Research institutions should make certain the responsibility for a successful informed consent (IC) process is primarily that of the researcher and not the potential participant. One way to do this is to educate researchers and others in human subjects research protection on successful IC strategies.

Simply asking participants, “Do you understand?” is not adequate, says Elizabeth A. Bankert, MA, director of the IRB office at Dartmouth College in Hanover, NH.

“About 10 to 15 years ago we developed an informed consent feedback tool for research subjects that simply lists the items you should understand before enrolling in a study,” Bankert says. “When we implemented the tool, we had a few questions at the end about how useful was the tool.”

Participants in the pilot study commonly replied that if they hadn’t been told what they needed to know, they wouldn’t have known what questions to ask, she notes.

“I use this as an example: When you’re getting a new mortgage, you don’t know what questions to ask,” Bankert says. “So we remind people that research participants aren’t as embedded in the whole research community as we are.”

The Dartmouth IRB now educates researchers and research staff in a two-hour program, called the Valid Informed Consent Education Program (VoICE), on why and how to obtain informed consent.

“The first part explains the importance of obtaining consent, acknowledging how difficult it is, especially with time constraints in the healthcare setting,” Bankert says. “We spend time on the elements of informed consent for research purposes, and we spend quite a bit of time on health literacy.”

The program also teaches researchers how to do the teach-back method of IC, ending with having them practice teach-back.

“We found in our pilot program that it takes practice,” Bankert says. “People are used to saying, ‘Do you understand?’ or ‘Do you have questions?’ and that’s not what we want.”

Instead, researchers conducting IC should ask open-ended questions, such as, “If your sister calls you tonight to ask about the research study, how are you going to describe it to her?” Bankert explains.

The project showed that researchers can increase their knowledge of teach-back questions and reduce the number of closed-ended questions they’ve been using habitually, she adds.

The pilot study’s findings showed that people learned how to ask more questions like, “Explain to me in your own words what the risks are?” Bankert says.

“What we aim to do is show that it increases comprehension in the research setting,” she adds. “It has been shown to improve comprehension in the clinical setting, and we’re only transferring this technique to a different setting.”

Bankert suggests IRBs and research institutions can take the following steps to improve IC process education:

Research teach-back online. There are a number of studies published about teach-back, and a number of institutions have published online information about the method.

For example, tools and videos are available at the Always Use Teach-Back website (www.teachbacktraining.org).

One tool is the one-page “10 Elements of Competence for Using Teach-back Effectively.” Among its suggestions are these three:

- Use a caring tone of voice and attitude.

- Use non-shaming, open-ended questions.

- Use reader-friendly print materials to support learning.

Another helpful Web page is about coaching to using teach-back (http://www.teachbacktraining.org/coaching-to-always-use-teach-back).

Help researchers develop new habits. Most people providing informed consent in research have developed habits and a method they use repeatedly. The goal of VoICE was to help them change their habits to a more effective IC method, according to Bankert.

For example, when teaching the teach-back method, instructors will produce better results among researcher attendees if they encourage them to use the new habit and to observe others using the method, according to the Always Use Teach-back coaching tips.

Instructors can use active and reflective listening and ask these questions:

- “What worries you about using teach-back?”

- “How did using teach-back with your patient make you feel?”

- “Tell me more about…”

“Research coordinators and team members are definitely looking for help in improving the dialogue and process of informed consent,” Bankert says. “They realize how difficult it is and appreciate it when we acknowledge that it’s difficult.”

Empathy for their challenges in conducting IC also helps build rapport and is far more helpful in improving the IC process than for IRBs to wordsmith an IC form, she notes.

Use the IC document’s headers as a guide. “What we find is the consent form is a useful document that individuals can use as a reference tool,” Bankert says. “It’s a good reference as you go through the process, but it’s not the only piece of obtaining informed consent; it’s just one part of it.”

By looking at the IC form’s headers, a researcher can steer the teach-back IC in direction of the most important facets of the study, Bankert says.

“You discuss the main sections of information and ask teach-back questions for each of these,” she explains. “I’ve had some research coordinators ask a teach-back question after each section and then not go on until there is good comprehension.”

Incorporate the main elements of IC in the class. “We cover the elements of informed consent,” Bankert says.

“We explain that every research study is different,” she adds. “The role of the IRB and research team moving forward should be to try to figure out the key components that people should understand for any research study in particular.”

For example, if they have a high-risk study, the question for researchers to ask themselves might be, “Is that toxicity far beyond what subjects might be exposed to in standard of care treatment?”

Whatever is different or challenging about a particular study and how these tie to the elements of IC should be the researcher’s focus during the IC process, she says.

“What are the key elements of each particular study?” Bankert says. “This needs to be discussed within the research team.”

Give researchers strategies for determining comprehension. If a research subject’s answers to open-ended questions are inaccurate or not very detailed, then it would suggest the person doesn’t fully understand the study and more informed consent is necessary. In these cases, the researcher can say, “I didn’t explain it correctly. Let me explain it again,” Bankert suggests.

Or they can say, “Let’s spend a little more time on this because it’s really important,” she adds.

This works better than post-IC tests because it is a more dynamic way of assessing a person’s level of comprehension, she says. “You’re not supposed to move on to the next topic until you’re comfortable with the comprehension level of the topic at hand,” Bankert says.