Abstract
Research involving children can contribute to generalizable knowledge regarding many important illnesses affecting children, however children represents a vulnerable group in which additional safeguards are necessary. The history of research involving children demonstrates that their interests were not always considered and they have, in the past, been exploited. This chapter will discuss the ethical issues involving children in research in the Arab region, characteristics of children that lead to their vulnerability, the criteria necessary to include children in research (scientific necessity, appropriate balance of risks and benefits, parental permission, and child assent), and special issues involving street-connected children and youths in research.
This is a preview of subscription content, log in via an institution to check access.
Notes
- 1.
As children can be exposed to risks that are no greater than minimal risk (first risk category), it is more exact to say that children cannot be exposed to net risks that are greater than minimal risks.
- 2.
In Phase I trials involving healthy adults, there are no potential direct benefits and hence, ALL of the risks of the study represent “net” risks, which then need to be justified by the knowledge to be gained for society.
References
Alahmad, G., and K. Dierickx. 2015. Pediatric research ethics: Islamic perspectives. British Journal of Medicine & Medical Research 5: 1158–1168.
Alahmad, G., M. Al-Jumah, and K. Dierickx. 2012. Review of national research ethics regulations and guidelines in Middle Eastern Arab countries. BMC Medical Ethics 13: 34. https://doi.org/10.1186/1472-6939-13-34.
Code of Federal Regulations (CFR) 46. 1981, June 18. Federal Policy for the protection of human subjects: Subpart D: Additional Protections for Children Involved as Subjects in Research.
Council for International Organizations of Medical Sciences (CIOMS), & World Health Organization (WHO). 2016. International ethical guidelines for health-related research involving humans. Geneva.
Duke, T., and D. Fuller. 2014. Randomised controlled trials in child health in developing countries: Trends and lessons over 11 years. Archives of Disease in Childhood 99 (7): 615–620. https://doi.org/10.1136/archdischild-2013-305702.
Embleton, L., M.A. Ott, J. Wachira, V. Naanyu, A. Kamanda, D. Makori, et al. 2015. Adapting ethical guidelines for adolescent health research to street-connected children and youth in low- and middle-income countries: A case study from western Kenya. BMC Medical Ethics 16: 89. https://doi.org/10.1186/s12910-015-0084-y.
International Conference on Harmonization (ICH). 1996. Good clinical practice. Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
Khalil, S.S., H.J. Silverman, M. Raafat, S. El-Kamary, and M. El-Setouhy. 2007. Attitudes, understanding, and concerns regarding medical research amongst Egyptians: A qualitative pilot study. BMC Medical Ethics 8: 9.
Nabulsi, M., Y. Khalil, and J. Makhoul. 2011. Parental attitudes towards and perceptions of their children's participation in clinical research: A developing-country perspective. Journal of Medical Ethics 37 (7): 420–423. https://doi.org/10.1136/jme.2010.035899.
Nakkash, R.T., A. Al Mulla, L. Torossian, R. Karhily, L. Shuayb, Z.R. Mahfoud, et al. 2014. Challenges to obtaining parental permission for child participation in a school-based waterpipe tobacco smoking prevention intervention in Qatar. BMC Medical Ethics 15: 70. https://doi.org/10.1186/1472-6939-15-70.
National Institutes of Health. 2016. Willowbrook hepatitis experiments. Available at: https://science.education.nih.gov/supplements/nih9/bioethics/guide/pdf/master_5-4.pdf
Richter, M., J.N. Groft, and L. Prinsloo. 2007. Ethical issues surrounding studies with vulnerable populations: A case study of south African street children. International Journal of Adolescent Medicine and Health 19: 117–126.
Roth-Cline, M., J. Gerson, P. Bright, C.S. Lee, and R.M. Nelson. 2011. Ethical considerations in conducting pediatric research. Handbook of Experimental Pharmacology 205: 219–244. https://doi.org/10.1007/978-3-642-20195-0_11.
Rothman, D.J. 1982. Were Tuskegg & Willowbrook 'Studies in nature? The Hastings Center 12: 5–7.
Silverman, H. 2005. Enhancing research ethics capacity: Implications for protection of research subjects, avoiding exploitation and achieving global health. Middle East Fertil Soc J 10: 105–109.
United Nations Expert Group Meeting On Adolescents, Y. a. D. 2011. Youth population and employment in the Middle East and North Africa: Opportunity or challenge? Available at: http://www.un.org/esa/population/meetings/egm-adolescents/p06_roudi.pdf
Vreeman, R., E. Kamaara, A. Kamanda, D. Ayuku, W. Nyandiko, L. Atwoli, et al. 2012. Community perspectives on research consent involving vulnerable children in Western Kenya. Journal of Empirical Research on Human Research Ethics 7 (4): 44–55. https://doi.org/10.1525/jer.2012.7.4.44.
Woan, J., J. Lin, and C. Auerswald. 2013. The health status of street children and youth in low- and middle-income countries: A systematic review of the literature. The Journal of Adolescent Health 53 (3): 314–321.e12. e312. https://doi.org/10.1016/j.jadohealth.2013.03.013.
World Medical, A. 2013. World medical association declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 310 (20): 2191–2194. https://doi.org/10.1001/jama.2013.281053.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2017 Springer International Publishing AG
About this chapter
Cite this chapter
Silverman, H. (2017). Children as Research Participants. In: Silverman, H. (eds) Research Ethics in the Arab Region. Research Ethics Forum, vol 5. Springer, Cham. https://doi.org/10.1007/978-3-319-65266-5_7
Download citation
DOI: https://doi.org/10.1007/978-3-319-65266-5_7
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-65264-1
Online ISBN: 978-3-319-65266-5
eBook Packages: Religion and PhilosophyPhilosophy and Religion (R0)