History/Ethical Principles

Question 1

Nuremberg Code (1947)

Answer 1

-created after nazi Germany experiments
-1st principles of IC
-voluntary IC is essential
-study designed based on animal experiments and hx of disease
-beneficence and freedom to withdraw
-risk should no the more than humanitarian existence
-protections against injury, disability or death
-investigator must prepare to terminate at any stage if learn it’s reasonably likely experiment is likely to result in injury, disability or death

Question 2

Declaration of Helsinki (1964)

Answer 2

-formal statement of ethical principles published by the World Medical Association (WMA) to guide the protection of human participants in medical research. (current revision 2013)
-cornerstone for human research and ethics
-IC must be obtained from pt or legal guardian
-protocols reviewed by independent committee
-human subject research based on lab and animal research results
-research conducted by medically qualified person
-risk not to exceed benefit

Question 3

Belmont Report (1978/79)

Answer 3

-created by National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
-lead to the creation of Office of Human Research Protection (OHRP) and Institutional Review Board (IRB)
-following Tuskegee
-Respect of persons: individual autonomy, protections for individuals w/decreased autonomy, voluntarily enroll w/adequate info (IC)
-beneficence: max benefits, min risk, respect decisions, secure wellbeing
-justice: equitable distribution of research costs and benefits, pts treated equally, selection based on reason related to the study