2018 Common Rule Update – Cooperative Review in 2020
CooperativeResearch.pdf
Human Research Protections
UCI Health EPIC and 21 CFR Part 11 Compliance
Dear Researchers, UCI Health researchers involved with FDA-regulated studies may be asked to certify compliance…
Register for TechnoExpo!
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Compliance Tip: Research Consent in Electronic Health Record
View in Browser Medical Record Requirements Clinical Research Informed Consent and HIPAA Authorization Are you…
NIH Extends Policy for Clinical Trial Registration and Results Reporting for NIH-Funded Basic Experimental Studies with Humans (BESH)
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Update! Exempt Registration Self Determination
Update! Exempt Registration Self Determination In an effort to facilitate research and focus on IRB…
Guidance on Posting Informed Consent Forms for Federally Supported Clinical Trials
Posting an Informed Consent Form for Federally Supported Clinical Trials Background The Department of Health…
NIMH Data Sharing Policy (NOT-MH-19-033)
NIMH Data Sharing Policy On June 17, 2019, the National Institute of Mental Health (NIMH)…
Change in IRB Fees Effective July 1, 2019
Change in IRB Fees Effective July 1, 2019 Background The Human Research Protections unit in…
NIH Streamlines the Review of Gene Therapy Trials
NIH Streamlines the Review of Gene Therapy Trials On April 25, 2019, the NIH Office…
