Institutional Review Board (IRB) Member Nomination and Orientation
As part of the Duke professional practice model, nurses contribute significantly to the Duke IRB Board review processes. Nurses serve as active members on all 9 IRB Boards at Duke.
The IRB’s primary responsibility is safeguarding the rights and welfare of patients engaged in human research. In addition to possessing the professional competence necessary to review research activities, the membership includes persons who are knowledgeable of, and who are able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. As the IRB regularly reviews research that involves vulnerable subjects, such as children, prisoners, pregnant women, or persons with diminished capacity, the membership includes one or more individuals who are knowledgeable about and experienced in working with such subjects.
Nurse are nominated to Board membership based on their experience, expertise, and standing in the community to ensure diversity of membership. The term of appointment is indefinite. Serving on an IRB Board is both educational and rewarding, a knowledge of clinical research is optimal though not required. Attention to detail combined with a willingness to learn new processes is essential.
Nomination process:
Members from within DUHS are nominated for IRB membership by their respective Department chair or director, whether the Department is an academic Department or a clinical Department within Duke.
CITI Training
New members joining the IRB are required to complete the same set of CITI modules that Duke researchers complete, as per the Duke Medicine DOCR policy entitled “Collaborative Institutional Training Initiative (CITI) Module Requirements for Duke Medicine Human Subject Protection (HSP).
A prospective nurse member who is interested in joining the IRB may send an email containing his/her qualifications and availability to Deborah (hutch) Allen Ph.D., Director of Nursing Research and EBP. After an initial review, Dr. Allen forwards nominees to the IRB Executive Director Jody Power.
When it is determined by the Executive Director and/or Lead Chair that the prospective member would be a suitable IRB member, a Compliance Specialist requests a CV from the prospective member and schedules new member orientation and meeting observations begin.
• The Compliance Specialist schedules new members to observe two complete, full board IRB meetings. Following each meeting, new members are encouraged to meet briefly with the Chair &/or Vice-Chair to discuss any questions they have about what they observed in the meeting.
• Before the first observational IRB meeting, the Compliance Specialist meets with the new member(s) for an IRB and protocol review tutorial to discuss the administrative organization of the meetings, staff, and office.
• The Compliance Specialist provides new members with orientation materials that include a packet of information on how to review a protocol as a primary reviewer.
• The Compliance Specialist and Board Specialists offer ongoing help to orient new members to the IRB system and explain navigation within the IRB system.
Assignment to a Board
Typically, board assignment is based on which of the board meeting times will best fit his/her schedule.
Usually, nurses present to their designated Board every other month (some members choose to participate monthly). Having two nurse representatives on the Board allows for rotation of dates and cross cover when needed.
Evaluation of IRB Board Member
Annually an online evaluation of each IRB member is conducted by the applicable Chair/Vice-Chair. Results of the evaluations are provided to each individual member. In addition, members are requested to complete a self-assessment.
If you are considering self-nomination and have questions about what is involved or to nominate a nurse to become an IRB member contact:
- Director of Nursing Research & EBP, Dr. Deborah H. Allen at 919-681-4719 or via email hutch.allen@duke.edu.
To learn more about the Duke IRB and to access all IRB policies, Click Here.
