teach-back” methods to ensure participants’ understanding, and
- using interactive technology so participants can learn at their own pace.
Is a prospective research participant struggling to comprehend a lengthy form on the risks and benefits of the study? “A complex consent process is mired in ethical problems,” says Linda Aldoory, PhD, an associate professor of communication at the University of Maryland in College Park.
One issue is low health literacy among potential participants. “Health literacy is the ability to get, understand, and use health information to make good health decisions,” says Aldoory. “Even people with high education levels can have low health literacy.” Aldoory was lead author of a 2014 paper commissioned by the Institute of Medicine, which found little research focusing on low health literate populations and health literacy disparities in informed consent outcomes.1
Simplified language increases the likelihood of participants making the best decision for themselves and their families, says Aldoory. “Oversimplification may seem patronizing or condescending,” she acknowledges. “But the risk of those feelings are minimal compared to the risk of participants not understanding consent procedures.”
PARTICIPANTS LIKELY OVERWHELMED
A lengthy, complex consent process could mean that the substantive information important to the subject is “lost,” says Michele Kennett, associate vice chancellor for research and director of the institutional review board (IRB) at the University of Missouri in Columbia. “It also has the potential to dissuade subjects who might otherwise participate, but are put off by the complex process.”
Camille Nebeker, EdD, MS, was particularly pleased to see attention on improving the informed consent process in the proposed changes to the Federal Policy for the Protection of Human Subjects, also known as the “Common Rule.”
Nebeker is an assistant professor of behavioral medicine at UC San Diego, where she serves on the IRB. “It seems we are more concerned with the letter of the law when it comes to informed consent, and have drifted away from the ethical principle of respect for persons,” she says.
Demonstrating respect would involve presenting potential participants with information that clearly conveys what the research involves, says Nebeker.
“The consent documents that we see during IRB meetings may meet the federal and institutional requirements, yet are likely overwhelming for most research participants, who are unfamiliar with research and the process of informed consent,” says Nebeker.
The research community owes it to potential participants to make information about a research study accessible, says Nebeker. “How to do that is challenging,” she adds. A shorter consent that features key points with options to access more details may improve the process. “However, we have not addressed the elephant in the room,” says Nebeker. People being consented often don’t understand what a research study is and are generally not familiar with the scientific method.
“While the idea of simplifying the consent process is a step in the right direction, we need to better understand what leads to an informed participant,” says Nebeker. The following are some approaches institutions are utilizing to simplify the informed consent process:
• Some IRBs have employed staff to review the consent forms with individuals one on one and answer their questions. “Teach-back methods — asking participants to teach the staff member what was stated — are used to ensure understanding before moving forward,” says Aldoory.
• Some studies are using multimedia and interactive technology, allowing participants to go at their own pace. “Institutions are looking at electronic consent and tiered consents, although there is some hesitancy about moving too far outside the box without some official sanction,” says Kennett.
If researchers give participants either too much or too little information, they cannot make informed decisions, says Nicholas H. Steneck, PhD, professor emeritus of history at the University of Michigan, and an Ann Arbor-based research integrity consultant. “For the most part, this does not matter. Most clinical research is not overly risky, and there is no doubt getting subjects to enroll is a problem,” he says.
However, there are times when subjects do not understand what they are agreeing to and could suffer adverse consequences, says Steneck.
“Consent forms are too long. Many studies have shown that subjects do not understand,” he adds. Steneck worked with a colleague to come up with a way to provide short, informative consent for enrollment in a biorepository.
“We showed that it is possible to shorten the consent form and still provide adequate information,” he says. This approach is now used by the University of Michigan’s central biorepository.
“Even with our shortened form, there are potential problems,” says Steneck. When researchers used the form to recruit in a general setting in the medical center, they saw fairly low enrollment rates. When the same form was used in the pre-surgery setting, rates increased significantly. “So coming up with the best consent form is only part of the process,” says Steneck. “Proper informing also depends on the setting in which the consent is conducted and who does the consenting.”
Steneck says one of the most important steps that could be taken would be to test informed consent forms on some subjects before finalizing for a full study.
“The current system does a reasonably good job of informing subjects,” says Steneck. “But there is considerable room for improvement.”
- Aldoory L, Ryan ELB, Rouhanni AM. Best practices and new models of health literacy for informed consent: Review of the impact of informed consent regulations on health literate communications. 2014: Commissioned Paper for the Institute of Medicine.
- Linda Aldoory, PhD, Associate Professor of Communication, University of Maryland, College Park. Phone: (301) 405-6520. Email: firstname.lastname@example.org.
- Michele Kennett, Associate Vice Chancellor for Research/Director, Institutional Review Board, University of Missouri, Columbia. Phone: (573) 882-3182. Email: email@example.com.
- Camille Nebeker, EdD, MS, Director/Founder, Collaborative for Advancing Professional and Research Integrity, Department of Family Medicine and Public Health, UC San Diego, La Jolla, CA. Phone: (858) 534-7786. Email: firstname.lastname@example.org.
- Nicholas H. Steneck, PhD, Professor Emeritus of History, University of Michigan/Research Integrity Consultant, Ann Arbor, MI. Phone: (734) 995-1815. Email: email@example.com.