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 […]
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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
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The Same but Clearer: Update to Conflicts of Interest in Human Subjects Research Project Policy The Conflict of Interest and Institutional Review Board recently updated the Conflicts of Interest in Human Subjects Research Policy to clarify key definitions, including researcher and disclosable financial interest. Please note the disclosable financial interest thresholds and procedures have
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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
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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
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Attention UCI Researchers: Collaborative Institutional Training Initiative (CITI) Program Website Downtime Starting Monday July 29, 2013 at 8 a.m., the CITI Program website will be unavailable for approximately two to three days to complete a major software upgrade. Please be mindful of this downtime should you or a member of your research team need to
THIS MESSAGE FROM OHRP IS BEING FORWARDED BY THE OFFICE OF RESEARCH TO ACTIVE RESEARCHERS AT UCI Dear Colleague: The U.S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) is delighted to announce a new series of educational workshops entitled: “Quality Assessment Workshop 2.0: Focus on
OHRP Workshop on Informed Consent – August 23, 2013 Read More »
To: UCI Researchers From: UCI Office of Research, Human Research Protections Children’s Hospital of Orange County (CHOC), MemorialCare Health System (MHS) and UCI Irvine (UCI) have entered into an agreement that allows human subjects research to be reviewed by one IRB when two or more institutions are engaged in the same human subject
Effective May 1, 2013, the Institute for Clinical and Translational Science (ICTS) Scientific Review Committee will no longer be responsible for the scientific review of research. The purpose of scientific review is to ensure that research studies conducted at UCI have scientific validity, feasibility, statistical relevance, potential benefit to participants and/or to society. For all
REMINDER TO RESEARCHERS – USE THE UCI IRB STAMPED CONSENT FORM: UCI Investigators are required to use the UCI IRB approved (UCI seal in footer) version of the consent form when obtaining signed informed consent (unless the IRB has granted a waiver or alteration of the consent process). To ensure that your research team is
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