Research

Newly recruited regular board members will have a two-year appointment, renewable for another two years at the end of the first year. The Human Protections Coordinator will keep track of Board members’ terms. Board appointment letters are generated every two years and signed by the Institutional Official or Vice President for Research.

 The IRB Chair will be appointed by the Institutional Officer or Vice President for Research with input from the Human Protections Coordinator and current IRB Chair. The appointment will be for a 2-year commitment, renewable for another two years. This same policy is in effect for co-Chairs. 

As IRB members cycle off the board, leave the university, or, for other reasons, step down from the board, new board members are sought to replace them. Possible new board members are identified by the Institutional Official, the Chair of the IRB, IRB members, or the Human Protections Coordinator; or, individuals interested in serving on the board may contact the IRB. When a potential new board member is identified, either the Human Protections Coordinator or the IRB Chair contacts that person to see if he or she would be interested in serving on the board.

That individual then proceeds though the following steps with an opportunity to discontinue at any time:

1. meet with Human Protections Coordinator to discuss the responsibilities and activities of the IRB, the possible start date for serving on the board, and any potential conflicts of interest;
2. submit a current resume or CV to the IRB;
3. take the CITI tutorials for IRB members (a series of 10 modules) with a pass rate of 80%;
4. attend a board meeting to meet the board, and ask and answer questions.

If the potential board member agrees to serve on the board and there are no objections from other board members or IRB office personnel, the board member is accepted onto the board as a regular member. 

All board members take a series of 10 modules through the Collaborative Institutional Training Initiative (CITI), available online at the IRB website. Tutorial completion must be current within the past 3 years. Board members must re-take the tutorial upon expiration of the 3-year period. A periodic review of board members is conducted to let members know when their tutorial is going to expire.

Additional board member training occurs on an as-needed basis, when the Human Protections Coordinator prepares a face-to-face training on IRB-related topics such as federal regulations, confidentiality, assessing risk, informed consent, etc. Continuing education opportunities also arise within regular board meetings as needed.

All board members are expected to attend all meetings throughout the year. If a member expects to not be able to attend a meeting, the member should arrange for his or her alternate to attend.

If a member misses more than two meetings without an alternate in attendance during the academic year (August through July), the member will lose his or her place on the IRB. The IRB Chair or designate will ask that member to step down from the IRB and the Director, Chair, and IO will work to find a replacement board member.

The IRB meetings are not open to the public. However, guests can attend under specific circumstances, such as:

• Investigators whose IRB applications are under full board review may attend a question-and-answer session during the board meeting in which their application is discussed. They must leave the meeting when asked.
• Alternates can attend any part of any meeting for observation and training purposes when they are not serving as a voting member at that particular meeting.
• Other guests may attend meetings if arranged in advance with the Director and Chair. However, they may not sit in during a full board review discussion.

The steps for adopting new policies by the IRB are as follows:

• the Human Protections Coordinator brings a draft policy statement to the board meeting
• the board reviews and discusses the statement, suggesting changes and revisions
• the board votes on whether or not to adopt the policy with the changes/revisions in place
• the Human Protections Coordinator brings the revised board-approved policy to the Institutional Officer (IO)
• The IO either approves the final policy or requests changes/revisions
• If the IO requests changes/revisions, the Human Protections Coordinator makes the changes, then sends it by e-mail or delivers to the board for second vote
• board members can vote by e-mail, telephone, or in-person to approve the policy

The policy will be adopted by a simple majority vote of any board quorum. For example, if five members constitute a quorum, a policy can be adopted with three of those five members present voting aye, or four of six members voting aye. Alternates may vote on policy items if the board member for whom they are attending is not present.

Conflicts of interest may occur when an IRB member’s responsibilities compete with his or her private or professional interests. Conflicts of interest can be ideological, personal, financial, or professional. Whether actual or potential, conflicts of interest may raise questions concerning IRB members’ objectivity and possible financial gain.

Upon appointment to the IRB, new members must report any actual or potential conflicts of interest. Board members inform the IRB when they are unable to participate in board deliberations due to conflict of interest. Members with conflicts of interest may also be identified by the Human Protections Coordinator, the IRB Chair, or other members.

Board members having a conflict of interest in a specific research project do take part in the IRB deliberations on that protocol; however, they may provide information about the protocol if requested by the IRB. Furthermore, members with a conflict of interest must exit the meeting during the time in which deliberations and voting on the protocol take place.