Document Type

Article

Publication Title

Maryland Law Review

Volume

58

Publication Date

1999

Keywords

AIDS, Acquired Immune Deficiency Syndrome, public health, communicable disease, genetic testing, Human Genome Project, managed care, informed consent

Abstract

Innovative medical technology has made it possible to test whether you are at increased risk for certain types of cancer. The mere processing of a vial of blood can reveal whether you have a genetic predisposition to develop breast, ovarian, or prostate cancer, or other life-threatening conditions. The Human Genome Project, an international endeavor seeking to map our genetic structures, has facilitated this increasing ability to test for genetic flaws. It is expected that as the human genetic map is filled in, and as flaws in our fundamental building blocks are identified, there will be a concomitant drive to test for these genetic differences outside of the research setting. Indeed, genetic tests already are being commercially marketed, particularly for genetic flaws linked to breast, ovarian, and prostate cancers. This marketing is occurring despite a dearth of guidance regarding the meaning of these tests, the situations in which they should be offered, the nature or availability of potential treatment, and the type of consent that should be obtained prior to their administration. This Article seeks to establish the contours of informed consent in this new arena of genetic testing for life-threatening conditions by setting forth the basic elements of what must be discussed with a patient to ensure that her consent to testing is, indeed, informed. Specifically, this Article proposes a set of basic statutory requirements for pre-test genetic counseling and suggests that these requirements can be adapted, in significant part, from the essential principles of HIV- related counseling. These basic elements are shaped, in part, by lessons learned from a critical assessment of current informed consent legal doctrine and by precautions to guard against the significant pressures posed by managed care reimbursement programs. This proposed regimen of genetic counseling represents a conscious approach to ensuring that each time a person consents to or refuses such testing, the decision is one that is voluntary and informed. Part I of the Article begins with a discussion of how blood tests generally are conducted and describes the presently available technology to detect flaws in genetic characteristics and reports on predictions of advancements in this area. It continues with an exploration of the ways in which genetic testing for life-threatening conditions is different from other kinds of blood testing. Part II contains both a review of the existing legal doctrine of informed consent, based in constitutional theory, statutes, and common law, and a critique of this doctrine based on pragmatic applications of these laws and on critical legal theories. Part III examines the development of statutory pre-test counseling in the context of the HIV/AIDS epidemic and assesses its strengths, weaknesses, and relevance to genetic pre-test counseling. Part IV presents a model for genetic pre-test counseling that is drawn from the HJV/AIDS statutory format, the critique of current informed consent doctrine, and a review of existing genetic testing statutes. The Article concludes with a recommendation to adopt the model statute introduced in Part IV to remedy the identified weaknesses in existing informed consent doctrine, particularly its failure to incorporate disclosure and discussion of social risks attendant to genetic testing.

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