Amendments / Modifications
A modification is defined as any change to a protocol from what was previously approved during the period for which approval was given. Changes in research procedures or consent/assent form(s) cannot be initiated by the investigator without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.
Approval is granted by the IRB Chairperson or an experienced IRB member unless the nature of the proposed changes warrant full IRB review. The Investigator and the IRB Contact Person will be notified through an electronic memo of the IRB's decision. If approved, the clean copy of the revised consent /assent form(s) with the valid "IRB approval" stamp and expiration date will accompany the approval letter.
Review the current IRB Fee Schedule for review charges.
Protocol or Consent Form Changes (changes to protocol, consent form, assent, or Investigator Brochure) (updated 08 Aug 2011)
- For minor changes, submit the signed original Protocol or Consent Form Changes Form, tracked changes and clean versions of all documents + one (1) photocopy of all forms/documents submitted.
- For greater-than-minor changes (study design changes, changes to medical inclusion/exclusion criteria, changes to enrollment greater than 10%, etc), submit the signed original Protocol or Consent Form Changes Form, tracked changes and clean versions of documents + two (2) photocopies of all documents submitted.
Feel free to contact the IRB office for guidance on whether an amendment constitutes a minor or greater-than-minor change.
Other Change/Updates (creation of, or changes to, letters, questionnaires, surveys, access to the National Jewish Health repositories, etc) (updated 08 Aug 2011)
- If requesting access to National Jewish Health repositories, include the Supplemental Access to NJH Repositories form (updated 10 Aug 2011).
- Submit the signed original Change/Updates Form, tracked changes and clean versions of all documents + one (1) photocopy of all forms/documents submitted.
Advertisement Submission Form (creation of, or changes to, brochures, posters, flyers, print ads, etc) (updated 08 Aug 2011)
Principal Investigator Change Form (updated 05 Sep 2012)
- Changing the Principal Investigator is considered a greater-than-minor change to the study.
- The form contains instructions for determining the correct number of copies.
Personnel Change Form (updated 29 Nov 2012)
- Submit the signed original Personnel Change Form + one (1) photocopy. Be advised that the IRB requires a signed Conflict of Interest form specific to the study for all individuals added to the study. A CV is also required of each co-investigator added to the study.