INFORMATION SHEETS

Guidance for Institutional Review Boards and Clinical Investigators

1998 Update

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. For questions regarding the use or interpretation of this guidance, contact the Office of Health Affairs, HFY-20, 5600 Fishers Lane, Rockville, MD 20857, phone 301-827-1685, facsimile 301-443-0232.

Food and Drug Administration
Office of the Associate Commissioner for Health Affairs
5600 Fishers Lane
Rockville, Maryland, 20857

Revised 10/95
Updated 9/98

Table of Contents

IRB Operations and Clinical Investigation Requirements

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