Regulations & Policies

Human Subjects Research Regulation and Guidance Materials

Human subjects research related regulations and policy(ies) are summarized below. 

Department of Health and Human Services (DHHS)

OHRP - Office for Human Research Protections

• 45 CFR 46 - Federal Regulations for the Protection of Human Subjects

OCR - Office for Civil Rights - HIPAA

• 45 CFR 164 - Health Insurance Portability and Accountability Act (HIPAA) Security and Privacy Regulations

NIH - National Institutes of Health

• Education:

  • NIH Education Requirement - Frequently Asked Questions regarding the NIH Education Requirement
  • NIH Bioethics Resources

• Data and Safety Monitoring Boards:

  • NIH Policy for Data & Safety Monitoring
  • Guidance on Data & Safety Monitoring for Phase I & Phase II Trials
  • National Eye Institute (NEI): Data & Safety Monitoring
  • National Institute on Aging (NIA) Policies for Human Intervention Studies

• Special Topics:

  • Certificates of Confidentiality
  • Data Management and Sharing Policy
  • Data Sharing
  • Guidelines for the Administration of Drugs to Human Subjects
  • Guidelines for Research Involving Recombinant DNA Molecules
  • Inclusion of Children in Research
  • Inclusion of Women & Minorities in Research
  • Letters or Notices from the FDA to NIH Grantees
  • New Review Criteria for Research Project Applications Involving Clinical Trials
  • Research Involving Human Stem Cells
  • Research Involving Human Subjects
  • Use of a Single Institutional Review Board for Multi-Site Research

FDA - Food and Drug Administration

• 21 CFR 50 - FDA regulations for  Protection of Human Subjects
• 21 CFR 56 - FDA regulations for Institutional Review Boards
• FDA Information Sheets - guidance for IRBs and clinical investigators on interpreting 21 CFR 50 and 56
• Good Clinical Practice in FDA-Regulated Clinical Trials - FDA web site for investigators conducting clinical trials
• Good Clinical Practice:  Consolidated Guidance - ICH guidance for investigators, sponsors, and IRBs
• Data and Safety Monitoring Boards - guidance for sponsors on establishing and operating a clinical trial data safety monitoring committee
• Payment and Reimbursement to Research Subjects - guidance on compensating subjects

CDER - Center for Drug Evaluation and Research (Investigational New Drugs)

• 21 CFR 312 - FDA regulations for Investigational New Drugs
• Information for Clinical Investigators - guidance for clinical investigators involved in clinical trials of investigational drugs
• International Conference on Harmonisation (ICH) - guidance from regulatory authorities from Europe, Japan, and US regarding drug development (click on "Guidelines")

CDRH - Center for Devices and Radiological Health (Investigational Medical Devices)

• 21 CFR 812 - FDA regulations for Investigational Device Exemptions
• 21 CFR 814.100 - 126 - FDA regulations for Humanitarian Use Devices
• Humanitarian Device Exemption (HDE) - questions and answers from the FDA

VHA - Veterans Health Administration 

• ORO (Office of Research Oversight)

NSF - National Science Foundation 

• Human Subjects - basic policy information
• Behavioral and Social Science Research - NSF interpretation of applying IRB regulations to behavioral/social science research

GDPR - General Data Protection Regulation 

PIPL - Personal Information Protection Law of the People's Republic of China

General

• The Belmont Report
• The Nuremberg Code
• Declaration of Helsinki
• The Common Rule - Federal Policy for the Protections of Human Subjects
• Research Compliance Resources (from the Association of American Medical Colleges)
• Guidelines for Assessing the Decision-Making Capacities of Potential Research Subjects with Cognitive Impairment, Am J Psychiatry 155:11, November 1998