Human Research Protection Program: Policy

Qualifications of IRB Personnel

 

Adopted By: All Campus IRB

Adoption Date: November 10, 2005

Revised: January 22, 2009

Purpose:  These policies and procedures describe the how the UW-Madison assures that IRB personnel have the knowledge, skills, and abilities necessary to carry out the function of the IRB.

Policy

I.      The policy of the UW-Madison is to choose IRB members, chairs, directors/administrators, staff reviewers and other IRB staff who have the highest level of knowledge, skills and abilities to carry out all of the functions of the IRBs and to regularly assess their performance through formal and informal means.

Procedure

II.     Selection Process

A.  IRB members.

 

1.  IRB members, including alternates, are selected primarily from the faculty and academic staff who have volunteered for service on the IRB or have been recommended by their department chairperson, by colleagues, or the IRB Chair.  Unaffiliated community members, including alternates, are identified through a collaborative process involving the director of the IRB office, IRB members and IRB staff, and other individuals at the institution as appropriate.  IRB members are chosen based on their expertise in relation to the subject matter of protocols reviewed by the IRB.  Representation from a broad spectrum of disciplines is sought and includes at least one non-University associated person.  IRB members are appointed by the UW-Madison Chancellor.

 

2.  Alternate IRB members serve as substitutes for primary IRB members who cannot be present at a meeting.  The IRB rosters designate the primary members for whom each alternate may serve as substitute. (See, IRB Roster Policy)

B.  IRB chairs are chosen by the Dean of the associated College or School.

C.  IRB staff.

 

1.  IRB directors, IRB managers and other IRB staff, including staff reviewers, are UW-Madison employees who are chosen by an ad hoc search committee in a competitive hiring process conducted by the UW-Madison.

III.    Qualifications

A.  IRB members. 

 

1.  In addition to complying with the Common Rule requirements for IRB members, UW-Madison chooses IRB members who are faculty and academic staff with experience in human research and expertise in the subject matter areas needed for review of protocols handled by the IRB for which they are being selected.

 

2.  Identifying non-scientific members:

 

a.  Health Sciences IRB, Health Sciences Minimal Risk IRB and Social and Behavioral Science IRB: A non-scientific member is a member whose current professional responsibilities are not in the areas of the research normally reviewed by the IRB.

 

b.  Education Research IRB: A non-scientific member is a member who is not faculty or who does not have a research title.

B.  IRB chairs. 

 

1.  IRB Chairs are tenured faculty members preferably with human research experience.

C.  IRB staff.

 

1.  Requirements for positions of IRB director, administrator, manager, staff reviewer and other IRB staff are those specified in the job descriptions for these positions. 

IV.   Performance Evaluation

A.  IRB members and chairs.

 

1.  ED IRB and SBS IRB: The ED/SBS IRB office director and Associate Deans for Research of the College of Letters and Science and School of Education will, at the time of annual re-appointment, informally evaluate the performance of the IRB chairs and members and recommend any necessary action to the Deans of the College and Letters and Sciences or School of Education.  In cases where problems become apparent, those problems will be addressed at the time they become known.

 

2.  HS IRB and MR IRB: The performance of IRB members is assessed by the IRB administrator and chair annually.  To facilitate IRB member review, an IRB Member Evaluation Form for the Health Sciences IRB & Health Sciences Minimal Risk IRB will be completed for each IRB member on an annual basis.  The IRB chair and IRB administrator will conduct the evaluation.  As part of this evaluation process, IRB members will be asked to perform as self-assessment to assist the IRB Chair and IRB administrator in evaluating the members’ performance. 

 

The Associate Dean for Clinical and Translational Research in the School of Medicine and Public Health will be responsible for the evaluation of the IRB chairs and vice-chairs.  Evaluation of the chairs and vice-chairs will occur on at least an annual basis.

B.  IRB staff.

 

1.  UW-Madison’s policy is to evaluate academic and classified staff, such as IRB director, administrator, manager, staff reviewer and other IRB staff, annually.

V.    IRB composition is reviewed when the IRB selects new members.  The selection of new members takes into account the expertise of departing members and the subject matter expertise needed for the types of protocols coming to the IRB.  The review of IRB composition and selection of members also takes into account the need for expertise for review of child centered and vulnerable adult protocols as well as protocols involving other vulnerable groups.

VI.   When a protocol involves a vulnerable group, the IRB office assures that at least one IRB member who is knowledgeable about or experienced in working with that vulnerable group reviews that protocol, whether the review is done by the full IRB or by the expedited review process.