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Human Subjects Research Regulations
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Assistance in Interpreting the Regulations
Guidance Documents Listing
FDA Information Sheets for Investigators and IRBs - 1998 Update
Codes of Research Ethics
Belmont Report
The World Medical Association (WMA) - Declaration of Helsinki
Nuremberg Code
Government Websites
DHHS Office for Human Research Protections (OHRP)
DHHS Office of Research Integrity
FDA Center for Drug Evaluation and Research (CDER)
FDA Center for Biologics Evaluation and Research (CBER)
FDA Center for Devices and Radiological Health (CDRH)
FDA: Laws, Regulations, Policies and Procedures for Drug Applications
National Cancer Institute (NCI)
Inclusion of Children Policy Implementation
NIH Inclusion of Children: Case Studies
Pediatric Research Ethics Guidelines
American Academy of Pediatrics Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations (RE9503)
Guidelines for Adolescent Health Research: A Position Paper of the Society for Adolescent Medicine - Journal of Adolescent Health: 1995;
FDA - Pediatric Medicine
Advisory Committee on Human Radiation Experiments (ACHRE) Report, Chapter 7: The Context for Nontherapeutic Research with Children
Association Websites
Applied Research Ethics National Association (ARENA)
Public Responsibility in Research and Medicine (PRIMR)
Centerwatch Clinical Trials Network
International Research Ethics Guidelines
Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects
Nuffield Council on Bioethics (UK)
World Health Organization (WHO) Ethics Publications, 1991-2002
Listing of International Bioethics Organizations:
Additional Ethics Information
NIH Bioethics Resources on the Web
National Library of Medicine, Current Bibliographies in Medicine: Ethical Issues in Research Involving Human Participants
Boston Area IRBs
Partners Health Care - Human Research Office
Harvard Medical School - Office for Research Subject Protection
Harvard University - IRB Information
Dana-Farber Cancer Institute - Office for the Protection of Research Subjects
Boston University Medical Campus - Boston Medical Center: Office of the Institutional Review Board
Information for Families
NIH New Web Site For Parents On Medical Research Studies For Children
Other Information
Harvard Policies on Integrity in Science
NIMH: Issues to Consider in Intervention Research with Persons at High Risk for Suicidality
Improving the Informed Consent Process at Children's Hospital
Data Safety Monitoring Plan Information
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