BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map these (...) strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.ConclusionsWe believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large. (shrink)
Background Currently there is increasing recognition of the need for research in developing countries where disease burden is high. Understanding the role of local factors is important for undertaking ethical research in developing countries. We explored factors relating to information and communication during the process of informed consent, and the approach that should be followed for gaining consent. The study was conducted prior to a family-based genetic study among people with podoconiosis (non-filarial elephantiasis) in southern Ethiopia. Methodology/Principal Findings We adapted (...) a method of rapid assessment validated in The Gambia. The methodology was entirely qualitative, involving focus-group discussions and in-depth interviews. Discussions were conducted with podoconiosis patients and non-patients in the community, fieldworkers, researchers, staff of the local non-governmental organisation (NGO) working on prevention and treatment of podoconiosis, and community leaders. We found that the extent of use of everyday language, the degree to which expectations of potential participants were addressed, and the techniques of presentation of information had considerable impact on comprehension of information provided about research. Approaching podoconiosis patients via locally trusted individuals and preceding individual consent with community sensitization were considered the optimal means of communication. Prevailing poverty among podoconiosis patients, the absence of alternative treatment facilities, and participants' trust in the local NGO were identified as potential barriers for obtaining genuine informed consent. Conclusions Researchers should evaluate the effectiveness of consent processes in providing appropriate information in a comprehensible manner and in supporting voluntary decision-making on a study-by-study basis. (shrink)
The UK Chief Medical Officer’s 2016 Annual Report, Generation Genome, focused on a vision to fully integrate genomics into all aspects of the UK’s National Health Service. This process of integration, which has now already begun, raises a wide range of social and ethical concerns, many of which were discussed in the final Chapter of the report. This paper explores how the UK’s 100,000 Genomes Project —the catalyst for Generation Genome, and for bringing genomics into the NHS—is negotiating these ethical (...) concerns. The UK’s 100 kGP, promoted and delivered by Genomics England Limited, is an innovative venture aiming to sequence 100,000 genomes from NHS patients who have a rare disease, cancer, or an infectious disease. GEL has emphasised the importance of ethical governance and decision-making. However, some sociological critique argues that biomedical/technological organisations presenting themselves as ‘ethical’ entities do not necessarily reflect a space within which moral thinking occurs. Rather, the ‘ethical work’ conducted by organisations is more strategic, relating to the politics of the organisation and the need to build public confidence. We set out to explore whether GEL’s ethical framework was reflective of this critique, and what this tells us more broadly about how genomics is being integrated into the NHS in response to the ethical and social concerns raised in Generation Genome. We do this by drawing on a series of 20 interviews with individuals associated with or working at GEL. (shrink)
BackgroundThe consent process for a genetic study is challenging when the research is conducted in a group stigmatized because of beliefs that the disease is familial. Podoconiosis, also known as 'mossy foot', is an example of such a disease. It is a condition resulting in swelling of the lower legs among people exposed to red clay soil. It is a very stigmatizing problem in endemic areas of Ethiopia because of the widely held opinion that the disease runs in families and (...) is untreatable. The aim of this study was to explore the impact of social stigma on the process of obtaining consent for a study on the genetics of podoconiosis in Southern Ethiopia.MethodsWe adapted a rapid assessment tool validated in The Gambia. The methodology was qualitative involving focus-group discussions (n = 4) and in-depth interviews (n = 25) with community members, fieldworkers, researchers and staff of the Mossy Foot Treatment and Prevention Association (MFTPA) working on prevention and treatment of podoconiosis.ResultsWe found that patients were afraid of participation in a genetic study for fear the study might aggravate stigmatization by publicizing the familial nature of the disease. The MFTPA was also concerned that discussion about the familial nature of podoconiosis would disappoint patients and would threaten the trust they have in the organization. In addition, participants of the rapid assessment stressed that the genetic study should be approved at family level before prospective participants are approached for consent. Based on this feedback, we developed and implemented a consent process involving community consensus and education of fieldworkers, community members and health workers. In addition, we utilized the experience and established trust of the MFTPA to diminish the perceived risk.ConclusionThe study showed that the consent process developed based on issues highlighted in the rapid assessment facilitated recruitment of participants and increased their confidence that the genetic research would not fuel stigma. Therefore, investigators must seek to assess and address risks of research from prospective participants' perspectives. This involves understanding the issues in the society, the culture, community dialogues and developing a consent process that takes all these into consideration. (shrink)
Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia.
Clinical practice and research are governed by distinct rules and regulations and have different approaches to, for example, consent and providing results. However, genomics is an example of where research and clinical practice have become codependent. The 100 000 genomes project is a hybrid venture where a person can obtain a clinical investigation only if he or she agrees to also participate in ongoing research—including research by industry and commercial companies. In this paper, which draws on 20 interviews with professional (...) stakeholders involved in 100kGP, we investigate the ethical issues raised by this project’s hybrid nature. While some interviewees thought the hybrid nature of 100kGP was its vanguard, interviewees identified several tensions around hybrid practice: how to decide who should be able to participate; how to determine whether offering results might unduly influence participation into wide-ranging but often as yet unknown research and how to ensure that patients/families do not develop false expectations about receiving results. These areas require further debate as 100kGP moves into routine healthcare in the form of the national genomic medicine service. To address the tensions identified, we explore the appropriateness of Faden et al.’s framework of ethical obligations for when research and clinical care are completely integrated. We also argue that enabling ongoing transparent and trustworthy communication between patients/families and professionals around the kinds of research that should be permitted in 100kGP will help to understand and ensure that expectations remain realistic. Our paper aims to encourage a focused discussion about these issues and to inform a new ‘social contract’ for research and clinical care in the health service. (shrink)
This article reviews practitioners’ evaluations of in-hospital ethics seminars. A qualitative study included 11 innovative in-hospital ethics seminars, preceded and followed by interviews with most participants. The settings were obstetric, neonatal and haematology units in a teaching hospital and a district general hospital in England. Fifty-six health service staff in obstetric, neonatal, haematology, and related community and management services participated; 12 attended two seminars, giving a total of 68 attendances and 59 follow-up evaluation interviews. The 11 seminars facilitated by an (...) ethicist addressed the key local concerns of staff about the social and ethical consequences of advances in genetics and their impact on professional policies and practice. Seminar agendas were drawn from prior interviews with 70 staff members. During evaluation interviews, participants commented on general aspects that they had enjoyed, how the sessions could be improved, timing, the mix of participants, the quality of the facilitation, whether sessions should be more challenging, after-effects of sessions, and interest in attending seminars and contacting the ethicist in future. Participants valued the increased interprofessional understanding and coherent discussion of many pressing issues that addressed important though seldom discussed ethical questions. The seminars worked well in the different hospitals and specialties. (shrink)
This paper aims to make an empirically informed analytical contribution to the development of a more socially embedded bioethics. Drawing upon 10 interviews with cutting edge stem cell researchers (5 scientists and 5 clinicians) it explores and illustrates the ways in which the role positions of translational researchers are shaped by the ‘normative structures’ of science and medicine respectively and in combination. The empirical data is used to illuminate three overlapping themes of ethical relevance: what matters in stem cell research, (...) experimental treatment, and responsible claim making (as contrasted with ‘hype’. Finally, we suggest that this kind of ‘descriptive’ ethical analysis has potential relevance for understanding other substantive areas of stem cell ethics in practice, and we briefly consider the questions our analysis raises about role positions and ethical agency, and the implications for bioethics as a field of scholarship. (shrink)
This paper reports from an ongoing multidisciplinary, ethnographic study that is exploring the views, values and practices (the ethical frameworks) drawn on by professional staff in assisted conception units and stem cell laboratories in relation to embryo donation for research purposes, particularly human embryonic stem cell (hESC) research, in the UK. We focus here on the connection between possible incidental findings and the circumstances in which embryos are donated for hESC research, and report some of the uncertainties and dilemmas of (...) our staff participants. We explore the views of our study participants in relation to two themes: (1) rights to information and anticipating how donors might be informed about future research findings and (2) occupational work goals and trust. (shrink)
_BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...) its likely impact. Studies must be scientifically valid; for research articles this includes a scientifically sound research question, the use of suitable methods and analysis, and following community-agreed standards relevant to the research field. Specific criteria for other article types can be found in the submission guidelines. _BMC series - open, inclusive and trusted_. (shrink)
A personal reflection upon a career in medical ethics leads to four conclusions on what makes for 'good medical ethics'. Good medical ethics is practical in approach, philosophically well grounded, cross disciplinary, and while it might not be a necessary feature, the experience of the author suggests that it is the work of 'good people'.
Background Rapid Ethical Assessment is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia. Methods Mixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health (...) researchers and regulators including ethics committee members in Ethiopian health research institutions and universities. Results In their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity, inadequate information, language barriers, cultural differences, undue expectations and power imbalances. About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed. Conclusion The study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders to address these gaps. Exploring further the feasibility and applicability of REA is recommended. (shrink)
The diagnostic and treatment possibilities made possible by the development and subsequent mainstreaming of clinical genomics services have the potential to profoundly change the experiences of families affected by rare genetic conditions. Understanding the potentials of genomic medicine requires that we consider the perspectives of those who engage with such services; there are substantial social implications involved. There are increasing calls to think more creatively, and draw on more participatory approaches, in evoking rich accounts of lived experience. In this article, (...) we discuss our rationale for, and experiences of, using ‘participatory-writing’ to understand the diverse, variable and multilayered everyday lives of families and how these correspond with the emerging, rapidly changing and complex field of genomic medicine. Participatory-writing has many benefits as a method for social inquiry. Writing can be expressive and self-revelatory, providing insight into personal and sensitive topics. Writing together produces new conversations and relationships. Pieces written by participants have the potential to affect readers, evoking and enlivening research and prompting professional change. Working with a writing tutor, we organised a participatory-writing programme for families touched by genetic conditions. This involved a series of workshops with an emphasis on building confidence in expressing lived experience through experimenting with different writing techniques. Afterwards we arranged reflective interviews with participants. We drew on dialogical narrative analysis to engage with participants’ written pieces, and highlight what everyday life is like for the people who live with, and care for, those with genetic conditions. The stories produced through our writing-groups unfold the implications of new genomic technologies, illuminating how genomics acts to reconfigure aspects of people’s lives outside of the clinic, while simultaneously existing as a sociotechnical frame that can eclipse the wider contexts, challenges and liveliness of life with rare genetic conditions. (shrink)