RECONSIDERING THE VALUE OF CONSENT IN BIOBANK RESEARCH

Biobanks for long‐term research pose challenges to the legal and ethical validity of consent to participate. Different models of consent have been proposed to answer some of these challenges. This paper contributes to this discussion by considering the meaning and value of consent to participants in biobanks. Empirical data from a qualitative study is used to provide a participant view of the consent process and to demonstrate that, despite limited understanding of the research, consent provides the research participants with some level of control and a form of self determination that they value. Participation is framed as a moral act of a responsible citizen providing reinforcement of self identity. Consent symbolizes the trust invested in researchers and research institutions to use the biobank for the public good. The paper argues that consent continues to play an important role in biobank participation and that a participant view should inform proposals to modify consent processes.     

ACCESS TO TREATMENT IN HIV PREVENTION TRIALS: PERSPECTIVES FROM A SOUTH AFRICAN COMMUNITY

Access to treatment, in HIV vaccine trials (HVTs), remains ethically controversial. In most prevention trials, including in South Africa, participants who seroconvert are referred to publicly funded programmes for treatment. This strategy is problematic when there is inadequate and uneven access to public sector antiretroviral therapy (ART) and support resources. The responsibilities, if any, of researchers, sponsors and public health authorities involved in HVTs has been hotly debated among academics, scholars, representatives of international organizations and sponsors. However, there is little published on community perceptions. Recent guidance asserts that communities should make inputs into treatment and care decisions. This qualitative study explored a South African community's perceptions of who should provide what to HVT participants as well as how and why this should be done. Twenty‐nine adults working at or attending five primary health care clinics in two rural areas in KwaZulu‐Natal participated in in‐depth interviews. Respondents expressed that researchers should ‘help participants to access’ treatment and care ‘because they are in a position to do so’ and ‘are in a relationship with’ trial participants. Respondents suggested that researchers could help by ‘facilitating referral’ until such time that participants can access care and treatment on their own. We highlight a series of implications for researchers in HVTs, including their need to be aware of prospective participants' considerable trust in and respect for researchers, the responsibility that this places on them, and the need for clear communication with communities so as not to erode community trust.     

Ancillary care in public health intervention research in low-resource settings: researchers' practices and decision-making

Little is known about researchers' practices regarding the provision of ancillary care (AC) in public health intervention studies they have conducted and the factors that influence their decisions about whether to provide ancillary care in low-resource settings. We conducted 52 in-person in-depth interviews with public health researchers. Data analysis was iterative and led to the identification of themes and patterns among themes. We found that researchers who conduct their research in the community setting are more likely to identify and plan for the AC needs of potential research subjects before a study begins, whereas those affiliated with a permanent facility are more likely to deliver AC to research subjects on an ad hoc basis. Our findings suggest that on the whole, at least for public health intervention research in low-resource settings, researchers conducting research in the community setting confront more complex ethical and operational challenges in their decision-making about AC than do researchers conducting facility-based studies.     

Community engagement in global health research that advances health equity

Community engagement is gaining prominence in global health research. So far, a philosophical rationale for why researchers should perform community engagement during such research has not been provided by ethics scholars. Its absence means that conducting community engagement is still often viewed as no more than a ‘good idea’ or ‘good practice’ rather than ethically required. In this article, we argue that shared health governance can establish grounds for requiring the engagement of low‐ and middle‐income country (LMIC) community members in global health research, where such research aims to help reduce health disparities. This philosophical basis has important implications for the ethical goals ascribed to engagement and the approach adopted to undertake it. We suggest the ethical goals of engagement in equity‐oriented global health research should include: (a) generating research topics and questions that reflect the key problems disadvantaged groups face in accessing healthcare, services and broader social determinants of health and (b) promoting the translation of research findings into policy and practice in ways that benefit the health of disadvantaged groups. We propose engagement practice should have the following features: deliberation with LMIC community members to make a range of project decisions, beginning with setting research topics and questions; inclusion of members of disadvantaged groups and those with the power to change policy and practice to benefit them; and purposeful structuring of deliberations to minimize the impact of power disparities between LMIC community members. Finally, we reflect on how these features differ from those typical of much current community engagement practice in LMICs.     

US IRBs confronting research in the developing world

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.     

TREATMENT NEEDS IN HIV PREVENTION TRIALS: USING BENEFICENCE TO CLARIFY SPONSOR‐INVESTIGATOR RESPONSIBILITIES

Some participants will get HIV‐infected in HIV prevention trials, despite risk reduction measures. The subsequent treatment responsibilities of sponsor‐investigators have been widely debated, especially where access to antiretroviral therapy (ART) is not available. In this paper, we explore two accounts of beneficence to establish whether they can shed light on sponsor‐investigator responsibilities. We find the notion of general beneficence helpful insofar as it clarifies that some beneficent actions will be obligatory where they can be dispensed without scuppering the trial. We find the notion of specific beneficence helpful insofar as it directs investigators to attend to the needs of trial participants; however the range of interventions that could be provided remains unhelpfully broad. We then examine accounts of the investigator‐participant relationship to narrow the range of interventions that investigators should provide, concluding that health‐care, and HIV infection, are appropriate foci. We conclude that when investigators are able to meet the ART needs of their participants (e.g. referral, assisted referral or direct provision) without sacrificing trial quality, they must do so. However, there is little of this explicit direction to be found in the account of specific beneficence itself, but rather it is found in accounts of the relationship that are compatible with beneficence.     

Ethical Issues in Field Trials of Genetically Modified Disease‐Resistant Mosquitoes

Mosquito‐borne diseases take a tremendous toll on human populations, especially in developing nations. In the last decade, scientists have developed mosquitoes that have been genetically modified to prevent transmission of mosquito‐borne diseases, and field trials have been conducted. Some mosquitoes have been rendered infertile, some have been equipped with a vaccine they transmit to humans, and some have been designed to resist diseases. This article focuses on ethical issues raised by field trials of disease‐resistant, genetically modified mosquitoes. Some of these issues include: protecting the public and the environment from harm, balancing benefits and risks, collaborating with the local community, avoiding exploitation, and safeguarding the rights and welfare of research subjects. One of the most difficult problems involves protecting the welfare of community members who will be impacted by the release of mosquitoes but who are not enrolled in the study as research subjects. To address this concern, field trials should take place only when the targeted disease is a significant public health problem in an isolated area, the benefits of the trial for the community are likely to outweigh the risks, community leaders approve of the trial, and there are measures in place to protect the welfare of un‐enrolled community members, such as informing the community about the study and offering free treatment to people who contract mosquito‐borne diseases. Since the justification of any field trial depends on a careful examination of the scientific and ethical issues, proposed studies should be evaluated on a case‐by‐case basis.     

Developing Clinical Research Relationship: Views from Within

The nature of the relationship between clinical investigator and research participant continues to be contested. The related discussions have largely focused on the doctor‐researcher dichotomy thought to permeate the work of a clinical investigator with research participants, whom in turn occupy two corresponding roles: patient and subject. This paper contributes to current debates on the topic by providing a voice to research participants, whose perspectives have been largely invisible. It draws on 42 in‐depth interviews conducted in Ghana and South Africa with respondents at different stages of involvement in clinical research, ranging from no experience in clinical research to enrollment in several clinical trials. The perspectives of all respondents were largely congruent and rooted in the common view that clinical research contributed to the improvement of local health. They went beyond the researcher/participant versus doctor/patient dichotomy, long established in research ethics, and preferred to view participants and investigators as partners working together to find ways to address local health needs. The conceptualization of investigator‐participant relations as a partnership reinforced expectations of care, transparency and accountability, which were viewed as necessary expressions of mutuality and respect within equal collaborations. It is important to engage with these views in order to avoid antagonizing societal expectations and to build up long‐term public trust, crucial for the continuous operation of clinical research.     

THE FUTURE OF BIOETHICS: THREE DOGMAS AND A CUP OF HEMLOCK

In this paper I argue that bioethics is in crisis and that it will not have a future unless it begins to embrace a more Socratic approach to its leading assumptions. The absence of a critical and sceptical spirit has resulted in little more than a dominant ideology. I focus on three key issues. First, that too often bioethics collapses into medical ethics. Second, that medical ethics itself is beset by a lack of self‐reflection that I characterize here as a commitment to three dogmas. Third, I offer a more positive perspective by suggesting how bioethics may benefit from looking towards public health ethics as a new source of inspiration and direction.     

Informed consent and collaborative research: perspectives from the developing world

Introduction: Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research. Methods: A survey of developing country researchers, involved in human subject research, was conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in-depth interviews and 78 responses to open-ended questions in the questionnaire provided qualitative data. Results: 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent. Discussion: This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research.     

Engagement as co‐constructing knowledge: A moral necessity in public health research

Undertaking engagement in public health research is ethically essential. There is a growing emphasis on practicing engagement as the co‐construction of knowledge, which goes beyond other common forms of engagement in health research practice: consulting and informing. Taking such an approach means researchers jointly construct knowledge with research users and beneficiaries; all parties design and conduct research together and share decision‐making power. This article makes the normative argument that such engagement is necessary to achieve the foundational moral aims of public health research—building relations of equality and addressing the health needs of those considered disadvantaged—which reflect the field's underlying commitment to social justice. It next identifies and discusses three ways in which co‐constructing knowledge advances those moral aims: by facilitating self‐determination, supporting individuals’ right to research, and maximizing social knowledge to address cognitive and epistemic injustice. Objections to the arguments presented in the article are then articulated and defended against.     

Engaging Diverse Social and Cultural Worlds: Perspectives on Benefits in International Clinical Research From South African Communities

The issue of benefits in international clinical research is highly controversial. Against the background of wide recognition of the need to share benefits of research, the nature of benefits remains strongly contested. Little is known about the perspectives of research populations on this issue and the extent to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low‐income South African communities on benefits in international clinical research. Twenty‐four individuals with and without experience of being involved in clinical research participated in in‐depth interviews. Respondents felt that ancillary care should be provided to clinical research participants, while a clinical study conducted in particular community should bring better health to its members through post‐trial benefits. Respondents' perspectives were grounded in the perception that the ultimate goal of international clinical research is to improve local health. We argue that perspectives and understandings of the respondents are shaped by local moral traditions rather than clinical research specificities and require attention as valid moral claims. It is necessary to acknowledge such claims and cultural worlds from which they emerge, thus building the foundation for equal and embracing dialogue to bridge different perspectives and handle contradicting expectations.     

WHAT MOTIVATES WOMEN TO TAKE PART IN CLINICAL AND BASIC SCIENCE ENDOMETRIOSIS RESEARCH?*

BACKGROUND: The objective of this study was to identify factors motivating women to take part in endometriosis research and to determine if these factors differ for women participating in clinical versus basic science studies. METHODS: A consecutive series of 24 women volunteering for participation in endometriosis-related research were asked to indicate, in their own words, why they chose to volunteer. In addition, the women were asked to rate, on a scale of 0 to 10, sixteen potentially motivating factors. The information was gathered in the form of an anonymous self-administered questionnaire. RESULTS: Strong motivating factors (mean score > 8) included potential benefit to other women's health, improvement to one's own condition, and participation in scientific advancement. Weak motivating factors (mean score < 3) included financial compensation, making one's doctor happy, and use of 'natural' products. No difference was detected between clinical and basic science study participants. CONCLUSION: This study is the first study to specifically investigate the factors that motivate women to take part in endometriosis research. Understanding why women choose to take part in such research is important to the integrity of the informed consent process. The factors most strongly motivating women to participate in endometriosis research related to improving personal or public health; the weakest, to financial compensation and pleasing the doctor.     

Adjusting the focus: A public health ethics approach to data research

This paper contends that a research ethics approach to the regulation of health data research is unhelpful in the era of population‐level research and big data because it results in a primary focus on consent (meta‐, broad, dynamic and/or specific consent). Two recent guidelines – the 2016 WMA Declaration of Taipei on ethical considerations regarding health databases and biobanks and the revised CIOMS International ethical guidelines for health‐related research involving humans – both focus on the growing reliance on health data for research. But as research ethics documents, they remain (to varying degrees) focused on consent and individual control of data use. Many current and future uses of health data make individual consent impractical, if not impossible. Many of the risks of secondary data use apply to communities and stakeholders rather than individual data subjects. Shifting from a research ethics perspective to a public health lens brings a different set of issues into view: how are the benefits and burdens of data use distributed, how can data research empower communities, who has legitimate decision‐making capacity? I propose that a public health ethics framework – based on public benefit, proportionality, equity, trust and accountability – provides more appropriate tools for assessing the ethical uses of health data. The main advantage of a public health approach for data research is that it is more likely to foster debate about power, justice and equity and to highlight the complexity of deciding when data use is in the public interest.     

EXPLOITATION IN PAYMENTS TO RESEARCH SUBJECTS

Offering cash payments to research subjects is a common recruiting method but there is significant debate about whether and in what amount such payments are appropriate. This paper is concerned with exploitation and whether there should be a lower limit on the amount researchers can pay their subjects. When subjects participate in research as a way to make money, fairness requires that researchers pay them a fair wage. This call for the establishment of a lower limit meets resistance in two places: (1) denial that the payments offered by researchers are wages for participation; and (2) concern about undue inducement. This paper critically examines these arguments for and against a lower limit. It shows that the need for a lower limit cannot be avoided by adopting a non‐wage payment model and that concerns about undue inducement are unjustified in all trials except those that present greater than minimal risk. This analysis suggests the following compromise position: there should be an unconditional lower limit on payment amounts so that researchers cannot offer less than a fair wage, and when researchers cannot satisfy this limit because fairness requires a problematically large payment, then researchers should offer no payment at all.     

LINKING INTERNATIONAL RESEARCH TO GLOBAL HEALTH EQUITY: THE LIMITED CONTRIBUTION OF BIOETHICS

Health research has been identified as a vehicle for advancing global justice in health. However, in bioethics, issues of global justice are mainly discussed within an ongoing debate on the conditions under which international clinical research is permissible. As a result, current ethical guidance predominantly links one type of international research (biomedical) to advancing one aspect of health equity (access to new treatments). International guidelines largely fail to connect international research to promoting broader aspects of health equity – namely, healthier social environments and stronger health systems. Bioethical frameworks such as the human development approach do consider how international clinical research is connected to the social determinants of health but, again, do so to address the question of when international clinical research is permissible. It is suggested that the narrow focus of this debate is shaped by high‐income countries' economic strategies. The article further argues that the debate's focus obscures a stronger imperative to consider how other types of international research might advance justice in global health. Bioethics should consider the need for non‐clinical health research and its contribution to advancing global justice.     

Analyzing the Practice of Life Cycle Assessment

Life cycle assessment (LCA) is a quantitative tool used to evaluate the environmental impacts of products or processes. With respect to buildings, LCA can be used to evaluate the environmental impacts of an entire building's life cycle. Currently LCA in the building area is used in a limited capacity, primarily to select building products. In order to determine the causality for the lack of whole‐building LCAs, focus groups with members of the architecture, engineering, and construction (AEC) communities were held. This article investigates the current level of knowledge of LCA in the AEC community and then discusses the benefits and barriers to the practice of LCA. In summary, the goal of the research was to identify why LCA is not used to its fullest potential in a whole‐building LCA. In an open forum and moderated setting, focus group participants were asked individually to self‐identify their experience with LCA, a brief education session on LCA was held, and then benefits and barriers to LCA were discussed. The focus group sessions were transcribed and systematically coded by social researchers in order to analyze the results. Hybrid flow and radar charts were developed. From the focus group results, the most important benefit to LCA was “provides information about environmental impacts.” The results did not identify a prominent barrier; however, building‐related metrics were ascertained to be one of the more crucial barriers. The benefits and barriers classified by this analysis will be utilized to develop a subsequent online survey to further understand the LCA and AEC community.     

Walking Sole Mates: Dogs Motivating,Enabling and Supporting Guardians' Physical Activity

ABSTRACT

Dog walking is receiving increasing attention in the public health literature as a strategy to improve dog guardians' physical activity levels. Quantitative research suggests that dog guardians walk more often and for longer than non dog-guardians, and offers suggestions as to the reasons for these differences. The purpose of this study was to qualitatively explore dog guardians' walking practices and relationships with their dogs, to better understand how and why dog walking might become an intervention point to enhance physical activity levels. Five focus groups and two interviews were conducted with 16 adult dog guardians. Following an initial analysis of the results, 10 additional dog guardians were individually interviewed to review and confirm the findings. Four themes emerged to explain the dog-walking phenomenon: Transcending the human–animal distinction; Dogs as walking sole mates; Activity/health benefits; and Dogs as social conduits. We argue that an empathetic stance benefits dog guardians because, as valued family members whose health and happiness they are responsible for, their canine companions serve to motivate, enable, and sustain walking behaviors.     

ON USING PEOPLE MERELY AS A MEANS IN CLINICAL RESEARCH

It is often argued that clinical research should not violate the Kantian principle that people must not be used merely as a means for the purposes of others. At first sight, the practice of clinical research itself, however, seems to violate precisely this principle: clinical research is often beneficial to future people rather than to participants; even if participants benefit, all things considered, they are exposed to discomforts which are absent both in regular care for their diseases and in other areas of daily life. Therefore, in this paper we will consider whether people are used merely as a means by being enrolled in clinical research. On the basis of recent studies of Kantian scholars we will argue that clinical research is compatible with the Kantian principle if the conditions of possible consent and end‐sharing have been met. Participants are not used merely as a means if they have sufficient reasons to consent to being enrolled in clinical research and can share the ends of the researchers who use them. Moreover, we will claim that even if people are used merely as a means by participating in clinical research, it may not always be morally wrong to use them in this way.