by Krystal Bradford, CIP, Research Compliance Specialist at Cincinnati Children’s Hospital Medical Center
PRIM&R is pleased to share a post from Krystal Bradford, CIP, a member of the PRIM&R Blog Squad for the 2014 Advancing Ethical Research (AER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, about the conference to give our readers an inside peek of what’s happening December 4-7 in Baltimore, MD.
As a veteran to the conference, I sometimes find the pre-conference programs to be overwhelming. So much information is provided to you that it can easily become information overload. I didn’t really know what to expect going into the pre-conference program IRB Chairs Boot Camp: Tools for Successful IRB Leadership, especially since I am not an IRB chair. Would I be accepted? Or just politely ignored?
In the end, all I can say is “wow!” I looked forward to completing the evaluation of this pre-conference program—it gets five stars and two thumbs up from me. The panel consisted of three existing IRB chairs: James Feldman, MD, MPH, FACEP, CIP, from Boston University Medical Center, Bruce Gordon, MD, from the University of Nebraska Medical Center, and Paul Reitemeier, PhD, from Grand Valley State University. The experience and knowledge they brought was amazing. As an IRB staff member, one of my responsibilities is to assist the IRB chair with facilitating convened IRB meetings, a task that has always been a highlight for me.
In the morning, Drs. Feldman, Gordon, and Reitemeier provided a description of their board makeup, as well as different things they do to show their appreciation for the efforts of board members. The overall feeling expressed by the program facilitators was appreciation for their board members, a sentiment that I think speaks volumes. Everyone wants to feel appreciated and these gentlemen not only spoke to that, but their body language also supported it.
Throughout the session, they also gave ideas about how to empower board members to have a voice in the discussion and deliberations that take place during meetings. The suggestions include, but are not limited to:
- Observe the body language of board members. Someone may show dissatisfaction by shaking their head, shifting in their seat, or crossing their arms. When you see that, one option is to ask that board member for their perception of what is being presented. In addition to the chair, IRB staff members who are sitting around the room can also focus on observing body language. If they note any body language you should be aware of, they can send you a discrete email with their concerns.
- Present the primary/secondary reviewers’ notes to protect the anonymity of the reviewers when a principal investigator is invited to a meeting.
- Remain accessible to the board members for discussion of any concerns.
The discussion then moved toward case scenarios. There was a great deal of experience in the room, and I walked away from the conversation with several helpful tips:
- When principal investigators are invited to a meeting, let them know what to expect. For instance, let them know that they may not be present for the entire presentation to the board, but they may be asked to clarify certain areas of their protocol.
- Focus on respect, and not suspect. That was an awesome statement. When a principal investigator is asked to attend a meeting, they may feel like they are being summoned, which may make them defensive. Such a mind frame doesn’t expedite the resolution of regulatory concerns the board may have. Thus, “respect, and not suspect” is one of my new favorite phrases.
- When dealing with a potentially sensitive situation, it is important to have all the facts before forming opinions. The panelists were very clear that the IRB chair role can be very intimidating when someone has made a mistake. Use this “power” wisely. It provides a wonderful opportunity to educate, so that the same mistakes are not made again.
I left this session extremely humbled. I was empowered to engage in conversation during the case studies. As case studies were shared, I asked specific questions to help form an opinion of what my decision would be. Afterwards, I was approached several times by different attendees, who thanked me for sharing my thought process. One word: wow!
I would encourage anyone that has the opportunity to attend a presentation by Drs. Feldman, Gordon, and/or Reitemeier to do so. You will not be disappointed.