Federal Guidelines/Regulations (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)
Office for Human Research Protections (OHRP)
IRB Guidebook
Code of Federal Regulations for Human Subjects Protection (45 CFR 46)
HIPAA Privacy Rule
Food and Drug Administration (FDA)
Guideline for Industry - E6 Good Clinical Practice
Protection of Human Subjects (21 CFR Part 50)
Institutional Review Boards (21 CFR Part 56)
Investigational New Drug Application (21 CFR Part 312)
FDA Forms 1572 , 1571, 3455, and 3674
Applications for FDA Approval to Market a New Drug (21 CRF Part 314)
Certificate of Confidentiality
Electronic Common Technical Documents (eCTD)
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Botanical Drug Products
FDA Device Advice Overview
FDA Device Advice - Early/Expanded Access, Compassionate/ Emergency Use
FDA Information Sheets: Guidance for IRBs and Clinical Investigators
National Institutes of Health
Required Education in the Protection of Human Research Participants
Computer-Based Training Module on Protection of Human Subjects
NIH Guidance on the collection and storage of tissue and data for research
Registry of Clinical Trials – clinicaltrials.gov
National Cancer Institute (NCI)
Ethical Principles of Human Subjects Protection
The Belmont Report
The Nuremberg Code
Declaration of Helsinki
ICH Consolidated Guidance