Activities that meet the federal definitions of “human subjects research” (HSR) or “clinical investigation involving human subjects” (FDA only) require IRB review. Activities that do not meet the definition of HSR (e.g. scholarly or journalistic activities, oral history, public surveillance, etc.) do not require IRB review. If you require a determination letter from the IRB of whether IRB review is required, you must submit documentation via Streamlyne Research as described in the IRB Submission Checklist.  HSR determinations are reviewed administratively.

Human research that is not funded by the federal government and that involves no greater than minimal risk can undergo minimal risk review.  Minimal risk review is different than exempt or expedited review because it includes additional categories of research that are not included in the Federal Register (see below). This is a determination made by the IRB upon review of the project. Minimal risk review allows an individual IRB member to review and approve projects on behalf of the full IRB. Projects that qualify for minimal risk review are reviewed on a weekly basis. Although not required, the IRB may determine that these projects require continuing review or post approval monitoring, depending on the type of research and participant population.

Certain categories of federally funded HSR can be determined to be exempt from the federal regulations as long as they meet prescribed ethical criteria including the requirement for informed consent and considerations for participant privacy and confidentiality. Any significant changes to an exempt project need to be submitted to the IRB to ensure that the exempt determination still applies. Exempt determinations can only made by the OIRB or IRB. Studies that qualify for exempt review are reviewed on a weekly basis.

Examples of exempt studies include online surveys, classroom curriculum evaluations, interviews on non-sensitive topics, review of existing academic, medical or other records without recording identifiers, etc. See SOP 302 “Exempt Review” for a complete list of exemption categories.  Note that the IRB may still require informed consent procedures for studies that are determined to be exempt.

Certain federally funded research that involves no greater than minimal risk and only includes procedures listed in the Federal Register expedited review categories can undergo expedited review. This is a determination made by the IRB upon review of the study. Expedited review procedures allow an individual IRB member to review and approve projects on behalf of the full IRB. Studies that qualify for expedited review are reviewed on a weekly basis. Some full board, greater than minimal risk studies may qualify for expedited review once the study is limited to data analysis or if no participants have been enrolled in the study.

Examples of expedited categories include blood draws, recorded interviews and focus groups, studies that access identifiable health or educational records, studies collecting biological specimens by noninvasive means, etc.

Studies that do not qualify for exempt or expedited review and/or present greater than minimal risk to participants must be reviewed at a fully convened IRB meeting. The full board meets once per month. The OIRB website lists monthly submission deadlines for each meeting agenda. A majority of the board including at least one non-scientific member must be present at the meeting in order for quorum to be established. If protocols include research with children or prisoners, then an IRB member with that expertise must be present in full board meetings that review such research protocols.

Examples of full board studies include research in prisons, studies administering drugs or alcohol, research involving invasive interventions (e.g. biopsies, tDCS), or intervention research involving high risk or vulnerable populations.

Minor changes to approved projects and study closures are reviewed administratively by OIRB staff. Submissions that qualify for administrative review are done on a daily, first come first serve basis.

Administrative changes include but are not limited to:

• changes to contact information or formatting in approved documents;
• changes to project timeline or project team;
• new or revised recruitment advertisements or scripts if similar to already approved recruitment materials;
• increase or decrease in enrollment numbers in minimal risk projects;
• submission of letters of support (but not addition of sites);
• submission of project or consent documents translated into a foreign language and the required translation certificate(s).

Research that is greater than minimal risk must be reviewed by the full convened IRB no less than once per year. Minimal risk research may or may not require continuing review. If the IRB approval has an expiration date, a Renewal (Continuing Review) as outlined in the IRB Submission Checklist must be submitted no later than 30 days prior to the expiration date to allow adequate time for IRB review. Researchers may update protocol personnel and CITI trainings at the time of renewal (continuing review). Streamlyne sends automated email reminders of continuing review at 60- and 30-days prior to expiration of IRB approval. Renewals (continuing reviews) are submitted as renewals within the existing Streamlyne protocol. Please note renewal (continuing review) and amendments may not be submitted at the same time.

Prior to implementing a change to a study, an amendment must be submitted to and approved by the IRB. Examples include adding or revising questionnaires or other study procedures, changing a study location or participant inclusion/exclusion criteria, changing recruitment and/or compensation procedures, etc. An Amendment Application must be completed and submitted along with any new or revised documents (using track changes).  An amendment is submitted as an amendment within the existing Streamlyne protocol. For further guidance, please see the IRBNet submission instructions. 

Projects that are not subject to continuing review will receive an administrative check-in. As part of this process, the PI and student investigator, if applicable, are emailed a link to a survey asking questions about the status of the project.  This email is sent based on the anticipated project end date identified in the IRB approved protocol.  Depending on the responses to the survey, the project will either be extended for the period indicated or will be administratively closed by the OIRB.  Exceptions are made on a case-by-case basis. Failure to respond to the administrative check-in request will result in a process hold on future submissions.

The PI and/or the IRB may close approved protocols under certain circumstances. The PI is responsible for promptly closing out an IRB approved project when:

• all research activities including analysis of identifiable data and reporting are complete;
• the PI never initiated the study;
• participant enrollment is closed, all data collection is complete and the only remaining activity is analysis of de-identified data with no identifying links or codes;
• the PI plans to leave the University and intends to continue the research activities at another institution;
• a student researcher leaves the University without notifying the IRB.

The study cannot be closed if the study:

• is still collecting data from participants;
• is analyzing identifiable data (including data with codes or links to identifiers).

To submit a closure request, the PI or student researcher will submit a Closure and other documents as outlined in the IRB Submission Checklist to the existing Streamlyne protocol. Closures are reviewed administratively.