Two decades ago, in 1994, in the context of the 4th EU Framework Programme, ELSA was introduced as a label for developing and funding research into the ethical, legal and social aspects of emerging sciences and technologies. Currently, particularly in the context of EU funding initiatives such as Horizon2020, a new label has been forged, namely Responsible Research and Innovation. What is implied in this metonymy, this semantic shift? What is so new about RRI in comparison to ELSA? First of (...) all, for both labels, the signifier was introduced in a top-down manner, well before the concept that was signified by it had acquired a clear and stable profile. In other words, the signifier preceded the research strategies actually covered by these labels. Moreover, the newness of RRI does not reside in its interactive and anticipatory orientation, as is suggested by authors who introduced the term, but rather in its emphases on social-economic impacts. (shrink)

A number of schemes have been attempted, both in public health and more generally within social programmes, to pay individuals to behave in ways that are presumed to be good for them or to have other beneficial effects. Such schemes are normally regarded as providing a financial incentive for individuals in order to outweigh contrary motivation. Such schemes have been attacked on the basis that they can ‘crowd out’ intrinsic motivation, as well as on the grounds that they are in (...) some sense ‘corrupt’. In response, they have been defended on the grounds that they can ‘crowd in’ improved motivation. I will argue that these debates have tended to overlook the difficulties individuals can have when attempting to behave against peer group norms. In some cases, financial payments can allow individuals to defend their actions on the grounds that ‘I am only doing it for the money’ in circumstances when it would be difficult to defend their action on their real motivations. Examples of paying children to read books, and paying women to give up smoking in pregnancy, will be discussed. (shrink)

Smoking is disproportionately common among the disadvantaged, both within many countries and globally; the burden associated with smoking is, therefore, borne to a great extent by the disadvantaged. In this paper, I argue that this should be regarded as a problem of social justice. Even though smokers do, in a sense, ‘choose’ to smoke, the extent to which these choices can legitimise the resulting inequalities is limited by the unequal circumstances in which they are made. An analysis of the empirical (...) literature reveals a variety of factors—such as targeted advertising, unequal dissemination of information about the health risks of smoking and inequalities in smoking norms—that make the disadvantaged more likely to become smokers and less likely to quit successfully. The paper then considers a range of common tobacco control policies from the perspective of social justice. The social justice perspective developed here poses a challenge for policy-makers: on the one hand, social justice concerns strengthen the case for tobacco control policies because such policies disproportionately benefit the health of the disadvantaged. At the same time, however, we must be particularly sensitive to any harms associated with such policies because such burdens, too, will fall largely on the disadvantaged. (shrink)

For over 100 years, the field of contemporary public health has existed to improve the health of communities and populations. As public health practitioners conduct their work – be it focused on preventing transmission of infectious diseases, or prevention of injury, or prevention of and cures for chronic conditions – ethical dimensions arise. Borrowing heavily from the ethical tools developed for research ethics and bioethics, the nascent field of public health ethics soon began to feel the limits of the clinical (...) model and began creating different frameworks to guide its ethical challenges. Several public health ethics frameworks have been introduced since the late 1990s, ranging from extensions of principle-based models to human rights and social justice perspectives to those based on political philosophy. None has coalesced as the framework of choice in the discipline of public health. This paper examines several of the most-known frameworks of public health ethics for their common theoretical underpinnings and values, and suggests next steps toward the formulation of a single framework. (shrink)

Within international development [1], public health [2], and clinical medicine [3]–[5], there is increasing interest in determining whether cash payments or other economic incentives can be used to influence the choices and behavior of individuals and groups in order to promote desired health goals. However, a number of complex issues affect the review and approval by research ethics committees of research studying the effectiveness of using financial incentives to promote desired health goals. Current ethical and regulatory frameworks regard the provision (...) of gifts or cash payments to participants in human research as potentially problematic. Specifically, these frameworks imply that such incentives may undermine the autonomy of participant choice, hinder the disclosure of medical information, exacerbate social inequalities, or result in the exploitation or degradation of vulnerable populations [6]–[9]. Typically, these frameworks provide guidance about payment to research participants to reimburse expenses, to compensate for time and effort, to provide insurance coverage, or as an incentive to participate in the research itself. However, the issue of payment as a component of the research intervention is relatively new. RECs thus lack explicit guidance about ethical issues surrounding research that evaluates the use of financial incentives as an intervention to promote health. (shrink)

In the article by Kristin Voigt in the April 2013 issue of Cambridge Quarterly of Healthcare Ethics, quotation marks around certain phrases were deleted.

Given that health systems research involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical areas we discuss include the (...) nature of intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, inclusion of vulnerable groups, and benefits of research. HSR involving human participants is necessary to ensure health systems strengthening and quality of care and to guide public policy intelligently. Health systems researchers must carefully define their intent and goals and openly clarify the values that may influence the premises and design of protocols. As new types of population-level research activities become more commonplace, it is critical that institutional review board and research ethics committee review processes evolve to evaluate these research protocols in ways that address the nuanced features of these studies. (shrink)

Scholarship focusing on how international research can contribute to justice in global health has primarily explored requirements for the conduct of clinical trials. Yet health systems research in low- and middle-income countries has increasingly been identified as vital to the reduction of health disparities between and within countries. This paper expands an existing ethical framework based on the health capability paradigm – research for health justice – to externally-funded health systems research in LMICs. It argues that a specific form of (...) health systems research in LMICs is required if the enterprise is to advance global health equity. “Research for health justice” requirements for priority setting, research capacity strengthening, and post-study benefits in health systems research are derived in light of the field's distinctive characteristics. Specific obligations are established for external research actors, including governments, funders, sponsors, and investigators. How these framework requirements differ from those for international clinical research is discussed. (shrink)

The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary – whether on grounds of primary purpose, temporality, underlying (...) legal authority, departure from usual practice, or direct benefits to participants – have been unsatisfactory. (shrink)

There is no cure or vaccine for HIV/AIDS. The only life-prolonging treatment available is antiretroviral (ARV) therapy. WHO estimates, however, that less than 5 percent of those who require treatment in developing countries currently enjoy access to these medicines. In Africa fewer than 50,000 people–less than 2 percent of the people in need–currently receive ARV therapy. These facts have elicited strongly divergent reactions, and views about the appropriate response to this crisis have varied widely.The intensity of the debate concerning access (...) to life-prolonging medicines for the treatment of HIV/AIDS, and the heated rhetoric with which they are often conducted, suggest that these disagreements may be rooted in deeper disagreements of value. It is not obvious, however, what disagreements of value are at stake in this debate. By analyzing the statements of scholars, public officials, activist organizations, and private sector representatives, each of whom may endorse very different policy recommendations on access to HIV/AIDS drugs, we have identified and created a typology of the different sources of disagreement in the debate. We conclude that the central disagreements concerning access to medicines arise from competing understandings of how responsibilities for bringing remedy to hardships should be allocated to different agents and institutions. A central lesson that emerges from our analysis is that thinking about “health equity” must extend beyond the explanation and justification of goals, values, and ideals, and engage more honestly with the difficult question of how responsibilities for bringing remedy to health crises should be allocated in complex social contexts. (shrink)

As Kenneth Pimple points out, scientists’ responsibilities to the larger society have received less attention than ethical issues internal to the practice of science. Yet scientists and specialists who study science have begun to provide analyses of the foundations and scope of scientsts’ responsibilities to society. An account of contributions from Kristen Shrader-Frechette, Melanie Leitner, Ullica Segerstråle, John Ahearne, Helen Longino, and Carl Cranor offers work on scientists’ social responsibilities upon which to build.

Book reviewed in this article: The Needs of Strangers. By Michael Ignatieff. The Health Economy. By Victor Fuchs. Just Health Care. By Norman Daniels.

Incentive programs have been criticized due to concerns that extrinsic rewards can ‘crowd out’ intrinsic motivation, and also that such programs might exert a corrupting influence on those receiving the incentive. Jonathan Wolff has argued that while these worries are in some instances well grounded, incentives can also operate by liberating people from social pressures that stand in the way of their intrinsic motivations. We further develop Wolff's insight by articulating a framework for assessing such incentives and discussing several areas (...) of public health where incentives may play a positive role. In so doing, we describe the limitations of Wolff's thesis as well as the opportunities it presents. Finally, we suggest that there is an additional attractive feature of incentives that has been overlooked, which is their capacity to serve as ‘conversation makers’. By providing people an occasion to discuss reasons for and against various health behaviors, incentives have the potential not only to impact the health behavior of individuals but to affect cultural change at the population level. (shrink)

Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from (...) considering them in their decisions. Yet IRBs often do consider the social implications of research protocols and sometimes create significant delays in initiating or even prevent such research. The social implications of research are important topics for public scrutiny and professional discussion. This article examines the reasons that the federal regulations preclude IRBs from assessing the social risks of research, and examines alternative approaches that have been used with varying success by national advisory groups to provide such guidance. The article concludes with recommendations for characteristics of a national advisory group that could successfully fulfill this need, including sustainability, independence, diverse and relevant expertise, and public transparency. (shrink)