Microsoft PowerPoint - Genetics-ethics-05

The ethics of genetics research Fiona A. Miller, PhD Assistant Professor, CE&B, CHEPA May 12, 2005

Overview Introductions Genetic exceptionalism? Yes? No? A resolution Ethical issues in genetics: 1.2.3 The response: Ethics; science; regulation

Genetic exceptionalism? Yes In the clinic: Provides distinctive and important knowledge: complex, familial, ‘ethnic’ & predictive Involves new medical practices: Genetic counselling, reproductive technologies; promises 3P medicine (predictive, preventive, personalized) In society: Involves complex and troubling developments in medical research: Large scale science; biobanks; life patents; geneticization/ racialization

Genetic exceptionalism? No In the clinic: Much that is not ‘genetic’ is familial or predictive: family history; multifactorial conditions such as obesity; HIV infection Not the only source of reproductive technologies & 3P medicine (which, in any event, is rhetoric not reality) In society: Genetics is associated with, but not ‘responsible for’ many trends: The ‘bigging’ of bioscience; commercialization (& associated IPR) of medical research; the instrumental importance of race and identity

Genetic exceptionalism: a resolution An ethical touchstone A constellation of challenging clinical and social issues; not individually unique, but perhaps uniquely combined Complex history Grand scientific claims Intense public interest and sometimes concern

Ethical issues in genetics 1 The plural subject? Highlighting problems with Autonomy / Consent For the patient Duty to act: Agreeing to a test to provide information to others Coerced consent? Duty to act: Refusing to participate in testing, where this has implications for biological family members Familial conflict? Duty to be “familial”: Obligation to be aware of or engage with biological family members who may be estranged (i.e., unknown, in conflict) Familial conflict (conflict between social and biological family)? Lack of access (where access is premised on knowledge of biological family)?

Ethical issues in genetics 1, cont’d Challenges of Autonomy/ Consent For the patient, cont’d. Consent for others:Test results for self that provide diagnostic or predictive information about others (e.g., Risks to carrier; Fragile X) Diagnosis by proxy and the right not to know? Stigmatization/ Discrimination: for individual; family; community For the provider Duty to warn: The need (or felt need) to inform biological family members of an unconsenting individual test results, because of risks to those third parties (i.e., reproductive risks, personal health risks) balancing harms and benefits overriding confidentiality/privacy

Ethical issues in genetics 2 Who owns your genes? Altruism vs. profiteering in genetic research The Moore case Benefit sharing in genetic research The Terry case/ Genetic Alliance

The Moore case: They own your genes John Moore, Seattle businessman 1976, UCLA doctors removed rare “hairy cell leukemia” cells from his spleen and then developed a line of cells which produced valuable antibacterial and cancer-fighting proteins. Moore had signed a surgery consent form, which included fairly standard language allowing research to be done on his discarded tissue. 1984, doctors received a patent on the “Mo” cell line. Moore sued, alleging that, at the least, he should receive a share of the profits; that he had a property right in his own body July 1990, the California Supreme Court denied the existence of such a right; though it allowed Moore to sue his doctors for a breech of fiduciary duty for failing to inform him of the potential commercial value of his cells

The Terry case: We own our genes Sharon Terry, Sharon Mass 2 children with a rare genetic disease: pseudoxanthoma elasticum (PXE), causing mineralization of elastic tissue: most serious consequence is blindness Terry established PXE International: found 2000 people with the disease, set up a repository to store tissue samples, began raising money for research; took just 4 years to isolate gene Had scientists sign agreement with PXE - agreed to the clause stating that the foundation had to be named in any patent applications arising from the work, that any profits or revenue from the discoveries to be shared with the foundation, that any genetic test be made readily available to the foundation. Terry is the first known lay advocate to hold a patent on a gene - the one involved in her kids’ disease, and she is a co-author in numerous scientific publications about PXE

Terry case: epilogue Sharon Terry now President and CEO of Genetic Alliance GA bring together over 600 advocacy groups representing people living with genetic conditions. Through this has spearheaded the development of the Genetic Alliance Biobank A repository for the standardized collection, storage and distribution of biological samples and clinical data for research purposes. A novel, advocacy-owned and managed repository to accelerate research while setting new standards for participant involvement in research, ethical re-contact and robust protections

Ethical issues in genetics 2, cont’d. Who owns your genes? Issues in the commercialization of medical research Patients as the last altruists in genetic research? Will they participate? Will they lose trust? Should patients benefit? Inducing consent? Can it be done?

Ethical issues in genetics 3 The thin line between bench & bedside Speed of developments and transfer Gene identified = genetic diagnostic Clinical expectations of research Gene transfer research, e.g., XSID “Leading edge” clinical practice Use of research labs in clinical practice Release of research test results Challenging diagnoses - variants of unknown significance; nosologic change

Ethical issues in genetics 3, cont’d The thin line: Issues arising from cross-over between research and clinical practice What to do with the knowledge? Is informed consent possible? Is paternalism (withholding information) appropriate?

The response Ethical response Canonical bioethics? Critical bioethics? Scientific response Accommodation? Regulatory response Regulation? Prohibition?

Microsoft PowerPoint - Genetics-ethics-05

by Pammy98 on Jul 26, 2010

Accessibility

Tags

Upload Details

Usage Rights

Statistics

Microsoft PowerPoint - Genetics-ethics-05 — Presentation Transcript