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?
Which of the following statements about protected health information are correct?
A. The Privacy Rule protects all "individually identifiable health information" held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral.
B. "Individually identifiable health information" is information, including demographic data, that relates to: — the individual's past, present or future physical or mental health or condition, — the provision of health care to the individual, or — the past, present, or future payment for the provision of health care to the individual, and that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual.
C. The Privacy Rule excludes from protected health information employment records that a covered entity maintains in its capacity as an employer and education and certain other records subject to, or defined in, the Family Educational Rights and Privacy Act, 20 U.S.§1232g.
D. There are no restrictions on the use or disclosure of de-identified health information.
What are the criteria for IRB review of a clinical trial protocol?
A. Risks … are minimized; risks are justified by anticipated benefits, if any, to the subjects or the importance of the knowledge to be gained.
B. The benefits & goals of the study are clear; the study protocol is ethically reasonable.
C. Subjects will be selected and treated fairly.
D. Informed consent is adequate.
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