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Who Must Be Trained?

The University’s assurance with the OHRP requires certification for all IRB members and alternates, and all individuals affiliated with the University (faculty, students, and staff) who conduct research involving human participants.   This assurance also requires that the University provide continuing education on research with human participants. 

The training requirements discussed herein cover all funded and non-funded projects that include human participants.  Research involving human participants refers to those project in which, “… a living individual about whom an investigator (whether professional or student) conducting research obtains; (1) data through intervention or interaction with the individual, or (2) identifiable private information.” (45 CFR 46.102)
This policy covers all proposed and ongoing projects submitted to the IRB for approval, regardless of the level of review required (i.e., full, expedited, exempt).

When Training Must Occur:

Training of all University-affiliated individuals (faculty, students and staff) must be completed before the project or renewal is approved.  In addition, funding agencies may require completion of training before funds are approved or released, and may have training requirements that exceed the University’s.  The PI is responsible for adhering to both Saginaw Valley State University’s and the funding agency’s training policies.

Initial certification is valid for three years.  All investigators and current research staff/students trained must renew certification every three years while working with human participants.  All IRB members and alternates must complete the certification when first appointed to the IRB; furthermore, they must participate in continuing education through IRB meeting activities.

Researchers may be recertified at any time within their three year certification period, but no less than 45 days before the expiration of certification.  Recertification of all investigators and research students/staff must occur before the IRB can renew approval of a project.