The Journal of Law, Medicine & Ethics
Fall 2015 Volume 43, Issue 3 Pages 437–666
http://onlinelibrary.wiley.com/doi/10.1111/jlme.2015.43.issue-2/issuetoc
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Special Issue: SYMPOSIUM: Should We Offer Genomic Research Results to a Participant’s Family, Including After the Participant’s Death?
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Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice (pages 594–609)
Leslie E. Wolf, Mayank J. Patel, Brett A. Williams Tarver, Jeffrey L. Austin, Lauren A. Dame and Laura M. Beskow
Article first published online: 19 OCT 2015 | DOI: 10.1111/jlme.12302
Abstract
The federal Certificate of Confidentiality plays an important role in research on sensitive topics by authorizing researchers to refuse to disclose identifiable research data in response to subpoenas in any legal setting. However, there is little known about how effective Certificates are in practice. This article draws on our legal and empirical research on this topic to fill this information gap. It includes a description of the purpose of Certificates, their legislative and regulatory history, and a summary of the few reported and unreported cases that have dealt with Certificates. In addition, we outline other statutory confidentiality protections, compare them to the Certificate’s protections, and analyze some of the vulnerabilities of a Certificate’s protections. This analysis allows us to make specific recommendations for strengthening the protections afforded to research data.
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Funding the Costs of Disease Outbreaks Caused by Non-Vaccination (pages 633–647)
Charlotte A. Moser, Dorit Reiss and Robert L. Schwartz
Article first published online: 19 OCT 2015 | DOI: 10.1111/jlme.12305
Abstract
While vaccination rates in the United States are high — generally over 90 percent — rates of exemptions have been going up, and preventable diseases coming back. Aside from their human cost and the financial cost of treatment imposed on those who become ill, outbreaks impose financial costs on an already burdened public health system, diverting resources from other areas. This article examines the financial costs of non-vaccination, showing how high they can be and what they include. It makes a case for requiring those who do not vaccinate to cover the costs of outbreak caused by their choice. Such recouping is justified because the choice not to vaccinate can easily be seen as negligent. But even if it is not, that choice involves imposing costs on others, and there are good reasons to require the actors to internalize those costs.
The article proposes alternative statutory and regulatory schemes to cover the costs imposed on the public purse, focusing on no-fault mechanisms. We consider both ex ante mechanisms like a tax or a fee that will go into a no-fault fund to cover the costs and ex post mechanisms like a statutory authorization for recoupment of those costs by health officials.
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Physician Dismissal of Families Who Refuse Vaccination: An Ethical Assessment (pages 654–660)
Douglas S. Diekema
Article first published online: 19 OCT 2015 | DOI: 10.1111/jlme.12307
Abstract
Thousands of U.S. parents choose to refuse or delay the administration of selected vaccines to their children each year, and some choose not to vaccinate their children at all. While most physicians continue to provide care to these families over time, using each visit as an opportunity to educate and encourage vaccination, an increasing number of physicians are choosing to dismiss these families from their practice unless they agree to vaccinate their children. This paper will examine this emerging trend along with the reasons given by those who advocate such an approach. I will argue that the strategy of refusing to allow families into a clinic unless they agree to vaccinate their children is misguided, and the arguments for doing so fail to stand up to close scrutiny. Such a strategy does not benefit the child or the health of the community, and may have a negative impact on both. Furthermore, some of the arguments in support of dismissal policies ignore the importance of professional obligation and appear to favor self-interest over the interest of the patient.