Procedure 8: Review and Approval for Cooperative Research

by Office of the Vice Provost for Research | April 23, 2026

Effective Date: 23 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 (W&M) to complete human subjects research overseen by the W&M Institutional Review Board (IRB). The purpose of this procedure is to detail W&M’s process for addressing multi-site or cooperative human subjects research conducted by W&M researchers. In this document, you will find the policy and standard operating procedures for the use of reliance agreements and how the W&M IRB facilitates cooperative research The purpose of this procedure is to detail W&M’s procedure to address multi-site or cooperative research with human subjects completed by W&M researchers. In this document, you will find the policy and standard operating procedures for the use of reliance agreements and how the W&M IRB facilitates cooperative research.

II. Definitions

Cooperative Research: Cooperative research involves more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. The institutional official (IO) is the individual who is legally authorized to act for each institution and, on behalf of the institution, obligates the institution to the terms of its Federalwide Assurance.
Federalwide Assurance (FWA): An FWA is the documentation of an institution’s commitment to comply with federal regulations and maintain policies and procedures for the protection of human participants. An institution must have an FWA to receive Department of Health & Human Services (DHHS) support for human subjects research. This is the principal mechanism for compliance oversight by the Office for Human Research Protections.
IRB of Record: The IRB of Record assumes primary responsibility for the review and approval of a study. Any IRB overseeing human subject protections for a study is considered an IRB of Record.
Multi-Site Study: A multi-site study is one that uses the same protocol to conduct non-exempt human research at more than one site.
Participating Site: In a multi-site study, a participating site is a domestic entity that will rely on the sIRB to carry out the site's IRB review of human research for the study.
Relying IRB: An IRB designated via an agreement to cede review to an external IRB for a particular study.
Single IRB: Single IRB is a process and a title. It is a process by which an IRB of record, selected on a study-by-study basis, provides the ethical review for all sites participating in a multi-site study. A single IRB is also a title and refers to an independent IRB or an IRB associated with an institution engaged in the multi-site study that serves as the “reviewing IRB” or “IRB of record” on the project. NIH refers to the single IRB as “sIRB.”

III. Procedure

W&M researchers engaging in cooperative research with another institution's IRB and/or external investigators must attach all applicable agreements to the protocol, including Institutional Authorization Agreements (IAAs), Individual Investigator Agreements (IIAs), and Acceptance of Exemption determinations. See Section B for details.

W&M researchers engaging in non-exempt federally funded human subjects research that is determined to be cooperative research as defined by the federal regulations at 45 CFR 46.114 must have their research reviewed and approved by a single IRB before human subjects research begins.

Cooperative research for which more than a single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or research for which any federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.

When Single IRB review applies, formal agreements will be used to establish the terms of cooperative review and approval.

For unfunded or privately sponsored non-exempt human subjects research, the W&M IRB will enter into agreements as appropriate. See Section B.4 for procedures applicable to research qualifying for an exemption determination.

A. Engagement in Human Subjects Research

A researcher must be “engaged in human subjects research” for the W&M IRB to consider entering into a reliance agreement for non-exempt research or providing an exemption determination acceptance letter for research eligible for exemption.
1. The W&M IRB makes this determination regarding their own employees or agents acting on behalf of W&M
2. The W&M IRB makes this determination regarding unaffiliated investigators engaged in research enacted by W&M
3. The W&M IRB does not make this determination for individuals affiliated with another IRB.
The W&M IRB will make an “engaged in human subjects research” determination when their employees or agents, acting on behalf of the institution, for purposes of human subjects research project (regardless of approval level), obtain:
1. the informed consent of human participants for research purposes*;
2. data about the participants through intervention, interaction*, or manipulation of environment;
3. identifiable or re-identifiable private data about the participants*; or
4. a federal award through a grant, contract, or cooperative agreement for the non-exempt human subjects research, even where all activities involving human subjects are carried out by employees or agents of another institution.
“Employees and agents” are individuals who
1. act on behalf of the institution; or
2. exercise institutional authority or responsibility; or
3. perform institutionally designated activities.
4. “Employees and agents” can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation.
Investigators from institutions engaged in the research retain responsibility for:
1. overseeing protocol-related activities;
2. ensuring the study interventions are administered in accordance with the IRB-approved protocol; and
3. ensuring appropriate arrangements are made for reporting protocol-related information to investigators at other engaged institutions, including the reporting of safety monitoring data, noncompliance, unanticipated problems, and adverse events as required under the IRB-approved protocol; and

B. Types of Agreements

Based on the level of review or researcher affiliation, varying types of agreements or acknowledgments are available.

Requirements to Serve as the IRB of Record:
1. The IRB of Record must hold a Federalwide Assurance (FWA) with the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS).
2. The agreement must be signed by the institutional official or designee at each institution with an FWA
3. The researcher may not serve as signatory on an agreement representing W&M.
Institutional Authorization Agreement (IAA)
1. Institutional authorization agreement (IAA) is a type of agreement between two institutions with current FWAs. The IAA specifies an IRB of Record (i.e. reviewing IRB) and a relying IRB.
2. An IAA is colloquially called a “Reliance Agreement”
3. An IAA allows an institution with an IRB that holds an FWA to rely on the IRB review and approval from another institution that holds an FWA.
4. IAAs can cover one project or multiple projects as described in the agreement itself.
5. IAAs are signed by the institutional official at each institution or their designee with the delegated authority to sign such agreements.
6. IAAs are not issued for exempt level research, including FLEX exemptions. Refer to section B.4 on letters of acceptance of exemption determinations.
Individual Investigator Agreement (IIA)
1. An individual investigator agreement (IIA) is an agreement between W&M and a researcher who is not affiliated with an IRB that holds an FWA.
2. An IIA binds the unaffiliated researcher to W&M’s rules and regulations regarding human subjects research.
3. An IIA is signed by W&M’s institutional official, the W&M principal investigator (or their designee), and the individual unaffiliated researcher.
4. IIAs are required for all both exempt and non-exempt human subjects research
5. The W&M IRB can only serve as the IRB of Record when its agents (e.g., current faculty, staff, students) are engaged in the research within the defined scope of their role. IIAs are not issued for individuals external to William & Mary who wish to conduct their own research without a W&M researcher on the protocol.
Letter of Acceptance of Exemption Determination
1. A letter of acceptance of an exemption determination is a letter from the W&M IRB. The letter indicates that the W&M IRB accepts the “exemption determination” of another IRB that holds an FWA.
2. If another institution’s IRB has reviewed a study as exempt, the W&M IRB may accept this determination so that the exempt project does not undergo dual IRB review.
3. The W&M IRB will provide their researchers with this letter if the researcher provides documentation to the W&M IRB that the reviewing IRB is aware that
  1. the W&M researcher is involved in the reviewed project, and
  2. all procedures carried out by the W&M researcher have been reviewed and approved by the reviewing IRB.
4. W&M researchers must submit documentation to the W&M IRB if they wish to serve on exempt-level study that has/will be reviewed and approved by another IRB.
5. If W&M IRB review and approves an exempt study with non-W&M collaborators, the approval from W&M IRB does not cover the collaborating researchers' activities. The collaborating researchers must contact their institution's IRB prior to beginning any work on the protocol.

C. Requesting an Agreement

Requesting an Institutional Authorization Agreement (IAA)
1. An IAA can be submitted to the IRB office at the initial submission of the research protocol or during protocol review. The IAA can be reviewed concurrently with the review of the research project.
2. An IAA can also be submitted after the protocol has been approved via a protocol modification request.
3. Cooperative research cannot commence until after the IRB protocol is approved, and an IAA is signed by the institutional officials (or designees) from W&M and the relying institution(s).
4. IAAs will not be executed for exempt level research, including FLEX exempt research. In rare circumstances, this may be waived.
Requesting an Individual Investigator Agreement (IIA)
1. Requests for individual investigator agreements can be submitted to the IRB at the initial submission of the research protocol, during the review of the protocol, or after the protocol has been approved via an amendment request.
2. All research activities carried out by the individual unaffiliated investigator must be detailed in the approved IRB protocol.
3. Individual Investigators must provide proof of completion of applicable human subjects training.
4. When executing the IIA, the individual investigators agree to adhere to all W&M ethical and compliant standards including requirements detailed in the IRB protocol.

D. Protocol Review and Approval

Site context review, also known as local context review.
1. The site context review furnishes the IRB of Record with all of the necessary information about human participants' protections and compliance at individual sites which enables the IRB of Record to make appropriate determinations.
2. Site context review is completed by the relying IRB(s) and provided to the IRB of Record.
When W&M is the IRB of Record for Non-Exempt Research
1. All research procedures, instruments, interventions, and materials that participants interact with must be provided to the W&M IRB for review and approval per IRB requirements for approval.
2. All roles and responsibilities of the collaborating researchers must be detailed in the IRB protocol.
3. All site context information from the cooperating sites or from the collaborating researchers must be provided to the W&M IRB for review and approval.
4. When W&M serves as the reviewing IRB, it may review the entire research study, even if information about the entire study is not necessary to approve W&M’s part of the research.
5. Site Context Review When W&M is the Reviewing IRB for a Reliance Agreement
  1. All relying IRBs must provide the necessary information to the W&M IRB:
    1. applicable state and local laws that may apply to the research
    2. all relevant conflict of interest information that is pertinent to the research being reviewed, including disclosures and any real or perceived conflicts of interest related to the proposed research project.
    3. all ancillary reviews required for the study to take place, such as institutional biosafety committee (IBC), radiation safety, institutional animal care and use committee (IACUC), health insurance portability and accountability act (HIPAA), export control, or other applicable reviews not otherwise specified
    4. proof of applicable, successful, and current human subjects research training completion for all members of the research team
When W&M is the Relying IRB for Non-Exempt Research
1. The W&M IRB will provide the reviewing IRB with all necessary site context information or ancillary reviews.
2. The W&M researchers will ensure that the reviewing IRB has all necessary information regarding human subjects research training and relevant COI information.
3. When W&M is engaged in only part of a cooperative research project, the reviewing IRB must review and approve the part(s) of the research in which W&M is engaged.
4. Site Context Review when W&M is the Relying IRB for a Reliance Agreement
  1. W&M IRB will provide the IRB of Record with the following information:
    1. applicable information relating to Virginia’s local and state laws that may apply to the research
    2. all relevant conflict of interest information that is pertinent to the research being reviewed, including disclosures and any real or perceived conflicts of interest related to the proposed research project
    3. all ancillary reviews required for the study to take place, such as institutional biosafety committee (IBC), radiation safety, institutional animal care and use committee (IACUC), export control
    4. proof of successful and current human subjects research training completion for all members of the research team
    5. any applicable W&M regulations, policies, or unit standards that are required for the study’s commencement
    6. all reasonable requests for information by the IRB of Record with the necessary information
When W&M is engaging in cooperative Exempt Research
1. The W&M IRB may provide the W&M researchers with a letter detailing the IRB’s acceptance of another IRB’s exemption determination.
2. The W&M researchers will ensure that the reviewing IRB has all necessary information regarding human subjects training and relevant COI information.
3. All research procedures, instruments, interventions, and materials that participants interact with must be provided to the reviewing IRB, and the role of the W&M researchers must be clearly detailed.
4. W&M researchers must provide the exemption determination letter and approved protocol to the W&M IRB for the exemption acceptance letter to be generated.
5. For exempt cooperative research that includes W&M researchers and unaffiliated individual research collaborators, the W&M IRB will require the unaffiliated individual to complete an Individual Investigator Agreement detailed in B.3.

E. International Partnerships for Implementing Research

When hiring a service to assist with the implementation of the research internationally, there will likely be a contract or agreement such as a sub-award, sub-contract, service contract, MOU, between the individual or organization and W&M that details obligations such as scope of work and adherence to laws, policies, and other practices.
Institutions, hired contractors, enumerators, or volunteers do not need IRB approval through W&M and do not need an Individual Investigator Agreement (IIA) with the W&M IRB when:
1. An individual is functioning within their regular work responsibilities and their involvement in the research is limited to those work responsibilities only, without further contribution to the research, then they are generally not considered study team members.
2. The employees or agents perform commercial or other services for investigators provided that all of the following conditions also are met:
  1. the services performed do not merit professional recognition or publication privileges; and
  2. the services performed are typically performed by those personnel for non-research purposes; and
  3. the institution’s employees or agents do not administer any study intervention being tested or evaluated in the study.
3. Institutions whose employees or agents provide clinical trial-related medical services dictated by the protocol, and would typically be performed as part of routine clinical monitoring and/or follow-up of participants enrolled at a study site do not need IRB approval through W&M and do not need an Individual Investigator Agreement with the W&M IRB provided that all of the following conditions also are met:
  1. the institution’s employees or agents do not administer the study interventions being tested or evaluated under the protocol;
  2. the study-related services are typically provided by the institution;
  3. the institution’s employees or agents do not enroll participants or obtain the informed consent of any participant for participation in the research
4. Institutions whose employees or agents administer the study interventions being tested or evaluated under the protocol limited to a one-time or short-term basis do not need IRB approval through W&M and do not need an Individual Investigator Agreement with the W&M IRB provided that all of the following conditions also are met:
  1. an investigator from an institution engaged in the research determines that it would be in the participant’s best interest to receive the study interventions being tested or evaluated under the protocol;
  2. the institution’s employees or agents do not enroll participants or obtain the informed consent of any participant for participation in the research
5. Institutions do not need IRB approval through W&M and do not need an Individual Investigator Agreement with the W&M IRB when their employees or agents:
  1. inform prospective participants about the availability of the research;
  2. provide prospective participants with information about the research (which may include a copy of the relevant informed consent document and other IRB approved materials) but do not obtain participants’ consent for the research or act as representatives of the investigators;
  3. provide prospective participants with information about contacting investigators for information or enrollment; and/or
  4. seek or obtain the prospective participants’ permission for investigators to contact them.
6. International institutions that permit use of their facilities for intervention or interaction with participants by investigators from another institution.

F. Record Retention and Communication Among IRBs

When W&M is the Reviewing IRB (IRB of Record)
1. Records must be retained and maintained for a minimum of five years and a maximum amount of time as required by the study procedures and applicable retention rules.
2. Communication expectations for issues such as reportable events, renewals, amendments, personnel updates, consent posting requirements, expectations for post-approval monitoring, and how participant complaints are to be addressed must be included within the IRB application as procedures to be approved.
When W&M is the Relying IRB (not the IRB of Record)
1. Records must be retained and maintained for a minimum of five years and a maximum amount of time as required by the study procedures.
2. Communication expectations for issues such as reportable events, renewals, amendments, personnel updates, consent posting requirements, expectations for post-approval monitoring, and how participant complaints are to be addressed will be included as the reviewing institution requires

G. National Institutes of Health (NIH) Multi-Site Studies

The use of a single IRB (sIRB) is required by NIH for all domestic sites of NIH-funded studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported by grants, cooperative agreements contracts, or the NIH Intramural Research Program.
Plans for the use of an sIRB must be included in all grant applications and contract proposals that are submitted to NIH.
This does not apply to foreign sites, career development, institutional training, or fellowship awards. The policy allows for exceptions in the following instances:
1. Sites for which federal, state, or tribal laws, regulations, or policies require local IRB review.
2. Other exceptions to allow for local IRB review may be considered by NIH based on compelling justification. These other exceptions must be reviewed and approved by NIH.
3. The NIH sIRB policy allows the consideration of requests for other exceptions not based on a legal, regulatory, or policy requirement if there is a compelling justification for the exception. These other exceptions must be reviewed and approved by NIH.

H. Collaborators NOT considered engaged in human subjects research and IRB approval is not needed for their activities:

No “Individual Investigator Agreement” will be associated with individuals who are “not engaged in human subjects research.”
1. There will likely be a different contract or agreement such as a sub-award, sub-contract, service contract, MOU, between the individual or organization and W&M that details obligations such as scope of work and adherence to laws, policies, and other practices.
Institutions, hired contractors, enumerators, or volunteers are not engaged when:
1. An individual is functioning within their regular work responsibilities and their involvement in the research is limited to those work responsibilities only, without further contribution to the research, then they are generally not considered study team members.
2. The institution's employees or agents perform commercial or other services for investigators provided that all of the following conditions also are met:
  1. the services performed do not merit professional recognition or publication privileges;
  2. the services performed are typically performed by those personnel for non-research purposes; and
  3. the institution’s employees or agents do not administer any study intervention being tested or evaluated in the study.
Institutions (including private practices or individuals) that are not selected as a research site, whose employees or agents provide clinical trial-related medical services dictated by the protocol, and would typically be performed as part of routine clinical monitoring and/or follow-up of participants enrolled at a study site provided that all of the following conditions also are met:
1. the institution’s employees or agents do not administer the study interventions being tested or evaluated under the protocol;
2. the study-related services are typically provided by the institution;
3. the institution’s employees or agents do not enroll participants or obtain the informed consent of any participant for participation in the research; and
4. when appropriate, investigators from an institution engaged in the research retain responsibility for:
  1. overseeing protocol-related activities; and
  2. ensuring appropriate arrangements are made for reporting protocol-related data to investigators at an engaged institution, including the reporting of safety monitoring data and adverse events as required under the IRB-approved protocol.
Institutions (including private practices and individuals) not initially selected as a research site whose employees or agents administer the study interventions being tested or evaluated under the protocol limited to a one-time or short-term basis, provided that all of the following conditions also are met:
1. an investigator from an institution engaged in the research determines that it would be in the participant’s best interest to receive the study interventions being tested or evaluated under the protocol;
2. the institution’s employees or agents do not enroll participants or obtain the informed consent of any participant for participation in the research;
Institutions whose employees or agents:
1. inform prospective participants about the availability of the research;
2. provide prospective participants with information about the research (which may include a copy of the relevant informed consent document and other IRB approved materials) but do not obtain participants’ consent for the research or act as representatives of the investigators;
3. provide prospective participants with information about contacting investigators for information or enrollment; and/or
4. seek or obtain the prospective participants’ permission for investigators to contact them.
Institutions that permit use of their facilities for intervention or interaction with participants by investigators from another institution.
Institutions whose employees or agents release identifiable private information or identifiable biological specimens pertaining to the participants of the research.
Institutions whose employees or agents access or utilize individually identifiable private information only while visiting an institution that is engaged in the research, provided their research activities are overseen by the IRB of the institution that is engaged in the research
Institutions whose employees or agents author a paper, journal article, or presentation describing a human subjects research study.

Footnotes

*Unless the individual is hired specifically for a commercial service; When hiring a service to assist with the implementation of the research internationally, there will likely be a contract or agreement such as a sub-award, sub-contract, service contract, MOU, between the individual or organization and W&M that details obligations such as scope of work and adherence to laws, policies, and other practices (ref. Section E).

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 policy and relevant law.

V. Related Policy & Procedures

OHRP: Engagement in Research with Human Subjects
OHRP: Extending an FWA for Individual Investigators
OHRP: Institutional Engagement in Research
OHRP: Research Ethics video series: "Institutional Engagement in Research"
Reliance Agreements
Decision Chart of Engagement of Individuals

Appendix A

Examples of Contractors or Volunteers Not Engaged in Research

The following are some examples, assuming the services described would not merit professional recognition or publication privileges:

an appropriately qualified laboratory whose employees perform routine serum chemistry analyses of blood samples for investigators as a commercial service.
a transcription company whose employees transcribe research study interviews as a commercial service.
a hospital whose employees obtain blood through a blood draw or collect urine and provide such specimens to investigators as a service.
a radiology clinic whose employees perform chest x-rays and send the results to investigators as a service.
A survey firm if the above conditions are met, the firm typically performs surveys for non-research purposes, the firm is not administering any intervention, and the firm is not involved in obtaining the informed consent of human subjects for research

Requesting an Institutional Authorization Agreement (IAA)
1. An IAA can be submitted to the IRB office at the initial submission of the research protocol or during protocol review. The IAA can be reviewed concurrently with the review of the research project.
2. An IAA can also be submitted after the protocol has been approved via a protocol modification request.
3. Cooperative research cannot commence until after the IRB protocol is approved, and an IAA is signed by the institutional officials (or designees) from W&M and the relying institution(s).
4. IAAs will not be executed for exempt level research, including FLEX exempt research. In rare circumstances, this may be waived.
Requesting an Individual Investigator Agreement (IIA)
1. Requests for individual investigator agreements can be submitted to the IRB at the initial submission of the research protocol, during the review of the protocol, or after the protocol has been approved via an amendment request.
2. All research activities carried out by the individual unaffiliated investigator must be detailed in the approved IRB protocol.
3. Individual Investigators must provide proof of completion of applicable human subjects training.
4. When executing the IIA, the individual investigators agree to adhere to all W&M ethical and compliant standards including requirements detailed in the IRB protocol.