Prior to any clinical research study commencing, a formal IRB review and approval are required. To begin this process the applicant needs to download and complete the IRB Application for Review of Research Involving Human Subjects. Applicants must submit one complete draft application (including protocol, consent form and Investigator’s Brochure) to the IRB office for initial review at least one month before the IRB meeting. After the initial review is completed, the applicant will be notified of any required revisions. Once the revisions are incorporated into the IRB Application, 18 final applications must be submitted to the IRB Office. These final applications should be submitted at two weeks prior to the IRB meeting.
- Application to Conduct Human Subjects Research
- Application to Conduct Research Using Existing Medical Records Jan 2014
- UPIRSO Reporting Form
- Noncompliance Report Form
- Final Report - Study Closure
- Application to Amend an Approved Protocol or Consent Form OR Communication
- Exempt Application
- Application for Continuing Review of Research
- Informed Consent Form
- Consent for Use of Tissue and Health Records for Research
All persons listed as investigators, research coordinators, or key personnel on a research project must have training in protection of human research participants.
Submit applications to Elaine Wall, IRB coordinator, Guthrie Foundation ( firstname.lastname@example.org, or call 570-887-4885)