References & Regulations

Ethics Codes - Bases for regulations and guidance

• The Nuremburg Code
  First definition of legitimate medical research resulting from Nazi war crimes.
• Belmont Report
  Respect for persons, beneficence, and justice.
• Declaration of Helsinki
  Ethical principles developed by the World Medical Association.
• CIOMS
  Applies the Declaration of Helsinki specifically to research in under-developed and low resource countries.

Regulations – Federal laws

• Office for Human Research Protections
  HHS Policy for the Protection of Human Subjects. A base set of rules, with additional protections in place for research involving:
  • Pregnant women, human fetuses, and neonates
  • Prisoners
  • Children
• FDA
  • Protection of Human Subjects
  • Drugs
  • Devices
• HIPAA
  Protections for personal health information and guidance for the proper use of this information in research
• VA

Guidance – Assistance and best practices for regulatory compliance

• ICH
  Good Clinical Practice; guidelines for the design, conduct, safety and reporting of clinical trials.
• National Institute of Health
  The leading supporter of biomedical research in the world.
• NIH Office of Behavioral and Social Sciences Research
• VA

Resources for Dartmouth and DHMC Researchers

• Office of Sponsored Projects
• Clinical Trials Office
• Office of Clinical Research
• Risk and Internal Control Services
• Environmental Health and Safety

Other

• Certificates of Confidentiality
• NH reportable diseases
• Ethics Core