Deciding to make informed consent as comprehensible as possible is the easy part. What is not easy is determining how to accomplish this goal.

“Some institutions are very accommodating in making the informed consent process as comprehensible as possible, and some aren’t,” says Baruch Fischhoff, PhD, Howard Heinz University Professor at Carnegie Mellon University in Pittsburgh. Fischhoff is one of the editors of an FDA book on risks and benefits called Communicating Risks and Benefits: An Evidence-Based User’s Guide.

“We’ve often had our IRB led by or including members who were cognitive psychologists who understand these issues,” he says.

One issue is: How does one determine whether an informed consent document is easily understood?

IRB members have their own intuition and theories based on their IRB and research experience. “But, at the end of the day, it’s an empirical question of whether people understand these things or not,” Fischhoff says.

There are several approaches IRBs might take to determine comprehensibility:

• Rely on the board’s clinical judgment.

“The way it’s typically done is relying on the clinical judgment of the people involved — the professional judgment of people running the study and the IRB approving the informed consent forms,” Fischhoff says.

IRBs that rely on their members’ clinical judgment would benefit from having a diverse set of professionals. Bioethicists and informed consent experts could be helpful to have on the board.

“If you don’t have a decision scientist on your IRB, you’re missing one important perspective,” Fischhoff says.

• Study priorities.

Determining study participants’ priorities is one of the hardest parts of making an informed consent form comprehensible, he says.

“We have a lot of science on helping people to think through difficult trade-offs, but thinking about what really matters is difficult,” Fischhoff says.

IRBs could ask potential candidates and the people helping them make decisions what they most want to know.

“Let the people who might be candidates shorten the form and see if that performs just as well as the long form,” Fischhoff says.

For example, researchers looking into a patient-centered approach to informed consent designed a study to identify prospective participants’ priorities and to test the use of these priorities in a shortened consent form.1

Specifically, they recruited asthma patients from an online pool and had them examine sections of a standard informed consent document for an asthma trial. Researchers asked participants to select the information they felt was most crucial to their decision-making process.1

Then another group of asthma patients was randomly assigned to a full informed consent form, a shortened form that was created from the results of the first study, and a video with content matching the shortened paper form. They found that participants who viewed the shortened form or the video reported greater engagement than those who saw the full informed consent form. And their comprehension was the same.1

IRBs and researchers could follow a similar process to shorten the document and test an informed consent form.

“There are various ways to recruit people online,” Fischhoff says. “You can give them an evaluation for how well the short form works.”

Ideally, a shortened informed consent form would result in good comprehension, good trust, and satisfaction that is on par with the full informed consent document, he says.

“I think that to replicate what we did on a routine basis is a trivial cost relative to the cost of the clinical trial,” he says. “You recruit people online, pay them decently, and give the shortened form to another group of people.”

The result is an informed consent document that is better understood by research participants.

“This strikes me as an ethically and scientifically sound and practical way of managing consent processes,” Fischhoff says.

• Use an analytical approach.

A process of information analysis can be used to calculate which information in an informed consent is the most important to participants, Fischhoff says.

“This is not familiar to most people in the informed consent world, which is why it has not taken off,” he says.

The analytical approach also is used in medical decision-making. Fischhoff describes how it works: “Imagine you are a candidate for this surgery, and this would be a good deal if there were no risks. What if I told you that the surgery could result in you having broken teeth? Would that tip the scale where you wouldn’t have the surgery? What if I said you might have migraines from this? Would that change the scale for you?”

These questions result in people identifying the risks that matter most to them. Knowing what those risks are, investigators can make sure the informed consent document lists all of the risks but particularly emphasizes the ones determined to be the most important, Fischhoff says.

For each of the most consequential risks, there are two things people want to know: What is the probability of the problem occurring, and what is the consequence of the risk?

“There are a lot of people in the medical decision-making world that have the skills to do this kind of analysis, but they work on other things like cost-effectiveness,” he says.

Medical decision aids were developed to help people think through their decisions about cancer treatment and other medical options. These also could be developed for IRBs and informed consent.

“If IRBs don’t have people on the board who know decision-making, they miss some expertise,” Fischhoff says. “Once you teach decision-making skills, people get it.”

REFERENCE

1. Krishnamurti T, Argo N. A patient-centered approach to informed consent: results from a survey and randomized trial. Med Decis Making. 2016;36:726-740.