This survey has been designed as a multinationalcollaboration to collect data from several countries focusing ondeveloping countries. The main purpose was to elaborate thefunctions of ethics committees regarding externally-sponsoredresearch . In March 2004 a total of 89 open-endedquestionnaires were sent to ethics review committees inmedical schools, medical research institutes and hospitalsaffiliated to the public and private medical universities inJapan.Twenty two ECs replied , and among them five ECshad reviewed eleven ESR proposals in 2002-3. Five of thoseESR proposals have been (...) approved and four proposals havebeen approved after some revisions. Two proposals weredeferred but not resumed. In their review, respondents weremore concerned about “individual consent” than “communityconsent”. Post-trial access to effective interventions was not areal concern. As for “Standard of care”, seven ECs replied thatthey review the ESR proposal based on the internationalstandards and four based on the local standards. WhetherESR proposal is matched with the national health prioritieswas not a great concern. Respondents expressed theirconcern about socio-cultural issues.Ethics in research especially dealing with externallysponsoredresearch is a relatively new subject and underdevelopment in Japan. Although Japan is not a developingcountry, in order to protect individual human subjects and localcommunity, capacity building in ethics review especially inresearch collaboration with other developed and developingcountries is crucial and it has to be included in ethics inresearch programs through out the country. (shrink)

In his paper entitled “Ethics and the Funding of Research and Development at Universities”1 Spier examines some of the potential problems of the relationship between 1) corporate sponsors of research and 2) the universities (and faculty) that receive that funding. Citing “He who pays the piper, calls the tune,” Spier suggests that a better way of funding research would be to “set up a dedicated publicly sponsored research establishment” with the stated goal of achieving particular (...) technical or engineering objectives. (Spier cited the successful Animal Virus Research of the UK as an example). Spier states that researchers at these establishments are “not subjected to the triple requirement to teach, research and administer as are university members, so they do not have to face the same ethical challenges of the academics.” This paper will examine the stated dangers of public/corporate research partnerships and whether the proposed alternative shares equally troubling ethical issues. (shrink)

Simple type theory is a higher-order predicate logic for reasoning about truth values, individuals, and simply typed total functions. We present in this paper a version of simple type theory, called PF*, in which functions may be partial and types may have subtypes. We define both a Henkin-style general models semantics and an axiomatic system for PF*, and we prove that the axiomatic system is complete with respect to the general models semantics. We also define a notion of an interpretation (...) of one PF* theory in another. PF* is intended as a foundation for mechanized mathematics. It is the basis for the logic of , an Interactive Mathematical Proof System developed at The MITRE Corporation. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Fallout from Government-Sponsored Radiation ResearchCarol Mason Spicer (bio)On December 28, 1993, Energy Secretary Hazel R. O'Leary publicly appealed to both the executive and legislative branches of the United States Government to consider compensation for individuals who were harmed by their exposure to ionizing radiation while enrolled in government-sponsored studies conducted between 1940 and the early 1970s.1 The call for compensation was issued three weeks after Secretary O'Leary (...) disclosed that radiation experiments involving humans, sometimes without their consent, had occurred under the auspices of the Atomic Energy Commission (AEC), a forerunner of the Department of Energy (DOE). Secretary O'Leary directed her department to investigate the nature and extent of the experiments, report on their medical and ethical acceptability, and locate the research subjects or their families.Background to the Federal Advisory CommitteeDespite the fact that the existence of many government-sponsored radiation experiments was not a secret—much of the research was reported at the time in scientific journals, and in 1986, Representative Edward J. Markey (D-MA) conducted congressional hearings on such radiation research—Secretary O'Leary's disclosure of the AEC experiments and her call for compensation made the experiments common knowledge and sparked a swift and complex governmental response involving both the executive and legislative branches.It is curious that the "radiation experiments" have garnered so much attention now, since they were virtually ignored in the wake of the 1986 hearings. Secretary O'Leary's disclosure of the radiation studies grew out of a general reassessment of secrecy in government. In April 1993, the Clinton administration set out to review the system of government secrecy that evolved during the Cold War, and in May 1993, DOE began reviewing and declassifying files pertaining to nuclear weapons research. When Dan Reicher, a top aide to Secretary O'Leary, informed her in November of the impending publication of an Albuquerque Tribune investigative report (Welsome 1993) on an experiment conducted between 1945 and 1947 in which 18 subjects were injected with plutonium, [End Page 147] the topic of questionable research involving the exposure of human subjects to radiation was added to the DOE list of information to be disclosed. At the time, it was thought to be but one small part of a massive quantity of DOE information to be made public.As part of its effort to investigate the radiation experiments, DOE established a toll-free telephone hot line for individuals who thought they might have been the subjects of radiation exposure experiments. The hot line, originally staffed by three people to handle the anticipated few dozen calls per day, received more than 2,000 calls in the first week. By early January the hot line was flooded with 6,000 to 10,000 calls daily, and its staff had increased more than ten-fold. Although many of the calls were deemed not to be candidates for further investigation, the extent of the radiation-related experiments, sponsored not only by AEC, but also by the military and other government departments and agencies, took officials by surprise.On December 30, the Department of Defense, the Department of Veterans Affairs, and the National Aeronautics and Space Administration all announced that they were initiating thorough reviews of their files to determine the extent and nature of any radiation experiments conducted under their auspices.2 In January, the CIA and the Department of Health and Human Services, including the National Institutes of Health, followed suit.The White House publicly entered the arena in late December announcing that it would hold a meeting on January 3, 1994, to help coordinate the government's investigative effort. At the same time, Senator Edward M. Kennedy (D-MA) called for a mid-January congressional hearing to investigate experiments conducted between 1946 and 1956 in which mentally retarded boys at the Fernald State School in Massachusetts were fed radioactive iron supplements or milk containing radioactive calcium to enable researchers to trace the absorption of those nutrients. Senator Kennedy's hearing, conducted by the Subcommittee on Health of the Senate Committee on Labor and Human Resources, was the first of a number of congressional hearings held earlier this year to investigate the... (shrink)

Private industry funds more than half of all medical research in the United States. While industry involvement in research has benefits, it can also create conflicts of interest. The most common policies adopted to address conflict of interest in medical research are focused primarily on the ways in which industry sponsorship may undermine a clinician’s judgment regarding patient care. Insufficient attention has been given to the ways in which industry sponsorship may undermine judgment relative to the goal (...) of scientific integrity in research. The most common conflict of interest policies do not adequately address this problem. Disclosure policies alone will not remove or ameliorate all conflicts. Further, severing or monitoring ties between clinicians and industries will not adequately address the problem, since in many cases it is not the clinicians who are making the relevant research judgments. In order to address the problem of conflict of interest inindustry-sponsored research, fundamental changes in strategy and practice must be adopted which either remove the power to make research decisions from industry employees, or increase the review of those decisions by independent investigators. (shrink)

Background:Data representing people’s behaviour, attitudes, feelings and relationships are increasingly being harvested from social media platforms and re-used for research purposes. This can be ethically problematic, even where such data exist in the public domain. We set out to explore how the academic community is addressing these challenges by analysing a national corpus of research ethics guidelines and published studies in one interdisciplinary research area.Methods:Ethics guidelines published by Research Councils UK, its seven-member councils and guidelines cited (...) within these were reviewed. Guidelines referring to social media were classified according to published typologies of social media research uses and ethical considerations for social media mining. Using health research as an exemplar, PubMed was searched to identify studies using social media data, which were assessed according to their coverage of ethical considerations and guidelines.Results:Of the 13 guidelines published or recom... (shrink)

Globalization, political upheavals, and Western economic struggles have caused a geographical reprioritization in the realm of drug development and human clinical research. Regulatory and cost hurdles as well as a saturation of research sites and subjects in Western countries have forced the pharmaceutical industry to place an unprecedented level of importance on emerging markets, injecting Western corporate initiatives into cultures historically and socially isolated from Western-centric value systems. One of the greatest recipients of this onslaught of Western business (...) and research practices is the Russian Federation. Namely, market forces are dictating a focused research initiative in the traditional emerging markets, but this focus may be at the expense of individual and societal dignity. (shrink)

In this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 for paroxetine pediatric use was negative for efficacy and positive for harm. Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential. Despite the role of named authors in revisions of the manuscript, the sponsor company remained in control of the message.

A volume of studies in natural language semantics which brings together work by philosophers, logicians and linguists. The main topics treated are: quantification and reference in natural language; the relations between formal logic, programming languages and natural language; pragmatics and discourse meaning; surface syntax and logical meaning. The volume derives from a colloquium organised in 1973 by the Kings College Research Centre, Cambridge and the papers have been edited for publication by Professor Keenan. It is hoped that the collection (...) will make available some of the best work in this fast-moving field and will stimulate further progress by juxtaposing the different approaches and interests represented here. (shrink)

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. (shrink)

The present research is the first part of econometric study of the so called sponsored goods and looks at one of the most common types of such goods namely art products created by theaters, concert organizations and museums. The aim of the paper is to analyse the performance of Russian art organizations to find out to what extend the conditions of their functioning in post Soviet times under the development of market economy, democratization of leisure and changes in (...) consumer preferences influence their economic results. Could Russian theaters, museums and concert organizations be self- sufficient in market economy established in Russian in 1991-2010?The set up task determined the object of the study and the statistical data to be used-40 years time series performance indicators that include equal time intervals-1971-1990 for performing arts organizations and 1991-2010-for theaters, concert organizations and museums. The specifics of calculations presented in the article result from the very approach to the testing of cost disease. Its essence is to reveal the symptoms of this disease in art organizations taken as an element of economy as a whole rather than only as a part of cultural activities. Accordingly a new method of diagnostics of the cost disease is suggested that is based on development of specific indexes measuring the lag of labor productivity, advancing dynamics of wages and priority growth in prices for tickets in relation to the corresponding indexes of macroeconomic dynamics as well as determination of cost disease consequences-the deficit of income of providers of cultural goods. The implementation of such an approach allowed to construct three-dimensional space which coordinates describe the dynamics of performance results of art organizations. (shrink)

Mit Beitragen von: Wolfgang U. Eckart, Christian Bonah, Wolfgang U. Eckart / Andreas Reuland, Alexander Neumann, Peter Steinkamp, Volker Roelcke, Anne ...

Contributed research papers presented in UGC sponsored National Seminar on "God and the Universe: Religious and Scientific Approaches" organized by the Department of Sanskrit, Mugberia Gangadhar Mahavidyalaya, Purba Medinipur, West Bengal on 22nd and 23rd November, 2016.

Projects may exist in many forms, depending on the purpose and organisational context. Irrespective of the type and nature, however, the effective management of any project requires a high degree of commitment by the project members to the accomplishment of project objectives. The high degree of reliance on external international funding makes project management in non-profit organisations of developing societies a challenging task. The marriage of two entirely different sets of values and philosophical orientations creates an invisible tensile force, impacting (...) the different stages of the project life cycle. The present paper, which is exploratory in nature, broadly aims to study the impact of sponsors’ values on the different project-management activities, including both the planning and the implementation stages of the project. The research involves conceptualisation of the different significant issues in effective project management. The analysis of the identified issues is first made on the basis of the experience of the selected stakeholders in Tanzanian non-profit organisations. The analysis is further linked to the selected context-specific contemporary philosophical thoughts affecting the socio-cultural values in the region. The analysis shows that the variation in the values of project owners and stakeholders is one of the major challenges in the effective implementation of a project in the given context. The study is novel in its approach and raises some fundamental issues arising due to the different philosophical orientations and value-sets of the different partner-project organisations. It is expected that the study will stimulate further academic debate on the broader theme of ‘values, philosophy and project management’. The study is also likely to contribute to knowledge development in the subject area of management in general and practical management philosophy in particular. (shrink)

Regulating clinical trials for testing new drugs is fraught with risk. Misregulation can slow development of innovative and useful new drugs, but in other ways misregulation can foster trials that are inefficient and unethical, driven by commercial rather than scientific ends, and that can harm patients. In this paper, we argue not for more but for better regulation, based on the goal of rapidly producing innovative and safe products that represent significant advances in medical care. Data on industry-funded, late-stage clinical (...) trials demonstrate an urgent need for dramatic changes in how these trials are designed, conducted, and analyzed. On the one hand, current patent rules can dissuade development of innovative new products with smaller markets and press trial designers to create positive results too rapidly. But at the same time, numerous studies show that when the pharmaceutical industry sponsors clinical trials, the results are systematically biased in favor of the sponsor's product, often to the detriment of patients and the public. The reasons for this bias are both complex and unavoidable, and the ways in which clinical trial design, conduct, and reporting can be inappropriately influenced are so varied and nuanced, that efforts to manage this conflict of interest and prevent harms are inevitably unsuccessful. Instead, we conclude such conflict should be avoided and a strong firewall should exist between drug developers and the final stages of clinical testing in humans. All financial support for phase III clinical trials should pass through a public-private partnership organization — perhaps tied to a broader clinical effectiveness research enterprise — which would be charged with designing, funding, and monitoring late-stage human clinical trials of new pharmaceutical products. (shrink)

Research suggests that interventions involving extensive training or counterconditioning can reduce implicit prejudice and stereotyping, and even susceptibility to stereotype threat. This research is widely cited as providing an “existence proof” that certain entrenched social attitudes are capable of change, but is summarily dismissed—by philosophers, psychologists, and activists alike—as lacking direct, practical import for the broader struggle against prejudice, discrimination, and inequality. Criticisms of these “debiasing” procedures fall into three categories: concerns about empirical efficacy, about practical feasibility, and (...) about the failure to appreciate the underlying structural-institutional nature of discrimination. I reply to these criticisms of debiasing, and argue that a comprehensive strategy for combating prejudice and discrimination should include a central role for training our biases away. (shrink)

Government-sponsored enterprises (GSEs) and quasi-autonomous non-governmental organizations (quangos) comprise a powerful organizational sector that has been criticized for its lack of accountability to governments and their citizens. These organizations are established to serve the public as a whole by targeting the needs of particular groups or fulfilling specific functions. Often they use practices adopted from the business sector, and sometimes they enter the marketplace as profitmaking enterprises. In light of the contribution of GSE Fannie Mae to the 2008 world (...) economic crisis, the impact of this sector on effective democratic government bears further examination. In this article, I present a systems model that suggests how researchers might comprehensively assess the accountability of organizations in this sector, here termed the "gray sector," with respect to their government missions. I focus on four systems dimensions: mission, organizational design, organizational outcomes, and the information feedback process. Organizational design and the nature of the sector population are cited as emerging issues of particular importance. (shrink)

Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear.METHODS: I conducted in-depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%).RESULTS: US (...) IRBs face ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long-standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and ‘negotiate’ for maximum benefits for participants and fearing ‘worst-case scenarios’.CONCLUSIONS: US and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice. (shrink)

Individual and institutional conflict of interests in biomedical research have becomes matters of increasing concern in recent years. In the United States, the growth in relationships — sponsored research agreements, consultancies, memberships on boards, licensing agreements, and equity ownership — between for-profit corporations and research universities and their scientists has made the problem of conflicts, particularly financial conflicts, more acute. Conflicts can interfere with or compromise important principles and obligations of researchers and their institutions, e.g., adherence (...) to accepted research norms, duty of care to patients, and open exchange of information. Disclosure is a key component of a successful conflict policy. Commitments which conflict with a faculty member's primary obligations to teaching, research, administrative responsibilities, or patient care also need attention. Institutional conflict of interests present different problems, some of which are discussed in an analysis of an actual problem posed by two proposed clinical trials. (shrink)

The article deals with trust in applied social science research in the light of applied researchers’ increased dependence on project funding. Taking Norway as a case study it shows how the societal organization of research funding has implications for scientific freedom and ultimately for the confidence we have in research. The article gives an account of various ways the sponsors can influence on applied social science research and discusses the legitimacy of different limitations on scientific freedom. (...) The article concludes with proposals for how the challenges to scientific freedom posed by the research funding framework can be addressed structurally, as well as on the level of the research community. (shrink)

Asia is the most diverse continent in the world in terms of culture, religion, population size, finance, education, health care, academic research, general population skills, and governmental drug regulations. Each Asian country has its own unique qualities when it comes to attracting industry sponsored clinical trials. Factors that influence selecting location of a study site for a sponsored trial are mainly population size, infrastructure, education levels, and quality of health care, cost and drug regulatory platform. Conducting (...) class='Hi'>research in traditional countries like Pakistan adds another dimension to the problems in assuring that research conducted in an ethical manner. The indigenous layer of the cultural values makes it even more difficult task, but this is the task that we are morally and ethically bound to shoulder. (shrink)

The treatment of the control group in externally sponsored clinical trials is the issue of one of the most heated debates in international research ethics. The paradigmatic cases are the mother-to-child HIV-transmission trials that took place in 16 developing countries in 1997, where the control group received a placebo while proven treatment was available in industrialized countries. From this circumstance results the controversy as to whether the sponsor and researchers of externally sponsored trials have to supply a (...) treatment that is usually not available in the host country. From the beginning of the debate the controversial level of treatment has been called “standard of care”. However, besides the disagreement about the quality of the care that has to be supplied, there is as yet no widely accepted clear meaning of this concept. This article examines the fundamental ambiguity of the term and its formal function as an ethical criterion including suggestions on its further use. (shrink)

The Common Rule creates a division of moral labor in research. It implies that investigators and sponsors can outsource their ethical obligations to IRBs and participants, thereby fostering a culture of compliance, rather than one of responsibility. The proposed revisions to the Common Rule are likely to exacerbate this problem. To harness the expressive power of the law, I propose the Common Rule be revised to include the ethical responsibilities of investigators and sponsors.

Imagine a study in which HIV-infected pregnant women are given antiretroviral treatment to determine how effectively it will prevent HIV transmission during childbirth. Each mother’s involvement in this study ends with the birth of her child, at which time her access to antiretrovirals provided by the study also ceases. At the outset of the study, the investigator and sponsor agree that after the child’s birth, they will refer mothers who require treatment for their HIV to a national program that provides (...) antiretroviral treatment and care. Assuming the Institutional Review Board raises no objections to this plan, should the research team consider their ethical obligations to participants fulfilled? If the investigator and sponsor were to consult the Common Rule, they would find little to suggest that there are any further ethical issues to address. (shrink)

This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects (...) that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust. (shrink)

The aim of the present paper is to show that the fundamental transformation of Russian society that had been realized by the Soviet government since the early twenties included not only the reforms of scientific institutions or the creation of a new educational system but also a radical reevaluation of the social role of the expert knowledge. It proposes a transversal analysis of the institutional history of the Soviet science and its complex relations with the state apparatus in order to (...) show that the research policy of the twenties should be considered not only as an attempt to stimulate a “catch up growth,” but rather as an anticipation of some essential problems discussed in the contemporary social epistemology. The early Soviet government had a very particular vision of “social engineering” that was both utopian and extremely pragmatic. The Soviet Union was considered as the first truly “scientific state,” based on the idea that the historical development could be accelerated due to a party lead popular mobilization. The result of this conviction was the policy of “state-sponsored evolutionism” that created a high demand for the experts in all fields of knowledge. First, it focuses on the dualism of scientific institutions in the twenties when the “old” Academy of Sciences composed of the scientists formed under the Old Regime was disputing the role of the leading research institution with the newly created Communist Academy. This period could be described as the era of “New Scientific Policy” or some kind of “primitive accumulation” of the expert knowledge. Later it explores another dualism that existed since the creation of the Soviet Union: it consisted of the opposition between two rival projects of state building. The first one was promoted by State Planning Committee and made an emphasis on the administrative division based on economical basis, the second one was a project of People’s Commissariat of Nationalities, that proposed a creation of multiple soviet “national states” based on the principle of self-determination. Both projects required a large amount of data in various fields of knowledge and promoted a creation of new research institutions and favored the pioneering study in both central economy planning and social engineering. The aim of this article is to place the soviet experience in the comparative perspective, claiming that the communist modernization should be analyzed in the context of elaboration, in Foucault’s terms, of new “governmental technologies” which are supposed to be the products of new research institutions directly or indirectly influenced by a modern state. (shrink)

Research projects sponsored by rich countries or companies and carried out in developing countries are often described as exploitative. One important debate about the prevention of exploitation in research centres on whether and how clinical research in developing countries should be responsive to local health problems. This paper analyses the responsiveness debate and draws out more general lessons for how policy makers can prevent exploitation in various research contexts. There are two independent ways to do (...) this in the face of entrenched power differences: to impose restrictions on the content of benefit-sharing arrangements, and to institute independent effective oversight. Which method should be chosen is highly dependent on context. (shrink)

: Widespread collection and use of identifiable information can promote social goods while, at the same time, infringing on personal privacy. Information systems are developing within the context of a fundamental transformation in the organization, delivery, and financing of health care. Changes in the health care system include rapid development of employer-sponsored health coverage, managed care organizations, and integrated delivery systems. These complex, multifaceted arrangements for delivering and paying for health care require ever-more-sophisticated information systems that facilitate extensive sharing (...) of personal data. Systemic flows of sensitive health information occur both vertically and horizontally among employers, hospitals, insurers, laboratories, and suppliers. Beyond this complex web of vertical and horizontal sharing are the multiple demands for information management, quality assurance, research, governmental regulation, and public health. Theoretical problems exist with the law and ethics of informational privacy. The traditional method of exercising control over personal health information is through informed consent. Informed consent, however, within a modern health information infrastructure becomes highly complex. In this kind of environment, the doctrine of informed consent is flawed and does not provide sufficient control over personal information to assure adequate protection of privacy. (shrink)

This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help ensure that (...) scarce resources such as tissue samples or limited subject popula- tions are employed where they do the most good; can support parallel efforts by providers and insurers to promote cost-effectiveness; and can ensure that research has social value and benefits subjects. I discuss and rebut potential objections to the consideration of cost-effectiveness in research, including the difficulty of predicting effectiveness and cost at the research stage, concerns about limitations in cost-effectiveness analysis, and worries about overly limiting researchers’ freedom. I then consider the advantages and disadvantages of having certain participants in the research enterprise, including IRBs, advisory committees, sponsors, investigators, and subjects, consider cost-effectiveness. The project concludes by qualifiedly endorsing the consideration of cost-effectiveness at the research stage. While incorporating cost-effectiveness considerations into the ethical evaluation of human subjects research will not on its own ensure that the health care system realizes cost-effectiveness goals, doing so nonetheless represents an important part of a broader effort to control rising medical costs. (shrink)

Background HIV prevention research has been fraught with ethical concerns since its inception. These concerns were highlighted during HIV vaccine research and have been elaborated in microbicide research. A host of unique ethical concerns pervade the microbicide research process from trial design to post-trial microbicide availability. Given the urgency of research and development in the face of the devastating HIV pandemic, these ethical concerns represent an enormous challenge for investigators, sponsors and Research Ethics Committees (...) (RECs) both locally and internationally. Discussion Ethical concerns relating to safety in microbicide research are a major international concern. However, in the urgency to develop a medically efficacious microbicide, some of these concerns may not have been anticipated. In the risk-benefit assessment of research protocols, both medical and psycho-social risk must be considered. In this paper four main areas that have a potential for medical and/or psycho-social harm are examined. Male partner involvement is controversial in the setting of covert use of microbicides. However, given the long-term exposure of men to experimental products, this may be methodologically, ethically and legally important. Covert use of microbicides may impact negatively on relationship dynamics leading to psychosocial harm to varying extents. The unexpectedly high rates of pregnancy during clinical trials raise important methodological and ethical concerns. Enrollment of adolescents without parental consent generates ethical and legal concerns that must be carefully considered by RECs and trial sites. Finally, paradoxical outcomes in recent trials internationally have advanced the debate on the nature of informed consent and responsibility of researchers to participants who become HIV positive during or after trials. Summary Phase 3 microbicide trials are an undisputed research and ethical priority in developing countries. However, such trials must be conducted with attention to both methodological and ethical detail. It is imperative that guidelines are formulated to ensure that high ethical standards are maintained despite the scientific urgency of microbicide development. Given the controversy raised by emergent ethical issues during the course of microbicide development, it is important that international consensus is reached amongst the various ethics and regulatory agencies in developing and developed countries alike. (shrink)

This paper explores the legal and ethical concept of human subject research in order to determine whether genetic research with already available biosamples and data falls within this concept. Although the ethical concept seems to have evolved to recognize research based on data as human research, from a supranational legal perspective this form of research is not considered human subject research. Thus human subject research regulations do not apply and therefore do not invoke (...) the requirement of obtaining consent prior to using an individual’s biosample or genetic data in research. Furthermore, it remains ambiguous in both the legal and ethical realm whether the use of biosamples or genetic data without additional links to the individual would invoke the same safeguards as research involving additional or specific identifiers. Seeing that research based on already available biosamples and genetic data is not governed by rules concerning human subject research, the second part of the paper analyses whether any consent requirements apply for the further use of already available bio‐samples or genetic data in research. Whereas further use of biosamples is subject to considerably lax consent requirements under Article 22 of the Oviedo Convention, under the General Data Protection Regulation further use of genetic data might not be subject to a prior consent requirement at all, unless it is stipulated in national laws. When it comes to clinical trials, however, sponsors will have the possibility under Article 28(2) of Regulation 536/2014 to obtain open consent for further use of data in any kind of future research. (shrink)

Discussions on the ethics and regulation of clinical research have a great deal to say about the responsibilities of investigators, sponsors, research institutions and institutional review boards, but very little about the responsibilities of research participants. In this article, we discuss the responsibilities of participants in clinical research. We argue that competent adult participants are responsible for complying with study requirements and fulfilling other obligations they undertake when they make an informed choice to enrol in a (...) study. These responsibilities are based on duties related to promise-keeping, avoiding harm to one's self or others, beneficence and reciprocity. Investigators and research staff should inform participants about their responsibilities during the consent process, and should stress the importance of fulfilling study requirements. They should address any impediments to compliance, and they may provide participants with financial incentives for meeting study requirements. In very rare cases, coercive measures may be justified to prevent immanent harm to others resulting from non-compliance with study requirements. (shrink)

This work resulted from a conference held in 2003 that was jointly sponsored by the Rockefeller Archive Center and Quinnipiac University. Drawing upon perspectives from history, philosophy, and the social sciences, as well as public health and medicine, the authors in this volume examine and critique the role of Foundations, most prominently the Rockefeller Foundation, in promoting and expanding the development of Western medicine around the world during the 20th century. The first half of the book examines the historical (...) involvement of philanthropic foundations in public heath, basic medical research, and related social and political issues. These studies range from an examination of the Rockefeller's Foundation's anti-malaria campaigns to the involvement of Foundations in promoting eugenic ideology and population control. The second half of the book considers current situations in which philanthropic foundations are active in promoting public health and westernized medicine, including consideration of the fight against AIDS in Africa, the resurgence of tuberculosis as a major public health threat, and the ongoing war against malaria. Finally, the book concludes with thoughts on the future of health, disease, and public health by Peter C. Goldmark, Jr., a former president of the Rockefeller Foundation. By considering issues of public health and health policy from a wide range of perspectives, this book seeks to contribute both to our understanding of the past successes and failures of growing dominance of Westernized medicine over global health, and to consider present and future possibilities for improving the delivery of health services to the population of the world. (shrink)

In their paper “Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better” Petrova and Barclay highlight concerns with the health research regulatory environment in the UK. As long-standing chairs of NHS research ethics committees, researchers, and also academics in research ethics, we are also often frustrated with the regulatory process in the UK. However, we think that Petrova and Barclay’s analysis is misleading because it (...) conflates research ethics with governance and funding processes, thus failing to adequately distinguish between the national coordinating function of the Health Research Authority, local research governance processes, and interactions with research sponsors and/or the Clinical Research Network. (shrink)