IRB Meetings and Recordkeeping

As an appointed Faculty Committee of the College, the Institutional Review Board maintains records of its meetings and decisions, available on request. It sets its meeting dates for each semester of the academic year at the beginning of that semester.

A PI must submit an IRB proposal document, which includes information concerning the purpose of the study, a description of the participants that will be recruited, a detailed description of the procedure of the study, a description of any risks that exceed minimal risk to the participants, and a copy of the informed consent form. The informed consent has to contain a good description of the procedure and any other relevant information the participant would need to make an informed decision regarding their participation in the study, information concerning the voluntary nature of their participation, information on how their data will remain confidential, and any potential risks that exceed minimal risk. In addition, the PI needs to provide documentation of human subjects training, which can be obtained either through the CITI program or through approved coursework.

IRB members review the documents, and can either approve the protocol or ask for further clarification or modifications to procedures so that the project is aligned with OHRP regulations for conducting research on humans. Exempt and Expedited Reviews happen on-line, while review of Full Reviews will take place at a meeting during which time the members of the IRB will convene.

Records pertaining to human subjects that come under Institutional Board purview will be kept for three years after the completion of an approved project, or declination of a proposal. Records will be kept electronically. Records may include: certification of completion in human subjects protection training, applications for approval by the Board, descriptions of project protocol and sample consent forms, sample questionnaires, copies of grant proposals, minutes of Board discussions of proposals, and related memoranda and correspondence.