title: A Qualitative Study into Dependent Relationships and Voluntary Informed Consent for Research in Pediatric Oncology.
abstract: BACKGROUND
  In pediatric oncology, many oncologists invite their own patients to participate in research. Inclusion within a dependent relationship is considered to potentially compromise voluntariness of consent. Currently, it is unknown to what extent those involved in pediatric oncology experience the dependent relationship as a threat to voluntary informed consent, and what they see as safeguards to protect voluntary informed consent within a dependent relationship.
  
  
  OBJECTIVE
  We performed a qualitative study among key actors in pediatric oncology to explore their experiences with the dependent relationship and voluntary informed consent.
  
  
  METHODS
  We conducted three focus groups and 25 semi-structured, in-depth interviews with pediatric oncologists, research coordinators, Research Ethics Committee members, parents of children with cancer, and adolescents with cancer.
  
  
  RESULTS
  Professionals regarded the dependent relationship both as a potential threat to and as a positive influence on voluntary decision making. Parents and adolescents did not feel as though dependency upon the oncologist influenced their decisions. They valued the involvement of their own physician in the informed consent process. The professionals suggested three strategies to protect voluntariness: emphasizing voluntariness; empowering families; involvement of an independent person.
  
  
  CONCLUSIONS
  Although the dependent relationship between pediatric oncologists, patients and parents may be problematic for voluntary informed consent, this is not necessarily the case. Moreover, the involvement of treating physicians may even have a positive impact on the informed consent process. Although we studied pediatric oncology, our results may also apply to many other fields of pediatric medicine where research and care are combined, for example, pediatric rheumatology, neurology and nephrology. Clinical trials in these fields are inevitably often designed, initiated and conducted by medical specialists closely involved in patient care.
authors.affiliation: Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands. S.A.S.Dekking@umcutrecht.nl.
authors.forename: Sara A S
authors.initials: SA
authors.lastname: Dekking
authors.affiliation: Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.
authors.forename: Rieke
authors.initials: R
authors.lastname: van der Graaf
authors.affiliation: Department of Pediatric Oncology, Emma Children's Hospital, Amsterdam Medical Center, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.
authors.forename: Antoinette Y N
authors.initials: AY
authors.lastname: Schouten-van Meeteren
authors.affiliation: Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.
authors.forename: Marijke C
authors.initials: MC
authors.lastname: Kars
authors.affiliation: Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508 GA, Utrecht, The Netherlands.
authors.forename: Johannes J M
authors.initials: JJ
authors.lastname: van Delden
mesh_terms: D000293:Adolescent; D000328:Adult; D035843:Biomedical Research; D002648:Child; D002675:Child, Preschool; D003657:Decision Making; D005260:Female; D017144:Focus Groups; D006801:Humans; D007223:Infant; D007258:Informed Consent / Q000941:ethics*; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D010290:Parents; D010372:Pediatrics; D036301:Qualitative Research; D012108:Research Personnel; D055815:Young Adult