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Re: Parents and paediatric research : Need for a wider perspective

Dear Editor,

Gammelgaard et al have to be commended for their study which attempts to throw light on some of the complex issues, ethical and otherwise, surrounding parental attitudes towards research in children.(1) While agreeing broadly with the authors' conclusions regarding the feasibility of setting up a research project which conforms to parental perceptions, we would like to stress the need for viewing this in a wider perspective.

The COPSAC study involves follow up of infants who are healthy at the outset, with a view to early identification of asthma and related allergic disorders, which are relatively common and usually not life threatening in the general paediatric population. All the mothers involved had suffered from similar conditions, thus equipping them with a unique insight into the disease, as well as a possible 'motive' to allow even invasive testing for early diagnosis in their children. In contrast, many paediatric research studies involve children newly diagnosed with severe and often fatal conditions such as malignancies and immunodeficiencies. Another major area of research in children is the evaluation of newer therapies by randomised trials. It is questionable whether parents faced with such situations can be compared with their counterparts in the COPSAC study.

It may be noted that the 'parent' in this study was almost always the mother. This possibly is based on the premise that it is more difficult to recruit fathers and that the mother's opinion on research is representative. However, previous workers have demonstrated the fallacy associated with both these assumptions.(2) An ideal study trying to address parental perceptions on research should hence aim to recruit comparable proportions of both mothers and fathers across a range of sociocultural backgrounds.

The 'motivation' of mothers as recorded in this study is based on the cumulative experiences over a couple of years since the start of the study. Whether this is consistent with actual feelings and true motivations at the point of inception of the study is not clear. This assumes obvious importance when applied to parents approached with consent for a research study soon after the disclosure of a serious and possibly lethal diagnosis. The emotional trauma inherent in such situations makes the dynamics of parental participation in the consenting process significantly different from the simplistic model of COPSAC study.(3)

It is obvious that parental outlooks are affected by a diverse set of variables and hence cannot be predicted from such a study with limited sample size confined to mothers who also had suffered from the same condition. Recent studies have highlighted issues like parental worries about possible financial tie-ups between physicians and pharmaceutical companies.(4) It is also worth pointing out that parents have been known to give consent for studies involving significant potential risks with no obvious benefit to their children, when placed in a vulnerable position.(5)

The authors have rightly concluded that it is possible to implement invasive research studies on children while achieving an accepable level of parental satisfaction. However, caution must be applied when extrapolating this conclusion to all types of paediatric research. The importance of realising the individualistic nature of each research study and the variety of factors influencing parental opinion cannot be over- emphasised.

References:

(1) Gammelgaard A, Knudsen LE, Bisgaard H. Perceptions of parents on the participation of their infants in clinical research. Arch Dis Child 2006; 91 : 977-980.

(2) Woollett A., White DG, Lyon ML. Studies involving fathers: Subject refusal, attrition and sampling bias. Current Psychological Reviews 1982; 2 : 193-212.

(3) Deatrick JA, Angst DB, Moore C. Parents' views of their children's participation in phase I oncology clinical trials. J Pediatr Oncol Nurs 2002; 19(4) : 114-121.

(4) Hampson LA, Agrawal M, Joffe S, Gross CP, Verter J, Emanuel EJ. Patients' views on financial conflicts of interest in cancer research trials. N Engl J Med 2006; 355(22) : 2330-2337.