Educational Resources

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Human Subjects Research Regulations
5 CFR 46 Human subject Regulations(DHHS)
21 CFR PART 50 (FDA Protection of Human Subjects)
21 CFR PART 56 (FDA IRB Regulations)
International Conference on Harmonization

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

Additional BCH Resources

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Clinical Research Program

Harvard Catalyst

Clinical Trials Office

Translational Research Program

Technology and Innovation Development Office

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The future of pediatrics will be forged by thinking differently, breaking paradigms and joining together in a shared vision of tackling the toughest challenges before us.”
- Sandra L. Fenwick, President and CEO
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