The ethics of anonymised HIV testing of pregnant women: a reappraisal

Seroprevalence monitoring of HIV in pregnant women by anonymised unlinked testing has been widely adopted in the UK and other countries. The scientific rationale is to eliminate participation and selection bias. The ethical justification is that the public good outweighs any harm to individuals. The assumption has been that individuals have had their autonomy respected by the offer of informed consent. In the light of new scientific evidence, it is doubtful that the public good is best served by the continuation of anonymously testing women receiving antenatal care. It is submitted that it is no longer ethical for health professionals to refrain from informing pregnant women of the benefits of voluntary named testing, or to request their consent to anonymised testing. The legal and moral concept of duty of care is examined, and the abrogation of this duty through anonymisation is explained.

Key Words: Anonymisation • HIV • antenatal testing • informed consent • duty of care

     

Routine antenatal HIV testing: the responses and perceptions of pregnant women and the viability of informed consent. A qualitative study

This qualitative cross-sectional survey, undertaken in the antenatal booking clinics of a hospital in central London, explores pregnant women's responses to routine HIV testing, examines their reasons for declining or accepting the test, and assesses how far their responses fulfil standard criteria for informed consent. Of the 32 women interviewed, only 10 participants were prepared for HIV testing at their booking interview. None of the women viewed themselves as being particularly at risk for HIV infection. The minority (n = 6) of the participants who declined testing differed from those who accepted, by interpreting test acceptance as risky behaviour, privileging the negative outcomes of HIV positivity and expressing an inability to cope with these, should they occur. Troublingly, only a minority of women (n = 9) had a broad understanding of the rationale for the test, and none fulfilled the standard criteria for informed consent. This study suggests that, although routine screening combined with professional recommendation may be successful in increasing uptake, this may be at the cost of eroding informed consent. Protecting third parties (notably fetuses) from a preventable disease may outweigh the moral duty of respecting autonomy, enshrined in Western bioethical tradition. Nevertheless, such a policy should be made transparent, debated in the public domain and negotiated with women seeking antenatal care.     

With HIV prevalence among women increasing, more provinces encourage prenatal testing

Testing of pregnant women for antibodies to HIV remains a thorny medical and ethical issue. On the one side are children who stand to benefit if their mothers' HIV status is determined. On the other is women's right to determine what tests they will receive. A majority of provinces now have counselling programs in place to encourage women to undergo testing. However, testing remains voluntary and informed consent is required before a test is done--policies that have CMA support.     

Confidentiality and the duties of care

Doctors have an ethical and legal duty to respect patient confidentiality. We consider the basis for this duty, looking particularly at the meaning and value of autonomy in health care. Enabling patients to decide how information about them is disclosed is an important element in autonomy and helps patients engage as active partners in their care. Good quality data is, however, essential for research, education, public health monitoring, and for many other activities essential to provision of health care. We discuss whether it is necessary to choose between individual rights and the wider public interest and conclude that this should only rarely be necessary. The paper makes some recommendations on practical steps which could help ensure that good quality information is available for work which benefits society and the public health, while still enabling patients' autonomy to be respected.     

Notifying patients exposed to blood products associated with Creutzfeldt-Jakob disease: integrating science, legal duties and ethical mandates

The issue of notifying people who have been exposed to blood products that have been associated with Creutzfeldt-Jakob disease (CJD) has arisen at a time when the Canadian blood system is under intense scrutiny. As a result, the Canadian Red Cross Society issued a recommendation to health care institutions that recipients of CJD-associated blood products be identified, notified and counselled. Although Canadian jurisprudence in the realm of informed consent may support a policy of individual notification, a review of the scientific evidence and the applicable ethical principles arguably favours a policy of a more general public notification. Indeed, situations such as this require a unique approach to the formation of legal and ethical duties, one that effectively integrates all relevant factors. As such, the authors argue that individual notification is currently not justified. Nevertheless, if a system of general notification is implemented (e.g., through a series of public health announcements), it should provide, for people who wish to know, the opportunity to find out whether they were given CJD-associated products.     

How economics could extend the scope of ethical discourse

Ethical discourse is typically inconclusive, and with good reason. But this inconclusiveness is a distinct disadvantage when it comes to helping publicly accountable policy-makers in the health care system provide an ethical justification for their decisions. It is suggested that instead of ending with platitudinous statements such as that a balance has to be struck between the rival ethical considerations, empirical research should be undertaken to elicit the quantitative trade-offs that the affected general public would be prepared to accept when striking this balance. In the expected absence of any consensus, it is further suggested that the views of the median person be taken as the best approximation to the group view. Finally it is argued that, far from this quantitative approach lacking humanity by treating individuals as "mere statistics", it shows greater compassion than the proponents of those approaches whose fellow feeling can only be stirred by information pertaining to identified individuals.     

Waiver of individual patient consent in research: when do potential benefits to the community outweigh private rights?

Health services research is important to ensure continued best quality of care, but often uses data obtained without explicit consent for this purpose. Obtaining consent may be difficult for many reasons, but excluding individuals may introduce biases that alter the significance of studies. Approval by ethics committees of a waiver of the need for consent allowed our study to proceed and provide evidence that has led to the implementation of a population-based screening policy for the prospective detection of hereditary non-polyposis colorectal cancer. This screening policy has resulted in more cases being detected routinely with better management for affected patients and their at-risk families. A need for consent would have prohibited this study, and the development of a more efficient screening policy could have been delayed for several more years. Ethics committees can effectively manage the need to uphold basic ethical principles without unnecessarily impeding socially useful research. Committees need to be familiar with the guidelines approved under sections 95 and 95A of the Privacy Act 1988 (Cwlth) in addition to the National Health and Medical Research Council National statement on ethical conduct in research involving humans.     

Balancing autonomy and responsibility: the ethics of generating and disclosing genetic information

Using data obtained during a retrospective interview study of 30 women who had undergone genetic testing-BRCA1/2 mutation searching-this paper describes how women, previously diagnosed with breast/ovarian cancer, perceive their role in generating genetic information about themselves and their families. It observes that when describing their motivations for undergoing DNA testing and their experiences of disclosing genetic information within the family these women provide care based ethical justifications for their actions. Finally, it argues that generating genetic information and disclosing this information to kin raise different types of ethical issues. The implications of these findings for ethical debates about informed choice in the context of genetic testing are discussed.     

从科研人员多采血看知情同意权

知情同意权是病人的一项基本权利.本文通过对临床上科研人员多采血这一事件的分析,初步探讨了知情同意权有没有限制的地方以及间接利益和公共利益是否可以成为限制的理由这样两个问题,进一步揭示了知情同意权的概念,为知情同意权作为一项实践准则提供了可供参考的伦理学依据.     

Transmission and postexposure management of bloodborne virus infections in the health care setting: Where are we now?

THERE HAS BEEN CONSIDERABLE DEBATE ABOUT THE NEED for mandatory serologic testing of individuals who are the source of bloodborne pathogen exposures in health care and other occupational settings. The transmission of hepatitis B (HBV), hepatitis C (HCV) and HIV between patients and health care workers (HCWs) is related to the frequency of exposures capable of allowing transmission, the prevalence of disease in the source populations, the risk of transmission given exposure to an infected source and the effectiveness of postexposure management. Transmission of HBV from patients to HCWs has been substantially reduced by vaccination and universal precautions. The transmission of HCV and HIV to HCWs does occur, although postexposure prophylaxis (PEP) is available to reduce the risk of HIV transmission. Transmission of bloodborne pathogens from infected HCWs to patients has also been documented. Policy-making concerning the mandatory postexposure testing of patients who may be the source of infection must weigh the relative infrequency of patients' refusals to be tested and the consequences for PEP recommendations with the ethical and legal considerations of bypassing informed consent and mandating testing. Mandatory postexposure testing of HCWs who are the source of infection will have a limited impact on reducing transmission because of the lack of recognition and reporting of exposures. Comprehensive approaches have been recommended to reduce the risk of transmission of bloodborne virus infections.     

How reproductive and regenerative medicine meet in a Chinese fertility clinic. Interviews with women about the donation of embryos to stem cell research

The social interface between reproductive medicine and embryonic stem cell research has been investigated in a pilot study at a large IVF clinic in central China. Methods included observation, interviews with hospital personnel, and five in-depth qualitative interviews with women who underwent IVF and who were asked for their consent to the donation of embryos for use in medical (in fact human embryonic stem cell) research. This paper reports, and discusses from an ethical perspective, the results of an analysis of these interviews. The participants talked of extreme social pressure to become pregnant. Once they had a baby, 'spare' embryos lost practical significance due to the Chinese one-child policy. In the context of decision making about donating embryos to research, the women used the clinical distinctions between 'good and bad quality' embryos and also between frozen and transferred embryos, as guiding moral distinctions. In the absence of concrete information about what sort of research their embryos should be used for, the women interviewed either refused consent (for fear that the embryo would be given to another couple) or accepted, expressing motives of solidarity with other women in a similar situation. This reveals that they filled the knowledge gap with an image of research improving fertility treatment.     

Legal and ethical considerations in processing patient-identifiable data without patient consent: lessons learnt from developing a disease register

The legal requirements and justifications for collecting patient-identifiable data without patient consent were examined. The impetus for this arose from legal and ethical issues raised during the development of a population-based disease register. Numerous commentaries and case studies have been discussing the impact of the Data Protection Act 1998 (DPA1998) and Caldicott principles of good practice on the uses of personal data. But uncertainty still remains about the legal requirements for processing patient-identifiable data without patient consent for research purposes. This is largely owing to ignorance, or misunderstandings of the implications of the common law duty of confidentiality and section 60 of the Health and Social Care Act 2001. The common law duty of confidentiality states that patient-identifiable data should not be provided to third parties, regardless of compliance with the DPA1998. It is an obligation derived from case law, and is open to interpretation. Compliance with section 60 ensures that collection of patient-identifiable data without patient consent is lawful despite the duty of confidentiality. Fears regarding the duty of confidentiality have resulted in a common misconception that section 60 must be complied with. Although this is not the case, section 60 support does provide the most secure basis in law for collecting such data. Using our own experience in developing a disease register as a backdrop, this article will clarify the procedures, risks and potential costs of applying for section 60 support.     

Emergency research in children: options for ethical recruitment

The paucity of research data to guide current paediatric practice has led to children being termed therapeutic orphans. This difficulty is especially pertinent to research in emergency situations, such as acute resuscitation or critical care, where accepted ethical standards for overall research, have historically created practical difficulties for researchers. The welcome establishment of organisations to support UK paediatric research is helping to ensure safer and more effective medications for children, however as the balance between protection and access at the heart of the paediatric research ethical debate shifts to ever increasing access for researchers to children, it remains crucial to ensure the protection for these vulnerable participants. The fundamental protection for research subjects, namely their full informed consent before any recruitment, is not tenable in true emergency situations and so other approaches are warranted if standards are to be improved by human subjects research in such areas. Proxy, deferred and retrospective consent have all been advocated as solutions to this difficulty and this paper explores the ethical justification for these approaches and their utility in safeguarding children and families in emergency situations when traditional informed consent, as currently defined, cannot be obtained in the necessary time frame to enable research.     

计生药具免费供应的伦理学思考

计生药具免费公共服务通过优质服务、知情选择等方式，实现了伦理学上对人的尊重和对大众生殖健康的人文关怀。但药具免费供应过程中仍存在着一些伦理学上的问题：①知情选择尚未到位，在基层免费药具知情选择过程中，基层药管员和群众都面临着两难选择。知情选择的缺失、不全或不到位、不规范等现象仍然普遍存在。②药具免费发放存在人群的不公，大多数未婚、独身、离异等人群享受不到免费避孕药具和服务。③药具管理体制和部门职责有所相悖。建议：明确管理机构性质，完善药具政策，改革管理机制，规范知情选择，优化药具服务。     

Legal issues affecting confidentiality and informed consent in reproductive health

The law governing confidentiality and informed consent has acquired unique characteristics in the area of reproductive health, as a consequence of both the establishment of a constitutional right to privacy in reproductive health matters and the reaction of those politically and morally opposed to the exercise of that right. The primary issues have involved: 1) the right of minors to receive reproductive health services without parental consent, which remains a political battleground; 2) laws requiring physicians to provide information to pregnant patients that is intended, not to inform them of the risks and benefits of the procedure, but to discourage them from obtaining abortions; 3) coerced and prohibited sterilizations; 4) court-ordered contraception and procedures to protect the fetus; and 5) restrictions on counseling about abortion, contraception, sterilization, and other reproductive health services authorized by state conscience or noncompliance clauses that shield such restrictions from the usual ethical, medical, and legal rules governing informed consent. The last area is of profound significance to the ability of women to make informed decisions about their reproductive health options. In the current economic environment, which fuels mergers and acquisitions involving sectarian and nonsectarian institutions, women are increasingly being put at risk as a result of such restrictions.     

What makes clinical research ethical?

Many believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, we propose 7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value-enhancements of health or knowledge must be derived from the research; (2) scientific validity-the research must be methodologically rigorous; (3) fair subject selection-scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects; (4) favorable risk-benefit ratio-within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks; (5) independent review-unaffiliated individuals must review the research and approve, amend, or terminate it; (6) informed consent-individuals should be informed about the research and provide their voluntary consent; and (7) respect for enrolled subjects-subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored. Fulfilling all 7 requirements is necessary and sufficient to make clinical research ethical. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted. JAMA. 2000;283:2701-2711.     

乌鲁木齐市汉族孕妇营养知识、态度及行为调查与分析

目的了解乌鲁木齐市汉族孕妇营养知识、态度及饮食行为现状及其影响因素,为孕妇营养教育工作提供科学依据。方法采用问卷调查法,对2011年5-11月在乌鲁木齐市妇幼保健院定期行产前检查的汉族孕妇共600例(孕早、中、晚期各200例)进行营养知识、态度、行为的问卷调查,并对结果进行分析。结果乌鲁木齐市汉族孕妇营养知识掌握情况欠佳,营养态度普遍较好。62.8%的孕妇有挑食、偏食现象,66.7%的孕妇不吃保健品,97.8%孕妇不吸烟,但是61.5%的孕妇受被动吸烟,1.3%孕妇在孕期偶尔饮酒,96.8%孕妇不知道如何安排孕期的饮食。孕妇营养知识水平与年龄、文化程度间差异有统计学意义(P<0.01),与职业间差异无统计学意义(P>0.05)。结论乌鲁木齐市汉族孕妇的营养知识水平和饮食行为有待改善,建议提高医护人员的营养知识水平,加强孕妇及家人的营养教育,以促进母子健康。     

Pregnancy and informed consent to research

Federal regulations governing research with human subjects have limited a pregnant woman's authority to decide to participate in research since 1975 by requiring the consent of the fetus's father. Recognition of pregnant women's legal rights has increased since then, in particular, their right to be treated no differently from other adults. In 1998 the Department of Health and Human Services proposed amendments to these regulations that recognize women as the sole decision makers in this area and eliminate requirements for paternal consent. These regulations have not been adopted, however.     

Individual autonomy and state involvement in health care

This article examines the ethical basis for government involvement in health care. It first provides the case for individual autonomy, focusing on the justifications--particularly ethical ones--for allowing individuals to make their own choices in health care, and to control more of their own resources in doing so. Next, it provides the opposite case--for abridging individual autonomy, and in particular, for redistributing resources from those who are well off to those who are not. The overriding reason for favouring the latter case, which trumps the notion of individual autonomy, is to ensure that individuals who are at a disadvantage have an equal probability of attaining good health.     

Are we teaching students that patients don't matter?

Medical students may fear that their training leeches away the caring attitudes which attracted them to medicine. Some research suggests they are right. The medical school has a duty to support and encourage their values, but the reverse may happen. Students are taught about legal consent but not ethical consent. They may see or participate in concealment of medical mistakes and learn to practise deceit. The use of unconscious females for gynaecology teaching may encourage the wrong attitudes to patients. Trainee GPs may learn that the doctors' rights are more important than those of the patient. Measuring patients' views should be included in research protocols.