The informed consent template that now is required through the revised Common Rule can be developed thoughtfully and effectively through the use of an expert panel or working group, experts say.

Wake Forest School of Medicine in Winston-Salem, NC, asked IRB members to rate the 10 required elements of informed consent (IC). The idea was to use the top-rated items in the IC summary.

“We asked our members to rate them from one to 10, most important to least important, with the most important at number one,” says Brian Moore, director of the IRB and the human research protection program at Wake Forest School of Medicine. “Then we averaged all of the scores, and the elements with the lowest scores [more #1s] were the ones we determined to be the most important.”

“The results were interesting,” he adds.

“They were pretty distinct in that there were about three groups,” he explains. “There were a couple of elements that were ones everyone felt strongly were important and should be in there; and then there were three to four in the middle group that some people felt were important and others did not; and the third group had several elements that were consistently on the less important side of the scale.”

The lowest ranked IC items, meaning these were ranked as most important, included the following:

• an explanation of the purposes of the research and the expected duration of participation;

• a description of any foreseeable risks or discomforts;

• a description of the procedures to be followed and identifying which procedures are experimental.1

With those data, the IRB developed a one-page template that could fulfill the informed consent summary requirement.

“It’s succinct and represents what reasonable people want to know,” Moore says. “It contains key information about a study, and we think it checks all the boxes in what the regulations require.”

The summary also is written in simple, reader-friendly language. The word choice is basic, and it has a low reading level, he adds.

For example, the paragraph about voluntary participation and risks states, “Your participation in this study is voluntary. You do not have to participate in this study if you do not want to. There may be other choices available to you. Some other choices may include...”

The next step is to survey participants in studies to find out whether the summary information is helpful. The IRB will want to know what they think of the format and whether they have any suggestions for improving it, he says.

Moore co-presented a poster about the summary template at PRIM&R’s Advancing Ethical Research Conference last fall, where attendees often asked whether the IRB could share the template.

“What we communicated to those folks is, ‘If you want to use our template, that’s fine, and it may work for you and it may not,’” Moore says. “What I would encourage IRBs and institutions across the country to do is to not just copy and paste our template, but to repeat our methodology.”

What’s important to IRB members and research participants in Winston-Salem might not be the same priorities in another part of the country, Moore says.

“Our rankings and results are good for us, and while they may be good for you, too, it’s probably worthwhile to develop a brief survey just to confirm this,” he says.

Since the IRB began to use the summary, IRB members have found it to be very helpful, and they’ve asked that the summary statement be added to industry-funded studies’ informed consent documents, Moore says.

“Industry-funded studies are not necessarily applicable to the Common Rule, and we can’t require those studies have the informed consent summary,” he explains. “But it’s been a frequent request from our IRB members that the summary statement be added because it’s been beneficial to participants.”

REFERENCE

1. Moore B, Wesley D, Andrews J. Assessing consent form elements to be included in a summary statement. Poster presented at PRIM&R’s Advancing Ethical Research Conference, Nov. 14-17, 2018, San Diego. Poster: 63.