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Reliance Agreements

A reliance agreement is a formal, written document that provides a mechanism for an institution engaged in human subjects research to delegate IRB review to an independent IRB or an IRB of another institution. These agreements may be referred to as a Reliance Agreement, IRB Authorization Agreement (IAA), Cooperative Agreement, or Memorandum of Understanding (MOU). Agreements may cover single studies, categories of studies, or all human subjects research under an organization’s Federalwide Assurance (FWA). Under these agreements, one IRB is the reviewing IRB (or IRB of record) and the other is the relying (or ceding) IRB.

The UTHSC IRB maintains a number of Reliance Agreements. When the UTHSC IRB is the reviewing IRB, the researcher will need to complete an application for review (and approval) via iMedRIS. When the UTHC IRB is the relying IRB, the researcher will need to complete a short registration form in iMedRIS so that the UTHSC IRB can maintain its responsibilities under the appropriate agreement. To learn more about these agreements and the procedures to follow, click the information below or view the UTHSC IRB SOP for Cooperative Agreements.

Agreements with the 3 UTHSC-Affiliated Institutions

The UTHSC IRB maintains reliance agreements with the following University-affiliated institutions:

  • Le Bonheur Children’s Hospital;
  • Methodist Healthcare – Memphis Hospitals; and
  • Regional One Health

Under these agreements, the UTHSC IRB is the reviewing IRB (or the IRB of record). The UTHSC IRB has full responsibility for the protection of human subjects including the initial review, continuing review, and oversight regarding amendments and safety reports. Applications for IRB review should be submitted to the UTHSC IRB via iMedRIS. However, you will also need to obtain separate institutional approval to conduct research in these institutions. Click here to access the contact information and requirements for each institution.

St. Jude Children’s Research Hospital

Under this agreement, the reviewing IRB is where the preponderance of the research is conducted. Please call the IRB if you are not sure where the preponderance of the research will be considered to be conducted.

  • When the preponderance or all of the research is conducted at UTHSC or one of his affiliated institutions (e.g., Le Bonheur Children’s Hospital, Methodist Healthcare – Memphis Hospitals, or Regional One Health), UTHSC is the reviewing IRB. Submit an application for review and approval to the UTHSC IRB via iMedRIS. Once the study is approved, the UTHSC IRB will forward a copy of the approved study documents to the St. Jude IRB.
  • When the preponderance or all of the research is conducted at St. Jude Children’s Research Hospital, St. Jude is the reviewing IRB. Submit an application for review and approval to the St. Jude IRB. Once the study is approved, the St. Jude IRB will forward a copy of the approved study documents to the UTHSC IRB and the UTHSC IRB will issue an acknowledgement via iMedRIS.
University of Memphis
Under this agreement, the UTHSC IRB is the reviewing IRB. The UTHSC IRB has full responsibility for the protection of human subjects including the initial review, continuing review, and oversight regarding amendments and safety reports. Applications should be submitted for review to the UTHSC IRB via iMedRIS. Once the study is approved, the UTHSC IRB will forward a copy of all approved study documents to the investigator and the University of Memphis IRB. The University of Memphis will acknowledge receipt of the reviews conducted by the UTHSC IRB.
Department of Defense (DoD)

Research involving the DoD occurs when any of the following are applicable:

  • The research is funded by a component of the DoD (e.g., Army, Navy, or Air Force)
  • The research involves cooperation, collaboration, or another type of agreement with a component of the DoD
  • The research uses property, facilities, or assets of a component of the DoD
  • The subject population will intentionally include personnel (military or civilian) from a component of the DoD

The UTHSC IRB maintains several agreements with the DoD in which the DoD is the reviewing IRB and the UTHSC IRB is the relying IRB. Contact the IRB to verify whether an agreement has already been executed with a component of the DoD or whether one needs to be established. Once an agreement has been executed, you will register the study in iMedRIS. To register a DoD-approved study, you will start a new application and in Section (418), you will select “I am submitting my research in accord with an IRB Authorization Agreement where another IRB has already approved it.” In addition, you will upload copies of the approved study documents and the executed reliance agreement. The UTHSC IRB will acknowledge receipt of this registration via iMedRIS. As the DoD is the reviewing IRB, the DoD will establish the IRB approval period and expiration date.

When the DoD issues approval for revisions, continuations, study closure, etc. for the study under an agreement, these approvals should be submitted to the UTHSC IRB via the “Documents from Reviewing IRB” form. The UTHSC IRB will acknowledge receipt of the approved DoD documents via iMedRIS.

National Cancer Institute (NCI) Central IRB

Under this agreement, the NCI CIRB is the sole IRB of record (i.e., the reviewing IRB) responsible for review of cooperative group oncology studies performed at participating institutions. However, the UTHSC IRB (the relying IRB) maintains the following responsibilities for local oversight of performance of CIRB-approved studies:

  • Ensuring the safe and appropriate performance of the research;
  • Ensuring initial and ongoing qualifications of investigators and research staff;
  • Overseeing conduct of the research;
  • Monitoring protocol compliance; and
  • Maintaining compliance with state, local, and institutional requirements.

You will need to register these studies with the UTHSC IRB via iMedRIS. To register a CIRB-approved study, you will start a new application and in Section (418), you will select “I am registering a research study that was approved by the NCI CIRB.” The registration form provides the project information necessary for related local review responsibilities such as conflict of interest, radiation safety, human subjects protection training, etc. In addition, you will upload copies of the study protocol, CIRB approval letter, most recent CIRB approval for continuation (if applicable), CIRB approval of the study-specific worksheets, and the CIRB-approved consent form that includes the approved UTHSC boilerplate language. As the NCI CIRB is the reviewing IRB, the NCI CIRB will establish the IRB approval period and expiration date.

The UTHSC IRB will acknowledge receipt of this registration via iMedRIS.

When the NCI CIRB issues approval for revisions, continuations, study closure, etc. for the study under the agreement, these approvals should be submitted to the UTHSC IRB via the “Documents from Reviewing IRB” form. The UTHSC IRB will acknowledge receipt of the approved NCI CIRB documents via iMedRIS.

National Institutes of Health (NIH)

Beginning January 25, 2018, all NIH-funded multi-site studies involving non-exempt human subjects research will be required to utilize a single IRB-of-Record (sIRB) for the review of human subject research. This policy is in effect for NIH grant applications (new, renewal, revision, resubmission) received on or after January 25, 2018 and for NIH contract solicitations issued on or after January 25, 2018. The NIH policy (link is external) applies to:

  • NIH-sponsored multi-site studies, where the same protocol is used at multiple sites; and
  • Domestic research only.

Only the IRB review functions will be handled centrally. Related local functions (e.g., ancillary committee review, training fulfillment verification) remain with the individual participating institutions. The conduct and reporting of the research remain the study team's responsibility.

When ceding to an external IRB (the reviewing IRB), whether commercial or other institutional partner, the researchers should register the study with the UTHSC IRB (the relying IRB) via iMedRIS. To register a sIRB-approved study, you will start a new application and in Section (418), you will select “I am submitting my research in accord with an IRB Authorization Agreement where another IRB has already approved it.” The registration form provides the project information necessary for related local review responsibilities such as conflict of interest, radiation safety, human subjects protection training, etc. In addition, you will upload copies of the approved study documents and the executed reliance agreement. The UTHSC IRB will acknowledge receipt of this registration via iMedRIS. As the sIRB is the reviewing IRB, the sIRB will establish the IRB approval period and expiration date.

When the sIRB issues approval for revisions, continuations, study closure, etc. for the study under an agreement, these approvals should be submitted to the UTHSC IRB via the “Documents from Reviewing IRB” form. The UTHSC IRB will acknowledge receipt of the approved sIRB documents via iMedRIS.

Be aware that there may be an IRB review fee associated with the project. Contact the external IRB to determine the IRB review fees for incorporation into the proposal budget. Commercial IRBs post their rates on their websites. Some academic IRBs may also charge a fee. The UTHSC IRB does not charge a review fee for research that is solely federally-funded.

Resources for NIH Policy on use of a Single IRB:

Advarra, Inc. (formerly Schulman Associates IRB, Inc.)

Under this agreement, Advarra is the reviewing IRB for all human subjects research studies conducted through the Therapeutic Diagnostic Network Coordinating Center (TDNCC) at Le Bonheur Children’s Hospital, and UTHSC is the relying IRB. However, the UTHSC IRB maintains the following responsibilities for local oversight of performance of these approved studies:

  • Ensuring the safe and appropriate performance of the research;
  • Ensuring initial and ongoing qualifications of investigators and research staff;
  • Overseeing conduct of the research;
  • Monitoring protocol compliance; and
  • Maintaining compliance with state, local, and institutional requirements.

You will need to register these studies with the UTHSC IRB via iMedRIS. To register a TDNCC study that will be conducted at Le Bonheur Children’s Hospital, you will start a new application and in Section (418), you will select “I am submitting my research in accord with an IRB Authorization Agreement where another IRB has already approved it.” In addition, you will upload copies of the approved study documents and the executed reliance agreement. As the Advarra is the reviewing IRB, Advarra will establish the IRB approval period and expiration date.

The UTHSC IRB will acknowledge receipt of this registration via iMedRIS.

When Advarra issues approval for revisions, continuations, study closure, etc. for the study under the agreement, these approvals should be submitted to the UTHSC IRB via the “Documents from Reviewing IRB” form. The UTHSC IRB will acknowledge receipt of the approved TrialNet documents via iMedRIS.

Be aware that there may be IRB review fees associated with these projects. Contact Advarra to determine the IRB review fees for incorporation into the proposal budget. Further, the UTHSC IRB fee schedule for the administrative review of external IRB submissions (for industry-sponsored research) is located on the UTHSC IRB fees webpage.

 OneIRB

Under this agreement, the University of Miami Institutional Review Board (IRB) is the reviewing IRB for all TrialNet studies conducted at UTHSC or one of its affiliated institutions, and UTHSC is the relying institution. However, the UTHSC IRB maintains the following responsibilities for local oversight of performance of these approved studies: 

  • Conduct a review of the protocol for local context issues;
  • Ensure investigators are aware of their responsibilities such as complying with determinations of reviewing IRB, disclosing conflict of interest, obtaining IRB approval before implementing changes, reporting unanticipated problems, etc.
  • Ensuring initial and ongoing qualifications of investigators and research staff;
  • Ensure researchers comply with OneIRB’s SOPs;
  • Overseeing conduct of the research; and
  • Investigate all research subject complaints.

You will need to register these studies with the UTHSC IRB via iMedRIS. To register a TrialNet study approved by the University of Miami, you will start a new application and in Section (418), you will select “I am submitting my research in accord with an IRB Authorization Agreement where another IRB has already approved it.” In addition, you will upload copies of the approved study documents and the executed reliance agreement. As the University Miami is the reviewing IRB, the University of Miami will establish the IRB approval period and expiration date.

The UTHSC IRB will acknowledge receipt of this registration via iMedRIS.

When the University of Miami issues approval for revisions, continuations, study closure, etc. for the study under the agreement, these approvals should be submitted to the UTHSC IRB via the “Documents from Reviewing IRB” form. The UTHSC IRB will acknowledge receipt of the approved TrialNet documents via iMedRIS.

Any Other Institution’s IRB

Another institution will provide IRB review:
These agreements are typically used when UT faculty, staff, fellows, residents, or students conduct research with another institution that is not affiliated with UTHSC, and the majority of the research will NOT occur at UTHSC or at a UTHSC-affiliated institution (e.g., Le Bonheur Children’s Hospital, Methodist Healthcare – Memphis Hospitals, or Regional One Health). Researchers should secure approval according to the appropriate institution’s IRB policy. However, you must also register these studies with the UTHSC IRB via iMedRIS. To register a study, you will start a new application and in Section (418), you will select “I am submitting my research in accord with an IRB Authorization Agreement where another IRB has already approved it.” In addition, you will upload copies of the approved study documents and a signed reliance agreement. The reviewing IRB will establish the IRB approval period and expiration date. The UTHSC IRB will acknowledge receipt of this registration via iMedRIS.

When the reviewing IRB issues approval for revisions, continuations, study closure, etc. for the study under an agreement, these approvals should be submitted to the UTHSC IRB via the “Documents from Reviewing IRB” form. The UTHSC IRB will acknowledge receipt of the approved study documents via iMedRIS.

To execute a reliance agreement, follow the IRB Agreement- Instructions for Use and either use the IRB Authorization Agreement template or you may use the template provided by the other institution. 

UTHSC IRB will be the Reviewing IRB:
These agreements are typically used when UT faculty, staff, fellows, residents, or students conduct research with another institution that is not affiliated with UTHSC, and the majority of the research WILL take place at UTHSC or one of its affiliated institutions (e.g., Le Bonheur Children’s Hospital, Methodist Healthcare – Memphis Hospitals, or Regional One Health). Submit an application for review (that includes a signed IRB reliance agreement) to the UTHSC IRB via iMedRIS. Once the UTHSC IRB approves the study, an approval letter will be issued via iMedRIS.

Contact the relying IRB to determine whether you need to undertake any interactions with their IRB.

To execute a reliance agreement, follow the IRB Agreement- Instructions for Use and either use the IRB Authorization Agreement template or you may use the template provided by the other institution. 

Individual Investigator Agreement (IIA)

An IIA is an agreement between UTHSC and an individual investigator who is not an employee of one of UTHSC’s affiliate institutions (e.g., Le Bonheur Children’s Hospital, Methodist Healthcare – Memphis Hospitals, or Regional One Health) AND who is not a UTHSC faculty, staff, student, resident, or fellow (e.g., former student who is not affiliated with an institution that has its own IRB and is working after graduation with his/her faculty mentor, professional in the community with specific expertise, community partner, friend of the University). The IIA outlines the responsibilities of the individual investigator for the protection of human research subjects. The IIA is signed by the Individual Investigator and the UTHSC Signatory Official or Designee. In addition, the Individual Investigator must provide a copy of his/her current curriculum vitae or resume.

Click the following links to download the IIA and for additional instructions about a collaborating investigator outside of the jurisdiction of the UTHSC IRB or one of its affiliate institutions.  

When a PI Leaves UTHSC or Affiliate Institution

Last Published: Mar 21, 2018