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
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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?
What features do easy-to-read informed consent documents have?
A. familiar, consistent words, Active voice and personal pronouns; short, simple, and direct sentences with limited line length
B. short paragraphs, one idea per paragraph, clear and logically sequenced ideas
C. important points highlighted, avoiding acronyms and abbreviations
D. good format: proper titles, subtitles, simple headers; balanced white space with words and graphics; proper font, style, & spacing; proper underline, bold, or boxes (rather than all caps or italics) give emphasis
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