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Peter D. Sly,^1,2 Brenda Eskenazi,³ Jenny Pronczuk,⁴ Radim Šrám,⁵ Fernando Diaz-Barriga,⁶ Diego Gonzalez Machin,⁷ David O. Carpenter,⁸ Simona Surdu,⁹ and Eric M. Meslin¹⁰

¹WHO Collaborating Centre for Research on Children’s Environmental Health, Curtin University of Technology, Perth, Australia; ²Centre for Child Health Research, University of Western Australia, Perth, Australia; ³Center for Children’s Environmental Health Research, University of California at Berkeley, Berkeley, California, USA; ⁴Public Health and Environment, World Health Organization, Geneva, Switzerland; ⁵Institute of Experimental Medicine, Prague, Czech Republic; ⁶WHO Collaborating Centre for Health Risk Assessment and Children’s Environmental Health, Universidad Autónoma de San Luis Potosí, San Luis Potosí, Mexico; ⁷Regional Advisor in Toxicology, World Health Organization/Pan American Health Organization Country Office, Brasilia, Brazil; ⁸Institute for Health and the Environment, University at Albany, The State University of New York, Albany, New York, USA; ⁹Public Health and Environment, World Health Organization/Interregional Research Unit, Research Triangle Park, North Carolina, USA; ¹⁰Indiana University Center for Bioethics, Indianapolis, Indiana, USA

Abstract
Background: Studying the impact of environmental exposures is important in children because they are more vulnerable to adverse effects on growth, development, and health. Assessing exposure in children is difficult, and measuring biomarkers is potentially useful. Research measuring biomarkers in children raises a number of ethical issues, some of which relate to children as research subjects and some of which are specific to biomarker research.

Objective: As an international group with experience in pediatric research, biomarkers, and the ethics of research in children, we highlight the ethical issues of undertaking biomarker research in children in these environments.

Discussion: Significant issues include undertaking research in vulnerable communities, especially in developing countries ; managing community expectations ; obtaining appropriate consent to conduct the research ; the potential conflicts of obtaining permission from an ethics review board in an economically developed country to perform research in a community that may have different cultural values ; returning research results to participants and communities when the researchers are uncertain of how to interpret the results ; and the conflicting ethical obligations of maintaining participant confidentiality when information about harm or illegal activities mandate reporting to authorities.

Conclusion: None of these challenges are insurmountable and all deserve discussion. Pediatric biomarker research is necessary for advancing child health.

Key words: biobanks, biomarkers, children, environmental exposure, genetics, infants, informed consent, research ethics. Environ Health Perspect 117:1185–1190 (2009) . doi:10.1289/ehp.0800480 available via http://dx.doi.org/ [Online 6 May 2009]

Address correspondence to P.D. Sly, Telethon Institute for Child Health Research, P.O. Box 855, West Perth, WA 6872, Australia. Telephone: 61 89489 7814. Fax: 61 89489. E-mail: peters@ichr.uwa.edu.au

Supplemental Material is available online (doi:10.1289/ehp.0800480.S1 via http://dx.doi.org/) .

This work was supported by the World Health Organization–National Institute of Environmental Sciences (WHO-NIEHS) Cooperative agreement, grant 5UO1 ESO2617. P.D.S. is supported by the National Health and Medical Research Council, Australia. B.E. is supported by grants RD 83171001 from the U.S. Environmental Protection Agency and PO1 ES009605 from the NIEHS. E.M.M. is supported by the Richard M. Fairbanks Foundation, Indianapolis, Indiana, and grant 1 R25 TW008183-01 from the Fogarty International Center, National Institutes of Health.

The authors declare they have no competing financial interests.

Received 12 December 2008 ; accepted 6 May 2009.