Society is failing in its moral obligation to improve the standard of healthcare provided to vulnerable populations, such as people who lack decision making capacity, by a misguided paternalism that seeks to protect them by excluding them from medical research. Uncertainties surround the basis on which decisions about research participation is made under dual regulatory regimes, which adds further complexity. Vulnerable individuals’ exclusion from research as a result of such regulation risks condemning such populations to poor quality care as a (...) result of ‘evidence biased’ medicine. This paper explores the research regulation provisions for proxy decision making for those unable to provide informed consent for themselves, and the subsequent legal and practical difficulties for decision-makers. There are two separate regulatory regimes governing research involving adults who lack capacity to consent in England and Wales. The Mental Capacity Act 2005 governs how incapacitated adults can be involved in research, however clinical trials of medicinal products are separately regulated by the Medicines for Human Use Regulations 2004. There are significant differences under these dual regimes in the provisions for those lacking capacity to participate in medical research. The level of risk permitted differs, with a greater requirement for justification for participation in a clinical trial than other types of research. Who acts as proxy decision maker, how much information is provided to the person lacking capacity, and whether they retain the power of veto also significantly differs. The development of two separate regulatory regimes has resulted in significant differences between the provisions for clinical trials and other forms of research, and from usual medical practice. The resulting uncertainty has reinforced the tendency of those approving and conducting research to exclude adults lacking capacity to avoid difficult decisions about seeking consent for their participation. Future developments, such as the incoming EU Regulations, may address some of these differences, however the justification and level of risk permitted requires review to ensure that requirements are appropriate and proportionate to the burdens and risks for the individual, and also to the benefits for the wider population represented. (shrink)

ObjectiveTo examine health and social care professionals’ understanding of the legislation governing research involving adults lacking mental capacity in England and Wales.MethodsA cross-sectional online survey was conducted using a series of vignettes. Participants were asked to select the legally authorised decision-maker in each scenario and provide supporting reasons. Responses were compared with existing legal frameworks and analysed according to their level of concordance.ResultsOne hundred and twenty-seven professionals participated. Levels of discordance between responses and the legal frameworks were high across all (...) five scenarios. Nearly half of the participants provided responses that were discordant in all scenarios. Only two participants provided concordant responses across all five scenarios.DiscussionParticipants demonstrated a lack of knowledge about the legal frameworks, the locus of authority and the legal basis for decision-making. The findings raise concern about the accessibility of research for those who lack capacity, the ability to conduct research involving such groups and the impact on the evidence base for their care.ConclusionThis is the first study to examine health and social care professionals’ knowledge and understanding of the dual legal frameworks in the UK. Health and social care professionals’ understanding and attitudes towards research involving adults with incapacity may warrant further in-depth exploration. The findings from this survey suggest that greater training and education is required. (shrink)

Background Research is fundamental to improving the quality of health care. The need for regulation of research is clear. However, the bureaucratic complexity of research governance has raised concerns that the regulatory mechanisms intended to protect participants now threaten to undermine or stifle the research enterprise, especially as this relates to sensitive topics and hard to reach groups. Discussion Much criticism of research governance has focused on long delays in obtaining ethical approvals, restrictions imposed on study conduct, and the inappropriateness (...) of evaluating qualitative studies within the methodological and risk assessment frameworks applied to biomedical and clinical research. Less attention has been given to the different epistemologies underlying biomedical and qualitative investigation. The bioethical framework underpinning current regulatory structures is fundamentally at odds with the practice of emergent, negotiated micro-ethics required in qualitative research. The complex and shifting nature of real world settings delivers unanticipated ethical issues and (occasionally) genuine dilemmas which go beyond easy or formulaic ‘procedural’ resolution. This is not to say that qualitative studies are ‘unethical’ but that their ethical nature can only be safeguarded through the practice of ‘micro-ethics’ based on the judgement and integrity of researchers in the field. Summary This paper considers the implications of contrasting ethical paradigms for the conduct of qualitative research and the value of ‘empirical ethics’ as a means of liberating qualitative (and other) research from an outmoded and unduly restrictive research governance framework based on abstract prinicipalism, divorced from real world contexts and values. (shrink)

This paper considers concerns that social care research may be stifled by health-focused ethical scrutiny under the Mental Capacity Act 2005 and the requirement for an ?appropriate body? to determine ethical approval for research involving people who are deemed to lack capacity under the Act to make decisions concerning their participation and consent in research. The current study comprised an online survey of current practice in university research ethics committees (URECs), and explored through semi-structured interviews the views of social researchers (...) engaged in or exploring work concerning people who may, under the Act, lack the capacity to make decisions to consent to participate in a research programme. The paper concludes that there was a lack of overt knowledge of and reference to the implications of the Act for research and some concerns that a restrictive focus on health-related scrutiny might prevent social care research from taking place. There was also a degree of creativity shown by social care researchers in responding to changing demands and a wish to assist people in making decisions to participate where possible. (shrink)

Background Conducting ethically sound research is a fundamental principle of scientific inquiry. Recent research has indicated that ethical concerns are insufficiently dealt with in dissertations. Purpose To examine which research ethical topics were addressed and how these were presented in terms of complexity of reasoning in Swedish nurses' dissertations. Methods Analyses of ethical content and complexity of ethical reasoning were performed on 64 Swedish nurses' PhD dissertations dated 2007. Results A total of seven ethical topics were identified: ethical approval (94% (...) of the dissertations), information and informed consent (86%), confidentiality (67%), ethical aspects of methods (61%), use of ethical principles and regulations (39%), rationale for the study (20%) and fair participant selection (14%). Four of those of topics were most frequently addressed: the majority of dissertations (72%) included 3–5 issues. While many ethical concerns, by their nature, involve systematic concepts or metasystematic principles, ethical reasoning scored predominantly at lesser levels of complexity: abstract (6% of the dissertations), formal (84%) and systematic (10%). Conclusions Research ethics are inadequately covered in most dissertations by nurses in Sweden. Important ethical concerns are missing, and the complexity of reasoning on ethical principles, motives and implications is insufficient. This is partly due to traditions and norms that discount ethical concerns but is probably also a reflection of the ability of PhD students and supervisors to handle complexity in general. It is suggested that the importance of ethical considerations should be emphasised in graduate and post-graduate studies and that individuals with capacity to deal with systematic and metasystematic concepts are recruited to senior research positions. (shrink)

Infectious disease outbreaks in residential care are complex to manage and difficult to control. Research in this setting that includes individuals who lack capacity must conform to national legislation. We report here on our study that is investigating outbreaks of scabies, an itchy skin infection, in the residential care setting in the southeast of England. There appears to be a gap in legislative advice regarding the inclusion of people who lack capacity in research that takes place during time-limited acute scenarios (...) such as outbreaks. We received inconsistent advice from experts regarding, in particular, the role of nominated consultees. There is a potential inequality for vulnerable populations who cannot themselves provide informed consent in terms of their access to participation in a range of health-related research. (shrink)