BACKGROUND: Disclosure is a key element of the informed consent process. This study examines and compares the priorities for disclosure of the elements of informed consent between parents of paediatric research subjects and investigators. METHODS: The study sample comprised 184 parents who had been approached for permission to allow their child to participate in a clinical anaesthesia or surgery study. Parents were asked to rank 11 elements of informed consent that they believed were most important for them to know before allowing their child to participate in a research study. In addition, 38 investigators were asked to rank, in order of importance, the same elements that they felt were most important for parents to know. RESULTS: The results showed that risk was the most important element considered by both parents and investigators. However, parents placed significantly greater importance on knowledge of the potential benefits to their child (direct) and to other children (indirect) compared with investigators, and less importance on the details of the protocol and the element of voluntariness. CONCLUSIONS: These results demonstrated differences in the priorities for disclosure of the elements of consent between parents and investigators. As such, they may be important in directing the investigator to focus on the elements that are most important to parents and thus maximize their ability to provide truly informed consent.
BACKGROUND: Disclosure is a key element of the informed consent process. This study examines and compares the priorities for disclosure of the elements of informed consent between parents of paediatric research subjects and investigators. METHODS: The study sample comprised 184 parents who had been approached for permission to allow their child to participate in a clinical anaesthesia or surgery study. Parents were asked to rank 11 elements of informed consent that they believed were most important for them to know before allowing their child to participate in a research study. In addition, 38 investigators were asked to rank, in order of importance, the same elements that they felt were most important for parents to know. RESULTS: The results showed that risk was the most important element considered by both parents and investigators. However, parents placed significantly greater importance on knowledge of the potential benefits to their child (direct) and to other children (indirect) compared with investigators, and less importance on the details of the protocol and the element of voluntariness. CONCLUSIONS: These results demonstrated differences in the priorities for disclosure of the elements of consent between parents and investigators. As such, they may be important in directing the investigator to focus on the elements that are most important to parents and thus maximize their ability to provide truly informed consent.
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Keywords:
Biomedical and Behavioral Research; Empirical Approach
Authors: Melissa K Cousino; Stephen J Zyzanski; Amy D Yamokoski; Rebecca A Hazen; Justin N Baker; Robert B Noll; Susan R Rheingold; J Russell Geyer; Stewart C Alexander; Dennis Drotar; Eric D Kodish Journal: J Clin Oncol Date: 2012-10-15 Impact factor: 44.544
Authors: Peter D Guarino; Julia E Vertrees; Sanjay Asthana; Mary Sano; Maria D Llorente; Muralidhar Pallaki; Susan Love; Gerard D Schellenberg; Maurice W Dysken Journal: Alzheimers Dement (N Y) Date: 2016-09-20