Search

Seemingly overnight, the kingpins of the direct-to-consumer genetic testing (DTC-GT) industry shifted their focus from exploring their customers' DNA to commodifying it. Companies like Ancestry or 23andMe that were once exclusively known as mere sources of 'infotainment' now regularly sell consenting customers' genetic data to pharmaceutical researchers or use it to develop drugs of their own. To gain these customers' consent, both firms employ a series of long, complex clickwrap contracts that largely fail to apprise their readers of the potential risks of sharing their genetic data. Nor do these agreements provide any form of compensation to those consumers whose data ultimately facilitates the development of a new, profitable drug. Understandably, the relative autonomy major DTC-GT firms wield over their customers' genetic information--and the manner in which that autonomy is gained--raises serious privacy and bioethical concerns. More directly, it reflects a stark lack of federal oversight of the data management and storage practices of the DTC-GT industry as a whole. The emerging patchwork of state consumer privacy laws--while certainly more robust than any existing federal legislation--likewise falls short in fully protecting the privacy and dignitary interests of the DTC-GT consumers whose genetic data is shared and mined for profit. This is not to say that DTC-GT consumers should be uniformly prohibited from contributing their genetic data to medicinal research. Such behavior should be encouraged to the extent this information can be transferred and stored securely. Nevertheless, the current exploitation of consumer data by major DTC-GT firms may, over the long term, inhibit medicinal progress by undermining demand for genetic testing and, thus, the pool of genetic data available for research. Accordingly, consumers and researchers alike would benefit from a more secure and equitable method of exchanging genetic information. This Note argues that the recent advent of 'blockchain genomics'--a form of exchange that allows consumers to securely loan out their genetic information for research purposes in return for compensation--fits that bill. With mainstream DTC-GT firms unlikely to adopt such a system and no legislative solution on the horizon, this Note further suggests a role for the FTC, the country's de facto privacy regulator, to nudge major DTC-GT firms in that direction by exercising various tools of its soft regulatory authority., Over the last decade, titans of the direct-to-consumer genetic testing (DTC-GT) industry, such as 23andMe and Ancestry, have fashioned themselves into monolithic 'banks' of genetic information. (1) These DNA-testing companies [...]

Recent genetic studies indicate that CRISPR-Cas9, a biological gene-editing mechanism derived from bacteria, may be capable of curing HIV and Sickle Cell Disease. Clinical research for HIV and SCD is prevalent in African nations because of the high incidence of those diseases in all forms. Because past research studies in Africa demonstrate how Western companies can abuse lax ethics regulations in developing African nations, ethics systems must prevent this new, potentially far-reaching CRISPR technology from being prematurely and unethically used on African research participants. In updating current international bioethics frameworks, drafters should pay particular attention to its application in African nations. International bioethics agreements cannot fully protect African research participants, however, until developing countries accord those agreements the power of law. African nations should accelerate the development of unitary systems of ethics laws and education programs unique to the cultural underpinnings of each nation. Only with both the reappraisal of international frameworks to better incorporate traditional African ideals and the development of coherent regional bioethics systems will African research participants be adequately protected., TABLE OF CONTENTS I. INTRODUCTION 460 IT. BACKGROUND 463 A. International Human Rights Develops into Bioethics of Genetic Modifications 463 B. The Severity of HIV and Sickle Cell Disease in [...]

After Chinese scientist Dr. He Jiankui's announcement that he had successfully edited the human genome using a new technology called CRISPR/Cas-9, Dr. He forced the world to address the ethical dilemmas introduced by gene-editing technologies. Born out of a historical tradition of human 'improvement,' gene-editing technologies like CRISPR/Cas-9 modify human genes down to DNA molecules. CRISPR can prevent and cure genetic diseases that have previously had no cure, but problems arise when CRISPR's use expands to enhancements or to modifications that would change the human genome permanently. Given CRISPR's potential profound impact, this Note analyzes how international bodies like the United Nations and countries like the United States, the United Kingdom, and Japan have attempted to regulate gene-editing technologies such that beneficial, individual modifications can flourish and rash, permanent modifications are avoided. This Note recommends the creation of the International Gene-Editing Ethics Commission, which would promulgate publicly approved ethical standards for gene editing while also providing member countries with access to publication in scientific journals, funding, and an international database., TABLE OF CONTENTS I. WHY WE NEED BETTER CRISPR REGULATIONS 1728 II. WHAT IS CRISPR AND WHY SHOULD WE REGULATE IT? 1732 A. Origins of Gene Editing Indicate the Need [...]

INTRODUCTION Medical tourism, as defined by scholar I. Glenn Cohen, is 'the travel of residents of one country to another country for treatment.' (1) Transplant tourism, a type of medical [...]

The development of accelerated gene-editing techniques, including clustered regularly interspaced short palindromic repeats (CRISPR), carries ethical, legal, and social implications for agriculture. There are some in the genomic sciences who dread continuation of--and others who hope to reset--fractious moral debates characteristic of social discourse during the advent of genetically engineered plants in the 1990s. First, we review the current ethical principles underlying regulation and governance of genetic technologies and research involving nonhuman animals. Second, we explore existing ethical tensions and social debates about hog farming, nuisance suits, and Right-to-Farm legislation in North Carolina, a U.S. context into which gene-edited pigs are likely to be introduced. The ethical issues of land use, environmental justice, global food security, and food ethics reach far beyond risk-based ethics frameworks that often lie behind standard research ethics and U.S. regulatory approaches. Third, we argue that gene editing in agriculture calls for a broader bioethics. We consider lessons learned and limitations of community engagement currently taking place around gene drives for reducing mosquito-borne illnesses. Bioethics can improve and develop new modes of engagement to bridge important policy gaps through novel forms of engagement among stakeholders, including those with genetic, farming, environmental, and local knowledge., INTRODUCTION 1274 I. RESEARCH ETHICS, REGULATION, AND GOVERNANCE OF GENE 1277 TECHNOLOGIES A. Standard Research Ethics, Animal Ethics, and U.S. 1279 Institutional Oversight B. U.S. Coordinated Framework for Federal Regulation [...]

Author(s): Gabriel T. Bosslet [sup.1], Jozef Kesecioglu [sup.2], Douglas B. White [sup.3] Author Affiliations: (1) grid.257413.6, 0000000122873919, Division of Pulmonary, Allergy, Critical Care, Occupational, and Sleep Medicine, Indiana University School [...]

ABSTRACT Bioethics in global biobanking touches upon several internationally accepted fundamental rights and values, namely the sample donor's right of privacy, the patient's right to health, and--at least implicitly--scientific freedom. [...]

This article is an edited version of a symposium presentation entitled 'Attorney Fred Gray: Another Drum Major for Justice' and was delivered on February 10, 2012, at Faulkner University, Thomas [...]

I. INTRODUCTION A. Introduction to Personalized Genomics / Pharmacogenomics Following the completion of the Human Genome Project (1) ('HGP'), genomics has come to the forefront of biomedical research. (2) Genomics [...]

I. INTRODUCTION Human embryonic stem cell (hESC) research has been one of the most discussed topics in bioethics during the last several years, and the conflicts associated with the hESC [...]

Bioethics lives in the shadow of great structures and practices of power, and yet, it has not been notable for its contributions to an understanding of power. (1) Indeed, the [...]

The United Nations Educational, Scientific, and Cultural Organization's (UNESCO) Universal Declaration on Bioethics and Human Rights announces a significant array of welfare entitlements--to personal health and health care, medicine, nutrition, water, improved living conditions, environmental protection, and so forth--as well as corresponding governmental duties to provide for such public health measures, though the simple expedient of announcing that such entitlements are 'basic human rights.' The Universal Declaration provides no argument for the legitimacy of the sweeping governmental authority, taxation, and regulation to create and impose such 'rights. 'As this paper explores that some action promotes a purported good, such as 'health,' does not thereby make the action morally permissible. Just as there are moral limits on legitimate personal actions, there are also moral limits on legitimate governmental actions to promote purported goods, including health. A core question of any governmental regulation, therefore, is whether it is a legitimate application of moral political authority or an unauthorized act of state coercion. Pace UNESCO's wide-ranging assertions, this paper argues that promoting health only falls within the legitimate authority of governments in very narrowly defined circumstances. As the paper critically explores, at stake are foundational moral and political questions concerning the limits of governmental authority to intervene in the consensual interaction of persons. Imposing such duties on others, including citizens of a state through regulatory activity and taxation, must be justified, nonarbitrary, and demonstrably within the limits of moral political authority. UNESCO's assertions do not meet this burden of proof. Keywords: human rights, smoking bans, UNESCO, Universal Declaration on Bioethics and Human Rights

The UNESCO Universal Declaration on Bioethics and Human Rights of 2005 purports to articulate universal norms for bioethics. However, this document has met with mixed reviews. Some deny that the elaboration of universal bioethics norms is needed; some deny that UNESCO has the expertise or authority to articulate such norms; some regard the content of the UNESCO document as too vague or general to be useful; and some regard the document as a cog in the effort of like-minded cosmopolitans to codify their particular moral intuitions in international law. This issue examines the potential merits and pitfalls of the Universal Declaration on Bioethics and Human Rights. Keywords: bioethics, consensus, cosmopolitanism, dignity, human rights, international ethics, international law, solidarity, Universal Declaration on Bioethics and Human Rights, UNESCO

Recent work has stressed the importance of the concept of solidarity to bioethics and social philosophy generally. But can and should it feature in documents such as the Universal Declaration on Bioethics and Human Rights as anything more than a vague notion with multiple possible interpretations? Although noting the tension between universality and particularity that such documents have to deal with, and also noting that solidarity has a political content, the paper explores the suggestion that solidarity should feature more centrally in international regulations. The paper concludes with the view that when solidarity is seen aright, the UDBHR is an implicitly solidaristic document. Keywords: bioethics, solidarity, UNESCO, universal declaration

Bioethics is best viewed as both a second-order discipline and also part of public discourse. Since their goals differ, some bioethical activities are more usefully viewed as advancing public discourse than academic disciplines. For example, the 'Universal Declaration on Bioethics and Human Rights' sponsored by the United Nations Educational, Scientific, and Cultural Organization seeks to promote ethical guidance on bioethical issues. From the vantage of philosophical ethics, it fails to rank or specify its stated principles, justify controversial principles, clarify key terms, or say what is meant by calling potentially conflicting norms 'foundational.' From the vantage of improving the public discourse about bioethical problems and seeking ethical solutions in the public arena, however, this document may have an important role. The goals and relations between bioethics as a second-order discipline and public discourse are explored. Keywords: bioethics, ethics, law, rights, UNESCO