Institutional Review Board Quality, Private Equity, and Promoting Ethical Human Subjects Research.

Evaluating the quality and effectiveness of the institutional review boards (IRBs) responsible for overseeing research involving human participants is critically important but perpetually challenging. Seemingly common-sense measures, such as the number of proposals approved with and without major modifications and the number of unexpected adverse events occurring in approved protocols, can be misleading indicators of participant protection, and regulatory compliance may not correspond to achieving ethical goals. These measurement challenges make it difficult to assess the validity of concerns about different IRB models. A group of U.S. senators recently raised questions about the increasing use of for-profit IRBs to review research proposals (as opposed to boards typically housed at academic medical centers and health care institutions) and, more specifically, about the growing trend of private equity ownership and consolidation of for-profit IRBs. Although all IRBs face pressure to speed reviews and none are entirely free of conflicts of interest, the private equity model is particularly susceptible to approaches that could undercut the ethical mission of IRBs to protect and promote the rights and welfare of research participants. Ideally, the quality of board oversight could be measured directly, rather than relying on the heuristic of board type; this article describes several current efforts toward this goal. In the meantime, one improvement may be to pursue a new model of IRB oversight: independent nonprofit boards that stand apart from research institutions, take advantage of business approaches to research review, and minimize conflicts of interest.

Pushing partnerships: corporate influence on research and policy via the International Life Sciences Institute.

OBJECTIVE: There are concerns that some non-profit organisations, financed by the food industry, promote industry positions in research and policy materials. Using Freedom of Information (FOI) requests, we test the proposition that the International Life Sciences Institute (ILSI), one prominent non-for profit in international health and nutrition research, promotes industry positions. DESIGN: U.S. Right to Know filed five FOI from 2015 to 2018 covering communications with researchers at four US institutions: Texas A&M, University of Illinois, University of Colorado and North Carolina State University. It received 15 078 pages, which were uploaded to the University of California San Francisco's Industry Documents Library. We searched the Library exploring it thematically for instances of: (1) funding research activity that supports industry interests; (2) publishing and promoting industry-sponsored positions or literature; (3) disseminating favourable material to decision makers and the public and (4) suppressing views that do not support industry. RESULTS: Available emails confirmed that ILSI's funding by corporate entities leads to industry influence over some of ILSI activities. Emails reveal a pattern of activity in which ILSI sought to exploit the credibility of scientists and academics to bolster industry positions and promote industry-devised content in its meetings, journal and other activities. ILSI also actively seeks to marginalise unfavourable positions. CONCLUSIONS: We conclude that undue influence of industry through third-party entities like ILSI requires enhanced management of conflicts of interest by researchers. We call for ILSI to be recognised as a private sector entity rather than an independent scientific non-profit, to allow for more appropriate appraisal of its outputs and those it funds.

Regulation of Stem Cell Technology in Malaysia: Current Status and Recommendations.

Stem cell technology is an emerging science field; it is the unique regenerative ability of the pluripotent stem cell which scientists hope would be effective in treating various medical conditions. While it has gained significant advances in research, it is a sensitive subject involving human embryo destruction and human experimentation, which compel governments worldwide to ensure that the related procedures and experiments are conducted ethically. Based on face-to-face interviews with selected Malaysian ethicists, scientists and policymakers, the objectives and effectiveness of the current Guideline for Stem Cell Research and Therapy (2009) are examined. The study's findings show that the guideline is rather ineffective in ensuring good ethical governance of the technology. A greater extent of unethical conduct is likely present in the private medical clinics or laboratories offering stem cell therapies compared with the public medical institutions providing similar services, as the latter are closely monitored by the governmental agencies enforcing the relevant policies and laws. To address concerns over malpractices or unethical conduct, this paper recommends a comprehensive revision of the current stem cell guideline so that adequate provisions exist to regulate the explicit practices of the private and public stem cell sectors, including false advertising and accountability. The newly revised Malaysian stem cell guideline will align with the Guidelines for Stem Cell Research and Clinical Translation (2016) of the International Society for Stem Cell Research (ISSCR) containing secular but universal moral rules. However, a regulatory policy formulated to govern the technology remains the main thrust of empowering the guideline for compliance among the stakeholders.

Donation of Human Biological Materials in the European Union: Commodifying Solidarity in the Era of the Biotechnological Revolution?

The use of human biological materials (HBMs) involves a number of issues from both an ethical and a legal point of view. In recent decades, the purposes for which this material has been used have increased. The development of therapeutic products has led to the configuration of a market in which products have acquired an economic value. As soon as the private sector crosses the threshold of access to the use of human cells and tissues, a conflict may arise between the altruistic principles motivating the act of donation and the profit-making objectives . When donated material emerges from the public management setting and becomes a source of profit, the instrument of informed consent may not adequately protect the dignity of the donors. In the era of medical biotechnology revolution, any use of the donated material must be justified and consistent with the values motivating the act of donation.

La formación de las enfermeras y la ética empresarial / No disponible

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The for-profit sector in humanitarian response: integrating ethical considerations in public policy decision making.

The engagement of the for-profit private sector in health, social and humanitarian services has become a topic of keen interest. It is particularly contentious in those instances where for-profit organizations have become recipients of public funds, and where they become key decision-makers in terms of how, and to whom, services are provided. We put forward a framework for identifying and organizing the ethical questions to be considered when contracting government services to the for-profit sector, specifically in those areas that have traditionally remained in the public or not-for-profit spheres. The framework is designed to inform both academic debate and practical decision-making regarding the acceptability, feasibility and legitimacy of for-profit organizations carrying out humanitarian work. First, we outline the importance of posing ethical questions in government contracting for-profit vs. not-for-profit organizations. We then outline five key areas to be considered before then examining the extent to which ethics concerns are warranted and how they may be safeguarded.

Out-of-pocket expenditure and its determinants in the context of private healthcare sector expansion in sub-Saharan Africa urban cities: evidence from household survey in Ouagadougou, Burkina Faso.

BACKGROUND: Conventional wisdom suggests that out-of-pocket (OOP) expenditure reduces healthcare utilization. However, little is known about the expenditure borne in urban settings with the current development of the private health sector in sub-Saharan Africa. In an effort to update knowledge on medical expenditure, this study investigated the level and determinants of OOP among individuals reporting illness or injury in Ouagadougou, Burkina Faso and who either self-treated or received healthcare in either a private or public facility. METHODS: A cross-sectional study was conducted with a representative sample of 1017 households (5638 individuals) between August and November 2011. Descriptive statistics and multivariate techniques including generalized estimating equations were used to analyze the data. RESULTS: Among the surveyed sample, 29.6% (n = 1666) persons reported a sickness or injury. Public providers were the single most important providers of care (36.3%), whereas private and informal providers (i.e.: self-treatment, traditional healers) accounted for 29.8 and 34.0%, respectively. Almost universally (96%), households paid directly for care OOP. The average expenditure per episode of illness was 8404XOF (17.4USD) (median 3750XOF (7.8USD). The total expenditure was higher for those receiving care in private facilities compared to public ones [14,613.3XOF (30.3USD) vs. 8544.1XOF (17.7USD); p < 0.001], and the insured patients' bill almost tripled uninsured (p < 0.001). Finally, medication was the most expensive component of expenditure in both public and private facilities with a mean of 8022.1XOF (16.7USD) and 12,270.5 (25.5USD), respectively. CONCLUSION: OOP was the principal payment mechanism of households. A significant difference in OOP was found between public and private provider users. Considering the importance of private healthcare in Burkina Faso, regulatory oversight is necessary. Furthermore, an extensive protection policy to shield households from catastrophic health expenditure is required.

Exploring corruption in the South African health sector.

Recent scholarly attention has focused on weak governance and the negative effects of corruption on the provision of health services. Employing agency theory, this article discusses corruption in the South African health sector. We used a combination of research methods and triangulated data from three sources: Auditor-General of South Africa reports for each province covering a 9-year period; 13 semi-structured interviews with health sector key informants and a content analysis of print media reports covering a 3-year period. Findings from the Auditor-General reports showed a worsening trend in audit outcomes with marked variation across the nine provinces. Key-informants indicated that corruption has a negative effect on patient care and the morale of healthcare workers. The majority of the print media reports on corruption concerned the public health sector (63%) and involved provincial health departments (45%). Characteristics and complexity of the public health sector may increase its vulnerability to corruption, but the private-public binary constitutes a false dichotomy as corruption often involves agents from both sectors. Notwithstanding the lack of global validated indicators to measure corruption, our findings suggest that corruption is a problem in the South African healthcare sector. Corruption is influenced by adverse agent selection, lack of mechanisms to detect corruption and a failure to sanction those involved in corrupt activities. We conclude that appropriate legislation is a necessary, but not sufficient intervention to reduce corruption. We propose that mechanisms to reduce corruption must include the political will to run corruption-free health services, effective government to enforce laws, appropriate systems, and citizen involvement and advocacy to hold public officials accountable. Importantly, the institutionalization of a functional bureaucracy and public servants with the right skills, competencies, ethics and value systems and whose interests are aligned with health system goals are critical interventions in the fight against corruption.

Corruption and the Other(s): Scope of Superordinate Identity Matters for Corruption Permissibility.

The decision to engage in corruption-public and private corruption, nepotism, and embezzlement-is often attributed to rational actors maximizing benefits to themselves. However, the importance of reciprocal relationships in humans suggests that an actor may weigh the costs of harms of her corrupt behavior to individuals who may generate future benefits for her. We hypothesize that actors who have a larger circle of actual and potential social partners will have more individuals to consider when generating harms and will thus be less likely to find corrupt acts permissible than actors with smaller circles of valued others. Using data from the World Values Survey and European Values Study (WVS), we explore whether participants with a larger geographic identity or a greater number of group memberships (i.e. a larger scope of actual and potential social partners) are less likely to find accepting bribes permissible. We find mixed support for our hypotheses, but consistently find that WVS participants with local, country, continent, or world geographic identities are less likely to find accepting a bribe permissible than those with regional identities-that is, actors whose primary identities that encompass more than their region find corruption less permissible. We discuss the importance of considering an actor's valuation of others when modeling corruption persistence, noting that establishing scopes of positive valuation is a precursor to predicting where actors will target benefits and shunt costs.

Does the Wage Gap between Private and Public Sectors Encourage Political Corruption?

We present a dynamic network model of corrupt and noncorrupt employees representing two states in the public and private sector. Corrupt employees are more connected to one another and are less willing to change their attitudes regarding corruption than noncorrupt employees. This behavior enables them to prevail and become the majority in the workforce through a first-order phase transition even though they initially represented a minority. In the model, democracy-understood as the principle of majority rule-does not create corruption, but it serves as a mechanism that preserves corruption in the long run. The motivation for our network model is a paradox that exists on the labor market. Although economic theory indicates that higher risk investments should lead to larger rewards, in many developed and developing countries workers in lower-risk public sector jobs are paid more than workers in higher-risk private sector jobs. To determine the long-run sustainability of this economic paradox, we study data from 28 EU countries and find that the public sector wage premium increases with the level of corruption.

The use of data mining by private health insurance companies and customers' privacy.

This article examines privacy threats arising from the use of data mining by private Australian health insurance companies. Qualitative interviews were conducted with key experts, and Australian governmental and nongovernmental websites relevant to private health insurance were searched. Using Rationale, a critical thinking tool, the themes and considerations elicited through this empirical approach were developed into an argument about the use of data mining by private health insurance companies. The argument is followed by an ethical analysis guided by classical philosophical theories-utilitarianism, Mill's harm principle, Kant's deontological theory, and Helen Nissenbaum's contextual integrity framework. Both the argument and the ethical analysis find the use of data mining by private health insurance companies in Australia to be unethical. Although private health insurance companies in Australia cannot use data mining for risk rating to cherry-pick customers and cannot use customers' personal information for unintended purposes, this article nonetheless concludes that the secondary use of customers' personal information and the absence of customers' consent still suggest that the use of data mining by private health insurance companies is wrong.

"Best care on home ground" versus "elitist healthcare": concerns and competing expectations for medical tourism development in Barbados.

INTRODUCTION: Many countries have demonstrated interest in expanding their medical tourism sectors because of its potential economic and health system benefits. However, medical tourism poses challenges to the equitable distribution of health resources between international and local patients and private and public medical facilities. Currently, very little is known about how medical tourism is perceived among front line workers and users of health systems in medical tourism 'destinations'. Barbados is one such country currently seeking to expand its medical tourism sector. Barbadian nurses and health care users were consulted about the challenges and benefits posed by ongoing medical tourism development there. METHODS: Focus groups were held with two stakeholder groups in May, 2013. Nine (n = 9) citizens who use the public health system participated in the first focus group and seven (n = 7) nurses participated in the second. Each focus group ran for 1.5 hours and was digitally recorded. Following transcription, thematic analysis of the digitally coded focus group data was conducted to identify cross-cutting themes and issues. RESULTS: Three core concerns regarding medical tourism's health equity impacts were raised; its potential to 1) incentivize migration of health workers from public to private facilities, 2) burden Barbados' lone tertiary health care centre, and 3) produce different tiers of quality of care within the same health system. These concerns were informed and tempered by the existing a) health system structure that incorporates both universal public healthcare and a significant private medical sector, b) international mobility among patients and health workers, and c) Barbados' large recreational tourism sector, which served as the main reference in discussions about medical tourism's impacts. Incorporating these concerns and contextual influences, participants' shared their expectations of how medical tourism should locally develop and operate. CONCLUSIONS: By engaging with local health workers and users, we begin to unpack how potential health equity impacts of medical tourism in an emerging destination are understood by local stakeholders who are not directing sector development. This further outlines how these groups employ knowledge from their home context to ground and reconcile their hopes and concerns for the impacts posed by medical tourism.

Future for hospital staff uncertain as private firm pulls plug on contract.

Nurses employed at the first NHS hospital to be taken over by a private company have been thrown into turmoil after the company decided to pull out of a ten-year contract after only two years.

Engaging for-profit providers in TB control: lessons learnt from initiatives in South Asia.

There has been a huge expansion in the private health-care sector over the past two decades, particularly in South Asia, resulting in over 80% of patients seeking care from private health providers. Despite concerns about the quality and equity of private sector service provision, most government public health bodies recognize that the private sector reaches individuals that public institutions cannot cater to, thereby being important in moving closer to universal health coverage. Numerous initiatives have been launched and are being planned to involve private practitioners in effectively diagnosing, reporting and managing infectious diseases such as tuberculosis. However, there is a notable dearth of papers discussing which elements of private sector engagement strategies are more or less successful and the ethical issues that arise when engagement strategies are operationalized. This article brings together the authors' experiences of working on projects to engage private allopathic health providers in Pakistan, Bangladesh and India for improved tuberculosis control. Motivations of and strategies required to engage private allopathic heath providers, specifically doctors, diagnostic laboratories and pharmacies, and some of the ethical issues that arise when designing programmes for engagement are discussed.

Blurring the boundaries between public and private health care services as an alternative explanation for the emergence of black medicine: the Israeli case.

Black medicine represents the most problematic configuration of informal payments for health care. According to the accepted economic explanations, we would not expect to find black medicine in a system with a developed private service. Using Israel as a case study, we suggest an alternative yet a complimentary explanation for the emergence of black medicine in public health care systems - even though citizens do have the formal option to use private channels. We claim that when regulation is weak and political culture is based on 'do it yourself' strategies, which meant to solve immediate problems, blurring the boundaries between public and private health care services may only reduce public trust and in turn, contribute to the emergence of black medicine. We used a combined quantitative and qualitative methodology to support our claim. Statistical analysis of the results suggested that the only variable significantly associated with the use of black medicine was trust in the health care system. The higher the respondents' level of trust in the health care system, the lower the rate of the use of black medicine. Qualitatively, interviewee emphasized the relation between the blurred boundaries between public and private health care and the use of black medicine.