ETSU researchers collaborating with personnel not affiliated with the university should consider the following information when seeking IRB approval for the proposed research. Research involving multiple collaborators and institutions may have specific considerations depending on the complexity of the research. The Human Research Protection Program (HRPP) may request a meeting to better understand roles and relationships of the institutions involved to determine the appropriate review process.

Research at Sites Outside of ETSU

There are additional considerations for ETSU researchers who conduct research at sites outside of ETSU or collaborate with researchers external to ETSU. The specific requirements will vary depending on the:

• Location of the external site;
• Engagement of the external site in the research;
• Type of regulatory infrastructure in place – namely whether the institution has a governing Institutional Review Board (IRB) or Independent Ethics Committee (IEC); and
• Source of funding for the research.

Research activities must not begin at external sites until the required approvals and agreements are complete. External researchers must not conduct activities related to the research until the required approvals and assurances are in place. The ETSU Principal Investigator bears ultimate responsibility for assuring compliance by all external investigators and sites.

• Defined Terms

  Collaborative Research: Collaborative research studies are those in which multiple institutions (academic or non-academic) are engaged in the research, usually by means of its investigators carrying out research activities at or on behalf of each engaged institution. See also cooperative research. Sometimes also called multisite research.

  Cooperative Research: This is a regulatory term; per the HHS Policy of Human Subjects (Common Rule), projects that involve more than one institution are considered cooperative research and must rely on approval by a single IRB for the research conducted in the United States. 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 requirement.

  Federalwide Assurance (FWA): Institutions that are engaged in non-exempt human subjects research must hold a FWA. Through the FWA, an institution commits to the U.S. Department of Health & Human Services (HHS) that it will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR part 46.

  IRB of Record: The IRB responsible for the ethical and regulatory review of human research on behalf of an engaged institution or independent individual investigator. Sometimes called Reviewing IRB.

  Reliance Agreement: A formal agreement that provides a mechanism for an institution engaged in research to delegate its IRB review to another IRB. Both the relying and the reviewing institutions must agree to the terms of the Reliance Agreement before collaborative research can begin. The agreement commits each institution to the terms, so institutional officials with the appropriate delegated signatory authority must sign the agreement. In the case where an external investigator is being added to a study, the Reliance Agreement must be approved before the external investigator can begin working on the research. Reliance Agreements may be executed through an IRB Authorization Agreement or SmartIRB.

  Relying institution: An institution that has agreed to cede IRB review and oversight to an external IRB for a particular study.

  Study Site: Specific non-ETSU locations where research will occur (i.e., Johnson City Schools) or other engaged institutions whose investigators are collaborating with ETSU by carrying out research procedures. Study sites should be identified in the New Protocol Submission xform for the IRB to determine engagement and any necessary site-specific approvals.

  Unaffiliated Investigator Agreement (UIA): A formal written agreement between an institution conducting research and an independent investigator who is engaged in the non-exempt human subjects research. An UIA extends an institution’s FWA to cover the non-exempt human research activities conducted by the independent investigator and commits the Investigator to federal regulations and the institution’s policies and procedures.

• Engagement Determination

  Sites are “engaged” in human subjects research if personnel from the site perform any of the following duties:

  • intervene with subjects to collect data or biospecimens about them by performing research procedures, or by manipulating the environment for research purposes;
  • conduct the informed consent process;
  • collect or create identifiable, private information about subjects; or have access to identifiable private information about research subjects.

  The IRB must have enough information to determine if the external sites are engaged in research. When completing your New Protocol Submission, ensure sufficient information is provided about each external site and the activities that will be performed there. The IRB application asks questions about each site's involvement.

Collaborative Research

Collaborative research studies are those in which multiple institutions are engaged in the research, usually by means of local investigators carrying out research activities at or on behalf of the institution.

If the study does not entail employees of external institutions collecting data from participants, obtaining informed consent, or being involved as members of the research team, then the work is probably not a collaborative study. Likewise, if study staff will be asking employees at other institutions to pass along recruitment information to prospective participants this, alone, does not constitute a collaborative study.

For collaborations that involve both ETSU investigators and external investigators, different approaches may be used to obtain approval depending on how the research will be conducted and type of study. Either each investigator can independently obtain approval from their respective IRBs or one institution can agree to be the reviewing IRB.

• Collaborations for Exempt Research

  ETSU is unable to execute reliance agreements for research deemed Exempt (unless required by the sponsor). Each institution engaged in the Exempt project will be responsible for reviews of their investigators. Each investigator should contact their institution’s IRB and seek an exemption per their institution’s policies.
• Collaborations for Non-Exempt Research (Expedited or Full Board)

  If a Non-Exempt project involves researchers from multiple institutions, all parties involved must determine in advance how IRB review will be handled—and by which institution(s). Responsibility for project review and approval typically falls to the IRB at the institution of the lead principal investigator (PI) or primary awardee for sponsored projects. The responsible board is known as the “IRB of record.”

  ♦ For unfunded research, there is flexibility about the IRB review. Either each investigator can independently obtain IRB approval from their institution’s IRB or one institution can agree to be the IRB of record for all sites (or some combination thereof). The investigators should communicate with their IRB offices to determine how the IRB review will be handled in advance. There is no requirement for an institution to agree to serve as the IRB of record for other institutions, and some institutions have limitations for when it when take on this role.

  ♦ When federally funded research studies engage multiple institutions, there must be a single IRB of record for the entire project, unless the federal agency grants an exception to this requirement. A Reliance Agreement is needed to assign responsibility for review of research and must be negotiated between the single IRB and each relying site. Federally funded research must comply with the Federalwide Assurance (FWA) for the Protection of Human Subjects of the awardee, and the researchers at each site must follow the single IRB’s policies and procedures to conduct the research. Relying sites may also require compliance with their FWA and policies for their local investigators. This means that each relying site and the single IRB must communicate about their FWA and IRB policies to draft an agreement that complies with all applicable institutional and regulatory requirements.

• Non-Collaborative, External Research

  When ETSU researchers visit sites or utilize a site's resources to conduct research, but the external sites are not engaged in the research, the project is not collaborative research. The ETSU Principal Investigator must assure that the site’s policies, procedures, or other rules are followed. The New Protocol Submission xform will ask each site to be identified and will request a Letter of Support from the external site to document their agreement to the research taking place. The letter should be signed by the appropriate authorizing official for the site.

  We do not have a template nor any requirements for the content of the Letter of Support, but the IRB expects the letter to contain sufficient information to appropriately document support for the research procedures. For example, if the site needs to agree to allow use of a particular space (i.e., a private clinic room) or a specific population (i.e., a fourth-grade class), the letter should specify such support.

  
  
  

Adding Collaborating External Investigators

Generally, ETSU does not want external investigators to be added to the study staff submission in IRBManager. The ETSU IRB does not assume responsibility for the compliance of external personnel who are affiliated with an external institution. Instead external personnel should contact their institution and follow their institution’s policies for training, credentialing, conflict of interest disclosure and other applicable compliance requirements.

• If the external investigator’s home institution has a FWA and there is going to be a reliance agreement in place for ETSU to be the IRB of record, only the external site’s lead investigator should be added as study staff to the ETSU project. ETSU will assure that the external collaborating lead investigator is copied on all IRB determinations for the duration of the reliance agreement.
• If the external investigator’s home institution or employer does not have an FWA, the site may need to obtain a FWA if researchers want ETSU to serve as the IRB of Record.
• If the external investigator is engaged in the research and are not performing the activities in connection with an employer or institution, please contact the IRB office to determine if ETSU is willing to serve as the IRB of record and execute an Unaffiliated Investigator Agreement (UIA). An executed UIA is required to be submitted with the request to add investigators that qualify for the agreement; only the IRB office can determine if this is appropriate.
• If the external investigator is from the Mountain Home VAMC, they can be added to the ETSU IRB project just like ETSU study staff. The ETSU Medical IRB is the IRB of record for the Mountain Home VAMC. VA researchers must comply with VA research requirements, including completing the VA required training and conflict of interest disclosures, which are verified by the VA R&D office prior to IRB approval.
• If the external investigator is an employee of Ballad Health, the ETSU IRB has an agreement to notify the Ballad IRB of any collaborative research proposals. Ballad Health researchers are required to complete Ballad Health training, credentialing, conflict of interest disclosure and other applicable compliance requirements. Ballad Health researcher may be required to obtain Ballad IRB approval separate from ETSU IRB approval, subject to the discretion of the Ballad IRB.

Learn more about seeking IRB approval for Collaborative Research.