Bioethics

• Advisory Comittee on Human Radiation Experiments (ACHRE)
• American Society for Bioethics and Humanities (ASBH)
• Case Western Reserve University Center for Biomedical Ethics
• Columbia University Center for the Study of Society and Medicine
• Georgetown University Kennedy Institute of Ethics
• National Bioethics Advisory Commission (NBAC)
• National Institutes of Health (NIH) Bioethics Resources on the Web
• Public Responsibility in Medicine and Research (PRIM&R)
• The Hastings Center
• Tuskegee University National Center for Bioethics in Research and HealthCare
• University of Buffalo Center for Clinical Ethics and Humanities in Health Care
• University of California at Los Angeles (UCLA) Office for the Protection of Research Subjects
• University of Pennsylvania Center for Bioethics

Ethical Codes and Guidelines

• The Nuremberg Code - 1947
• Declaration of Helsinki - 1964, revised 2000
• The Belmont Report - 1979

FDA Documents

• Compliance References
• Disqualified/Restricted/Assurances List for Clinical Investigators
• Guidance Documents
• Information Sheets for Institutional Review Boards and Clinical Investigators
• Inspectional References
• Laws Enforced by FDA
• Warning Letters

Government Health Agencies

• Australia Department of Health and Aged Care
• Health Canada (HC)
• Ireland Department of Health and Children
• Japan National Institute of Health Sciences (NIHS)
• New Zealand Ministry of Health (MOH)
• Sweden National Board of Health and Welfare
• UK Department of Health (DOH)
• US Department of Health and Human Services (HHS)
  • Agency for Health Care Policy and Research (AHCPR)
  • Centers for Disease Control and Prevention (CDC)
  • Food and Drug Administration (FDA)
  • National Institutes of Health (NIH)
    • ClinicalTrials.gov
    • Office of Human Subjects Research (OHSR)
  • Office for Human Research Protections (OHRP)
  • Office of Inspector General (OIG)
  • Office of Research Integrity (ORI)

Historical Exhibits

• Exhibits in the History of Medicine
• FDA History
• US Holocaust Memorial Museum, The Doctor's Trial.

Libraries

• US Library of Congress (LOC)
• US National Library of Medicine (NLM)

Organizations, Industry

• Association of the British Pharmaceutical Industry (ABPI)
• Biotechnology Industry Organization (BIO)
• Centre for Medicines Research International (CMR)
• Health Industry Manufacturers Association (HIMA)
• International Federation of Pharmaceutical Manufacturers Association (IFPMA)
• Medical Devices Canada (MEDEC)
• Pharmaceutical Manufacturers Association of Canada (PMAC)
• Pharmaceutical Research and Manufacturers of America (PhRMA)

Organizations, Professional

• American Academy of Pharmaceutical Physicians (AAPP)
• American Association of Pharmaceutical Scientists (AAPS)
• American Medical Association (AMA)
• American Medical Writers Association (AMWA)
• American Nurses Association (ANA)
• American Pharmaceutical Association (APhA)
• Applied Research Ethics National Association (ARENA)
• American Society for Bioethics and Humanities (ASBH)
• Association of Clinical Research Professionals (ACRP)
• Drug Information Association (DIA)
• Food and Drug Law Institute (FDLI)
• Oncology Nursing Society (ONS)
• Project Management Institute (PMI)
• Regulatory Affairs Professionals Society (RAPS)
• Society of Clinical Research Associates (SoCRA)
• Society of Clinical Trials (SCT)
• Society of Research Administrators (SRA)

Publications

• FDA Consumer
• FDA Consumer Special Report: From Test to Patient: Improving Health Through Human Drugs
• Research Practitioner, formerly Research Nurse
• Science
• US Government Printing Office (GPO), Superintendent of Documents
• Code of Federal Regulations (CFR)
• Federal Register (FR)

Regulatory Agencies

• Australian Therapeutic Goods Administration (TGA)
• Canada Health Protection Branch (HPB)
• European Medicines Evaluation Agency (EMEA)
• Germany Federal Institute for Drugs and Medical Devices (BfArm)
• Japan Ministry of Health and Welfare (MHW)
• Sweden Medical Products Agency (MPA)
• UK Medical Device Agency (MDA)
• UK Medicines Control Agency (MCA)
• US Department of Energy (DOE)
  • DOE Human Subjects Research Program
• US Department of Health and Human Services (HHS)
• Food and Drug Administration (FDA)
  • Center for Biologic Evaluation and Research (CBER)
  • Center for Devices and Radiological Health (CDRH)
  • Center for Drug Evaluation and Research (CDER)
  • Center for Food Safety and Applied Nutrition (CFSAN)
  • Office of Regulatory Affairs (ORA)

Other Noteworthy Resources

• Association of American Medical Colleges (AAMC)
• Center for Clinical Research Practice (CCRP)
• Clinical Research Site Training (CRST)
• FedWorld
• Institute of Medicine (IOM)
• International Conference on Harmonization (ICH)
• International Organization for Standardization (ISO)
• Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
• Lippincott's Nursing Center
• Medical College of Wisconsin IRB (MCWIRB)
• National Guideline Clearinghouse (NGC)
• Tufts Center for the Study of Drug Development (CSDD)
• US Pharmacopeia (USP)
• World Health Organization (WHO)
• World Medical Association (WMA)

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Janet F. Zimmerman, MS, RN, President
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