Cchmc Review Flashcards
Nuremberg code
Year?
1947
Nuremberg code
Who created?
After WWII, from trials of German scientist. 1st written code for research
Nuremberg Code Major themes (3)
- Voluntary consent
- Risk vs benefit
- Research must be conducted by experienced staff
Declaration of Helsinki
Year?
1964
Declaration of Helsinki
Who created?
World Medical Association (WMA)
Declaration of Helsinki Major themes (5)
- Physicians duty to protect subjects/collect accurate data/disclose conflict
- Medical progress is based on research but individuals take precedence over the interests of science
- Research should be summarized in a protocol/IC/assent
- New methods should be tested against the best current methods
- Physicians should be aware of ethical, legal, and regulatory requirements of research
Belmont Report
Year?
1979
Belmont Report
Purpose
Summarize basic ethical principles
Belmont Report Major themes (3)
- Respect for persons
- Beneficence
- Justice
Belmont Report
Respect for persons, define:
- individuals treated as autonomous
- protect those with diminished autonomy
Belmont Report
Beneficence, define:
- minimize harm
- maximize benefits
Belmont Report
Justice, define:
Fairness in distribution
Nuremberg code
Purpose
After WWII, 1st written code for research
Declaration of Helsinki
Purpose
International, first significant effort is medical community to regulate itself for research
ICH, stands for:
International Conference on Harmonization
ICH, who is it (what countries)?
Governmental agencies of Japan, US, European Union, Australia, Canada, WHO, Nordic countries
ICH, what is it
Governmental agencies and pharmaceutical industry met to develop and promote global standards in clinical research (GCP)
GCP (Good clinical practices)
What is it?
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
GMP, means?
Good manufacturing practice. Standards for the manufacturing, storing and handling of investigational products. A principle in GCP.
