Implementing post-trial access plans for HIV prevention research.

Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access (PTA) to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-level barriers can threaten the viability of PTA plans. The aggregate experience across these HIV prevention trials suggests that simply referring participants to local healthcare systems for PTA will not necessarily result in continued access to beneficial interventions for trial participants. Serious commitments to PTA will require additional efforts to learn from future approaches, measuring the success of PTA plans with dedicated follow-up and further developing normative guidance to help research stakeholders navigate the complex practical challenges of realising PTA.

Avances y retos de las Comisiones Estatales de Bioética en México / State Bioethics Commissions in Mexico, Achievements and Challenges

Se han realizado estudios comparativos sobre comisiones nacionales de bioética, comités hospitalarios de bioética y de ética en investigación de diversos países; sin embargo existen pocos datos sobre la aplicación de la bioética a nivel subnacional. Este trabajo ofrece una aproximación a la evolución de las Comisiones Estatales de Bioética en México, se identifican como actividades de su quehacer acciones de capacitación, difusión, asesoría y promoción de la bioética en la atención médica y la vinculación con la Comisión Nacional de Bioética y otras instituciones de salud y educativas. Las Comisiones Estatales ayudan a fomentar la bioética a nivel subnacional y a extender la atención integral en situaciones complejas en el ámbito médico e investigativo (AU)

Comparative studies have been developed on the infrastructure on bioethics of different countries, comprised mainly by national commissions, hospital bioethics and research ethics committees; however, there are few data on the application of bioethics at the subnational level. This work offers an approximation to the evolution of the State Commissions of Bioethics in Mexico and accounts for their work in outreach, education, and counseling, as well as entrenching a culture of bioethics in medical care and networking with the National Bioethics Commission and other health and educational institutions. State Commissions help to promote bioethics at the subnational level and to foster comprehensive care in complex medical and research settings (AU)

Ethics-sensitivity of the Ghana national integrated strategic response plan for pandemic influenza.

BACKGROUND: Many commentators call for a more ethical approach to planning for influenza pandemics. In the developed world, some pandemic preparedness plans have already been examined from an ethical viewpoint. This paper assesses the attention given to ethics issues by the Ghana National Integrated Strategic Plan for Pandemic Influenza (NISPPI). METHODS: We critically analyzed the Ghana NISPPI's sensitivity to ethics issues to determine how well it reflects ethical commitments and principles identified in our review of global pandemic preparedness literature, existing pandemic plans, and relevant ethics frameworks. RESULTS: This paper reveals that important ethical issues have not been addressed in the Ghana NISPPI. Several important ethical issues are unanticipated, unacknowledged, and unplanned for. These include guidelines on allocation of scarce resources, the duties of healthcare workers, ethics-sensitive operational guidelines/protocols, and compensation programs. The NISPPI also pays scant attention to use of vaccines and antivirals, border issues and cooperation with neighboring countries, justification for delineated actions, and outbreak simulations. Feedback and communication plans are nebulous, while leadership, coordination, and budgeting are quite detailed. With respect to presentation, the NISPPI's text is organized around five thematic areas. While each area implicates ethical issues, NISPPI treatment of these areas consistently fails to address them. CONCLUSIONS: Our analysis reveals a lack of consideration of ethics by the NISPPI. We contend that, while the plan's content and fundamental assumptions provide support for implementation of the delineated public health actions, its consideration of ethical issues is poor. Deficiencies include a failure to incorporate guidelines that ensure fair distribution of scarce resources and a lack of justification for delineated procedures. Until these deficiencies are recognized and addressed, Ghana runs the risk of rolling out unjust and ethically indefensible actions with real negative effects in the event of a pandemic. Soliciting inputs from the public and consultation with ethicists during the next revision of the NISPPI will be useful in addressing these issues.

When psychiatric diagnosis becomes an overworked tool.

A psychiatric diagnosis today is asked to serve many functions-clinical, research, medicolegal, delimiting insurance coverage, service planning, defining eligibility for state benefits (eg, for unemployment or disability), as well as providing rallying points for pressure groups and charities. These contexts require different notions of diagnosis to tackle the particular problem such a designation is meant to solve. In a number of instances, a 'status' definition (ie, a diagnostic label or category) is employed to tackle what is more appropriately seen as requiring a 'functional' approach (ie, how well the person is able to meet the demands of a test of performance requiring certain capabilities, aptitudes or skills). In these instances, a diagnosis may play only a subsidiary role. Some examples are discussed: the criteria for involuntary treatment; the determination of criminal responsibility; and, assessing entitlements to state benefits. I suggest that the distinction between 'status' versus 'function' has not been given sufficient weight in discussions of diagnosis. It is in the functional domain that some of the problematic relationships between clinical psychiatry and the social institutions with which it rubs shoulders are played out. A status, signified by a diagnosis, has often been encumbered with demands for which it is poorly equipped. It is a reductive way of solving problems of management, allocation or disposal for which a functional approach should be given greater weight.

Ethical challenges: managing oncology drug shortages.

This vignette highlights the ethical issues surrounding restricted access to oncology drugs caused by drug shortages. A review of selected literature and a framework for creating institutional guidelines for reacting to shortage is provided.

Committee opinion: no. 563: ethical issues in pandemic influenza planning concerning pregnant women.

Pregnant women traditionally have been assigned priority in the allocation of prevention and treatment resources during outbreaks of influenza because of their increased risk of morbidity and mortality. The Committee on Ethics of the American College of Obstetricians and Gynecologists explores ethical justifications for assigning priority for prevention and treatment resources to pregnant women during an influenza pandemic, makes recommendations to incorporate ethical issues in pandemic influenza planning concerning pregnant women, and calls for pandemic preparedness efforts to include clinical research specifically designed to address safety and efficacy of treatment interventions or prevention strategies used by pregnant women.

Canadian national surveys on pandemic influenza preparations: pre-pandemic and peri-pandemic findings.

BACKGROUND: Prior to the 2009 H1N1 Influenza pandemic, public health authorities in Canada and elsewhere prepared for the future outbreak, partly guided by an ethical framework developed within the Canadian Program of Research on Ethics in a Pandemic (CanPREP). We developed a telephone-based survey based on that framework, which was delivered across Canada in late 2008. In June, 2009, the WHO declared pandemic Phase 6 status and from the subsequent October (2009) until May 2010, the CanPREP team fielded a second (revised) survey, collecting another 1,000 opinions from Canadians during a period of pre-pandemic anticipation and peri-pandemic experience. METHODS: Surveys were administered by telephone with random sampling achieved via random digit dialing. Eligible participants were adults, 18 years or older, with per province stratification approximating provincial percentages of national population. Descriptive results were tabulated and logistic regression analyses used to assess whether demographic factors were significantly associated with outcomes, and to identify divergences (between the pre-pandemic and intra-pandemic surveys). RESULTS: N = 1,029 interviews were completed from 1,986 households, yielding a gross response rate of 52% (AAPOR Standard Definition 3). Over 90% of subjects indicated the most important goal of pandemic influenza preparations was saving lives, with 41% indicating that saving lives solely in Canada was the highest priority and 50% indicating saving lives globally was the highest priority. About 90% of respondents supported the obligation of health care workers to report to work and face influenza pandemic risks excepting those with serious health conditions which that increased risks. Strong majorities favoured stocking adequate protective antiviral dosages for all Canadians (92%) and, if effective, influenza vaccinations (95%). Over 70% agreed Canada should provide international assistance to poorer countries for pandemic preparation, even if resources for Canadians were reduced. CONCLUSIONS: Results suggest Canadians trust public health officials to make difficult decisions, providing emphasis is maintained on reciprocity and respect for individual rights. Canadians also support international obligations to help poorer countries and associated efforts to save lives outside the country, even if intra-national efforts are reduced.

Ethical implications of diversity in disaster research.

Enhancing the effectiveness, efficiency, and fairness of interventions is an increasing source of concern in the field of disaster response. As a result, the expansion of the disaster relief evidence base has been identified as a pressing need. There has been a corresponding increase in discussions of ethical standards and procedures for disaster research. In general, these discussions have focused on elucidating how traditional research ethics concerns can be operationalized in disaster settings. Less attention has been given to the exploration of the ethical implications of heterogeneity within the field of disaster research. Hence, while current efforts to discuss the ethics of disaster research in low-resource settings are very encouraging, it is clear that further initiatives will be crucial to promote the ethical conduct of disaster research. In this article, we explore how the ethical review of disaster research conducted in low-resource settings should account for this diversity. More specifically, we consider how the nature of the project (what?), sociopolitical and physical environment of research sites (where?), temporal proximity to the disaster event (when?), objectives motivating the research (why?), and identity of the stakeholders involved in the research process (who?) all relate to the ethics of disaster research.

Ethical reasoning in pandemic preparedness plans: Southeast Asia and the Western Pacific.

The emergence of H1N1 in 2009 shows that it is a mistake to regard the scenario of having to implement pandemic plans as merely hypothetical. This recent experience provides an opportunity to inquire into the current state of pandemic preparedness plans with regard to their ethical adequacy. One aspect that deserves consideration in this context is the disclosure of ethical reasoning. Accordingly, the following is an analysis of examples of pandemic plans and drafts of plans from Southeast Asia and the Western Pacific. It is an analysis of the occurrence of explicit ethical reflection in these documents as well an inquiry into the related question of how ethical reflection can be understood as a constitutive element of ethical pandemic preparedness. In the analysis, different fields of ethical consideration concerning equity, personal rights and accountability are distinguished. There are both pragmatic and genuinely ethical reasons to explicitly address issues of these types in pandemic plans. The extent to which ethical language appears in the national plans in South East Asia and the Western Pacific suggests that there is limited awareness of ethical considerations, or at least insufficient ethical substantiation of pandemic action. The aim of the analysis is to show that further inclusion of ethical considerations into pandemic plans is ethically demanded. It is of particular significance that these considerations are formulated and remain discernible as instances of ethical deliberation.

[Precariousness, DRG's and health planning: pilot study at the Lariboisière hospital in Paris]. / Précarité, tarification à l'activité et planification sanitaire et sociale: étude pilote à l'hôpital Lariboisière de Paris.

OBJECTIVES: This paper considers the specific administrative procedures set up by managers of public healthcare establishments and those responsible for health and welfare policies to care for low-income pregnant women for whom 100% of the "price per act" (T2A) is refunded. What are the limitations and what improvements can be suggested? PATIENTS AND METHOD: The results are based on an analysis of data from semi-structured interviews, legislation and documents. RESULTS: The State, health insurance systems, public health establishments, local authorities, charities and outpatient services are involved in handling low-income parturients in different services and different establishments, both locally and regionally. A health and welfare policy comprising specific, coordinated actions and measures has been developed. The T2A "price per act" system may threaten its survival: the limited number of front-line facilities is often saturated and demand is increasing, treatment is often reduced to reactive management leading to unwanted readmissions, ethics are sometimes called into question and there is a risk of patient selection. DISCUSSION AND CONCLUSION: This pilot study provided some encouraging information but also indicated the limitations of the approach adopted. However, it was still of interest to see whether it was possible to use this approach, which did not require considerable resources, to reveal useful markers. This appeared to be the case. Regional Health Agencies (ARS) and local authorities could support the system. Additional funding is needed.