Maintaining IRB Approval

Continuing Review

Steps for submitting your continuing review application:

  • Go to “Forms and Applications” on the IRB home page at http://www.ccny.cuny.edu/irb .

  • Select 'Continuing Review' Form.

  • Make sure to submit the form to the IRB with a copy of the new consent form that you plan to use and a copy of the old consent form.

  • Make sure to include the most recent versions of all relevant documents and material, such as the following: study instruments {i.e., questionnaire(s) or survey(s)}, IND/IDE documentation, non-CUNY site approvals (e.g., IRB approvals from other institutions, Department of Education), consent forms, new funding proposal (grant or contract), sponsor protocol.

  • Please file your renewal well in advance of the expiration date to allow processing time for the IRB review. (At least 14 days in advance for Expedited/Exempt review. All Full Board Applications must be submitted in time for a Full Board Meeting before the protocol Expiration date.)

  • If the request for continuing review is filed, research activities (including data analysis) must cease on the expiration date of the protocol. Once the protocol has been renewed, research activities may resume. Federal Regulations and CUNY policy permit research activities to continue uninterrupted ONLY if the continuing review is approved by the IRB prior to the expiration date.

Amending the Approved IRB Protocol

Amending an Approved Protocol

Submit an amendment request if there will be any change to an approved protocol. Requesting information, reporting a change or planned changed via correspondence does not change the protocol.

To submit an amendment, please follow these steps:

  • Go to “Forms and Applications” on the IRB home page at http://www.ccny.cuny.edu/irb .
  • Complete and submit your amendment/modification by mailing 2 hard copies if you think it is an expedited or exempt modification. Submit 6 copies if you think the modification will require a full committee review.

On the application, be sure to:

    • Explain why the modification is requested (under #3).
    • Revise the protocol, consent forms, or other documents as necessary.
    • Attach new documents, such as consent forms, with changes/additions highlighted in bold.
    • Attach old approved consent form.
    • Review the Key Personnel section to ensure that the list is still current. Attach new current list if adding new personnel.