General Discussions

I have some questions I hope you all can help me out with.  I have recently had a number of members roll off the committee and am about to set out to find replacements.  I am just wondering how things work in your institutions. How often do you turn over IRB members?  Do you have term limits?  What ways do you train your new members?  Has anyone used a mentor type program for new members?  If so, how has it worked out?

------------------------------
Angela Bain, CIP, CIM
Director, IRB Office
Kennesaw State University
------------------------------

Hi! We just added 3 new members due to retirements of 2 older faculty who served on the IRB along with a need to have a second public member. We do have 3-year renewable terms, and all are appointed by our Provost after recommendations from Department Chairs or other administration. I oversee the IRB.  We do ask that they take, obviously, PHRP training, and then I spend individual time with each going over the regulatory requirements, provide links to additional trainings, etc. I also present to faculty on IRB requirements, as well as how-to for Cayuse. IRB members all have backgrounds in research, so much of the stuff related to 45CFR46  and 21CFR56 is not new and most have already had some sort of IRB training. However, we are a small institution.

------------------------------
Dana J. Lawrence, DC, MMedEd, MA
Senior Director of Faculty Development and Special Projects
Parker University
Dallas, TX
------------------------------

Original Message:
Sent: 06-02-2022 12:32
From: Angela Bain
Subject: IRB Member Terms

I have some questions I hope you all can help me out with.  I have recently had a number of members roll off the committee and am about to set out to find replacements.  I am just wondering how things work in your institutions. How often do you turn over IRB members?  Do you have term limits?  What ways do you train your new members?  Has anyone used a mentor type program for new members?  If so, how has it worked out?

------------------------------
Angela Bain, CIP, CIM
Director, IRB Office
Kennesaw State University
------------------------------

Hi Angela,

At Villanova we have terms for IRB members (3  years) but no limits on the number of times terms can be renewed. If the member is interested in renewing and the IO agrees, the member can continue indefinitely. We recently revamped our member training program and I'm happy to share the documentation if you want to reach out via email - essentially members undergo asynchronous standard training (e.g. CITI), live orientation to Villanova policies and procedures, observe meetings, and get review practice using an apprenticeship/mentor model with one of our more experienced IRB members. We recently onboarded three new members and their time to independence using this program has been significantly shorter than our non-standardized training plan.

------------------------------
Kaitlin Gottuso
Director - Office of Research Protections
Villanova University
------------------------------

Original Message:
Sent: 06-02-2022 12:32
From: Angela Bain
Subject: IRB Member Terms

I have some questions I hope you all can help me out with.  I have recently had a number of members roll off the committee and am about to set out to find replacements.  I am just wondering how things work in your institutions. How often do you turn over IRB members?  Do you have term limits?  What ways do you train your new members?  Has anyone used a mentor type program for new members?  If so, how has it worked out?

------------------------------
Angela Bain, CIP, CIM
Director, IRB Office
Kennesaw State University
------------------------------

Hi Angela,

I work for an IACUC, but we encounter similar concerns, so I thought you might be interested in our processes.

Members are appointed for two-year terms, and are usually offered the opportunity to remain onboard for as long as they would like; some stay, and some don't.  We haven't yet had a case where we're happy to see someone go, but we instituted the term limits just in case such a situation arises.  Some who choose to continue serving are groomed to assume the Chair role some day, being assigned to Vice Chair preliminarily.

A few months before their term ends, we ask members that are rotating off the IACUC to identify a successor from the same department (we only have a handful of departments doing animal research and prefer that each is represented).  We try to ensure there is at least a month of appointment overlap, so that the outgoing member can actively mentor the new member in review activities; new members truly appreciate this, and departing members are generally supportive mentors.  This mentorship is supplementary to the training that I provide on the responsibilities of membership and how to use the Cayuse software.

We also try to ensure that <1/3 of the IACUC members' terms would be ending at any given time.  On the flip side, it's also more efficient to onboard 2-3 new members at the same time, which minimizes the number of times per year that I have to devote to training new members. Our IACUC usually consists of 12-15 members total.

Cheers,
Cheryl

------------------------------
Cheryl Cheney, CPIA
IACUC Coordinator/Compliance Specialist
Biogen
Cambridge, MA
------------------------------

Original Message:
Sent: 06-02-2022 12:32
From: Angela Bain
Subject: IRB Member Terms

I have some questions I hope you all can help me out with.  I have recently had a number of members roll off the committee and am about to set out to find replacements.  I am just wondering how things work in your institutions. How often do you turn over IRB members?  Do you have term limits?  What ways do you train your new members?  Has anyone used a mentor type program for new members?  If so, how has it worked out?

------------------------------
Angela Bain, CIP, CIM
Director, IRB Office
Kennesaw State University
------------------------------

We are a very small institution with many clinical faculty w/o PhDs, so often the Chair and I brainstorm about potential candidates.  We also got very lucky that when our unaffiliated, scientist member resigned she identified a replacement from her own institution.

• We start with a 1 year term to see if it's a good fit and then move to 3-year terms with no limits. 
• We have an SOP for removing members, but have never used it.
• Most members come with some IRB experience, if at least as a PI. 
• We provide every member with the Amdur and Bankert IRB Member Handbook.
• We have very few full board submissions, so we have the luxury of continuing ed at most meetings.  One year I worked through the Handbook, a few chapters at a time, for the Cont Ed. I always present a summary of the PRIMR sessions I attend.
• We have not used a mentoring approach.

Regards,
Darcy

------------------------------
Darcy Hammar
Director, HRPP
Rocky Mountain University of Health Professions
------------------------------

Original Message:
Sent: 06-02-2022 12:32
From: Angela Bain
Subject: IRB Member Terms

I have some questions I hope you all can help me out with.  I have recently had a number of members roll off the committee and am about to set out to find replacements.  I am just wondering how things work in your institutions. How often do you turn over IRB members?  Do you have term limits?  What ways do you train your new members?  Has anyone used a mentor type program for new members?  If so, how has it worked out?

------------------------------
Angela Bain, CIP, CIM
Director, IRB Office
Kennesaw State University
------------------------------

Hi Angela,

For board members we have appointment terms of 2 years and they may serve consecutive terms.  We try to have alternate members for each board member for times when members cannot make a meeting and the alternate fills in, or if a member does not wish to serve another term we will offer the member position to the alternate before seeking out new members.  Our chairperson is appointed for 1 year terms and may also serve consecutive terms.

We train our members through CITI using two courses: good clinical practice and human subject training, each being renewed every 3 years.  We also have a 20 minute orientation video presentation/powerpoint explaining the IRB, our IRB's history, and what is expected of members.

Rayna Potkonjak
IRB Coordinator
Logan Health Kalispell, MT

------------------------------
Rayna Potkonjak
IRB Coordinator
Logan Health
------------------------------

Original Message:
Sent: 06-02-2022 12:32
From: Angela Bain
Subject: IRB Member Terms

I have some questions I hope you all can help me out with.  I have recently had a number of members roll off the committee and am about to set out to find replacements.  I am just wondering how things work in your institutions. How often do you turn over IRB members?  Do you have term limits?  What ways do you train your new members?  Has anyone used a mentor type program for new members?  If so, how has it worked out?

------------------------------
Angela Bain, CIP, CIM
Director, IRB Office
Kennesaw State University
------------------------------

Hi Angela,

At Lamar University, the IRB members have 3 year terms and they are staggered so not all members roll off at the same time. We also allow the members to serve consecutive terms at the invitation of the IRB Chair and the Associate Provost for Research. The board members are required to complete the CITI training course, The IRB Member Module. We also train new members by assisting them with the first few reviews that are assigned to them but they can reach out anytime for help.

------------------------------
Beverly Kemp
eRA Research Coordinator
Lamar University
Beaumont 77710
409-880-7670
brkemp@lamar.edu
------------------------------

Original Message:
Sent: 06-08-2022 12:05
From: Rayna Potkonjak
Subject: IRB Member Terms

Hi Angela,

For board members we have appointment terms of 2 years and they may serve consecutive terms.  We try to have alternate members for each board member for times when members cannot make a meeting and the alternate fills in, or if a member does not wish to serve another term we will offer the member position to the alternate before seeking out new members.  Our chairperson is appointed for 1 year terms and may also serve consecutive terms.

We train our members through CITI using two courses: good clinical practice and human subject training, each being renewed every 3 years.  We also have a 20 minute orientation video presentation/powerpoint explaining the IRB, our IRB's history, and what is expected of members.

Rayna Potkonjak
IRB Coordinator
Logan Health Kalispell, MT

------------------------------
Rayna Potkonjak
IRB Coordinator
Logan Health

Original Message:
Sent: 06-02-2022 12:32
From: Angela Bain
Subject: IRB Member Terms

I have some questions I hope you all can help me out with.  I have recently had a number of members roll off the committee and am about to set out to find replacements.  I am just wondering how things work in your institutions. How often do you turn over IRB members?  Do you have term limits?  What ways do you train your new members?  Has anyone used a mentor type program for new members?  If so, how has it worked out?

------------------------------
Angela Bain, CIP, CIM
Director, IRB Office
Kennesaw State University
------------------------------

Hi, Angela!

Similar to other institutions that have responded, our reviewers serve a 3-year term after IRB onboarding.

Reviewers are welcome to stay on the IRB as long as they want. However, to build capacity, many do step down to allow others to join.

I devised an IRB Reviewer onboarding process that provides:

1. Independent reading i.e., Belmont Report, internal protocols, process documents, including the OHRP Decision Charts
2. Completing IRB training i.e., provide link to OHRP's set of online modules
3. Shadow experience i.e., a new reviewer assigned to a seasoned reviewer
3. Practice i.e., review approved IRB applications by type (exempt, expedited, full committee, limited) to see applied regulations
4. Observe a Convened Meeting

The extent of the Practice component depends on the reviewer's knowledge of IRB i.e., many join the reviewer rotation as they were former IRB submitters or served as a PI on a research project. I tend to spend more time with non-scientists given their learning curves.

At our institution, many join the IRB at different points in time (so there won't be a mass exodus should everyone step down at once).

Let me know if you have any questions on our home-grown "mentor" type program.

------------------------------
Dawn Leusner
IRB Manager
Educational Testing Service
Princeton, NJ 08541
irb@ets.org
------------------------------

Original Message:
Sent: 06-02-2022 12:32
From: Angela Bain
Subject: IRB Member Terms

I have some questions I hope you all can help me out with.  I have recently had a number of members roll off the committee and am about to set out to find replacements.  I am just wondering how things work in your institutions. How often do you turn over IRB members?  Do you have term limits?  What ways do you train your new members?  Has anyone used a mentor type program for new members?  If so, how has it worked out?

------------------------------
Angela Bain, CIP, CIM
Director, IRB Office
Kennesaw State University
------------------------------