What are “Revisions/Conditions”requested by the IRB?
After the Principal Investigator submits a study, the IRB may ask for revisions or place conditions on the study before final approval is granted. For example, the IRB may request revisions to the consent form after the IRB staff, designated IRB reviewers, or the Full Board reviews the study. Instructions: To fulfill the conditions, (a) re-submit the documents of your protocol which require the revisions (e.g., if the revisions are only to the consent form, submit only the consent form). (b) submit a cover memo referencing the revisions by the corresponding item number in the revisions letter. (e) Highlight, bold, or underline each revision referencing them by the corresponding item number in the revisions letter. Once you have fulfilled the conditions, you will be notified by email with a formal letter attached that your protocol is approved.
Related Questions
- How do I make changes, requested by the IRB, to the protocol and/or consent form during the initial review process, i.e., before the study receives initial approval?
- When should an Institutional Review Board (IRB) or institution request a "407" review for research involving children as subjects?
- What are the exact freight charges / weight / dimensions for the products I requested?
