Center for Genetic Research Ethics and Law

Will investments in large-scale prospective cohorts and biobanks limit our ability to discover weaker, less common genetic and environmental contributors to complex diseases?

Environ Health Perspect. 2005 Feb ; 113(2): 119-22 Foster MW, Sharp RR

Using communities as building blocks for larger cohorts and biobanks presents some practical and ethical challenges but also enhances opportunities for interdisciplinary, multilevel investigations of the multifactorial contributors to complex diseases.

Informed consent, participation in, and withdrawal from a population based cohort study involving genetic analysis.
Matsui et al.

J Med Ethics.2005; 31: 385-392.

We examined the results of a population based genetic cohort study to identify the factors affecting the participation rate by members of the general public and also specifically to examine the impact of different consent procedures on the rate of participation by prospective candidates and their subsequent withdrawal rate from the study. The general population responded sceptically towards genetic research. It is crucial that genetic researchers utilise an informative and educational consent process worthy of public trust.

In One's Own Image: Ethics and the Reproduction of Deafness.

J Deaf Stud Deaf Educ. 2005 Jul 6

Johnston T.

The ethics of the use of genetic screening and reproductive technologies to select against and for deafness is presented. I argue that the premise that deafness is not a disability of some sort is false and thus the claim that genetic selection against deafness is unethical and untenable.

 

Democracy and genetic privacy: the value of bodily integrity.

Med Health Care Philos. 2005; 8(1): 97-103
Beckman L

An argument is developed that genetic privacy is fundamental to the democratic participation of all citizens. By referring to the preconditions of democratic citizenship, genetic privacy can be justified in a way that respects the plurality of comprehensive doctrines of morality and religion in contemporary societies.

Genetic nondiscrimination.

Nat Genet. 2005 Jun; 37(6): 559-60
Billings PR

The identification and investigation of sentinel cases has illuminated genetic discrimination in the US. Its occurrence impedes applications of biotechnology and is a primary focus of public policy activity at the federal level. Continued research and informed responses may make genetic nondiscrimination more likely.

 

Global gene mining and the pharmaceutical industry.

Toxicol Appl Pharmacol. 2005 Jun 23;
Knudsen LE

Ethical issues related to data protection of the individuals providing samples to bio-banks are several: nature and extent of information prior to consent, coverage of the consent given by the study person, labeling and storage of the sample and data (coded or anonymized). Discussions on how to handle sampling and data are ongoing within the industry and the regulatory sphere.

 

Pragmatic approaches to genetic screening.

Med Health Care Philos. 2005; 8(1): 69-77

Mallia P, ten Have H

Pragmatic approaches to genetic testing are discussed and appraised.

 

Priorities and standards in pharmacogenetic research.

Nat Genet. 2005 Jul; 37(7): 671-81
Need AC, Motulsky AG, Goldstein DB

In most instances, drug responses will probably prove to be complex, influenced by both the environment and multiple genetic factors. For pharmacogenetics to deliver on its potential, this complexity will need to be recognized and accommodated, both in basic research and in clinical application of pharmacogenetics. As the attention of researchers begins to shift toward more systematic pharmacogenetic investigations, we suggest some priorities and standards for pharmacogenetic research.

What should we want to know about our future? A Kantian view on predictive genetic testing.

Med Health Care Philos. 2005;8(1):29-37. Heinrichs B.

What should we want to know about our future? In the following I shall discuss this question against the background of Kant's Doctrine of Virtue. It will be demonstrated that the system of duties of virtue that Kant elaborates in the second part of his Metaphysics of Morals offers a theoretical framework for addressing the question of a proper scope of future knowledge as provided by genetic tests.

Definition and clinical importance of haplotypes.

Annu Rev Med. 2005; 56: 303-20
Crawford DC, Nickerson DA

Here we review basic concepts of high-density genetic maps of SNPs and haplotypes and how they are typically generated and used in human genetic research. We also provide useful examples and tools available for researchers interested in incorporating haplotypes into their studies. Finally, we discuss the latest concepts for the analysis of haplotypes related to human disease, including haplotype blocks, the International HapMap Project, and the future directions of these resources.

J Law Med. 2005 May;12(4):426-40.

Blood rights: the body and information privacy.

Alston B.

This article examines the existing coverage of privacy legislation, arguments in favour of baseline protection for bodily samples as sources of information and possible approaches to new regulation protecting individual privacy rights in bodily samples.

Gene patents: the need for bioethics scrutiny and legal change.

Yale J Health Policy Law Ethics. 2005; 5(1): 403-12
Andrews LB, Paradise J

Regulating preimplantation genetic diagnosis: the pathologization problem.
Harv Law Rev. 2005 Jun; 118(8): 2770-91

How lay people respond to messages about genetics, health, and race.
Clin Genet. 2005 Aug;68(2):97-105.

Condit C, Bates B.

This mini-review examines research in three areas: studies that address the effects of these messages about genetics on levels of genetic determinism and genetic discrimination; studies that address the effects of these messages on attitudes about race; and, studies of the impacts of race-specific genetic messages on recipients. We suggest that the current literature appears fragmented because of methodological and measurement issues and offers strategies for future research. A path model helps organize future research examining the effects of messages about genetics on socioculturally based racism, genetically based racism, and unaccounted for racism.

Disability Rights, Prenatal Diagnosis and Eugenics: A Cross-Cultural View.

J Genet Couns. 2005 Jun; 14(3): 183-187
Raz AE

This paper considers the disability rights critique of genetic testing in the context of different communities and the issue of nondirectiveness. Despite the wide usage of genetic diagnosis in Israel, no public debate has emerged there concerning disability rights and prenatal testing. The common attitude that emerged from interviews with Israeli representatives of organizations "of'' and "for'' people with genetic diseases and congenital disabilities can be described as a two-fold view of disability: support of genetic testing during pregnancy, and support of the disabled person after birth. This two-fold view is explained as a secular construction situated in legal, economic and cultural contexts.

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Genetics in the News

Can DNA Reveal Your Roots?

An article in the TIME Magazine about the growing numbers of people turning to DNA tests to find out about their ethnic heritage points out that many of these testing companies are relying on insufficient data, and thus are probably providing faulty results. This is especially true for some companies that claim to be able to trace your ancestry back to a specific ethnic group in Africa

Ashkenazi women to pay more for BRCA tests

The ruling means that doctors offering tests for BRCA2 mutations are now legally obliged to ask women if they are Ashkenazi Jews. If they say they are, doctors must pay a licence fee to Myriad. No fee is due if a patient says she does not know.

Home test shows sex of fetus at five weeks

A finger prick test for pregnant women that can tell them the sex of their child has aroused huge public interest.

Ethics, science and human rights come together

UNESCO has issued a draft declaration it says will be the first ever to commit governments to take a position on the ethical and human rights dilemmas raised by modern research.

The Awful Truth About Drugs in Sports

Cheaters can't be stopped. Testing costs a fortune. It's shockingly easy to beat the system. The drug cops are perpetually playing catch-up. So says Don Catlin, the doping detective who helped break the BALCO scandal wide open—and the man who's about to launch a radical new campaign to finally solve the problem.

Ethnoancestry is now offering sub-haplogroup determination tests; DNA Heritage is now offering SNP (haplogroup) testing services.

Genetics center to launch new genetic-testing initiative

The Pew Charitable Trusts announced today that it is making a significant new investment in the Genetics and Public Policy Center to improve the overall effectiveness, safety, and reliability of genetic testing, and to develop and promote recommendations where appropriate.

Technology could grow beyond human control
A UN report argues that "the possibility of technology growing beyond human control must now be taken seriously."

Thai Govt, Oracle To Develop Medical, Genetic Database

Oracle Corp. said it has launched a pharmacogenomics project with the Thai government to collect and unify medical, health and genetic records in a nationwide electronic database.

Going From Genome to Pill
Science, Vol 308, Issue 5730, 1858-1860 , 24 June 2005
A new medicine for African Americans with heart failure hints at what the drug industry sees as the enormous payoff from pharmacogenomics

Scientists predict brave new world of brain pills

A new report by leading scientists in the fields of psychology and neuroscience argues that, very soon, there really will be a pill for every ill. "It is possible that [advances] could usher in a new era of drug use without addiction," said the report by Foresight, the UK government's science-based thinktank.

Drug That Responds Better to Blacks Raises Ethics Concerns; Don't Ignore Genetics, Says BiDil's Maker

The development has raised ethics concerns about gearing medicines to a certain race, but could help usher in so-called "personalized" medical treatments tailored to an individual's genetics.

Among Science's top unanswered questions: What Genetic Changes Made Us Uniquely Human? Why Do Humans Have So Few Genes? Are Humans Still Evolving? How Much Can Human Life Span Be Extended?

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Human Enhancement Technologies: Through the Looking Glass of Drama

On July 14-17, CGREAL joined with Hiram College’s Center for Literature and Medicine, the Bioethics Network of Ohio, and Cleveland State University to co-sponsor a Summer Symposium for high school and college teachers, writers and dramatists, entitled “Human Enhancement Technologies: Through the Looking Glass of Drama.”

The symposium combined scholarly presentations by philosophers, sociologists and legal scholars with the performance and discussion of five short plays that illustrate the ethical and social issues raised by the application of biomedical technologies to improve on human form and function beyond the treatment of disease.

The goal of the symposium was to stimulate the approximately 50 participants to develop creative ways to teach and present the issues to wider public audiences, to enhance democratic deliberation in this area.

The schedule can be found online.

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Human enhancement on NPR

Jennifer Fishman and Eric Juengst, along with Julian Savulescu, appeared on WCPN/NPR (90.3 FM) last Thursday morning to discuss human enhancement.

Paola Ortiz, in a review of the show, points out five major themes that emerged in the discussion: physiological differentiation (won’t enhancement prove to be another mode for extending the divide that already exists between the well-off and the poor?), closing options vs. opening options (will enhancing really end up proving to be an irreversible limiting of the self/), “easy fix” criticism (is dealing with and accepting one’s limitations and problems an intrinsic part of human development?), differentiation vs. normalization (will individual’s empowerment over their own make-up manifest itself as homogenization of humankind?), and defense for autonomy vs. defense for enhancement.

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July 05, 2005

Genetics in the Literature

'At the point at which you can do something about it, then it becomes more relevant': Informed consent in the pharmacogenetic clinic.
Hedgecoe A
Soc Sci Med. 2005 Sep ; 61(6): 1201-10

This paper draws on ideas from the Sociology of Science and Technology, to explore informed consent issues surrounding the use of the drug Herceptin, widely cited as an example of a novel approach to drug development called pharmacogenetics. Drawing on qualitative semi-structured interviews with 25 UK-based breast cancer specialists, this paper explores Herceptin's disputed epistemological status, as an example of pharmacogenetics or as something out of the ordinary in terms of clinical practice. It considers how, in turn, this impacts on the way in which informed consent is sought and influenced by clinicians' desire to protect patients from possibly distressing test results. It highlights the flexible, contingent and context dependent nature of informed consent in the clinical setting.

Public health and the challenge of genomics.
Kirkman M
Aust N Z J Public Health. 2005 Apr ; 29(2): 163-5

There is controversy in Australia and internationally over the eugenic implications of genomics, with desirable outcomes for public health set against 'slippery slope' arguments. Controversy cannot be avoided; we risk divisiveness if it is not carefully managed with informed, social-consensus-building debate. Furthermore, the intrinsic tension between genomics (with its individual and family choices) and public health (operating for the public good) may even necessitate a reconceptualisation of public health.

Building on relationships of trust in biobank research.
Hansson MG
J Med Ethics. 2005 Jul ; 31(7): 415-418

The submission of an informed consent is an act of trust by a patient or a research subject, but a strict application of the rule of informed consent may not be sensitive to the multiplicity of patient interests at stake, and could thus be detrimental to trust. According to a recently proposed law on "genetic integrity" in Sweden, third parties will be prohibited from requesting or seeking genetic information about an individual. Cumbersome restrictions on research may be lifted, thus creating a more favourable climate for medical research.

Potential harms, anonymization, and the right to withdraw consent to biobank research.
Eriksson S, Helgesson G
Eur J Hum Genet. 2005 Jun 29;

There is less risk involved in biobank research than in human subject research; it should therefore be treated differently. Apart from not being particularly appropriate for protecting the interests of individuals, anonymization of samples has a negative impact on research. We suggest that the current view on withdrawal from research, supported by the Declaration of Helsinki and subsequent ethical guidelines, be abandoned in the context of biobank research and be replaced by an approach inspired by the Nuremberg Code. This approach requires those wishing to withdraw their samples from research to present sufficient reason for doing so.

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