Challenges with implementing malaria rapid diagnostic tests at primary care facilities in a Ghanaian district: a qualitative study.

BACKGROUND: Rapid diagnostic Tests (RDTs) for malaria enable diagnostic testing at primary care facilities in resource-limited settings, where weak infrastructure limits the use of microscopy. In 2010, Ghana adopted a test-before-treat guideline for malaria, with RDT use promoted to facilitate diagnosis. Yet healthcare practitioners still treat febrile patients without testing, or despite negative malaria test results. Few studies have explored RDT implementation beyond the notions of provider or patient acceptability. The aim of this study was to identify the factors directly influencing malaria RDT implementation at primary care facilities in a Ghanaian district. METHODS: Qualitative interviews, focus groups and direct observations were conducted with 50 providers at six purposively selected primary care facilities in the Atwima-Nwabiagya district. Data were analysed thematically. RESULTS: RDT implementation was hampered by: (1) healthcare delivery constraints (weak supply chain, limited quality assurance and control, inadequate guideline emphasis, staffing limitations); (2) provider perceptions (entrenched case-management paradigms, limited preparedness for change); (3) social dynamics of care delivery (expected norms of provider-patient interaction, test affordability); and (4) limited provider engagement in policy processes leading to fragmented implementation of health sector reform. CONCLUSION: Limited health system capacity, socio-economic, political, and historical factors hampered malaria RDT implementation at primary care facilities in the study district. For effective RDT implementation providers must be: (1) adequately enabled through efficient allocation and management of essential healthcare commodities; (2) appropriately empowered with the requisite knowledge and skill through ongoing, effective professional development; and (3) actively engaged in policy dialogue to demystify socio-political misconceptions that hinder health sector reform policies from improving care delivery. Clear, consistent guideline emphasis, with complementary action to address deep-rooted provider concerns will build their confidence in, and promote uptake of recommended policies, practices, and technology for diagnosing malaria.

Playing God or just unnatural? Religious beliefs and approval of synthetic biology.

Using evidence from a 2010 survey of 32 European publics, this article argues that belief in God increases disapproval for synthetic biology through two different mechanisms, depending on the strength of the individual's belief. Among weak believers, belief in God appears to be associated with the increased availability and accessibility of the idea that genetic manipulation interferes with nature. Strong believers, in contrast, appear to also engage in an explicitly theological evaluation of synthetic biology, with opposition to synthetic biology resulting from the perception that the creation of new types of organisms encroaches on a domain of activity (creation) that has traditionally been considered to be a divine prerogative. Overall, our findings suggest that value predispositions can influence public attitudes towards synthetic biology even when individuals engage in explicit deliberation about the technology in question.

Stem cell tourism and future stem cell tourists: policy and ethical implications.

Stem cell tourism is a small but growing part of the thriving global medical tourism marketplace. Much stem cell research remains at the experimental stage, with clinical trials still uncommon. However, there are over 700 clinics estimated to be operating in mostly developing countries--from Costa Rica and Argentina to China, India and Russia--that have lured many patients, mostly from industrialized countries, driven by desperation and hope, which in turn continue to fuel the growth of such tourism. While much research has focused on such dimensions as the promotions that allow such businesses to make their services known, media coverage, some patient research, and regulatory conditions for developing country clinics, little attention has been paid to the non-affected members of the general population, the future potential users of such services. This empirical study based on five focus group discussions with a diverse group of healthy adults in a Canadian city, explored participant views of patients who use stem cell tourism services, the likelihood they would avail themselves of such services if they were to suffer similar illnesses, and the conditions under which they might do so, and the impact that admonitions and advice from international expert bodies might have on their decisions. Our findings suggest that these healthy adults are sympathetic to the drivers of hope and desperation, and, despite cautions about research limitations, may seek such treatments themselves under similar conditions. These findings are discussed in the context of the policy and ethical issues raised by this form of medical tourism.

Trust, patents and public perceptions: the governance of controversial biotechnology research.

The sustainability of many research endeavors, particularly in controversial areas, requires an understanding of public concerns. As such, governance strategies should be developed to sustain public trust.

Technology assessment and resource allocation for predictive genetic testing: a study of the perspectives of Canadian genetic health care providers.

BACKGROUND: With a growing number of genetic tests becoming available to the health and consumer markets, genetic health care providers in Canada are faced with the challenge of developing robust decision rules or guidelines to allocate a finite number of public resources. The objective of this study was to gain Canadian genetic health providers' perspectives on factors and criteria that influence and shape resource allocation decisions for publically funded predictive genetic testing in Canada. METHODS: The authors conducted semi-structured interviews with 16 senior lab directors and clinicians at publically funded Canadian predictive genetic testing facilities. Participants were drawn from British Columbia, Alberta, Manitoba, Ontario, Quebec and Nova Scotia. Given the community sampled was identified as being relatively small and challenging to access, purposive sampling coupled with snowball sampling methodologies were utilized. RESULTS: Surveyed lab directors and clinicians indicated that predictive genetic tests were funded provincially by one of two predominant funding models, but they themselves played a significant role in how these funds were allocated for specific tests and services. They also rated and identified several factors that influenced allocation decisions and patients' decisions regarding testing. Lastly, participants provided recommendations regarding changes to existing allocation models and showed support for a national evaluation process for predictive testing. CONCLUSION: Our findings suggest that largely local and relatively ad hoc decision making processes are being made in relation to resource allocations for predictive genetic tests and that a more coordinated and, potentially, national approach to allocation decisions in this context may be appropriate.

Evaluating online direct-to-consumer marketing of genetic tests: informed choices or buyers beware?

Commercialization of genetic technologies is expanding the horizons for the marketing and sales of genetic tests direct-to-consumers (DTCs). This study assesses the information provision and access requirements that are in place for genetic tests that are being advertised DTC over the Internet. Sets of key words specific to DTC genetic testing were entered into popular Internet search engines to generate a list of 24 companies engaging in DTC advertising. Company requirements for physician mediation, genetic counseling arrangements, and information provision were coded to develop categories for quantitative analysis within each variable. Results showed that companies offering risk assessment and diagnostic testing were most likely to require that testing be mediated by a clinician, and to recommend physician-arranged counseling. Companies offering enhancement testing were less likely to require physician mediation of services and more likely to provide long-distance genetic counseling. DTC advertisements often provided information on disease etiology; this was most common in the case of multifactorial diseases. The majority of companies cited outside sources to support the validity of claims about clinical utility of the tests being advertised; companies offering risk assessment tests most frequently cited all information sources. DTC advertising for genetic tests that lack independent professional oversight raises troubling questions about appropriate use and interpretation of these tests by consumers and carries implications for the standards of patient care. These implications are discussed in the context of a public healthcare system.

Stem cell research ethics: consensus statement on emerging issues.

This article is a consensus statement by an international interdisciplinary group of academic experts and Canadian policy-makers on emerging ethical, legal and social issues in human embryonic stem cells (hESC) research in Canada. The process of researching consensus included consultations with key stakeholders in hESC research (regulations, stem cell researchers, and research ethics experts), preparation and distribution of background papers, and an international workshop held in Montreal in February 2007 to discuss the papers and debate recommendations. The recommendations provided in the consensus statement focus on issues of immediate relevance to Canadian policy-makers, including informed consent to hESC research, the use of fresh embryos in research, management of conflicts of interest, and the relevance of public opinion research to policy-making.

Risk assessment for inherited susceptibility to cancer: a review of the psychosocial and ethical dimensions.

The objective of this study was to conduct a broad-based systematic review of social, ethical, and legal considerations associated with genetic cancer risk assessment technologies (CaRATs). This paper focuses on psychosocial and ethical issues. Search results were limited to papers published in English, French, or German from January, 1990, to May, 2003. A quality assessment tool was developed and applied to retrieved papers. Application of the quality assessment tool resulted in 77 of 247 qualitative and quantitative primary research papers being reviewed and synthesized. A broad range of issues were addressed and grouped into content areas. Despite a large literature addressing psychosocial and ethical issues associated with CaRATs, many existing studies are not adequate to inform decision-makers and stakeholders. Careful policy analysis, as in some of the economic analyses reviewed here, is important to bridge this gap.

Commentary: On the position paper of the Ethics Committee of the International Xenotransplantation Association.

The Position Paper of the Ethics Committee of the International Xenotransplantation Association has argued in favor of moving forward with xenotransplantation trials but only under highly controlled conditions, including consideration of ethical concerns. Although stressing the importance of ethics, this recommendation to proceed was ultimately based on a risk-benefit calculus. There are two areas that need to be addressed more fully: 1) the nature of the decision to be made; and 2) the nature and extent of participation by publics as part of this political process.

Synthetic biology confronts publics and policy makers: challenges for communication, regulation and commercialization.

The novelty of synthetic biology lies in the use of synthesized parts that can be arranged to make useful products. Such advanced, high-throughput genetic engineering projects redesign and fabricate existing biological systems as well as new biological parts, devices and systems that do not occur in nature. This Opinion discusses challenges raised by synthetic biology for public acceptance, regulation, commercialization and the emerging global issue of access to genetic resources and information. As with all new fields of research, maintaining the trust of the public and policy regulators is paramount. Hype and exaggerated claims are counterproductive to developing adaptive and ethically sound regulatory models responsive to stakeholder concerns.

Publics and vaccinomics: beyond public understanding of science.

Vaccines have been among the most effective tools for addressing global public health challenges. With the advent of genomics, novel approaches for vaccine discovery are opening up new opportunities for vaccine development and applications, particularly with the expectation of personalized vaccines and the possibility of addressing a broader range of infectious diseases. In this context, it is useful to reflect on the social contexts of vaccine development as these have been influenced by social, ethical, political challenges. This article discusses the historical context of vaccine controversies and factors that help explain public acceptance and resistance, illustrating that these challenges go well beyond simple public misunderstandings. The broader vaccine challenges evident along the innovation trajectory, from development to commercialization and implementation include problems in research and development, organizational issues, and legal and regulatory challenges that may collectively contribute to public resistance or confidence. The recent history of genomics provides further lessons that the developing field of vaccinomics can learn from.

Institutional policy learning and public consultation: the Canadian xenotransplantation experience.

Attempts to evaluate public consultations, participatory technology assessment, and deliberative democracy have typically considered impacts on either policy or participants. The determination of impacts on policy institutions has been limited due to the challenges of tracing effects through the policy process, or penetrating bureaucratic walls. This paper presents findings from a retrospective study exploring the institutional lessons learned from a 2001 Canadian national public consultation on xenotransplantation. The consultation was conducted through an arm's-length process and involved the use of citizen juries in six regional sites. We conducted in-depth interviews of regulatory and policy actors who were engaged in early policy discussions and the consultation process. We reviewed evaluations of this process, both internal and external, which gave us richer insights into what institutional actors saw as the impacts of this consultative experience on their policy environment. Participants in our research identified a broader shift toward openness in policy culture which they linked specifically to the innovative consultation process employed for xenotransplantation. We argue that beyond input into policy decisions, a consultation may have an impact in terms of its contribution to overall shifts in institutional culture (related to institutional learning), such as an "opening" of technological decision processes to a broader range of actors, knowledge, and values.

Diversity in public views toward stem cell sources and policies.

Studies of public views on stem cell research have traditionally focused on human embryonic stem cells. With more recent scientific research on developing other stem cell sources, a series of focus group studies was undertaken with Canadian adults to examine their views on different stem cell sources (adult, umbilical cord blood, human embryonic stem cells, somatic cell nuclear transfer or SCNT, and interspecies nuclear transfer, or iSCNT). Views on three different policy models--a permissive, middle-of-the-road and restrictive policy approach--were also explored. Participants were recruited from several different social groups including patients, young adults, seniors, members of two ethnic communities, and a mixed group of adults. Participants were generally supportive of the use of adult stem cell sources. While there was also majority support for the use of hESC and SCNT, this was conditional on strict regulatory oversight. There was also majority support for a permissive policy which allows research on hESC and SCNT. General themes that cut across different groups included the potential cost of new technologies to the health care system, issues around who would gain access to these technologies, and trust in the scientific establishment and regulatory systems. A diversity of viewpoints was found as participants justified their positions on stem cell sources and policy approaches, showing more complexity and nuance than has been generally portrayed.

Science communication reconsidered.

As new media proliferate and the public's trust and engagement in science are influenced by industry involvement in academic research, an interdisciplinary workshop provides some recommendations to enhance science communication.

The stem cell research environment: a patchwork of patchworks.

Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a 'patchwork of patchworks'. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application.

Patents, commercialization and the Canadian stem cell research community.

AIMS: There has been a great deal of discussion in relevant literature on the adverse impact of commercialization agendas and the patenting regime on research in emerging fields. We sought to assess the perceived impact of these factors on the stem cell research community in Canada. MATERIALS & METHODS: We surveyed 283 researchers from Canada's Stem Cell Network using a survey instrument informed by relevant literature and systematic consultations with Canadian and international regulators, stem cell researchers and research ethics experts designed to identify pressing ethical, legal and social issues relevant to stem cell research. A total of 108 researchers responded to the survey. RESULTS & CONCLUSIONS: Results indicate that although many researchers believe that patents may have adverse effects on research, very few have encountered any such effects in practice. The researchers admitted to withholding data to protect patenting opportunities, while also maintaining that patents did not contribute to publication delays. The pressure to commercialize their research was largely held to be reasonable by researchers.

Animal spare parts? A Canadian public consultation on xenotransplantation.

Xenotransplantation, or the use of animal cells, tissues and organs for humans, has been promoted as an important solution to the worldwide shortage of organs. While scientific studies continue to be done to address problems of rejection and the possibility of animal-to-human virus transfer, socio-ethical and legal questions have also been raised around informed consent, life-long monitoring, animal welfare and animal rights, and appropriate regulatory practices. Many calls have also been made to consult publics before policy decisions are made. This paper describes the Canadian public consultation process on xenotransplantation carried out by the Canadian Public Health Association in an arm's length process from Health Canada, the ministry overseeing government health policy and regulation. Focusing on six citizen for a conducted around the country patterned after the citizen jury deliberative approach, the paper describes the citizen panelists' recommendations to hold off on proceeding with clinical trials and the rationales behind this recommendation. The consultation process is discussed in the context of constructive technology assessment, a framework which argues for broader input into earlier stages of technology innovation, particularly at the technology design stage.