Institutional Review Board Guidelines

INSTITUTIONAL REVIEW BOARD FORMS
IRB APPLICATION (FORM A) - For Initial IRB Approval Submission Only
IRB PROPOSAL TEMPLATE - Proposal Outline that Must be Submitted with Form A
IRB APPLICATION (FORM A-1) - Assists in Determining if IRB Review is Applicable
IRB APPLICATION (FORM B-1) - For Research Amendments or Modifications
IRB APPLICATION (FORM B-2) - For Annual Renewal or Project Completion Report
IRB APPLICATION (FORM C)  - For Projects Requiring Data and Safety Monitoring
CONSENT DOCUMENTATION - Sample Consent Documents
CONSENT TRANSLATION - Affirmation Form for Translated Consent Documents

ADDITIONAL RESOURCES
CODE OF FEDERAL REGULATIONS - Department of Health and Human Services 45 CFR 46
FDA REGULATIONS - Food and Drug Administration Human Subject Research Guidelines
HUMAN SUBJECTS DECISION CHARTS - Charts to assist in determining types of IRB review
ENGAGEMENT - Guidance on the engagement of institutions in human subjects research
GUIDANCE ON CODED DATA - Coded private information or biological specimens
DATA SETS APPROVED FOR USE - Data sets that can be used without obtaining IRB approval
ORAL HISTORY & IRB REVIEW - Guidance to clarify the issue of oral history projects
ETHNOGRAPHY & IRB REVIEW - Guidance to clarify the issue of ethnographic projects
CERTIFICATES OF CONFIDENTIALITY - Guidance on protecting sensitive information
RESPONSIBLE CONDUCT OF RESEARCH - An introduction from the Office of Research Integrity
BELMONT REPORT - Ethical Principles and Guidelines
OHRP IRB GUIDEBOOK - Guidance from the Office for Human Research Protections
SOCIAL SECURITY NUMBERS - Notification of Collection and Usage of Social Security Numbers

VULNERABLE POPULATIONS
SPECIAL PROTECTIONS FOR CHILDREN AS RESEARCH SUBJECTS
GUIDANCE ON THE "407" REVIEW PROCESS FOR CHILDREN
FAQ's ON RESEARCH WITH CHILDREN
GUIDANCE ON THE INVOLVEMENT OF PRISONERS IN RESEARCH

FEDERAL OVERSIGHT AGENCIES
OFFICE OF HUMAN RESEARCH PROTECTIONS
FDA CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
FDA CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
DHHS OFFICE OF RESEARCH INTEGRITY

FEDERAL AGENCIES THAT HAVE ADOPTED "THE COMMON RULE"
CENTRAL INTELLIGENCE AGENCY
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
NATIONAL SCIENCE FOUNDATION
NATIONAL INSTITUTES OF HEALTH
U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT
U.S. DEPARTMENT OF AGRICULTURE
U.S. DEPARTMENT OF COMMERCE
U.S. DEPARTMENT OF DEFENSE
U.S. DEPARTMENT OF EDUCATION
U.S. DEPARTMENT OF ENERGY
U.S. DEPARTMENT OF HOUSING & URBAN DEVELOPMENT
U.S. DEPARTMENT OF JUSTICE
U.S. DEPARTMENT OF TRANSPORTATION
U.S. DEPARTMENT FOR VETERAN AFFAIRS
U.S. ENVIRONMENTAL PROTECTION AGENCY
U.S. FOOD AND DRUG ADMINISTRATION
U.S. PRODUCT SAFETY COMMISSION