How do parents experience being asked to enter a child in a randomised controlled trial?

Shilling, Valerie and Young, Bridget (2009) How do parents experience being asked to enter a child in a randomised controlled trial? BMC Medical Ethics, 10 (1). pp. 1-11. ISSN 1472-6939

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Background: As the number of randomised controlled trials of medicines for children increases,
it becomes progressively more important to understand the experiences of parents who are asked
to enrol their child in a trial. This paper presents a narrative review of research evidence on
parents' experiences of trial recruitment focussing on qualitative research, which allows them to
articulate their views in their own words.
Discussion: Parents want to do their best for their children, and socially and legally their role is
to care for and protect them yet the complexities of the medical and research context can
challenge their fulfilment of this role. Parents are simultaneously responsible for their child and
cherish this role yet they are dependent on others when their child becomes sick. They are keen
to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the
'wrong' decision. They make judgements about the threat of the child's condition as well as the risks
of the trial yet their interpretations often differ from those of medical and research experts.
Individual parents will experience these and other complexities to a greater or lesser degree
depending on their personal experiences and values, the medical situation of their child and the
nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these
complexities if practitioners have the flexibility to tailor discussions to the needs and situation of
individual parents. In this way, parents may be helped to retain a sense that they have acted as good
parents to their child whatever decision they make.
Summary: Discussing randomised controlled trials and gaining and providing informed consent is
challenging. The unique position of parents in giving proxy consent for their child adds to this
challenge. Recognition of the complexities parents face in making decisions about trials suggests
lines for future research on the conduct of trials, and ultimately, may help improve the experience
of trial recruitment for all parties.

Item Type: Article
Keywords: Clinical Trials Consent Decision Making Judgment Negotiation Parents -- Psychosocial Factors Patient Selection Adolescence Adult Altruism Child Child, Preschool Emotions Female Male Professional-Family Relations Social Responsibility Special Populations Trust Truth Disclosure Human
Schools and Departments: Brighton and Sussex Medical School > Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
Subjects: R Medicine > RJ Pediatrics > RJ0101 Child health. Child health services
Depositing User: Valerie Shilling
Date Deposited: 15 Aug 2016 06:33
Last Modified: 31 Oct 2019 10:51

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