Chapter 2 Part 2 Flashcards
World Health Organization made regulations for conducting biomedical research called the Declaration of Helsinki
1964
Patient Self Determination Act was created in _____
1990
What year was Oregon death with dignity act created?
1994
What year did informed consent come about?
1972
Military Tribunal for War Crimes was created in ____
1946
What year did substituted judgement come about
1976
What year did HIPAA come about?
1996
14th Amendment attached to terminally ill patients and physician assisted deaths
1996
Tuskegee syphilis experiment happened in ____
1932-1972
Abortion became legal in ____
1973
First durable power of attorney legislation became active in ____
1983
What year was the human genome sequenced?
2003
Kennedy institute of ethics was created in _____
1971
Holocaust happened in ____
1933-1945
Code of Medical Ethics was created in ____ by the WMA
1946
What ethical principles are related to research, experimentation, and clinical trials?
Respect for person, beneficence, hippocratic oath, justice, autonomy
International code of ethics that governs human research, requires human subjects to be informed
Nuremberg code
Ethical principles for human experimentation, cornerstone of human research ethics, principles apply equally to non-physicians
Declaration of Helsinki
Created by US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974, recognized ethical principles such as justice, beneficence, respect for persons
Belmont report
What 2 documents are important for the ethics of research?
Nuremberg, Helsinki
Federal regulations control experiments involving…(3)
Drugs, medical devices, medical procedures
What must organizations provide during clinical trials?
Education, nurse participation, ongoing monitoring
Review proposed research studies, approve protocols, conduct oversight of the research, protects rights of human subjects in research
Institutional review board (IRB)
IRB used for clinical trials
Full IRB
How do we define minimal risk?
Risks and discomforts people are exposed to in everyday life
IRB used for studies that present no more than minimal risk
Expedited IRB
IRB used for de-identified data (anonymous people), education type of research
Exempt IRB
Specifies what is done to the participant before research, risks of the intervention, benefits of the intervention, alternatives to treatment, treatment costs, educate the staff
Informed consent