糖心原创

糖心原创 human subject research must be reviewed by the 糖心原创 IRB unless a written reliance agreement is in place that appropriately cedes IRB review to an external IRB (also called the Reviewing IRB).听 A reliance agreement is also required for collaborative research for which the 糖心原创 IRB acts as the Reviewing IRB for an external organization or investigator. This page provides basic information regarding the 糖心原创 institutional approval process required for IRB reliance; however, it is recommended that you also review the Collaborative Research and External IRB Review Policy before applying for reliance approval.听

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External Reliance Request Process

糖心原创鈥檚 reliance on an external Reviewing IRB only transfers IRB review responsibilities to the other entity to avoid duplication of effort regarding IRB review.听 糖心原创 and its investigators still maintain full responsibility for the conduct and oversight of that research (e.g., institutional review of investigator qualifications, training, financial disclosure, biosafety and other ancillary reviews), in addition to ensuring compliance with the terms of the Reviewing IRB approval.听

To help meet those responsibilities, 糖心原创 requires submission of an abbreviated application (External Reliance Request Form) and institutional review and approval of that application prior to local study start.听 This institutional review is coordinated by the HRPP Director.

The external reliance request process uses the same Human Subjects module in RSP Gateway as 糖心原创 IRB applications.听 After clicking Create New, select External Reliance Request.听 This will allow you to create the required abbreviated application and attach the following required information: 听

• Informed consent form(s)
• Study protocol or similar document
• External IRB鈥檚 reliance agreement template and/or external IRB contact information

Negotiating reliance agreements and coordination between institutions can take several weeks, so it is important to submit your request as soon as possible.听 Once your external reliance submission is fully approved, you will receive a 5-year reliance approval letter via email.

Master Reliance Agreements

糖心原创 has master reliance agreements in place to rely on the following external IRBs:

• Dayton Children鈥檚 Hospital IRB
• Kettering Health IRB
• Wright-Patterson Medical Center IRB
• Air Force Research Lab IRB
• Advarra (Commercial IRB)
• WIRB (Commercial IRB)

Investigators who want to conduct research approved under these agreements must still complete and submit an External Reliance Request, however negotiating a separate reliance agreement will not be required.听 You will be responsible for any costs associated with utilizing an external IRB and 糖心原创 may disapprove a request to use an IRB even though a master reliance agreement is in place.
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Clinical Trials Research Alliance (CTRA), Premier Health, and Dayton VAMC

糖心原创 is considered to be 鈥渆ngaged鈥� in human subject research for all human subject research conducted via the CTRA and therefore reliance on external IRBs for this research must be reviewed and approved via the External Reliance Request process in RSP Gateway.

糖心原创鈥檚 submission requirements, however, do not apply to human subject research conducted solely by Premier Health or the Dayton Veterans Affairs Medical Center (Dayton VAMC) when either organization decides to cede IRB review to an IRB other than the 糖心原创 IRB.听 For example, human subject research conducted at Premier Health in which 糖心原创 will not be named in any publications/presentations and the research does not involve 糖心原创 information, facilities or funding.

The Single IRB Mandates

糖心原创 has created processes to comply with the National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board of Record (sIRB) for Multi-Site Research effective January 25, 2018, and the sIRB Common Rule requirements effective January 21, 2020. 听However, 糖心原创 will not agree to act as the sIRB for federally-funded research, but may participate in such research as a Relying Organization. (See Section 5.4 of the Collaborative Research Policy for more information).

It is also important to note that 糖心原创 is not a member of the SMART IRB Program and cannot enter into reliance agreements via that program at this time.

Research Exempt from IRB Approval Requirements

Requests to rely on an external IRB will only be executed for non-exempt human subject research.听 For all research that qualifies for an exemption under the Common Rule, investigators must still apply to the 糖心原创 IRB using the Initial Review Form to obtain an exemption determination even if a collaborating institution has already determined the research to be exempt.听

Likewise, 糖心原创 will not provide exemption determinations for external organizations or individual external collaborators, except for Premier Health and Dayton VAMC investigators.

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Requests for 糖心原创 IRB to Act as Reviewing IRB

In certain cases, the 糖心原创 IRB may serve as the Reviewing IRB for a collaborative research site and/or collaborative investigator engaged in 糖心原创 research.听

These agreements are used when:

Faculty, staff, students, residents, or fellows from an FWA-holding institution that is NOT affiliated with 糖心原创 wish to conduct research in conjunction with 糖心原创 faculty, staff, students, residents, or fellows; or with employees of any of our affiliate institutions.

The review and approval of this reliance will be managed via the regular IRB new study submission process (i.e., Initial Review Form) in RSP Gateway.听 Investigators must provide the information requested in the form to facilitate negotiation of reliance agreement.

糖心原创 investigators should not initiate the Authorization Agreement with another institution without first checking with the 糖心原创 IRB to:

• Verify the collaborator鈥檚 research activity meets the definition of 鈥渆ngaged in research:
• Identify the appropriate type of agreement
• Facilitate the signing of the agreement by 糖心原创鈥檚 Institutional Official
• Implement and management the agreement

IRB Agreement Types:

IRB Authorization (or Reliance) Agreement (IAA)

An IAA is an agreement between 糖心原创 and another institution that holds a Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS). Any institution (e.g., university, medical centers, NGOs, community organization, survey research organization) receiving funds from HHS must have an FWA. This agreement type is used to establish the IRB-of-Record (whether that's 糖心原创 or the other institution). The IAA is signed by the Institutional Officials at each institution.

Individual Investigator Agreement (IIA)

An IIA is an agreement between 糖心原创 and an individual collaborator who is not affiliated with an FWA institution (e.g., former student working after graduation with their faculty mentor, professional in the community with specific expertise, community partners). This agreement type outlines the responsibilities of the individual investigator for the protection of human subjects.

The IIA is signed by the:

• Individual investigator
• 糖心原创 Principal Investigator (PI)
• 糖心原创 Institutional Official

Master Reliance Agreement

Long-standing master reliance agreements are in place to allow the 糖心原创 IRB to act as the Reviewing IRB for both Premier Health (includes Miami Valley Hospital, Upper Valley Medical Center and Atrium Medical Center) and the Dayton Veterans Affairs Medical Center (Dayton VAMC).听 These agreements were put into place as many 糖心原创 Boonshoft School of Medicine investigators also hold staff appointments at these health care organizations and neither organization currently operates their own local IRBs.听

Premier Health or Dayton VAMC investigators conducting studies via these master agreements should indicate this reliance in the Initial Review Form (see Sections 5.1-5.3 of Collaborative Research Policy for more information).

Data Use Agreement (DUA)

A DUA covers the physical or electronic transfer of data between unaffiliated institutions. Examples include records from government agencies, institutions or corporation, student records information, medical records information, and existing human subject鈥檚 data.听 Please contact the IRB Office for assistance in determining if a DUA is appropriate for your study.

Multisite Research Studies

At this time, the 糖心原创 IRB cannot serve as the IRB of record (i.e., the reviewing IRB) for a multicenter study where all the sites are not local. Please contact the IRB with any questions.

External Collaborator Engagement

External collaborators are not considered 鈥渆ngaged in research鈥� if they do not interact with subjects or the identified data, analyze deidentified data only, or assist with recruitment only. For more information see the .听

Resources

Decision Tree

IRB Authorization Agreement Needed Flowchart

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Office of Human Research Protections (OHRP)

Federalwide Assurance Number (FWA): 00002427
Expiration Date: 12-07-2022

IRB Registration Number: IORG0000025
Expiration Date: 05-19-2023
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Who Should I Contact for More Information or Guidance?

For questions about reliance processes,听please contact the IRB Office听at rsp-irb@wright.edu or 937-775-4462.