External Collaborations in Human Subjects Research

Collaborating with researchers or institutions outside of Teachers College? This page outlines the guidance, responsibilities, and agreement processes that apply to external collaborations involving human subjects research.

Quick Links

• TC IRB Engagement Determination Checklist for External Collaborators

• TC IRB Researcher Guidance for External Collaborations

• SMART IRB Platform

  • TC IRB Guide on Creating a Reliance Agreement (SMART IRB)

• OHRP Guidance on Engagement

Understanding Engagement in Research

Before initiating any collaboration, determine whether the external party is “engaged” in human subjects research per 45 CFR 46. This determines whether IRB oversight, reliance agreements, or other protections are required.

Use the TC IRB Engagement Determination Checklist for External Collaborators to evaluate:

• Interventions or interactions with participants

• Access to identifiable private information

• Consent or assent responsibilities

• Role in data analysis or interpretation

If the external collaborator is not engaged, IRB oversight may not be required, but a Data Use Agreement (DUA) or institutional documentation might still be necessary.

Reliance Agreements

When TC researchers collaborate with external institutions, a reliance agreement may be required to designate a single IRB of record.

When a Reliance Agreement Is Required:

• Non-exempt HSR involving multiple institutions

• Federally funded multisite research under the NIH Single IRB policy

• When TC is the reviewing IRB for a multisite project

When It’s Not Required:

• Research determined to be exempt

• Collaborators not engaged in HSR

• Each institution prefers an independent review

TC participates in the SMART IRB agreement. Please visit the Creating a Reliance Agreement (SMART IRB) page for more information, and contact IRB@tc.edu to explore reliance options early in the process.

Requirements for External Collaborators

CITI Training

All external collaborators engaged in research must complete CITI Program training.

• TC prefers affiliation with “Teachers College – Columbia University” in CITI

• Equivalent training from other institutions may be accepted with prior approval

• Proof of completion must be submitted before IRB review

Please refer to the TC IRB Training and Certification page for more information. 

System Access

If your collaborator is not affiliated with Teachers College but requires access to TC platforms (e.g., Mentor IRB, Google Drive, Box), the following steps are required:

1. Submit a request to Human Resources to create a temporary TC-affiliated profile.
2. Coordinate with TCIT to grant specific system access once the profile has been activated.
3. Ensure CITI training is complete and linked to the TC profile before the collaborator logs into Mentor IRB.

Note: System access is typically time-limited and must align with the duration of the research collaboration.

Data Use Agreements (DUAs)

DUAs are required for the transfer of data between institutions, especially when PHI or PII is involved. TC uses the HIGHQ Contract Management Portal for all DUA processing.

• Initiate via the TC General Counsel Contracts Portal

• Complete mandatory training before submission

• Ensure you're added to the QUIS system

Note: The IRB does not manage DUAs directly.

International Research

For collaborations involving non-U.S. partners, the following must be addressed:

• Local context review using TC's template

• Translation verification for consent and other study materials (e.g., recruitment materials)

• Compliance with applicable privacy laws (e.g., GDPR, PIPL)

Visit our International Research page for full guidance and templates.

Steps to Launch an External Collaboration

Use this workflow to stay compliant and on track:

1. Assess engagement using the TC IRB Engagement Determination Checklist for External Collaborators

2. Consult with the TC IRB early in the planning phase

3. Complete CITI training for all external collaborators

4. Initiate reliance/DUA processes via appropriate portals, if applicable

5. Prepare materials for international compliance, if applicable

6. Submit your protocol to Mentor IRB

7. Request system access, if needed

Contact & Support

For questions, please submit a ticket via AskIRB or email irb@tc.edu.