- Survey Results (2018-2019 Panel Year Q1 Results)
- What's New
- New Common Rule effective January 21, 2019.
- eProtocol is rolling out a new user interface (UI) on the updated Exempt form that includes the new Common Rule Exempt categories. While the new UI has a different appearance, the application questions have not changed. The Exempt form is the only IRB form using the new UI at this time.
- New Exempt form in eProtocol (video)
- Sample eProtocol Template Forms.
- Two new eProtocol forms, Single Patient IND and Humanitarian Use Device (HUD)
- European Union General Data Protection Regulation (GDPR) is now in effect. Learn more.
- New Guidance - Pregnant Partner Consent Process
- New AID - Data Safety Monitoring Board in Phase I/II Cell and Gene Transfer Clinical Trials
- Single IRB (sIRB)
- Short Form Consent Process (updated to note that the witness does not have to speak the participant's language)
- ClinicalTrials.gov
- Revised Intake Process for Industry Clinical Trials
- Changing policies impact NIH-funded studies involving human subjects In your proposal application packet, be sure to complete the “R&R Other Project Information” form page before you complete the “PHS Human Subjects and Clinical Trials Information” form page as the first will populate the second. Please view this 9 min You Tube video: PHS Human Subjects and Clinical Trial Information Form Walk-through.
- Revised Intake Process for Industry Clinical Trials
- New Common Rule effective January 21, 2019.
| Quick links for researchers |
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Getting started
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Consent Templates, Forms, eProtocol attachments |
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FAQs
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- About the IRB (the Administrative Panels on Human Subjects Research)
- Charge to the IRBs
