Thursday, October 13, 2011

Evaluation of IRB Members and IRB Chairs Results in Better IRBs

Most IRB administrators and staff know which “go-to” IRB members they can count on to review applications on time and to attend IRB meetings regularly. Unfortunately, these members often bear a disproportionate share of the workload and are susceptible to burnout. Other members might need some education or guidance—or simply information about expectations—to be able to become more productive members of the IRB. Under the AAHRPP Accreditation Standards, Element II.1.B. requires that all IRB members and IRB chairs (and vice chairs, if any) be periodically evaluated and provided feedback on their evaluations. AAHRPP’s Tip Sheet on the evaluation of IRB chairs and IRB members gives both process and content suggestions (

IRB chairs (and vice chairs if any) are usually evaluated by supervisors or IRB administrators. Sometimes IRB members are asked for their input, and the evaluation process might also include a self-evaluation component. Some chair evaluations incorporate objective criteria such as number of meetings chaired, number of exemption determinations made, and number of protocols reviewed by the expedited procedure. Subjective criteria might cover leadership abilities, preparedness for meetings, knowledge of the federal regulations to protect research participants and of the organization’s policies and procedures, and communication skills with IRB members, IRB staff, administrators, and researchers. 

IRB members are usually evaluated by the IRB chair, HRPP director, or IRB administrators and might also self-evaluate, particularly for knowledge or educational needs. Objective criteria for IRB members include number of meetings attended, number of protocols reviewed, timeliness of reviews, and education. Subjective criteria address preparedness for meetings, contributions made at meetings, quality of reviews, knowledge of the federal regulations to protect research participants and of the organization’s policies and procedures, and ability to work and communicate with IRB staff and researchers.

The process should specify the time frame for periodic evaluations, which could be annual or at the time of reappointment. Feedback on evaluations to IRB chairs and members, either face-to-face or in writing, is essential. Feedback enables people to understand their performance and offers an opportunity for reflection and change. For some, it is validation of a job well done. For others, it is a time to decide to improve performance or resign from the IRB. 

The process should name those who review the evaluation (for example, an administrator or committee) and spell out the steps for taking any action. It should also indicate how aggregate information from all the evaluations helps to identify and address areas needing improvement, such as topics for education. In this regard, the evaluation of knowledge, often by self-assessment, identifies areas of need that can be used to remedy deficiencies in knowledge of individual members or in the IRB as a whole.  

While at first IRB administrators were reluctant to evaluate IRB chairs and members, pointing out that it is hard to recruit and keep IRB members or that they did not want to say anything negative about IRB chairs and members, the experience has been the opposite. Along with other IRB composition processes, such as defining term length and term limits, enhancing recruitment and rotations of IRB chairs, vice chairs, and members, and planning for succession, evaluations are being implemented as an important part of policies, procedures, and practice.

As a result of this evaluation requirement IRBs are changing. When IRB members receive feedback on their performance, some realize they cannot dedicate the necessary time and effort, drop off the IRB, and are replaced by a member who will attend meetings and produce timely reviews. Other members, when receiving their feedback, make efforts to fulfill their responsibilities and become more productive members. Self-assessment of knowledge is enabling administrators to tailor education to the needs of their IRB members, resulting in a more knowledgeable, confident, and efficient IRB. Furthermore, setting out the evaluation parameters and process makes the responsibilities and expectations of members readily and specifically known. The composition of IRBs are changing, and for the better. Workloads are shared more equitably, burnout is less likely, and the reputation of the IRB with the organization is strengthened. Evaluating IRB chairs and IRB members yields more knowledgeable and efficient IRBs that can only help to raise the overall quality of research as well as enhance the protections for research participants.

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