Review Categories

Following is a summary of the research categories that determine the type and level of review required. Instructions for submitting research applications are posted in the How to Apply for IRB Approval section of this website.

  1. Not Human Subjects Research
  2. Exempt Research
  3. Non-Exempt Research
    1. Expedited Review
    2. Full IRB Review

1. Not Human Subjects Research

The UH Human Studies Program has authority under federal regulations and through an agreement between the University of Hawaii and the federal Office for Human Research Protections (OHRP) to review, approve and provide oversight to human subjects research . If a study does not qualify as human subjects research, it does not require review and approval by the UH Human Studies Program or a UH IRB.

To qualify as human subjects research, as defined by federal regulation, a project must meet the following standards:

If the project involves only the analysis of publicly available data (e.g., census data, large public survey datasets with no individual identifiers, or public information available on the internet), it is not considered to be human subjects research.

If this is a UH class project from which data will only be submitted to your instructor for a class grade and will not be published, presented at an academic conference, provided to an agency as a formal report, or used to qualify for a graduate degree, it is also not considered to be human subjects research.

Typically, if a focus group is being convened to develop a study instrument, this is not human subjects research, even if the study instrument will eventually be used to conduct a research project that will qualify as human subjects research.

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2. Exempt Research

Federal regulations permit some human subjects research to be exempt from IRB review, approval and oversight. Most human subjects regulations do not apply to exempt research; however, exempt research must be performed according to the principles described in The Belmont Report. Consistent with these principles, informed consent is generally required unless specifically waived by the Human Studies Program. For more information, see Informed Consent: Model Forms and Guidance on this website.

Research involving prisoners, fetuses, pregnant women, or in vitro fertilization do not qualify as exempt. Categories that qualify a study as exempt include:

Only the UH Human Studies Program may approve a study as exempt. If you believe that your research qualifies for exempt status, complete the Human Studies Program, Application for Exempt Status for Human Subjects Research. This application form is only for exempt research. If it is determined that the research is non-exempt, a completed Application for Approval of a New Study Involving Human Subjects is required.

Exempt research does not require continuing review. However, if changes in the study design, methods or IRB-approved documents are proposed, the Human Studies Program must be contacted, prior to implementing the change. See How to Apply

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3. Non-Exempt Research

Non-exempt research is governed by federal regulations, including the DHHS regulations (45 CFR 46, Protection of Human Subjects) also known as the Common Rule. Non-exempt research may also be governed by US Food & Drug Administration regulations (21 CFR 50, Protection of Human Subjects and 56, Institutional Review Boards). Other regulations may apply.

Non-exempt research must be reviewed by the IRB, either in a convened meeting or through an expedited review process. The type of review process used is determined by federal regulation as interpreted by the Human Studies Program staff.

Approval of a non-exempt study cannot exceed one year. Prior to expiration of IRB approval, the PI must submit an IRB Continuing Review Application. If IRB approval expires before the IRB has re-approved the study under a continuing review process, all study activities must stop except those necessary to prevent apparent immediate hazards to study subjects or others.

In order for non-exempt research to be approved, the IRB must determine that all of the following criteria are satisfied:

The IRB has several options following review of a proposed study. It can:

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3.A. Expedited Review

Federal regulations permit some non-exempt research to be reviewed under an expedited review procedure. Initial and continuing review applications must qualify as minimal risk and fulfill at least one of the expedited review categories defined by federal regulations. Applicable regulations and UH policies and procedures on the expedited review process is documented in SOPP 106, Expedited Review of Human Subjects Research.

Minor modifications to IRB-approved research may also qualify for expedited review as described in the Human Studies Program SOPP 103, Submitting Modification Requests to the IRB .

Expedited review is performed by the IRB Chair or an experienced member of the IRB designated by the Chair. All applications received by the Human Studies Program are screened to determine if they qualify for expedited review. The decision to use the expedited review procedure is made by the Human Studies Program staff. Even if the staff determines that a study qualifies for expedited review, the IRB expedited reviewer may request that the study be forwarded to the IRB for review at the next convened meeting.

Approval under an expedited review procedure does not guarantee a faster turn-around time than review by the full IRB at a convened meeting. Turn-around time is determined by a number of factors including the complexity of the research, the workload of the reviewer, and the quality of the IRB submission.

Studies approved under an expedited review procedure are subject to all applicable regulations, including requirements for informed consent and continuing review.

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3.B. Full IRB Review

Research that does not qualify for exempt status or expedited review must be reviewed and approved by a quorum of IRB members at a convened IRB meeting. The convened IRB may perform initial review of proposed research studies, continuing review of IRB-approved studies, review of proposed study modifications, as well as review of unanticipated problem and protocol violation reports. Each of the UH IRBs meets monthly and has the authority to:

 

The process for applying for full IRB review is the same as for expedited review; except, for full IRB review, submission deadlines apply. For information on the application process, see the How to Apply for IRB Approval section of this website.

When the IRB has completed its review, the Human Studies Program will communicate the IRB’s decisions, stipulations and recommendations to the Principal Investigator (PI) in writing. Study activities may not be initiated until the PI has received written documentation of final IRB approval.

 

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