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.

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.

"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.

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.

The case for moderate gun control.

In addressing the shape of appropriate gun policy, this essay assumes for the sake of discussion that there is a legal and moral right to private gun ownership. My thesis is that, against the background of this right, the most defensible policy approach in the United States would feature moderate gun control. The first section summarizes the American gun control status quo and characterizes what I call "moderate gun control." The next section states and rebuts six leading arguments against this general approach to gun policy. The section that follows presents a positive case for moderate gun control that emphasizes safety in the home and society as well as rights whose enforcement entails some limits or qualifications on the right to bear arms. A final section shows how the recommended gun regulations address legitimate purposes, rather than imposing arbitrary restrictions on gun rights, and offers concluding reflections.

HIV testing among pregnant women living with HIV in India: are private healthcare providers routinely violating women's human rights?

BACKGROUND: In India, approximately 49,000 women living with HIV become pregnant and deliver each year. While the government of India has made progress increasing the availability of prevention of mother-to-child transmission of HIV (PMTCT) services, only about one quarter of pregnant women received an HIV test in 2010, and about one-in-five that were found positive for HIV received interventions to prevent vertical transmission of HIV. METHODS: Between February 2012 to March 2013, 14 HIV-positive women who had recently delivered a baby were recruited from HIV positive women support groups, Government of India Integrated Counseling and Testing Centers, and nongovernmental organizations in Mysore and Pune, India. In-depth interviews were conducted to examine their general experiences with antenatal healthcare; specific experiences around HIV counseling and testing; and perceptions about their care and follow-up treatment. Data were analyzed thematically using the human rights framework for HIV testing adopted by the United Nations and India's National AIDS Control Organization. RESULTS: While all of the HIV-positive women in the study received HIV and PMTCT services at a government hospital or antiretroviral therapy center, almost all reported attending a private clinic or hospital at some point in their pregnancy. According to the participants, HIV testing often occurred without consent; there was little privacy; breaches of confidentiality were commonplace; and denial of medical treatment occurred routinely. Among women living with HIV in this study, violations of their human rights occurred more commonly in private rather than public healthcare settings. CONCLUSIONS: There is an urgent need for capacity building among private healthcare providers to improve standards of practice with regard to informed consent process, HIV testing, patient confidentiality, treatment, and referral of pregnant women living with HIV.

United States private-sector physicians and pharmaceutical contract research: a qualitative study.

BACKGROUND: There have been dramatic increases over the past 20 years in the number of nonacademic, private-sector physicians who serve as principal investigators on US clinical trials sponsored by the pharmaceutical industry. However, there has been little research on the implications of these investigators' role in clinical investigation. Our objective was to study private-sector clinics involved in US pharmaceutical clinical trials to understand the contract research arrangements supporting drug development, and specifically how private-sector physicians engaged in contract research describe their professional identities. METHODS AND FINDINGS: We conducted a qualitative study in 2003-2004 combining observation at 25 private-sector research organizations in the southwestern United States and 63 semi-structured interviews with physicians, research staff, and research participants at those clinics. We used grounded theory to analyze and interpret our data. The 11 private-sector physicians who participated in our study reported becoming principal investigators on industry clinical trials primarily because contract research provides an additional revenue stream. The physicians reported that they saw themselves as trial practitioners and as businesspeople rather than as scientists or researchers. CONCLUSIONS: Our findings suggest that in addition to having financial motivation to participate in contract research, these US private-sector physicians have a professional identity aligned with an industry-based approach to research ethics. The generalizability of these findings and whether they have changed in the intervening years should be addressed in future studies. Please see later in the article for the Editors' Summary.

Common and conflicting interests in the engagements between conservation organizations and corporations.

The conservation community increasingly views the corporate sector as a positive force for conservation. Collaborations between corporations and nongovernmental conservation organizations (NGOs) seek to mitigate the negative effects of corporate activities and augment positive conservation outcomes. I reviewed the establishment of corporate social responsibility (CSR) policies by corporations; the emerging focus on environmental practices and sustainability; and the history of engagement between corporations and nongovernmental organizations. I considered the ethical and reputation vulnerabilities of these collaborations, which depend especially on the financial nature of the relationship and reviewed how CSR approaches have influenced corporate practices. I concluded that whereas CSR practices can act to mitigate negative environmental impact, to date they have had limited positive effect on biodiversity conservation.

How to regulate medical tourism (and why it matters for bioethics).

A growing literature examines descriptive and normative questions about medical tourism such as: How does it operate? What are its effects? Are home country patients or their governments failing in moral duties by engaging in or permitting medical tourism? By contrast, much less has been written on the regulatory dimension: What might be done about medical tourism if we were convinced that it posed ethical issues and were motivated to act? I shall argue that this kind of regulatory analysis is essential for bioethical analysis of medical tourism. This article focuses on these regulatory questions more directly, evaluating available methods, restrictions, costs, and benefits of home and destination country unilateral regulatory moves. This article also discusses more briefly multilateral treaty and private sector responses.

PGTandMe: social networking-based genetic testing and the evolving research model.

The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and--highlighting the challenges associated with a new paradigm of "patient-driven" genomic research--focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article also explores potential ethical, legal, and regulatory issues that arise from the hybrid between personal genomic research and online social networking, particularly regarding informed consent, institutional review board (IRB) oversight, and ownership/intellectual property (IP) considerations.

Clarifying conflict of interest.

As the debate over how to manage or discourage physicians' financial conflicts of interest with the drug and medical device industries has become more heated, critics have questioned or dismissed the concept of "conflict of interest" itself. A satisfactory definition relates conflict of interest to concerns about maintaining social trust and distinguishes between breaches of ethical duty and temptations to breach duty. Numerous objections to such a definition have been offered, none of which prevails on further analysis. Those concerned about conflicts of interest have contributed to misunderstandings, however, by failing to demonstrate when social arrangements leading to temptations to breach duties are in themselves morally blameworthy. Clarifying "conflict of interest" is important if we are eventually going to develop productive modes of engagement between medicine and for-profit industry that avoid the serious ethical pitfalls now in evidence.

A cure for dyslexia?

A company is promoting behavioral exercises as a cure for dyslexia. Scientists worry that evaluation of the program is compromised by design flaws and conflicts of interest and that responses to critics restrict academic freedom.

How to do research fairly in an unjust world.

International research, sponsored by for-profit companies, is regularly criticised as unethical on the grounds that it exploits research subjects in developing countries. Many commentators agree that exploitation occurs when the benefits of cooperative activity are unfairly distributed between the parties. To determine whether international research is exploitative we therefore need an account of fair distribution. Procedural accounts of fair bargaining have been popular solutions to this problem, but I argue that they are insufficient to protect against exploitation. I argue instead that a maximin principle of fair distribution provides a more compelling normative account of fairness in relationships characterised by extreme vulnerability and inequality of bargaining potential between the parties. A global tax on international research would provide a mechanism for implementing the maximin account of fair benefits. This model has the capacity to ensure fair benefits and thereby prevent exploitation in international research.

The elephant in the room: collaboration and competition among relief organizations during high-profile disasters.

The non-governmental organizations (NGOs) that assume the bulk of emergency care during large-scale disasters in the developing world must expend considerable time and resources to ensure donations to sustain their field operations. This long-standing dilemma for the humanitarian community can create a competitive environment that: Compromises the delivery and quality of services, Allows the effectiveness of operations to be compromised by a lack of cooperation and collaboration, Disrupts the timely and accurate coordination and analysis of outcome measures that are crucial to successful response in the future, and Undermines the long-term capacity of indigenous aid organizations. This article addresses problems and potential solutions for improved coordination and long-term capacity-building of humanitarian aid.