4. External IRBs, External Investigators, and Reliance Agreements

Updated May 19, 2026

Purpose

This policy describes the requirements and procedures for:

• Ceding review of human research studies conducted by UNR faculty, staff or students to external IRBs;
• Accepting UNR IRB review of human research studies involving external investigators.

Definitions

Reviewing IRB (also referred to as IRB of Record or Single IRB): An IRB that agrees to review research from participating external sites.

Relying IRB: An IRB that agrees to cede review of a study to an external IRB.

Reliance: A process to establish that a Relying IRB accepts to cede review of a study to another institution's Reviewing IRB.

IRB Authorization Agreement (IAA): A written agreement between IRBs where one IRB is acting as the IRB of Record and the other is ceding review to that IRB.

Independent Investigator Agreement (IIA): A written agreement between an IRB and an individual who is not affiliated with an institution that has an IRB, and the individual wants the IRB to serve as their IRB of Record.

SMART IRB: A platform that offers a master IRB reliance agreement and a web-based system that provides a central process for participating institutions and their investigators to request, track, and document study-specific reliance arrangements. Note that SMART IRB is not an IRB.

Overview

UNR researchers may participate in research that involves multiple organizations, also referred to as cooperative projects. IRB reliance agreements allow one IRB to review and serve as the IRB of record for human research that is occurring at multiple sites or research that involves personnel from multiple institutions and documents respective authorities, roles, responsibilities, and communication between organizations.

For any collaboration, IRB staff will evaluate the activities of the UNR faculty, staff or student to determine if those activities engage UNR in human research. In case of difficult engagement decisions, IRB staff will use the Engagement Determination Worksheet to discern the role of UNR investigators on collaborative projects. If the activities engage UNR in non-exempt human research, the researcher’s involvement in the collaboration may not begin until the UNR IRB has approved the research or, alternatively, an agreement to rely on another IRB is formalized and that IRB has granted final approval. If the activities engage UNR in exempt human research, the UNR IRB will generally allow reliance on another IRB’s determination of exemption status without initiation of a formal reliance agreement.

If a cooperative project is funded by a federal agency that complies with the Common Rule, sites are expected to utilize a Single IRB. Specifically, any institution located in the United States that is engaged in cooperative research must rely upon approval by a Single IRB for that portion of the research that is conducted in the United States. The Single IRB may be identified by the federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the federal department or agency supporting the research.

In certain cases, it may be inappropriate to utilize Single IRB. The following research is not subject to Single IRB requirements:

1. Cooperative research for which more than 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
2. 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.

If a Single IRB is utilized, only the IRB review functions will be handled centrally. Awardee organizations are responsible for ensuring authorization agreements are in place and that documentation is maintained. Related local functions (e.g., ancillary committee review, conflict of interest (COI) disclosure, other required institutional approvals) remain with the individual participating institutions. The conduct and reporting of the research remain the project team's responsibility. For federally funded cooperative projects, UNR researchers should contact the IRB office to set up a meeting prior to proposal submission to determine which IRB should serve as the Single IRB and to discuss researcher responsibilities (see below).

Reliance on External IRB (non-exempt research)

Criteria for Reliance on External IRB

Decisions about whether to rely on an external IRB or serve as the Reviewing IRB for cooperative projects will be made on a case-by-case basis considering factors such as funding, location and experience of the Principal Investigator (PI), risk level of the research, characteristics and location of the participant population(s), extent of the procedures performed at UNR, adequacy of IRB policies and procedures at the collaborating institution(s), the scope of existing agreements, and the University investigator’s role on the collaborative project. When a University investigator is the lead researcher (responsible for the overall conduct of the research), the University prefers the external investigator's institution cede review to the UNR IRB.

The UNR IRB will verify that the external IRB is qualified to review the project. The following criteria must be met:

• The institution whose IRB will serve as IRB of Record has a current Federalwide Assurance (FWA) with OHRP.
• The IRB is in good standing with OHRP (no recent warning letters, no open investigations).
• The IRB conducts its review consistent with applicable ethical standards, laws and regulations. The policies and procedures of the IRB will be reviewed to determine compliance with the regulations, as appropriate.
• The IRB has relevant expertise to review the research.
• The IRB is AAHRPP accredited (usually required for greater than minimal risk research and preferred for minimal risk research). For institutions that are not AAHRPP accredited, decisions are made on a per-protocol basis to ensure that the institution can maintain equivalent standards to AAHRPP accreditation

The UNR IRB may allow for external IRB review when:

• Federal regulations, state laws, or local policies require use of a specific IRB (e.g., the Revised Common Rule requirement for single IRB for cooperative research conducted in the United States).
• The funding entity requires use of an external IRB when UNR is a participating site in multi-site research.
• The UNR researcher is a collaborator on human research primarily conducted at another institution.

The UNR IRB may not allow for external IRB review when:

• The proposed IRB of Record does not have a robust human research program or sufficient knowledge of local context (as required by federal guidelines and AAHRPP accreditation) to assume IRB oversight for sites that fall under the University’s purview.
• The project involves prisoners or vulnerable populations that require special considerations.
• A study team member has a conflict of interest that requires a management plan, and the management plan prohibits or limits activities that the individual can engage in related to human research.
• A team member has a history of noncompliance with IRB policies or processes.
• The proposed IRB of Record or participating research sites are located outside the United States.

In certain situations, the UNR IRB may voluntarily decide to rely on an external IRB. Examples of voluntary reliance include:

• Recommending another IRB of Record if the UNR IRB lacks sufficient expertise to review the research.
• Identifying an external IRB to act as the IRB on behalf of UNR IRB if the University has determined that conducting its own review or serving as the IRB for a multi-site project is not feasible given its resources or due to legal, institutional conflict of interest, or other concerns.

The HRPP Manager is responsible for overseeing IRB reliance agreements, in consultation with the Institutional Official (IO) or designee as needed. Reliance agreements may pertain to an individual project or to a defined group of projects. For a reliance agreement to be considered valid, a fully executed IRB Authorization Agreement (IAA) must be in place.

Requesting Reliance on External IRB

Researchers are encouraged to consult with UNR IRB staff about reliance on an external IRB. The formal reliance request must be submitted in IRBNet and include at least the following documentation:

• Part I, Cover Sheet.
• Request to Use an External IRB form.
• Documentation of local committee approval from UNR ancillary committees (e.g., biosafety, radiation safety, etc.).
• Research proposal or externally approved protocol, consent form, data collection tools and recruitment materials (if available).
• Approval letter from the IRB of Record (if available).

The protocol or proposal must clearly specify each site’s role in the project. Additional documents may be requested as needed to assess the appropriateness of external IRB review.

IRB staff will perform an administrative review of the research materials. The purpose of the review is to determine potential exemption status, consider issues of local context and to make a final decision about reliance on the external IRB. Local context issues include, but are not limited to, local and state laws, institutional policies, community standards, researcher credentials, resources to ensure safety and welfare of participants (such as adequate facilities and equipment, staff training, medical or psychosocial resources), tribal review and demographics/cultural issues of the local population.

UNR will not cede oversight to an external IRB until all UNR project team members are current with regard to annual UNR COI disclosure requirements and all ancillary institutional reviews, such as biosafety, radiation safety, etc. have been completed.

When a project team member has a COI related to the research, external reliance arrangements will not be finalized until a management plan has been approved (following review by the University’s COI Committee, if warranted) and communicated by the University’s COI Designated Official. This management plan must be provided to the IRB of record. UNR reserves the right not to cede review to an external IRB when a COI management plan or other stipulations are required.

Documenting Reliance on External IRB

Researchers will be notified of the UNR IRB’s decision to rely on an external IRB via an Acknowledgment Letter issued in IRBNet. If necessary, IRB staff will communicate with the external IRB about any applicable state laws governing the research, local requirements for the informed consent document, approvals by ancillary committees and other topics related to local context. Relevant changes in local policies, laws or requirements will be communicated to the external IRB as needed.

After the UNR IRB confirms that review by an external IRB is acceptable, IRB staff will work with the PI to determine whether an existing reliance agreement applies. If the reliance is not covered by a previous agreement, IRB staff will guide the PI on either obtaining an IAA or using the SMART IRB platform to navigate the reliance process and document the agreement.

Within sixty days of the initial submission of a Request to Use an External IRB form in IRBNet, the PI should submit a follow-up package containing the approval letter from the IRB of Record (if not previously provided) along with the externally approved protocol, consent form, data collection tools and recruitment materials in their final form. The final consent form must include all University/AAHRPP-required elements of informed consent, including local contacts for research participants’ questions or compensation for injuries, where applicable. For sponsored projects, investigators should use the “Consent Form Checklist: Requirements When Using Sponsor Consent Form Templates” to review the consent form template provided by the sponsor and add any locally required information that is missing.

Post-Approval Compliance with UNR IRB Requirements

When reliance on an external IRB is approved, the external IRB becomes the IRB of Record and is responsible for initial review, reviews of amendments, continuing reviews, adverse events, and other reportable information. The reliance agreement outlines the duties and responsibilities of both the UNR IRB as a Relying IRB and the external IRB as a Reviewing IRB.

To enable the local IRB to ensure requirements for post-approval monitoring are met, University PIs conducting research reviewed by an external IRB must promptly notify the UNR IRB of:

• the IRB of Record's determinations of serious or continuing noncompliance, unanticipated problems, and suspension or termination of the IRB approval or investigator's involvement in the research;
• study closures.

Further, all University researchers conducting research reviewed by an external IRB are responsible for maintaining compliance with UNR’s training requirements, conflict of interest disclosure requirements, and any other requirements for review by UNR ancillary committees as applicable.

The University retains the right to revoke a reliance agreement at any time in order to conduct its own IRB review.

Reliance on External IRB (exempt research)

The UNR IRB does not enter into reliance agreements for human research activities that are exempt from the federal regulations, including exempt projects involving limited IRB review (exceptions may be made on a case-by-case basis). To facilitate collaboration among researchers and institutions engaged in such studies, the University will generally accept another institution’s determination that a study is exempt.

If a study determined exempt by an external institution involves UNR faculty, staff, or students, the UNR researcher must submit the following documentation in IRBNet:

• Part I, Cover Sheet.
• Exemption determination from the external institution.
• Documentation that the UNR researcher is listed as an investigator on the externally reviewed project.
• Protocol determined exempt by the external institution.

The UNR IRB reserves the right not to accept an external institution’s determination, and may require local IRB of the project in addition to the external review. Examples of circumstances that may warrant local exempt review include enrollment of UNR students or other vulnerable populations, sensitivity of the research topic, and researcher conflict of interest.

Reliance on External IRB (UNR Med students on external rotation)

Medical students on external rotation may be asked to join a non-exempt research study approved by an external IRB. The UNR IRB will accept reliance on an external IRB in the case of UNR Med students who temporarily train at an external institution under the supervision of an external PI. UNR Med students on external rotation must submit the following documentation concerning the externally approved research in IRBNet:

• Part I, Cover Sheet.
• UNR Med External Research Rotation form.
• Approval letter from the external IRB.
• Documentation that the UNR Med student on external rotation is listed as an investigator on the externally approved project.
• Externally approved consent form.
• External PI’s signature obtained electronically through IRBNet (alternatively, the UNR Med Research Director or designee may sign the submission).

UNR as Reviewing IRB (non-exempt research)

When the University IRB serves as the Reviewing IRB for external sites, the UNR PI is responsible for submitting the project to the IRB for review. The protocol must contain a detailed description of each site’s proposed activities, any information related to local context for each site and any documentation related to individual site review such as external investigators’ COI management plans and ancillary approvals from the external institutions.

IRB staff will facilitate the reliance process by providing a Cover Letter for Relying Sites that outlines the steps necessary to enter an agreement and maintain compliance with UNR’s requirements. External sites must complete the Relying Site Local Context form at the time of initial review, and periodically thereafter at preestablished intervals. The relying sites are prompted to provide the University IRB with site-specific information needed to assess the acceptability of the reliance and, if applicable, to complete the IRB review (e.g., FWA, Point of Contact/Signatory Authority, ancillary reviews, local consent language, local laws, investigator qualifications, local resources, recruitment materials, and communication plan).

The UNR IRB is responsible for initial review, reviews of amendments, continuing reviews, adverse events, and other reportable information. When research sites are added to approved projects, the UNR IRB will review those requests as amendments. Individual institutions are responsible for ensuring the project has continued compliance with the UNR IRB requirements and institutional COI requirements related to human research for their researchers. Each relying site is expected to comply with its own institution’s HIPAA policies and procedures. The IAA outlines the duties and responsibilities of both the relying institution and the reviewing institution.

External investigators who are not affiliated with an institution that has an IRB or an institution that has a Memorandum of Understanding (MOU) with the UNR IRB will be asked to sign an Independent Investigator Agreement (IIA) in lieu of an IRB Authorization Agreements (IAAs) as a condition for engaging in research overseen by the UNR IRB. Independent investigators that are external to UNR and its affiliated sites are not allowed to serve as Principal Investigator (PI) on research overseen by the UNR IRB.

The UNR IRB notifies the investigators of its review decisions consistent with any reliance agreement. The UNR IRB makes available relevant IRB records, including (but not limited to) minutes, approved protocols, consent documents, and other records that document the IRB’s determinations to the relying institution upon request. The University’s Research Integrity & Security website contains relevant IRB policies readily available to the relying organization. The UNR PI is responsible for forwarding any applicable updates to collaborators at relying institutions.

Open communication between relying sites and the University IRB is encouraged. The UNR IRB provides contact information to researchers for asking questions, expressing concerns, and conveying suggestions regarding the IRB review, anonymously if they so choose. The relying institution staff members may also reach out via phone or email using the contact information provided in the reliance agreement.

Navigating Reliance Agreements

SMART IRB Portal

SMART IRB (acronym for Streamlined, Multisite, Accelerated Resources for Trials IRB) is a reliance platform designed to harmonize and streamline the IRB review process for multisite studies. The SMART IRB master reliance agreement replaces an individual IRB Authorization Agreement (IAA). The University has signed the SMART IRB agreement affording UNR researchers the ability to propose the use of SMART IRB for their research study. SMART IRB represents UNR’s preferred reliance agreement model.

It is up to the IRB of Record to determine what method will be used to obtain reliance. The UNR IRB encourages collaborative research teams to enter into reliance via SMART IRB, although UNR can be flexible if the IRB of Record prefers a different method. UNR IRB staff will guide the local researchers on how to create a SMART account and initiate the reliance process for their collaborative study.

IRB Authorization Agreements (IAAs)

A reliance agreement, also called an IRB Authorization Agreement (IAA), is a document signed by two or more institutions engaged in human research that permits one or more institutions to cede review to another IRB. This is generally initiated and provided by the relying IRB. If the research project is NOT using SMART IRB or another partner for which the University already has an existing agreement, then a reliance agreement is needed. The UNR IRB will route the agreement to the appropriate person for signature when a request is submitted for review. Templates are available in the Forms and Templates section of IRBNet. IRB staff will assist the investigator in preparing the IAA and obtaining the requisite signatures of the two Institutional Signatories. The University templates specify responsibilities for the participating sites (including the University) that are relevant to the protection of human participants. Therefore, the University IRB prefers investigators use its templates, but may allow use of the external site's IAA or the investigator's agreement form on a case-by-case basis. IRB agreements may apply to one or more specific projects; to select aspects of a project; or to all projects conducted by a single investigator or overseen by a specific IRB. The agreement should specify the research to which it applies.

Independent Investigator Agreements (IIAs)

An Individual Investigator Agreement (IIA) is a contract whereby an institution agrees to serve as the IRB of record for an external investigator who is collaborating on a research study and is not affiliated with an institution that has its own IRB. The UNR IRB requires a signed IIA from all independent investigators listed as research team members on non-exempt research studies involving a University affiliated PI. An IIA agreement template is available in the Forms and Templates section of IRBNet. IRB staff will assist the investigator in preparing the IIA and obtaining the requisite signature from UNR’s Institutional Signatory. The template specifies the responsibilities of the independent investigator that are relevant to the protection of human participants.

NOTE: The University does not permit independent investigators to serve as PI on human research overseen by the UNR IRB.

Additional Resources

Reliance-specific forms and templates available in the IRBNet library:

• Request to Use an External IRB form
• UNR Med External Research Rotation form
• Relying Site Local Context form
• Consent Form Checklist: Requirements When Using Sponsor Consent Form Templates
• IRB Authorization Agreement (IAA): University of Nevada, Reno IRB as IRB of Record template
• IRB Authorization Agreement (IAA): External IRB as IRB of Record template
• Independent Investigator Agreement (IIA) template

SMART IRB webpage resources:

• https://smartirb.org/join/
• https://smartirb.org/resources/