There is a gap between what is required in the informed consent process for human subjects research, and the reality of how well the information is actually understood by participants. This was the focus of a March 2015 workshop convened by the Institute of Medicine’s Roundtable on Health Literacy. It is possible to make consent documents “massively shorter and easier to understand,” says Michael Paasche-Orlow, MD, MA, MPH, a Roundtable participant and associate professor in the Department of Medicine at Boston University School of Medicine. However, that is not enough. “Readability will not be our salvation. In the end, it is a consent process — not a form,” he says.

Leah Eisenberg, JD, assistant professor in the division of medical humanities at the University of Arkansas for Medical Sciences in Little Rock is concerned that too many people sign consent forms without understanding them. “If we are serious about the importance of informed consent, it is vital that potential research participants are given information about research in a way that is understandable and meaningful to them,” says Eisenberg.

Bioethicists serve a unique role in championing this cause. “Regardless of how we come to read a consent form, it is always our job to bring up ethical concerns,” says Eisenberg. “In addition to addressing such concerns as they arise, we should work to mitigate future problems.” Bioethicists can do this by educating students and researchers, serving on IRBs, and working to develop institutional policies about informed consent.

Bioethicists can encourage investigators to be more involved in the enrollment process. “It’s not that the investigator wants to be an absentee landlord. The investigator is busy,” he says. “But it’s important to show that you care not just about how many people were enrolled, but also the quality of the process.”

The more that investigators can demonstrate that participants understand the process and are satisfied with it, says Paasche-Orlow, the more solid a footing the whole research enterprise is standing on.

“It is tremendously better protection for you if there does end up being a problem. It gives the institution a much stronger leg to stand on, and the investigators too,” says Paasche-Orlow. “It’s more work up front, but it’s a much stronger positon to be in, ethically.”

During the enrollment process, a prospective participant’s comprehension of complex information isn’t typically confirmed. “It should not come as a surprise that some additional work is needed for a potential subject to understand conflicts of interest, risk, randomization and clinical equipoise,” says Paasche-Orlow. “In the end, if you want to do a good job, it requires evaluation of comprehension.”

Simple yes/no questions won’t suffice. Paasche-Orlow promotes a teach-back approach, with the potential subject conveying their current understanding. The research coordinator can say, for instance, “We’ve been talking about a lot of things. It’s my job to communicate properly and make sure you understand this research project. So tell me, please, do you need to be in this study?”

This reveals whether the individual truly understands that his or her participation is voluntary. “If you don’t do this, you really don’t know if the person understands what they are getting themselves into,” he says. Paasche-Orlow advocates shifting the role of the research coordinator, or whoever is in charge of the enrollment process, from “persuasion to pedagogy.”

“It is a fair assessment to say that what they are doing now is persuasion,” he says. Some researchers worry that confirming subjects’ comprehension will slow up the enrollment process. “But if people are enrolling in studies they don’t understand, this could lead to lower retention rates or fewer people adhering to the protocols,” he says.

Training of staff involved in the enrollment process is a related consideration. “It’s wise to think not only that everyone needs to be certified accordingly, but also about the communication skills that are needed for what is a relatively complicated interaction,” he says.

Paasche-Orlow says that in his own work, he has found that spending significantly more time up front in the consent process improves trust and has no negative effect on enrollment. “We have to go into the process of consent more like an educator and advocate and supporter of this potential subject, rather than just getting the wheel rolling as quickly as possible,” he says.

Consent forms often contain complex medical language that is not easily understood by research participants. Lack of reading comprehension skills and low health literacy are two contributing factors. “The challenge of simplifying medical language is huge in the world of consent,” says Kristen Senetar, MA, a regulatory assistant at Dallas-based UT Southwestern Medical Center’s Institutional Review Board (IRB). Bioethicists can do the following, she says:

• Educate medical and research personnel about the importance of using common language that everyone can understand in the consent form;

• conduct site visits where bioethicists sit in on the consent process to help identify areas that might need improvement.

• work with IRBs to create suggested language that can be used in a template consent form.

“By working together, the medical community can create some simpler language for common medical terms that are currently difficult to explain to participants,” says Senetar.

When a participant does not possess information regarding the risks, benefits, and alternatives to a proposed intervention, they are only giving consent, not informed consent, says Eisenberg: “This violates the spirit, if not the letter, of the Common Rule.”

Researchers do not typically directly withhold information from potential participants; rather, they make it difficult for patients to access by presenting it in complicated, jargon-ridden language. “IRBs are generally predisposed to approve consent forms that follow existing institutional templates, since it is easier to review and regulate such forms,” says Eisenberg.

Many researchers focus on including as much information as possible in the consent form in order to protect themselves from future liability. They may also use a complex consent form if they are part of a multisite study for which a consent was already written.

“In all of these situations, a researcher who takes the time to draft a simple and streamlined consent form will likely run into a slower approval process than one using a more typical consent,” says Eisenberg.


  • Leah Eisenberg, JD, Assistant Professor, Division of Medical Humanities, University of Arkansas for Medical Sciences, Little Rock. Email:
  • Michael Paasche-Orlow, MD, MA, MPH, Associate Professor of Medicine, Department of Medicine, Boston University School of Medicine. Email:
  • Kristen Senetar, MA, Regulatory Assistant, Institutional Review Board, UT Southwestern Medical Center, Dallas. Phone: (214) 648-3680. Fax: (214) 648-2171. Email: