Should administrators be voting members?
Yes, but beware of potential conflicts
Particularly at smaller institutions, IRB administrators who also serve as voting members can offer many benefits. They attend and coordinate all meetings, so counting them as members helps the board achieve quorum. The additional knowledge and experience with federal research regulation — as well as their familiarity with many of the protocols and principal investigators — helps improve efficiency and function.
But there are also some potential drawbacks to allowing administrators to serve as voting members, says Erica Heath, CIP, MBA, president of Independent Review Consulting (IRC) Inc., a private institutional review board and consulting company in San Anselmo, CA.
"First, it’s important not to compare apples and oranges. A CIP in a university is at a different level than a medical staff coordinator working 25% of the time on the IRB," she says." When there is an integrated program with sufficient staff, I see few problems. The problems I have seen and heard about are almost always in smaller institutions where the administration and IRB is taking advantage of the goodwill of a staff member."
At smaller institutions, the administrator may be the frontline person bearing the brunt of enforcing IRB rules or giving unwelcome news to investigators. If the administrator is also a voting member, he or she may feel pressure to help certain applications get approved.
Administrators often help investigators develop their submissions — interpreting IRB questions or helping draft consent document language, Heath adds. "As the person in the middle, the administrator should not be in the position of voting on their own work or of explaining to the investigator why the vote went the way it did."
Make expedited reviews off-limits?
The potential conflicts are particularly acute when it comes to expedited reviews. These are typically conducted by a single IRB member representing the entire board. First, says Heath, the potential for objective decision making may be compromised — since an administrator may be tempted to exceed his or her expertise or appropriate level of authority.
"The issue of membership is negligible until the administrator is asked to serve as the primary expedited reviewer making decisions for the IRB," she states. "Then, it is easy to take on more and more power if there is a vacuum of authority. The administrator, who is often someone who is ineligible for tenure but perhaps reviewing the work of someone who is tenured or has a higher position, may feel more pressure to have an efficient process or to exceed his or her appropriate authority or expertise."
Beware of overloading
There also is the potential for the administrator to unfairly bear the brunt of doing all expedited reviews.
"In a smaller institution [like a community hospital with a few protocols] there is likely to be only one staff member who does everything. It is a part-time job, and the administrator with very little training about IRB functions may be the best-trained person there. This person may be asked to serve in multiple roles," Heath says. "This definitely has the potential for exploiting the administrator, asking more of the person than should be asked. It may be to the detriment of the person — without tenure — who is vulnerable to being made the scapegoat. It may be to the detriment of the research community if the person is exceeding their level of expertise. Many of the expedited review applications are trivial and should be dealt with administratively, rather than wasting the time of the members," she says. "But knowing when to pass the review to another reviewer is critical."
To insulate the administrator from potential conflicts or inappropriate influence, Heath suggests the following steps:
- Have a good job description in which roles and authorities and chain of command are clearly laid out.
- Only extend the function to a mature adult.
- Offer some administrative protection for the person.
- Ensure proper supervision and oversight.
- Make the standard operating procedures SOPs clear about extent of authority.
Clarifying the issue
A conference call with officials at OHRP helped members of the IRB at the Community Medical Center in Toms River, NJ, decide that it was OK for their IRB coordinator to serve as a voting member.
"My institution had assumed that someone involved in the day-to-day activities of the protocols may have a perceived conflict of interest due to that relationship," says coordinator Lucinda Girtain, CIM. "In order to avoid any unforeseen conflict of interest, my institution played it safe. I was told from the beginning that I wouldn’t vote due to the possible conflict of interest."
However, during a transition to a new IRB director, they sought advice from OHRP via a "mock audit."
The representative clarified that having Girtain as a member offered the IRB some substantial benefits, and that there was no automatic prohibition against someone in that position serving, she says. After a great deal of discussion and examination by the full IRB, she was recently appointed as a voting member.
"After giving it a lot of thought, I don’t think a person in my position has a conflict of interest with being a voting member," Girtain says. "Other than the medical professionals on the board, I probably know more about the informed consent process than anyone since it is my job to scrutinize the entire submission, including the consent.
"My job is not to push for research approval at my facility, it is very simply to protect research participants, put myself in their shoes, and see that every possible courtesy is extended to them. I feel that being able to cast a vote — other than just sharing my thoughts — helps me ensure that human subject participant protection is fully considered," she adds.
Particularly at smaller institutions, IRB administrators who also serve as voting members can offer many benefits. They attend and coordinate all meetings, so counting them as members helps the board achieve quorum.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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