Is there a duty to participate in a health research? A viewpoint of children 6–8 years of age and their parents

References

• World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Adopted June 1964, amended October 2013. JAMA published online October 19, 2013.
   Google Scholar
• Finnish Medical Research Act 488/1999, last amendment 2010 [cited 2015 August 26]. Available from: https://www.finlex.fi/en/laki/kaannokset/1999/en19990488.
   Google Scholar
• Harris J. Scientific research is a moral duty. J Med Ethics. 2005;31:242–8. doi: 10.1136/jme.2005.011973
   PubMed Web of Science ®Google Scholar
• Shapshay S, Pimple KD. Participation in biomedical research is an imperfect moral duty: a response to John Harris. J Med Ethics. 2007;33:414–7. doi: 10.1136/jme.2006.017384
   PubMed Web of Science ®Google Scholar
• Schaefer GO, Emanuel EJ, Wertheimer A. The obligation to participate in biomedical research. J Am Med Assoc. 2009;302:67–72. doi: 10.1001/jama.2009.931
   Web of Science ®Google Scholar
• Brassington I. Defending the duty to research? Bioethics. 2011;25:21–6. doi: 10.1111/j.1467-8519.2009.01745.x
   PubMed Web of Science ®Google Scholar
• Brassington I. The case for a duty: not yet proven. J Med Ethics. 2014;40:329–30. doi: 10.1136/medethics-2013-101370
   PubMed Web of Science ®Google Scholar
• Resnik DB, Ness E. Participants' responsibilities in clinical research. J Med Ethics. 2012;38:746–50. doi: 10.1136/medethics-2011-100319
   PubMed Web of Science ®Google Scholar
• Hein IM, Troost PW, Lindeboom R, deVries MC, Zwaan CM, Lindauer RJL. Assessing children's competence to consent in research by a standardized tool: a validity study. BMC Pediatrics. 2012;12:156. doi: 10.1186/1471-2431-12-156
   PubMed Web of Science ®Google Scholar
• Leibson T, Koren G. Informed consent in pediatric research. Pediatr Drugs. 2015;17:5–11. doi: 10.1007/s40272-014-0108-y
   PubMed Web of Science ®Google Scholar
• Ondrusek N, Abramovitch R, Pencharz P, Koren G. Empirical examination of the ability of children to consent to clinical trials. J Med Ethics. 1998;24:158–65. doi: 10.1136/jme.24.3.158
   PubMed Web of Science ®Google Scholar
• Simon CM, Siminoff LA, Kodish ED, Burant C. Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology. J Clin Oncol. 2004;22:2708–17. doi: 10.1200/JCO.2004.10.034
   PubMed Web of Science ®Google Scholar
• Grootens-Wiegers P, deVries MC, van Beusekom MM, van Dijck L, van den Broek JM. Comic strips help children understand medical research. Patient Educ Couns. 2015; doi: 1016/j.pec.2014.12.005
   PubMed Web of Science ®Google Scholar
• Daniels SR, Arnett DK, Eckel RH, Gidding SS, Hayman LL, Kumanyika S, et al. Overweight in children and adolescents: pathophysiology, consequences, prevention, and treatment. Circulation. 2005;111(15):1999–2012. doi: 10.1161/01.CIR.0000161369.71722.10
   PubMed Web of Science ®Google Scholar
• Juonala M, Magnussen CG, Berenson GS, Venn A, Burns TL, Sabin MA, et al. Childhood adiposity, adult adiposity, and cardiovascular risk factors. N Engl J Med. 2011;365:1876–85. doi: 10.1056/NEJMoa1010112
   PubMed Web of Science ®Google Scholar
• Gibson BE, Stasiulis E, Gutfreund S, McDonald M, Dade L. Assessment of children's capacity to consent for research – a descriptive qualitative study of researchers' practices. J Med Ethics. 2011;37:504–9. doi: 10.1136/jme.2010.040097
   PubMed Web of Science ®Google Scholar
• Veijalainen A, Tompuri T, Laitinen T, Lintu N, Viitasalo A, Laaksonen DE, et al. Metabolic risk factors are associated with stiffness index, reflection index and finger skin temperature in children – Physical Activity and Nutrition in Children (PANIC) Study. Circ J. 2013;77:1281–8. doi: 10.1253/circj.CJ-12-0704
   PubMed Web of Science ®Google Scholar
• Lintu N, Tompuri T, Viitasalo A, Soininen S, Laitinen T, Savonen K, et al. Cardiovascular fitness and haemodynamic responses to maximal cycle ergometer exercise test in children 6–8 years of age. J Sport Sci. 2014;32:652–9. doi: 10.1080/02640414.2013.845681
   PubMed Web of Science ®Google Scholar
• Viitasalo A, Eloranta A-M, Lintu N, Väistö J, Venäläinen T, Kiiskinen S, et al. The effects of a 2-year individualized and family-based lifestyle intervention on physical activity, sedentary behavior and diet in children. Prev Med. 2016;87:81–8. doi: 10.1016/j.ypmed.2016.02.027
   PubMed Web of Science ®Google Scholar
• Länsimies-Antikainen H, Pietilä A-M, Laitinen T, Schwab U, Rauramaa R, Länsimies E. Evaluation of informed consent: a pilot study. J Adv Nurs. 2007;59:146–54. doi: 10.1111/j.1365-2648.2007.04279.x
   PubMed Web of Science ®Google Scholar
• Länsimies-Antikainen H, Laitinen T, Rauramaa R, Pietilä A-M. Evaluation of informed consent in health research: a questionnaire survey. Scand J Caring Sci. 2010;24:56–64. doi: 10.1111/j.1471-6712.2008.00684.x
   PubMed Web of Science ®Google Scholar
• Saari A, Sankilampi U, Hannila ML, Kiviniemi V, Kesseli K, Dunkel L. New Finnish growth references for children and adolescents aged 0 to 20 years: length/height-for-age, weight-for-length/height, and body mass index-for-age. Ann Med. 2011;43:235–48. doi: 10.3109/07853890.2010.515603
   PubMed Web of Science ®Google Scholar
• Burns N, Grove SK. The practice of nursing research: conduct, critique & utilization. 4th ed. Philadelphia, USA: WB Saunders Company; 2001.
   Google Scholar
• Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurs Educ Today. 2004;24:105–12. doi: 10.1016/j.nedt.2003.10.001
   PubMed Web of Science ®Google Scholar
• Cheng TL, Jenkins RR. Health disparities across the lifespan: where are the children? J Am Med Assoc. 2009;301:2491–2. doi: 10.1001/jama.2009.848
   Web of Science ®Google Scholar
• Rhodes ET, Ludwig DS. Childhood obesity as a chronic disease: keeping the weight off. J Am Med Assoc. 2007;298:1695–6. doi: 10.1001/jama.298.14.1695
   Web of Science ®Google Scholar
• John T, Hope T, Savulescu J, Stein A, Pollard AJ. Children's consent and paediatric research: is it appropriate for healthy children to be the decision-makers in clinical research? Arch Dis Child. 2008;93:379–83. doi: 10.1136/adc.2007.118299
   PubMed Web of Science ®Google Scholar
• Rhodes R. In defense of the duty to participate in biomedical research. Am J Bioethics. 2008;8:37–8. doi: 10.1080/15265160802478594
   PubMed Web of Science ®Google Scholar
• Evans HM. Should patients be allowed to veto their participation in clinical research? J Med Ethics. 2004;30:198–203. doi: 10.1136/jme.2003.002444
   PubMed Web of Science ®Google Scholar
• Allhoff F. Free-riding and research ethics. Am J Bioethics. 2005;5:50–1. doi: 10.1080/15265160590927688
   PubMed Web of Science ®Google Scholar
• Wachbroit R, Wasserman D. Research participation: are we subject to a duty? Am J Bioethics. 2005;5:48–9. doi: 10.1080/15265160590927831
   PubMed Web of Science ®Google Scholar
• de Melo-Martín I. A duty to participate in research: does social context matter? Am J Bioethics. 2008;8:28–36. doi: 10.1080/15265160802393017
   PubMed Web of Science ®Google Scholar
• Brassington I. John Harris' argument for a duty to research. Bioethics. 2007;21:160–8. doi: 10.1111/j.1467-8519.2007.00539.x
   PubMed Web of Science ®Google Scholar
• Sharp RR, Yarborough M. Additional thoughts on rethinking research ethics. Am J Bioethics. 2005;5:40–2. doi: 10.1080/15265160590927804
   PubMed Web of Science ®Google Scholar
• Viitasalo A, Lakka TA, Laaksonen DE, Savonen K, Lakka HM, Hassinen M, et al. Validation of metabolic syndrome score by confirmatory factor analysis in children and adults and prediction of cardiometabolic outcomes in adults. Diabetologia. 2014;57:940–9. doi: 10.1007/s00125-014-3172-5
   PubMed Web of Science ®Google Scholar
• Lakka HM, Laaksonen DE, Lakka TA, Niskanen LK, Kumpusalo E, Tuomilehto J, et al. The metabolic syndrome and total and cardiovascular disease mortality in middle-aged men. J Am Med Assoc. 2002;288(21):2709–16. doi: 10.1001/jama.288.21.2709
   PubMed Web of Science ®Google Scholar