Transgenerational epigenetics and environmental justice.

Human transmission to offspring and future generations of acquired epigenetic modifications has not been definitively established, although there are several environmental exposures with suggestive evidence. This article uses three examples of hazardous substances with greater exposures in vulnerable populations: pesticides, lead, and diesel exhaust. It then considers whether, if there were scientific evidence of transgenerational epigenetic inheritance, there would be greater attention given to concerns about environmental justice in environmental laws, regulations, and policies at all levels of government. To provide a broader perspective on environmental justice the article discusses two of the most commonly cited approaches to environmental justice. John Rawls's theory of justice as fairness, a form of egalitarianism, is frequently invoked for the principle that differential treatment of individuals is justified only if actions are designed to benefit those with the greatest need. Another theory, the capabilities approach of Amartya Sen and Martha Nussbaum, focuses on whether essential capabilities of society, such as life and health, are made available to all individuals. In applying principles of environmental justice the article considers whether there is a heightened societal obligation to protect the most vulnerable individuals from hazardous exposures that could adversely affect their offspring through epigenetic mechanisms. It concludes that unless there were compelling evidence of transgenerational epigenetic harms, it is unlikely that there would be a significant impetus to adopt new policies to prevent epigenetic harms by invoking principles of environmental justice.

Biobanking Research and Privacy Laws in the United States.

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU-US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations.

Comparative Approaches to Biobanks and Privacy.

Laws in the 20 jurisdictions studied for this project display many similar approaches to protecting privacy in biobank research. Although few have enacted biobank-specific legislation, many countries address biobanking within other laws. All provide for some oversight mechanisms for biobank research, even though the nature of that oversight varies between jurisdictions. Most have some sort of controlled access system in place for research with biobank specimens. While broad consent models facilitate biobanking, countries without national or federated biobanks have been slow to adopt broad consent. International guidelines have facilitated sharing and generally take a proportional risk approach, but many countries have provisions guiding international sharing and a few even limit international sharing. Although privacy laws may not prohibit international collaborations, the multi-prong approach to privacy unique to each jurisdiction can complicate international sharing. These symposium issues can serve as a resource for explaining the sometimes intricate privacy laws in each studied jurisdiction, outlining the key issues with regards to privacy and biobanking, and serving to describe a framework for the process of harmonization of privacy laws.

Health risk reduction programs in employer-sponsored health plans: Part II-law and ethics.

OBJECTIVE: We sought to examine the legal and ethical implications of workplace health risk reduction programs (HRRPs) using health risk assessments, individually focused risk reduction, and financial incentives to promote compliance. METHODS: We conducted a literature review, analyzed relevant statutes and regulations, and considered the effects of these programs on employee health privacy. RESULTS: A variety of laws regulate HRRPs, and there is little evidence that employer-sponsored HRRPs violate these provisions; infringement on individual health privacy is more difficult to assess. CONCLUSION: Although current laws permit a wide range of employer health promotion activities, HRRPs also may entail largely unquantifiable costs to employee privacy and related interests.

Health risk reduction programs in employer-sponsored health plans: Part I-efficacy.

OBJECTIVE: We sought to determine whether workplace health risk reduction programs (HRRPs) using health risk assessments (HRAs), individually focused risk reduction, and financial incentives succeeded in improving employee health and reducing employer health benefit costs. METHODS: We reviewed the proprietary HRA available to us and conducted a literature review to determine the efficacy of HRRPs using HRAs, individualized employee interventions, and financial incentives for employee participation. RESULTS: There is some evidence that HRRPs in employer-sponsored programs improve measures of employee health, but the results of these studies are somewhat equivocal. CONCLUSION: Employer-sponsored HRRPs may have some benefits, but problems in plan design and in the studies assessing their efficacy complicate drawing conclusions.