Institutional Review Boards & Human Subjects Office

     OHRP - Office for Human Research Protections

                        45 CFR 46 - Federal Regulations for the Protection of Human Subjects
                        Institutional Review Board Guidebook - OHRP guidance for IRB members and investigators

     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 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
                  Research Involving Human Pluripotent Stem Cells
                  Research on Human Specimens
                                

Food and Drug Administration (FDA)

    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

     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