Revision/Addendum Request
Investigators must seek IRB approval before making any changes in approved research - even though the changes are planned for the period for which IRB approval has already been given - unless the change is necessary to eliminate an immediate hazard to the subject, in which case the IRB must then be notified at once.
Minor changes may be authorized by the IRB chairperson, such as changes that do not involve increased risk or discomfort. A letter specifying the changes requested, a revised consent form, and a copy of the approved protocol with the proposed changes highlighted, should be sent directly to the IRB office for approval.
To initiate a revision, the PI must submit a CPHS Revisions and Additions Request Form. Any study documents that are being revised or added must also be submitted to the CPHS. This includes changes to the protocol, consent, advertisements, letters of support from new sites, assessment tools, scripts, treatment manuals and handouts. Any changes to the protocol that are described in the Revisions and Additions Request Form, must also be incorporated into the protocol. All requested additions to materials previously submitted to the CPHS must be in bold print or highlighted in the submitted materials. All deletions must be struck through. In edition to the edited version of the consent, which has highlighted additions and struck through deletions, a clean copy shall also be submitted to be stamped.
When a request for revision approval arrives, the materials will be reviewed by the administrator to assure the submission packet is complete. If it is not complete, the administrator will contact the PI to request the added materials. Based on a risk assessment evaluation the CPHS office will determine the process of which the revision is best suited for administrative review, expedited review, or full committee review.
Submission Deadline: For revisions that are an increase in risk, the deadline is the first Wednesday of each month by noon. Items received after this deadline may or may not be included in that month's review, depending on the lateness of their receipt.
Submission Requirements:
- A completed revision request form with signature and date. Department Chair or equivalent supervisor must sign if this increases risks.
- Copy of the new or revised documents. If revised, then additions must be highlighted and deletions strike-through. If not provided, the submission will be returned.
- Clean copy of revised documents.
- If you are adding new sites, please include a letter of support for all sites under the jurisdiction of NH CPHS.
Sample Forms & Documents: All necessary documents with instructions can be downloaded from the www.irbnet.org in the "State of New Hampshire DHHS CPHS, Manchester, NH" Library.