Engaging the public on biobanks: outcomes of the BC biobank deliberation.

In April 2007, a research team led by M. Burgess conducted a public engagement, the BC Biobank Deliberation, focused on the issue of biobanks. The project was motivated by an observation that current policy approaches to social and ethical issues surrounding biobanks manifest certain democratic deficits. The public engagement was informed by political theory on deliberative democracy with the aim of informing biobanking policies, in particular in British Columbia (BC), Canada. The purpose of this paper is to provide a comprehensive outline of the conclusions reached by the deliberants (both recommendations based on consensus and issues that emerged as persistent disagreements). However, the process whereby the specific conclusions to be delivered to policy makers are identified is not a self-evident process. We thus provide a critical analysis of how the results of a public engagement such as the BC Biobank Deliberation can be conceptualized given the context of a large qualitative data set and an imperative to provide useful information to policy makers, while honoring the mandate under which deliberants were recruited. In particular, we make the case for distinguishing between deliberative outputs of public engagement and analytical outputs that are the product of social scientific analyses of such engagements.

Beyond consent: ethical and social issues in genetic testing.

Informed consent is a vital ethical doctrine in clinical medicine and, through genetic counselling, is being applied to genetic testing. But genetic testing raises issues that transcend the traditional concept of informed consent. Genetic tests are adopted without demonstrable clinical benefit, and the consequences of testing can reach beyond the individual to their families and communities. Understanding the social and cultural context of genetic testing will lead to more informed discussion and debate on these issues.

Commentary: ethical issues in the use of computerized databases for epidemiologic and other health research.

Computerization of databases has increased apprehension about loss of privacy. The intent of this paper is to facilitate health research that gives proper respect to ethical principles, thereby increasing public comfort and reducing demands for restrictive legislation concerning access to databases. We review how computerization has increased the saliency of concerns and discuss examples of the application of ethical analysis in published database research. Extreme positions notwithstanding, there is general agreement among researchers that research curiosity and the convenience of database research cannot justify the suspension of moral concerns about privacy and confidentiality. Public and professional concerns may affect policy development; therefore, the methods of ensuring privacy and protecting confidentiality must be routinely described in research proposals and published reports along with the benefits of the research. An important issue requiring further attention is that the moral responsibility to respect privacy increases with the sensitivity of information.

Bioethics for clinicians: 14. Ethics and genetics in medicine.

Information about a patient's inherited risk of disease has important ethical and legal implications in clinical practice. Because genetic information is by nature highly personal yet familial, issues of confidentiality arise. Counselling and informed consent before testing are important in view of the social and psychological risks that accompany testing, the complexity of information surrounding testing, and the fact that effective interventions are often not available. Follow-up counselling is also important to help patients integrate test results into their lives and the lives of their relatives. Genetic counselling should be provided by practitioners who have up-to-date knowledge of the genetics of and the tests available for specific diseases, are aware of the social and psychological risks associated with testing, and are able to provide appropriate clinical follow-up. Some physicians may elect to refer patients for genetic counselling and testing. However, it is inevitable that all physicians will be involved in long-term follow-up both by monitoring for disease and by supporting the integration of genetic information into patients' lives.

Dilemmas of anonymous predictive testing for Huntington disease: privacy vs. optimal care.

Some persons at risk for Huntington disease (HD) seek predictive testing under the protection of anonymity to reduce the risk of insurance discrimination for themselves and their families. While Canadian and European health care systems seem to limit insurance discrimination to life and disability insurance, U.S. residents do not have national health insurance and are concerned about health insurance discrimination. Two persons residing outside Canada requested predictive testing anonymously. Their primary reason for doing so was to avoid the risks of medical insurance discrimination. After a detailed preparatory session and agreement to counselling and to receipt of results in person, we agreed to provide anonymous testing to these persons. One participant, whose psychological assessment was unremarkable, coped well with the predictive testing process and did not have the CAG expansion. The other participant had considerable emotional problems prior to testing, which necesitated postponement of discussion of results and referral for psychiatric assessment and support. Both participants had difficulty maintaining anonymity. The provision of anonymous predictive testing raises several problems. With anonymous testing, clinicians cooperate with participants to exclude insurance companies from information. This may invalidate the contract with insurance companies. A policy response by insurance companies or a universal health care system to protect individuals is preferable. Individuals who request anonymous testing may be precisely those most vulnerable and in need of additional support and counselling. However, the preservation of anonymity is a burden to participants and may frustrate the clinicians' ability to establish rapport in counselling and to provide appropriate follow-up typically available through genetic counselling in predictive testing programs.

Bioethics for clinicians: 2. Disclosure.

In the context of patient consent, "disclosure" refers to the provision of relevant information by the clinician and its comprehension by the patient. Both elements are necessary for valid consent. Disclosure should inform the patient adequately about the treatment and its expected effects, relevant alternative options and their benefits and risks, and the consequences of declining or delaying treatment. The clinician's goal is to disclose information that a reasonable person in the patient's position would need in order to make an informed decision. Therefore, clinicians may need to consider how the proposed treatment (and other options) might affect the patient's employment, finances, family life and other personal concerns. Clinicians may also need to be sensitive to cultural and religious beliefs that can affect disclosure.

Ethical issues in prenatal testing.

Many ethical concerns raised by prenatal testing are based on the use and effects of genetic information in nonclinical contexts. Correct or incorrect beliefs about social uses of genetic information may limit the voluntariness of informed consent to prenatal testing. A qualitative study of persons predictively tested for Huntington's disease illustrates how the social context, in this case the family history of being at risk, affects the interpretation of the genetic information and alters relationships. This constitutes a risk of genetic testing. Prenatal testing also requires ethical analysis based on careful understanding of how social attitudes and nonclinical uses affect voluntariness and potential harm and benefits of testing. Investigators conducting research on prenatal tests share the responsibility to evaluate social attitudes toward at-risk persons, nonclinical uses of genetic information, and the social benefits and harm of such uses.

Issues in molecular genetic testing of individuals with suspected early-onset familial Alzheimer's disease.

The identification of mutations in the amyloid precursor protein (APP) gene associated with the presence of early-onset familial Alzheimer disease (AD) raises the possibility of their practical clinical application, at least in some circumstances, in the diagnostic assessment for AD. As a stimulus for discussion, a hypothetical, illustrative case vignette is presented. A 48-year-old man, concerned about recent memory loss and with a family history of early-onset AD, requested testing for the APP717 Val-->Ile mutation, previously identified in his relatives affected with AD. Whether the testing should be undertaken is considered in the context of the current interpretation of potential test results as well as the competency of the individual who requested the test to provide informed consent. Informed consent includes an understanding of the foreseeable risks and benefits associated with disclosure of test results. Although molecular genetic testing in particular individuals, such as the man described herein, could be appropriate, it should not be interpreted to apply in general at this stage to individuals suspected of having AD. In view of a number of caveats, including the genetic heterogeneity of AD, which significantly limits the sensitivity and specificity of the currently available genetic tests, further research and discussion is strongly recommended before widespread introduction of molecular genetic testing for individuals with suspected AD.

Ethical issues in genetic testing for Alzheimer's disease: lessons from Huntington's disease.

This article discusses an ethics research project in predictive testing for Huntington's disease (HD) and the relevance of the findings for genetic testing for Alzheimer's disease (AD). Participants were videotaped during their pre- and posttest counseling sessions, as well as when the results were given. Half of these were then interviewed in their homes. Changes that accompanied the receipt of decreased risk suggested that counseling as well as the genetic information led the participants through a rite of passage. The most significant changes seemed to be in relation to other family members. Application to persons at risk for AD needs to be qualified, since persons at risk for AD will not usually have as well developed a sense of "family risk," and are less likely to receive as definite a reduced risk. In diagnostic testing for AD, a substitute decision-maker will often be involved. An unavoidable result is that some of the related substitute decision-makers will receive results which may have, or be mistaken to have, predictive value. Substitute decision-makers must therefore be included in genetic counseling, and the psychosocial effects of their participation must be evaluated.

The medicalization of dying.

Physician assisted suicide or active euthanasia is analyzed as a medicalization of the needs of persons who are suffering interminably. As with other medicalized responses to personal needs, the availability of active euthanasia will likely divert attention and resources from difficult social and personal aspects of the needs of dying and suffering persons, continuing the pattern of privatization of the costs of caregiving for persons who are candidates for active euthanasia, limiting the ability of caregivers to assist suffering persons to make their continued suffering tolerable, and casting doubt on the voluntariness of the choice of active euthanasia.

Point and counterpoint. Should HECs involved in case review have a healthcare ethics consultant?

What level of bioethics expertise (1) must an HEC involved in case review have to ensure full discussion of the complexities of cases in an emotionally supportive manner, and to educate healthcare professionals about relevant moral aspects of these cases? Is there a necessary level of bioethics expertise required to ensure that discussions of ethics are sensitive to relevant community values as well as to legal context and constraints? In this article, three positions are explored: one requiring a healthcare ethics consultant, one arguing that some level of training of all committee members is adequate, and another which claims that multidisciplinarity and community representation without specific education is sufficient.

Ethical and economic aspects of noncompliance and overtreatment.

Physicians have an ethical responsibility for cost-saving within the current medical care delivery system. Noncompliance and overtreatment are among the causes of excessive health care expenses. An effective means of improving compliance and avoiding unwanted or fruitless treatment is improved physician-patient communication. Improved communication is also the most ethical means of avoiding these expenses. The educated participation of patients in treatment decisions and of the public in health policy formation is ethically and economically preferable to bureaucratic responses and user fees. The public must be made aware of the costs and limited benefits of medical treatments and of the effects of lifestyle on health. The medical encounter must become more supportive and educational. Medical school curricula must emphasize patient involvement, which must be reinforced to medical students and residents by staff physicians' genuine concern and effort. Quality assessments and assurance should include evaluation of communication, patient satisfaction, use of follow-up and duplication of services.