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Early Hum Dev. 2000 Dec;60(2):89-100.

Proxy informed consent in pediatric research: a review.

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Unit of Epidemiology, Burlo Garofolo Maternal and Child Health Institute, Trieste, Italy.


This paper is aimed at discussing the issue of proxy consent for medical research with children carried out in the context of developed countries. First, requirements for valid informed consent are reviewed, and differences with clinical practice highlighted. In the second part the findings from empirical studies, and implications for improving the consent process, are discussed. Perceived benefit for their child is the most important factor motivating parents to grant consent, but also a desire to contribute to medical research and benefit others are frequently mentioned. Abstract concepts such as randomization are more difficult to grasp and remember than practical issues. The type and style of the consent-seeking process (quality of the information, physician's attitude, allocated time, readability of consent forms) have an influence on how the invitation to participate is received. Rather than as a one-sided delivery of information, consent should be viewed as a continuous, two-way communication process developing in a context of transparency and partnership between the investigator and potential research subjects.

[Indexed for MEDLINE]

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