Parents’ perceptions of their infants’ participation in clinical research

Anne Gammelgaard ^1*, Lisbeth Ehlert Knudsen ² and Hans Bisgaard ³

¹ Dept of Medical Philosophy and Clinical Theory, University of Copenhagen, Denmark
² Environmental Medicine, University of Copenhagen, Denmark
³ Dept of Paediatrics, University of Copenhagen, Denmark

^* To whom correspondence should be addressed. E-mail: a.gammelgaard{at}pubhealth.ku.dk.

Accepted 28 June 2006

Abstract

Objective: To analyze parents’ motivations and perceptions of their infants and young children’s participation in a comprehensive and invasive clinical research study.

Methods: Semi-structured qualitative interviews were conducted with 23 asthmatic mothers of infants and young children participating in the COPSAC (The Copenhagen Prospective Study on Asthma in Childhood) study. The interviews were audiotaped, transcribed and analyzed using the method of template analysis.

Results: Parents were motivated by altruism and by the opportunity to get their child checked regularly by medical experts to prevent the possible development of asthma. Parents found it very important that their children enjoyed their visits at the research clinic and they would withdraw from the study if their child started responding negatively to those visits. There was no apparent difference in attitude between parents of children suffering from lung or skin symptoms and parents of healthy children.

Conclusions: Our study suggests that it is indeed possible to design and accomplish invasive clinical research with infants and young children in a manner that parents find ethically sound.

Keywords: COPSAC, asthma, clinical trials, ethics, infants

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