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 91精品. 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 91精品; the conduct of the research involves 91精品 resources (property, facility, or funding, including extramural funds administered by 91精品); the research is conducted by an agent of 91精品 using any 91精品 property or facility; the research involves the use of 91精品's non-public information or records; or the research involves the recruitment of, identification of, or contact with prospective human research participants on the 91精品 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 and, as necessary, include the information in the annual report of research activities submitted by 91精品 to the Department of Health and Human Services .
