Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment (2007) / Chapter Skim
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11 Ethical, Legal, and Social Issues
11 Ethical, Legal, and Social Issues
Pages 172-200
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From page 172... ...
Privacy Rule, equitable selection of subjects, informed consent, privacy and confidentiality, and special protections for vulnerable populations. Third, toxicogenomic research with human subjects involves distinct issues related to the collection and use of biorepositories in research, special issues of informed consent in genetics research, community 172
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From page 173... ...
The Federal Rule for the Protection of Human Subjects The federal Rule for Protection of Human Subjects (45 C.F.R. Part 46, Subpart A)
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From page 174... ...
As a result, the Common Rule applies to much, but not all, research involving human subjects in the United States. The Common Rule is designed to safeguard the welfare of human subjects of research, and therefore an important preliminary matter is to define "research." The Common Rule defines it as "a systematic investigation, including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge" (45 C.F.R.
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From page 175... ...
, but they are not of equal scope. The Privacy Rule and the Common Rule also differ on other key issues, including reviews preparatory to research, research involving health records of deceased individuals, and revocation of consents and authorizations (Rothstein 2005a)
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From page 176... ...
. For example, over and above informed consent, who ultimately controls the use, distribution, and disposal of donated tissue samples?
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From page 177... ...
. They also have been applied more broadly, and they form the basis of the National Human Genome Research Institute's policies of prompt or immediate disclosure of genomic information generated by NIH-supported research or collected in NIH-supported repositories.
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From page 178... ...
ETHICAL AND SOCIAL ISSUES A number of ethical and social issues may apply to toxicogenomics. These issues include privacy and confidentiality, issues related to socially vulnerable populations, health insurance discrimination, employment discrimination, individual responsibility, issues related to race and ethnicity, and implementation.
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From page 179... ...
A socially vulnerable population also can be based on shared somatic mutations. For example, workers with an acquired mutation or biomarker based on a particular occupational exposure or residents of a certain area with toxic exposures who demonstrated the subclinical effects of a particular exposure may also be said to be socially vulnerable populations.
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From page 180... ...
. Health Insurance Discrimination The leading concern among individuals at a genetically increased risk of illness is that they will be unable to obtain or retain their health insurance (Rothstein and Hornung 2004)
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From page 181... ...
. These laws are seriously deficient because, although they make discrimination based on genetic information illegal, they do not prohibit employers from lawfully obtaining genetic information contained within the comprehensive health records that employers may require individuals to disclose as a condition of employment.
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From page 182... ...
It has been suggested that the following guidelines, intended to supplement the Common Rule, should apply to medical research in volving workers. These guidelines appear to have equal force when applied in the context of toxicogenomic research.
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From page 183... ...
To what extent does society have a duty to respect the autonomy of individuals to decline to learn of possible increased risks or to accept those risks? To what extent is society obligated to provide special protections for such individuals and health care if they become sick?
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From page 184... ...
Fourth, screen ing out workers from exposure, even indirectly, is no substitute for industrial hy giene controls to ensure the health of all workers. Race and Ethnicity Concerns about race and ethnicity are subsumed under the heading of "socially vulnerable populations," discussed above, but they are raised in distinctive ways by pharmacogenomics.
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From page 185... ...
. In addition, even though genetic testing for medication purposes is more limited in scope than genetic tests for assessment or prediction of health status, the test results will still contain sensitive genetic information.
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From page 186... ...
. REGULATORY IMPLICATIONS Toxicogenomic data have numerous potential applications in environmental, pharmaceutical, and occupational health regulation (Rothstein 2000b; Baram 2001; Marchant 2003a,b; Salerno and Lesko 2004; Grodsky 2005; Gallagher et al.
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From page 187... ...
Regulatory Decisions Based on Screening Assays The availability of relatively inexpensive and quick toxicogenomic assays that can be used for hazard characterization of otherwise untested materials offers a number of potential regulatory opportunities (Gallagher et al.
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From page 188... ...
. This Interim Policy states that the EPA expects to receive genomic data for various risk assessment and regulatory purposes and expresses the agency's belief "that genomics will have an enormous impact on our ability to assess the risk from exposure to stressors and ultimately to improve our risk assessments." Specifi cally, the EPA identifies potential applications of genomic data to include better understanding of the relationship between exposure, mechanisms of action, and adverse effects in risk assessment as well as in setting agency priorities, ranking chemicals for testing programs, and supporting possible regulatory actions.
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From page 189... ...
. Regulations under other environmental statutes, such as pesticide regulations under the Food Quality Protection Act and drinking water standards under the Safe Drinking Water Act, may likewise focus on genetically susceptible individuals in the future, as might occupational exposure standards promulgated by the Occupational Safety and Health Administration.
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From page 190... ...
To address such disincentives, agencies have adopted different approaches to encourage data submission. The FDA has adopted an approach under which the voluntary submission of certain types of toxicogenomic data will be for informational purposes only to help regulators and regulated parties better understand toxicogenomic responses, with an assurance that the data will not be used for regulatory purposes (Salerno and Lesko 2004)
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From page 191... ...
Both plaintiffs and defendants are likely to seek to use toxicogenomic data for various purposes in future toxic tort litigation (Marchant 2002, 2006)
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From page 192... ...
Toxicogenomic data can also play a role in proving or disproving specific causation. Current toxicologic methods are generally incapable of determining whether a toxic agent caused an adverse health effect in a specific individual for all but so-called "signature diseases" that usually have a single cause (for example, mesothelioma and asbestos; diethylstilbestrol and adenocarcinoma)
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From page 193... ...
Damages Toxicogenomic data may also be relevant in the damages stage of toxic tort litigation. A defendant who is liable for a plaintiff's injuries may seek to undertake genetic testing of the plaintiff to identify potential predispositions to disease that might have contributed to his or her disease or that might otherwise reduce the plaintiff's life expectancy (Rothstein 1996)
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From page 194... ...
. Legal, Policy, and Ethical Aspects of Toxic Tort Applications The many potential applications of toxicogenomic data in toxic tort litigation raise a number of scientific, legal, policy, and ethical issues.
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From page 195... ...
Given that it is not reasonable to impose greater barriers to the introduction of toxicogenomic data than other types of toxicologic evidence used in toxic tort litigation, data satisfying most of the above criteria would likely be sufficiently reliable to be admitted. The use of toxicogenomic data in toxic tort litigation raises a series of other issues.
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From page 196... ...
. Indeed, "the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions" has become the prime definition of "health literacy" and has been proposed as an essential component of health and risk communication programs (IOM 2004, p.
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From page 197... ...
The potential consequences of disclosure of toxicogenomic information are greater with the growth of electronic health records. There is a lack of comprehensive legislation protecting the privacy, confidentiality, and security of health information, including genetic information.
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From page 198... ...
6. To minimize the risk of adverse impacts on socially vulnerable populations from toxicogenomic research and implementation, access to adequate health care for diagnostic and treatment purposes will be critical and should be a priority for funding agencies and legislators.
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Risk communication is an essential component of translating toxicogenomic information into reduced health risks for the public. Currently, the general public, as well as health care practitioners, are ill-equipped to understand and use toxicogenomic information to alter adverse health outcomes.
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From page 200... ...
Federal agencies should increase their support for research on the issues of ethical, legal, and social implications in applying toxicogenomic technologies, including public attitudes toward individualized risk, social effects of personalized information on increased risks, and regulatory criteria for toxicogenomics.
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