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HRPP Policy - Reliance
About This Policy
- Effective date:
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IU Human Subjects Office
This policy applies to the conduct of human subjects research under the jurisdiction of the IU Human Research Protection Program (HRPP). This includes research under the oversight of the IU IRBs and research for which IU or its affiliates are relying on an external IRB for oversight.Back to top
Where appropriate, IU may enter into reliance arrangements, under which IU-affiliated research personnel utilize the services of and rely on an external, reviewing IRB for IRB review and oversight. Alternatively, the IU IRBs may provide IRB review and oversight for non-affiliated research personnel. Reliance may be appropriate for any of the following reasons, among others:
- Sponsor or funding agency request or requirement
- Study is part of an existing network, consortium, or agency which encourages or mandates single IRB review
- Proposed external IRB has already reviewed the study or a similar study
- IRB expertise concerns (e.g., special subject population, untypical research design, sensitive topics)
- Efficiency considerations, especially for collaborating research
- Feedback or request from Institutional Official, HRPP staff, IRB, etc.
- Conflict of interest concerns (e.g., institutional conflict of interest)
Reliance is generally not considered appropriate for the following types of research, unless a compelling reason for reliance exists:
- Research previously approved by the IU IRBs When research has already been approved by the IU IRBs, arguments for potential efficiencies to be gained by use of a single IRB are difficult to make. Transfer of oversight between IRBs places additional burden on both IRB and study staff for little benefit and may give the perception of forum-shopping. In addition, institutional knowledge about a protocol created through multiple IRB reviews is likely to be lost during the transfer process.
- Research for which an IU investigator holds the IND or IDE As the IND or IDE holder, the investigator assumes the responsibilities of the sponsor, resulting in additional responsibility and oversight which make reliance on an external IRB inappropriate.
- Compassionate use protocols when approval of each patient is required by the FDA, IRB, or sponsor in order to provide treatment at the participating institution Since treatment is specific to the local institution, local IRB review is required.
- Comparative effectiveness research, as identified by the HRPP, unless an IRB Chair or member with expertise in the relevant specialty agrees to the reliance. This type of research often compares standard-of-care methodologies which can vary by location and require specific knowledge of local context.
- Planned emergency research Planned emergency research requires a community consent plan which would require specific knowledge of local context; as such, reliance on an external IRB would not be sufficient to protect subjects.
- VA research, unless the reviewing IRB is the VHA Central Office IRB, an IRB of another VA facility, an IRB of another federal agency, or a non-affiliated IRB that has been specifically designated by ORD, pursuant to VHA Handbook 1200.05(f)(8)(a)
When reliance is accepted, the relying institution may not approve the research if not approved by the reviewing IRB and vice versa.
When reliance on an external IRB is requested for research which is greater than minimal risk, the reviewing IRB must be deemed qualified by HRPP and Office of Research Compliance (ORC) leadership in accordance with 3.3 below. Qualification of the reviewing IRB is not required when the reviewing IRB will review only (1) minimal risk research or (2) greater than minimal risk research when IU-affiliated research personnel are only engaged in minimal risk research activities.Back to top
Study teams may request reliance on an external IRB for any of the above reasons by submitting a Reliance Request to the HRPP. HRPP staff evaluate the request, ensure all institutional responsibilities are met, and determine on a case-by-case basis whether reliance on the external IRB is acceptable. If the HRPP determines that reliance is not appropriate, the study must be submitted to the IU IRB for review.
Research personnel conducting VA research utilizing the VA CIRB are not required to submit a Reliance Request.
After the HRPP has accepted reliance on an external IRB for review and oversight of research, the following information must be reported to the HRPP:
- PI and personnel changes
- Changes that require revisions to the HIPAA authorization
- Potential conflicts of interest, including institutional and potential financial interests, that could affect or be affected by the research
- Study closure
Reviewing, external IRBs are evaluated and deemed qualified based on a balance of the following factors:
- IRB has been granted AAHRPP-accreditation
- IRB's membership satisfies the requirements of 45 CFR 46.107 and 21 CFR 56.10 and documentation has been provided
- Policies and procedures for the IRB are publicly available for review, or the IRB has an appropriate process in place for making policies and procedures available to research personnel
- IRB has a process for notifying ORC of determinations of unanticipated problem involving risks to subjects (UPIRTSO), serious and/or continuing noncompliance, suspensions, and terminations
- IRB has a process for ensuring ORC has access to IRB approvals, determinations, and documentation, either in real-time or upon request.
Insufficiency in one of the above factors may be outweighed by consideration of the other factors and does not automatically deem the external IRB unqualified. Qualification requests are approved by the University Director, HRPP, and Associate Vice President for Research Compliance and documented via the IRB Qualification Request.
Study teams may request that the IU IRB provide IRB approval for non-affiliated research personnel. The study team must provide a plan for management and communication of IRB-related information, including ensuring non-affiliated research personnel are familiar with and will follow IU HRPP policies and procedures. The study team must also ensure all required reporting and requests for amendments by non-affiliated research personnel are submitted to the IU IRB, and IRB decisions and approved documents are communicated to sites and/or non-affiliated research personnel. HRPP staff evaluate the request, ensure all institutional responsibilities are met, and determine on a case-by-case basis whether reliance is acceptable. If the HRPP determines that reliance is not appropriate, the non-affiliated research personnel must obtain IRB approval from an appropriate, external IRB for their participation in the research.
When non-affiliated research personnel are conducting the research on behalf of an external institution, the external institution must agree to rely upon the IU IRB for IRB review and approval of the research personnel's participation.
When the IU HRPP agrees to rely on an external IRB, or when an external institution agrees to rely on the IU IRB, the responsibilities of the reviewing IRB and the relying institution are documented through a written agreement between the reviewing IRB and the relying institution (e.g. reliance agreement). When the IU IRB provides approval for non-affiliated research personnel in research not federally-funded who are not conducting research on behalf on an institution, the research personnel must provide written attestation of knowledge of and agreement to follow the IU HRPP Policies. Alternatively, the HRPP may determine that an agreement or attestation is unnecessary and that responsibilities may be documented in institutional policy or the specific research protocol.
When IU extends its Federalwide Assurance to cover non-affiliated research personnel, the extension will be documented by a written agreement signed by IU, the IU PI, and the non-affiliated research personnel.
Responsibilities are governed by the relevant reliance agreement, where applicable, and the reviewing IRB and relying institution shall comply with all terms and conditions of the reliance agreement. At a minimum, responsibilities should include those listed below.
Reviewing IRB Responsibilities
Unless otherwise dictated by the written reliance agreement, the reviewing IRB shall:
- Perform initial and continuing review and review amendments and reportable events for all sites
- Ensure criteria for approval are met for all research and all sites, taking into account local context information provided by relying institution
- Review consent forms, when applicable
- Make Privacy Board determinations per HIPAA, when applicable
- Consider conflict of interest determinations, including any management plans, relating to the research and ensure plans are incorporated into IRB review as applicable
- Notify PI of IRB decisions, etc., and ensure appropriate communication plan for dissemination between sites
- Maintain appropriate IRB records and documents relating to the IRB review, and make records available to relying institution upon request
- Notify the relying institution of any of the following which relate to the conduct of research at the relying institution
- Serious and/or continuing noncompliance, suspensions, and/or terminations
- Audits, including findings and corrective actions
- Reporting to a federal agency
- Communication with regulatory agencies
Relying Institution Responsibilities
Unless otherwise dictated by the written reliance agreement, the relying institution shall:
- Ensure research personnel are appropriately qualified and meet relying institution standards for eligibility to conduct research, including but not limited to human subjects protection training and collection and maintenance of conflict of interest disclosure forms
- Provide local context information to the reviewing IRB and ensure required information is incorporated into IRB-approved documents
- Ensure research personnel are notified of their responsibilities when conducting research pursuant to a reliance agreement
- Ensure compliance with the reviewing IRB determinations and requirements, applicable federal regulations, and all applicable state and local laws and institutional requirements
- Ensure appropriate monitoring of research and perform reviewing IRB-directed audits upon request
- Establish a process for reviewing conflicts of interest and creating management plans when appropriate
- Notify the reviewing IRB of any of the following which relates to research under the oversight of the reviewing IRB:
- Serious and/or continuing noncompliance
- Restriction/suspension of research activities
- Audits, including findings and corrective actions
- Communication with regulatory agencies
- Legal claims
- Research misconduct
- Receive notifications of issues from the reviewing IRB and take additional local action, if applicable
IU IRB Responsibilities
Unless otherwise dictated by written agreement, the IU IRB retains the following responsibilities even when IU has relied upon an external IRB for review:
- Provide IRB review upon request by the HRPP or the institution. This may include local review of reviewing IRB determinations of unanticipated problem involving risks to subjects or others (UPIRTSO), serious/continuing noncompliance, suspensions and terminations.
- Review reports of audits conducted by the ORC Human Subjects Auditors.
Research Personnel Responsibilities
IU-affiliated research personnel conducting research for which an external, reviewing IRB has provided approval must fulfill all responsibilities outlined by the IU HRPP Policy on Research Personnel Responsibilities, plus the following:
- Submit Reliance Request via KC IRB
- Obtain IRB approval for conduct of the research by IU-affiliated research personnel from the reviewing IRB, including ensuring all IU-affiliated research personnel are listed on the IRB documentation as required by the reviewing IRB
- Ensure the IRB-approved documents are accurate and consistent with conduct of the research by IU-affiliated research personnel
- Conduct research in accordance with the reviewing IRB's policies and procedures, the IRB-approved documents and conditions of approval, and any applicable laws and regulations
- Ensure all IU-affiliated research personnel are appropriately qualified and have met IU or IU-affiliate standards for eligibility to conduct research, including but not limited to human subjects protection training and disclosure of conflict of interest disclosure forms
Individuals found to be in violation of this policy may be subject to sanctions relating to their participation in research with human subjects, up to and including permanent suspension or debarment from engaging in research with human subjects at Indiana University.Back to top
IU HRPP Policies
Related Policy Documents
IU HRPP Guidance
Related Guidance Documents
IU HRPP Documents
Related IRB Questionnaires
- Reliance Request
- Questionnaire C – Sites & Collaborations
Related Forms and Templates
- IU HRPP Reliance Forms
- IRB Qualification Request
- Research Personnel Responsibilities
- Relying Site Local Context Checklist
- Relying Site Personnel List
- IU-PU-ND Request for Deferral Form
- Non-Affiliated Investigator Agreement
- AAHRPP Standards
- Standard I-9
- NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
- SMART IRB master reliance agreement and online reliance system
- VHA Directive 1200.05 - Requirements for the Protection of Human Subjects in Research, especially 1200.05(5)(f)(8)(a)
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