IRB Applications
Post IRB Approval Responsibilities
Please note: You must continue utilizing your original submission method until your study is closed (e.g. paper studies remain in paper, eIRB studies remain in eIRB).
- Submit Modification(s) (any change to your originally approved study)
- Submit Progress Report or Continuing Review (if required)
- Submit Reportable Event
- Consent Posting Requirement for Clinical Trials not regulated by the FDA
The 2018 Revised Common Rule (45 CFR 46.116(h)) requires that "for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame. The consent form must have been used in enrolling participants in order to satisfy this new provision." Learn More
At this time, two publicly available federal websites that will satisfy the consent form posting requirement, as required by the revised Common Rule, have been identified: ClinicalTrials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021), (View Posting Instructions).
Deadline To Post: The form must be posted after recruitment closes, and no later than 60 days after the last study visit by any subject, as required by the protocol (See 46.116(h)(3))
Note: Currently, the FDA has not signed on to the Revised Common rule (Learn More). This means, that this requirement does not apply to Clinical Trials governed by the FDA.