Please include a cover letter justifying and describing the changes and the documents affected by this change. The currently approved protocol must be included with the changes highlighted. OHRP recommends that each revision to a research protocol be incorporated into the written protocol. This practice ensures that there is only one complete protocol with the revision dates noted on each revised page and the first page of the protocol itself. This procedure is consistent with the procedure used for revised and approved informed consent documents which then supersede the previous one(s).
Modifications can include:
- change of research title
- PI’s name change
- change of PI
- new study staff
- new funding
- change to consent forms
- recruitment materials
- research question
- increase in risk to subjects