Best practices to engender a more balanced IRB input

Using mentors, education, trial periods help

IRBs should work to create balanced IRB discussions and ensure cooperation between members of diverse backgrounds.

Regulations require IRBs to include an unaffiliated and non-scientific member on the board. But it's up to the IRB and its leadership to make certain these members are encouraged to speak and fulfill their role as a voice for research participants.

"There are a number of different ways IRBs can engage the nonscientist, unaffiliated member," says Robert V. Bienvenu, II, PhD, CIP, public health analyst for the Office for Human Research Protections (OHRP) of Rockville, MD.

For people who don't have a science background and might never have served on an IRB before, being plopped into that environment can be challenging and intimidating," Bienvenu says.

Sometimes IRBs are imbalanced in their review discussions, notes Tanya Carrillo, CIP, CIM, clinical research leader, Primary Care Ultrasound Vscan, of GE Healthcare of Wauwatosa, WI. Carrillo and Bienvenu spoke about the dynamics of an IRB meeting at the Public Responsibility in Medicine & Research (PRIM&R) Advancing Ethical Research Conference, held Dec. 6-8, 2010, in San Diego, CA.

Physician scientists might dominate the IRB discussion and non-scientist members may tend to hold back because of a lack of knowledge about some aspects of the research under review.

"Being plopped in that environment can be challenging and intimidating," Bienvenu says.

Bienvenu and Carrillo offer these suggestions for how an IRB might facilitate a more cooperative environment in which every voice is heard:

• Educate all IRB members when they are brought on board: "Some non-scientific members don't speak up because they don't understand what their role is," Carrillo says. "Helping them understand their role is very important."

Having IRB members train in human subjects research protection history and regulations will help community members gain a perspective about how important the non-scientist voice is.

Training could include the institution's internal policies and procedures, as well.

Also, IRBs might provide ongoing member education with articles on ethical and regulatory issues or special populations, Carrillo suggests.

"When IRB members are sent out for training in different events, it should include unaffiliated members," Bienvenu says.

• Pair scientists and non-scientists in reviews: Another strategy is to use a primary reviewer system where scientist members and non-scientist members are paired to work together on a protocol, Carrillo suggests.

"They can present their comments before the IRB engages in deliberations on the protocol, and that obligates them to speak," she says.

Some IRBs that use this strategy have the scientist member serve as the primary reviewer with the non-scientist member serving as a secondary reviewer, Bienvenu says.

"There are issues a non-scientist member might recognize and weigh more heavily," he adds. "So they're a good combination."

• Assign a mentor to new members: For new unaffiliated and non-scientist members, it might be especially important to have mentors available to answer their questions and help them , Bienvenu suggests.

"This gives them someone to talk with and orients them to what's going on, guiding them, and helping them assimilate their acculturation to the IRB," he adds.

• Have IRB chairs empower quieter members: IRB chairs are responsible for noting when one member is disrupting or dominating the review conversation and subtly changing the focus.

"The chair has a leading responsibility to ensure that all voices are allowed to be heard in the IRB's deliberation," Bienvenu says.

"But there's also an obligation on the part of members to speak up," he adds. "If they've analyzed the protocol and seen issues that need to be raised, they certainly should bring those to the table, and the chair can facilitate that process."

The chair could keep the conversation moving, bringing in new voices to a discussion.

"The chair might call on someone who looks like he or she has something to say," Carrillo says. "I've seen that work effectively."

Chairs can help end a monologue by validating the speaker's perspective and moving the conversation to the next stage, Bienvenu says.

"A good chair should be able to recognize the appropriate thing to do," he adds.

• Have support staff sit in different places around the table: In Carrillo's experience, IRB support staff can help facilitate conversation by strategically placing different members around the table. This way they will notice when someone whispers a comment to a neighbor, and the staff member can prompt the person to speak up to the entire group.

"Having an IRB support staff person near them often gave them more inclination to speak up," she adds. "I'd sit next to newer IRB members for the first few months so if they had questions during the review I could answer those questions for them."

• Give non-scientist, unaffiliated members the task of reviewing informed consent: Some IRBs choose to divide duties this way and it has the advantage giving an important role to these members.

"So when the IRB comes to the point in the protocol review where they focus on the informed consent document, that person would report on it in the role of a reviewer of informed consent document," Bienvenu says.

The disadvantage is it might pigeon-hole community members when their role should be the same as other members – to look at the entire study protocol, Carrillo says.

• Put new members through a trial period: "The first three months could be a trial run," Carrillo says. "New members might not be given protocols to review, but they could review items."

Experienced IRB members could help them learn how to analyze their IRB packet, answer their questions, point out the way they would handle a review of a particular protocol item, and provide them with a checklist, she adds.

After three months, if the new IRB member still is uncomfortable with reviewing studies, the IRB could give him or her some extra time.

"The key point is for an IRB meeting to include all parties in the discussion," Bienvenu says.

"IRBs have the full spectrum of people who are very outspoken and engage with no hesitancy whatsoever to people who are quieter and may need some encouragement," he adds. "A good chair would ensure there's a full discussion, and that all perspectives are engaged."