This letter must contain the project number, title, name of principal investigator, and should specifically state that an amendment to the currently approved study is being requested. The letter should clearly detail what the modification is, why it is being requested, and any potential changes to risks to subjects, risk/benefit ratio, risk management procedures, etc. If revisions have been made to study documents, the cover letter must provide an outline of those revisions as well as why those revisions are being made. The cover letter must be provided over the PI's signature.
If the amendment/modification requires revision to the application Facesheets, revised application Facesheets must be submitted. The revised Facesheets must be signed and dated by the PI. If a change in the study PI is being requested, revised application Facesheets reflecting the change in PI that is signed and dated by the Department Chair and incoming PI must be provided. (As noted above, please do not submit as a New Project submission.)
Two copies of a revised Research Plan are required if revisions have been made to this document. One copy must clearly and specifically highlight all the changes made to the document including additions and deletions by using the track changes function in Microsoft Word (or a similar function in other word processing software), and one clean copy of the document must be submitted. This is only required if there are revisions to any item of the Research Plan.
Two copies of the revised document(s) must be submitted. One copy must clearly and specifically highlight all the changes made to the document including additions and deletions by using the track changes function in Microsoft Word (or a similar function in other word processing software). Consent/assent forms are stamped by the HRPP once they have been approved; therefore, the second copy submitted should be a clean copy of the revised consent/assent with a 2-inch by 2-inch "content-free" space on the upper left-hand corner of the first page of the document and the lower right-hand corner on the remaining pages for appropriate placement of the IRB stamp-of-approval.
Additional information should be submitted including updated Master Protocol, Investigator's Brochure, package insert, recruitment materials, etc., if applicable. If any of the documents have been revised, two copies must be provided, one that highlights the changes and one clean copy, as noted above.
The addition of minors to a protocol requires review a convened IRB. This modification also requires the addition of a parental consent, adolescent assent (for children age 13-17 years) and child assent (for children aged 7-12 years), as needed. The cover letter should also clearly describe specific risks, risk/benefit, and risk-management procedures, etc. in regards to the addition of this vulnerable population.