Reliance Agreements - External IRB Requests
A reliance agreement (or IRB Authorization Agreement or IAA) is a formal, written document indicating a collaborative arrangement between institutions that allows one or more institutions to cede human subjects research review to another Institutional Review Board (IRB). A reliance agreement describes the responsibilities of the relying institution and researcher as well as the responsibilities of the Reviewing IRB and its institution. WSU IRB would be either the Reviewing IRB (IRB of Record) or the Relying IRB (ceding review). Reliance agreements can be used to avoid having duplicate IRB reviews at multiple sites, and they are also needed for meeting the NIH Single IRB Policy for Multi-site Research and The Revised Common Rule's Cooperative Research Provision (45 CFR 46.114). Reliance agreements may be for a specific study, or for specific classes or categories of research.
See submission instructions below and for more information an External IRB Guidance Tool is available.
Submissions for where WSU IRB is not the reviewing IRB there are two types of initial submissions:
(Type 1) Reliance agreement is already in place (e.g. SMART IRB). The reliance agreement should be referenced with your request submission. For SMART IRB agreement use, please provide an acknowledgement form as explained below. If the Reviewing IRB is one of the >700 sites on SMART IRB and they are willing to use the SMART IRB master agreement, that will expedite the process. Outside of SMART IRB, WSU has reliance agreements with some institutions please include the name of the Institution with your IRB External IRB Submission Request.
(Type 2) Reliance agreement is not yet in place. Creation or negotiation of the reliance agreement, review by IRB Staff and Office of General Counsel, and signatures of the Institutional Officials at both institutions will be needed. If there is not an existing agreement, please note that this process of establishing one takes additional time.
Submission Process for Types 1 and 2:
Complete and submit the following:
- Complete the Initial External IRB Worksheet (revised May 2023 previous version accepted until June 5, 2023) and attach to the eProtocol submission.
- Create an eProtocol submission.
- For detailed guidance regarding the eProtocol external IRB submission process see the External IRB Guidance Tool
Attach the following to the eProtocol submission:
- Consent document with HIPAA Authorization (Reviewing IRB's consent template, with WSU local context language and WSU HIPAA Authorization inserted or as an appendix to the master consent). For the Advarra template, see FAQs section below. For others, please use the consent local context guidance document available by clicking here.
- Reviewing IRB's SMART IRB Acknowledgement Form, or SMART IRB Online System or, if a new agreement-the reliance agreement document
- Reviewing IRB's Local Context Worksheet required by Reviewing IRB (if requested). Please fill out study specific information to the best of your ability, and the WSU IRB Staff will fill in the rest.
WSU Notification to PI - The WSU IRB will notify the investigators once the proposed research has been cleared for submission to the External IRB by providing an email confirmation along with the approved WSU External IRB Request Form and approved HIPAA Summary Form (if applicable).
PI Communication Responsibility - The PI is responsible for sharing the approved WSU External IRB Request Form with the External IRB to indicate that WSU IRB has approved the instance of reliance when applying to the External IRB for approval.
Once approved by the External IRB, investigators must submit a copy of their approval notice and any approved consent document(s) to the HRPP/IRB office through the usual channels for reliance requests. If the protocol was modified during the external IRB review process, the approved version of the protocol should be provided as well. For eProtocol submissions please submit these documents as an amendment request.
Investigators must be familiar with and comply with the External IRB's policies and procedures and any additional requirements or procedures outlined in the IRB reliance agreement or companion materials (e.g., reliance SOPs). WSU will support compliance with the terms of Reliance Agreements by providing investigators with information relevant to their responsibilities, such as a copy or summary of the Reliance Agreement, an information sheet, or reliance SOPs.
Changes in PI and other key personnel changes must be submitted to the WSU IRB office prior to the new PI or research team member assuming any study responsibilities. The WSU IRB office must verify CITI training, COI review, and any other applicable requirements. HIPAA changes and other local context modifications need to be submitted to the WSU IRB for administrative review using this form as well.
- For Active protocols on the submitter's dashboard select "Start Amendment" and complete the Amendment Form.
- Follow instructions on the eProtocol Amendment Form.
- Provide highlighted copies of revised documents and attach for the appropriate sections of eProtocol
- Do not submit any additional Amendment or Modification Forms.
- Key Personnel Changes:
- make modifications to the eProtocol Personnel Information section
- complete the applicable sections of the eProtocol Amendment Form
- HIPAA Changes
- make modifications to the eProtocol HIPAA section and applicable HIPAA Authorization Forms.
- Consent/Assent Changes:
- Attach highlighted revised consent/asents for the consent/assent sections.
- For detailed guidance regarding the eProtocol Amendment submission process see the External IRB Guidance Tool.
Non eProtocol submissions:
- Complete the External Modification Worksheet (admin correction 6.2023) and email to email@example.com
- Follow instructions on the External Modification Worksheet
- Provie highlighted copies of revised documents (i.e. consent/assents)
- If making key personnel additions or HIPAA changes additional submission forms may be required (noted below).
Additional Submission Forms:
- HIPAA Summary Form (pdf) (upated 8/2023) This form is used for Non eProtocol submissions ONLY
- Key Personnel List (pdf)(updated 9/2021 open and save as an Adobe Acrobat document)
- This form is used for Non eProtocol Submissions ONLY.
- For eProtocol Submissions updated the Personnel Information section
Investigators approved through External IRB review must still report local unanticipated problems, complaints, and any noncompliance to the Wayne State University HRPP/IRB office. This is in addition to reporting to the Reviewing IRB per their reporting policies. Notices about and reports from external monitors, auditors, or inspectors must be provided to the WSU IRB Office. Copies of the report submitted to the Reviewing IRB are generally acceptable, but additional information may be requested on an as-needed basis.
UP Reporting: All SERIOUS unanticipated problems/adverse events occurring at WSU and its affiliated institutions should be submitted to the WSU IRB within 5 working days.
Protocol Violations/Deviations submitted/being submitted to the Reviewing (External) IRB:
Non eProtocol submissions:
- complete the External IRB Modification Worksheet follow the instructions for the Modification Worksheet, include any supporting documents/forms provided to the external IRB, and email to: firstname.lastname@example.org
- start and submit a Protocol Violation/Deviation Form and attached any supporting documents/forms provided the external IRB.
Local Context Protocol Violations/Deviations:
Local Context Protocol Violations/Deviations iclude HIPAA, key personnel, and breach of confidentiality.
- Complete the Unanticipated Problem Event & Reporting Form (pdf) (pdf) (pdf) and followng submssion instructions for this form.
Site Visits: Upon notification of an impending regulatory site visit, hold notification, and/or external audit, the WSU IRB Administration Office must be contacted immediately. Please e-mail Monica Malian, Director HRPP at email@example.com
In the case of post-approval monitoring or an audit by the WSU IRB, the Reviewing IRB, or a third-party hired to conduct an audit, the study binder documents should be readily available.
Any of the following issues must be promptly reported to the WSU IRB office by phone or email:
- Any negative actions by a government oversight office, including, but not limited to, OHRP Determination Letters, FDA Warning Letters, FDA 483 Inspection Reports with official action indicated (classification as "OAI" is typically made after the FDA has the opportunity to review any responses to a 483), FDA Restrictions Placed on IRBs or Investigators, and corresponding compliance actions taken under non-US authorities related to human research protections;
- Any litigation, arbitration, or settlements initiated related to human research protections; and/or
- Any press coverage (including but not limited to radio, TV, newspaper, online publications) of a negative nature regarding Wayne State University's HRPP.
Investigators are reminded that other Wayne State University reporting requirements, such as those related to compliance, privacy, and risk management, remain applicable in addition to HRPP reporting requirements
Questions & Additional Information
Questions regarding External IRB Requests other than WIRB and NCI CIRB please email: firstname.lastname@example.org.
For WIRB and NCI CIRB requests, please see the respective pages of the WSU IRB web site.
External IRB Policy: To view the External IRB & Reliance Agreements for Multi Site Research Policy (Policy 4-17) visit the IRB's policy website.
A CITI training module for External IRB review is available at citiprogram.org under Supplemental Modules for the Social & Behavioral Resarchers module and the Biomedical Invesitgators module.
WSU is a SMART IRB participating institution. For a listing of SMART IRB participating institutions and an extensive collection of guidance about single IRB, see https://smartirb.org/participating-institutions/ and https://smartirb.org/study-teams/
Reliance Agreements FAQs
What WSU studies are eligible for submission to an external IRB (other than WIRB or CIRB)?
Non-exempt research studies may be considered for submission to an external IRB if they are multi-site studies, particularly NIH-funded studies to which the NIH Single IRB policy applies. Please see the policy link to determine whether the NIH Single IRB policy applies to your study https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm
Non-exempt cooperative research involving a Common Rule agency (e.g. NSF, EPA, etc.) will also be considered for external IRB submission. The list of Common Rule agencies can be found here: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html and the Common Rule Requirement can be found here: https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-requirement/index.html
If an external IRB will be the IRB for my study, what does the WSU IRB Administration Office review?
When another IRB is the Reviewing IRB, certain regulatory responsibilities still remain the responsibility of WSU. The submission materials, together with all appropriate documents relating to the request, will be reviewed by an assigned designee and/or appropriate WSU IRB administration staff. The main focus of the review will be local context considerations such as the targeted population and related cultural issues, Michigan and local laws, WSU regulations and policies, as well as key personnel and local investigator credentials.
- These responsibilities include:
- Ensuring adequate personnel training in Protection of Human Subjects via the Collaborative Institutional Training Initiative (CITI) training modules. See the IRB's Mandatory Training website for more information. Note, Good Clinical Practice training is required for NIH funded/supported studies.
- Maintaining a compliance oversight role locally.
- Ensuring that site specific requirements are in place and that a reliance agreement is in place.
- Ensuring that required local ancillary reviews (i.e. Radiation Safety Committee, Institutional Biosafety Committee, etc.) have been completed.
Is there guidance regarding NIH Single IRB?
What if the study sponsor wants us to use Advarra IRB?
You would follow the instructions and use the forms above for Initial Submissions, and we have a note on file with Advarra that we always use the SMART IRB Agreement with them, so there is no need to submit an agreement for this sort of submission. No local context worksheet is needed for them. Please use the Advarra-specific local context consent template.
How much money should be budgeted for external IRB reliance studies?
For initial submissions for sponsored clinical trials, the fee for WSU Administrative Review can be found here: https://research.wayne.edu/irb/irb-fees.
Please make sure you include the external IRB's fees as direct charges in your budget, and plan enough funds to cover amendments, continuing reviews, and other actions during the life of the study.
What if DMC review is required for my study?
If DMC Review is required DMC Review Authorization can be submitted concurrently at the time of IRB submission.
- When submitting your request to email@example.com also cc: firstname.lastname@example.org
- Complete the DMC online submission process.
- For more information regarding DMC Review: https://www.dmc.org/for-health-professionals/clinical-translation-research-office
If you have additional questions, please contact email@example.com.
Education Session: A practical approach to collaborative research and single IRB review