Is there a duty to participate in a health research? A viewpoint of children 6–8 years of age and their parents
DOI:
https://doi.org/10.1080/20573316.2016.1274170Keywords:
Duty, Children, Parents, Participation, Health, ResearchAbstract
It has been discussed in recent years whether participants should have a duty to participate in health research. Despite these theoretical discussions, there is little empirical evidence about study participants' perceptions of duties. We studied children's and their parents' sense of duty regarding participation in The Physical Activity and Nutrition in Children (PANIC) Study. In addition, we evaluated whether the sense of duty was related to the long-term participation in the study. The original study group of PANIC Study consisted of 512 children aged 6–8 years. Complete data of this sub-study were available for 312 children and their parents. Data on long-term participation were evaluated after 24 months. Analysis protocol was exploratory. The data show that 30% of parents felt a duty to participate in the study. However, only a minority of children (11%) felt the same. Parents' sense of duty in the early stages of the study improved long-term commitment to ongoing research. Thus, we can state that study participants have a sense of duty to participate although we cannot impose a duty to take part in any research.
Downloads
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.
Finnish Medical Research Act 488/1999, last amendment 2010 [cited 2015 August 26]. Available from: https://www.finlex.fi/en/laki/kaannokset/1999/en19990488.
Harris J. Scientific research is a moral duty. J Med Ethics. 2005;31:242–8. doi: 10.1136/jme.2005.011973
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
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
Brassington I. Defending the duty to research? Bioethics. 2011;25:21–6. doi: 10.1111/j.1467-8519.2009.01745.x
Brassington I. The case for a duty: not yet proven. J Med Ethics. 2014;40:329–30. doi: 10.1136/medethics-2013-101370
Resnik DB, Ness E. Participants' responsibilities in clinical research. J Med Ethics. 2012;38:746–50. doi: 10.1136/medethics-2011-100319
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
Leibson T, Koren G. Informed consent in pediatric research. Pediatr Drugs. 2015;17:5–11. doi: 10.1007/s40272-014-0108-y
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
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
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
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
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
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
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
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
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
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
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
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
Burns N, Grove SK. The practice of nursing research: conduct, critique & utilization. 4th ed. Philadelphia, USA: WB Saunders Company; 2001.
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
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
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
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
Rhodes R. In defense of the duty to participate in biomedical research. Am J Bioethics. 2008;8:37–8. doi: 10.1080/15265160802478594
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
Allhoff F. Free-riding and research ethics. Am J Bioethics. 2005;5:50–1. doi: 10.1080/15265160590927688
Wachbroit R, Wasserman D. Research participation: are we subject to a duty? Am J Bioethics. 2005;5:48–9. doi: 10.1080/15265160590927831
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
Brassington I. John Harris' argument for a duty to research. Bioethics. 2007;21:160–8. doi: 10.1111/j.1467-8519.2007.00539.x
Sharp RR, Yarborough M. Additional thoughts on rethinking research ethics. Am J Bioethics. 2005;5:40–2. doi: 10.1080/15265160590927804
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
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
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2016 Foundation of European Nurses in Diabetes
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
