BENEFITS TO RESEARCH SUBJECTS IN INTERNATIONAL TRIALS: DO THEY REDUCE EXPLOITATION OR INCREASE UNDUE INDUCEMENT?

There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally‐sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. It proceeds from the premise that there are good grounds for thinking that, at least some, international research sponsors exploit trial participants because they do not provide the research population with a fair share of the benefits of research. This provides a prima facie argument for increasing the benefits for research participants. Concern over undue inducement is a legitimate moral concern; however, if this concern is to prevent research populations from receiving their fair share of benefits from research there must be sufficient evidence that these benefits will unduly influence patients’ decision‐making regarding trial participation. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants’ motivations and the influence of payments on research subjects’ behaviour and risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects’ behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants.     

Is the coral‐algae symbiosis really ‘mutually beneficial’ for the partners?

The consideration of ‘mutual benefits’ and partner cooperation have long been the accepted standpoint from which to draw inference about the onset, maintenance and breakdown of the coral‐algae endosymbiosis. In this paper, I review recent research into the climate‐induced breakdown of this important symbiosis (namely ‘coral bleaching’) that challenges the validity of this long‐standing belief. Indeed, I introduce a more parsimonious explanation, in which the coral host exerts a ‘controlled parasitism’ over its algal symbionts that is akin to an enforced domestication arrangement. Far from being pathogenic, a range of well‐established cellular processes are reviewed that support the role of the coral host as an active ‘farmer’ of the energy‐rich photoassimilates from its captive symbionts. Importantly, this new paradigm reposes the deleterious bleaching response in terms of an envelope of environmental conditions in which the exploitative and captive measures of the coral host are severely restricted. The ramification of this new paradigm for developing management strategies that may assist the evolution of bleaching resistance in corals is discussed.     

Epilepsy patient-participants and genetic research results as "answers"

Better understanding of how research participants with a known condition ascribe meaning to individual genetic results is important to help researchers and institutional review boards evaluate the potential benefits and harms of disclosing results in the context of genotype-driven research recruitment. Based on 29 in-depth interviews with epilepsy patients participating in a genetic study, we found that this population of research subjects anticipated that genetic research results would provide answers to a range of questions about the research process and their condition. Their multi-layered interpretations underscore the need for clear communication about the nature and limitations of results if individual or aggregate genetic results are returned in the process of recruitment for additional research.     

Informed Consent in Health Research: Challenges and Barriers in Low‐and Middle‐Income Countries with Specific Reference to Nepal

Obtaining ‘informed consent’ from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require ‘informed consent form’ as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low‐and middle‐income countries (LMICs) in recent years, only limited work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent.     

‘Bioethical Realism’: A Framework for Implementing Universal Research Ethics

Implementation of existing ethical guidelines for international collaborative medical and health research is still largely controversial in sub‐Saharan Africa for two major reasons: One, they are seen as foreign and allegedly inconsistent with what has been described as an ‘African worldview’, hence, demand for their strict implementations reeks of ‘bioethical imperialism’. Two, they have other discernible inadequacies – lack of sufficient detail, apparent as well as real ambiguities, vagueness and contradictions. Similar charges exist(ed) in other non‐Western societies. Consequently, these guidelines have been correctly judged as an inadequate response to the complex and ever shifting dilemmas met by researchers and research regulators in the field. This paper proposes a framework for effective implementation of existing guidelines without much worry about bioethical imperialism and other inadequacies. This framework is proposed using an analogy of Legal Realism, specifically its key assertions on how, in reality, judicial systems operate using general legal rules to settle specific cases. Legal realists assert that in judicial decision‐making, general legal rules do not totally dictate court decisions in specific cases. This analogy is used to coin a new term, ‘Bioethical Realism.’ The framework suggests that local Research Ethics Committees ought to be construed as analogues of judicial courts with the resulting implications. Consequently, just like legal rules are general rules that do not always dictate court decisions, similarly international bioethical guidelines are general ethical rules that should not always dictate local RECs’ decisions and such decisions (ought to) enjoy considerable immunity from outsiders.     

Comparison of U.S. and Japanese Consumers’ Perceptions of Remanufactured Auto Parts

This study compares U.S. and Japanese consumers’ perceptions of remanufactured auto parts. Remanufactured parts have a long history and enjoy continuing success in the U.S. domestic aftermarket. In contrast, although Japan's domestic aftermarket is growing, it remains comparatively underdeveloped. This research examines whether customers’ perceptions of remanufactured products explain their lower acceptance in Japan. Our Internet survey of 440 U.S. and 300 Japanese respondents examined their knowledge of remanufactured auto parts, perceptions of their benefits and risks, and price consciousness. The results reveal that Japanese consumers know less about remanufactured products, perceiving them as entailing lower benefits and greater risk, especially concerning quality, and are less price conscious. Drawing on its results, this study suggests measures to promote markets for remanufactured auto parts in Japan and in economies in which such markets are in an early stage of development.     

‘Ghost’ experiments and the dissection of social learning in humans and animals

The focus of this review is the experimental techniques used to identify forms of social learning shown by humans and nonhuman animals. Specifically, the ‘ghost display’ and ‘end‐state’ conditions, which have been used to tease apart imitative and emulative learning are evaluated. In a ghost display, the movements of an apparatus are demonstrated, often through the discrete use of fishing‐line or hidden mechanisms, without a live model acting directly upon the apparatus so that the apparatus appears to be operated as if by a ‘ghostly’ agent. In an end‐state condition, an observing individual is shown the initial state of the test apparatus, the apparatus is then manipulated out‐of‐sight and then represented to the individual in its final state. The aim of the ghost display condition is to determine whether individuals are able to emulate by replicating the movements of an apparatus, or perform a task, without requiring information about the bodily movements required to do so (imitation). The end‐state condition is used to identify goal‐emulation by assessing whether the observer can replicate the steps required to solve the task without having been shown the required body actions or task movements. The responses of individuals tested with either the ghost display and/or end‐state conditions are compared to those of further individuals who have observed a full demonstration by either a human experimenter or a conspecific. The responses of a control group, to whom no information has been provided about the test apparatus or required actions, are also compared and evaluated. The efficacy of these experimental techniques employed with humans, nonhuman primates, dogs, rats and birds are discussed and evaluated. The experiments reviewed herein emphasise the need to provide ghost displays and end‐state conditions in combination, along with full live demonstrations and a no‐information control. Future research directions are proposed.     

What can we Learn from Patients’ Ethical Thinking about the right ‘not to know’ in Genomics? Lessons from Cancer Genetic Testing for Genetic Counselling

This article is based on a qualitative empirical project about a distinct kinship group who were among the first identified internationally as having a genetic susceptibility to cancer (Lynch Syndrome). 50 were invited to participate (42 were tested; eight declined genetic testing). 15, who had all accepted testing, were interviewed. They form a unique case study. This study aimed to explore interviewees’ experiences of genetic testing and how these influenced their family relationships. A key finding was that participants framed the decision to be tested as ‘common sense’; the idea of choice around the decision was negated and replaced by a moral imperative to be tested. Those who did not follow ‘common sense’ were judged to be imprudent. Family members who declined testing were discussed negatively by participants. The article addresses what is ethically problematic about how test decliners were discussed and whether these ethical concerns extend to others who are offered genetic testing. Discussions showed that genetic testing was viewed as both an autonomous choice and a responsibility. Yet the apparent conflict between the right to autonomy and the moral imperative of responsibility allowed participants to defend test decliners’ decisions by expressing a preference for or defending choice over responsibility. The ‘right not to know’ seemed an important moral construct to help ethically manage unpopular decisions made by close family who declined testing. In light of this research, the erosion of the ‘right not to know’ in the genomic age could have subtle yet profound consequences for family relationships.     

Idiopathic environmental intolerance attributed to electromagnetic fields (formerly ‘electromagnetic hypersensitivity’): An updated systematic review of provocation studies

Idiopathic Environmental Intolerance attributed to electromagnetic fields (IEI‐EMF; formerly ‘electromagetic hypersensitivity’) is a medically unexplained illness in which subjective symptoms are reported following exposure to electrical devices. In an earlier systematic review, we reported data from 31 blind provocation studies which had exposed IEI‐EMF volunteers to active or sham electromagnetic fields and assessed whether volunteers could detect these fields or whether they reported worse symptoms when exposed to them. In this article, we report an update to that review. An extensive literature search identified 15 new experiments. Including studies reported in our earlier review, 46 blind or double‐blind provocation studies in all, involving 1175 IEI‐EMF volunteers, have tested whether exposure to electromagnetic fields is responsible for triggering symptoms in IEI‐EMF. No robust evidence could be found to support this theory. However, the studies included in the review did support the role of the nocebo effect in triggering acute symptoms in IEI‐EMF sufferers. Despite the conviction of IEI‐EMF sufferers that their symptoms are triggered by exposure to electromagnetic fields, repeated experiments have been unable to replicate this phenomenon under controlled conditions. A narrow focus by clinicians or policy makers on bioelectromagnetic mechanisms is therefore, unlikely to help IEI‐EMF patients in the long‐term. Bioelectromagnetics 31:1–11, 2010. © 2009 Wiley‐Liss, Inc.     

‘It is an entrustment’: Broad consent for genomic research and biobanks in sub‐Saharan Africa

In recent years, there has been an increase in the establishment of biobanks for genetic and genomic studies around the globe. One example of this is the Human Heredity and Health in Africa Initiative (H3Africa), which has established biobanks in the sub‐region to facilitate future indigenous genomic studies. The concept of ‘broad consent’ has been proposed as a mechanism to enable potential research participants in biobanks to give permission for their samples to be used in future research studies. However, questions remain about the acceptability of this model of consent. Drawing on findings from empirical research about the role of trust in decision‐making, we argue that an account of entrustment may be an appropriate way of addressing current challenges of seeking consent for biobank research in Africa. We propose a set of key points to consider that can support the proposed entrustment framework.     

Internet racism,journalism and the principle of public access: ethical challenges for qualitative research into ‘media attractive’ court cases

This paper addresses the risk of research exposing people with an immigrant background in criminal court cases to Internet-based racist persecution, due to mismanagement of general ethical guidelines. The principle of informed consent, ideally serving to protect people under study from harm may, in fact, cause them more harm due to the interest among certain Internet-based networks of spreading identifiable, degrading information. Arguments are based on ethically challenging experiences from two ethnographic research projects carried out in Swedish district court environments, focused on immigrant court cases. Ethical advice provided by ethical review boards and established research guidelines, were based on an unawareness of the potentially destructive rendezvous in media attractive immigrant court cases between ‘ethically informed’ research, crime journalism, freedom of information legislation and ‘Internet vigilantes’ on a quest to persecute court participants and their families in the global digital arena.     

Attitudes toward Post‐Trial Access to Medical Interventions: A Review of Academic Literature,Legislation, and International Guidelines

There is currently no international consensus around post‐trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post‐trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post‐trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes towards post‐trial access and participants and community members. Given that clinical trials conducted in low‐income countries will likely continue, there is an urgent need for consideration of post‐trial benefits for participants, communities, and citizens of host countries. While this issue may not be as pressing in countries where participants have access to healthcare and medicines through public schemes, it is particularly important in regions where this may not be available.     

WHICH BENEFITS OF RESEARCH PARTICIPATION COUNT AS ‘DIRECT’?

It is widely held that individuals who are unable to provide informed consent should be enrolled in clinical research only when the risks are low, or the research offers them the prospect of direct benefit. There is now a rich literature on when the risks of clinical research are low enough to enroll individuals who cannot consent. Much less attention has focused on which benefits of research participation count as ‘direct’, and the few existing accounts disagree over how this crucial concept should be defined. This disagreement raises concern over whether those who cannot consent, including children and adults with severe dementia, are being adequately protected. The present paper attempts to address this concern by considering first what additional protections are needed for these vulnerable individuals. This analysis suggests that the extant definitions of direct benefits either provide insufficient protection for research subjects or pose excessive obstacles to appropriate research. This analysis also points to a modified definition of direct benefits with the potential to avoid these two extremes, protecting individuals who cannot consent without blocking appropriate research.     

Survival costs of within‐ and between‐season mate change in the European blackbird Turdus merula

Many studies of socially monogamous birds discuss the adaptive role of between‐season partner change, but only a handful of them refer to the benefits of pair fidelity in terms of increased survival. Moreover, there are no studies describing the benefits of within‐season mate retention. Our data relating to an urban population of European blackbirds Turdus merula enabled us to test the dependence of survival on pair faithfulness. Because blackbirds divorce within and between seasons, we were able to test the influence of pair faithfulness on their within‐ and between‐season survival and mate fidelity. For this purpose, we used a multievent capture–mark–recapture (MECMR) statistical model, which is based on recapture rates and different pair states (faithful to mate, paired with new partner, or dead). Our study indicated that between‐ and within‐season survival depends on pair states: pair‐bond duration increases survival to the next capture occasion in both sexes. We found that the pair‐bond duration to the current partner increased the chances of being with the same partner during the next breeding occasion, although we failed to find any within‐season pair‐bond influence for females. Our results showed sex differences in mating at the end of the season: females had a much smaller chance of breeding with the current new partner in the next year. This study has demonstrated that within‐ and between‐season survival is dependent on mate retention, and we discuss this in the context of how searching for a new partner could affect the birds’ survival.     

International research and just sharing of benefits in Mexico

International research enrolling human subjects has raised an ethical concern regarding the just distribution of benefits between the countries that design the research and the host communities. Although several universal declarations have expressed this concern, a gap between theory and practice continues to exist, as well as a significant divergence between the design of the research protocol and the social context where it will be implemented. Although institutional review boards have made a valuable effort to evaluate international research, their sensitivity to the just sharing of research benefits as well as their attention to the social context must be evaluated. This article analyzes the distribution of benefits in a review of international research in Mexico and produces an ethical reflection based on the results.     

What is wrong with ethics review,the impact on teaching anthropology,and how to fix it: results of an empirical study

There is no empirical evidence that ethics review protects anthropologists’ research participants, but there is ample evidence that it is stifling research agendas and reshaping how we teach anthropological research methods, entrenching a positivist, clinical model of what constitutes research. This paper examines the impact of ethics review on student research in Australia, based on interviews conducted at 14 Australian universities. The data clearly show that the risks posed by student research are minor, and vastly overestimated by ethics committees. To avoid problems with ethics committees, we shepherd students into undertaking low‐risk, and consequently low‐impact, research. Many departments are abandoning research‐led teaching altogether because of the obstacle of ethics review. One solution would be to locate ethics discussions in disciplines and departments, radically restructuring the encounter to reconceptualise it as collegial debate about ethics dilemmas rather than ‘ethics review’.     

‘I am helping them’: ‘Traffickers’, ‘anti‐traffickers’ and economies of bad faith

For several years, aid programs in the Mekong region have taken an increasing interest in cross‐border mobility and human trafficking and its relationship with development. More recently, there has been an increasing interest in the identification of trafficked victims and the investigation, arrest and prosecution of traffickers. Whereas anti‐trafficking programs ubiquitously define themselves as being in a battle with traffickers, this article argues that although they are not homologous social actors, both engage in acts of bad faith. The article elaborates this argument by drawing attention to the recruitment process within the Lao sex industry as well as to the way in which aid programs attempt to identify trafficked victims. It concludes that imaginary aspects of development underpin a simultaneous disjuncture yet enable the social reproduction of the life worlds of ‘traffickers’ and ‘anti‐traffickers’ alike.     

Women’s preferences regarding options for management of atypical,borderline or low‐grade cervical cytological abnormalities: a review of the evidence

M. Z. Sadique and R. Legood Women’s preferences regarding options for management of atypical, borderline or low‐grade cervical cytological abnormalities: a review of the evidence Objectives: To review the evidence on women’s preferences for and valuation of alternative management pathways following identification of low‐grade cytological abnormalities as part of routine cervical cancer screening. The aim was to identify empirical studies evaluating women’s preferences regarding alternative management pathways and to compare the impact of alternative elicitation methods on results. Methods: A systematic review of the literature was conducted using the online bibliographic information service PubMed database. Empirical studies were identified that elicited general preferences, utilities or valuations based on willingness to pay (WTP) with respect to management of low‐grade cytology results. Data were extracted on the methodology used and the empirical results. Results: Where quality of life data were elicited directly from patients that were undergoing management of low‐grade abnormalities utilizing direct elicitation techniques such as WTP, general preference questionnaires and the Euroqol, the studies tended towards a preference in favour of HPV testing (and colposcopy referral if HPV positive) rather than repeat cytology. In contrast, where studies included the general population and presented hypothetical scenarios of treatment pathways, and explicitly tried to incorporate assessment of process utility, the evidence indicated a slight tendency to favour repeat cytology. Conclusion: Consideration of patient preferences in the management of low‐grade cytology is important for designing screening protocols. The reviewed studies indicate that potentially different conclusions may be drawn depending on the elicitation methodology and selection of participants in the research.     

The common rule's ‘reasonable person’ standard for informed consent

Laura Odwazny and Benjamin Berkman have raised several challenges regarding the new reasonable person standard in the revised Common Rule, which states that informed consent requires potential research subjects be provided with information a reasonable person would want to know to make an informed decision on whether to participate in a study. Our aim is to offer a response to the challenges Odwazny and Berkman raise, which include the need for a reasonable person standard that can be applied consistently across institutional review boards and that does not stigmatize marginal groups. In response, we argue that the standard ought to be based in an ordinary rather than ideal person conception of reasonable person and that the standard ought to employ what we call a liberal constraint: the reasonability standard must be malleable enough such that a wide variety of individuals with different, unique value systems would endorse it. We conclude by suggesting some of the likely consequences our view would have, if adopted.