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Reliance Agreements

What is a Reliance Agreement?

A reliance agreement (also called an IRB Authorization Agreement, Cooperative Agreement, or Memorandum of Understanding) is a document signed by two or more institutions engaged in human subjects research that permit one or more institutions to cede review to another IRB. The signed agreement permits a single IRB to review human subject research activities for more than one site. Agreements may cover single studies, categories of studies, or all human subjects research under an organization’s Federalwide Assurance (FWA).

Does UTHSC Utilize Reliance Agreements?

Yes, the UTHSC has both agreed to act as the reviewing IRB in limited situations, allowing other institutions to cede review to the UTHSC IRB, and the UTHSC IRB has also agreed to cede review to external IRBs in certain situations. However, the UTHSC IRB does not currently engage in reliance agreements with international IRBs.

To learn more about the IRB Reliance Agreements maintained by the UTHSC IRB, click the information below or view the UTHSC IRB SOPs for Cooperative Agreements or the Use of the NCI CIRB.

What is the Purpose of a Reliance Agreement?

A reliance agreement avoids duplicate IRB initial review and continued oversight when multiple IRBs have jurisdiction for the same multi-site research protocol.

Contact the UTHSC IRB FIRST!

Contact Kate Menke Cummings, IRB Reliance Manager, at 448-3281 or kmenkecu@uthsc.edu if you would like to conduct a research study under a Reliance Agreement. There are times when the UTHSC IRB will not cede IRB review, or will not be the reviewing IRB for other institutions, or when a reliance agreement is unnecessary. Further, it is important for you to understand the reliance process and to understand your responsibilities under the Reliance Agreement.

Procedures

Ceding IRB Oversight to another IRB

How to request that UTHSC rely on an external IRB.

  1. Contact the UTHSC IRB office if you would like to conduct a study under an IRB Reliance Agreement. The UTHSC IRB will collect preliminary information to determine whether to cede IRB review for a particular project. In addition, the UTHSC IRB will review the local PI responsibilities with you.
  2. If the UTHSC IRB will cede review to an external IRB, a Reliance Agreement will need to be executed. To execute a reliance agreement, follow the IRB Agreement- Instructions for Use and either use the IRB Authorization Agreement template or the template provided by the other institution. 
  3. Please note that the IRB Reliance Agreement may dictate additional responsibilities of the UTHSC IRB and the local PI.
  4. The local Principal Investigator (PI) is responsible for obtaining all study information (approved protocol, consent form(s), Investigator’s Brochure, questionnaires, etc.) from the overall PI.
  5. The study will need to be registered via iMedRIS. Only local key study personnel will need to be listed in the registration form.  Make sure that all key study personnel have a UT Net ID and password because iMedRIS uses the UT Net ID system to allow and monitor access.
  6. To register a study in iMedRIS, you should start a new application in iMedRIS and in Section (418) select, “I am submitting my research in accord with an IRB Authorization Agreement where another IRB has already approved it.” Be sure to click ‘Save and Continue’ to proceed through the electronic form. In addition, you will upload copies of the approved study documents from the reviewing IRB.
  7. Consent form(s) utilized in the study will be reviewed and approved by the reviewing IRB. However, the consent form(s) should include UTHSC-specific information, 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. Incorporate UTHSC boilerplate language in the study consent form(s).
  8. The reviewing IRB may require local context forms be completed by the local IRB, local PI, and/or affiliated institution prior to issuing approval for your local site.  These form(s) may be emailed to you or you may be required to submit them via a separate electronic system.
  9. You must still obtain separate institutional approval if the local study site(s) include Le Bonheur Children’s Hospital, Methodist Healthcare– Memphis Hospitals, and/or Regional One Health. Click here to access the contact information and requirements for each institution.
  10. After reviewing the registration form in iMedRIS, the UTHSC IRB may first issue a proviso letter with questions that you must address, or the UTHSC IRB will issue acknowledgment of the submission via iMedRIS.
  11. As the external IRB is the reviewing IRB, the external IRB will establish the IRB approval period and expiration date, if applicable.
  12. Please note that this submission is not an IRB review process, rather, it is a means to conduct the Human Research Protections Program review – to approve the cede request, trigger applicable ancillary reviews, and track research activities occurring at UTHSC or one of its affiliate institutions.
  13. When the external IRB reviews revisions, continuations, unanticipated problems, study closures, etc., these actions and supporting documents must be submitted to the UTHSC IRB in a timely manner via the Documents from Reviewing IRB form in iMedRIS. The UTHSC IRB will acknowledge receipt of these documents via iMedRIS.
  14. When there are changes in any local key study personnel, submit a revised UTHSC IRB Form 1: Study/Project Application via Documents from Reviewing IRB submission form.  The UTHSC IRB will verify CITI training and issue an acknowledgement via iMedRIS
Procedures when UTHSC IRB is the reviewing IRB

The UTHSC IRB will collect preliminary information to determine whether the UTHSC IRB will be the reviewing IRB for a particular project.

If you are planning to be the Overall Principal Investigator (PI), it is important to know the reliance process and expectations when engaging in a multi-site research project utilizing a single IRB. Your responsibilities will substantially increase, as you will be accountable for both the lead site and the relying site(s).

Not only are you responsible for the IRB review/oversight/reporting of research activities conducted at UTHSC and its affiliated institution(s), but you now become responsible for IRB review and reporting for the sites that are relying on the UTHSC IRB as part of your protocol. It is important that before you consider assuming this responsibility, you have the resources and infrastructure to do so. This will also likely depend on relationships with investigators at the other sites since you will need to depend on them to provide information about the research activities at their sites.

If the UTHSC IRB agrees to be the reviewing IRB, a Reliance Agreement will need to be executed. To execute a reliance agreement, follow the IRB Agreement- Instructions for Use and either use the IRB Authorization Agreement template or the template provided by the other institution. 

Once a reliance agreement has been executed for other sites to rely upon (i.e., cede review to) the UTHSC IRB, you are considered the ‘overall PI’ for the multi-site research protocol and obtain overall responsibility for the protection of human subjects for all sites. This includes the collection of all regulatory information needed by the UTHSC IRB and the external sites. You must also ensure external sites are complying with local state laws and regulations.

The protocol, investigator’s brochure, consent form(s), questionnaires, etc. will be submitted to the UTHSC IRB for review and approval via iMedRIS.

At the time of continuing review, you will submit the appropriate form to the UTHSC IRB via iMedRIS. You will also need to collect all required information from relying sites to complete the continuing review submission form, including enrollment numbers, withdrawals, complaints, reportable unanticipated problems, etc.

All unanticipated problems, suspensions, terminations, noncompliance, subject complaints, etc. from any relying site should be reported to the UTHSC IRB. The UTHSC IRB will review and notify the relying sites’ IRBs of any such issues.

 

Reliance Agreements Maintained by the UTHSC IRB

Agreements with the 3 UTHSC-Affiliated Institutions

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

  • 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. 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 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 actions 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 Le Bonheur Children’s Hospital, Methodist Healthcare – Memphis Hospitals, and/or Regional One Health.
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.

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.

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, if applicable.

When the DoD reviews revisions, continuations, study closure, etc. for the study under an agreement, these actions 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 Le Bonheur Children’s Hospital, Methodist Healthcare – Memphis Hospitals, and/or Regional One Health.

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, if applicable.

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

When the NCI CIRB reviews revisions, continuations, unanticipated problems, study closure, etc. for the study under the agreement, these actions 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 Le Bonheur Children’s Hospital, Methodist Healthcare – Memphis Hospitals, and/or Regional One Health.

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.
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

Whether you will be a relying site PI and the UTHSC IRB will be a relying IRB, or whether you want to be the Overall Principal Investigator (PI) and the UTHSC IRB be the reviewing IRB, contact the UTHSC IRB office. It is important for you to understand the reliance process and to understand your responsibilities under the agreement before you begin any submissions.

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 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 registration 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 approvals actions 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.

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 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 registration 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 actions 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.

Smart IRB (Streamlined, Multisite, Accelerated Resources for Trials Institutional Review Board)

The SMART IRB is a reliance platform 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:

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

When you want to be the Overall Principal Investigator and have the UTHSC IRB as the reviewing IRB: If a researcher is planning to be the Overall Principal Investigator (PI), it is important to know the expectations when engaging in a multi-site research project utilizing a single IRB. For this reason, when in the planning stages researchers must contact the IRB to review the reliance process with the UTHSC IRB before you begin any submissions.

It is the Lead PI’s responsibility to know the expectations of both the lead and relying sites, which are outlined in the SMART IRB Agreement and Standard Operating Procedures manual. A few responsibilities as an Overall PI under the SMART IRB agreement are:

  • Work in collaboration with the Reviewing IRB and Point of Contact (POC) to determine and document specific roles and responsibilities for communicating and coordinating key information to Relying Institutions and the Reviewing IRB as described throughout these SOPs and summarized in the Appendix: Additional Multi-Site Research Management Roles and Responsibilities.
  • Obtaining and collating information from Relying Site Study Teams and/or Relying Site Points of Contacts (depending on who is designated to provide that information at the Relying Institution) regarding local variations in study conduct, such as recruitment materials and process, consent process and language, and subject identification processes.
  • Providing the Site Investigators with the IRB policies of the Reviewing Institution. This will include but is not limited to policies for reporting unanticipated problems, noncompliance, and subject complaints.
  • Providing participating Relying Site Study Teams with the IRB-approved versions of all study documents (e.g., consent and authorization forms, protocol, recruitment materials).
  • Assisting Relying Site Study Teams and/or POCs at the Relying Institution(s) (depending on who is designated to provide that information) in ensuring consent documents follow the Reviewing IRB’s template form and include applicable site-specific required language from each Relying Institution.
  • When agreed upon in coordination with the Reviewing IRB, promptly reporting to the Site Investigator (or designee on the Relying Site Study Team) any unanticipated problems involving risks to subjects or others, research-related subject injuries, or significant subject complaints that are related to or may affect subjects participating in the Research (i.e., the specific study or studies ceded to the Reviewing IRB) at the Relying Institution.
  • If a Relying Site Study Team does not provide the Lead Study Team (or designee) with the required information before the continuing review application is submitted to the Reviewing IRB, reporting the absence of this information as part of the continuing review and notifying affected Relying Site Study Team of lapse in approval for their site and any applicable corrective action plans.
  • Following all requirements of the Relying Institution with regard to ceded review, such as ensuring administrative requirements for documenting ceded review have been met before study activation occurs at a Relying Institution.

Follow the procedures above under the section entitled, “Procedures when UTHSC is the reviewing IRB”.

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

 

When you want to be a relying site PI and have 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, “Procedures when UTHSC IRB cedes review to an external IRB”.

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 with regard to ceded review, such as ensuring other reviews or sign-offs required by the institution have been completed before a study is activated.
  • Working with the Lead Study Team and the POC from their home institution, as applicable, to incorporate site-specific required language into the consent template to be used at their institution.
  • Providing the POC from their home institution with information regarding local Site Investigator or other Relying Site Study Team personnel changes.
  • Reporting to their home institution POC 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.

 

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., a former student who is not affiliated with an institution that has its own IRB and is working after graduation with his/her faculty mentor, a professional in the community with specific expertise, a community partner, a friend of the University, etc.).

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, and medical license if applicable.

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: Oct 9, 2019