OR Human Research Protections

Anticipated Launch of a new application for reporting Unanticipated Problems

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.

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30-day Extension of the Comment Period on the Proposal to Improve Rules Protecting Human Research Subjects

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

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Reminder- November COIOC Deadline: October 26th

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.

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NIH reminder regarding Human Fetal Tissue used in Research

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

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HHS Announces Proposal to Improve Rules Protecting Human Research Subjects

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

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Workshop: “Getting through Human Research Reviews with Skill” – 10/14/15

  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

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Newborn Dried Blood Spots & Human Subject Research

  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

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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