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Reliance Agreements

Relying on the Review of Another IRB

Both the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) permit an IRB to rely on the review of another IRB. When this is the intention, institutions may enter into a joint review arrangement referred to as a Reliance Agreement, Cooperative Agreement, IRB Authorization Agreement, or Memorandum of Understanding. The UTHSC IRB maintains several IRB reliance agreements. To learn more about these agreements, 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. 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. If and when 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 through iMedRIS.

National Cancer Institute (NCI) Central IRB

Under this agreement, the NCI CIRB is the sole IRB of record responsible for review of cooperative group oncology studies performed at participating institutions. However, the UTHSC 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.” 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.

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

National Institutes of Health (NIH)

As of September 25, 2017, the NIH has mandated that all domestic sites participating in multi-center research studies use a single IRB (sIRB).  The Final NIH Policy on the Use of a Single Institutional Review Board for Multi- Site Research will apply to all "competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after September 25, 2017, all contract solicitation issued on or after May 25, 2017, and all NIH Intramural studies submitted for initial IRB review after September 25, 2017."  The NIH uses the term sIRB to distinguish between IRBs (generally for-profit) that are structured to serve as the central IRB for multi-center studies and institution-based IRBs whose primary function is to serve the investigators at that institution.  The policy was originally scheduled to take effect as of May 25, 2017 but NIH has issued an extension of the date for implementation which moves the effective date back until September 25, 2017.

Resources for NIH Policy on use of a Single IRB:

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 [https://ris01.uthsc.edu]. 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 an executed reliance agreement. The UTHSC IRB will acknowledge receipt of this registration through 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 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 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 an executed IRB reliance agreement) and approval to the UTHSC IRB via iMedRIS. Once the study is approved, the UTHSC IRB will issue an approval letter 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.

 

Individual Investigator Agreement

All collaborating investigators outside of the jurisdiction of the UTHSC IRB or its affiliated institutions (e.g., Le Bonheur Children’s Hospital, Methodist Healthcare – Memphis Hospitals, or Regional One Health) who qualify as an “independent” or “institutional” investigator (according to the instructions below) should submit an Individual Investigator Agreement for review with each protocol submission. 

When a PI Leaves UTHSC or Affiliate Institution

Last Published: Jun 13, 2017