Privacy and Ethics in Pediatric Environmental Health Research-Part II: Protecting Families and Communities
Fisher, Celia B., Environmental Health Perspectives
BACKGROUND: In pediatric environmental health research, information about family members is often directly sought or indirectly obtained in the process of identifying child risk factors and helping to tease apart and identify interactions between genetic and environmental factors. However, federal regulations governing human subjects research do not directly address ethical issues associated with protections for family members who are not identified as the primary "research participant." Ethical concerns related to family consent and privacy become paramount as pediatric environmental health research increasingly turns to questions of gene-environment interactions.
OBJECTIVES: In this article I identify issues arising from and potential solutions for the privacy and informed consent challenges of pediatric environmental health research intended to adequately protect the rights and welfare of children, family members, and communities.
DISCUSSION: I first discuss family members as secondary research participants and then the specific ethical challenges of longitudinal research on late-onset environmental effects and gene-environment interactions. I conclude with a discussion of the confidentiality and social risks of recruitment and data collection of research conducted within small or unique communities, ethnic minority populations, and low-income families.
CONCLUSIONS: The responsible conduct of pediatric environmental health research must be conceptualized as a goodness of fit between the specific research context and the unique characteristics of subjects and other family stakeholders.
KEY WORDS: communities, confidentiality, culture, environmental health, ethics, families, genetic determinants, informed consent, pediatric research, prenatal testing, privacy.
In pediatric environmental health research, information about family members is often directly sought or indirectly obtained in the process of identifying child risk factors and helping to tease apart and identify interactions between genetic and environmental factors. For example, research on neurodevelopmental disorders such as autism or other developmental disabilities may benefit from biological or psychological testing of healthy siblings, the collection of health or occupational information from parents, the sampling of home items for toxicants, or observation of family social interactions. A common model of survey and epidemiologic research is to ask the primary participant (e.g., the child or adolescent) for information about the home environment that may elicit personal data about family members. For example, a study of pesticide exposure may ask children or adolescents about parental occupation and hygiene habits (e.g., does the parent wear his/her work shoes into the house?). Research on the effects of secondary smoke on children's respiratory health may include questions directed to the child regarding parent or sibling smoking behaviors and health history (asthma, lung cancer, emphysema). Although parents may have given permission for their child to be involved in the research, they may not be aware of the extent of the questions asked.
Increasingly, research involving children uses longitudinal designs to identify the developmental trajectories of environmental health problems and the single or joint health effects of heredity and prenatal and postnatal exposure to environmental agents. By its nature, such research often involves asymptomatic children who will or will not be affected by environmental agents under investigation or who will develop a disorder previously not known to be associated with an environmental agent. For example, the functional expression of prenatal or postnatal exposure to environmental neurotoxins on brain development may not appear until late childhood or early adolescence or may appear in different forms throughout the life span (Weiss 2001).
Further, a disease suspected to be a product of gene-environment interactions may occur more frequently in certain population groups, and these groups may be disproportionately exposed to stigmatization when research results are disseminated. …