Office of Research Integrity and Assurance

IRB Review Process

About the IRB Review Process

The GMU IRB fulfills their goal to protect human research participants and support the design and conduct of sound research by reviewing and approving IRB submissions for new applications, modifications, and continuing reviews.

All projects that meet the definition of research with human subjects (45 CFR 46.102) must be reviewed and approved by an IRB, or receive an exempt determination, prior to beginning the research. Once the application is received by the IRB, it is assigned to an IRB Specialist who conducts a pre-review to determine the completeness of the application and the appropriate type of review. Submissions may be returned to the study team for changes before the review type is assigned. The review type may be reassessed at any time during the review process.

Types of IRB Review

The basic types of IRB Review are: Full Board/Expedited, Exempt, and Not Research/Not Human Subjects Research. The type of IRB review is determined by the:

  • Level of risk to research participants
  • Type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)
  • Sensitivity of the research questions or complexity of the research design
  • Involvement of vulnerable populations as research participants
  • Use of identifiable information or identifiable biospecimens
  • Applicability of one or more of the criteria for exempt or expedited review

1. Full Board and Expedited Review

The IRB may conduct either an expedited or full board review for IRB-regulated research (i.e. research that meets the regulatory definition of Research with Human Subjects) to ensure:

  • Risks to the subjects are minimal, and are reasonable in relation to anticipated benefits
  • The subject selection is equitable
  • Privacy and confidentiality are protected
  • Informed consent processes meet federal regulatory and GMU requirements

In the context of IRB review, the terms “Full Board” and “Expedited” refer to a review process.  Studies that fall into these categories of review are subject to the same regulatory requirements.  Expedited studies may be reviewed and approved by a single IRB member, while Full Board studies are reviewed at a convened IRB meeting.

Full Board Review

Federal regulations and institutional policy require a review by the IRB Full Board for applications where the research involves more than minimal risk to human subjects, does not meet the criteria for one of the categories of expedited review, or has been referred to the committee by an expedited reviewer or the Chair. Regardless of risk level, the IRB may require full board review when the research involves:

  • Vulnerable populations, particularly prisoners
  • Sensitive topics, including illegal behaviors which may require an NIH Certificate of Confidentiality (CoC) to protect subject data from compelled disclosure
  • A complex research design requiring the expertise of multiple board members to evaluate

The IRB meets once each month. If an application is “board ready”, meaning that it contains all of the information and materials necessary for the full board to conduct its review, the application will be assigned to the next available IRB meeting date. Investigators may be invited to attend the meeting to answer questions from the board. At the conclusion of the meeting, the board votes and issues a determination for the submission. Full Board studies generally require an annual Continuing Review.

Expedited Review

Federal regulations (45 CFR 46.110) authorize the use of an expedited review process for:

  • Minimal risk human research that meets one or more of the OHRP Expedited Review Categories
  • Minor changes to research previously approved by the full board

Applications qualifying for expedited review are assigned to a designated reviewer (an IRB member appointed to the role by the IRB Chair). The designated reviewer has the authority to make a determination or to refer a submission for full board review. Most studies that qualify for the expedited review process do not require annual Continuing Review.

2. Exempt Research Review

Per university policy, investigators must submit an IRB application for determination of exemption before research begins.  Projects that meet the criteria for a federal exemption category (45 CFR 46.104) may be granted a determination of exemption by the IRB. The review determination is limited in scope to the information necessary to determine if the proposed exemption applies. Exemptions may be granted by the IRB Chair, expedited reviewers, or (in most cases) qualified IRB staff members.

Projects receiving an exempt determination are not subject to the Continuing Review process. Modifications are required only if the changes to the project would alter the exemption criteria. See the IRB’s Exempt Review Guidance for more information.

An exempt determination does not lessen the researcher’s ethical obligations to participants as articulated in the Belmont Report or to the codes of conduct for specific disciplines.

You may use the Exempt Determination Worksheet for assistance in determining whether your study meets the criteria for exemption. This is a resource only and should not be submitted in RAMP.

3. Not Research/Not Human Subjects Research

Not all research-related activities that involve people, their data, or their biospecimens are covered by the regulations governing human research. GMU policy allows researchers to determine whether their project requires IRB approval on their own. However, investigators may wish to submit an IRB application for a formal determination for funding or publication purposes.  See Do I Need IRB Review for more information.

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