Human Research Protection Program

Policies and Guidance Documents

IRB Procedures

Accessing PHI with Waiver of HIPAA Authorization Updated 11/6/2020 Adverse Event Procedure  Updated 4/1/2019 Adverse Event Flow Chart Updated 3/28/2019 Deviation, Violation and Exception Request Procedure Updated 03/05/2020 Deviation, Violation and Exception Request Flow Chart Updated 03/05/2020 Frequency of IRB Review and Verification of Material Changes  New 9/16/2019 HRPP Written Procedure Revised 7/26/2022

Department Guidance

Human Research Protection Overview Updated 04/09/2020 Guidance for IRB Review of QI/QA Projects Updated 08/13/2020 Guidance for Obtaining Informed Consent via Telephone Updated 12/15/2020 Guidance for Online Tools for Research Activities, Data Collection and Storage Updated 10/14/2020 What Reviewers Need From Your Research Application Guidance for Removal of Individual Identifiers from information/Records/Samples Guidance for Research Involving Children Guidance for Student Researchers Guidance for When to Submit an FYI xForm Updated 01/25/2021 How to Copy a Submitted xForm New 9/10/2021 Site Permission Letter Template New 11/04/2021

Institutional Policies

Policy on Use of Human Subjects in Research Policy on Payment for Injury to Study Subjects Financial Conflict of Interest Policy for Sponsored Programs