成人抖阴

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

Quick Links

• • 成人抖阴 IRB Guide on Creating a Reliance Agreement (SMART IRB)

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 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 成人抖阴 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 human subjects research (HSR) involving multiple institutions

• Federally funded multisite research under the NIH Single IRB policy

• When 成人抖阴 is the reviewing IRB for a multisite project

When It’s Not Required:

• Research determined to be exempt

• Collaborators not engaged in human subjects research (HSR)

• Each institution prefers an independent review

成人抖阴 participates in the 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.

Important Timeline Consideration

If your research involves external institutions or collaborators, additional review steps, such as establishing IRB reliance agreements, may be required. These processes are often dependent on the policies, review timelines, and responsiveness of the external institution(s), and may add 2-4 weeks to the IRB review timeline that applies to your study (e.g., Exempt, Expedited, or Full Board review as described above). While the 成人抖阴 IRB will actively support and help coordinate reliance agreements, certain delays may be outside of our control. Researchers are strongly encouraged to begin discussions with external partners early and plan accordingly when preparing their submission.

Requirements for External Collaborators

CITI Training

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

• 成人抖阴 prefers affiliation with “成人抖阴 – 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 成人抖阴 IRB Training and Certification page for more information. 

Independent Investigator Agreement (IIA)

If an external collaborator is not affiliated with an institution that maintains an IRB, or is conducting research independently of their affiliated institution’s IRB oversight, they must enter into an Independent Investigator Agreement (IIA) with the 成人抖阴 IRB. This agreement documents the Investigator’s responsibilities for complying with federal regulations and 成人抖阴 policies for human subjects protection.

Please refer to the for more information.

System Access

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

1. Submit a request to to create a temporary 成人抖阴-affiliated profile.
2. to grant specific system access once the profile has been activated.
3. Ensure CITI training is complete and linked to the 成人抖阴 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. 成人抖阴 uses the HIGHQ Contract Management Portal for all DUA processing.

• Initiate via the 成人抖阴 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 成人抖阴's

• 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

2. Consult with the 成人抖阴 IRB early in the planning phase

3. Complete CITI training for all external collaborators

4. Complete an Independent Investigator Agreement (IIA), if applicable 

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

6. Prepare materials for international compliance, if applicable

7. Submit your protocol to Mentor IRB

8. Request system access, if needed

Contact & Support

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