ObjectiveTo examine health and social care professionals’ understanding of the legislation govern... more 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 (76%–82%). Nearly half of the participants (46%) provided responses that were discordant in all scenarios. Only two participants (2%) 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 finding...
In response to increasing concerns regarding inconsistency in the decision-making of institutiona... more In response to increasing concerns regarding inconsistency in the decision-making of institutional review boards (IRBs), we introduce the decision-maker's dilemma, which arises when complex, normative decisions must be made regularly. Those faced with such decisions can either develop a process of algorithmic decision-making, in which consistency is ensured but many morally relevant factors are excluded from the process, or embrace discretionary decision making , which makes space for morally relevant factors to shape decisions but leads to decisions that are inconsistent. Based on an exploration of similarities between systems of criminal sentencing and of research ethics review, we argue for a discretionary system of decision-making, even though it leads to more inconsistency than does an algorithmic system. We conclude with a discussion of some safeguards that could improve consistency while still making space for discretion to enter IRBs' decision-making processes.
Biomedical research funding bodies across Europe and North America increasingly encourage-and, in... more Biomedical research funding bodies across Europe and North America increasingly encourage-and, in some cases, require-investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what 'good' or 'successful' public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public ...
This paper reports the process and outcome of a consensus finding project, which began with a mee... more This paper reports the process and outcome of a consensus finding project, which began with a meeting at the Brocher Foundation in May 2015. The project sought to generate and reach consensus on standards of practice for Empirical Bioethics research. The project involved 16 academics from 5 different European Countries, with a range of disciplinary backgrounds. The consensus process used a modified Delphi approach. Consensus was reached on 15 standards of practice, organised into 6 domains of research practice (Aims, Questions, Integration, Conduct of Empirical Work, Conduct of Normative Work; Training & Expertise). Through articulating these standards we outline a position that encourages responses, and through those responses we will be able to identify points of agreement and contestation that will drive the conversation forward. In that vein, we would encourage researchers, funders and journals to engage with what we have proposed, and respond to us, so that our community of pra...
The European journal of cardiovascular medicine, 2016
Research in the emergency setting involving patients with acute clinical conditions is needed if ... more Research in the emergency setting involving patients with acute clinical conditions is needed if there are to be advances in diagnosis and treatment. But research in these areas poses ethical and practical challenges. One of these is the general inability to obtain informed consent due to the patient's lack of mental capacity and insufficient time to contact legal representatives. Regulatory frameworks which allow this research to proceed with a consent 'waiver', provided patients lack mental capacity, miss important ethical subtleties. One of these is the varying nature of mental capacity among emergency medicine patients. Not only is their capacity variable and often unclear, but some patients are also likely to be able to engage with the researcher and the context to varying degrees. In this paper we describe the key elements of a novel enrolment process for emergency medicine research that refines the consent waiver and fully engages with the ethical rationale for co...
The Journal of medicine and philosophy, Jan 2, 2016
The language of ethics expertise has become particularly important in bioethics in light of effor... more The language of ethics expertise has become particularly important in bioethics in light of efforts to establish the value of the clinical ethics consultation (CEC), to specify who is qualified to function as a clinical ethics consultant, and to characterize how one should evaluate whether or not a person is so qualified. Supporters and skeptics about the possibility of ethics expertise use the language of ethics expertise in ways that reflect competing views about what ethics expertise entails. We argue for clarity in understanding the nature of expertise and ethics expertise. To be an ethics expert, we argue, is to be an expert in knowing what ought to be done. Any attempt to articulate expertise with respect to knowing what ought to be done must include an account of ethics that specifies the nature of moral truth and the means by which we access this truth or a theoretical account of ethics such that expertise in another domain is linked to knowing or being better at judging wha...
Http Dx Doi Org 10 1080 15265161 2010 489417, Jun 23, 2010
Like Murphy (2010), we wish to begin our commentary with a disclosure. At least one us has found ... more Like Murphy (2010), we wish to begin our commentary with a disclosure. At least one us has found ourselves being sexually attracted to participants that we have recruited into our studies, and at least one of us has found ourselves in the position of being propositioned by our participants while undertaking such research. However, in both situations, no relationship—sexual, or of any other personal kind—was pursued. After all, this was research, and these women were participants.
Http Dx Doi Org 10 1080 15265160903088151, Jul 10, 2009
Either your web browser doesn't support Javascript or it is currently turned off. In the lat... more Either your web browser doesn't support Javascript or it is currently turned off. In the latter case, please turn on Javascript support in your web browser and reload this page. ... Disclosing clinical trial results: publicity, significance and independence. ... Find all citations by this author (default). ... Find all citations by this author (default). ... Find all citations by this author (default). ... Find all citations in this journal (default). ... Pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, ...
Multiple sclerosis (Houndmills, Basingstoke, England), Jun 14, 2015
To date, no treatment for neuromyelitis optica (NMO) has been granted regulatory approval, and no... more To date, no treatment for neuromyelitis optica (NMO) has been granted regulatory approval, and no controlled clinical studies have been reported. To design a placebo-controlled study in NMO that appropriately balances patient safety and clinical-scientific integrity. We assessed the "standard of care" for NMO to establish the ethical framework for a placebo-controlled trial. We implemented measures that balance the need for scientific robustness while mitigating the risks associated with a placebo-controlled study. The medical or scientific community, patient organizations, and regulatory authorities were engaged early in discussions on this placebo-controlled study, and their input contributed to the final study design. The N-MOmentum study (NCT02200770) is a clinical trial that randomizes NMO patients to receive MEDI-551, a monoclonal antibody that depletes CD19+ B-cells, or placebo. The study design has received regulatory, ethical, clinical, and patient approval in ove...
ObjectiveTo examine health and social care professionals’ understanding of the legislation govern... more 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 (76%–82%). Nearly half of the participants (46%) provided responses that were discordant in all scenarios. Only two participants (2%) 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 finding...
In response to increasing concerns regarding inconsistency in the decision-making of institutiona... more In response to increasing concerns regarding inconsistency in the decision-making of institutional review boards (IRBs), we introduce the decision-maker's dilemma, which arises when complex, normative decisions must be made regularly. Those faced with such decisions can either develop a process of algorithmic decision-making, in which consistency is ensured but many morally relevant factors are excluded from the process, or embrace discretionary decision making , which makes space for morally relevant factors to shape decisions but leads to decisions that are inconsistent. Based on an exploration of similarities between systems of criminal sentencing and of research ethics review, we argue for a discretionary system of decision-making, even though it leads to more inconsistency than does an algorithmic system. We conclude with a discussion of some safeguards that could improve consistency while still making space for discretion to enter IRBs' decision-making processes.
Biomedical research funding bodies across Europe and North America increasingly encourage-and, in... more Biomedical research funding bodies across Europe and North America increasingly encourage-and, in some cases, require-investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what 'good' or 'successful' public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public ...
This paper reports the process and outcome of a consensus finding project, which began with a mee... more This paper reports the process and outcome of a consensus finding project, which began with a meeting at the Brocher Foundation in May 2015. The project sought to generate and reach consensus on standards of practice for Empirical Bioethics research. The project involved 16 academics from 5 different European Countries, with a range of disciplinary backgrounds. The consensus process used a modified Delphi approach. Consensus was reached on 15 standards of practice, organised into 6 domains of research practice (Aims, Questions, Integration, Conduct of Empirical Work, Conduct of Normative Work; Training & Expertise). Through articulating these standards we outline a position that encourages responses, and through those responses we will be able to identify points of agreement and contestation that will drive the conversation forward. In that vein, we would encourage researchers, funders and journals to engage with what we have proposed, and respond to us, so that our community of pra...
The European journal of cardiovascular medicine, 2016
Research in the emergency setting involving patients with acute clinical conditions is needed if ... more Research in the emergency setting involving patients with acute clinical conditions is needed if there are to be advances in diagnosis and treatment. But research in these areas poses ethical and practical challenges. One of these is the general inability to obtain informed consent due to the patient's lack of mental capacity and insufficient time to contact legal representatives. Regulatory frameworks which allow this research to proceed with a consent 'waiver', provided patients lack mental capacity, miss important ethical subtleties. One of these is the varying nature of mental capacity among emergency medicine patients. Not only is their capacity variable and often unclear, but some patients are also likely to be able to engage with the researcher and the context to varying degrees. In this paper we describe the key elements of a novel enrolment process for emergency medicine research that refines the consent waiver and fully engages with the ethical rationale for co...
The Journal of medicine and philosophy, Jan 2, 2016
The language of ethics expertise has become particularly important in bioethics in light of effor... more The language of ethics expertise has become particularly important in bioethics in light of efforts to establish the value of the clinical ethics consultation (CEC), to specify who is qualified to function as a clinical ethics consultant, and to characterize how one should evaluate whether or not a person is so qualified. Supporters and skeptics about the possibility of ethics expertise use the language of ethics expertise in ways that reflect competing views about what ethics expertise entails. We argue for clarity in understanding the nature of expertise and ethics expertise. To be an ethics expert, we argue, is to be an expert in knowing what ought to be done. Any attempt to articulate expertise with respect to knowing what ought to be done must include an account of ethics that specifies the nature of moral truth and the means by which we access this truth or a theoretical account of ethics such that expertise in another domain is linked to knowing or being better at judging wha...
Http Dx Doi Org 10 1080 15265161 2010 489417, Jun 23, 2010
Like Murphy (2010), we wish to begin our commentary with a disclosure. At least one us has found ... more Like Murphy (2010), we wish to begin our commentary with a disclosure. At least one us has found ourselves being sexually attracted to participants that we have recruited into our studies, and at least one of us has found ourselves in the position of being propositioned by our participants while undertaking such research. However, in both situations, no relationship—sexual, or of any other personal kind—was pursued. After all, this was research, and these women were participants.
Http Dx Doi Org 10 1080 15265160903088151, Jul 10, 2009
Either your web browser doesn't support Javascript or it is currently turned off. In the lat... more Either your web browser doesn't support Javascript or it is currently turned off. In the latter case, please turn on Javascript support in your web browser and reload this page. ... Disclosing clinical trial results: publicity, significance and independence. ... Find all citations by this author (default). ... Find all citations by this author (default). ... Find all citations by this author (default). ... Find all citations in this journal (default). ... Pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, ...
Multiple sclerosis (Houndmills, Basingstoke, England), Jun 14, 2015
To date, no treatment for neuromyelitis optica (NMO) has been granted regulatory approval, and no... more To date, no treatment for neuromyelitis optica (NMO) has been granted regulatory approval, and no controlled clinical studies have been reported. To design a placebo-controlled study in NMO that appropriately balances patient safety and clinical-scientific integrity. We assessed the "standard of care" for NMO to establish the ethical framework for a placebo-controlled trial. We implemented measures that balance the need for scientific robustness while mitigating the risks associated with a placebo-controlled study. The medical or scientific community, patient organizations, and regulatory authorities were engaged early in discussions on this placebo-controlled study, and their input contributed to the final study design. The N-MOmentum study (NCT02200770) is a clinical trial that randomizes NMO patients to receive MEDI-551, a monoclonal antibody that depletes CD19+ B-cells, or placebo. The study design has received regulatory, ethical, clinical, and patient approval in ove...
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