Reproductive outsourcing: an empirical ethics account of cross-border reproductive care in Canada.

Cross-border reproductive care (CBRC) can be defined as the movement from one jurisdiction to another for medically assisted reproduction (MAR). CBRC raises many ethical concerns that have been addressed extensively. However, the conclusions are still based on scarce evidence even considering the global scale of CBRC. Empirical ethics appears as a way to foster this ethical reflection on CBRC while attuning it with the experiences of its main actors. To better understand the 'in and out' situation of CBRC in Canada, we conducted an ethnographic study taking a 'critically applied ethics' approach. This article presents a part of the findings of this research, obtained by data triangulation from qualitative analysis of pertinent literature, participant observation in two Canadian fertility clinics and 40 semidirected interviews. Based on participants' perceptions, four themes emerged: (1) inconsistencies of the Canadian legal framework; (2) autonomy and the necessity to resort to CBRC; (3) safety and the management of CBRC individual risks; and (4) justice and solidarity. The interaction between these four themes highlights the problematic of 'reproductive outsourcing' that characterised the Canadian situation, a system where the controversial aspects of MAR are knowingly pushed outside the borders.

Health and Ethical Consequences of Outsourcing Pivotal Clinical Trials to Latin America: A Cross-Sectional, Descriptive Study.

INTRODUCTION: The implications of conducting clinical trials in low and middle income countries on the financial accessibility and safety of the pharmaceutical products available in those markets have not been studied. Regulatory practices and ethical declarations lead to the commercialization of the new products, referred to as New Molecular Entities (NMEs), in the countries where tested as soon as they are approved in high surveillance countries. Patients and patients' associations use the Latin American courts to access new and expensive treatments, regardless of their safety profile and therapeutic value. DESIGN AND OBJECTIVES: Cross-sectional, descriptive study. To determine the therapeutic value and safety profile of the NMEs approved by the Food and Drug Administration (FDA) in 2011 and 2012 that had been tested in Latin America, and the implications of their market approval for the pharmaceutical budgets in the countries where tested. SETTING: Latin America. MEASURES: To assess the therapeutic value and safety of the NMEs commercialized in the different countries we used f independent drug bulletins. The prices of the NMEs for the consumers were obtained from the pharmaceutical price observatories of the countries were the medicines had been tested. If the price was not available in the observatories, it was obtained from pharmaceutical distributors. We used the countries' minimum wage and per capita income to calculate the financial accessibility of a course of treatment with the NMEs. RESULTS: We found that 33 NMEs approved by the FDA in 2011 and 2012 have been tested in Latin America. Of these, 26 had been evaluated by independent drug bulletins and only five were found to add some value to a subset of patients and had significant side-effects. The pharmaceutical prices were very high, varied widely across countries and were unrelated to the countries' income per capita or minimum wage. CONCLUSION: The implementation of clinical trials in Latin America results in the commercialization of medicines with questionable safety profiles and limited therapeutic value, putting patients at risk and causing budgetary strains in pharmaceutical budgets.

OUTSOURCING ETHICAL DILEMMAS: REGULATING INTERNATIONAL SURROGACY ARRANGEMENTS.

This article argues that the English legislative regime is ineffective in regulating international surrogacy, particularly with regard to commercial payments. It suggests that if English law views surrogacy as exploitative, we have a responsibility to protect women both in England and abroad, and the only way to do so effectively is to create a domestic system of regulation that caters adequately for the demand in this country. This requires a system of authorisation for surrogacy before it is undertaken; ex-post facto examinations of agreements completed in other jurisdictions, after the child is already living with the commissioning parents, cannot be seen as an acceptable compromise, as authorisation will inevitably be granted in the child's best interests.

Nonconsensual clinical trials: a foreseeable risk of offshoring under global corporatism.

This paper explores the connection of offshoring and outsourcing to nonconsensual global pharmaceutical trials in low-income countries. After discussing reasons why the topic of nonconsensual offshored clinical trials may be overlooked in bioethics literature, I suggest that when pharmaceutical corporations offshore clinical trials today, nonconsensual experiments are often foreseeable and not simply the result of aberrant ethical conduct by a few individuals. Offshoring of clinical trials is structured so that experiments can be presented as health care in a unique form of outsourcing from the host country to pharmaceutical corporations. Bioethicists' assessments of the risks and potential benefits of offshore corporate pharmaceutical trials should therefore systematically include not only the hoped for benefits and the risks of the experimental drug but also the risk that subjects will not have consented, as well as the broader international consequences of nonconsensual experimentation.

Fast, cheap, and out of control? Speculations and ethical concerns in the conduct of outsourced clinical trials in India.

The globalization of biopharmaceutical clinical trials and their offshore outsourcing, from the West to low and middle-income countries, has come under increasing scrutiny from academic scholars, practitioners, regulatory agencies and the media. This article reports the results of a study conducted in Bangalore and Hyderabad between 2007 and 2009, to elicit the perspectives of stakeholders, concerning media representations of their work and the ethical issues that emanate from their engagement in the clinical trials enterprise. In acknowledging the inherently problematic nature of the outsourcing of clinical trials to low income countries, I argue that the practice of not prioritizing research on diseases that are most prevalent among communities, from which subjects are recruited, demands a coordinated and sustained critique. I propose that the critical discourse on the outsourcing of clinical trials should not only emphasize the perils of this practice, but also address some broader issues of equity and distributive justice that determine people's access to basic health care in low income countries. Close attention to the specific context of clinical trials in an increasingly neoliberal medical and health environment in emerging economies such as India can provide critical insights into the on-the-ground complexities and challenges of outsourced global clinical trials.

Outsourcing medical data analyses: can technology overcome legal, privacy, and confidentiality issues?

BACKGROUND: Medical data are gold mines for deriving the knowledge that could change the course of a single patient's life or even the health of the entire population. A data analyst needs to have full access to relevant data, but full access may be denied by privacy and confidentiality of medical data legal regulations, especially when the data analyst is not affiliated with the data owner. OBJECTIVE: Our first objective was to analyze the privacy and confidentiality issues and the associated regulations pertaining to medical data, and to identify technologies to properly address these issues. Our second objective was to develop a procedure to protect medical data in such a way that the outsourced analyst would be capable of doing analyses on protected data and the results would be comparable, if not the same, as if they had been done on the original data. Specifically, our hypothesis was there would not be a difference between the outsourced decision trees built on encrypted data and the ones built on original data. METHODS: Using formal definitions, we developed an algorithm to protect medical data for outsourced analyses. The algorithm was applied to publicly available datasets (N=30) from the medical and life sciences fields. The analyses were performed on the original and the protected datasets and the results of the analyses were compared. Bootstrapped paired t tests for 2 dependent samples were used to test whether the mean differences in size, number of leaves, and the accuracy of the original and the encrypted decision trees were significantly different. RESULTS: The decision trees built on encrypted data were virtually the same as those built on original data. Out of 30 datasets, 100% of the trees had identical accuracy. The size of a tree and the number of leaves was different only once (1/30, 3%, P=.19). CONCLUSIONS: The proposed algorithm encrypts a file with plain text medical data into an encrypted file with the data protected in such a way that external data analyses are still possible. The results show that the results of analyses on original and on protected data are identical or comparably similar. The approach addresses the privacy and confidentiality issues that arise with medical data and is adherent to strict legal rules in the United States and Europe regarding the processing of the medical data.

Off-shoring clinical research: exploitation and the reciprocity constraint.

The last 20 years have seen a staggering growth in the practice of off-shoring clinical research to low-and middle-income countries (LICs and MICs), a growth that has been matched by the neoliberal policies adopted by host countries towards attracting trials to their shores. A recurring concern in this context is the charge of exploitation, linked to various aspects of off-shoring. In this paper, I examine Alan Wertheimer's approach and offer an alternative view of understanding exploitation in this context. I will suggest that the justification for the enterprise of research is largely dependent on its integration within a health system from which participants regularly benefit and I argue that an attention to a principle of reciprocity will enable us to better recognize and address exploitation in international research.

India's growing participation in global clinical trials.

Lower operational costs, recent regulatory reforms and several logistic advantages make India an attractive destination for conducting clinical trials. Efforts for maintaining stringent ethical standards and the launch of Pharmacovigilance Program of India are expected to maximize the potential of the country for clinical research.

[Challenges in the organization of investigator initiated trials: in transplantation medicine]. / Herausforderungen in der Organisation "investigator initiated trials": Am Beispiel der Transplantationsmedizin.

INTRODUCTION: Transplantation medicine offers multiple translational questions which should preferably be transferred to clinical evidence. The current gold standard for testing such questions and hypotheses is by prospective randomized controlled trials (RCT). The trials should be performed independently from the medical industry to avoid conflicts of interests and to guarantee a strict scientific approach. A good model is an investigator initiated trial (IIT) in which academic institutions function as the sponsor and in which normally a scientific idea stands before marketing interests of a certain medical product. METHODS: We present a model for an IIT which is sponsored and coordinated by Regensburg University Hospital at 45 sites in 13 nations (SiLVER study), highlight special pitfalls of this study and offer alternatives to this approach. RESULTS: Finances: financial support in clinical trials can be obtained from the medical industry. Alternatively in Germany the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) offers annual grants. The expansion of financial support through foundations is desirable. Infrastructure: sponsorship within the pharmaceutics act (Arzneimittelgesetz) demands excellent infrastructural conditions and a professional team to accomplish clinical, logistic, regulatory, legal and ethical challenges in a RCT. If a large trial has sufficient financial support certain tasks can be outsourced and delegated to contract research organizations, coordinating centers for clinical trials or partners in the medical industry. CONCLUSIONS: Clinical scientific advances to improve evidence are an enormous challenge when performed as an IIT. However, academic sponsors can perform (international) IITs when certain rules are followed and should be defined as the gold standard when scientific findings have to be established clinically.

Ethical sourcing of dental instruments and materials.

There is evidence that dental instruments and materials are being manufactured in the developing world under poor labour conditions. It is suggested that the level of awareness of the dental team with regard to this is raised and that a culture of greater inquiry into the sourcing of instruments and materials is developed.

Fair shares: a preliminary framework and case analyzing the ethics of offshoring.

Much has been written about the offshoring phenomenon from an economic efficiency perspective. Most authors have attempted to measure the net economic effects of the strategy and many purport to show that "in the long run" that benefits will outweigh the costs. There is also a relatively large literature on implementation which describes the best way to manage the offshoring process. But what is the morality of offshoring? What is its "rightness" or "wrongness?" Little analysis of the ethics of offshoring has been completed thus far. This paper develops a preliminary framework for analyzing the ethics of offshoring and then applies this framework to basic case study of offshoring in the U.S. The paper following discusses the definition of offshoring; shifts to the basic philosophical grounding of the ethical concepts; develops a template for conducting an ethics analysis of offshoring; applies this template using basic data for offshoring in the United States; and conducts a preliminary ethical analysis of the phenomenon in that country, using a form of utilitarianism as an analytical baseline. The paper concludes with suggestions for further research.

Contracts to devolve health services in fragile states and developing countries: do ethics matter?

Fragile states and developing countries increasingly contract out health services to non-state providers (NSPs) (such as non-governmental organisations, voluntary sector and private sector). The paper identifies ethical issues when contracts involve devolution of health services to NSPs and proposes procedures to prevent or resolve these ethical dilemmas. Ethical issues were identified by examining processes of contracting out. Health needs could be used to select areas to be contracted out and to identify service needs. Health needs comprise "disease-burden-related needs", "health-service needs", and "urgency of health-service needs". The mix of services should include an analysis of cost-effectiveness. NSPs should be selected fairly, without bias, and conflicts of interest during their work must be avoided. The population's views must be respected and accountability structures established. Devolved health services should ensure equity of access to healthcare. The services ought to be sustainable and evaluated objectively. Of these issues, conflicts of interest among NSPs and sustainability of health services have not attracted attention in the literature on ethics of health policy. Fair procedures could address these ethical issues-for example, public consultation on issues; decisions based on the public consultation and made on evidence; principles of decisions stated and reasonable; decisions given adequate publicity; a mechanism established to challenge decisions; assurance that mechanisms meet the above conditions; and regular review of the policies. These procedures are complemented by improving self-governance of NSPs, countries' development of guidelines for devolving health services, and measures to educate the public of the client countries on these issues.

[Outsourcing of nursing human resources from ethical to management: a survey in a Lazio Region Hospital]. / Outsourcing delle risorse umane infermieristiche tra etica e managements: indagine in una azienda U.S.L. della Regione Lazio.

In 2006, 279 nurses of a Lazio Region Hospital were assessed to verify whether certain Human Resources decisions, such as outsourcing, can negatively influence their working motivation and sense of belonging to a health organization and whether any dissatisfaction can be attributed to poor ethical information within the health service. The research method had a descriptive basis and for data collection a questionnaire with 35 questions was issued. Results showed that nurses felt strongly involved in the study and interesting aspects for management of human resources emerged, depicting an organization lacking in motivation : this confirmed one of the aspects of the study : poor levels of motivation and sense of belonging can be correlated to insufficient ethical information in local health organizations. The main working needs that emerged among the nurses of this hospital regarded economical retribution (90%), security and success (88%) , belonging (86%) and self-satisfaction (77%): the need for power was relatively low (40%). The strong points of the study were : the strong involvement of nurses, the value of the information gathered regarding working motivation, sense of belong to a nursing organization , working needs , ethical information in health environments, organization according to targets. The limits of the study were: limited number of nurses in outsourcing at the time of the study (12%), impossibility of comparing the results with data prior to the outsourcing choices made by the hospital in question.

Clinical trials in India.

The concept of outsourcing for the development and global studies on new drugs has become widely accepted in the pharmaceutical industry due to its cost and uncertainty. India is going to be the most preferred location for contract pharma research and development due to its huge treatment naïve population, human resources, technical skills, adoption/amendment/implementation of rules/laws by regulatory authorities, and changing economic environment. But still 'miles to go' to fulfill the pre-requisites to ensure India's success. In spite of all the pitfalls, the country is ambitious and optimist to attract multinational pharmaceutical companies to conduct their clinical trials in India.