2013
DOI: 10.1177/0969733013487190
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Protecting boundaries of consent in clinical research

Abstract: Successful clinical research outcomes are essential for improving patient care. Achieving this goal, however, implies an effective informed consent process for potential research participants. This article traces the development of ethical and legal requirements of informed consent and examines the effectiveness of past and current practice. The authors propose the use of innovative monitoring methodologies to improve outcomes while safeguarding consent relationships and activities. Additional rigorous researc… Show more

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Cited by 6 publications
(4 citation statements)
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References 39 publications
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“…Similar findings have been reported across the globe, for example in the Asia-Pacific region [4,[63][64][65], United States [66][67][68][69][70][71], and Europe [72,73]. However, the complexities tend to be more pronounced in SSA countries due to among others; the socio-cultural context, poverty and power relations.…”
Section: Discussionsupporting
confidence: 77%
“…Similar findings have been reported across the globe, for example in the Asia-Pacific region [4,[63][64][65], United States [66][67][68][69][70][71], and Europe [72,73]. However, the complexities tend to be more pronounced in SSA countries due to among others; the socio-cultural context, poverty and power relations.…”
Section: Discussionsupporting
confidence: 77%
“…Furthermore, in developed countries such as the USA and Canada, state laws and nursing councils have given clear guidelines on the role of nurses in the IC process (120)(121)(122)(123)(124). For example, the position statement from the New York State Board of Nursing (122) recommends that:…”
Section: Implications For Nurse-training In South Africamentioning
confidence: 99%
“… Respondents should be treated as independent agents in a manner that accord them respect, and the right to hold views, make choices, and opinions with respect to their particular values and beliefs. [2] and [16].  Respondents with lowered autonomy should be entitled to fresh protections [37].…”
Section: Choice Of Research Design and Ethical Issuesmentioning
confidence: 99%