Gary Gaffield, Wittenberg University
Andrea Halpern and Beth Cunningham, Bucknell University

20 attendees

Beth and Andrea covered:

1.  Getting started; scope and composition of IRBs.  This section provided a very basic overview of 45 CFR 46 and discussed three issues: 
a)whether IRBs have jurisdiction over all research or just federally funded research;
b)what activities constitute research that is cognizable to an IRB; and
c)how IRBs review the risks associated with NON-biomedical research.  It also specified who must be on an IRB and offered suggestions for recruiting members. 

2. Interfacing with the campus, accessibility of documents, spirit of the IRB, and other issues.  This section offered suggestions for managing an IRB's functions -- how best to communicate with the campus, to orient new faculty, to make forms and information available, and how to facilitate cooperation (e.g., offering proactive assistance to researchers to foster good human subjects practices, designing easy-to-understand and easy-to-use forms, providing examples of informed consent forms and other such documents, and providing quick turn-around on reviews).

Gary covered:

Sustaining an IRB

1.  Center your attention on ethics, not compliance
2.  Distribute the workload
3.  Preserve institutional memory and records
4.  Proactively encourage compliance after the novelty (of creating an IRB) wears off.

How?

1.  Assign administrative tasks to administrators (and focus the IRB on the rest)
2.  Allows others to rule on exemptions
3.  Rotate IRB membership, and target the departments most affected
4.  Educate the IRB's new members
5.  Educate the campus -- and remind it regularly
6.  Assume the role of adviser, not censor
7.  Attend to even the exempt projects
8.  Visit classes that conduct research

There were two types of questions that dominated the discussion: 
(1) hypothetical questions on situations that might be presented to an IRB -- "How should an IRB respond to ...?"  
(2) Practical questions on IRB operations -- "How do you do ... on your campus?"

Submitted by Gary Gaffield