Multi-site or collaborative research tools for investigators


Last 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

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

  • Local Research Locations
  • Local Site Documents

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:

  • Basic Study Information
  • Study Funding Sources

Participating site submission:

  • Local Site Documents

Parent study:

  • Huron protocol should reflect the multi-site or collaborative nature of the research, as applicable,* including:
    • Study Design & Procedures
    • Participant Population (number of participants)
    • Confidentiality and Management of Study Materials
  • HRP-510 Appendix H – Multi-site Research
  • Grant application
  • Ohio State ICF & HIPAA**

Participating site submission:

  • Executed IAA

Scenario 4

Ohio State provides IRB oversight for:

  • Engaged independent external collaborator
  • Employee or agent of an external organization that is not engaged
  • Employee or agent of an external organization that does not have a Federalwide Assurance (FWA)

Individual Investigator Agreement (IIA)

ORRP IRB reliance coordinator will coordinate agreement process

  • CV or résumé
  • Letter of Support, if applicable
  • Executed IIA

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

  • Basic Study Information
  • Local Site Documents
  • Huron protocol should reflect the multi-site or collaborative nature of the research, as applicable,* including:
  • Ohio State ICF & HIPAA**
  • External IRB approval

Scenario 6

External organization performs IRB review for local research activities; Ohio State is not the lead site

No reliance agreement required

  • Basic Study Information
  • Local Site Documents

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:

  • Basic Study Information

Participating site submission:

  • Local Site Documents

Parent study:

  • Huron protocol should reflect the multi-site or collaborative nature of the research, as applicable,* including:
    • Study Design & Procedures
    • Number of Participants
    • Confidentiality and Management of Study Materials
  • HRP-510 Appendix H – Multi-site Research
  • Ohio State ICF & HIPAA**

Participating site submission:

  • Executed IAA**

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:

  • Basic Study Information
  • Study Funding Sources

Participating site submission:

  • Local Site Documents

Parent study:

  • Huron protocol should reflect the multi-site or collaborative nature of the research, as applicable,* including:
    • Study Design & Procedures
    • Participant Population
    • Informed Consent Process
    • Confidentiality and Management of Study Materials
    • HIPAA Research Authorization (as applicable, if Ohio State is serving as HIPAA Privacy Board for the external organization)
    • Monitoring (if greater than minimal risk)
  • HRP-510 Appendix H – Multi-site Research
  • Ohio State ICF & HIPAA**

Participating site submission:

  • External IRB approval

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:

  • Basic Study Information
  • Basic Site Information
  • External IRB
  • Study Funding Sources
  • Additional Local Funding Sources
  • Local Study Team Members
  • Study Scope
  • Local Research Locations
  • Study-Related Documents
  • Local Site Documents

Footnotes

Huron IRB tips for multi-site and collaborative research

Migrated multi-site studies

Transitioning a single-site study to multi-site or collaborative research

Adding independent external collaborators



Article ID: 148
Created: September 1, 2026
Last Updated: September 1, 2026

Online URL: https://ohiostateresearch.knowledgebase.co/article/multi-site-or-collaborative-research-tools-for-investigators-148.html