Perceptions of parents on the participation of their infants in clinical research

In recent years, various initiatives have aimed at furthering paediatric research, as the absence of adequate studies in the paediatric population has hampered progress in the care of children. ^{1, 2} In the US, several laws have been enacted to make drug manufacturers test their products on children, ^{3- 5} and in Europe, the European Research Commission has proposed granting companies testing their medicinal products on children an extended period of patent and data protection. ⁶

There is a growing body of literature discussing specific ethical dilemmas in relation to paediatric research, such as the inclusion of healthy children in non-therapeutic research ^{2, 7} and the role of children's assent and dissent in decision making. ^{8, 9} Considering the ethical debate about children as research subjects, it is relevant to investigate how parents and children perceive their participation in research.

In this study, we report the perceptions of parents on the participation of their children in a birth cohort study associated with both therapeutic and non-therapeutic invasive procedures, such as sedation and lung-function testing at the age of 1 month, repeated skin tests and venepunctures. To our knowledge, this particular birth cohort study is the most comprehensive and invasive study on healthy infants and young children in recent years.

METHODS

Participants

Mothers whose children were participating in the Copenhagen Prospective Study on Asthma in Childhood (COPSAC) were eligible for this study. COPSAC is a single-centre longitudinal clinical-epidemiological birth cohort study on children of mothers with asthma. Objective assessments begin at birth, with scheduled visits every 6 months and when acute symptoms manifest. Clinical outcomes comprise asthma, atopic dermatitis, allergic rhinitis, allergy, lung function and bronchial responsiveness. ¹⁰ A total of 411 infants of mothers with asthma were enrolled at the age of 1 month. At the age of 3 years, 90% of the infants were still participating in the study. ¹⁰

Design

Qualitative interviews were conducted with 23 mothers of children participating in COPSAC. Mothers of children from the following three categories were selected randomly from the COPSAC database:

children without any symptoms of asthma or atopic dermatitis

children diagnosed with asthma or atopic dermatitis

children diagnosed with asthma and atopic dermatitis.

The sampling was based on the assumption that the motivation of parents to...