RESEARCH ETHICS

A questionnaire on factors influencing children’s assent and dissent to non-therapeutic research

O D Wolthers

Correspondence to:
Correspondence to:
Ole D Wolthers
MD, DMSci, Consultant Paediatrician, Children’s Clinic Randers, Dytmaersken 9, DK-8900 Randers, Denmark; akk.odws{at}dadlnet.dk

Background: Knowledge about assent or dissent of children to non-therapeutic research is poor.

Objectives: To assess sociodemographic characteristics in healthy children and adolescents who were invited to participate in non-therapeutic research, to evaluate their motives for assent or dissent and their understanding of the information given.

Methods: A total of 1281 healthy children and adolescents six to sixteen years of age were invited to participate in a non-therapeutic study and a questionnaire.

Results: Assenting children were motivated by a desire to help sick children (n = 638, 98%) and to gain experience with participating in a research study (n = 503, 82%). Dissenting children made their decision because of worries about having a blood (n = 193, 46%) or a urine sample (n = 94, 26%) taken or because of worries about a doctor’s examination (n = 136, 33%). Fewer children in the assent group (n = 166, 25%) than in the dissent group (136, 33%) worried about the doctor’s examination (p = 0.01). In the assent and dissent group, 568 (86%) and 343 (85%) children, respectively, said they were able to understand some or all of the written information (p = 0.42), and 650 (97%) and 330 (98%), respectively, were able to understand some or all of the verbal information (p = 0.07).

Conclusions: Sociodemographic characteristics may not influence healthy children’s decision to volunteer for non-therapeutic research. Assenting children have altruistic and educational motives, whereas worries about procedures may cause children to dissent. A great majority of school children and adolescents feel capable of understanding and giving assent or dissent to non-therapeutic research.

Keywords: ethics; informed consent; clinical research; healthy volunteers; research subjects

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