title: Are Parents of Preschool Children Inclined to Give Consent for Participation in Nutritional Clinical Trials?
abstract: OBJECTIVE
  Micronutrient deficiencies can lead to anemia, growth restriction, and poor motor and cognitive development. A clinical trial was planned to assess the impact of nutritional supplementation on cognitive measures in preschool children. Conducting clinical trials in children is difficult due to underlying laws, hesitation of the research community, and difficult enrollment. We carried out a questionnaire-based feasibility survey to assess the interest of parents towards participation in such a nutrition-based study.
  
  
  METHODS
  After approval from the Institutional Human Research Ethics Committee, the principals of four kindergarten schools at Vallabh Vidyanagar, Anand, Gujarat, India consented to participate. Children at the participating schools were distributed a consent form and pre-tested questionnaire, to be taken home for parents to sign, fill and return.
  
  
  RESULTS
  Out of a total of 1049 consent forms and questionnaires distributed, 602 (57.39%) signed and filled forms were returned. Despite fair awareness regarding the need of research, parents' willingness to involve their children in a 6 month duration research study, not requiring invasive measures like blood pricks, was 180 (29.9%). Nearly half (250, 41.5%) did not respond and more than a quarter (172, 28.6%) declined participation on behalf of their children.
  
  
  CONCLUSIONS
  The interest level of a pre-school child's parents for participation of the child in a nutrition intervention study evaluating cognitive measures like memory is low. Understanding the study population's motivating and inhibiting factors leading to decreased participation in clinical trials is necessary to facilitate the creation of a pertinent evidence base.
authors.affiliation: Department of Pediatrics, Shree Krishna Hospital, Pramukhswami Medical College, Karamsad, Anand, Gujarat, India.
authors.forename: Somashekhar Marutirao
authors.identifier: http://orcid.org/0000-0003-2825-2819
authors.initials: SM
authors.lastname: Nimbalkar
authors.affiliation: Department of Pediatrics, Shree Krishna Hospital, Pramukhswami Medical College, Karamsad, Anand, Gujarat, India.
authors.forename: Dipen Vasudev
authors.initials: DV
authors.lastname: Patel
authors.affiliation: Central Research Services, Charutar Arogya Mandal, Karamsad, Anand, Gujarat, India.
authors.forename: Ajay Gajanan
authors.initials: AG
authors.lastname: Phatak
mesh_terms: D002675:Child, Preschool; D002986:Clinical Trials as Topic; D006801:Humans; D009749:Nutrition Surveys; D010290:Parents / Q000523:psychology*; D011795:Surveys and Questionnaires