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HRPP Policy - Reliance
About This Policy
- Effective date:
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IU Human Research Protection Program (HRPP)
This policy applies to non-exempt human subjects research for which Indiana University or its affiliates are relying on an external IRB for oversight and human subjects research for which IU Institutional Review Boards (IRBs) are serving as IRB of record pursuant to a reliance agreement.Back to top
IU may enter into reliance agreements, under which IU or IU-affiliated research personnel utilize the services of and rely on an external IRB for review and oversight. Alternatively, IU IRBs may agree to provide IRB review and oversight for external sites and non-affiliated personnel.
The IU HRPP may agree to rely on an external IRB when required by federal regulations, sponsor, or funding agency or for any other reason deemed appropriate by the IU HRPP.
When reliance on an external IRB is requested for research which is greater than minimal risk, the reviewing IRB must be qualified by the IU HRPP and Office of Research Compliance (ORC) leadership in accordance with 3.1 below.
For studies utilizing external IRBs, the following information must be reported to the IU HRPP (in addition to reporting to the reviewing IRB if required by their policies and procedures):
- PI and personnel changes
- Changes that require revisions to a standalone HIPAA authorization
- Any new potential conflicts of interest or changes in previously reported conflicts of interest, including institutional and potential financial interests, that could affect or be affected by the research
- Reportable events as defined in the IU HRPP Policy on Reportable Events, section 2.2
- Study closure
Local context for certain research populations
Research involving adults who may lack consent capacity, or may lose capacity during the course of the research, for which IU or its affiliates are relying on an external IRB for oversight must comply with Section 2.1 of the IU HRPP Policy on Adult Individuals Lacking Consent Capacity in Research, as applicable.
Research involving children, for which IU or its affiliates are relying on an external IRB for oversight must comply with Sections 2.1 and 2.2 of the IU HRPP Policy on Children in Research, as applicable.
Research involving prisoners being conducted within an Indiana Department of Corrections facility for which IU or its affiliates are relying on an external IRB for oversight must comply with Section 2.4 of the IU HRPP Policy on Prisoners in Research, as applicable.
The IU HRPP and IRB may agree to provide IRB review and oversight for non-affiliated personnel at their discretion.
Reliance agreements, at a minimum, must document the following responsibilities:
- Initial and continuing review of research
- Review of unanticipated problems involving risk to subjects or others
- Review of serious and/or continuing noncompliance
- Preparation, review, and submission of reports to federal agencies
- Conflict of interest review
- Post approval monitoring and access to research records
- Maintenance of IRB records
Reliance agreements are reviewed and approved by the University Director, HRPP, and upon approval, signed by an authorized IU signatory official or their designee.
When the IU IRB provides approval for non-affiliated research personnel who are not conducting research on behalf on an institution, a reliance agreement is not required. Instead, the research personnel must provide written attestation of knowledge of and agreement to follow the IU HRPP Policies. For federally-funded research, IU must extend its Federalwide Assurance to cover non-affiliated research personnel. For these studies, the written attestation must also be signed by the IU Institutional Official or his/her designee.
Submission to the IU HRPP and review
Study teams may request reliance on an external IRB by submitting a Request to Rely on a non-IU IRB to the IU HRPP via Kuali Protocols. IU HRPP staff will conduct a review of the Request to Rely to determine whether reliance is appropriate and ensure all institutional responsibilities are met. Specifically, IU HRPP review will include:
- Verification of the PI’s qualifications to conduct the research
- Verification of completion of human subjects protection training and conflict of interest disclosures as required by study personnel
- Verification that all required ancillary reviews have been completed
- Communication of local context information to the reviewing IRB, as appropriate for the specific study
- Verification of the inclusion of appropriate language to satisfy local institutional requirements in the draft informed consent document, when applicable
- Review of standalone HIPAA Authorization forms, when applicable
If the HRPP determines that reliance is not appropriate, the study must be submitted to the IU IRB for review.
When local policies or state laws or regulations impacting the research are changed, the IU HRPP shall notify the reviewing IRB.
Qualification of external IRBs
When reliance on an external IRB is requested for research which is greater than minimal risk, the reviewing IRB must be qualified by the IU HRPP and ORC leadership.
Reviewing, external IRBs are evaluated and 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.
Research personnel responsibilities
In addition to the responsibilities outlined in the IU HRPP Policy of Research Personnel Responsibilities, PIs and research personnel participating in a study for which an external IRB is providing review and oversight must be familiar with and ensure compliance with the policies and procedures of the reviewing IRB, including policies regarding reporting of noncompliance and unanticipated problems to the reviewing IRB.
Submission to the IU IRB and review
Study teams may request that the IU IRB provide IRB approval for non-affiliated research personnel and/or external sites by submitting an Amendment. An IRB reviewer, or the convened committee, evaluate the request and determine on a case-by-case basis whether reliance is acceptable.
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 review and approval of the research personnel’s participation.
When an external site is added as an Amendment, the IRB may use an expedited review procedure, unless otherwise directed by the IRB at initial study review, the local site identifies additional risks to subjects specific to the relying site, or the Amendment includes other major revisions which would require review and approval by the convened IRB.
Research personnel responsibilities
In addition to the responsibilities outlined in the IU HRPP Policy of Research Personnel Responsibilities, PIs of studies for which the IU IRB is serving as IRB of record for external sites and/or non-affiliated personnel must fulfill the following requirements:
- Ensure non-affiliated personnel have access to and are familiar with IU HRPP Policies relevant to their conduct of the study
- Ensure non-affiliated personnel receive all IRB-related documentation, including approved study documents related to their conduct of the study
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 Reliance Forms
- External IRB Qualification Checklist
- IU Local Context Information Sheet
- NIH sIRB Communication Plan Template
- Relying Site Local Context Checklist
- Non-Affiliated Research Personnel Attestation
- Agreement to Extend FWA to Non-Affiliated Research Personnel
- AAHRPP Standards
- Element I.1.G
- Standard I-2
- Standard I-9
- 45 CFR 46
- 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)
adult individuals lacking consent capacity, audit, authorization, children, continuing noncompliance, corrective action, federally-funded, federalwide assurance, HIPAA, human subject, institutional review board (IRB), investigator, IU-affiliated research personnel, minimal risk, non-affiliated research personnel, noncompliance, principal investigator, prisoner, privacy board, regulatory agencies, reliance, relying institution, reportable event, research, research personnel, reviewing IRB, serious noncompliance, sponsor, suspension, termination, unanticipated problem involving risks to subjects or others (UPIRTSO)
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