Information for Panel Members
General Guidance
- eIRB+ Review Guide For IRB Members
- Tips for Preparing a Review
- Guidance on Use of Investigational Medical Devices in Human Subjects Research
- Considerations from a DEIJ Perspective
Federal Guidance
- Notice of Proposed Rulemaking (NPRM) affecting the Common Rule 9/2/2015
- Official posting in the Federal Register
- Summary of changes in the Quorum IRB Blog
- Discussion thread on IRB Forum website
- Presidential Commission for the Study of Bioethical Issues Blog Series: Modernizing Human Subjects Research Protections
- Public Responsibility In Medicine & Research (PRIM&R) NPRM webpage
- Links to Regulatory Agencies
- FDA Information Sheets: Clinical Trials Guidance
- OHRP Education Videos, includes:
- Research Use of Human Biological Specimens and Other Private Information
- Reviewing and Reporting Unanticipated Problems and Adverse Events
- General Informed Consent Requirements
- Institutional Review Board (IRB) Membership
- Complex Issues
- OHRP Webinar Slides: Internet Research 5-8-14
- OHRP Webinar Slides: Incident Reporting 7-24-14
- FDA Webinar Slides: IDE Guidance 9-4-14