New York University Skip to Content Skip to Search Skip to Navigation Skip to Sub Navigation
Main Navigation

Quick Tips to Facilitate Efficient Protocol Review


Initial Submission


  1. Go to the Forms & Guidance page on our web site and download the appropriate application (Application for Review by the UCAIHS). Do not use previously downloaded copies as they may be obsolete.
  2. Complete all sections of the application before submitting the protocol via email to apply.humansubjects@nyu.edu. If a section is not relevant to your study, please type “Not applicable,” so that we know that you meant to omit the section.
  3. Attach all relevant material, e.g., funding proposal (grant or contract), study instruments  (questionnaire(s) or survey(s)), non-NYU site approvals (permission to conduct the study, other institutional IRB approvals, if relevant) and the Investigator Checklist/Data Entry Form.
  4. Verify that information is consistent between documents, e.g., is the number of subjects listed on the data entry form the same as the number in the protocol application?
  5. Name only one individual as Principal Investigator.  If the Principal Investigator is a student, administrator or non-NYU individual, a Faculty Sponsor must also be named. Please ensure that all personnel are entered on the Investigator Checklist/Data Entry Form.
  6. Ensure that all personnel have completed required training, i.e., UCAIHS Human Subjects Tutorial for NYU faculty/staff/students or have taken the Collaborative Institutional Training Initiative (CITI )Training for human subjects research [choose NYU as the Participating Institution. Once completed, print your grade book page and attach to your application].
  7. If requesting an exemption, thoroughly review the exemption categories to ensure that the protocol is eligible for exemption.  Consult with the UCAIHS Office staff if necessary. 
  8. Clearly identify the nature of the data collection, i.e., state whether it is anonymous, de-identified, coded, or non-coded.  Explain what mechanisms are in place to protect private, identifiable information.
  9. Describe in detail how subjects will be recruited, e.g., who will introduce the prospective subject to the study.  Attach all advertisements, recruitment letters or other materials that will be used for the recruitment of subjects, e.g., videos, scripts for radio ads, etc..
  10. Construct and attach all applicable consent documents, e.g., consent form(s), parental permission form, assent, information sheet/project summary form, or provide a justification if requesting a waiver of consent or a waiver of documentation of consent in accordance with 45 CFR 46.116(d).  Whenever possible, use the consent form generator. Final versions should be on departmental letterhead.
  11. Include details of appropriate additional protections if subjects may be considered a vulnerable population, e.g., how capacity to consent will be determined, what procedures will be implemented to avoid coercion or undue influence factors.
  12. Attach a cover letter if the protocol includes any factors that may not be self-evident, e.g., eligibility for review per the terms of a cooperative amendment, collaborative relationships, unique funding arrangements, issues that may arise during the review that have been resolved by an IRB during the review of a similar protocol, etc.).


Revisions (in response to Correspondence from the UCAIHS)


  1. Respond in memo format; be sure to address all questions and concerns.
  2. Revise the protocol, consent forms, or other documents as necessary.
  3. Attach your correspondence and any revised documents and send via e-mail to revise.humansubjects@nyu.edu
  4. Please ensure you reference the appropriate protocol number in the subject line of your email and reference it in all attached documents.


Amending an Approved Protocol


  1. Submit an Amendment to Approved Protocols form if there will be any change to an approved protocol.  A request via email correspondence or memo is not sufficient.
  2. Explain why the amendment is requested.
  3. Modify relevant fields in your protocol application and modify any relevant documents.
  4. Attach new documents.
  5. Review personnel section to ensure that the list is still current.
  6. Send your amendment request to: amend.humansubjects@nyu.edu.
  7. Please ensure that you reference the appropriate protocol number in the subject line of your email and reference it in all attached documents.


Renewing an Existing Protocol (Continuing Review)


  1. Submit your Request for Continuing Review far enough in advance to avoid expiration.  Expired protocols cannot be reactivated; a new protocol must be submitted if the study is to continue.
  2. Attach the latest versions of all relevant material, e.g., funding proposal (grant or contract), study instruments, i.e., questionnaire(s) or survey(s), non-NYU site approvals. e.g., permission to conduct the study.
  3. Submit the Request for Continuing Review sufficiently in advance of the expiration date to allow processing time.  If the Continuing Review is submitted prior to the expiration date, the protocol will not expire, however, you cannot continue to conduct research with human subjects until you have received a notification of approval from the UCAIHS.
  4. Send your Request for Continuing Review to: continue.humansubjects@nyu.edu.
  5. Please ensure that you reference the appropriate protocol number in the subject line of your email and reference it in all attached documents.

Have Questions?

Contact the UCAIHS office at
ask.humansubjects@nyu.edu
or via phone at (212) 998-4808
about IRB review or procedures.

NYU Footer

Unless otherwise noted, all content copyright New York University. All rights reserved.
Designed by The Office of Web Communications