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 IRB Fee Schedule for review charges.
Protocol or Consent Form Changes (changes to protocol, consent form, assent, or Investigator Brochure) (updated 03 Dec 2009)
* 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 major 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 version of documents + seventeen (17) photocopies of all documents submitted. If a long protocol is amended, you may submit two copies (tracked changes and clean versions) of the complete protocol + 15 copies of a protocol summary.
* Feel free to contact the IRB office for guidance on whether an amendment constitutes a minor or major change.
Other Change/Updates (creation of, or changes to, letters, questionnaires, surveys, access to the National Jewish Health repositories (for recruitment or medical history collection), etc) (updated 03 Dec 2009)
* If requesting access to NJH repositories, also include the IRB Supplemental Access to NJH Repositories form (updated 23 Nov 2009).
* 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 29 Jun 2009)
* Submit the signed original Advertisement Submission Form, tracked changes and clean versions of all documents + one (1) photocopy of all forms/documents submitted.
Principal Investigator Change Form (updated 16 Nov 2009)
* Changing the Principal Investigator is considered a major change to the study.
* The form contains instructions for determining the correct number of copies.
Personnel Change Form (updated 11 August 2009)
* Submit the signed original Personnel Change Form + one (1) photocopy. Be advised that submission of co-investigators requires a CV on file with the IRB office and a signed Conflict of Interest form specific to the study.
