Board Member Responsibilities

Responsibilities of the IRB Chair

The IRB Chairs shall hold leadership responsibility for IRB review and approval of human subject research in accordance with current guidelines, institutional policies, and federal and state regulations governing human subject protections.

In addition, the IRB Chair shall:

• oversee the recruitment, orientation, continuing education and retention of IRB members.

• oversee the development and implementation of appropriate policies, procedures and guidelines directed at human subject protections and the functions and activities of the IRB. The IRB Chair is responsible for reviewing the IRB’s policies and procedures for currency, accuracy and consistency on an ongoing basis but not less than every three years. Ad hoc committees will be formed to review guidance issued by regulatory agencies to determine whether updated to the policies and procedures are required.

• preside over IRB Executive Committee meetings.

• communicate IRB Executive Committee decisions, directives, and sanctions relating to known or suspected problems in the conduct of human subject research to involved investigators.

• have authority to request audits of human subject research activities.

• have the authority to suspend some or all research activities if exceptional human subject safety issues are identified. (Note that this authority is only exercised if an action is required prior to a convened meeting and it is not feasible to assemble an emergency meeting) When this authority is exercised, it shall be reported at the next convened IRB meeting.

• represent the IRB in interactions related to issues surrounding the ethical and regulation-compliant conduct of human subject research.

• approve written correspondence to state and federal regulatory agencies having jurisdiction over human subject research.

• represent the IRB at national and local meetings related to institutional review board activities and human subject protections All deans, department chairs, program directors, and/or other unit administrators of the institutional sites that fall under the authority of the IRB are responsible for ensuring that the human subject research activities of faculty, staff and students under their span of responsibility are carried out in compliance with IRB guidelines and directives. These individuals shall take direction from the IRB Chair in fulfilling these responsibilities. All research investigators involved in the conduct of human subject research that falls under the authority of the IRB shall take direction from the IRB Chair.

Responsibilities of the IRB Vice-Chair

The Vice-Chair is a member of the IRB as outlined under the responsibilities of IRB Members and shall act in place of the Chair as requested by the President or the IRB Chair.

Responsibilities of IRB Members

• Reviewing research study proposals and evaluating them from the perspective of the regulatory criteria for approval addressed under 45 CFR 46.111, 21 CFR 56.111 (if applicable); and any other relevant ethical, scientific or compliance considerations.

• Reviewing informed consent documents and evaluating them from the perspective of addressing the required and additional elements of informed consent addressed under 45 CFR 46.116, 21 CFR 50.20 (if applicable) and any other relevant ethical or compliance considerations.

• Attending IRB meetings in person, unless exigent circumstances prevent such attendance on an occasional basis; reporting promptly at the designated time that the meeting convenes; and remaining in attendance at the meeting until the full agenda has been addressed.

• Participating in IRB deliberations concerning issues inherent to proposed research studies and related informed consent documents, and making recommendations for reducing risk and improving the informed consent process and otherwise for improving human subject protections.

• Voting for full approval, approval subject to modification(s), reconsideration, or disapproval of the human subject research.

• Evaluating the risk level (i.e., minimal or greater than minimal) of the proposed research. In performing this evaluation, IRB members shall use the following absolute definition for “minimal risk” at 45 CFR 46.102(i) unless the research is directed at prisoner-subjects: “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life (i.e., of the general population) or during the performance of routine physical or psychological examinations or tests.”

• Deciding, for research studies of greater than minimal risk, if IRB continuing review of the research is warranted on a more frequent basis than the requisite annual review.

• Deciding, for research studies involving greater than minimal risk, complexity, or conflict-of-interest concerns, if the informed consent process and/or other aspects of the research study should be audited by the College.

• Deciding, for research studies involving an unapproved device, if the device and its proposed use constitute a non-significant or significant risk to research subjects.

• Deciding, for research studies subject to IRB continuation approval, if verification is required from sources other than the investigator that no material changes have occurred since previous IRB review.

• Recommending improvements to IRB policies and procedures so as to enhance the IRB review process and/or human subject protections.

• Informing the IRB Chairs of human subject research noncompliance problems or ethical issues of which they become aware.

• Conforming, at all times, their behavior to be within legal and ethical principles accepted by the IRB; including, but not limited to, maintaining confidentiality/nondisclosure of human subject research submitted for IRB review and approval, and good faith participation in IRB deliberations without appearance of discrimination or conflict-of-interest.