Regulatory & Ethics Tools

Laws and Regulations

The Belmont Report

Office of the Secretary 
Ethical Principles and Guidelines for the Protection of Human Subjects of Research 
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
April 18, 1979
View: Belmont Report

Code of Federal Regulations

United States Department of Human Health Services:
Basic HHS Policy for Protection of Human Research Subjects
Code of Regulations

Good Clinical Practices

Food and Drug Administration (FDA) Guidances, Information Sheets, and Important Notices on Good Clinical Practice in FDA-Regulated Clinical Trials

These guidances and information sheets represent the Agency's current guidance on good clinical practice and the conduct of clinical trials. Notices contained on this page are those that have been published by the Agency that contain important information about good clinical practices and the conduct of clinical trials.

ICH guidance:  http://www.fda.gov/RegulatoryInformation/Guidances/UCM122049
Running Clinical Trials: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm

United States Department of Health and Human Services Office for Civil Rights - HIPAA

Medical Privacy - National Standards to Protect the Privacy of Personal Health Information
http://www.hhs.gov/ocr/hipaa/