Multi-site or collaborative research tools for investigators
Estimated Reading Time: 8 MinutesLast reviewed: 09/29/2025 by Office of Responsible Research Practices
The Office of Responsible Research Practices recommends following the steps below when submitting an initial IRB application or modification for multi-site or collaborative research.
Step 1: Determine engagement
Use HRP-311 – WORKSHEET – Engagement Determination (located in the Huron IRB System Toolkit Library) to determine if an entity (Ohio State, an external collaborator, or an external organization) is engaged in multi-site or collaborative research with Ohio State.
Step 2: Determine applicable multi-site or collaborative research scenarios
Use the Cheat Sheet: Multi-site and Collaborative Research Scenarios to determine which multi-site or collaborative research scenarios apply to your study, including the type of reliance agreement that may be needed, a list of Huron application requirements, and a list of new or revised documents that should be submitted.
Step 3: Access the BuckeyeLearn online class
Access The Huron System for Principal Investigators and Study Staff in BuckeyeLearn. The training includes materials for multi-site and external study submissions, is indexed so you can go directly to the topics relevant to your submission, and provides step-by-step instructions.
Reminders
- More than one multi-site or collaborative research scenario may be applicable to your research. If multiple external collaborators or organizations are involved in the research, then make determinations for each individual or organization separately.
- Questions? Contact the ORRP IRB reliance team at IRBAgreements@osu.edu for further guidance.
Cheat sheet: multi-site and collaborative research scenarios
|
Scenario |
Description |
Reliance agreement |
Huron application |
New and/or revised documents |
|---|---|---|---|---|
|
Scenario 1 |
External individual or organization receives deidentified or coded (without code key) data and/or biospecimens; external entity is not engaged in human subjects research |
No reliance agreement required |
Not applicable. External collaboration does not need to be noted in Huron. |
Not applicable |
|
Scenario 2 |
Ohio State personnel conduct offsite research; external organization is not engaged |
No reliance agreement required |
|
Letter of Support |
|
Scenario 3 |
External organization is primary awardee of federal funds, but no human subjects research activities occurring at external site; Ohio State acting as IRB of record |
IRB Authorization Agreement (IAA) ORRP IRB reliance coordinator will coordinate agreement process |
Parent study:
Participating site submission:
|
Parent study:
Participating site submission:
|
|
Scenario 4 |
Ohio State provides IRB oversight for:
|
Individual Investigator Agreement (IIA) ORRP IRB reliance coordinator will coordinate agreement process |
|
|
|
Scenario 5 |
External organization performs IRB review for local research activities; Ohio State is the lead site for multi-site research |
No reliance agreement required |
|
|
|
Scenario 6 |
External organization performs IRB review for local research activities; Ohio State is not the lead site |
No reliance agreement required |
|
|
|
Scenario 7 |
Ohio State is IRB of record for the external organization; no direct participant interaction or intervention at the external site (for example, external site collaborator receives identifiable data and/or specimens for analysis) |
IRB Authorization Agreement (IAA) ORRP IRB reliance coordinator will coordinate agreement process |
Parent study:
Participating site submission:
|
Parent study:
Participating site submission:
|
|
Scenario 8 |
Ohio State is IRB of record for the external organization; direct participant enrollment, interaction, and/or intervention at the external site |
IRB Authorization Agreement (IAA) ORRP IRB reliance coordinator will coordinate agreement process |
Parent study:
Participating site submission:
|
Parent study:
Participating site submission:
|
|
Scenario 9 |
Ohio State is engaged in human subjects research; external IRB acting as IRB of record |
IRB Authorization Agreement (IAA) ORRP IRB reliance coordinator will coordinate agreement process |
Huron pages:
|
|
Footnotes
- * As appropriate, the protocol and appendices should reflect the multi-site or collaborative nature of the research. When possible, consider referencing external collaborations in the research protocol and appendices in general terms, rather than listing individual organizations.
- ** As applicable, Ohio State's consent-HIPAA authorization language should reflect the multi-site or collaborative nature of the research. For example, the Confidentiality and HIPAA Research Authorization sections should state that collaborating organizations may have access to information.
- *** If an external collaborator being added with an Individual Investigator Agreement (IIA) has already completed the appropriate CITI training for another organization, then they may link their CITI completion records to Ohio State by following the instructions provided on the CITI website: How to add or change your affiliated institution or transfer completions.
Huron IRB tips for multi-site and collaborative research
Migrated multi-site studies
- Participating sites relying on Ohio State before the Huron migration have been grandfathered into the parent study and are listed on the Local Research Locations page.
- Any new sites should be added with a separate pSite submission.
- All study documents approved before the Huron transition, including relying site materials, have migrated into the Local Study Documents page and should not be moved.
- Any new study-related documents should be uploaded on the Study-Related Documents page.
- Employees and agents of external institutions, including those with a primary appointment at Nationwide Children's Hospital, should not be listed in Huron. Participating sites are responsible for approving their own study personnel based on their institution's policies and procedures.
Transitioning a single-site study to multi-site or collaborative research
- A parent study modification changing a single-site study to multi-site or collaborative research must be submitted and approved before a pSite can be added.
- The modification summary should include a brief description of the collaborative or multi-site nature of the research, including how pSites will be involved and what new or revised documents have been submitted.
- Upload a revised protocol and any new or revised appendices, as appropriate, to accurately reflect the multi-site or collaborative nature of the research. Refer to sites in general terms when possible.
- HRP-510 Appendix H – Multi-site Research is required.
- Make sure employees and agents from engaged pSites are not listed in Huron.
- Make sure new pSites are not listed as local research locations in the parent study.
- Consent form and recruitment material templates that pSites are expected to use to create their site-specific versions are not required but should be included on the Study-Related Documents page.
- Any study-wide documents approved before the modification will remain on the Local Site Documents page and should not be moved.
- After the modification is approved, the "Add Participating Sites" option becomes available to create a participating site submission.
Adding independent external collaborators
- Make sure that the external collaborator has an active Ohio State ID (name.#) and has completed the Ohio State-required CITI training and conflict of interest (COI) disclosure.
- In the modification summary, describe whether the external collaborator is involved in the research as an independent external collaborator or as an employee or agent of another organization, as this will help determine whether an Individual Investigator Agreement (IIA) is appropriate.
- Add the external collaborator to the Local Study Team Members page using the lookup tool.
- Upload a resume or CV in the "External team member information" section of the Local Study Team Members page.