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
Which of the following statements about the HIPAA Privacy Rule (US, 1996) are correct?
A. The Standards for Privacy of Individually Identifiable Health Information ("Privacy Rule") establishes a set of national standards for the protection of certain health information.
B. The U.Department of Health and Human Services (HHS) issued the Privacy Rule to implement the requirement of the Health Insurance Portability and Accountability Act of 1996 ("HIPAA").
C. A major goal of the Privacy Rule is to assure that individuals' health information is properly protected while allowing the flow of health information needed to provide and promote high quality health care and to protect the public's health and well being.
D. Key elements of the Privacy Rule are: who is covered by the privacy rule? what information is protected? how protected health information can be used and disclosed?
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