THE HUMAN RESEARCH PROTECTION PROGRAM

THE COMMITTEE ON HUMAN RESEARCH WEB SITE MAP AND DIRECTORY About the Committee on Human Research Contact Information Applying and Reporting to the CHR •  What is the CHR ? • Responsibilities in Research Involving Human Subjects • Important Dates • Who Must Have CHR Approval Before Enrolling Human Subjects In Research • History and Composition • Charge •  UCSF Federalwide Assurance of Compliance with DHHS • Office • Questions • HRPP Personnel • CHR Chairs and Vice Chairs • Status Checks     •  General Information • Do I Need to Apply to the CHR? • What Type of Application Should I Submit? •  Additional Information • Applications for Initial Review • Full Committee Review Application •  Expeditied Review Application • Exempt Application • Emergency Use and Compassionate Use of Experimental Drugs and Devices • Modifications • Renewals •  Administrative Review for Human Research Studies Not Being Conducted by a UCSF PI But Accessing UCSF Facilities, Patients or Personnel •  Adverse Event Reporting •  Protocol Violations and Incident Reporting • CHR Review Process Top of Page Applications and Forms Recruitment and Consent Process UCSF Guidance on Research Topics and Issues • Full Committee Review Application • Supplements • Expeditied Review Application • Supplements • Obsolete Application - Full and Expedited • Modification Forms • Renewal Forms • Exempt Certification Forms • Administrative Review for Human Research Studies Not Being Conducted by a UCSF PI But Accessing UCSF Facilities, Patients or Personnel • Adverse Event Reporting • Protocol Violations or Incident Reporting • Emergency Use and Compassionate Use of Experimental Drugs and Devices • Human Stem Cell Supplements • Sample Consent and Assent Forms • HIPAA Forms • Experimental Subject's Bill of Rights     • Recruitment Information:   • Recruitment Guidelines   • Abbreviated Recruitment Guidelines   • Standard Consent Form Format for Recruitment/Future Contact • Consent Guidelines • Guidelines for Vulnerable Subject Populations • Treatment and Compensation for Injury Statement • Experimental Subject's Bill of Rights • Lay Language Resources for Preparing Consent Forms • Translation Services     • Information Security: Data Security • Types of Research:   • Experimental Drugs, Devices and Biologics   • Research in Emergency Settings   • Medical Records Review   • Laboratory Test Results: CLIA Compliance   • Human Tissues and Cells   • Human Gene Transfer   • Clinical Trials   • Social and Behavioral Research   • Epidemiological Research   • Vulnerable Subject Populations   • Financial Issues   • CHR Guidelines "Blue Book" Table of Contents (1999)   Top of Page Working With the VAMC Working with Other Institutions and Units For Researchers and Staff • US Department of Veterans Affairs Medical Center San Francisco ( SF VAMC)   • US and International • CHR, UCSF, Federalwide Assurance Information   • Blood Centers of the Pacific (BCP)   • Blood Systems Research Institute (BSRI)   • Ernst Gallo Clinical and Research Center   • Institute on Aging   • J. David Gladstone Institutes   • Northern California Institute for Research & Education (NCIRE)   • San Francisco Department of Public Health (SF DPH)   • San Francisco General Hospital (SFGH)   • US Department of Veterans Affairs Medical Center San Francisco (SF VAMC) • Additional UCSF Units • SF Bay Area IRB Contacts • Federal Agencies - Center for Disease Control & Prevention (CDC) • Roles and Responsibilities • CHR Review Process • Applying and Reporting to the CHR • CHR Meeting Dates • UCSF School of Medicine Clinical & Translational Research • A Quick Guide to Starting Your Research at UCSF • Campus Maps     Top of Page About the Quality Improvement Unit Education and Training Status Checks and Research Online • Overview of Activities • Frequently Asked Questions • Clinical Research Tools, Checklists, Templates • QIU Staff and Contact Information • Clinical Research Coordinators Group • Subscribe to Group (CRCGROUP) E-mail List • Educational Needs Assessment Survey   • HRPP Quarterly Training • UCSF Human Subject Protections: Basic Course • UCSF and HRPP Presentations, Classes, and Programs • Other Sources • National Conferences and Workshops • Upcoming UCSF Training Opportunities   • Frequently Asked Questions About Research Online Status Checks           Top of Page For Research Volunteers HIPAA and Human Research Federal Regulations and Guidance • Information for Prospective Volunteers • UCSF Clinical Trials • UCSF Seeking Clinical Trial Volunteers • UCSF Donating Tissue for Medical Research • Guidance for Reporting Research Concerns and Complaints • Reporting Form for Research Concerns or Complaints   • Background • HIPAA Definitions • HIPAA Guidance • HIPAA Forms • Authorizations to be Used at Other Hospitals or Institutions • HIPAA Research Training • Other HIPAA Links • Questions   • Office for Human Research Protections • Food and Drug Administration • National Institutes of Health • Ethical Principles and Codes   Top of Page Other Useful Links CHR Member Information What's New • UCSF • UCSF Affiliates • UC Office of the President & UC Schools • Universities and Medical Centers • San Francisco Bay Area Hospitals • Organizations • Listserv Email Newsgroups Organization Charts   Program Description   New Investigator Quick Guide   • CHR Meeting Dates • Member Responsibilities • Meeting Details • Letter to Sponsors About Membership   • Laurel Heights Committee   • Parnassus Committee   • San Francisco General Hospital Committee   • Summary Sheet for Post-Approval Reporting Requirements • Adverse Events (AE) Reporting Guidelines • Reporting Violations and Incidents in Research Protocols • Memorandum of Understanding (MOU) Between Human Research Protection Programs at University of California Campuses and UC-Managed Laboratories for IRB Review of Multi-Campus Human Subject Research for Exempt and Expedited Categories • Memorandum of Understanding (MOU) Between Human Research Protection Programs at UC Berkeley, UC Davis and UCSF for all Categories of Research • Data Safety Monitoring Plans: Information Sheet for Principal Investigators • HRPP Bulletin - Volume 9, October 2005 • Investigator Conflicts of Interest and CHR Review • UCSF Guide for the Research Use of Human Biological Specimens: Collecting, Banking, and Sharing Specimens • Consent Guidelines • Consent Form Standards – Section by Section Discussion • Sample Consent Forms • Applications • More New and Revised Guidelines • Working with Other Institutions • Vulnerable Subject Populations • PI Roles and Responsibilities • Clinical Research Coordinators Roles and Responsibilities • For Research Volunteers • Clinical Research Educational Needs Assessment Survey • Use of Inactive Interventions • HRPP Bulletin • Emergency Use and Compassionate Use of Experimental Drugs and Devices • CHR Requirements for Human Specimen Research • Investigational Devices • Investigational New Drugs and Biologics • Medical Records Review • Email and Fax Restrictions for Using PHI • Subscribe to Clinical Research Coordinator Group (CRCGROUP) E-mail List

HRPP Home Page | Search | Feedback | Site Map | Help | Top of Page For Researchers and Staff | About the Committee | Organization | Contact Information Applying & Reporting to the CHR Applications & Forms Recruitment & Consent Process | UCSF Guidance on Research Topics & Issues Working With the VA | Working With Other Institutions & Units | For Research Volunteers About the Quality Improvement Unit (QIU) | Education & Training | Status Checks & Research Online HIPAA & Research | Federal Regulation & Guidance | Other Useful Links CHR Member Information | What's New

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Page updated: April 26, 2007