Federal & State Regulations & Guidance Materials [1]

Department of Health and Human Services (DHHS)

OHRP [2] - Office for Human Research Protections

• 45 CFR 46 [3] - Federal Regulations for the Protection of Human Subjects

OCR [4] - Office for Civil Rights - HIPAA

• 45 CFR 164 [5] - Health Insurance Portability and Accountability Act (HIPAA) Security and Privacy Regulations

NIH [6] - National Institutes of Health

• Education:

  • NIH Education Requirement [7] - Frequently Asked Questions regarding the NIH Education Requirement
  • NIH Bioethics Resources [8]

• Data and Safety Monitoring Boards:

  • NIH Policy for Data & Safety Monitoring [9]
  • Guidance on Data & Safety Monitoring for Phase I & Phase II Trials [10]
  • National Eye Institute (NEI): Data & Safety Monitoring [11]
  • National Institute on Aging (NIA) Policies for Human Intervention Studies [12]

• Special Topics:

  • Certificates of Confidentiality [13]
  • Data Sharing [14]
  • Guidelines for the Administration of Drugs to Human Subjects [15]
  • Guidelines for Research Involving Recombinant DNA Molecules [16]
  • Inclusion of Children in Research [17]
  • Inclusion of Women & Minorities in Research [18]
  • Letters or Notices from the FDA to NIH Grantees [19]
  • New Review Criteria for Research Project Applications Involving Clinical Trials [20]
  • Research Involving Human Pluripotent Stem Cells [21]
  • Research on Human Specimens [22]
  • Use of a Single Institutional Review Board for Multi-Site Research [23]

FDA [24] - Food and Drug Administration

• 21 CFR 50 [25] - FDA regulations for  Protection of Human Subjects
• 21 CFR 56 [26] - FDA regulations for Institutional Review Boards
• FDA Information Sheets [27] - guidance for IRBs and clinical investigators on interpreting 21 CFR 50 and 56
• Good Clinical Practice in FDA-Regulated Clinical Trials [28] - FDA web site for investigators conducting clinical trials
• Good Clinical Practice:  Consolidated Guidance [27] - ICH guidance for investigators, sponsors, and IRBs
• Data and Safety Monitoring Boards [29] - guidance for sponsors on establishing and operating a clinical trial data safety monitoring committee
• Payment and Reimbursement to Research Subjects [30] - guidance on compensating subjects

CDER [31] - Center for Drug Evaluation and Research (Investigational New Drugs)

• 21 CFR 312 [25] - FDA regulations for Investigational New Drugs
• Information for Clinical Investigators [32] - guidance for clinical investigators involved in clinical trials of investigational drugs
• International Conference on Harmonisation [33] (ICH) - guidance from regulatory authorities from Europe, Japan, and US regarding drug development (click on "Guidelines")

CDRH [34] - Center for Devices and Radiological Health (Investigational Medical Devices)

• 21 CFR 812 [35] - FDA regulations for Investigational Device Exemptions
• 21 CFR 814.100 [36] - 126 - FDA regulations for Humanitarian Use Devices
• Humanitarian Device Exemption (HDE) [37] - questions and answers from the FDA

VHA [38] - Veterans Health Administration 

• ORO [39] (Office of Research Oversight)

NSF [40] - National Science Foundation 

• Human Subjects [41] - basic policy information
• Behavioral and Social Science Research [42] - NSF interpretation of applying IRB regulations to behavioral/social science research

General

• The Belmont Report [43]
• The Nuremberg Code [44]
• Declaration of Helsinki [45]
• The Common Rule - Federal Policy for the Protections of Human Subjects [46]
• Guidelines for Assessing the Decision-Making Capacities of Potential Research Subjects with Cognitive Impairment [47], Sourced from Am J Psychiatry 155:11, November 1998