WHAT ARE THE FACTORS INFLUENCING PARENTAL APPREHENSION ABOUT CONSENTING CHILDREN TO PARTICIPATE IN PEDIATRIC OBSERVATIONAL STUDIES? A SURVEY CONDUCTED IN FRANCE WITH IN FINE PHARMA, A PHARMACIST NETWORK
Author(s)
El Kebir S1, Bourhis Y2, Hussein R3, Gauchoux R41Regsitrat Mapi, Lexington, KY, USA, 2Registrat Mapi, Lyon, France, 3Université de Bourgogne, Dijon, France, 4REGISTRAT MAPI, Lyon, France
Presentation Documents
BACKGROUND: Conducting pediatric studies is complex and the most significant barrier is infant enrollment by parental consent. This obstacle is currently found both for healthy and sick infants. The reason for the parents’ refusal to consent is not obvious and may be due to multiple factors. OBJECTIVES: To identify the factors influencing parents’ decisions to refuse infant participation in pediatric studies. METHODS: Observational, transversal study carried out by French pharmacists randomly selected among the 2,090 pharmacies of the In fine PHARMA® network (representative of French pharmacies in terms of geographic location and sales). Parents presenting to participating pharmacies were eligible. Data were collected through questionnaires fulfilled by participating parents. RESULTS: Twenty-one pharmacists agreed to participate and enrolled 105 participating parents. Among them, 78 (74%) filled out a questionnaire. Participating families had an average of 2.3 children, 81% were living in an urban environment, and 51% of the infants were males. Most of the parents (97%) had never enrolled their children in a study. Main deterrents to parental consent were: they viewed pediatric studies as risky (35%), they did not want their infant to be treated as an experimental animal (20%), their infant was not ill (12%), the information provided by the physician was too confusing and/or complicated (10%). Parents may have been willing to have their child participate in a study only if the study was evaluating a new drug, their child’s participation would further medical research (31%), their child suffered from a severe illness (24%), and they had great confidence in their physician (22%). CONCLUSIONS: The results of this survey show that the factors negatively influencing parents’ decisions to consent were the perceived risk presented by the studies, the lack of interest to medical research if their child was not ill, and the lack of information about the study.
Conference/Value in Health Info
2011-11, ISPOR Europe 2011, Madrid, Spain
Value in Health, Vol. 14, No. 7 (November 2011)
Code
PIH32
Topic
Patient-Centered Research
Topic Subcategory
Adherence, Persistence, & Compliance
Disease
Pediatrics