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HRP News Briefs

RP News Briefs

Winter 2017:  2017 Updated Human Subjects Policies and Regulations

  • ClinicalTrials.gov Registration:  DHHS Regulation and NIH Policy
  • Updated Common Rule Regulation
  • NIH GCP Policy
  • NIH sIRB Policy

Late Fall 2016

  • IACUC RMS
  • HSCRO Updates
  • HRP
    • Single IRB (sIRB) Review
    • Quality Improvement (QI) Activities
    • Employees as Research Participants
    • Deception and Incomplete Disclosure
    • General Tips for Student Research IRB Application Submission
    • Exempt Research vs Expedited Research

Spring 2016

  • About IACUC
  • IACUC RMS
  • HSCRO Updates
  • HRP Updates
    • New Unanticipated Problems Form
    • NIH RAC Review
    • GINA
    • NIH COC
    • CITI Training
    • Lotteries
    • Ethnography Cloud STorage

Fall 2015

  • Special Edition - Proposed Changes to the Common Rule (NPRM)
    • Informed Consent
    • Biospecimen
    • Single IRB Review
    • Continuing Review
    • Excluded Research
    • Exempt Research
    • Waiver of Consent
    • Submit comments to OHRP by December 7, 2015

Summer 2015

  • Internet Based Research and Using Social Media Tools in Research
  • Comparative Effectiveness Research (CER) and Qualitative Social Science Research
  • Submitter's Corner
  • Education & Reminders: Research HIPAA Authorization

Fall 2014

  • The New Office of Research Website
  • The Short Form Consent Process
  • Advertisements and Recruitment Materials
  • Education & Reminders: Retrospective Data

Fall 2013

  • Waiver of Written (Signed) Informed Consent
  • HRP Staff Contact Information
  • Education and Reminders: Expiration of IRB Approval

Summer 2013

  • Surrogate Consent Process: In Practice
  • The Surrogate Consent Process: Differentiation of Conditions
  • HRP Staff Contact Information
  • Education and Reminders: New Scientific Review Process

Spring 2013

  • The Short Form Consent Process – REVISED
  • The Consent Process
  • Clinicaltrials.gov
  • HRP Staff Contact Information
  • Education and Reminders: Record Keeping

Fall 2012

  • Use the UCI IRB Approved (Stamped) Consent Form
  • The Honest Broker Process
  • The Extended 3 Year IRB Approval
  • HRP Staff Contact Information
  • Education and Reminders: Clinical Research and Finance Administration (CRFA)

Summer 2012

  • Changes to Conflict of Interest Regulations for PHS Funded Research
  • IRB 101 – A Workshop for the New Submitter
  • Considerations: Including Pregnant Women in Human Subject Research
  • HIPAA Research Authorization Reminders
  • HRP Staff Contact Information
  • Education and Reminders: IRB Member Rosters and Enrollment

Spring 2012

  • Increased IRB Fees
  • CITI Research Tutorial Requirement Reminder
  • Human Research Records Retention
  • The New Submitter's Workshop in 2012
  • HRP Staff Contact Information
  • Education and Reminders: Information Commonly Requested

Winter 2011-2012

  • The New Submitter’s Workshop in 2012
  • New Deadline Day for IRB- Full Committee
  • Human Subjects Application & Protocol Preparation Checklist
  • HRP Staff Contact Information
  • Education and Reminders: Information Commonly Requested

Fall 2011

  • Changes to Human Research Education: CITI
  • It's Official! AAHRPP Re-accreditation
  • Changes to Other Committee Reviews
  • Attention Student Researchers!
  • HRP Staff Contact Information
  • Education and Reminders: Completing Drug Logs

Summer 2011

  • AAHRPP Site Visit a Success!
  • Privacy vs. Confidentiality: Main Differences
    • Understanding How to Address Privacy
    • Understanding How to Address Confidentiality
  • Education & Reminders: Methods of Recruitment-Tips to Remember
  • HRP Staff Contact Information

Spring 2011

  • The Informed Consent Process- Reminders and Updates
  • When a Witness to the Consent Process is Required
  • What is "CIP"?
  • AAHRPP Site Visit Scheduled
  • Education & Reminders: ICTS Clinical Research Ethics Consult Service
  • HRP Staff Contact Information

Winter 2010-2011

  • Important Points to Remember When Conducting Human Subjects Research
  • Data and Biospecimen Repositories
  • Submitting e-CPAs - Timing to Avoid Expiration of Approval
  • UC Irvine Pursues Reaccreditation with AAHRPP
  • Education and Reminders: Does Your IRB-Approved Study Require HIPAA Research Authorization?
  • HRP Staff Contact Information

Fall 2010

  • New Location—Office of Research / Human Research Protections
  • Other UCI Compliance Committees/Groups
  • Reference Chart: Other Clearance Committees
  • Use of the Social Sciences Lab – No More Penalty Credits
  • UC Irvine Pursues AAHRPP Reaccreditation
  • The 'EQUIP' Program

Summer 2010

  • All About the IRB Approval Letter
  • Meet Dr. Linden– Chair of IRB "B"

Early Spring 2010

  • Establishing Research Repositories and Databases
  • Tips for Continuing Review Submissions

Fall 2009

  • IRB Registration with the FDA
  • Incomplete IRB Submissions
  • Meet Dr. Mulnard – Chair of IRB C!
  • The Seven-Year De Novo Review
  • What is a Limited Data Set?
  • HIPAA and Research

Summer 2009

  • Why Does the IRB Need to Conduct a Continuing Review?
  • Changes to the IRB & Conflict of Interest Process
  • Meet Dr. Mozaffar– Chair of IRB A!
  • Who May Serve as a Witness to the Consent Process?
  • Preparing for a Routine Clinical Research Audit: Essential Documentation
  • Databases & Registries
  • What is the 'EQUIP' Program?

Spring 2009

  • Preparing for a Routine Audit - Tips from the Office of Research Oversight
  • UCI IRB Statistics for 2008
  • Non-Human Subject Research Determination Form
  • Vulnerable Populations: Prisoners in Research
  • The HRP Staff Pre-Review Process

December 2008

  • Important Changes Effective in 2009
  • ICTS Scientific Review Committee
  • Human Subjects Protections and Conflict of Interest

April/May 2008

  • AAHRPP Update
  • Emergency Use of a Test Article
  • Clinical Research and Data Safety Monitoring Plans
  • Pregnant Women and Fetuses

March 2008

  • Criteria for IRB Review and Approval (§46.111 and §56.111)
  • Human Research Records Retention
  • Investigator Responsibilities when Conducting Human Subjects Research
  • Vulnerable Populations—Children

January/February 2008

  • AAHRPP Site Visit Announced
  • Privacy and Confidentiality
  • Data Security and Human Subjects Research
  • UCI IRB Statistics for 2007

November/December 2007

  • AAHRPP Reaccreditation Update
  • Belmont Report Basics
  • Modifications (Amendments) to Approved Research
  • Filing a Closing Report When Research Concludes

October 2007

  • The Informed Consent Process
  • Informed Consent Waivers Simplified...
  • Use of Surrogate Consent
  • Informed Consent Do's and Don'ts
  • Consenting Subjects Who Cannot Read, Speak or Understand English

September 2007

  • Revised AE-UP Reporting Module
  • Determining the Level of IRB Review
  • Why Does the IRB Conduct Continuing Review?
  • Importance of Avoiding Lapses in Approval

August 2007

  • IRB Task Force Recommendations Received
  • UC Irvine Pursues AAHRPP Reaccreditation
  • What is Human Subjects Research?
  • Tips for Submitting Complete IRB Applications
  • Tips for Student Research Projects

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