Patricia A. Roche

Drafting the Genetic Privacy Act: Science, Policy, and Practical Considerations:

0 nly 27 percent of Americans in a 1995 Harris poll said they had read or heard “quite a lot” about genetic tests. Nonetheless, 68 percent said they would be either “very likely” or “somewhat likely” to undergo genetic testing even for diseases “for which there is presently no cure or treatment.” Perhaps most astonishing, 56 percent found it either “very” or “somewhat acceptable” to develop a government computerized DNA bank with samples taken from all newborns, and their names attached to the samples.’ This does not necessarily mean the public is unconcerned about genetic privacy. More likely it means that the public is still uninformed about the risks associated with genetic testing, and has not thought at all about the risks involved in storing identifiable DNA samples. A central question presented by genetic screening and testing is whether the genetic information so obtained is different in kind from other medical information (such as family history and cholesterol levels), and, if so, whether this means that it should receive special legal protection. Genetic information can be considered uniquely private or personal information, for at least three reasons: it can predict an individual’s likely medical future for a variety of conditions; it divulges personal information about one’s parents, siblings, and children; and it has historically been used to stigmatize and victimize individuals. The highly personal nature of the information contained in one’s DNA can be illustrated by thinking of DNA as containing an individual’s coded “future diary.”2 A diary is perhaps the most personal and private document an individual can create. It contains a person’s innermost thoughts and perceptions, and is usually hidden and locked to assure its secrecy. Diaries describe the past. The infor-

Protecting genetic privacy.

This article outlines the arguments for and against new rules to protect genetic privacy. We explain why genetic information is different to other sensitive medical information, why researchers and biotechnology companies have opposed new rules to protect genetic privacy (and favour anti-discrimination laws instead), and discuss what can be done to protect privacy in relation to genetic-sequence information and to DNA samples themselves.

The Genetic Privacy Act and commentary

The Genetic Privacy Act is a proposal for federal legislation. The Act is based on the premise that genetic information is different from other types of personal information in ways that require special protection. The DNA molecule holds an extensive amount of currently indecipherable information. The major goal of the Human Genome Project is to decipher this code so that the information it contains is accessible. The privacy question is, accessible to whom? The highly personal nature of the information contained in DNA can be illustrated by thinking of DNA as containing an individual`s {open_quotes}future diary.{close_quotes} A diary is perhaps the most personal and private document a person can create. It contains a person`s innermost thoughts and perceptions, and is usually hidden and locked to assure its secrecy. Diaries describe the past. The information in one`s genetic code can be thought of as a coded probabilistic future diary because it describes an important part of a unique and personal future. This document presents an introduction to the proposal for federal legislation `the Genetic Privacy Act`; a copy of the proposed act; and comment.

Rules for donations to tissue banks--what next?

The authors discuss two legal cases involving patients claiming property rights to human tissue used for research after the tissue was surgically removed or donated and a third involving a dispute between a researcher and a university over the ownership of tissue samples.

GINA, genism, and civil rights.

Culminating its 13-year legislative gestation, The Genetic Information Nondiscrimination Act (GINA), was signed by President George W. Bush on May 21, 2008. GINA is the first major federal law to come out of the Ethical, Legal and Social Implications (ELSI) portion of the Human Genome Project. The passage of GINA has been widely celebrated. For the genetic research community, the act was sought to encourage people to become research subjects by providing them with some assurance that genetic research results would not be used against them by health insurance companies or employers. For Francis Collins, the projects leader, the long gestation period was a ‘silver lining’ in that it provided many opportunities ‘to educate policymakers about the potential of genomic medicine and the challenges that must be addressed if we are to realize that potential’.1

The ethical challenge of stem cell research

This article analyzes the ethical issues raised by embryonic stem cell research and recent recommendations by the National Bioethics Advisory Commission (NBAC) regarding federal support for this research. The authors identify the key ethical issue as the moral significance that should be granted to early embryos and discuss arguments supporting the diverse answers to that question and the implications each view has on the formulation of rules and policies for stem cell research. The authors conclude that several of NBACs recommendations regarding the derivation of stem cells from embryos for research are ethically justifiable and sound public policy.

The Property/Privacy Conundrum over Human Tissue

This paper analyzes court rulings on tissue samples as property and critiques objections that have been raised to the recognition of DNA samples as personal property. The cases are: Moore v. Regents of the University of California (1988, 1990), Greenberg v. Miami Children’s Research Institute (2003), and Washington University v.Catalona (2007). The paper argues that it is possible for the law to support both individual privacy and property rights in DNA, recognizing nevertheless that some unresolved questions remain, including what exercising those rights means on a practical level. Finally, it offers suggestions for changes in law based on those considerations.

Gift giving to biobanks.

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Ethical Challenges Encountered in Genomic Research

Scientists tell us that the human genome is essentially the same in all people and that genetic differences make up about one tenth of a percent of our DNA.1 Nevertheless, those genetic differences can have a profound impact on health problems encountered by individuals, some of which may be successfully alleviated whereas others continue to elude satisfactory treatment. One could make a similar observation about the ethical problems and dilemmas encountered in genomic research, because although studies of human genomic variation may fundamentally be similar, differences in how studies are carried out can give rise to complex or unique ethical issues, including ones that defy easy resolution. In this article, I present an overview of the basic and some of the specific ethical questions presented by genomic research with a focus on challenges to maintaining privacy and confidentiality in genome-wide association (GWA) studies and sequencing studies. This narrowing of the issues should not be taken as an indication that these are the only challenges that arise in such research. Other issues, such as when and how results of genetic analysis should be reported back to individuals, are certainly worthy of attention but beyond the scope of this article. In keeping with this focus, I discuss some of the practices used by researchers for collecting, maintaining, and publishing genomic data and conclude that one radical approach (used by the highly publicized Personal Genome Project [PGP]) should be viewed as a social experiment rather than a model of best practices to be adopted by other projects. Although scientists have recognized genomics as a special field of study for decades,2 it is only recently that technological advances have made possible the rapid and cost-effective sequencing of whole human genomes. This achievement along with advances in computational capacity has paved the way …