Conducting an IRB Self-Assessment

Conducting an Institutional Review Board (IRB) self-assessment may help administrators refine standard operating procedures and streamline communication. It’s an essential part of performance evaluation and provides an opportunity to celebrate achievements, conduct appraisals, and reflect upon past decisions. It also provides a thoughtful written review of established goals, competencies, and overall office performance.

The IRB Administrator Boot Camp sessions hosted by PRIM&R in September 2019 offered an ideal setting for designing an evaluation study because they “go back to basics,” refreshing basic principles, while also challenging IRB administrators to consider why an office policy exists and if that policy is aligned with Federal Regulations.

Attendees reflected upon office policies aimed to protect the rights and welfare of human subjects involved in research activities. The first session, IRB Administrator 101, identified the primary responsibilities of IRB administrators and staff and offered attendees strategies and policies for creating a culture of compliance and ethical responsibility.

Speakers encouraged attendees to network with one another; inspiring conversations between policy makers, new administrators, institutional officials, and new board members with administrative responsibilities. These discussions resulted in methods for ensuring administrators and staff support, improve, and strengthen compliance offices.

Conversing with each other sparked meaningful reflection and solutions to challenging issues. For example, one IRB administrator explained that during full board meetings, she audio recorded the session, transcribed it word-for-word, and provided primary investigators these exact transcriptions with board member names attached. She explained this was a long-standing office policy and often resulted in wordy requests for revisions, confused Primary Investigators (PIs), and miscommunication as PIs contacted board members directly instead of the IRB administrator.

IRB administrators may take these examples as inspiration to ask questions about program or policy implementation, effectiveness, efficiency, or attribution. For example, is the policy implemented as originally intended? Are policies effectively reaching intended goals? Are resources utilized appropriately and efficiently? Of the goals met, how many are attributed to the current policy?

Our IRB office recently conducted a self-evaluation study to refine our standard operating procedures and address researcher’s frequently asked questions. To begin, office staff and board members met to determine which questions best reached our evaluation goal. During our self-assessment, we asked if we were:

  • Trying to implement a new policy?
  • Testing the effectiveness of an existing policy or its efficiency?
  • Determining what goal was attributed to which policy?

After we decided on our evaluation approach (implementation, effectiveness, efficiency, or attribution) we built our evaluation materials around that goal. Our evaluation strategies included surveying researchers, analyzing our research protocol submissions, collecting existing data from similar organizations and analyzing their procedures, and interviewing current and past board members about ways to best engage our research community.

The IRB Administrator Boot Camp was helpful for building this office evaluation study using topics presented at the session. The Boot Camp also offered an opportunity to ask other administrators how they operate and what strategies they might apply to similar situations.

When administrators self-assess, they become an active participant in the evaluation process. Involvement in the self-assessment allows administrators to honestly assess office strengths and areas to improve. Self-assessments serve to increase competency, planning, goal setting, and can result in resource development and policy refinement. Learning from experts, colleagues, board members, and researchers can strengthen an office and its overall efficiency.

IRB Administrators can also use The Office for Human Research Protections (OHRP) self-assessment tool as a guide.

Myra Luna-Lucero, EdD, is a Research Compliance Manager at the Teacher’s College of Columbia University. As a researcher and teacher, people are her highest priority and she instinctively communicates personal concern with others. She is an adept communicator who thrives on face-to-face interactions with a diverse body of students, faculty, and staff. She brings these qualities to her work to empower others to make informed decisions and reach their goals. She encourages researchers to ponder the roles they might play in the alleviation of the troubling inequities that continue to shape our world. She guides researchers on how to treat everyone as autonomous decision-makers who possess unique opinions. I present campus workshops on the importance of ethics, confidentiality, and protecting vulnerable populations. She meets individually with researchers to strategize ways to protect human subjects and do good work in the world.

Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.