Procedure 7: Renewals, Amendments, Closures, and Transfers

by Office of the Vice Provost for Research  | August 19, 2026

Effective Date: 19 August 2026

Responsible Office: Office of the Vice Provost for Research 

Last Updated: 03 September 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 (W&M), to complete research with human subjects.

The purpose of this procedure is to detail W&M’s procedure to address W&M’s IRB’s standard for the continuing review, renewal, closure, or transfer of an IRB-approved research protocol.

II. Definitions

Continuing Review: ongoing review of research already approved by an IRB.
Approval Renewal: A renewal of IRB approval is when researchers submit a request to the IRB office to extend the approval period of their IRB protocol.
- Convened full board studies require a minimum of annual renewal.
- Expedited studies do not require renewal unless specified at the initial approval.
- Exempt studies and studies exempted with a limited review do not require renewal unless specified at the initial approval.
- Some studies that are sponsored or contractually obligated require annual renewal. This should be specified at the time of initial approval.
Amendments/Modifications: when researchers seek to change one or more elements of their study. Modifications can be administrative or substantive changes.
IRB Protocol Closure: A protocol should be closed by the research team when all research procedures with humans are complete and the identifiable information linked to the data or the identifiable data has been destroyed.
IRB Protocol Transfer : Whenever the institutional affiliation of the principal investigator (PI) changes from or to W&M, the protocol must be transferred to either a W&M-affiliated researcher or to the new institution of the PI.

III. Procedure

Researchers must ensure that the W&M IRB is updated with a study’s status including amendments, approval renewals, study transfers and bequeathals, and study closures. This enables the IRB to ensure that a study continues to meet the federal criteria for approval at 45 CFR 46.111 as well as all applicable laws, regulations, and standards.

Renewal of IRB Approval
1. The principal investigator must file an approval renewal request for their protocol with the W&M IRB if the study protocol has an approval expiration date.
2. Investigators are responsible for fulfilling requirements associated with their approval renewal requests in time for the IRB to carry out all review and approval procedures prior to their protocol’s expiration date.
  1. If this does not occur, all recruitment, consent, implementation of intervention, data collection, and data analysis on identifiable data must cease.
3. The approval renewal request asks the principal investigator to provide information about research implementation, funding, adverse events, unanticipated problems, participant complaints, and issues of noncompliance.
4. Approval renewal is required for all studies receiving convened full board approval, all studies with NIH funding, , and some protocols that are contractually obligated to employ annual approval renewal.
  1. As appropriate to the study, the IRB may require approval renewal to occur multiple times a year, but it is required to occur at minimum once a year.
  2. The IRB may also require approval renewal for studies under special circumstances, such as studies involving conflicts of interest, genetic or genomic research, collaborative research where a reliance or individual investigator agreement exists, or prior compliance concerns.
  3. As required by a contract, the IRB may require approval renewal to occur when it otherwise would not.
  4. As required by a funding agency, the IRB may require approval renewal to occur when it otherwise would not.
5. Approval renewal of a study is not required for:
  1. Most research that qualifies for an exemption determination or is eligible for expedited review.
  2. Research that has completed all interventions and now only includes data analysis, even if the information or biospecimens are identifiable.
    1. If approval renewal was previously required, the researcher must update the IRB with this new status and the IRB will notify the researcher that approval renewal is no longer required.
  3. Research that has completed all interventions and now only includes accessing follow-up clinical data from clinical care procedures.
    1. If approval renewal was previously required, the researcher must update the IRB with this new status and the IRB will notify the researcher that
6. Required Information to be Submitted to the IRB Regarding Approval Renewal:
  1. The number of participants enrolled. For multi-site research studies, the number of participants accrued at the local institution and the number accrued study-wide.
  2. A brief summary of any amendments to the research approved by the IRB since the IRB’s initial review or the last approval renewal.
  3. Any new and relevant information since the last approval date, especially information about changes in risks associated with the research.
  4. A brief summary of all unanticipated problems and adverse events.
    1. For any problems or events discussed, indicate whether the IRB has already been informed.
    2. If adverse events have occurred, indicate whether they are at expected frequency and level of severity as documented in the research protocol, the informed consent document, and the investigator’s brochure (if applicable).
    3. A summary of all subject withdrawals from the research since the last IRB review, and the reasons for withdrawal, if known.
    4. A summary of all complaints about the research since the last IRB review.
    5. Any proposed modifications to the informed consent document or protocol (this should be submitted and will be reviewed as a concurrent amendment request).
    6. An update on the protocol’s funding status, including, but not limited to:
      1. confirmation of current funding;
      2. any changes in funding since the last approval period; and
      3. any expected changes in funding in the upcoming approval period.
    7. An updated National Institutes of Health (NIH) required data management and sharing plan if the study is funded or supported by the NIH.
7. IRB Review and Approval Considerations for Approval Renewal
  1. In order to approve research at the time of renewal, the W&M IRB must determine that the regulatory criteria for approval continue to be satisfied.
  2. The W&M IRB focuses its considerations at the time of approval renewal on whether any new information is available that would affect the W&M IRB’s prior determination that the criteria for approval are satisfied.
  3. The W&MIRB pays particular attention to four aspects of the research:
    1. Risk assessment and monitoring
    2. Adequacy of the informed consent process
    3. Local investigator and organizational issues and, when appropriate, the reviewing IRB
    4. Research progress and confirmation that renewal information is consistent with the IRB-approved protocol.
8. Approval Renewal for Full Board Studies that Qualify for Expedited review under Category 8
  1. Expedited review procedures may be used for the approval renewal of a study that was approved by the convened Full Board under Expedited Category 8, if all of the following is true:
    1. The research is permanently closed to the enrollment of new participants;
    2. All participants have completed all research-related interventions and research remains active only for long-term follow-up of participants;
    3. Where no participants have been enrolled and no additional risks have been identified;
    4. Where the remaining research activities are limited to data analysis;
    5. Eligibility for expedited category 8 review 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.
    6. For Full Board studies eligible for expedited review under category 8, approval renewal is required to occur, at minimum annually. The approval period can be shorter if required by the convened IRB.
9. Approval Renewal is not required for Full Board Studies that Qualify for Expedited review under Category 9 where the convened full board voted at the study’s initial approval that the protocol could be continually reviewed via Expedited 9 in the future.
10. Approval Lapse
  1. Approval for a research study expires at 11:59pm on the date of expiration.
    1. If re‐approval does not occur within the current approval period IRB, all research activities must stop. This includes recruitment (media advertisements must be withdrawn), enrollment, consent, data collection (including interventions and interactions) and analysis of identifiable/re-identifiable data.
    2. The W&M IRB is responsible for notifying the investigator of the date of expiration of approval at initial review and any renewal notification thereafter. The IRB has no obligation to remind researchers about their approval expiration.
    3. The regulations governing research with human subjects permit no grace period or approval extension after expiration of approval. The IRB recognizes that, while enrollment of new participants cannot occur after the expiration of IRB approval, temporarily continuing participation of already enrolled participants may be necessary for the protection of participants' rights, welfare, or safety.
    4. The failure to meet approval renewal obligations may be grounds for suspension or termination of the research.
    5. Research that continues after the approval period has expired, even if implementing previously approved procedures, is considered research conducted without IRB approval and is considered noncompliance
    6. If the W&M IRB notes a pattern of noncompliance with the requirements for approval renewal (e.g., an investigator repeatedly or deliberately neglects to submit materials for continuing review in a timely fashion), the W&M IRB will determine the reasons for the non‐compliance and take appropriate corrective actions.
    7. Approval of an amendment during a study does not affect the approval expiration date nor does the approval of an amendment constitute approval renewal. These are separate approval types and may occur concurrently.

B. Amendment to an Approved IRB Protocol

The principal investigator must file an amendment request for their protocol with the W&M IRB.
Amendments must be submitted to the IRB and approved by the IRB prior to implementation.
Amendment requests are required for all IRB reviewed research, including studies deemed exempt by the IRB office.
Department of Defense (DoD) affiliated research protocols must engage HRPO review after the renewal is approved.
Required Information to be Submitted to the IRB:
1. Editorial changes
  1. Editorial changes are when the only proposed changes to the research are related to language used, sentence structure, or issues of communication that need clarity. This may be changing sentence structure or adding and removing words.
  2. For many exemptions, an amendment for this activity may not be required.
2. Procedural changes
  1. Edits to an existing procedure is when the researcher proposes to change something about an already approved procedure and how it is implemented.
  2. An addition of a procedure is when the researcher proposes to add an entirely new procedure to the recruitment, consent, and/or data collection process. This includes changes in reporting data when that change is related to the identifiability of the data.
  3. A removal of a procedure is when the researcher proposes to remove an entire procedure from the recruitment, consent, and/or data collection process. For many exemptions, an amendment for this activity may not be required.
3. Administrative changes
  1. Any changes to study personnel must be updated with the IRB office via a modification (or amendment), and it should be noted if their involvement affects issues such as undue influence or possible coercion due to relationships with participants.
  2. Any changes to funding information must be updated with the IRB office via an amendment and it should be noted if the funding introduces any conflicts of interest and how the funding affects study design and supplemental materials.
4. Ramifications of changes
  1. The researcher must identify what the ramifications of the proposed changes are related to the research protocol. These include changes to study materials, addition of study materials, removal of study materials, changes in identifiability of the data collected, and changes within the application.
  2. The researcher must provide a risks/benefits assessment resulting from the changes. This should focus on how the changes affect the risks/benefits ratio that participants experience.
5. Documentation of changes
  1. All proposed study changes where study materials are edited must have the edited study materials provided to the IRB for review and approval before they are implemented.
  2. All proposed study changes where new study materials are added must have the new study materials provided to the IRB for review and approval before they are implemented.
  3. The IRB will document what has changed about the study and any resulting decisions regarding approval, including changes to the approval type.
6. IRB Review and Approval Considerations
  1. When the W&M IRB reviews amendments to already approved protocols, we consider the requested changes, the ramifications of those changes on study design and material, and the consequences thereafter on the risks/benefits ratio that participants experience.
  2. Approval for proposed amendments for studies approved by the convened full board must take place at a convened meeting at which a majority of the IRB members are present, including at least one member whose primary concerns are in nonscientific areas. In some cases, minor amendments to full board studies may be reviewed via expedited procedures.
7. For Full Board Studies that qualify for Expedited review under Category 9 at the study’s initial approval, modifications must be submitted to the IRB for review and approval before implementation. These modifications will be reviewed via expedited procedures unless they increase risk to participants.

C. Closing an IRB Protocol

IRB Protocols should be closed when:
1. all related study activities will no longer involve research with human participants, or
2. the investigator(s) are no longer under the purview of W&M’s IRB, and no other W&M researcher will remain engaged in the research.
Once a protocol is closed, IRB approval ceases and no research activities with human participants should occur.
In rare circumstances, closed protocols may be re-opened. To do this, a new protocol must be submitted for review and approval including updated documents and a new risks/benefits assessment.

D. Bequeathing an IRB Protocol within W&M

Protocol bequeathal is initiated through a modification to the protocol that is submitted to the W&M IRB.
The new investigator, who the protocol is bequeathed to, must have access to all procedures, documentation, and data after the protocol modification is approved by the W&M IRB.
In rare circumstances where a lead investigator has left the University without updating a protocol, the initial PI’s department head can work with the IRB staff to address changes in the protocol.
Required Information to be Submitted to the IRB:
1. The modification(s) to bequeath a protocol must include the following:
  1. Documentation of which PI is being removed from the protocol; and which researcher is assuming the leaving PI responsibilities.
  2. Provision of proof of completion of human subject training requirements for all new personnel on the research team.
  3. Any necessary updates to the IRB application and supporting documentation due to the personnel change such as COI disclosures or editorial changes.

E. Transferring a Protocol to W&M

When a researcher becomes an agent of W&M and they want to continue research from a protocol that was already approved by a non-W&M IRB that is registered with an FWA number, they must apply to the IRB to transfer their protocol to W&M.
Researchers should transfer all studies reviewed at any IRB level (i.e., exempt, exempt with a limited review, expedited, and convened full board) if they plan to continue the research as an agent of W&M, and the research is not cooperative.
To transfer a study to W&M, a researcher will complete the relevant application processes for either an exempt or non-exempt research protocol.
Cooperative research that will continue to be cooperative may not need to be transferred to W&M and instead, a cooperative agreement may be executed.
Required Information to be Submitted to the IRB:
1. Transferring a study involves submitting a new study protocol for review and approval to the W&M IRB.
2. Investigators wanting to transfer a study to W&M must provide the IRB with the following information:
  1. If appropriate, a request for a reliance agreement or letter of exemption determination acceptance;
  2. A protocol submission that includes:
  3. A completed IRB application;
  4. All materials that must continue to be implemented;
  5. Proof of human subjects training completion in accordance with W&M IRB standards for all W&M affiliates (faculty, staff, students, and any individual investigators) on the research team;
  6. Applicable agreements such as data use agreements (DUAs) or material transfer agreements (MTAs); and
  7. Approval letter or exemption determination letter for the previously approved protocol from the previous IRB.
3. The protocol should detail any future primary data collection that will occur and provide necessary instruments, consent forms, and other relevant study materials.
4. If the researcher wants to use the identifiable data generated under the prior IRB protocol from the other institution, the W&M IRB protocol should state that the researchers are requesting the use of secondary identifiable information to be used as data for research where the secondary data were collected under the previously approved IRB protocol with the same research purpose.

IV. Authority & Amendment

This procedure was approved by the W&M Institutional Review Board on August 19, 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

Appendix A

Amendments, Renewals, Closures, and Transfers at a Glance

Renewals

All studies approved via convened full board review and all NIH-funded studies require renewal of approval at minimum once per year, but the IRB may increase the frequency for approval renewal
The approval for a study expires at 11:59pm on the date noted as the approval expiration date.
Some studies receiving expedited approval may be required to undergo approval renewal if the expedited reviewer has deemed it necessary.
Genomic research approved via expedited procedures must undergo approval renewal at minimum every 5 years. This may apply to genomic studies determined to be exempt.

Closures

Protocols can be closed once all related research with human participants activities cease.
Protocols must be closed if the principal investigator leaves W&M unless:
- the principal investigator sets up an institutional authorization agreement (colloquially known as reliance and individual investigator agreements), and/or
- someone else at W&M will be continuing the research in the role as the principal investigator.
IRB approval of research ceases once protocols are closed. No research with human participants associated with the protocol may be conducted. This includes data analysis with identifiable data.

Transfers

If a principal investigator wants to or needs to be removed from the W&M research team, but the research activities associated with that protocol will continue, the leaving investigator must formally transfer the protocol to another W&M researcher prior to leaving their role.
The protocol must be amended to describe this personnel change. All aspects of the protocol’s procedures and any relevant supporting documentation (e.g., human participants research training, updated consent forms with the new principal investigator, etc.) must be updated in this amendment.

Amendments

Studies approved by the IRB full board that were determined to be minimal risk and the convened board voted to review the study in the future as expedited category 9, must still submit amendment requests for any changes made to the study procedures or materials.
All amendment changes will then be reviewed at the expedited (mid-level review) unless the amendment adds new procedures or populations that changes the risks/benefits portfolio which will require re-review by the convened full board.
Studies that were approved by the convened full board may have minor amendments approved via expedited procedures even if there was no expedited category 9 vote.
- Minor amendments include editorial changes to participant-facing materials that do not overtly change messaging, administrative changes such as adding/removal of research staff, removal of procedures, and any change that decreases risk to participants.
Approval of an amendment does not constitute and cannot replace approval renewal as the review process and considerations are different.
All non-exempt studies must submit an amendment request if something needs to be changed about the study, including administrative or editorial changes.
When a researcher proposes a change to an approved study, they must articulate in writing what that change will influence including making necessary changes to sections of the application and study materials.