About the IRB

The IRB is guided by the ethical principles regarding all research involving human participants as subjects, as set forth in the Belmont Report, regardless of whether or not the research is subject to federal regulation involving human subjects. The IRB is responsible for determining whether research complies with the letter and spirit of these human research participant protections as well as the three principles defined in the Belmont Report: respect for persons, beneficence, and justice.

The IRB is charged with the responsibility to review all research, whether externally sponsored or not, conducted at the University and/or by University faculty, staff, or students, for conformity to Federal Regulations and all other applicable laws and regulations. To that end, Central’s IRB is dedicated to ensuring that the University’s use of human participants in research conforms to federal and state laws and regulations designed to ensure that the rights of participants are fully protected.

The IRB consists of members of the campus and non-campus community. The IRB Administrative Team consists of the IRB Administrator and the IRB Chair(s) and is responsible for the oversight of all IRB activities. The IRB and its Administrative Team serve the campus research community under the direction of the Vice President of Academic Affairs and Associate Vice President of Academic Affairs. The IRB is charged with reviewing and approving submissions, requiring modifications, or disapproving protocols for all research activities conducted at Central. The IRB must notify investigators in writing of its decision to approve or disapprove the proposed research activity or of modifications required to secure IRB approval of the research activity.

The IRB is required to review all human subjects research activities for which: the research is conducted by or under the direction of any employee, student, or agent of Central; the conduct of the research involves Central resources (property, facility, or funding, including extramural funds administered by Central); the research is conducted by an agent of Central using any Central property or facility; the research involves the use of Central's non-public information or records; or the research involves the recruitment of, identification of, or contact with prospective human research participants on the Central campus.

Both Principal Investigators (PIs) and Lead Investigators (LI) are responsible for ensuring their submissions are complete and accurate and for allowing sufficient time in their overall research design of their protocol to be reviewed and approved before beginning data collection (as according to the procedures outlined in the Review Process section of this document).

PIs must promptly report any incidences of unanticipated problems or adverse events to the IRB. The IRB Administrative Team must forward to the Associate Vice President of Academic Affairs any report (from either the investigator or an informed source associated with the research) of unanticipated problems involving risk to participants or others or serious or continuing noncompliance with IRB requirements.

In consultation with the Vice President of Academic Affairs and Associate Vice President of Academic Affairs, if appropriate, a designated University official will also forward the information to the relevant agencies, regulatory bodies, and/or the Office for Human Research Protections and, as necessary, include the information in the annual report of research activities submitted by Central to the Department of Health and Human Services Office of Research Integrity.

To maintain a review process that is responsive to the concerns of all involved, the IRB committee members reflect diverse experience and expertise as well as diversity in academic research interests, professional backgrounds, demographics, and awareness of and sensitivity to community attitudes.

IRB members are appointed by the Associate Vice President of Academic Affairs, who also provides administrative oversight. The IRB committee is comprised of faculty members and staff representing a variety of academic and professional fields, includes at least one non-scientist, and includes at least one non-University affiliated member. The IRB may, at its discretion, invite individuals with competence in special areas or advocates of vulnerable populations to assist in the review of projects which require expertise beyond or in addition to that of the committee.

Members of the IRB Administrative Team are authorized by the Vice President of Academic Affairs to act on behalf of Central for exempted projects and expedited review. These members may enlist the assistance of an experienced IRB member to review research that meets the criteria for expedited review.

No member of the IRB may participate in the initial or continuing review of any research protocol for which that member has a conflict of interest, except to provide information requested by the IRB.