Emerging issues in paediatric health research consent forms in Canada: Working towards best practices

BMC Medical Ethics

Volumn 14, Issue 1, 2013, Pages

  Dove, Edward S ^a   Avard, Denise ^a   Black, Lee ^a   Knoppers, Bartha M ^a  

^a MCGILL UNIVERSITY   (Canada)

Author keywords

Children; Confidentiality; Consent; ELSI; Paediatric research; Research ethics; Return of results; Withdrawal

Indexed keywords

ADOLESCENT; ARTICLE; BIOETHICS; CANADA; CHILD; CONFIDENTIALITY; EPIDEMIOLOGY; ETHICS; HEALTH CARE FACILITY; HEALTH SERVICES RESEARCH; HUMAN; INFORMED CONSENT; PARENTAL CONSENT; PEDIATRICS; PRACTICE GUIDELINE; PRESCHOOL CHILD; RESEARCH ETHICS; RESEARCH SUBJECT; STANDARD;

ADOLESCENT; BIOETHICAL ISSUES; BIOLOGICAL SPECIMEN BANKS; CANADA; CHILD; CHILD, PRESCHOOL; CONFIDENTIALITY; CONFOUNDING FACTORS (EPIDEMIOLOGY); CONSENT FORMS; ETHICS, RESEARCH; HEALTH SERVICES RESEARCH; HUMANS; INFORMED CONSENT; PARENTAL CONSENT; PEDIATRICS; PRACTICE GUIDELINES AS TOPIC; RESEARCH SUBJECTS;

MLCS; MLOWN;

EID: 84873025492     PISSN: None     EISSN: 14726939     Source Type: Journal    
DOI: 10.1186/1472-6939-14-5     Document Type: Article

References (57)

1. Towards harmonization of pediatric research ethics review protocols among Canadian institutions: a Canadian pediatric rheumatology experience. Matheson LA, Huber AM, Warner A, Rosenberg AM, Paediatr Child Health 2012 17 313 316
2. Informed consent for MRI and fMRI research: analysis of a sample of Canadian consent documents. Palmour N, Affleck W, Bell E, Deslauriers C, Pike B, Doyon J, Racine E, BMC Med Ethics 2011 12 1 10.1186/1472-6939-12-1 21235768
3. Qualitative thematic analysis of consent forms used in cancer genome sequencing. Allen C, Foulkes WD, BMC Med Ethics 2011 12 14 10.1186/1472-6939-12- 14 21771309
4. The adequacy of informed consent forms in genetic research in Oman: a pilot study. Al-Riyami A, Jaju D, Jaju S, Silverman HJ, Dev World Bioeth 2011 11 57 62 10.1111/j.1471-8847.2010.00293.x 21266001
5. Analysis of the compliance of informed consent documents with good clinical practice guideline. Padhy BM, Gupta P, Gupta YK, Contemp Clin Trials 2011 32 662 666 10.1016/j.cct.2011.05.016 21664297
6. Problematic variation in local institutional review of a multicenter genetic epidemiology study. McWilliams R, Hoover-Fong J, Hamosh A, Beck S, Beaty T, Cutting G, JAMA 2003 290 360 366 10.1001/jama.290.3.360 12865377 (Pubitemid 37430522)
7. Variation in institutional review board responses to a standard protocol for a multicenter clinical trial. Stair TO, Reed CR, Radeos MS, Koski G, Camargo CA, MARC Investigators, Acad Emerg Med 2001 8 636 641 10.1111/j.1553-2712.2001. tb00177.x 11388939 (Pubitemid 32522205)
8. Variability among institutional review boards' decisions within the context of a multicenter trial. Silverman HJ, Hull SC, Sugarman J, Crit Care Med 2001 29 235 241 10.1097/00003246-200102000-00002 11246299 (Pubitemid 32171764)
9. To protect human subjects, review what was done, not proposed. Klitzman R, Appelbaum PS, Science 2012 335 1576 1577 10.1126/science.1217225 22461594
10. Ethical and practical challenges of sharing data from genome-wide association studies: the eMERGE Consortium experience. McGuire AL, Basford M, Dressler LG, Fullerton SM, Koenig BA, Li R, McCarty CA, Ramos E, Smith ME, Somkin CP, Waudby C, Wolf WA, Clayton EW, Genome Res 2011 21 1001 1007 10.1101/gr.120329.111 21632745
11. Variation in ethics review of multi-site research initiatives. Caulfield T, Ries N, Barr G, Amsterdam Law Forum 2011 3 85 100
12. Harmonization of ethics policies in pediatric research. Blake V, Joffe S, Kodish E, J Law Med Ethics 2011 39 70 78 10.1111/j.1748-720X.2011.00551.x 21314796
13. Engaging with children in research: Theoretical and practical implications of negotiating informed consent/assent. Lambert V, Glacken M, Nurs Ethics 2011 18 781 801 10.1177/0969733011401122 21646321
14. Avard D, Black L, Samuël J, Griener G, Knoppers BM, Canadian Institutes of Health Research (CIHR), Best Practices for Health Research Involving Children and Adolescents http://www.genomicsandpolicy.org/best- practices.html
15. Biobanks and longitudinal studies: where are the children? Samuël J, Ries NM, Malkin D, Knoppers BM, GenEdit 2008 6 1 8
16. Avard D, Samuël J, Knoppers BM (eds): Paediatric Research in Canada Les Éditions Thémis, Montréal 2009
17. Split views among parents regarding children's right to decide about participation in research: a questionnaire survey. Swartling U, Helgesson G, Hansson MG, Ludvigsson J, J Med Ethics 2009 35 450 455 10.1136/jme.2008.027383 19567697
18. Informed consent in genetics. Knoppers BM, Avard D, Thorogood A, eLS in press
19. Informed consent and the bio-banking of material from children. Holm S, Genomics Soc Policy 2005 1 16 26
20. Pediatric research and the return of individual research results. Avard D, Sénécal K, Madadi P, Sinnett D, J Law Med Ethics 2011 39 593 604 10.1111/j.1748-720X.2011.00626.x 22084845
21. Paediatric research and the communication of not-so incidental findings. Knoppers BM, Paediatr Child Health 2012 17 190 192
22. Ethical implications of including children in a large biobank for genetic-epidemiologic research: a qualitative study of public opinion. Kaufman D, Geller G, Leroy L, Murphy J, Scott J, Hudson K, Am J Med Genet C Semin Med Genet 2008 148C 31 39 10.1002/ajmg.c.30159 18189289 (Pubitemid 351294850)
23. Genetic research on stored tissue samples from minors: a systematic review of the ethical literature. Hens K, Nys H, Cassiman JJ, Dierickx K, Am J Med Genet A 2009 149A 2346 2358 10.1002/ajmg.a.33032 19764035
24. Dove ES, Black L, Avard D, Knoppers BM, Privacy in Canadian paediatric biobanks: a changing landscape. A report delivered to the Office of the Privacy Commissioner of Canada http://www.humgen.org/int/GI/Privacy-in-Canadian- paediatric-Biobanks.pdf
25. A.B. v. Bragg Communications Inc 2012 2012 SCC 46 (Supreme Ct. of Canada)
26. Neuendorf KA, The Content Analysis Guidebook Sage Publications, Thousand Oaks 2002
27. 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS-2- FINAL-Web.pdf
28. Halushka v. University of Saskatchewan 1965 53 D.L.R. (2d) 436 (Sask. Ct. of Appeal)
29. Weiss v. Solomon 1989 48 CCLT 280 (Que. Sup. Ct.)
30. Seven-year-old children's perceptions of participating in a comprehensive clinical birth cohort study. Gammelgaard A, Bisgaard H, Clin Ethics 2009 4 79 84 10.1258/ce.2009.009004
31. Growing up as a research subject: ethical and legal issues in birth cohort studies involving genetic research. Ries NM, Health Law J 2007 15 1 41 19702179
32. International normative perspectives on the return of individual research results and incidental findings in genomic biobanks. Zawati MH, Knoppers BM, Genet Med 2012 14 484 489 10.1038/gim.2012.13 22344229
33. Return of research results: how should research results be handled? Knoppers BM, Levesque E, J Law Med Ethics 2011 39 575 576
34. Whole-genome sequencing and the physician. Thorogood A, Knoppers B, Dondorp W, de Wert G, Clin Genet 2012 81 511 513 10.1111/j.1399-0004.2012.01868. x 22404433
35. Incidental findings in pediatric research. Wilfond BS, Carpenter KJ, J Law Med Ethics 2008 36 332 340 10.1111/j.1748-720X.2008.00277.x 18547202
36. The return of individual research findings in paediatric genetic research. Hens K, Nys H, Cassiman J, Dierickx K, J Med Ethics 2011 37 179 183 10.1136/jme.2010.037473 21059631
37. Genetic dilemmas and the child's right to an open future. Davis DS, Rutgers Law J 1997 28 549 592 12465646
38. The Babel of genetic data terminology. Knoppers BM, Saginur M, Nat Biotechnol 2005 23 925 927 10.1038/nbt0805-925 16082354 (Pubitemid 41114909)
39. Consent forms in genomics: the difference between law and practice. Boddington P, Curren L, Kaye J, Kanellopoulou N, Melham K, Gowans H, Hawkins N, Eur J Health Law 2011 18 491 519 10.1163/157180911X598744 22128519
40. Privacy and ethics in pediatric environmental health research-part I: genetic and prenatal testing. Fisher CB, Environ Health Perspect 2006 114 1617 1621 10.1289/ehp.9003 17035153 (Pubitemid 44509665)
41. Research involving children: some ethical issues. Helseth S, Slettebø A, Nurs Ethics 2004 11 298 308 10.1191/0969733004ne697oa 15176643 (Pubitemid 43933967)
42. Privacy for children. Shmueli B, Blecher-Prigat A, Columbia Human Rights Law Rev 2011 42 759 795
43. Is the commercialisation of human tissue and body material forbidden in the countries of the European Union? Lenk C, Beier K, J Med Ethics 2012 38 342 346 10.1136/jme.2010.038760 21697294
44. Novel approach to parental permission and child assent for research: improving comprehension. O'Lonergan TA, Forster-Harwood JE, Pediatrics 2011 127 917 924 10.1542/peds.2010-3283 21518711
45. Readability of the written study information in pediatric research in France. Ménoni V, Lucas N, Leforestier JF, Doz F, Chatellier G, Jacqz-Aigain E, Giraud C, Tréluyer JM, Chappuy H, PLoS One 2011 6 18484 10.1371/journal.pone.0018484 21494689
46. Enhancing the "informed" in informed consent: a pilot test of a multimedia presentation. Wanzer MB, Wojtaszczyk AM, Schimert J, Missert L, Baker S, Baker R, Dunkle B, Health Commun 2010 25 365 374 10.1080/ 10410231003775198 20512718
47. The ethics of paying for children's participation in research. Wendler D, Rackoff JE, Emanuel EJ, Grady C, J Pediatr 2002 141 166 171 10.1067/mpd.2002.124381 12183709
48. Paying for children to participate in research: a slippery slope or an enlightened stairway? Fernhoff PM, J Pediatr 2002 141 153 154 10.1067/mpd.2002.126454 12183703
49. Payments to children and adolescents enrolled in research: a pilot study. Iltis AS, DeVader S, Matsuo H, Pediatrics 2006 118 1546 1552 10.1542/peds.2006-0821 17015545 (Pubitemid 46393800)
50. Is a "wage-payment" model for research participation appropriate for children? Bagley SJ, Reynolds WW, Nelson RM, Pediatrics 2007 119 46 51 10.1542/peds.2006-1813 17200270 (Pubitemid 46397841)
51. Manson NC, O'Neill O, Rethinking Informed Consent in Bioethics Cambridge University Press, Cambridge 2007
52. Empty ethics: the problem with informed consent. Corrigan O, Sociol Health Illn 2003 25 768 792 10.1046/j.1467-9566.2003.00369.x 16523548 (Pubitemid 37533088)
53. Is informed consent broken? Henderson GE, Am J Med Sci 2011 342 267 272 10.1097/MAJ.0b013e31822a6c47 21817873
54. Procedure versus process: ethical paradigms and the conduct of qualitative research. Pollock K, BMC Med Ethics 2012 13 25 10.1186/1472-6939-13- 25 23016663
55. A randomized controlled trial of short and standard-length consent forms for a genetic cohort study: is longer better? Matsui K, Lie RK, Turin TC, Kita Y, J Epidemiol 2012 22 308 316 10.2188/jea.JE20110104 22447213
56. Improving the quality of informed consent to research. Schwartz V, Appelbaum PS, IRB 2008 30 19 20 18953773
57. Assessment of children's capacity to consent for research: a descriptive qualitative study of researchers' practices. Gibson BE, Stasiulis E, Gutfreund S, McDonald M, Dade L, J Med Ethics 2011 37 504 509 10.1136/jme.2010.040097 21636608