The periodic assessment of IRB chairs, vice-chairs, IRB members, and IRB staff is essential to a well-functioning HRPP and IRB. Evaluations serve to validate performance, identify areas which need improvement (both in function and knowledge), and make changes when appropriate. Evaluations should be performed periodically, usually annually, and scheduled to occur at the time of re-appointment. The types of assessments that are performed vary widely from self-assessments to objective and subjective evaluation by peers or supervisors. Whatever the technique, the evaluations should be used in support of an action, such as direct feedback, changes, or providing individual or group education for identified areas of need.

While IRB staff are routinely evaluated according to general human resources policies and procedures, the organization should perform additional evaluation pertaining specifically to the unique requirements and knowledge necessary for IRB staff. In some cases, where IRB staff also serve as IRB members, they should be evaluated by both processes.

Below are recommendations for evaluation processes and content. The criteria used for the evaluation may appear in an evaluation form and only be referenced in a written procedure.

Evaluation of IRB chairs and vice-chairs

Process

• Indicate the individual who performs the evaluation, such as:
  • Self-evaluation
  • Supervisor or other administrator
  • Peers (e.g., IRB members or other chairs or vice-chairs)
• Indicate the timeframe for periodic evaluation (e.g., annually)
• Indicate how feedback is provided (e.g., face-to-face or letter)
• Indicate whether the evaluation is provided to other people (e.g., vice president for research or chief executive officer)

Content of Evaluation – examples of criteria

• Objective criteria
  • Number of meetings attended and chaired out of total number of meetings
  • Number of exempt determinations made
  • Number of protocols reviewed by the expedited procedure
  • Number of protocols reviewed that went to the convened IRB
  • Number of reviews completed as the primary reviewer
  • Completion of educational requirements vii. Attendance at educational sessions
  • Number of educational sessions conducted b.
• Subjective criteria
  • Leadership of the IRB
  • Ability to lead meetings
  • Preparedness for meetings
  • Knowledge of regulations and identification of areas for improvement
  • Knowledge of organizational policies and procedures and identification of areas for improvement
  • Communication with investigators
  • Communication with organizational officials viii. Communication with IRB staff
  • Ability to work with IRB staff
  • Ability to help investigators
  • Issues related to being a general IRB member

Evaluation of IRB members

Process

• Indicate the individual who performs the evaluation, such as:
  • Self-evaluation
  • IRB chair
  • HRPP or IRB administrator
• Indicate the timeframe for periodic evaluation (e.g., annually)
• Indicate how feedback is provided (e.g., face-to-face or letter)
• Indicate whether the evaluation is provided to other people (e.g., department chair or vice president for research)
• Indicate how aggregate information is used to identify and address areas needing improvement (e.g., focus for education)

Content of Evaluation – examples of criteria

• Objective criteria
  • Number of meetings attended out of total number of meetings
  • Number of exempt determinations made
  • Number of protocols reviewed by the expedited procedure
  • Number of protocols reviewed that went to the convened IRB
  • Number of reviews completed as the primary reviewer
  • Timeliness of reviews
  • Completion of required checklists
  • Completion of educational requirements
  • Attendance at educational sessions
  • Number of educational sessions conducted
• Subjective criteria
  • Preparedness for meetings
  • Contribution to IRB meetings
  • Quality of reviews
  • Knowledge of regulations and identification of areas for improvement
  • Knowledge of organizational policies and procedures and identification of areas for improvement
  • Communication with investigators
  • Communication with IRB staff
  • Ability to work with IRB staff

Evaluation of IRB staff

Process

• Indicate who performs the evaluation, such as:
  • Self-evaluation
  • HRPP or IRB administrator
  • IRB chair
• Indicate the time frame for periodic evaluation (e.g., annually)
• Indicate how feedback is provided (e.g., face-to-face or letter)
• Indicate whether the evaluation is provided to other people (e.g., vice president for research)
• Indicate how aggregate information is used to identify and address areas needing improvement (e.g., focus for education)

 Content of Evaluation – examples of criteria

• Objective criteria
  • Workload – handles workload efficiently
  • Number of exempt determinations made
  • Number of protocols processed that were reviewed by the expedited procedure
  • Number of protocols processed that went to the convened IRB
  • Timeliness of processing materials
  • Completion of required checklists
  • Completion of checklists and documentation
  • Maintains paper files efficiently and correctly
  • Prepares agenda in a timely manner
  • Prepares convened IRB minutes in a timely manner
  • Maintains IRB rosters efficiently and correctly
  • Prepares IRB records efficiently and correctly
  • Completion of educational requirements
  • Attendance at educational sessions xv. Number of educational sessions conducted xvi. Attainment and maintenance of certification (e.g., CIM or CIP)
• Subjective criteria
  • Preparedness for meetings
  • Quality of pre-reviews
  • Completes and maintains convened IRB records efficiently and correctly
  • Completes and maintains convened IRB minutes efficiently and correctly
  • Knowledge of regulations and identification of areas for improvement
  • Knowledge of organizational policies and procedures and identification of areas for improvement
  • Communication with IRB chair and vice-chair
  • Communication with supervisor
  • Communication with investigators
  • Ability to help investigators