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DOUBLE PROTECTION: reaching accord on the ethical conduct of child observational research.

Barrett JR - Environ. Health Perspect. (2009)

View Article: PubMed Central - PubMed

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There are so many toxic compounds that haven’t been examined sufficiently for us to know whether to ban them or regulate them. ” Furthermore, even well-regulated contaminants such as lead remain a public health concern... Decades of lead regulations have resulted in a significant decrease in the amounts found in children’s bodies, but children nevertheless remain at risk... Groups that have opposed certain observational exposure studies, such as the Washington, DC–based nonprofit Environmental Working Group (EWG), agree that studies are needed, but their design, intended end points, and potential conflicts of interest have been stumbling blocks. “There are a lot of observational data gaps just in terms of kids’ general behavior that would extend beyond pesticide exposure to other contaminants,” says Sonya Lunder, a senior analyst at EWG. “Can we fill in some of these research gaps by observing children in less-hazardous settings?” Moreover, long-term observational studies that involve pesticides and other contaminants may not be in child participants’ best interests, says Lunder. “What is the added benefit of observing kids for years on end as opposed to a shorter-term or cross-sectional study?” she asks. “Does the additional information gleaned in a given study outweigh the fact that we may be condoning or permitting potentially unsafe exposures to continue for years?” Roy Fortmann, acting director of the Human Exposure and Atmospheric Sciences Division in the EPA National Exposure Research Laboratory, explains that longitudinal studies are important because they help understand variability of exposure among individuals and even within an individual’s day-to-day routine. “It is very useful to make multiple measurements of exposures over time, which might be over days, weeks, or years, to understand this variability and the factors that affect the exposures,” he says. “For many chemicals, the intra-person variability is much higher than the inter-person variability; this has been demonstrated in air pollution studies. ” Complexities involving the design of observational studies have sometimes led to misunderstandings, with studies and research proposals being cancelled amid charges of being unethical... Consequently, after the cancellation of CHEERS, the EPA, policy makers, and a cross-section of experts in ethics and exposure research, together and separately, scrutinized the adequacy of existing safeguards for observational studies... The primary set of rules, which have applied to almost all human research studies conducted or funded by the federal government since 1991 (with exemptions for certain types of studies such as educational tests), is the Federal Policy for the Protection of Human Subjects (45 CFR § 46)... The Common Rule, as it is often called, draws on earlier literature that outlines three principles of ethical research: respect for individuals’ autonomy, which includes the idea of informed consent; beneficence, which emphasizes maximizing benefits and minimizing risks to individuals and society; and justice, which requires fair and balanced treatment of all groups and individuals... However, the Common Rule was written with medical research studies in mind... Closer to the goal but still falling short is the EPA’s Protections for Subjects in Human Research Rule, which went into effect 7 April 2006 and almost immediately became the subject of a lawsuit (a settlement is currently being discussed)... To overcome this shortcoming, the EPA sponsored an expert panel workshop in late 2006 to specifically consider observational exposure studies, placing emphasis on key elements such as design, protection of vulnerable groups, and clear communication among researchers, participants, the public, and other stakeholders... In an effort to promote dialog and to resolve lingering misunderstandings, a group of senior exposure researchers that included Lebowitz and Lioy collaborated on “The Necessity of Observing Children’s Exposure to Contaminants in Their Real-World Environmental Settings,” a white paper posted on the International Society of Exposure Science website in December 2008. (A slightly revised version of the paper was later posted on the website of the International Society for Environmental Epidemiology.) The authors emphasized the necessity of observational studies and bluntly stated that not pursuing this knowledge is in itself unethical... Lebowitz says observational studies are essential to know what is happening in the real world so better protections can be formed. “We think that a lot of the increased effects in children compared with adults due to various contaminants have probably been underestimated,” he says. “So, these studies will probably lead to even more rigorous statutes, rules, and regulations to protect children. ” The white paper also called for better communication between all stakeholders, including members of Congress... Clear and effective communication must include investigators and subjects, as well as the community and public, according to Resnik (who was not a coauthor). “It is important that the subjects, community, and public understand the nature of the research and why it is important,” he says. “They need to understand that children are being observed, not experimentally manipulated... Investigators need to communicate this clearly in the way they write their protocols, consent forms, advertisements, and other study documents. ” Lebowitz believes stakeholders are finding accord. “Congress, both sides, has been much more favorably interested in this research than the Bush administration itself, which didn’t even want the National Children’s Study to go forth,” he says. “That—plus some proactive, positive steps that a number of us have taken to stimulate discussion and stimulate changes within the EPA—have, I think, been beneficial. ” According to the Committee on Environment and Public Works, this optimism is well-founded... An updated ethical guidance document that consolidates lessons learned from CHEERS and other studies is currently under review. “I think the path is becoming clearer because both the EPA and Congress are talking,” Lioy says. “There was just a lot of miscommunication and ambiguity at one point in time.

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Children are often at greater risk than adults for adverse effects from environmental agents. But without a better understanding of when, where, how, and why children’s exposures occur, reliable protection is impossible.
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f1-ehp-117-a354: Children are often at greater risk than adults for adverse effects from environmental agents. But without a better understanding of when, where, how, and why children’s exposures occur, reliable protection is impossible.


DOUBLE PROTECTION: reaching accord on the ethical conduct of child observational research.

Barrett JR - Environ. Health Perspect. (2009)

Children are often at greater risk than adults for adverse effects from environmental agents. But without a better understanding of when, where, how, and why children’s exposures occur, reliable protection is impossible.
© Copyright Policy - public-domain
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2721893&req=5

f1-ehp-117-a354: Children are often at greater risk than adults for adverse effects from environmental agents. But without a better understanding of when, where, how, and why children’s exposures occur, reliable protection is impossible.

View Article: PubMed Central - PubMed

AUTOMATICALLY GENERATED EXCERPT
Please rate it.

There are so many toxic compounds that haven’t been examined sufficiently for us to know whether to ban them or regulate them. ” Furthermore, even well-regulated contaminants such as lead remain a public health concern... Decades of lead regulations have resulted in a significant decrease in the amounts found in children’s bodies, but children nevertheless remain at risk... Groups that have opposed certain observational exposure studies, such as the Washington, DC–based nonprofit Environmental Working Group (EWG), agree that studies are needed, but their design, intended end points, and potential conflicts of interest have been stumbling blocks. “There are a lot of observational data gaps just in terms of kids’ general behavior that would extend beyond pesticide exposure to other contaminants,” says Sonya Lunder, a senior analyst at EWG. “Can we fill in some of these research gaps by observing children in less-hazardous settings?” Moreover, long-term observational studies that involve pesticides and other contaminants may not be in child participants’ best interests, says Lunder. “What is the added benefit of observing kids for years on end as opposed to a shorter-term or cross-sectional study?” she asks. “Does the additional information gleaned in a given study outweigh the fact that we may be condoning or permitting potentially unsafe exposures to continue for years?” Roy Fortmann, acting director of the Human Exposure and Atmospheric Sciences Division in the EPA National Exposure Research Laboratory, explains that longitudinal studies are important because they help understand variability of exposure among individuals and even within an individual’s day-to-day routine. “It is very useful to make multiple measurements of exposures over time, which might be over days, weeks, or years, to understand this variability and the factors that affect the exposures,” he says. “For many chemicals, the intra-person variability is much higher than the inter-person variability; this has been demonstrated in air pollution studies. ” Complexities involving the design of observational studies have sometimes led to misunderstandings, with studies and research proposals being cancelled amid charges of being unethical... Consequently, after the cancellation of CHEERS, the EPA, policy makers, and a cross-section of experts in ethics and exposure research, together and separately, scrutinized the adequacy of existing safeguards for observational studies... The primary set of rules, which have applied to almost all human research studies conducted or funded by the federal government since 1991 (with exemptions for certain types of studies such as educational tests), is the Federal Policy for the Protection of Human Subjects (45 CFR § 46)... The Common Rule, as it is often called, draws on earlier literature that outlines three principles of ethical research: respect for individuals’ autonomy, which includes the idea of informed consent; beneficence, which emphasizes maximizing benefits and minimizing risks to individuals and society; and justice, which requires fair and balanced treatment of all groups and individuals... However, the Common Rule was written with medical research studies in mind... Closer to the goal but still falling short is the EPA’s Protections for Subjects in Human Research Rule, which went into effect 7 April 2006 and almost immediately became the subject of a lawsuit (a settlement is currently being discussed)... To overcome this shortcoming, the EPA sponsored an expert panel workshop in late 2006 to specifically consider observational exposure studies, placing emphasis on key elements such as design, protection of vulnerable groups, and clear communication among researchers, participants, the public, and other stakeholders... In an effort to promote dialog and to resolve lingering misunderstandings, a group of senior exposure researchers that included Lebowitz and Lioy collaborated on “The Necessity of Observing Children’s Exposure to Contaminants in Their Real-World Environmental Settings,” a white paper posted on the International Society of Exposure Science website in December 2008. (A slightly revised version of the paper was later posted on the website of the International Society for Environmental Epidemiology.) The authors emphasized the necessity of observational studies and bluntly stated that not pursuing this knowledge is in itself unethical... Lebowitz says observational studies are essential to know what is happening in the real world so better protections can be formed. “We think that a lot of the increased effects in children compared with adults due to various contaminants have probably been underestimated,” he says. “So, these studies will probably lead to even more rigorous statutes, rules, and regulations to protect children. ” The white paper also called for better communication between all stakeholders, including members of Congress... Clear and effective communication must include investigators and subjects, as well as the community and public, according to Resnik (who was not a coauthor). “It is important that the subjects, community, and public understand the nature of the research and why it is important,” he says. “They need to understand that children are being observed, not experimentally manipulated... Investigators need to communicate this clearly in the way they write their protocols, consent forms, advertisements, and other study documents. ” Lebowitz believes stakeholders are finding accord. “Congress, both sides, has been much more favorably interested in this research than the Bush administration itself, which didn’t even want the National Children’s Study to go forth,” he says. “That—plus some proactive, positive steps that a number of us have taken to stimulate discussion and stimulate changes within the EPA—have, I think, been beneficial. ” According to the Committee on Environment and Public Works, this optimism is well-founded... An updated ethical guidance document that consolidates lessons learned from CHEERS and other studies is currently under review. “I think the path is becoming clearer because both the EPA and Congress are talking,” Lioy says. “There was just a lot of miscommunication and ambiguity at one point in time.

Show MeSH
Related in: MedlinePlus