About HRPP Contact Us Consent Assistant Dates Fact Sheets e-IRB Services Forms Guidelines Links News Public Notices Research Directory School of Medicine Training UCSD InfoPath		The HRPP  has both a formal set of Standard Operating Policies and Procedures written first in 2002 and kept updated, an older (1999) Investigator Guidelines document that describes how the program works.  Also provided here are the Veterans Health Administration VHA Handbook 1200.5 which provides guidance for VA investigators.  These documents are in Adobe Acrobat 4.0 format.  If you do not have the Acrobat reader, you can get it here.  UCSD Human Research Protections Program Standard Operating Policies and Procedures (150 pages - 838k PDF; 10/30/08) UCSD Human Research Protections Program Standard Operating Policies and Procedures (134 pages - 545K PDF; 1/30/2008) UCSD Human Research Protections Program Standard Operating Policies and Procedures (125 pages - 511K PDF; 2/15/2007) UCSD Human Research Protections Program Standard Operating Policies and Procedures (124 pages - 450K PDF; 5/28/2004) Human Research Guidelines (1999) Veterans Health Administration Handbook 1200.05 VA Data Security and Safety Plan VA Procedures for Reporting Security Incidents Involving Personally Identified Information Tools and Checklists Used by the IRB to Review Projects Project Review Checklist Checklist for Informed Consent   Advertising Guidelines Amendment Fact Sheet: Making Changes to an existing, approved Protocol Child Assent Children as Research Subjects Closure/Withdrawal of Study Death Records use in Research Diabetes Research: Glycemic Control Guidelines for Type 2 Diabetes studies Duration of IRB Approval Exempt from IRB Review FWA statement letter Guide for Providing Investigator Comments on Sponsor-Supplied Adverse Event Reports HIPAA Privacy Rule Information HIV Reporting and Research (a letter from the California Dept. of Health Services, Office of AIDS, November 2003) IRB recommendations on treatment of Postdural Puncture Headaches IRB review fees for commercially-sponsored projects Decisional Capacity Assessment DNA and Informed Consent Medical Devices Placebo-controlled Studies in High Risk Psychiatric Populations - Updated November, 2004 Project Approval Checklist Radiation doses - lay language equivalents Reporting Unanticipated Problems Involving Risk to Participants or Others (UPRs) to the IRB Research Involving the Use of Existing Data Screening Tests Prior to Study Enrollment Surrogate Consent Use UCSD Human Subjects Literature Monitoring Use of Chemicals and other substances that are not regulated by the FDA VA Receipt of Review Request