Research Integrity



	INFORMATION & RESOURCES IRB INVESTIGATOR MANUAL - Provides procedures and policies for investigators EXEMPT AND EXPEDITED CRITERIA - For determining the IRB review category INFORMED CONSENT - Information on obtaining informed consent DATA & SAFETY MONITORING - For use with clinical trials and/or interventions DATA SECURITY - Tips to manage and protect confidential human subjects data ADVERSE EVENT REPORTING - Policies and forms relating to adverse events IRB SOP MANUAL - Standard Operating Procedures for the FIU IRB 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 INTERNATIONAL COMPILATION - An International Compilation of Human Research Protections MIAMI-DADE COUNTY SCHOOL RESEARCH - Guidance on how to submit an application through both the FIU IRB and the MDCPS RCC 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