Reliance Agreements

The UTHSC IRB maintains reliance agreements with the following partner institutions:

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

Under these agreements, 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 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. Access contact information and requirements for each institution.

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 its affiliate institutions (e.g., Le Bonheur Children’s Hospital, Methodist Healthcare – Memphis Hospitals, or Regional One Health), UTHSC is the reviewing IRB. You should 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. You should 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 acknowledgment via iMedRIS.
• When the St. Jude IRB reviews revisions, continuations, unanticipated problems, study closures, etc., these outcome letters and supporting documents must be submitted to the UTHSC IRB via the Documents from Reviewing IRB form in iMedRIS. The UTHSC IRB will acknowledge receipt of these documents via iMedRIS.
• You must still obtain separate institutional approval if the study site(s) include Campbell Clinic, Le Bonheur Children’s Hospital, Methodist Healthcare – Memphis Hospitals, and/or Regional One Health.

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.

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 (UTHSC IRB Memphis Form 1: Study/Project Application) and in Section (418), you will select “I am submitting my research in accord with an IRB Authorization Agreement. I am requesting to use an external IRB.” In addition, you will upload copies of the approved study documents and the executed reliance agreement. The UTHSC IRB will acknowledge receipt of this application via iMedRIS. As the DoD is the reviewing IRB, the DoD will establish the IRB approval period and expiration date, if applicable.

When the DoD reviews revisions, continuations, study closure, etc. for the study under an agreement, these outcome letters and supporting documents should be submitted to the UTHSC IRB via the Documents from Reviewing IRB form. The UTHSC IRB will acknowledge receipt of the documents via iMedRIS.

You must still obtain separate institutional approval if the study site(s) include Campbell Clinic, Le Bonheur Children’s Hospital, Methodist Healthcare – Memphis Hospitals, and/or Regional One Health.

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 (UTHSC IRB Memphis Form 1: Study/Project Application) and in Section (418), you will select “I am submitting my research in accord with an IRB Authorization Agreement. I am requesting to use an external IRB.” The application 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, if applicable.

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

When the NCI CIRB reviews revisions, continuations, unanticipated problems, study closure, etc. for the study under the agreement, these outcome letters and supporting documents approvals should be submitted to the UTHSC IRB via the Documents from Reviewing IRB form. The UTHSC IRB will acknowledge receipt of the documents via iMedRIS.

You must still obtain separate institutional approval if the study site(s) include Campbell Clinic, Le Bonheur Children’s Hospital, Methodist Healthcare – Memphis Hospitals, and/or Regional One Health.

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.

Purpose

The National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board of Record for Multi-Site Research establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects at 45 CFR Part 46. This policy, which is consistent with 45 CFR Part 46.114, is intended to enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed as expeditiously as possible without compromising ethical principles and protections for human research participants.

Scope and Applicability

This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training, or fellowship awards.

This policy applies to domestic awardees and participating domestic sites. Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.

Consistent with the Roles and Responsibilities section, applicants/offerors will be expected to include a plan for the use of an sIRB in the applications/proposals they submit to the NIH. The NIH’s acceptance of the submitted plan will be incorporated as a term and condition in the Notice of Award or in the Contract Award. This policy also applies to the NIH Intramural Research Program.

Roles and Responsibilities

Applicant/Offeror: In the application/proposal for research funding, the applicant/offeror is expected to submit a plan describing the use of an sIRB that will be selected to serve as the IRB of record for all study sites. The plan should include a statement confirming that participating sites will adhere to the sIRB Policy and describe how communications between sites and sIRB will be handled. If, in delayed-onset research, an sIRB has not yet been identified, applications/proposals should include a statement that awardees will follow this Policy and communicate plans to use a registered IRB of record to the funding NIH Institute/Center prior to initiating a multi-site study. The applicant/offeror may request direct cost funding for the additional costs associated with the establishment and review of the multi-site study by the sIRB, with appropriate justification; all such costs must be reasonable and consistent with cost principles, as described in the NIH Grants Policy Statement and the Federal Acquisition Regulation (FAR) 31.302 (Direct Costs) and FAR 31.203 (Indirect Costs).

Awardees: Awardees are responsible for ensuring that authorization agreements are in place; copies of authorization agreements and other necessary documentation should be maintained in order to document compliance with this policy, as needed. As appropriate, awardees are responsible for ensuring that a mechanism for communication between the sIRB and participating sites is established. Awardees may delegate the tasks associated with these responsibilities.

Funding Institute or Center (IC): Funding ICs are responsible for management and oversight of the award, including communicating with the awardee regarding the implementation of its proposed plan to comply with the sIRB Policy. In the event that questions arise about the awardee’s plan, including the IRB that has been selected to serve as the sIRB, the funding IC will work with the awardee to resolve them. 

sIRB: The sIRB is responsible for conducting the ethical review of NIH-funded multi-site studies for participating sites. The sIRB will be expected to carry out the regulatory requirements as specified under the HHS regulations at 45 CFR Part 46. In reviewing multi-site research protocols, the sIRB may serve as a Privacy Board, as applicable, to fulfill the requirements of the HIPAA Privacy Rule for use or disclosure of protected health information for research purposes. The sIRB will collaborate with the awardee to establish a mechanism for communication between the sIRB and the participating sites.

Participating Site: All sites participating in a multi-site study are expected to rely on an sIRB to carry out the functions that are required for institutional compliance with IRB review set forth in the HHS regulations at 45 CFR 46. Participating sites are responsible for meeting other regulatory obligations, such as obtaining informed consent, overseeing the implementation of the approved protocol, and reporting unanticipated problems and study progress to the sIRB. Participating sites must communicate relevant information necessary for the sIRB to consider local context issues and state/local regulatory requirements during its deliberations. Participating sites are expected to rely on the sIRB to satisfy the regulatory requirements relevant to the ethical review. Although IRB ethical review at a participating site would be counter to the intent and goal of this policy, the policy does not prohibit any participating site from duplicating the sIRB. However, if this approach is taken, NIH funds may not be used to pay for the cost of the duplicate review.

Exceptions

Exceptions to this policy will be made where review by the proposed sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy. Requests for exceptions that are not based on a legal, regulatory, or policy requirement will be considered if there is a compelling justification for the exception. The NIH will determine whether to grant an exception following an assessment of the need.

Contact the UTHSC IRB

If you want to request to be a relying site PI and for the UTHSC IRB to be a relying IRB, contact the UTHSC IRB office at 901.448.4824. It is important for you to understand the reliance process and to understand your responsibilities under the agreement before you begin any submissions.  Please note that the UTHSC IRB does not have the staff or resources at this time to serve as the Single IRB/reviewing IRB for a multisite (e.g., national) study.

Note 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:

• Final NIH Policy on the Use of a Single Institutional Review Board for Multi- Site Research
• FAQs and case studies (link is external)
• NIH Deputy Director's blog (link is external)
• NIH Clinical Trials Policy website (link is external)
• Video: Overview of New NIH Policies on Human Subjects Research (link is external)

Under this agreement, Advarra is the reviewing IRB for all human subject’s research studies conducted through the Therapeutic Diagnostic Network Coordinating Center (TDNCC) and the Institute for Advanced Clinical Trials (I-ACT) 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 or I-ACT study that will be conducted at Le Bonheur Children’s Hospital, you will start a new application (UTHSC IRB Memphis Form 1: Study/Project Application) and in Section (418), you will select “I am submitting my research in accord with an IRB Authorization Agreement. I am requesting to use an external IRB.” In addition, you will upload copies of the executed reliance agreement, approved study documents, and consent form(s) that incorporate the UTHSC specific language, i.e., UTHSC letterhead, compensation and treatment for injury language, contact information, HIPAA language (if UTHSC is acting as the privacy board), and appropriate signature lines according to the UTHSC IRB consent form template.

As the Advarra is the reviewing IRB, Advarra will establish the IRB approval period and expiration date, if applicable.

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

You must still obtain separate institutional approval from Le Bonheur Children’s Hospital to conduct the study.

When Advarra reviews revisions, continuations, unanticipated problems, study closure, etc. for the study under the agreement, these outcome letters and supporting documents should be submitted to the UTHSC IRB via the Documents from Reviewing IRB form. The UTHSC IRB will acknowledge receipt of the documents via iMedRIS.

Note 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.

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 (UTHSC IRB Memphis Form 1: Study/Project Application)and in Section (418), you will select “I am submitting my research in accord with an IRB Authorization Agreement. I am requesting to use an external IRB.” In addition, you will upload copies of the executed reliance agreement, approved study documents, and consent form(s) that incorporate the UTHSC specific language, i.e., UTHSC letterhead, compensation and treatment for injury language, contact information, HIPAA language (if UTHSC is acting as the privacy board), and appropriate signature lines according to the UTHSC IRB consent form template.  As the University Miami is the reviewing IRB, the University of Miami will establish the IRB approval period and expiration date, if applicable.

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

You must still obtain separate institutional approval if the study site(s) include Le Bonheur Children’s Hospital, Methodist Healthcare – Memphis Hospitals, and/or Regional One Health.

When the University of Miami reviews revisions, continuations, unanticipated problems, study closure, etc. for the study under the agreement, these outcome letters and supporting documents should be submitted to the UTHSC IRB via the Documents from Reviewing IRB form. The UTHSC IRB will acknowledge receipt of the documents via iMedRIS.

The SMART IRB is a reliance platform (not an IRB), designed to streamline the IRB reliance agreement process between institutions. The SMART IRB master reliance agreement facilitates the authorization agreement process between participating institutions.
 
SMART IRB offers several options for documenting reliance between institutions for a specific research study. It is up to the Reviewing IRB to determine which of the following documentation methods will be used for a specific study:

• SMART IRB Letter of Acknowledgment; or
• The SMART IRB Online Reliance System; or
• IRB Reliance Exchange (IREX)

When you want to be a relying site PI and request that the UTHSC be a relying IRB: If you are planning to be the PI at a relying site, you have responsibilities to both to the UTHSC IRB and the Reviewing IRB. The UTHSC IRB is responsible for conducting the Human Research Protections Program review – to cede the request, trigger applicable ancillary reviews, and track research activities occurring at UTHSC and/or at one of its affiliate institutions.

When ceding to an external IRB, follow the procedures above under the section entitled, “The Reliance Procedures”.

You must still obtain separate institutional approval if the study site(s) include Le Bonheur Children’s Hospital, Methodist Healthcare – Memphis Hospitals, and/or Regional One Health.

The Reviewing IRB is responsible for providing the regulatory oversight for the research protocol. The Reviewing IRB will provide the IRB review for the initial review, and any modifications, continuing reviews, or reportable events for the duration of the study. A few responsibilities as a relying site PI under the SMART IRB agreement are:

• Following all requirements of their home institution (UTHSC) regarding ceded review, outlined above under the section entitled, “The Reliance Procedures” before a study is activated.
• Working with the UTHSC IRB to incorporate site-specific required language into the consent template to be used at their institution.
• Providing the UTHSC IRB with information, via iMedRIS, regarding local Site Investigator or other Relying Site Study Team personnel changes.
• Reporting to the UTHSC IRB, via iMedRIS, any changes in conflict of interest (COI) disclosures and resulting changes in COI management plans related to the Research (i.e., the specific study or studies ceded to the Reviewing IRB).
• Reporting to the Lead Study Team (or designee) any changes (including funding changes and personnel changes), reportable events, and continuing review progress reports, for submission to the Reviewing IRB in accordance with the Reviewing IRB’s policies and procedures for timing and content of such submissions.
• Promptly reporting to the Overall PI via the Lead Study Team (or designee) any unanticipated problems involving risks to subjects or others, subject injuries related to the research, or significant complaints that could impact the conduct of the Research (i.e., the specific study or studies ceded to the Reviewing IRB) in accordance with the Reviewing IRB’s policies and procedures for timing and content of such submissions. Significant complaints are defined as those that cannot be resolved by the study team and a) suggest an increased or unexpected new risk or harm or b) change the risk/benefit ratio of the Research. Other complaints should be reported in accordance with the Reviewing IRB’s policies and procedures.
• Promptly reporting to the Overall PI via the Lead Study Team (or designee) any potential noncompliance that occurs in relation to the Research (i.e., the specific study or studies ceded to the Reviewing IRB) in accordance with the Reviewing IRB’s policies and procedures for timing of submission and content of such submissions.