The duty to recontact: attitudes of genetics service providers.
The term "duty to recontact" refers to the possible ethical and/or legal obligation of genetics service providers (GSPs) to recontact former patients about advances in research that might be relevant to them. Although currently this practice is not part of standard care, some argue that such an obligation may be established in the future. Little information is available, however, on the implications of this requirement, from the point of view of GSPs. To explore the opinions of genetics professionals on this issue, we sent a self-administered questionnaire to 1,000 randomly selected U.S. and Canadian members of the American Society of Human Genetics. We received 252 completed questionnaires. The major categories of respondents were physician geneticist (41%), Ph.D. geneticist (30%), and genetic counselor (18%); 72% of the total stated that they see patients. Respondents indicated that responsibility for staying in contact should be shared between health professionals and patients. Respondents were divided about whether recontacting patients should be the standard of care: 46% answered yes, 43% answered no, and 11% did not know. Those answering yes included 44% of physician geneticists, 53% of Ph.D. geneticists, and 31% of genetic counselors; answers were statistically independent of position or country of practice but were dependent on whether the respondent sees patients (43% answered yes) or not (54% answered yes). There also was a lack of consensus about the possible benefits and burdens of recontacting patients and about various alternative methods of informing patients about research advances. Analysis of qualitative data suggested that most respondents consider recontacting patients an ethically desirable, but not feasible, goal. Points to consider in the future development of guidelines for practice are presented. (+info)
Ethical, social and economic issues in familial breast cancer: a compilation of views from the E.C. Biomed II Demonstration Project.
Demand for clinical services for familial breast cancer is continuing to rise across Europe. Service provision is far from uniform and, in most centres, its evolution has been determined by local conditions, specifically by local research interests, rather than by central planning. However, in a number of countries there is evidence of progress towards co-ordinated development and audit of clinics providing risk assessment, counselling, screening and, in some cases, prophylactic intervention. Much important information should emerge from continued observation and comparative assessment of these developments. In most countries for which relevant data are available, there is a distinct bias towards higher social class among those who avail themselves of clinic facilities (in line with findings from many other health-promotion initiatives). This should be addressed when considering future organisation of clinical services. Molecular genetic studies designed to identify the underlying mutations responsible for familial breast cancer are not generally regarded as part of the clinical service and are funded through research grants (if at all). Economic considerations suggest that there is a case for keeping this policy under review. Familial cancers throw into sharp relief certain ethical and legal issues that have received much recent attention from government advisory bodies, patients' representatives, professional commentators and the popular media. Two are of particular importance; first, the right to gain access to medical records of relatives, in order to provide accurate risk assessment for a given family member, versus the right to privacy in respect of personal medical information and, second, the obligation (or otherwise) to inform family members of their risk status if they have not actively sought that knowledge. The legal position seems to vary from country to country and, in many cases, is unclear. In view of pressures to establish uniform approaches to medical confidentiality across the EC, it is important to evaluate the experience of participants in this Demonstration Programme and to apply the principle of "non-malfeasance" in formulating regulations that should govern future practice in this field. Data on economic aspects of familial breast cancer are remarkably sparse and outdated. As evidence accrues on the influence of screening and intervention programmes on morbidity and mortality, there is a strong case for evaluating the cost-effectiveness of different models of service provision. (+info)
Ignorance is bliss? HIV and moral duties and legal duties to forewarn.
In 1997, a court in Cyprus jailed Pavlos Georgiou for fifteen months for knowingly infecting a British woman, Janet Pink, with HIV-1 through unprotected sexual intercourse. Pink met Georgiou in January 1994 whilst on holiday. She discovered that she had contracted the virus from him in October 1994 but continued the relationship until July 1996 when she developed AIDS. She returned to the UK for treatment and reported Georgiou to the Cypriot authorities. There have been a number of legal cases involving deliberate transmission of HIV, but most have involved forced exposure to infected bodily fluids for example, rape or biting, and have been dealt with using the existing legislation for rape or assault. While it is often difficult to prove responsibility for transmission in cases of forced exposure to HIV, it is even more contentious in cases like those of Janet Pink where an individual has consented to sex but claims that he/she was not forewarned of his/her partner's HIV-positive status. At present there is no specific criminal offence of having unprotected sexual intercourse without disclosing one's HIV-positive status but a prosecution could possibly be brought under any one of a number of existing offences. Perhaps a change of policy needs to be considered. The Home Office has issued a consultation document which outlines a proposal that will allow the criminalization of intentional transmission of diseases, like HIV, that are likely to cause serious harm. This revised legislation would cover all other potentially fatal diseases (including salmonella and legionnaire's disease, for instance) but seems primarily to be targeted at HIV transmission. Should transmission of HIV through consensual sex, without the HIV-positive status of the individual being disclosed, be an offence? This question, and that of whether there is a moral obligation to disclose a positive HIV status prior to having a sexual relationship is the subject of this paper. (+info)
AIDS and ethics: an analytic framework.
The acquired immunodeficiency syndrome (AIDS) pandemic has raised difficult ethical issues in public policy formulation and in the care of patients infected with the human immunodeficiency virus (HIV). Many issues relate to measures proposed for the protection of the public from HIV infection. This article presents an analytic framework from which these measures can be rationally evaluated. Specific measures are assessed on the basis of their likelihood of success, in relation to their justification for infringement on individual rights, and with reference to other less intrusive measures that could accomplish the same objective. Case histories are discussed which raise ethical dilemmas in the care of HIV infected and high-risk patients. The application of this framework could assist physicians in analysing public health policy and making judgements in individual clinical situations. (+info)
General requirements for blood, blood components, and blood derivatives; donor notification. Final rule.
The Food and Drug Administration (FDA) is amending the biologics regulations to require blood and plasma establishments to notify donors, including autologous donors, whenever the donor is deferred or determined not to be suitable for current or future donations of blood and blood components. A donor is deferred based on results of tests for communicable disease agents or determined not to be suitable for donation based on failure to satisfy suitability criteria. Blood and plasma establishments also are required to notify the referring physician of an autologous donor when the autologous donor is deferred based on tests for evidence of infection with a communicable disease agent(s). A standard operating procedure (SOP) and recordkeeping also are required. This final rule is intended to help protect public health and to promote consistency in the industry. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule on the requirements for testing human blood donors for evidence of infection due to communicable disease agents. (+info)
Common sense and common consent in communicable disease surveillance.
The need to protect the public against the spread of communicable (infectious) disease provides a good example of the need for a commonsense approach to the use of confidential data. Laboratories need to notify different professionals in order to trace the sources of outbreaks of infection and eradicate the cause. It is often not possible to obtain consent from individual patients, given the rapid time scale required. In doing so, however, laboratory staff and others would contravene the Data Protection Act in passing on information without consent. Section 60 of the Health and Social Care Act was designed to overcome barriers to research relying on data accumulated in the past and this type of public health work. But this is proving a sluggish procedure. It is an awkward solution to the problem of data use without specific consent. This problem will be overcome only when the public can have sufficient trust in safeguards that are in place to protect their safety and confidentiality so that these important activities can be pursued without specific informed consent. (+info)