Test 4, The Helsinki Syndrome Flashcards
What is the definition of Medical research?
to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments).
What is the duty of the physician?
to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects.
What should take precedence in medical research?
the well-being of the individual research subject
What research populations are considered vulnerable and need special protection?
those who cannot give or refuse consent for themselves and those who may be vulnerable to coercion or undue influence.
To whom should the experimental protocol be submitted?
a research ethics committee
Who is responsible for the human subject?
the physician or other health care professional and never the research subjects,
What is the role of risks and benefits to the subject?
Every medical research study involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and communities involved in the research in comparison with foreseeable benefits to them and to other individuals or communities affected by the condition under investigation.
When is medical research justified?
if the importance of the objective outweighs the inherent risks and burdens to the research subjects.
What safeguards must be provided to research subjects?
protect the privacy of research subjects and the confidentiality of their personal information and to minimize the impact of the study on their physical, mental and social integrity.
What requirements are there for “informed”?
each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study.
For persons who are unable to give consent, what 2 requirements must be met?
if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research population
must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the population
At the conclusion of the study, what must be assured to every patient?
patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it,
