550. Research Integrity Oversight and IRB Review

Updated July 13, 2021

Research Integrity 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 Research Integrity website.

The purposes of Research Integrity 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. The IRB may require modifications to secure approval or disapprove all research activities overseen and conducted by the organization.

Research that may involve human participants in which University or affiliate faculty, staff, or students are engaged (see Engaged in Non-exempt Human Subjects Research in IRB Policy Manual Definitions) is subject to the one of the following:

• Administrative Review by Research Integrity staff or an IRB member 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 Research Integrity, acknowledging use of an external IRB;
• Exempt Review by an IRB member for new qualified exemptions and subsequent oversight by Research Integrity;
• 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.

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 Research Integrity staff or an IRB member, and review IRB policies for information about review types and submission requirements.

Assessment of Review Type

New Projects

Upon notification of a new project submission, Research Integrity staff determine whether the project constitutes a research study or investigation.

Next, Research Integrity staff determine if the research involves human participants. Office for Human Research Protections (OHRP) decision charts may be used for these initial assessments. Research Integrity staff may consult with the Research Integrity Director, or IRB Chair or member in making these determinations.

If a project does not constitute research or does not involve human participants, neither Research Integrity 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 a new project is eligible for Exempt Review, according to 45 CFR 46.104 or the University Flexibility policy. The University grants exclusive authority to Research Integrity for exempt determinations.

For non-exempt human research, the IRB must:

1. Conduct initial review using Full Committee or Expedited Review procedures,
2. Determine whether the research satisfies all relevant criteria for approval, and
3. 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.