OR Human Research Protections

UCI students, staff, faculty and research personnel can now log in to the Collaborative Institutional Training Initiative (CITI) website using their UCINetID and password.  This process, known as Single Sign-On or SSO, provides distinct advantages over the old system of individual account access: ·Enhanced security ·No additional Username/Password for users to remember ·Automatic log-in if […]

NIH has changed its policy regarding Recombinant DNA Advisory Committee’s (RAC) review of individual human gene transfer trials. Effective April 27, 2016, UCI’s Institutional Biosafety Committee will determine whether investigator-initiated research requires RAC review based on specific criteria.  The RAC Revision Factsheet includes a list of the criteria and a summary of the changes.  Also

Dear Researchers, We are launching a new application for reporting Unanticipated Problems (UP) on May 04, 2016. Any draft versions using the current AE/UP application must be submitted by April 29, 2016 5:00PM.  All un-submitted drafts will be deleted after this date. Please look for upcoming announcements regarding the new UP application process.

Dear Colleagues: This is to let you know that there is a Senior ERA Analyst position open on the Electronic Research Administration (ERA) team. The summary of the job is: Under the general direction of the Assistant Director, Electronic Research Administration (eRA), and in collaboration with Research Administration (RA) and Office of Information Technology (OIT),

HHS Proposal to Improve Rules Protecting Human Research Subjects Comment period extended to new deadline – January 6, 2016   Dear Researchers,   The Department of Health and Human Services and fifteen other Federal Departments and Agencies are extending by 30 days the comment period on the Federal Policy for the Protection of Human Subjects

Due to scheduling conflicts, this November’s COIOC Deadline is October 26, 2015.  Complete disclosures should be submitted by October 26, 2015 to Amy Green, COI Analyst, at acgreen1@uci.edu to be considered for review during the November 19th COIOC meeting.   Thank you for your help.  Please contact me at nadiaw@uci.edu if you have any questions.

Process Improvements UCI Human Research Protections (HRP) and the Institutional Review Board (IRB) are always looking for ways to reduce administrative burden on researchers, IRB Members and IRB Staff. We are pleased to announce the first of several changes in our procedures that should help reduce burden. Reminder of Recent Changes… Research Protections Roadmap –

Reminder of Requirements Regarding Human Fetal Tissue Used in Research Posted on August 31, 2015 by NIH Staff NIH reminds all grantees and contractors that research involving human fetal tissue must be conducted in accordance with applicable federal, state and local laws, regulations, and policies, including the NIH Grants Policy Statement. For more information, see Notice

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