What are the ethical requirements for informed consent?
A. Codes of research ethics, regulations, and laws (limited exceptions) require informed consent from the research participant or her legally authorized representative (and documentation): ICH-GCP, Declaration of Helsinki, US Federal Regulations (Common Rule (45CFR46) and FDA (21CFR50)), & National, state, institutional requirements.
B. Respect for autonomy — an individual's capacity & right to define his/her own goals & make choices consistent with those goals.
C. "Informed consent is rooted in the fundamental recognition…that adults are entitled to accept or reject health care interventions on the basis of their own personal values and in furtherance of their own personal goals" Presidents Commission for the study of ethical problems…1982.
D. Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided…[when] informed consent are satisfied — The Belmont Report.
What rights do human subjects have according to the National Institute of Justice in the United States?
A. voluntary, informed consent, respect for persons: treated as autonomous agents
B. right to end participation in research at any time, right to safeguard integrity
C. benefits should outweigh cost, protection from physical, mental and emotional harm
D. access to information regarding research, protection of privacy and well-being
Which of the following statements about the goals of clinical research are correct?
A. The goal of clinical research is to generate useful knowledge about human health & disease.
B. Clinical research results in compelling societal health benefits – development of therapies, diagnostic & preventive strategies, improvement in quality of life, & understanding of health & disease.
Clinical research provides evidence which clinicians use to know how to safely & effectively treat, prevent, or diagnose diseases or promote health.
D. A small number of participants are asked to participate in the research; benefit to participants is not the purpose (although it does occur); participants are the means to developing useful knowledge; & are thus at risk of exploitation.
What are the ethical requirements in clinical research?
A. Promote the responsible conduct of useful clinical research & progress in understanding & intervening in human health & illness
B. Minimize the possibility of exploitation & harm
C. Ensure that the rights & welfare of subjects are respected while they contribute to the generation of knowledge
D. Help to maintain public trust
What challenges does informed consent has?
A. stored data and biospecimens
B. pragmatic trials, learning health care systems
C. digital data
D. What kind of consent is appropriate? – What and how should information be disclosed? – What level of understanding? – Voluntary choice?
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