Online Program

Anticipating the Legal Challenges of Regulating the Use of Human Genetic Information in Infectious Disease Control

Wednesday, November 4, 2015 : 10:30 a.m. - 10:45 a.m.

Theodore Bailey, MD, JD, MA, Johns Hopkins Berman Institute of Bioethics, Baltimore, MD
Michelle Huckaby Lewis, MD, JD, Johns Hopkins Berman Institute of Bioethics, Baltimore, MD
Human genomics is of rapidly increasing relevance to understanding and controlling infectious diseases.  There is growing evidence that human genetic factors can affect the acquisition, clinical course, transmission, testing, treatment, and prevention of various infectious diseases.  However, US federal and state regulation of genetic information and of infectious disease control have so far been distinct areas of political concern, legislation, administrative rule-making, case law, and jurisprudence, each with different prevailing principles and norms.  Consideration of the possible relevance of human genetic factors to the public health control of infectious diseases has not been central to the development of these disparate regulatory domains.  As a result, there is a significant but underappreciated potential for gaps, conflicts, and perverse or undesirable consequences in how these domains will intersect in regulating uses of genetic information in infectious disease control.  In this paper, we identify and analyze key legal challenges posed by the possible intersection of these two distinct and non-harmonized regulatory domains in relation to potential uses of genetic information in infectious disease control.   We do so through a discussion of five illustrative scenarios of ways that genetic information may be used or excluded from use in the administration of privacy-limiting and liberty-limiting infectious disease control measures.  Specifically, we analyze the legal issues posed by scenarios of either using or not using genetic information in 1) mandatory disease reporting, 2) partner notification, 3) quarantines, 4) employer-based vaccine requirements, and 5) mandatory testing of disease contacts.  We intend the paper for a lay audience.

Learning Areas:

Public health or related laws, regulations, standards, or guidelines

Learning Objectives:
Identify applicable domains of legal authority relevant to uses of human genetic information in infectious disease control. Describe the legal parameters of infectious disease control policies that include or exclude the use of human genetic information. Evaluate the legal issues posed by potential uses of human genetic information in privacy-limiting and liberty-limiting infectious disease control measures.

Keyword(s): Genetics, Law

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have completed medical training as a board eligible infectious disease physician and have completed both a law degree and masters in philosophy with a research focus on the ethical and legal issues of infectious disease control. I am currently a fellow in bioethics and have previously co-authored on a paper on the ethical, legal, and social issues posed by genomic science in infectious disease control.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.