Pediatric Assent for a Study of Antiretroviral Therapy Dosing for Children in Western Kenya: A Case Study in International Research Collaboration

Abstract

Multinational collaborators in health research face particular ethical challenges when conducting studies involving vulnerable populations such as children. We use an example from our first attempt to implement pediatric assent in the context of a longstanding research and clinical partnership between Kenyan and American medical schools to highlight the ethical and procedural issues related to pediatric assent that must be considered for multinational, pediatric studies. We consider relevant domestic, professional, and international guidelines for assent in pediatric research subjects, and we discuss the particular ethical challenges related to pediatric assent in the Kenyan context. Finally, we propose a way forward for approaching pediatric assent within our collaborative research program in Kenya that may apply to other multinational research partnerships.

Keywords

assent pediatric assent children

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References

Appelbaum

P. S.

Roth

L. H.

, & Lidz

C. W.

(1982). The therapeutic misconception: Informed consent in psychiatric research. International Journal of Law and Psychiatry, 5(3–4), 319–329.

Barfield

R. C.

& Church

(2005). Informed consent in pediatric clinical trials. Current Opinion in Pediatrics, 17(1), 20–24.

Broome

M. E.

& Richards

D. J.

(1998). Involving children in research. Journal of Child and Family Nursing, 1(1), 3–7.

Broome

M. E.

& Richards

D. J.

(2003). The influence of relationships on children's and adolescents' participation in research. Nursing Research, 52(3), 191–197.

Childress

Meslin

, & Shapiro

(Eds.) (2005). Belmont revisited: Ethical principles for research with human subjects. Washington, D.C.: Georgetown University Press.

Committee on Bioethics, American Academy of Pediatrics. (1995). Informed consent, parental permission, and assent in pediatric practice. Pediatrics, 95(2), 314–317.

Committee on Drugs, American Academy of Pediatrics. (1995). Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics, 95(2), 286–294.

Council for International Organizations of Medical Sciences, in collaboration with the World Health Organization. (2002). International ethical guidelines for biomedical research involving human subjects. Geneva: Council for International Organizations of Medical Sciences. Available online at http://www.cioms.ch/publications/layout_guide2002.pdf.

Dickerson-Putman

& Brown

J. K.

(Eds.) (1998). Women among women: Anthropological perspectives on female age hierarchies (pp. 30–51). Champaign, IL: University of Illinois Press.

10.

Dorn

L. D.

Susman

E. J.

, & Fletcher

J. C.

(1995). Informed consent in children and adolescents: Age, maturation and psychological state. Journal of Adolescent Health: Official Publication of the Society of Adolescent Medicine, 16(3), 185–190.

11.

Emanuel

E. J.

Wendler

Killen

, & Grady

(2004). What makes clinical research in developing countries ethical? The benchmarks of ethical research. Journal of Infectious Diseases, 189(5), 930–937.

12.

Ember

C. R.

& Ember

(Eds.) (2003). Encyclopedia of sex and gender: Men and women in the world's cultures (pp. 247–256). New York: Kluwer Academic Publishers.

13.

Fairhead

Leach

, & Small

(2006). Public engagement with science? Local understandings of a vaccine trial in the Gambia. Journal of Biosocial Science, 38(1), 103–116.

14.

Gikonyo

Bejon

Marsh

, & Molyneux

(2008) Taking social relationships seriously: Lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast. Social Science and Medicine, 67(5), 708–720.

15.

Halperin

(2005). I laugh so I won't cry: Kenya's women tell the story of their lives. Trenton, NJ: Africa World Press.

16.

Hardy

Osis

M. J. D.

Bento

S. F.

Jiménez

A. L.

, & Carnevalli

C. R.

(1998). Informed consent and Fertility Regulation in Brazil: Final Report . Unpublished. Cited in: National Bioethics Advisory Commission. (2001). Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Bethesda, MD: NBAC. Available online at http://www.bioethics.gov/reports/past_commissions/nbac_international.pdf.

17.

Havens

P. L.

& Gibb

D. M.

(2007). Increasing antiretroviral drug access for children with HIV infection. Pediatrics, 119(4), 838–845.

18.

Indiana University-Purdue University Indianapolis (IUPUI). (2008). Standard operating procedures for research involving human participants. Available online at http://www.iupui.edu/∼resgrad/spon/policiescontent.htm.

19.

Johnston

T. E.

(2006). Issues surrounding protection and assent in pediatric research. Pediatric Physical Therapy: The Official Publication of the Section on Pediatrics of the American Physical Therapy Association, 18(2), 133–140.

20.

Kimberly

M. B.

Hoehn

K. S.

Feudtner

Nelson

R. M.

, & Schreiner

(2006). Variation in standards of research compensation and child assent practices: A comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials. Pediatrics, 117(5), 1706–1711.

21.

Kipnis

(2003). Seven vulnerabilities in the pediatric research subject. Theoretical Medicine and Bioethics, 24(2), 107–120.

22.

Kodish

(2003). Informed consent for pediatric research: Is it really possible? Journal of Pediatrics, 142(2), 89–90.

23.

Lavery

J. V.

McDonald

, & Meslin

E. M.

(2005). Research ethics across the 49th Parallel: The potential value of pilot testing “equivalent protections” in Canadian research institutions. Health Law Review, 13, 85–96.

24.

Laws of Kenya. (2001). The Children Act. CAP 586.

25.

Lewis

C. C.

(1981). How adolescents approach decisions: Changes over grades seven to twelve and policy implications. Child Development, 52, 538–544.

26.

Lijembe

J. A.

(1969). The valley between: A Muluyia's story. In Fox

L. K.

(Ed.), East African childhood (pp. 1–41). Nairobi: Oxford University Press.

27.

Meaux

J. B.

& Bell

P. L.

(2001). Balancing recruitment and protection: Children as research subjects. Issues in Comprehensive Pediatric Nursing, 24(4), 241–251.

28.

Molyneux

C. S.

Peshu

, & Marsh

(2004). Understanding of informed consent in a low-income setting: Three case studies from the Kenyan coast. Social Science & Medicine, 59(12), 2547–2559.

29.

Molyneux

C. S.

Peshu

, & Marsh

(2005a). Trust and informed consent: Insights from community members on the Kenyan coast. Social Science & Medicine, 61(7), 1463–1473.

30.

Molyneux

C. S.

Wassenaar

D. R.

Peshu

, & Marsh

(2005b). “Even if they ask you to stand by a tree all day, you will have to do it (laughter)… !”: Community voices on the notion and practice of informed consent for biomedical research in developing countries. Social Science & Medicine, 61(2), 443–454.

31.

National Bioethics Advisory Commission. (2001). Ethical and policy issues in international research: Clinical trials in developing countries. Bethesda, MD: NBAC. Available online at http://bioethics.georgetown.edu/nbac/clinical/Vol1.pdf.

32.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1977). Report and recommendations: Research involving children. Washington, D.C.: U.S. Government Printing Office. Available online at http://www.bioethics.gov/reports/past_commissions/Research_involving_children.pdf.

33.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Washington, D.C.: U.S. Government Printing Office; (1979). Available online at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm.

34.

National Council for Science and Technology, Kenya. (2004). Guidelines for ethical conduct of biomedical research involving human subjects in Kenya (NCST No. 45). Nairobi, Kenya: National Council for Science and Technology.

35.

Nelson

R. M.

& Reynolds

W. W.

(2003). We should reject passive resignation in favor of requiring the assent of younger children for participation in nonbeneficial research. American Journal of Bioethics, 3(4), 11–13.

36.

Nyambedha

E. O.

(2008). Ethical dilemmas of social science research on AIDS and orphanhood in Western Kenya. Social Science & Medicine, 67(5), 771–779.

37.

Oboler

(1985). Women, power, and economic change. The Nandi of Kenya. Palo Alto, CA: Stanford University Press.

38.

Ondrusek

Abramovitch

Pencharz

, & Koren

(1998). Empirical examination of the ability of children to consent to clinical research. Journal of Medical Ethics, 24(3), 158–165.

39.

Organization for Economic Co-operation and Development. (2008) Guidelines for human biobanks and genetic research databases. Available online at http://www.oecd.org/sti/biotechnology/hbgrd.

40.

Pinheiro

P. S.

(2005). World report on violence against children (pp. 31–42). The United Nations Secretary General's Study on Violence Against Children. Geneva: U.N. Publishing Services. Available online at http://www.unicef.org/violencestudy/I.%20World%20Report%20on%20Violence%20against%20Children.pdf.

41.

Schenk

, & Williamson

(2005). Ethical approaches to gathering information from children and adolescents in international settings: Guidelines and resources. Washington D.C.: Population Council. Available online at http://www.popcouncil.org/pdfs/horizons/childrenethics.pdf.

42.

Shapiro

H. T.

& Meslin

E. M.

(2001). Ethical issues in the design and conduct of clinical trials in developing countries. New England Journal of Medicine, 345(2), 139–142.

43.

Sidle

Were

Wools-Kaloustian

Chuani

Salmon

Tierney

, & Meslin

(2006). A needs assessment to build international research ethics capacity at Moi University and Indiana University. Journal of Empirical Research on Human Research Ethics, 1(2), 23–38.

44.

Tait

A. R.

Voepel-Lewis

, & Malviya

(2003). Do they understand? (Part II): Assent of children participating in clinical anesthesia and surgery research. Anesthesiology, 98(3), 609–614.

45.

Ungar

Joffe

, & Kodish

(2006). Children are not small adults: Documentation of assent for research involving children. Journal of Pediatrics, 149(1), S31–S33.

46.

United Nations Children's Fund (UNICEF). (2007). The State of the World's Children 2007. Women and Children: The Double Dividend of Gender Equality. New York: UNICEF. Available online at http://www.unicef.org/sowc07/docs/sowc07.pdf.

47.

United Nations Educational, Scientific, and Cultural Organization (UNESCO). (2003). International declaration of human genetic data. Available online at: http://portal.unesco.org/en/ev.php-URL_ID?17720&URL_DO?DO_TOPIC&URL_SECTION?201.html.

48.

U.S. Department of Health and Human Services, National Institutes of Health, and Office for Human Research Protections. (2005). Code of Federal Regulations, Title 45 (Public Welfare), Part 46 (Protection of Human Subjects). Available online at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

49.

Vreeman

Nyandiko

Ayaya

Walumbe

Marrero

, & Inui

(2008). Pediatric adherence to antiretroviral therapy among HIV-infected children in Western Kenya: A culturally grounded conceptual model. Paper presented at AIDS 2008 Conference, Mexico City, Mexico.

50.

Weisner

T. S.

Bradley

, & Kilbride

P. L.

(Eds.) (1997). African families and the crisis of social change. Westport, CT: Bergin & Garvey.

51.

Wendler

& Shah

(2003). Should children decide whether they are enrolled in nonbeneficial research? American Journal of Bioethics, 3(4), 1–7.

52.

Wendler

D. S.

(2006). Assent in paediatric research: Theoretical and practical considerations. Journal of Medical Ethics, 32(4), 229–234.

53.

World Medical Association. (2004). Declaration of Helsinki: Ethical principles for medical research involving human subjects. Journal International de Bioethique, 15(1), 124–129.

54.

World Medical Association. (2008). Declaration of Helsinki: Consultation draft. Available online at http://www.wma.net/e/pdf/doh_review_consultation_draft_may2008.rtf.