How to Modify a Study

Follow the Instructions below if you are:

  • Modifying any study documents (consent, protocol, advertisement, questionnaires, etc.)
  • Adding or Removing Study Personnel
  • Changing the Principal Investigator
  • Requesting a Protocol Exception- A temporary protocol deviation that is not to eliminate immediate hazards to a subject (e.g., enrollment of a subject who does not meet the eligibility criteria). A protocol exception must be approved by the IRB prior to its initiation

Step 1:

Complete the appropriate sections on the following form: Application for Requested Modifications, located on our IRB Forms page

Personnel Changes

Step 2A:

If the modification involves adding personnel to a study the following should be completed by each individual being added to the study:

    • Electronic Conflict of Interest Disclosure via the eRA portal. If study personnel does not have a Northwell Health log in: Complete the paper Conflict of Interest Questionnaire located on our IRB Forms page
  • Researcher Registration Form (if not previously completed for other study OR if the CITI Protection of Human Subjects training course was completed on 12/1/2013 or later)
  • If the study has been deemed greater than minimal risk by the IRB and the individual will obtain informed consent from subjects: Submit a copy of a copy of the individual’s registration certificate for valid NY state licenses (with expiration date)
  • Don’t forget to complete questions 1-4 on the Application for Requested Modifications form, page 3.

To remove personnel, simply list them as removed in the appropriate section on the form

Change in Principal Investigator

Step 2B:

If the modification involves changing the Principal Investigator, follow these instructions:

  • Modify the protocol and the consent document to reflect the change
  • If the study has been deemed greater than minimal risk by the IRB:
    • Submit a CV documenting the PI’s research experience
    • Submit a copy of a copy of the individual’s registration certificate for valid NY state licenses (with expiration date)

Modifying or Amending Study Documents

Step 2C:

If the modification involves modifying or amending study documents, the following instructions should be followed:

  • Revised documents should be submitted in an editable format (Word, Excel, etc.) whenever possible
  • Any changes made to the protocol, consent, questionnaires, etc. should be modified with the “track changes” feature in MS Word.
  • Sponsored studies should submit modified protocol in a text-searchable PDF with a Summary of Changes if a tracked changes version of the protocol is not available
  • Any changes made to data collection documents that are in Excel format should be highlighted

Step 3:

Submit completed form, revised study documents and any other requested information to the IRB.