IRB questions sometimes arise about the role and responsibility of community members/nonscientists on review boards. Should their — and other nonaffiliated members’ — contributions be limited? Do they have enough training to be primary or secondary reviewers?

These questions were raised in a recent online IRB Forum post in which an IRB director asked if other IRBs had community members review protocols as primary reviewers on their own or paired with someone else. Responses were varied, and IRB Advisor asked a couple of IRB leaders to explain how they handle responsibilities for community/unaffiliated members of the board. The following are their strategies:

• Evaluate nonaffiliated IRB members by their particular CVs. “We have nonaffiliated IRB members with different backgrounds and expertise,” says Kevin R. Johnson, PhD, CIP, IRB manager at Novant Health in Winston-Salem, NC.

For example, the IRB’s nonaffiliated members include a pathologist, a CPA, and a member who is bilingual in Spanish and English. When the IRB reviews studies with informed consent forms in English and in Spanish, the bilingual nonaffiliated board member is asked to review them to see if the translations differ in tone or accuracy with regard to medical terminology.

The pathologist board member sometimes performs first reviews, so there is no policy limiting first reviews to affiliated IRB members. Also, nonaffiliated members often contribute observations about studies from a community-oriented perspective, as well as drawing on their medical, scientific, and clinical trial expertise, Johnson says.

“Every person on the IRB lives in the area and can represent the general community,” he adds.

Community members of the IRB are longstanding members and are well-trained on human subjects research regulations. All IRB members are trained through videos from the Office for Human Research Protections (OHRP) and CITI, he says.

Occasionally, the IRB will have members take ad-hoc training, such as a brief review related to handling pediatric research when a rare pediatric study is submitted for review.

“It’s similar for genetic research,” Johnson says. “We have the brief reviews at our meetings. I send out a blurb about it, and if there are any articles or documents, I’ll send those out ahead of time with the meeting agenda.”

Johnson gives board members one-and-a-half weeks’ notice, and the presentations are held at the end of the meeting.

When Johnson was with a previous IRB, community/unaffiliated members lacked scientific expertise, so their input usually centered around the language of informed consent documents and the general quality of a study, he recalls.

“But I’ve never felt that community members were undervalued,” he says. “It always felt like they brought a good, fresh look to the review.”

• Capitalize on the fresh perspective community members bring to IRB. “The spirit behind the requirement is that you have a community member who brings to the table the perspective, thoughts, and interests of the general public,” says Megan Roth, PhD, director of research and sponsored programs, and chair of Abilene Christian University IRB in Abilene, TX.

People who work in an academic and research setting develop certain ways of understanding research ethics. Having a nonacademic, nonscientist IRB member brings a different perspective, one that might mirror the thoughts of the average person who will be a research volunteer, she explains.

“Academics are necessary on IRBs, but they have certain biases that have an impact when they review a study,” she notes.

The community IRB member could explain what the average person in the community would think about a particular study and explain their concerns. While the community member might not become a primary reviewer of a study, it’s not because it’s prohibited, Roth says.

When Roth first became the director of research and sponsored programs, she wanted to find a community IRB member who would be enthusiastic about participation on the board. The previous community member was not attending meetings regularly or providing feedback, she says. “This was not acceptable; it was not fulfilling the purpose of this role.”

As a small institution, Abilene Christian University has only one IRB and a spot for one community board member. A change was necessary. “When it was time to start a new year, I didn’t renew with the previous community member,” Roth says. “We had a discussion on the board about the value of having a student perspective.”

The IRB’s idea was to find a mature graduate student who was not a part of the institution and who could bring to the IRB the perspective of a student, as well as that of a community member.

“I reached out to a colleague at another institution and asked for someone who could fit that description,” Roth says. “I found someone who was very eager to participate.”

The new community member is an older student who has professional work experience. “She also has a student’s perspective and a community perspective, and I find that she’s particularly eager to participate and tries not to miss meetings,” she says.

Roth conducts orientation and training meetings for all new IRB members, and she has additional training meetings for the entire IRB at the start of each year.

“We try to catch anything that’s changed or issues that have come up, and we refresh people’s memories on things,” Roth says.

New IRB members also can meet with Roth to talk about their role and to ask questions.

“This establishes a good rapport, so they feel comfortable reaching out to me as things go along,” she says.

A community member can participate in reviews to the level with which he or she is comfortable. Input is not limited just because the member is a nonscientist, Roth says.

“It depends on the community member’s skill level and competency,” she says. “Usually, senior IRB members mentor a newer member.”

Community members often have a great deal of insight and maturity to offer an IRB review, Roth adds.

IRB training includes online modules and a couple of hours of in-person orientation, conducted by Roth.

All new members are given an IRB member handbook to read, as well as human research protection regulations.

“In my orientation, I break it down to a little less legal language and hit the highlights, walking people through those,” Roth says. “We talk about consent, what needs to be in the informed consent document, and what research can be waived. We walk through vulnerable populations and expectations, and we touch on the spirit of the Common Rule.”

Roth explains privacy rules and HIPAA, the institution’s research review process, the different types of IRB applications, and timelines for submission.

For returning IRB members, there are refresher courses that look at what’s changed and new issues.