Institutional Review Board Medical Campus

Reports to:

Vice Provost for Research

Charge:

The Institutional Review Board (IRB) is charged with protecting human participants in research conducted on behalf of ETSU through ensuring compliance with federal, state, and local laws and regulations, ethical codes of conduct, institutional policy, and accreditation standards pertaining to the conduct of research involving human participants and data by:

• Approving all IRB Policies and Procedures to operationalize procedures for compliance with applicable guidelines associated with research involving human participants and data
• Reviewing all research proposals involving human participants conducted by faculty, staff, and students, or collaborators from other institutions under contractual agreements with ETSU
• Providing review and approval of research involving protected health information in accordance with the Privacy Rule (HIPAA)
• Notifying researchers in writing of its decision to approve, require modifications, or disapprove research proposals
• Monitoring ongoing research to ensure participant safety and quality assurance through audits or other appropriate review of research sites and records
• Taking appropriate action to suspend, terminate, or remediate research involving human participants that is not conducted in accordance with applicable regulations or policies, or that is associated with unexpected harm to participants or compromises integrity of the human research protection program

Frequency of Meetings:

The Board meets at least monthly.

Selection:

Nominations are solicited as vacancies arise and with consideration for the breadth and depth of expertise needed to facilitate review and approval of research routinely evaluated by the Board. The HRPP Director is responsible for ensuring that the composition of the Board meets regulatory and institutional criteria.

Alternates:

A pool of alternates may be appointed to the Board upon the approval of the Vice Provost for Research.  Alternates have full voting authority (in the absence of their assigned regular members) and are designated to replace regular members at meetings to which the latter cannot attend.  Alternates are appointed for three-year terms, as are regular members, and are encouraged to attend the meetings so as to gain from their experience in serving on the IRB.  Alternates may be recommended by the HRPP Director, with concurrence of the IRB Chair, for service as needed to supplement the expertise and availability of regular members.