Good Clinical Practice (GCP) jds
Belmont Report Ethical Principles (1979) - ANS - - Respect for Persons
• Informed consent
• Protection of vulnerable populations
- Beneficence
• Non-malfeasance
- Justice
• Fairness
Compare Helsinki and ICG-GCP - ANS - DECLARATION OF HELSINKI:
• Ethical principles e.g. ethical and scientific
• Focus: Physicians in research
• World Medical Assembly - International medical societies
• Guidance with broad recommendations
ICH-GCP:
• Broader principles e.g. ethical, scientific & operational for designing, conducting,
reporting & recording trials
• Focus: Drug sponsors, investigators & IRB
• Representatives from industry and public health
• Guidance document but has the effect of law ?when put into Regulation
Declaration of Helsinki (1964) - ANS - - Well-being of subject takes precedence
- Respect for persons
- Protection of subjects health and rights
- Special protection for vulnerable populations
How does FDA implement GCP? - ANS - 21 CFR 11 - Electronic Records &
Signatures
21 CFR 50 - Protection of Human Subjects
21 CFR 54 - Financial Disclosure
21 CFR 56 - Institutional Review Boards
Belmont Report Ethical Principles (1979) - ANS - - Respect for Persons
• Informed consent
• Protection of vulnerable populations
- Beneficence
• Non-malfeasance
- Justice
• Fairness
Compare Helsinki and ICG-GCP - ANS - DECLARATION OF HELSINKI:
• Ethical principles e.g. ethical and scientific
• Focus: Physicians in research
• World Medical Assembly - International medical societies
• Guidance with broad recommendations
ICH-GCP:
• Broader principles e.g. ethical, scientific & operational for designing, conducting,
reporting & recording trials
• Focus: Drug sponsors, investigators & IRB
• Representatives from industry and public health
• Guidance document but has the effect of law ?when put into Regulation
Declaration of Helsinki (1964) - ANS - - Well-being of subject takes precedence
- Respect for persons
- Protection of subjects health and rights
- Special protection for vulnerable populations
How does FDA implement GCP? - ANS - 21 CFR 11 - Electronic Records &
Signatures
21 CFR 50 - Protection of Human Subjects
21 CFR 54 - Financial Disclosure
21 CFR 56 - Institutional Review Boards
