External Collaborations and IRB Authorization Agreements

IRB Authorization Agreements with Other Institutions

When researchers from different institutions conduct collaborative non-exempt human research, it is possible, and in some cases required, for one IRB to lead the review process and oversee the study. This is called “single IRB” or sIRB Study.

Single IRB (sIRB) Study: A study in which two or more institutions (participating sites, or pSites) coordinate to complete the research activities, but all institutions rely on a single institution’s/organization’s IRB for ethical review. The reviewing IRB may or may not be affiliated with any of the pSites.

When a sIRB is used, the institutions must agree to this arrangement. This is documented by an Authorization Agreement.

Authorization Agreement: Also called a Reliance Agreement, is the agreement that documents respective authorities, roles, responsibilities, and communication between an institution/organization. Purdue is a member of SMART IRB and frequently utilizes the SMART IRB Letter of Acknowledgement (LOA) as the authorization agreement with other SMART IRB member institutions.

All authorization agreements are established on a case-by-case basis as outlined in HRP-101-Human Research Protection Plan. In general, the Purdue HRPP does not enter into authorization agreements for the following studies:

• Exempt research — When Purdue makes an exempt determination, it is only applicable to Purdue affiliated researchers. Researchers not affiliated with Purdue University will need to work with their respective institutions on local requirements for exempt research. Each institution must follow their own practices for exemptions.
• Studies where Purdue researchers are not considered engaged in human research. Examples of engagement: A site is considered engaged in human research when researchers interact or intervene with human participants, perform the informed consent process, obtain personally identifiable data or biospecimens, or are considered engaged by funding regulations (Example: NIH Single IRB Policy.)

See HRP-311 – Worksheet – Engagement Determination

Note that some sponsors and grant agencies may require sIRB and request information about the proposed arrangement during a proposal submission or prior to issuance of an award. Please make these considerations during proposal preparation. For guidance on specific NIH-based sIRB requirements, see this link.

Submitting Requests for Reliance

The Purdue IRB may serve in one of these two roles:

Reviewing IRB (sIRB)	Relying IRB (p-site)
IRB determined to have the authority to review and oversee the study. Also called the IRB of Record, single IRB (sIRB), lead IRB.	The IRB whose human research protection program (HRPP) has agreed to cede review of a collaborative research project to the reviewing institution(s). Also called a participating site (p-site).

Purdue as the Reviewing IRB/Single IRB (sIRB)/IRB of Record

When deciding if Purdue will serve as the sIRB in a multi-site study, we use HRP-833-Worksheet- Considerations for Serving as the sIRB.

The investigator at the participating site (p-site), the site/institution external to Purdue, may need to initiate a notification and review process at their home institution.

Information needed about the p-site:

HRP-593-Appendix-G-Multi-site-Research must be completed and uploaded in the PERA SmartForm with the study protocol. Other information we will need:

• Contact information including their email address and work phone number
• Their role(s) in the study: (e.g. interacting or intervening with participants, consenting participants, analyzing identifiable data.)
• Documentation from the External Personnel’s IRB that they may be willing to cede review to Purdue’s IRB. Institutions vary in how this is provided (e.g. e-mail, signed document, memo).

For detailed instructions on how to request Purdue be the sIRB please see: Purdue as the sIRB Submission Guidance

Purdue as the Relying IRB/Participating Site/P-site

When deciding if Purdue will cede IRB review to a sIRB, we use HRP-832 – WORKSHEET – Considerations for Ceding IRB Review. We recommend that you contact irbreliance@purdue.edu prior to submitting in PERA if you have questions.

Use Purdue as the p-site Submission Guidance to assist you in submitting your request in PERA. You will need to upload the following documents to your PERA IRB submission:

• HRP-503e-Protocol-External-IRB-Site-Supplement
• HRP-593-Appendix-G-Multi-site-Research
• Approval memo from the sIRB if available
• Study protocol and consent document(s); these can be obtained from the collaborator.
• Recruitment materials to be used by Purdue investigators
• Authorization agreements, local context forms, or other forms provided by the sIRB.

HRPP staff will review the request for reliance and work with the requested sIRB to complete the agreement.

External Collaborators Not Affiliated with an Institution with an IRB

When an External Collaborator is not affiliated with an institution that has an IRB, you will need to work with them to complete and submit an Independent Investigator Agreement (IIA). The collaborator will also need to complete Purdue required training. There are two types of IIAs, one for non-federally funded and exempt research and one for federally funded non-exempt research:

• Exempt and Non-Federally Funded Independent Investigator Acknowledgement Agreement — for exempt human subjects research or non-exempt research that is not part of a federally sponsored project.
• Federally Sponsored Non-Exempt Independent Investigator Agreement — for non-exempt human subjects research on a federally sponsored project.

Additional Information

Clarification for Common Terms

IRB Authorization Agreement (IAA) / Reliance Agreement / Deferral Agreement – a written agreement between IRBs when one IRB is acting as the IRB of record and the other is ceding review to that IRB.

FWA – Federalwide Assurance – an assurance of compliance that an institution commits to HHS that it will comply with the Common Rule 45 CFR 46. An institution must have an FWA to receive US federal funds for human research. An FWA is a number that represents an institution and is separate from an IRB study number. Purdue University’s FWA is FWA00001548.

SMART IRB – a reliance platform and system and accompanying master reliance agreement that have been accepted by all participating members. Purdue is a participating institution to the SMART IRB platform and it is our preference to use SMART IRB when possible.

Accreditation Status – The Purdue University Human Research Protection Program is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

Federal Policies Requiring the Use of a Single IRB

Federally Supported Research – Beginning January 20, 2020, the revised Common Rule requires that institutions in the US that are engaged in cooperative research conducted or supported by a Common Rule department or agency must rely upon a single IRB for non-exempt research. This does not apply to international research or exempt research.

NIH Single IRB Policy – This policy applies to NIH-sponsored, domestic, multi-site studies, where the same protocol is used at multiple sites for non-exempt research.