Training Program Overview
The IRB-internship program is an 8-week training program designed to provide trainees the basic knowledge needed to becoming a functioning member of the IRB. The IRB internship is a required rotation for some programs on the BUMC campus, but it is open to students and faculty across the medical campus based on availability of training rotations. Rotations begin in the fall semester with the academic calendar and run through Summer II. A schedule of training slots can be obtained from the IRB Administrative Secretary, Annette Wingard. The internship is comprised of three components: orientation, observation, and presentation.
Interns are mentored by Dr. Eric Devine who has been serving as board member and Vice-chair of panel blue since 2009. The program begins with a training led by Dr. Devine which covers the essential components of federal regulations that govern human subject protections. Interns will become familiar with the criteria for approval of research, the general requirements for informed consent, conditions under which consent can be waived, and the requirements for documentation of informed consent. Interns will also learn about special protections for vulnerable populations including pregnant women, fetuses, prisoners and children. This training will include a discussion of ethics, undue inducement, coercion, and how to apply the Belmont principles when reviewing a study. Interns receive specific instructions for how to evaluate a study from the perspective of an IRB member evaluating the potential for risk, protections taken to minimize risk, and the potential for benefit. The orientation meeting is 90 minutes long is scheduled at the convenience of the intern and Dr. Devine.
Following this initial training, interns observe two IRB meetings and complete a brief training with the director of the IRB, Jamie Merrill, or an appropriate designee, to learn how to navigate through the electronic IRB record. The observation period of the internship provides an opportunity for interns to learn from board members’ reviews and observe the board as they deliberate and vote on issues. This portion of the training can be particularly valuable to future investigators as it provides investigators with awareness of common issues that can impinge on the approval of a study. This observation period is also valuable for interns to prepare them for the protocol review phase of the internship. The observation includes attendance at two full board meetings which are held on Thursdays from 12:00-2:00PM
Interns are required to complete two protocol reviews during the IRB internship. Interns are assigned to be the primary reviewer of a study for two meetings during their IRB internship. When possible, studies are matched to the interests and/or expertise of the IRB intern. Assignments are made on the Friday preceding a Thursday afternoon meeting. The IRB intern is responsible for presenting the protocol to the board and participating in the discussion of issues and potential protocol stipulations. The IRB Intern does not have the authority to make motions or participate in the vote. The presentation phase of the internship is also valuable as a learning tool to help future investigators develop protocols which are more readily approved by the board. The observation includes attendance at two full board meetings which are held on Thursdays from 12:00-2:00PM. The presentation phase will also require some time to read the study protocol and supporting materials prior to the meeting. Interns should budget between 3-5 hours for each presentation.
Dr. Devine is available throughout the internship to help IRB interns navigate the review process, to discuss ethics issues which may present during the review, or to answer questions about how to evaluate the merits of a study. The internship provides a wealth of experience and knowledge for future investigators that will prepare them to be more successful in their own IRB applications. Feedback from graduating interns has been positive and includes the following:
“I think that understanding the review process and expectations of IRB boards will be very helpful in the future.”
“It gave me a better idea on what to keep in mind when reviewing other colleagues work, or developing my own protocols, great internship!”
“I now have a better understanding of the process and how to resolve if IRB is not approved.”