Collaborative Research

• Multiple domestic institutions
• Schools or school districts
• Healthcare organizations
• Community-based participatory research
• Tribal communities or sovereign Tribal Nations
• Federal sponsors requiring the use of a Single IRB (sIRB)

• Recruiting or interacting with research participants
• Obtaining informed consent
• Collecting, accessing, or analyzing identifiable private information or identifiable biospecimens
• Providing research facilities or study locations
• Serving as a performance site for study procedures
• Conducting research activities under the direction of the study team
• Receiving or sharing research data
• Serving as a collaborating institution under a grant or contract

SMU researchers are responsible for obtaining organizational permission to confirm that the external organization or site is aware of and supports the proposed research activities. This type of documentation must be attached to your Cayuse IRB application.

Examples of acceptable documentation include:

• A Site Authorization Letter signed by an authorized representative (e.g., superintendent, principal, clinic director, department head, or agency administrator)
• Approval from the site's ethics committee or research review committee
• Other written documentation granting permission to conduct the research

Many school districts may have their own research review processes, application requirements, timelines, and restrictions regarding recruitment, data collection, and access to educational records.

1. What documentation is required?

Before final IRB approval can be issued, investigators must submit written documentation to confirm that the appropriate school official has authorized the research. Depending on the institution, this documentation may include:

• A letter of permission or support from the school principal or authorized administrator.
• Approval from the school district's research review committee or research office.
• Documentation from a charter school, private school, or other educational organization authorizing the research.
• Other site-specific approvals required by the participating educational institution.

The documentation should identify the study and clearly indicate that the school or district authorizes the research to be conducted at its site.

     2. Conditional IRB Approval for Research Conducted in Schools

Research conducted in K–12 schools, school districts, or other educational institutions often requires approval from both the SMU Institutional Review Board (IRB) and the participating school or school district. Because schools maintain authority over research conducted within their facilities or involving their students, staff, or educational records, investigators must obtain the appropriate permissions before research activities may begin.

If a school or school district requires IRB approval before granting their organizational approval, the SMU IRB may issue a Conditional Approval stating the IRB has completed its review and determined that the research meets the criteria for approval under applicable regulations; however, the investigator has not yet obtained the required written authorization from the participating school, school district, or educational organization.

 Conditional Approval indicates:

• The IRB’s review of the study is complete, pending receipt of the required school authorization.
• The investigator may not begin any human subjects research activities, including recruitment, informed consent, data collection, or access to identifiable school records, until the required documentation has been submitted to and acknowledged by the IRB.
• The IRB will issue a final approval notice once all required school permission or letters of cooperation have been received and verified.

    3. What activities are permitted under Conditional Approval?

Conditional Approval does not constitute IRB approval and does not authorize investigators to begin human subjects research.

Until final IRB approval is issued, investigators may not:

• Recruit participants.
• Obtain informed consent or assent.
• Access identifiable student records for research purposes.
• Collect data.
• Conduct interviews, surveys, observations, or interventions.
• Begin any other human subjects research activities.

 

   4. When will final IRB Approval be issued?

Once approval from the school or school district has been obtained, the SMU investigator must post their approval documentation in Cayuse for IRB review.

When a conditional approval is issued by the SMU IRB, the project status in Cayuse is changed to “In-Draft – Submission is with researchers” which allows the investigator to attach the approval documentation to their research project and certify their submission is complete. The IRB will automatically receive a notification that the project is complete and will conduct its final review. Research activities may begin only after investigators have received the final IRB approval and all other institutional or sponsor requirements have been satisfied.

Investigators are encouraged to begin obtaining school or district approvals as early as possible, as these approvals often require additional review time and may delay the start of the research if not obtained before IRB review is complete.

In some collaborative research projects, Southern Methodist University (SMU) may serve as the Reviewing IRB, also known as the IRB of Record, for one or more participating institutions. When SMU serves as the Reviewing IRB, it assumes primary responsibility for the ethical review and ongoing oversight of the human subjects research on behalf of the relying institution(s) under a formal reliance agreement.

Serving as the Reviewing IRB helps streamline the review process, reduce duplicative IRB reviews, and promote consistent protections for research participants across collaborating sites.

In order to formalize this arrangement, SMU must execute a reliance agreement with the participating institutions.

Reliance Agreements

Before SMU can serve as the Reviewing IRB, a formal reliance agreement must be established between SMU and each participating institution(s). The reliance agreement outlines the responsibilities of the Reviewing IRB, the relying institution, the investigators and defines how regulatory oversight will be managed throughout the study.

Before a reliance agreement process is initiated, the SMU investigator must confirm with each investigator at the participating institution/research site that they agree to rely on SMU IRB as the IRB of Record. This is often the source of delay if not considered in advance.

How to Initiate a Reliance Agreement

1. The SMU investigator submits a new IRB application through Cayuse and describes all SMU activities, but external sites or external investigators are NOT listed in the Cayuse application.
2. The SMU IRB reviews application and study-related materials. Only research projects reviewed under an expedited category or by the full committee are eligible to initiate reliance agreements.
3. The SMU IRB issues an approval letter for SMU activities only. External sites are excluded from this review approval.
4. External investigators seeking to have SMU serve as the Reviewing IRB (IRB of Record) should contact their home IRB as early as possible during study development to address any site-specific requirements.
5. The SMU investigator should submit a Modification through Cayuse listing all participating sites, external research personnel and the research responsibilities that will occur at each of the external sites. All fully-executed reliance agreements should be posted in the Cayuse application under the Attachments section. Refer to the Reliance Process Flowchart (SMU as IRB of Record) for additional information.

Reliance agreements are generally used for collaborative Full Board, Expedited, and Limited IRB review categories.

Note: For Exempt research, SMU will not serve as the Reviewing IRB for participating institutions. If a study receives an exemption determination from the SMU IRB, external collaborators should work with their own institution to determine any institution-specific requirements for their role in the research. Typically, each institution will conduct its own review and issue an independent exemption determination, if required, under its policies.

For some collaborative research projects, Southern Methodist University (SMU) may rely on the review and oversight of another institution's Institutional Review Board (IRB). In these arrangements, the external IRB serves as the Reviewing IRB (or IRB of Record), while SMU serves as a relying institution under a formal reliance agreement.

In this single IRB (sIRB) arrangement, another institution’s IRB serves as the Reviewing IRB and SMU agrees to rely on that institution's IRB review.

How to Request a Reliance Agreement if SMU relies on another institution’s IRB review:

• The SMU Principal Investigator (PI) should submit a reliance request via a new study application in Cayuse and provide:
• The Reviewing IRB's approval letter
• The Reviewing IRB’s approved protocol
• Any consent forms, recruitment materials, or other study documents that will be used by SMU researchers
• Reliance documents or other forms provided by the Reviewing IRB, if applicable

Research Integrity & Compliance (RIC) will review the request and coordinate with the Reviewing IRB to establish the appropriate reliance arrangement. Reliance agreements are generally executed for Full Board, Expedited, and Limited IRB review categories.

Note: For collaborative Exempt research, reliance agreements are not required. If a participating institution has issued an exemption determination, SMU researchers should submit a new study application in Cayuse for review.

In some collaborations, each participating institution obtains approval from its own IRB, rather than relying on one institution's IRB review, if it is allowed by the sponsor.

This approach is often used when:

• The research qualifies for Exempt review
• The institutions have distinct research activities
• Reliance is not feasible or practical

When each institution conducts its own IRB review, researchers must comply with the requirements of their home institution and obtain all necessary approvals before beginning human subjects research activities.

Note: NIH-funded collaborative research require the use of a Single IRB (sIRB).

A reliance agreement is an arrangement that allows one institution's IRB to rely on the review and oversight of another institution's IRB for a specific study. The IRB conducting the review is referred to as the Reviewing IRB (or IRB of Record), while the participating institution is referred to as the Relying Institution.

Reliance agreements help avoid duplicative IRB review and regulatory oversight.

A reliance agreement may be required when:

• SMU investigators are collaborating with researchers at another institution that is engaged in the same human subjects research.
• Researchers from multiple institutions will obtain informed consent, recruit participants, conduct study procedures, interact or intervene with participants, or access identifiable private information or identifiable biospecimens for research purposes.
• A federal sponsor requires the use of a Single IRB (sIRB) for a multi-site study.
• SMU investigators will rely on another institution's IRB to review and oversee the research.
• Another institution requests that SMU serve as the Reviewing IRB for the study.

Not all collaborative projects require a reliance agreement. The need for an agreement depends on the roles and responsibilities of each collaborating institution and whether each institution is considered to be engaged in human subjects research under applicable federal regulations.

A reliance agreement is generally not required when:

• Collaborators are providing only consultation or technical expertise and are not engaged in the human subjects research.
• An outside individual is performing services under a contract (e.g., laboratory testing or data analysis) without interacting with participants or receiving identifiable private information beyond what is necessary to perform the service.
• An institution is providing a letter of support for access to facilities, or obtaining permission to recruit participants but is not otherwise engaged in the research.
• Collaborators receive only de-identified data or specimens and are not conducting human subjects research as defined by federal regulations.

The IRB will determine whether a reliance agreement is appropriate based on the specific circumstances of each study.

A Single IRB (sIRB) is an arrangement in which one Institutional Review Board (IRB) serves as the IRB of Record (Reviewing IRB) for all participating sites involved in a multi-site human subjects research study. Rather than each institution conducting its own independent IRB review, the participating institutions rely on the reviewing IRB through an IRB Reliance Agreement (also called an IRB Authorization Agreement (IAA)).

Single IRB review is generally required when:

• A federally funded cooperative or multi-site study involves one or more domestic institutions engaged in the same non-exempt human subjects research.
• The sponsoring federal agency requires the use of a Single IRB as a condition of funding.
• The study involves multiple domestic research sites conducting the same research protocol under a common research plan.

Federal agencies that may require Single IRB review include the National Institutes of Health (NIH), the U.S. Department of Health and Human Services (HHS), and other federal sponsors that have adopted Single IRB requirements.

Single IRB review is generally not required when:

• Only one institution is engaged in the human subjects research.
• The collaborating organizations are not considered engaged in human subjects research under federal regulations.
• The research qualifies for an exception permitted by the sponsoring agency or federal regulations.
• The research is exempt from IRB review.
• The study is conducted entirely outside the United States and is not subject to the federal Single IRB requirement.

Depending on the study, SMU may serve as either:

• The Reviewing IRB (IRB of Record): SMU provides ethical review and continuing oversight for all participating sites covered under the reliance agreement.
• A Relying Institution: SMU relies on another institution's IRB to conduct the ethical review while SMU maintains responsibility for its institutional oversight obligations, including investigator qualifications, conflict of interest management, training, and other local requirements.

The determination of whether SMU will serve as the Reviewing IRB or rely on another institution's IRB is made on a study-by-study basis and depends on sponsor requirements, the capabilities of the participating institutions, and the willingness of each institution to enter into a reliance agreement.

Investigators planning collaborative research should:

• Notify the SMU IRB early in the study planning process.
• Identify all collaborating institutions and their roles in the Cayuse Human Ethics application
• Indicate whether a sponsor requires a Single IRB (sIRB) Review.
• If SMU is the IRB of Record, obtain all required institutional approvals and site-specific documents before collaborative research begins.
• If an external IRB is the IRB of Record for the collaborative project, obtain the required IRB approval and site-specific documents before initiating any research.

Execution of a reliance agreement may take several weeks and require review by the participating institutions. Investigators should allow sufficient time for this process before the anticipated study start date.

If you are unsure whether your collaborative research requires a reliance agreement or Single IRB review, contact Research Integrity & Compliance (RIC) early in the planning process. RIC help investigators to determine the appropriate review pathway, whether a reliance agreement is appropriate, and coordinate the institutional review process with collaborating organizations. Early consultation can help avoid delays in study approval and ensure the appropriate review pathway is identified.

• Go to the Basic Information section and select ‘Yes’ to External Collaborations. Be sure to select External Individual Investigators as the Type of External Collaboration
• Upload the completed IIA and documentation of required Human Subjects Research training.
• Ensure the IIA is signed by both the individual investigator and the SMU Principal Investigator (PI).

Note: If the individual is acting on behalf of an institution or organization that maintains its own IRB, an IIA is not appropriate. Instead, the individual should conduct research under their institution's oversight and an IRB reliance arrangement may be required.

External organizations or sites may be considered “engaged” in human subjects research if their employees or agents obtain informed consent, interact with participants for research purposes (i.e., conduct interviews), or access identifiable private information. If an external site is engaged in a SMU IRB-approved research project, additional IRB review, agreements, or institutional approvals may be required. Each of the external personnel will also be required to complete the mandatory Human Subjects Protection training.

Contact Research Integrity & Compliance (RIC) at researchcompliance@smu.edu to discuss the activities that will be conducted by the employees or agents of the external organizations or sites and how the training requirements can be completed by a community partner through the CITI Program.

A reliance agreement may be needed when researchers from multiple institutions are engaged in the same human subjects research study, and one institution's IRB will serve as the Reviewing IRB (IRB of Record) for all participating sites.

Collaborators are not considered “engaged in research” if they do not interact with subjects or the identified data, analyze deidentified data only, or assist with recruitment only. For more information, see the OHRP Guidance on Engagement of Institutions in Human Subjects Research.

Contact Research Integrity & Compliance (RIC) at researchcompliance@smu.edu to discuss the proposed collaboration and determine the most appropriate review arrangement.

If you believe a reliance agreement may be appropriate for your study, contact Research Integrity & Compliance (RIC) to discuss the proposed collaboration and determine the most appropriate review arrangement.

If a reliance agreement is needed, indicate within your Cayuse submission whether:

• SMU will serve as the Reviewing IRB (IRB of Record), or
• SMU will rely on another institution's IRB

RIC will work directly with the participating institution(s) to establish and execute the appropriate agreement.

SMART IRB is not an IRB. Rather, it is a master reliance agreement with an accompanying online reliance platform and resources that together offer a roadmap for single IRB (sIRB) review.

It is up to the Reviewing IRB (IRB of Record) to determine the method used to document reliance. SMU's preference is to establish reliance through SMART IRB; however, SMU can be flexible if the Reviewing IRB prefers a different method.

Once a reliance request is submitted by the PI through Cayuse Human Ethics, Research Integrity & Compliance (RIC) will help facilitate and coordinate the reliance process with the participating institutions. See the above External Domestic Collaborators (Multi-Site Collaborations) section for more information.

Use of the SMART agreement is documented in one of two ways:

1. SMART online reliance platform – An electronic process that documents the reliance arrangement and results in a reliance determination being issued to the participating institutions.
2. SMART Letter of Authorization – A standalone document used to document reliance when appropriate, outlining institution-specific responsibilities and reliance terms agreed upon by the participating parties.

It depends.

If the other institution is collecting data specifically for your project, that institution is generally considered “engaged” in the research and IRB oversight is required for their role on the project (either by their home IRB or by the SMU IRB).

If the institution is only providing access to data that has already been collected, IRB review may not be required for that institution's role. In these cases, a Data Sharing Agreement (DSA) may be needed instead. Researchers should consult with RIC for additional guidance.

Reliance agreements are generally not used for Exempt research. Instead, the review process depends on the role of the collaborating institution(s).

• Collaborators who only assist with study design, analyze de-identified data, or do not interact with participants or identifiable data may not require IRB review.
• If collaborators are engaged in human subjects research activities, such as recruiting participants, obtaining consent, or collecting identifiable data, each institution will need to obtain its own exemption determination for activities conducted at its site.

Researchers should consult with their home IRB office to determine the requirements applicable to their role in the project.

A study team needs to document IRB oversight of an external collaboration when:

1. The project involves IRB-regulated research (i.e., the project is reviewed by the Full Board or Expedited review process), and
2. The external collaborator is engaged in the conduct of human subjects research (e.g., obtaining informed consent from subjects, interacting or intervening with subjects as part of the research, or obtaining or analyzing personally identifiable subject data).

Even when SMU relies on another institution's IRB, the SMU PI and researchers are still responsible for complying with all applicable SMU requirements.

This may include:

• Financial Conflict of Interest (FCOI) disclosures
• Export Control requirements
• Environmental Health & Safety reviews
• Institutional Biosafety Committee (IBC) review, when applicable

Several types of agreements may be used depending on the collaboration:

• IRB Authorization Agreement (IAA): An IAA is a reliance agreement between SMU and another institution that holds a Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS). Any institution (e.g., university, NGOs, community organization, survey research organization) receiving funds from the HHS must have an FWA. This agreement type is used to establish the IRB of Record (whether that’s SMU or the other institution). The IAA is signed by the authorized officials at each institution.
• Individual Investigator Agreement (IIA): An Individual Investigator Agreement (IIA) is an agreement between SMU and an individual collaborator who is not affiliated with an FWA institution (e.g., former student working after graduation with their faculty mentor, professional in the community with specific expertise, community partners). This agreement type outlines the responsibilities of the individual investigator for the protection of human subjects. The IIA is signed by the Individual investigator and SMU Principal Investigator (PI)
• Collaborating Institution Agreement (CIA): The Collaborating Institution Agreement (CIA) is an agreement between SMU and an institution/organization that does not have an FWA. This agreement type is typically used for non-federally sponsored research projects involving multiple collaborators who are affiliated with the organization (e.g., research assistants affiliated with a non-profit agency, teachers offering educational interventions in a public school). It outlines the responsibilities of the collaborating institution for the protection of human subjects. A CIA is signed by a representative who has the authority to make commitments on behalf of the organization and by the SMU designated official.

Reliance agreements are established on a case-by-case basis. Generally, SMU does not enter into reliance agreements for:

• Exempt research (unless determined to require Limited review under applicable exemption categories)
• International research
• Development-only or Just-in-Time applications that lack definite plans for the involvement of human subjects at the time of research proposal submission
• Projects in which SMU researchers are not considered “engaged” in human subjects research (e.g. SMU researchers do not interact or intervene with human subjects, do not perform the informed consent process, do not obtain personally identifiable data or biospecimens, or are not considered engaged by funding regulations.)