Frequently Used Services
NIH policy requires multi-site research studies to rely on single IRB (sIRB) review. Check here HRPO guidance, resources, FAQs and the required form to submit for initiating an IRB reliance request
HRPO/IRB Policies and guidelines, including the IRB Standard Operating Procedures, and a link to the Clinical Research Handbook provide a comprehensive overview of the policies and guidelines for conducting human subjects research at the University
NEW! If you don't see your question addressed, please don't hesitate to contact us directly at: 212-305-5883 or email: [email protected].
Find out about the revised federal regulations for human subjects research protection and how they affect you
IRB consultations are offered at the Morningside, Manhattanville and Medical Center campuses. Check here for times and locations for walk-in consults - no appointment necessary
The recently revised federal regulations for human subjects research are now listed here, along with other relevant federal and state regulations, and ethical principles of human subjects research
IRB reviews, creating and submitting a protocol, Consent Form templates and suggested language
All changes to the research protocol must be submitted for prospective IRB approval unless a change needs to be implemented immediately to remove or minimize an imminent harm to subjects
Find information about participating in research at the University
As a prerequisite for IRB approval, all human subjects researchers must complete CITI Human Subjects Protection and HIPAA Privacy training. Access training programs here.
IRB 101s and Monthly Investigator meetings (MIMs) are regularly scheduled information sessions. Slidedecks and materials from the meetings are posted here.
Recent Announcements
New DoD/CDMRP Requirements: Use of Common Forms and Certification Now Mandatory
Dear Colleagues,
Please be advised that the Department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP) now require the use of the federal-wide Common Forms for both biosketches and current & pending (other) support in all applications. NIH-format Word templates are no longer acceptable for CDMRP submissions.
This requirement is part of CDMRP’s implementation of federal research security policy under the National Security Memorandum-33 (NSPM-33), which mandates standardized disclosure of researcher support and affiliations.
What’s New in the Common Forms:
- Certification of non-participation in a Malign Foreign Talent Recruitment Program (MFTRP) must be completed via electronic signature on both the biosketch and other support form.
- Expanded disclosure of consulting activities: Any consulting arrangement that involves research, is related to the individual’s research portfolio, or has the potential to affect funding, effort, or scientific integrity must be disclosed.
→ See Columbia’s guidance: Consulting Disclosure in Current and Pending (Other) Support - In-kind contributions (e.g., lab space, equipment, data or data sets) with an estimated dollar value of $5000 or more and that require a commitment of the individual's time must be disclosed.
- Expanded biosketch disclosures: Senior/Key persons must identify all domestic and foreign professional appointments and positions outside of the primary organization for a period up to three years from the date the applicant submits the application to CDMRP.
How to Complete the Forms:
- Researchers can use SciENcv to generate the Common Forms — note that only the NSF version is currently available, but will be accepted by DoD/CDMRP. See Columbia’s SciENcv resources.
- Alternatively, complete the Word templates made available on ourDOD Researcher Disclosure Requirementswebpage, which include all required fields and MFTRP certification language. These must be electronically signed.
- For electronic signatures:
- If you already use DocuSign for NIH forms, you may continue to use it.
- If you do not already have DocuSign, contact CUIT at [email protected].
- For assistance completing the Current and Pending (Other) Support form, see Have I Included...?
Please share this guidance with any faculty or administrators preparing CDMRP applications. The information, forms and resources above can also be located at DoD Researcher Disclosure Requirements.
For questions related to the forms, feel free to contact your SPA Project Officer.