Human Research Protections

The U.S. Department of Health and Human Services has announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991.  A Notice of Proposed Rulemaking (NPRM) (copy here) was published today, September 8, with a 90 day […]

  OHRP is delighted to announce an education workshop for research investigators and coordinators relatively new to human subjects research. Please pass the information to relevant personnel.   The Office for Human Research Protections (OHRP) co-hosts with The Office of Extramural Research (OER) at the National Institutes of Health A one-day pre-seminar workshop “Getting through

  Newborn Dried Blood Spots & Human Subject Research   On December 18, 2014 the Newborn Screening Saves Lives Reauthorization Act of 2014 (Public Law No: 113-240), an extension of the Newborn Screening Saves Lives Act of 2008 was signed into law.    The law, effective March 16th, applies to HHS-funded research that specifically involves

Reminder for Submitters: When submitting to the IRB, please be mindful of the following: Provide the IRB with necessary copies and signatures– in a timely manner After the Lead Researcher has electronically submitted the Application (APP), the following documentation must be submitted: 1 copy of the APP (including the Investigator’s Assurance(s) and Disclosure of Financial

IRB Full Committee Agenda Notification: Repeat Emails to Researchers Agenda Clearance: When a researcher submits an item for full committee review, Human Research Protections (HRP) Staff verify that the item – a modification request, continuing application, or new application – is ready for review. HRP Staff assure that the item is complete; including required signatures

UCI IRB accepts Western IRB Review   UCI has established an IRB Authorization Agreement with Western IRB (WIRB).  WIRB is an independent IRB, located in Olympia, Washington, that provides review services for academic and non-academic institutions. WIRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).   Why has UCI

Institutional Review Board Human Research Protection Updates   ·         Independent IRB Review for industry-authored clinical trials is coming To facilitate single IRB review of multi-site industry-authored clinical trials, UCI has signed an IRB reliance agreement with Western IRB (WIRB).  When the study sponsor or the CRO contracts with WIRB for IRB services, UCI investigators may