Benefit sharing in health research has been the focus of international debates for many years, particularly in developing countries. Whilst increasing attention is being given to frameworks that can guide researchers to determine levels of benefits to participants, there is little empirical research from developing countries on the practical application of these frameworks, including in situations of extreme poverty and vulnerability. In addition, the voices of those who often negotiate and face issues related to benefits in practice - frontline researchers (...) and fieldworkers - are rarely included in these debates. Against this background, this paper reports on experiences of negotiating research participation and benefits as described by fieldworkers, research participants and researchers in two community based studies. (shrink)

Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of research ethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposed research, and secondly, to ensure that participants give informed consent. The extent to which the role of the (...) REC includes the former is not uncontroversial. Indeed, the most prevalent debate on the role of RECs sees liberals and strong paternalists arguing over the importance of informed consent given by competent agents versus the significance of making benevolent decisions on behalf of others. On the one hand, liberals argue for the rights of competent adults to decide for themselves the kinds and extents of risks to which they wish to expose themselves. On the other hand, proponents of strong paternalism raise concerns about the likelihood of participants being able to truly understand the complex data involved in research. They support a role for RECs in which they exercise duties of benevolence towards patients and participants by limiting the extent to which they can be exposed to significant, permanent and irreversible harms. In this paper, we will argue that when it comes to decisions about risk it is neither possible nor desirable for RECs to adopt either role. (shrink)

The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biological resources (...) are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: - Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. - With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). - Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement. (shrink)

DNA databases have significant commercial value. Direct-to-consumer genetic testing companies have built databanks using samples and information voluntarily provided by customers. As the price of genetic analysis falls, there is growing interest in building such databases by paying individuals for their DNA and personal data. This paper maps the ethical issues associated with private companies paying for DNA. We outline the benefits of building better genomic databases and describe possible concerns about crowding out, undue inducement, exploitation, and commodification. While certain (...) objections deserve more empirical and philosophical investigation, we argue that none currently provide decisive reasons against using financial incentives to secure DNA samples. (shrink)

A book chapter exploring the potential consquences and ethical ramifications of using coercive measures within community mental healthcare. We argue that, althogh the move towards 'care in the community' may have had liberalising motivations, the subsequent reduction in inpatient or other supported residential provision, means that there has been an increasing move towards coercive measures outside of formal inpatient detention. We consider measures such as Community Treatment Orders, inducements, and other forms of leverage, explaining the underlying concepts, aims, and exploring (...) adverse consequences and ethical difficulties. (shrink)

Some normative problems are difficult because of the number and complexity of the issues they involve. Rational resolution might be hard but it seems at least possible. Other problems are not merely complex and multi-faceted but ‘deep’. They have a logical structure that precludes rational resolution. Treatments of deep disagreement often hint at sinister implications. If doubt is cast on our 'final vocabulary', writes Richard Rorty, we are left with "no noncircular argumentative recourse.... [B]eyond them there is only helpless passivity (...) or a resort to force.” I will argue that some normative problems are deep, but that we need not accept these pessimistic consequences. Settling disagreements by way of rhetoric or incentive, for instance, may fall short of ideals of rational argumentation, but the moral issues raised by such strategies are different from those raised by compulsion, and realising that a disagreement is deep might have positive implications. More generally, appreciating that a disagreement is deep and hence that rational resolution is off the table may provide an incentive to seek other defensible strategies rather than returning to the frustrating and fruitless paths of a stalled debate. (shrink)

Controversy over providing financial incentives to research participants has a long history and remains an issue of contention in both current discussions about research ethics and for institutional review bodies/human research ethics committees which are charged with the responsibility of deciding whether such incentives fall within ethical guidelines. The arguments both for and against financial incentives have been well aired in the literature. A point of agreement for many is that inducement in the form of financial incentive is permissible when (...) the risk of harm to the individual is negligible in terms of degree and probability of occurrence. In the absence of harm to the individual, encouraging more people to participate in research would appear to be a good thing in so far as it will lead to statistically more robust research outcomes, which can then be translated into better healthcare and other practice. Whilst, on the face of it, this position seems highly defensible, I will explore the possibility that it is counterproductive – that is, providing individuals with financial incentives to become research participants may have the unintended outcome of reducing participation rates in some areas of research. In exploring this idea I will draw on empirical findings from the literature on crowding-out – the hypothesis that providing monetary incentives to people can backfire by overall reducing intrinsic motivation, in this instance intrinsic motivation to behave altruistically or undertake civic duties. (shrink)

This paper argues that significant aspects of the vaccination debate are ‘deep’ in a sense described by Robert Fogelin and others. Some commentators have suggested that such disagreements warrant rather threatening responses. I argue that appreciating that a disagreement is deep might have positive implications, changing our moral assessment of individuals and their decisions, shedding light on the limits of the obligation to give and respond to arguments in cases of moral disagreement, and providing an incentive to seek alternative ways (...) of going on in the face of intractable moral disagreement. Non-coercive, non-reasoned strategies have been used or recommended to increase vaccination rates. Such strategies look problematic when judged by the standards of ideal moral and rational argumentation, but more acceptable if seen as responses to deep disagreements. (shrink)

The American Board of Internal Medicine (ABIM) Foundation has recently initiated a campaign called “Choosing Wisely,” which is aimed at reducing “low-value” care services. Lists of low-value care services are being developed and the ABIM Foundation is urging the American Medical Association and other organizations to get behind the lists, disseminate them, and implement them. Yet, there are many ethical questions that remain about the development, dissemination, and implementation of these low-value care lists. In this paper I argue for conceptual (...) clarity with respect to the label “low-value care.” Thus far it has not been precisely defined, and I argue that there are actually 10 distinct categories of low-value care. I discuss the ethical challenges and considerations associated with each category. I also provide arguments that can be used to justify the reduction of some of these categories of low-value care. These arguments rely on Rawlsian and Hegelian notions of justice, as well as on concepts about the fiduciary obligations of physicians. Finally, I outline the various mechanisms that could be utilized for the reduction of low-value care (i.e., incentives, punishments, nonrational influences such as appeals to social norms, emotions, or ego, and creation of conditions that make avoidance easy such as defaults and reminders). I provide normative guidelines for the use of each. (shrink)

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)

Background Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Aim Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Method Postal survey of all RECs in Ireland. Results Response rate was 62.5% (n=50). 80% of RECs (...) reported not to have any established policy on the payment of research subjects while 20% had refused ethics approval to studies because the investigators proposed to pay research participants. The most commonly cited concerns were the potential for inducement and undermining of voluntary consent. Conclusions There is considerable variability among RECs on the payment of research participants and a lack of clear consensus guidelines on the subject. The development of standardised guidelines on the payment of research subjects may enhance recruitment of research participants. (shrink)

1. The opinions expressed are the author's own. They do not reflect any position or policy of the National Institutes of Health, Public Health Service, Department of Health and Human Services, or any of the authors affiliated organizations.

Volume 19, Issue 9, September 2019, Page 1-4.

Decisions on which new health technologies to provide are controversial because of the scarcity of healthcare resources, the competing demands of payers, providers and patients and the uncertainty of the evidence base. Given this, additional information about new health technologies is often considered valuable. One response is to make access to a new health technology conditional on further research. Access can be restricted to patients who participate in a research study, such as a randomised controlled trial; alternatively, a new treatment (...) can be made generally available, but only on condition that further evidence is collected (eg, on long-term outcomes and adverse events, in patient registries). The National Institute for Health and Clinical Excellence (NICE), which provides guidance on which new health technologies to make available under the UK's NHS, for example, has made some research conditional recommendations, and the current interest in such options suggests that they are likely to become more prevalent in the future. This paper identifies and discusses the main ethical issues created by this distinctive range of recommendations. We argue that decisions to put research conditions on access to new technologies are compatible with widely accepted values, principles and practices relevant to resource allocation. However, there are important features of these distinctive judgements that must be taken into account by resource allocation decision-making bodies and research ethics committees, and that require new sorts of empirical data. (shrink)

Volume 19, Issue 9, September 2019, Page 5-7.

In contrast to most publications on the ethics of paying research subjects, which start by identifying and analyzing major ethical concerns raised by the practice (in particular, risks of undue inducement and exploitation) and end with a set of—more or less well-justified—ethical recommendations for using payment schemes immune to these problems, this paper offers a systematic, principle-based ethical analysis of the practice. It argues that researchers have aprima faciemoral obligation to offer payment to research subjects, which stems from the principle (...) of social beneficence. This principle constitutes an ethical “spine” of the practice. Other ethical principles of research ethics (respect for autonomy, individual beneficence, and justice/fairness) make up an ethical “skeleton” of morally sound payment schemes by providing additional moral reasons for offering participants (1) recompense for reasonable expenses; and (2a) remuneration conceptualized as a reward for their valuable contribution, provided (i) it meets standards of equality, adequacy and non-exploitation, and (ii) it is not overly attractive (i.e., it does not constitute undue inducement for participation or retention, and does not encourage deceptive behaviors); or (2b) remuneration conceptualized as a market-driven price, provided (i) it is necessary and designed to help the study achieve its social and scientific goals, (ii) it does not reinforce wider social injustices and inequalities; (iii) it meets the requirement of non-exploitation; and (iv) it is not overly attractive. The principle of justice provides a strong ethical reason for not offering recompenses for lost wages (or loss of other reasonably expected profits). (shrink)

The recruitment of respondents belonging to ethnic minorities poses important challenges in social and health research. This paper reflects on the enablers and barriers to recruitment that we encountered in our research work with persons belonging to ethnic minorities. Additionally, we applied the Matching Model of Recruitment, a theoretical framework concerning minority recruitment, to guide our reflection. We also explored its applicability as a research design tool. In assessing our research experience, we learned that minority recruitment in social and health (...) research is influenced by the social context of all key players involved in the research. Also, there are enablers and barriers within that social context facilitating or delaying the recruitment process. The main enablers to recruit respondents belonging to ethnic minorities include working with community agencies and gatekeepers who share a common vision with researchers and the latter’s ability to gain the trust of potential respondents. The main barriers include demanding too much from these same community agencies and gatekeepers and ignoring factors that could delay the completion of the research. Although we found the Matching Model of Recruitment to be an effective tool in assessing the processes of recruiting respondents belonging to ethnic minorities, further empirical research is needed to explore its usefulness during the research planning phase. (shrink)

It is generally agreed that the current methods of providing health care in the West need to be reformed. Such reforms must operate within the practical limitations to which any future system of health care will be subject. These limitations include an increase in the demand for costly end-of-life health care coupled with a reduction in the proportion of the population who are working taxpayers (and hence a reduction in the proportionate amount of health care funding that can be secured (...) through taxation) and the fact that the imposition of bureaucratic regulations on health care systems is costly. Recognizing these limitations should naturally lead one to consider market-based reforms. Yet despite the practical impetus for such reforms, there is still widespread concern that market-based health care is unethical. The purpose of this paper is to address this concern and, in so doing, to pave the way for the market-based reform of health care to proceed. (shrink)

Background: Conducting video-research in birth settings raises challenges for ethics review boards to view birthing women and research-midwives as capable, autonomous decision-makers. Aim: This study aimed to gain an understanding of how the ethical approval process was experienced and to chronicle the perceived risks and benefits. Research design: The Birth Unit Design project was a 2012 Australian ethnographic study that used video recording to investigate the physical design features in the hospital birthing space that might influence both verbal and non-verbal (...) communication and the experiences of childbearing women, midwives and supporters. Participants and research context: Six women, 11 midwives and 11 childbirth supporters were filmed during the women’s labours in hospital birth units and interviewed 6 weeks later. Ethical considerations: The study was approved by an Australian Health Research Ethics Committee after a protracted process of negotiation. Findings: The ethics committee was influenced by a traditional view of research as based on scientific experiments resulting in a poor understanding of video-ethnographic research, a paradigmatic view of the politics and practicalities of modern childbirth processes, a desire to protect institutions from litigation, and what we perceived as a paternalistic approach towards protecting participants, one that was at odds with our aim to facilitate situations in which women could make flexible, autonomous decisions about how they might engage with the research process. Discussion: The perceived need for protection was overly burdensome and against the wishes of the participants themselves; ultimately, this limited the capacity of the study to improve care for women and babies. Conclusion: Recommendations are offered for those involved in ethical approval processes for qualitative research in childbirth settings. The complexity of issues within childbirth settings, as in most modern healthcare settings, should be analysed using a variety of research approaches, beyond efficacy-style randomised controlled trials, to expand and improve practice-based results. (shrink)

Volume 19, Issue 9, September 2019, Page 32-34.

Crowdsourcing is an increasingly popular method for researchers in the social and behavioral sciences, including experimental philosophy, to recruit survey respondents. Crowdsourcing platforms, such as Amazon’s Mechanical Turk (MTurk), have been seen as a way to produce high quality survey data both quickly and cheaply. However, in the last few years, a number of authors have claimed that the low pay rates on MTurk are morally unacceptable. In this paper, I explore some of the methodological implications for online experimental philosophy (...) research if, in fact, typical pay practices on MTurk are morally impermissible. I argue that the most straightforward solution to this apparent moral problem—paying survey respondents more and relying only on “high reputation” respondents—will likely increase the number of subjects who have previous experience with survey materials and thus are “non-naïve” with respect to those materials. I then discuss some likely effects that this increase in experimental non-naivete will have on some aspects of the “negative” program in experimental philosophy, focusing in particular on recent debates about philosophical expertise. (shrink)

BackgroundPatients not attending their appointments without giving notice burden healthcare services. To reduce non-attendance rates, patient non-attendance fees have been introduced in various settings. Although some argue in narrow economic terms that behavioural change as a result of financial incentives is a voluntary transaction, charging patients for non-attendance remains controversial. This paper aims to investigate the controversies of implementing patient non-attendance fees.ObjectiveThe aim was to map out the arguments in the Norwegian public debate concerning the introduction and use of patient (...) non-attendance fees at public outpatient clinics.MethodsPublic consultation documents (2009–2021) were thematically analysed (n=84). We used a preconceived conceptual framework based on the works of Grant to guide the analysis.ResultsA broad range of arguments for and against patient non-attendance fees were identified, here referring to the acceptability of the fees’ purpose, the voluntariness of the responses, the effects on the individual character and institutional norms and the perceived fairness and comparative effectiveness of patient non-attendance fees. Whereas the aim of motivating patients to keep their appointments to avoid poor utilisation of resources and increased waiting times was widely supported, principled and practical arguments against patient non-attendance fees were raised.ConclusionA narrow economic understanding of incentives cannot capture the breadth of arguments for and against patient non-attendance fees. Policy makers may draw on this insight when implementing similar incentive schemes. The study may also contribute to the general debate on ethics and incentives. (shrink)

The payment of human subjects is an area where Institutional Review Boards have wide discretion. Although the “Common Rule” requires the provision of full information to human research participants to secure valid consent, the Rule is silent on the issue of payment. Still, some federal agencies offer guidance on the matter. For example, the National Science Foundation cautions that high payments for risky research “may induce a needy participant to take a risk that they normally would prefer not to take.” (...) For research under its purview, the Food and Drug Administration guidance provides that “[a]dvertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.” One might read the FDA guidance to permit the advertisement for human subjects to state the specific amount of payment, as long as it is not emphasized. (shrink)

Incentivising has shown to improve participation in clinical trials. However, ethical concerns suggest that incentives may be coercive, obscure trial risks and encourage individuals to enrol in cli...