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THE COMMITTEE ON HUMAN RESEARCH

UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES - TABLE OF CONTENTS

The Guidelines have been Revised as noted below; Guidelines that do not have a Revised date are being revised.

I | II | III | IV | V | VI | | VII | VIII | IX | X | XI |
Appendices: XIIA | XIIB | XIIC | XIID | XIIE | XIIF | XIIG | XIIH | XIII | | XIIJ | XIIK

I. Introduction
II. Mandate of the Committee (Revised October 2004)
III. Overview of the Application Process (Revised November 2003)
IV. Initial Full Committee Review Application (Revised February 2004)
V. Initial Subcommittee (Expedited) Review Application (Revised February 2004)
VI. Renewal Application (Revised February 2005; Revised November 2003)
VII. Modification Application (Revised February 2005)
VIII. Exempt Categories of Research (Revised February 2004)
IX. General Approval - Discontinued -
X. Consent Guidelines (Revised February 2005)
XI. Sample Forms (Revised June 2004: See forms page)
XII. Appendices
	A.	Adverse Events (AE) Reporting Guidelines (Revised June 2006)
	B.	Experimental Subject's Bill of Rights
	C.	DHHS General Requirements for Informed Consent
	D.	FDA Guidance on Significant and Non-Significant Risk Device Studies
	E.	Emergency Use and Compassionate Use of Experimental Drugs and Device (Revised August 2004)
	F.	Medical Records Review (Revised December 2004)
	G.	Vulnerable Subject Populations
	H.	Treatment and Compensation for Injury Statement: Background and UCSF Policy
	I.	Consent Form and Review Checklist
	J.	Research Subjects Accounts Payable Guideline
	K.	Use of Human Biological Specimens for Research (Revised April 2005)