550. RI Oversight and IRB Review
Updated July 1, 2019
Research Integrity (RI) and the IRB offer five Review Types through IRBNet, the University's online submission, review, and document management system. Instructions for using the online system can be found on the IRBNet page of the RI website.
The purposes of RI oversight and IRB review are to ensure that the rights and welfare of research participants are protected and that research projects meet regulatory and institutional requirements.
Research that may involve human participants in which University or affiliate faculty, staff, or students are engaged* is subject to the one of the following:
- Administrative Review by the RO for determinations of not human research; changes to study personnel or sites; closures; emergency use of test article, preliminary review of problem reports, and sponsor amendments or safety reports that do not involve changes to consent materials or processes, or risks/benefits;
- Administrative Review and monitoring by the RI, acknowledging use of an external IRB;
- Exempt Review by an IRB member for new qualified exemptions and subsequent oversight by RI;
- Expedited or Full Committee Review by the IRB for new projects, and subsequent IRB oversight (and review) for amendments and continuing reviews for non-exempt research involving human subjects.
*See Engaged in Non-exempt Human Subjects Research in IRB Policy Manual Definitions.
IRB policy for assessment of problem reports is noted elsewhere.
Before submitting a new project, amending an approved non-exempt project, or responding to a request for continuing review or status report, investigators are encouraged to consult with RI staff or an IRB member, and review IRB policies for information about Review Types and submission requirements.
Assessment of Review Type
Upon notification of a new project submission, RI staff determine whether or not the project constitutes a research study or investigation.
Next, RI staff determine if the research involves human subjects.
As noted previously, OHRP decision charts are used for these initial assessments. RI staff may consult with the RI Director, or IRB Chair or member in making these determinations.
If a project does not constitute research or does not involve human subjects, neither the RI nor the IRB has responsibilities for review or approval beyond the determination that the project does not constitute research with human participants.
The next determination is whether or not a new project is eligible for Exempt Review, according to 45 CFR 46.101 or the University Flexibility policy. The University grants exclusive authority to the RI for exempt determinations.
For non-exempt human research, the IRB must:
- Conduct initial review using Full Committee or Expedited Review procedures,
- Determine whether the research satisfies all relevant criteria for approval, and
- Perform subsequent continuing review as appropriate.
Continuing and Amendment Reviews
Continuing and amendment reviews are generally subject to the same review type as the new project submission, although there are exceptions. See IRB policy Review Types for considerations for Full Committee and Expedited Reviews.