week 6 Flashcards
why do we need research ethics
- correct past problems and abuses
- prevent new problems and abuses
- law is not enough
what are 2 major atrocities in the 20th century that led to codification of research ethics
- nazi science
- tuskagee institute (Alabama)
what is the tuskagee study
399 untreated syphilitic african americans to observe the natural history of disease, they saw this as an “opportunity”
Nuremeburg Code 1947
the code that came up from nazi science
- the voluntary consent of the human subject is absolutely essential
what is declaration of helsinki 1964
a set of ethical principles for medical research involving human subjects
The document was created in response to the unethical medical experiments that occurred during World War II, particularly those conducted by Nazi doctors on concentration camp prisoners.
- need for informed consent
therapy and research
- distinction between research where aim is
- diagnostic or therapeutic for the patient
- purely scientific without implying therapeutic value to the person subjected to the research
right to standard of care: amended as part of the helsinki act in 1996
every patient including those of a control group, should be assured of the best proven diagnostic and thereapeutic method
right to standard of care
every patient including those of a control group, should be assured of the best proven diagnostic and thereapeutic method
TPS (tri council policy statment) AKA - tri-council code
this joint policy expresses the continuing commitment of the 3 councils to the people of Canada, to promote the ethical conduct of research involcing human subjects
TPSi.1
abiding by the trial-council code is a condition for public funding of research (and many universities have similar rules for private funding for its researchers)
four basic ethical principles of the tri-council code
- respect for persons
- non-maleficience
- beneficience
- justice
guiding ethical principles
- human dignity
- free and informed consent
- vulnerable persons
- privacy and condifentiality
- justice and inclusiveness
- balancing harms and benefits
- non-maleficience
- minimizing harm
- maximizing benefits
coercion
expectation of favour
forcibly against your will
threat of force is almost always not allowed in research recruitment
vulnerable populations
groups who have structural or systemic vulnerability to the powerful who may want to research using them
inducement
reward, ultimately your choice
- threat of force is allowed so long as their not “undue”