Procedure 3: Expedited Review of Human Subjects Research

Effective Date: 04 April 2026

Responsible Office: Office of the Vice Provost for Research

Last Updated: 03 August 2026

I. Scope & Purpose

This procedure applies to all faculty, staff, students, and affiliated researchers, working within the scope of their roles at William & Mary, to complete human subjects research that is overseen by the Institutional Review Board (IRB).

The purpose of this procedure is to detail William & Mary’s procedure to address the IRB’s standard and operating practices for the conduct of expedited reviews. This document outlines the processes of preparing, conducting, and documenting expedited reviews.

II. Definitions

1. Children: Children are defined in the HHS regulations as persons who have not obtained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. 45 CFR 46.402(a).
2. Criteria for Approval: The criteria detailed in 45 CFR 46.111 address qualities of a human subjects research protocol that are eligible for approval. These criteria must be met for all human subjects research where 45 CFR 46 is applied.
3. Expedited Review: A list of categories of research that may be reviewed by the IRB through an expedited review procedure. Expedited review procedures are for certain kinds of research involving no more than minimal risk, and minor changes in IRB Full Board approved research.
4. Identifiable Private Information: Identifiable private information is private data for which the identity of the participant is or may readily be ascertained by the investigator or associated with the information. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public.
5. Identifiable Biospecimen: Identifiable biospecimen is a natural sample for which the identity of the participant is or may readily be ascertained by the investigator or associated with the sample data.
6. Informed Consent: The informed consent process involves three key features: (1) disclosing to potential research participants’ information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. Informed consent must be legally effective and prospectively obtained. Requirements for Informed Consent are detailed in 45 CFR 46.116.
7. Minimal Risk: Minimal risk is the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
8. More than Minimal Risk: More than minimal risk are situations where the probability and magnitude of harm or discomfort anticipated in the research are greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
9. Pregnant: Pregnancy encompasses the period from implantation until delivery. A person shall be assumed to be pregnant if they exhibit any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.
10. Prisoners: A person who is incarcerated is any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. Individuals who are incarcerated if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. People who are incarcerated may be convicted of a crime or may be untried persons who are detained pending judicial action, for example, arraignment or trial.
11. Subparts: Subparts are sections of 45 CFR 46 with additional information and requirements. In the case of human subjects research regulations, subparts identify some vulnerable populations (pregnant people, fetuses, neonates, those who are incarcerated, and minors) that require additional protections in research.
12. Vulnerable Populations: Vulnerable populations are identified in the human subjects research regulations as pregnant people, fetuses, neonates, those who are incarcerated, minors, individuals with impaired decision-making capacity, and economically or educationally disadvantaged persons. The IRB may also require additional protections for any other group not specified in the regulations but determined, by the IRB, to be vulnerable.

III. Procedure

All William & Mary researchers conducting human subjects research are expected to submit an IRB protocol to the IRB for review and approval before implementation, including study protocols eligible for expedited review. 

IRB members will conduct initial reviews, continuing reviews for annual approval renewal where applicable, and amendments as applicable for all non-exempt, minimal risk research eligible for review via the expedited procedures as outlined in 45 CFR 46.

Expedited review is appropriate when the proposed research poses no more than minimal risk to participants, and study procedures involve only one (or several) of the categories of research outlined by 45 CFR 46 and supplemental guidance. These categories are maintained by the Secretary of Health and Human Services (HHS), updated as appropriate, and posted as a notice in the Federal Register.

A. Eligibility for Expedited Review

1. When obligated to apply 45 CFR 46 to an IRB protocol, the IRB Chair (or their designee(s) will conduct an expedited review for minimal risk research eligible under 45 CFR 46 and the William & Mary Policy, including this standard.
2. All requirements from 45 CFR 46 are applicable when human subjects research is eligible for Expedited review and the research is:
   1. Subject to the DoD, USDA, FDA regulations, or other signatories of the Common Rule,
   2. Sponsored or Funded,
   3. Contractually Obligated,
   4. Associated with an Agreement, or
   5. Cooperative
3. When not obligated to apply 45 CFR 46 to an IRB protocol, the IRB Chair (or their designee(s)) will either conduct an expedited review for minimal risk research eligible under 45 CFR 46, or they will determine the research is eligible for W&M’s FLEX exemption category in accordance with the procedure for exempt research and this procedure.
4. When 45 CFR 46 applies, research activities should not be deemed to be “of minimal risk” because they are included on the list maintained by the Secretary of HHS. Inclusion on this list means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human participants.
5. When 45 CFR 46 applies, the categories on this list apply regardless of the age of participants, except as noted by the Secretary of HHS.
6. When 45 CFR 46 applies, the expedited review procedure may not be used where identification of the participants and/or their responses would reasonably place participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal risk.
7. The expedited review procedure may not be used for classified human subjects research.
8. The standard requirements for informed consent found at 45 CFR 46.116 (or its waiver, alteration, or exception) and the Criteria for Approval found at 45 CFR 46.111 apply to research reviewed via expedited procedures.

B. Expedited Review Process

An expedited review procedure consists of reviewing human subjects research by either the IRB chairperson or by one or more reviewers from among members of the IRB:

1. The IRB members conducting the expedited review may exercise all the authority of the IRB except that the reviewers may not disapprove the research. The reviewers shall refer any research project, which the reviewer would have disapproved, to the convened IRB for review.
2. The reviewer may also refer other research activities to the convened IRB whenever the reviewer believes that Full IRB review is warranted.
3. The reviewer must apply all Criteria for Approval as outlined in 45 CFR 46 to approve any human subjects research with via expedited procedures.
4. Full Board Notification of Expedited Study Approval
5. When the expedited review procedures are used, the IRB office shall inform the IRB members of research projects that have been approved using expedited procedures.
6. Notification includes sharing the study title, PI, date of approval, and expedited approval category at a convened IRB committee meeting.

C. Information Submitted to the IRB for Expedited Review

All required materials must be submitted to the IRB through the electronic IRB application system. Once submitted, the IRB office staff prepares the application before sending it to an IRB member for expedited review. Once the expedited reviewer completes their review, they return it to the IRB office staff for processing. IRB staff serving as Full Board members may, with the permission of the IRB chairperson, review research protocols at the Expedited level.

1. At William & Mary, the IRB application is an electronic application that outlines all study activities involving research with human participants. The application is completed by the researcher and electronically submitted to the IRB.
2. The IRB application must include final supplemental documents when necessary. These documents include: 
   1. Recruitment materials intended to be seen or heard by potential participants. This includes but is not limited to recruitment messages, fliers, announcements, and talking points.
   2. Informed consent materials including adult participant consent forms, minor participant assent forms, parental permission forms for minor participation, and any letters/scripts where consent/assent/permission is addressed.
   3. Finalized data collection instruments and research protocols for interventions, interactions, or manipulations of a participant’s environment.
   4. When applicable, the supplemental documentation may include other applicable documents such as agreements, data management plans, letters of support, etc.

D. Expedited Review: Protocol Pre-Review

1. Once the application is submitted through the electronic system, the IRB office staff will perform a pre-review. This pre-review consists of reading through the application and supplemental documents for consistency, detail, step-by-step procedures, information required by regulations, and required legal information. The pre-review may require the IRB office staff to communicate with the researcher and return the protocol to the researcher for needed changes related to internal consistency, cohesiveness, adherence to applicable laws, regulations, and standards.
2. In some cases, a study may require additional ancillary review before IRB approval is granted. These may include reviews such as Conflict of Interest (COI), Export Control, Research Security, Institutional Biosafety Committee (IBC), Information Technology (IT), Local Context or Participant Context, Site Context, or other applicable reviews.

E. Protocol Final (Expedited) Review

The designated IRB member completing the review of the study application makes a determination regarding approval based on the criteria for approval as detailed in 45 CFR 46.111. Possible outcomes of this review include:

1. Approve. The research, proposed modification to previously approved research, or some approval renewals is approved. The expedited reviewer has made the determinations required for approval (i.e., approval criteria and any applicable special determinations (e.g., waivers, alterations, vulnerable population determinations, etc.). No further action is needed.
2. Minor Stipulations Required. The proposed modification to the previously approved research is approved with conditions that must be satisfied before the approval is in effect. The reviewer communicates the stipulations required to meet the criteria for approval through comments made in the IRB system. The IRB office staff works with the researcher to process approval once the stipulations are verified.

F. Expedited Review for Qualifying Full Board Studies

For research previously approved by a convened IRB, the IRB may use the expedited review procedure to review minor changes in previously approved research in accordance with 45 CFR 46.110(b)(1)(ii) and the William & Mary IRB Human Subjects Research policy and applicable procedures.

1.  Renewal of full board studies that qualify for review under expedited category 8
   1. The research is permanently closed to the enrollment of new participants;
   2. All participants have completed all research-related interventions; and
   3. The research remains active only for long-term follow-up of participants.
      1. “Long-term follow-up” includes:
         1. Research interactions that involve no more than minimal risk to participants (e.g., quality of life surveys); and
         2. Collection of follow-up data from procedures or interventions that would have been done as part of routine clinical practice to monitor a participant for disease progression or recurrence, regardless of whether the procedures or interventions are described in the research protocol.
         3. Some research studies that are not eligible for expedited review under category (8)(a) at the time of renewal may be eligible for expedited review under one of the other expedited review categories.
         4. Where no participants have been enrolled and no additional risks have been identified:
            1. “No participants have been enrolled” means that no participants have ever been enrolled at a particular institution; and
            2. The criterion that “no additional risks have been identified” means that neither the investigator nor the IRB at a particular institution has identified any additional risks from any institution engaged in the research project or from any other relevant source since the IRB’s most recent prior review.
         5. Where the remaining research activities are limited to data analysis.
         6. An IRB may use an expedited review procedure to conduct review of a renewal request when the only remaining human participants research activity is the analysis of data that includes identifiable private information and the IRB chair or their designee determines that this activity involves no more than minimal risk.
            1. The process for conducting renewal approval of research under expedited review category 8 can be accomplished through an abbreviated process.
            2. Expedited category 8 does not apply when a research study continues to involve human participants where the investigators conducting the research continue to obtain:
               1. Data about the participants of the research through intervention or interaction with them; or
               2. Identifiable private information about the participants of the research.
                  1. For a multi-site research project, an expedited review procedure may be used by the reviewing IRB whenever the conditions of category 8 are satisfied for all sites involved
2. Full board studies that qualify for review under expedited category 9
   1. An expedited review procedure may be used for the continuing review of research for renewal approval and amendments for previously approved research by the convened IRB if the study meets all the following conditions:
   2. The research is not conducted under an investigational new drug application (IND) or an investigational device exemption (IDE);
   3. Expedited review categories (2) through (8) do not apply to the research; and
   4. The convened IRB has determined and documented that the research involves no greater than minimal risk to the participants:
   5. The convened IRB must have determined that either the research project involved no more than minimal risk, or the remaining research activities involving human participants present no more than minimal risk to the participants.
      1. This determination could occur as early as the convened IRB meeting at which the IRB conducted its initial review.
      2. No additional risks or issues with the research have been identified.
      3. When a full board study is initially approved, a majority of the quorum vote that the study can be reviewed via expedited category 9.
         1. All amendments to a full board study where a category 9 vote took place, are eligible for expedited review, unless they increase risk to participants or are outside of the limits described in the Expedited categories. These studies may be approved via expedited procedures where the reviewer is the IRB Chair or their designee.
         2. All approval renewal requests for full board studies where a category 9 took place are eligible for expedited review and may be approved via expedited procedures where no information shared during the renewal process indicates an increase in risk to participants or where the history of the study implementation suggests issues with study management.

G. Annual Approval Renewal (i.e., Continuing Review) for Expedited Studies

Approval renewal for studies approved at the Expedited level do not undergo the annual renewal unless the IRB reviewer has documented the determination that it must undergo renewal approval.

A study reviewed via expedited procedures would undergo renewal approval if the risks/benefits of the study are likely to change based on the implementation of procedures, issues with researcher’s compliance or history of ethical practices, the role technology may play in the research, considerations regarding genomics, and contractual or sponsor obligations. Refer to the IRB’s unit standard for renewals, amendments, closures, and transfers.

IV. Authority & Amendment

This procedure was approved by the William & Mary IRB on April 4, 2026. This procedure will be reviewed every 2 years to ensure it remains relevant, usable, and in compliance with university policy and relevant law. 

V. Related Policy & Procedures

• Federal Regulations Governing Research with Human Subjects 45 CFR 46
• The Belmont Report
• Nuremberg Code of 1947
• Office for Human Research Protections (OHRP)
• Code of Virginia, Research with Human SubjectsWilliam & Mary Policy for Conflicts of Interest
• William & Mary Policy for Financial Conflicts of Interest
• William & Mary Research Compliance Website
• William & Mary Data Classification and Protection Policy
• FDA Regulations
  • 21.CFR.50 Protection of Human Subjects 
  • 21.CFR.56 Institutional Review Boards
  • 21.CFR.312 Investigational New Drug Application  
  • 21.CFR.812 Investigational Device Exemptions   
  • 21.CFR.600 Biologics
• DoD Regulations Governing Research with Human Subjects 32.CFR.219
  • DoD Instructions 3216.02
• NIH Website for Human Subjects’ Research
• NSF Website for Human Subjects’ Research
• William & Mary’s Policy for Research with Human Subjects
• William & Mary’s Policy for Research Misconduct