IRBs may be less effective if policies fail to address psychological dynamics
Credentials and personality should be weighed
IRBs are no different from other boards in how their psychological structure could lead to personality clashes and conflicts. However, unlike many organizations, when IRBs ignore such conflicts, the outcome might be a less-effective human subjects protection program or regulatory problems.
"I think, traditionally, IRBs have power differentials that we need to pay attention to," says Mary Faith Marshall, PhD, director of the Institute for Bioethics Law and Policy at Kansas University Medical Center in Kansas City.
"One thing that happens quite frequently is that there may be people who dominate the conversation at the table and/or jump in and interrupt other people while they’re speaking," she says. "And the chair and their colleagues need to meet that issue head-on and stop that person."
While IRBs primarily function as highly organized and structured organizations with clear agendas, there also is a psychological aspect that comes into play. IRBs primarily comprise members who have worked together and with investigators in a variety of ways and are from the same types of backgrounds and experiences, says Gerald Mozdzierz, PhD, who is retired as the chief senior manager of psychology service at Hines (IL) VA Hospital and professor of psychiatry and behavioral neurosciences at Loyola University Stritch School of Medicine in Maywood, IL.
This dynamic that exists between IRB members and investigators can lead to psychological conflicts that impact IRB deliberation on protocols, he says.
"It’s a low probability, but potentially high impact when psychodynamics influence in subtle ways the outcomes of IRB proceedings," Mozdzierz says. "That is where IRB chairs can play a more active part in being sensitive to and monitoring the group for the kinds of comments that are made."
Take, as an example, this psychological dynamic that he observed: An IRB was discussing a protocol submitted by a professor/investigator who had proposed using students as research subjects. One member of the IRB said if the investigator recruited subjects from among the professor’s own students, then this would be a potential conflict of interest. Another IRB member, who knew the investigator personally, made an off-the-cuff remark that called the other IRB member’s motivations into question and sullied that member’s character in an attempt to verbally bully the IRB into deciding in favor of the investigator’s recruitment tactics.
The IRB chair did not react to the verbal exchange, even when the same derisive comment was repeated, and the IRB discussion was chilled by the shock other members experienced from the bullying remarks, Mozdzierz notes.
In a subsequent meeting, the IRB member who had questioned the potential conflict of interest returned to the subject, and eventually it was decided that the investigator would have to change recruitment tactics and closely follow the principles of research ethics, he says.
However, the psychological damage to the group dynamics had already occurred. Even if the individual who had been singled out for the verbal bullying chose to continue to make comments in the future, there likely would be less free exchange among other members who would be inhibited by the prospect of being criticized and singled out during IRB discussions, Mozdzierz notes.
"There are other dynamics where people raise their voices or pound the table, and these all are power tactics that can be employed," he says. "Physicians in hospital settings are accustomed to getting their way — they need to write orders and have those orders followed — which is in most cases the appropriate thing to do."
When that same attitude is transferred to an IRB setting, problems may occur because the IRB is supposed to be composed of individuals who share an equal responsibility in the protection of human subjects, and one member’s status or experience should not trump another member’s concerns or opinion, Mozdzierz says.
Community members, who already may feel intimidated by the professional stature of other IRB members, could be vulnerable to being silenced by power tactics.
Marshall also has witnessed verbal bullying at IRB meetings.
"It’s quite often from medical-science folks who have a very narrow perspective of the research itself or of the scientific questions, and they aren’t open to hearing other things or other questions," Marshall says. "Comments are made like it’s the final word."
For this reason, Marshall recommends that IRBs have a minimum of 25% of their membership composed of community members.
"There needs to be more than one community member, and ideally a minimum — if not more — of 25%," Marshall says. "I’d like to see a co-chair who is one of the community members, and we need to train IRB chairs to be more cognizant in bringing out the community member’s voice."
Chairs set the course
The IRB chair also has a responsibility in making certain an IRB meeting is conducted with respect for all members and their comments, Marshall notes.
"I think there should be some education through PRIM&R [Public Responsibility in Medicine & Research] or guidelines by OHRP that speak to the training of IRB chairs in the dynamics of committee leadership," she says.
"The chair needs to focus on bringing out the community members’ voice to make certain these members are called upon and their contributions aren’t minimized by other people at the table and that they’re taken seriously," Marshall says. "The community representatives bring important perspectives to the table that no one else has, and this perspective too often is marginalized or not paid attention to in a serious way."
IRB chairs have a responsibility to make certain discussions do not turn into power plays, and one way to do this is for the chair to call a person out of order when a personal and derisive comment is made, Mozdzierz suggests.
"IRB chairs need some training in the subtle overuse of power, and they need more familiarity with the Robert’s Rules of Order, as well as exposure to cultural diversity," he says. "As society becomes more culturally diverse, it makes sense for people to know that people who come from different cultures may express themselves in different ways."
At the beginning of each IRB meeting, the chair could remind members about privacy rules and remind them that the public funds most research and because the research ultimately will affect everyone, then the public voice is very important, Marshall suggests.
"The chair could remind members to be respectful of the beliefs of everyone else at the table and that they need to be respectful of each other as colleagues, as far as not interrupting, and to be respectful in how they couch their remarks," she adds. "People can and should disagree — that’s the whole idea, but they need to be respectful in how they put their ideas forward."
For instance, when one member cuts off the remarks of another member, then the chair could intercede by saying, "So and so is speaking, and let’s not interrupt," Marshall says.
Or another way to handle the situation is for the chair to say, "I’m really interested in what Jane Community Member has to say," she adds. "Part of this may be gender related because we know from research that men tend to dominate conversations and interrupt, and women let them do that."
The key is to address the situation immediately and stop the interruption at once, Marshall says. "Let them know these sorts of dynamics can’t or shouldn’t happen."
If an IRB member consistently violates these norms, then the chair should take an active role in telling the member that the behavior needs to be corrected and in offering the person help in doing so, or the chair should ask the person to leave because the behavior cannot be tolerated, Marshall says.