Knowing why parents decide to consent or dissent to participation of their child in pediatric clinical research is essential to further the ethical debate concerning pediatric research. We performed this qualitative focus group study with 16 parents from the Dutch general public to explore their perspectives on decisions to participate in pediatric clinical research. Group discussion revealed the following: Parents conflate clinical research and clinical care, they do not grasp the trajectory of pediatric drug development, their protectiveness matches current research guidelines, and benefit for their child is the most important factor in their decision. Research professionals should be aware of the knowledge gap of parents, the pitfalls of jargon, and unintended false expectations.
AppelbaumP. S.RothL. H.LidzC. W.BensonP.WinsladeW. (1987). False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report, 17(2), 20-24.
2.
BinikA. (2014). On the minimal risk threshold in research with children. American Journal of Bioethics, 14(9), 3-12. doi:10.1080/15265161.2014.935879
3.
BosW.WestraA. E.PinxtenW.MayerM. P.LantosJ. D. (2015). Risks in a trial of an innovative treatment of Duchenne muscular dystrophy. Pediatrics, 136, 1173-1177.
4.
CaldwellP. H.ButowP. N.CraigJ. C. (2003). Parents’ attitudes to children’s participation in randomized controlled trials. Journal of Pediatrics, 142, 554-559. doi:10.1067/mpd.2003.192
5.
CaveE. (2010). Seen but not heard? Children in clinical trials. Medical Law Review, 18(1), 1-27.
6.
ChappuyH.BouazzaN.Minard-ColinV.PatteC.BrugieresL.Landman-ParkerJ.. . . DozF. (2013). Parental comprehension of the benefits/risks of first-line randomised clinical trials in children with solid tumours: A two-stage cross-sectional interview study. BMJ Open, 3(5), e002733.
7.
Council for International Organizations of Medical Sciences. (2016). International ethical guidelines for health-related research involving humans (4th ed.). Geneva, Switzerland: Author.
8.
DentM.PahorM. (2015). Patient involvement in Europe—A comparative framework. Journal of Health Organization and Management, 29, 546-555.
9.
ErraguntlaV.De la HuertaI.VohraS.AbdolellM.LevinA. V. (2012). Parental comprehension following informed consent for pediatric cataract surgery. Canadian Journal of Ophthalmology, 47, 107-112.
10.
European Parliament and the Council of the European Union. (2014). Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, and repealing directive 2001/20/EC. Official Journal of the European Union, 57(L 158), 1-76.
11.
EversJ. (2015). Het uitvoeren van een focusgroep [Performing a focus group]. In EversJ. (Ed.), Kwalitatief interviewen: Kunst én kunde [The qualitative interview: Art and skill] (pp. 115-126). The Hague, The Netherlands: Lemma.
12.
FloryJ.EmanuelE. (2004). Interventions to improve research participants’ understanding in informed consent for research: A systematic review. Journal of the American Medical Association, 292, 1593-1601.
13.
Grootens-WiegersP.de VriesM. C.van den BroekJ. M. (2015). Research information for minors: Suitable formats and readability. A systematic review. Journal of Paediatrics and Child Health, 51, 505-511.
14.
HallinanZ. P.ForrestA.UhlenbrauckG.YoungS.McKinneyR.Jr. (2016). Barriers to change in the informed consent process: A systematic literature review. IRB: Ethics & Human Research, 38(3), 1-10.
15.
HobermanA.ShaikhN.BhatnagarS.HaralamM. A.KearneyD. H.ColbornD. K.. . . ChesneyR. W. (2013). Factors that influence parental decisions to participate in clinical research: Consenters vs nonconsenters. JAMA Pediatrics, 167, 561-566.
16.
JansenL. A.MahadevanD.AppelbaumP. S.KleinW. M. P.WeinsteinN. D.MoriM.. . . SulmasyD. P. (2017). Variations in unrealistic optimism between acceptors and decliners of early phase cancer trials. Journal of Empirical Research on Human Research Ethics, 12, 280-288.
17.
KoelchM.SingerH.PrestelA.BurkertJ.SchulzeU.FegertJ. M. (2009). “. . . because I am something special” or “I think I will be something like a guinea pig”: Information and assent of legal minors in clinical trials—Assessment of understanding, appreciation and reasoning. Child and Adolescent Psychiatry and Mental Health, 3(1), Article 2.
18.
LebensburgerJ. D.SidonioR. F.DebaunM. R.SaffordM. M.HowardT. H.ScarinciI. C. (2013). Exploring barriers and facilitators to clinical trial enrollment in the context of sickle cell anemia and hydroxyurea. Pediatric Blood & Cancer, 60, 1333-1337. doi:10.1002/pbc.24486
19.
MacNeillV.NwokoroC.GriffithsC.GriggJ.SealeC. (2013). Recruiting ethnic minority participants to a clinical trial: A qualitative study. BMJ Open, 3(4), e002750. doi:10.1136/bmjopen-2013-002750
20.
StaphorstM. S.HunfeldJ. A. M.van de VathorstS. (2017). Are positive experiences of children in non-therapeutic research justifiable research benefits?Journal of Medical Ethics, 43, 530-534. doi:10.1136/medethics-2016-103404
21.
StaphorstM. S.van de VathorstS. (2015). Empirical data on benefits children experience in clinical research. American Journal of Bioethics, 15(11), 20-21.
22.
SynnotA.RyanR.PrictorM.FetherstonhaughD.ParkerB. (2014). Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews,5, Article CD003717.
23.
TaitA. R.Voepel-LewisT.MalviyaS. (2003a). Do they understand? (Part I): Parental consent for children participating in clinical anesthesia and surgery research. Anesthesiology, 98, 603-608.
24.
TaitA. R.Voepel-LewisT.MalviyaS. (2003b). Do they understand? (Part II): Assent of children participating in clinical anesthesia and surgery research. Anesthesiology, 98, 609-614.
25.
TongA.SainsburyP.CraigJ. (2007). Consolidated criteria for reporting qualitative research (COREQ): A 32-item checklist for interviews and focus groups. International Journal for Quality in Health Care, 19, 349-357. doi:10.1093/intqhc/mzm042
26.
TrompK.ZwaanC. M.van de VathorstS. (2016). Motivations of children and their parents to participate in drug research: A systematic review. European Journal of Pediatrics, 175, 599-612. doi:10.1007/s00431-016-2715-9
27.
WendlerD. S. (2012). Time to stop worrying about the therapeutic misconception. Journal of Clinical Ethics, 23, 272-287.
28.
WoodsS.HaggerL. E.McCormackP. (2014). Therapeutic misconception: Hope, trust and misconception in paediatric research. Health Care Analysis, 22, 3-21. doi:10.1007/s10728-012-0201-8
29.
World Medical Association. (2013). World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. Journal of the American Medical Association, 310, 2191-2194. doi:10.1001/jama.2013.281053
Supplementary Material
Please find the following supplemental material available below.
For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.
