Guidance for Institutional Review Boards and Clinical Investigators


FDA Home \| Search FDA Site \| A-Z Index \| Contact FDA

Guidance for Institutional Review Boards and Clinical Investigators 1998 Update Table of Contents

		General Frequently Asked Questions IRB Organization IRB Membership IRB Procedures IRB Records Informed Consent Process Informed Consent Document Content Clinical Investigations General Questions Cooperative Research Non-local IRB Review Continuing Review After Study Approval Continuing Review Criteria Continuing Review Process Serious Adverse Reactions, Unexpected Events Process Changes During Approval Period Review Process Sponsor - Investigator - IRB Interrelationship Foreign Clinical Studies, Acceptance of (Revised March 16, 2001) Charging for Investigational Products Recruiting Study Subjects Payment to Research Subjects Screening Tests Prior to Study Enrollment Informed Consent, A Guide To Consent Document Content IRB Standard Format Sponsor prepared model consent documents Revision of Consent during the Study General Requirements, 21 CFR 50.20 FDA Approval of Studies Non-English Speaking Subjects Illiterate English Speaking Subjects Assent of Children Elements of Informed Consent, 21 CFR 50.25 Compensation v. Waiver of Subject's Rights The Consent Process Documentation of Informed Consent, 21 CFR 50.27 Use of Investigational Products When Subjects Enter a Second Institution Coverage of Personal Importations (updated 12/14/2001) Exception from Informed Consent for Studies Conducted in Emergency Settings: Regulatory Language and Excerpts from Preamble "Off-Label" and Investigational Use of Marketed Drugs, Biologics and Medical Devices				Drugs and Biologics Emergency Use of an Investigational Drug or Biologic Obtaining an Emergency IND Emergency Exemption from Prospective IRB Approval Exception From Informed Consent Requirement Planned Emergency Research, Informed Consent Exception Treatment Use of Investigational Drugs Waiver of IRB Requirements Drug Study Designs Evaluation of Gender Differences Medical Devices Medical Devices Frequently Asked Questions about IRB Review of Medical Devices Significant Risk and Nonsignificant Risk Medical Device Studies List of Non Significant Risk Devices List of Significant Risk Devices Emergency Use of Unapproved Medical Devices FDA Operations FDA Institutional Review Board Inspections FDA Clinical Investigator Inspections Clinical Investigator Regulatory Sanctions Appendices Appendix A: A List of Selected FDA Regulations Appendix B: 21 CFR PART 50 Appendix C: 21 CFR PART 56 Appendix D: Federal Register Notice: Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board Through an Expedited Review (updated 12/19/2001) [Also available as a PDF File] Appendix E: Significant Differences in FDA and HHS Regulations Appendix F: The Belmont Report Appendix G: Declaration of Helsinki: 1989 version or 1983 version Appendix H: A Self-evaluation Checklist for IRBs Appendix I: FDA District Offices Appendix J: Important FDA Contacts for Clinical Trials Appendix K: Web Sites of Interest for Good Clinical Practice and Clinical Trial Information			This document represents the agency's current guidance on protection of human subjects of research. It is published as Level 2 guidance in accordance with the FDA "Good Guidance Practices." It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. However, in many places throughout this document, a specific regulation is cited and the requirements of the regulation are reiterated. The regulations are enforceable. This guidance document represents an update of the October 1995 revision of the Information Sheets. Comments and suggestions may be submitted at any time for Agency consideration. Comments received after publication may not be acted upon by the Agency until the document is next revised. Revised 10/95 Updated 9/98 Dear Colleague Letter re: 1998 Update of Information Sheets

Health Professionals Home Page FDA Home \| Search FDA Site \| A-Z Index \| Contact FDA \| Privacy \| Accessibility FDA/Website Management Staff Web page updated by clb 2001-DEC-19. Design by zwr.