Research Integrity Office

Federal Regulations & Guidelines

OHRP - Office for Human Research Protections, DHHS, home page
45 CFR 46 - DHHS Regulations for the Protection of Human Subjects
45 CFR Parts 160, 162 and 164 - Health Insurance Reform: Security Standards; Final Rule
Exempt Guidelines - Categories of Research That May Be Reviewed by the IRB through an Exempt Review Procedure
Expedited Guidelines - Categories of Research That May Be Reviewed by the IRB through an Expedited Review Procedure

21 CFR 50 - FDA regulations for Protection of Human Subjects
21 CFR 56 - FDA regulations for Institutional Review Boards
21 CFR 312 - FDA regulations for Investigational New Drugs
21 CFR 812 - FDA regulations for Investigational Device Exemptions
21 CFR 814.100 - 126 - FDA regulations for Humanitarian Use Devices
Information for Clinical Investigators - Guidance for clinical investigators involved in clinical trials of investigational drugs
FDA Information Sheets - Guidance for IRBs and clinical investigators on interpreting 21 CFR 50 and 56

Good Clinical Practice: - Consolidated Guidance - guidance for investigators, sponsors, and IRBs
Good Clinical Practice in FDA-Regulated Clinical Trials - FDA web site for investigators conducting clinical trials

Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research
Declaration of Helsinki - Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects
Nuremberg Code - Directives for Human Experimentation

Download Free Adobe Reader

Adobe Acrobat Reader is required to view items marked with this icon:

Please click on the left image to download the free version.