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1.  Can animal data translate to innovations necessary for a new era of patient-centred and individualised healthcare? Bias in preclinical animal research 
BMC Medical Ethics  2015;16:53.
The public and healthcare workers have a high expectation of animal research which they perceive as necessary to predict the safety and efficacy of drugs before testing in clinical trials. However, the expectation is not always realised and there is evidence that the research often fails to stand up to scientific scrutiny and its 'predictive value' is either weak or absent.
Problems with the use of animals as models of humans arise from a variety of biases and systemic failures including: 1) bias and poor practice in research methodology and data analysis; 2) lack of transparency in scientific assessment and regulation of the research; 3) long-term denial of weaknesses in cross-species translation; 4) profit-driven motives overriding patient interests; 5) lack of accountability of expenditure on animal research; 6) reductionist-materialism in science which tends to dictate scientific inquiry and control the direction of funding in biomedical research.
Bias in animal research needs to be addressed before medical research and healthcare decision-making can be more evidence-based. Research funding may be misdirected on studying 'disease mechanisms' in animals that cannot be replicated outside tightly controlled laboratory conditions, and without sufficient critical evaluation animal research may divert attention away from avenues of research that hold promise for human health. The potential for harm to patients and trial volunteers from reliance on biased animal data1 requires measures to improve its conduct, regulation and analysis. This article draws attention to a few of the many forms of bias in animal research that have come to light in the last decade and offers a strategy incorporating ten recommendations stated at the end of each section on bias. The proposals need development through open debate and subsequent rigorous implementation so that reviewers may determine the value of animal research to human health. The 10Rs + are protected by a Creative Commons Attribution 3.0 Unported License and therefore may be 'shared, remixed or built on, even commercially, so long as attributed by giving appropriate credit with a link to the license, and indicate if changes were made.’
Electronic supplementary material
The online version of this article (doi:10.1186/s12910-015-0043-7) contains supplementary material, which is available to authorized users.
PMCID: PMC4517563  PMID: 26215508
Systematic review; Bias; Animal models; Research volunteers; Patients; Pre-clinical; Translational; Reproducibility; Waste in research; Phase 1 trials
2.  Ethical decision making in dental education: a preliminary study 
BMC Medical Ethics  2015;16:52.
In terms of ethical decision making, every clinical case, when seen as an ethical problem, may be analyzed by means of four topics: medical indications, patient preferences, quality of life, contextual features. The aim of this study was to compare the performance of 4th year dental students on Ethical Decision Making before and after a course on ethics.
Fourth year dental students (n = 37) from academic year 2013–2014 participated in the study. A 3-h lecture, which was about four topics approach to clinical ethical case analysis, was given to the students. The lecture was based on case scenarios related with dental ethics. After the completion of lectures,a case scenario was presented to the students to assess their ethical decision making abilities. At the end of the exam, four topics and ethical judgment were evaluated. Their performances on this examination were evaluated before and after lectures. Statistical evaluation was performed with the significance level set at p < 0.05.
A statistically significant difference was found between the means of four topics (p < 0.05). There was no statistically significant difference between the mean scores of judgment of ethical decision (p > 0.05). The mean total score of the students after the course was significantly higher than before course (67.5 and 54.4, respectively; p < 0.05).
More lectures should be implemented to the curriculum to increase the student awareness of ethical issues and to reach the ultimate goals of dental education.
PMCID: PMC4517630  PMID: 26215591
Ethical decision making; Dental education; HIV
3.  Can UK NHS research ethics committees effectively monitor publication and outcome reporting bias? 
BMC Medical Ethics  2015;16:51.
Publication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service (NHS) research ethics committee to monitor both types of reporting bias.
As part of an internal audit we accessed research ethics database records for studies submitting an end of study declaration to the Hampshire A research ethics committee (formerly Southampton A) between 1st January 2010 and 31st December 2011. A literature search was used to establish the publication status of studies. Primary and secondary outcomes stated in application forms were compared with outcomes reported in publications.
Out of 116 studies the literature search identified 57 publications for 37 studies giving a publication rate of 32 %. Original Research Ethics Committee (REC) applications could be obtained for 28 of the published studies. Outcome inconsistencies were found in 16 (57 %) of the published studies.
This study showed that the problem of publication and outcome reporting bias is still significant in the UK. The method described here demonstrates that UK NHS research ethics committees are in a good position to detect such bias due to their unique access to original research protocols. Data gathered in this way could be used by the Health Research Authority to encourage higher levels of transparency in UK research.
PMCID: PMC4513637  PMID: 26206479
Publication ethics; Reporting bias; Publication bias; Research ethics; Ethics committees
4.  How do physicians perceive quality of life? Ethical questioning in neonatology 
BMC Medical Ethics  2015;16:50.
The outcome of very preterm infants is marked by the development of complications that can have an impact on the quality of life of the children and their families. The concept of quality of life and its evaluation in the long term raise semantic and ethical problems for French physicians in perinatal care. Our reflection aims to gain a better understanding of the representations surrounding quality of life in neonatal medicine.
If French physicians hesitate to face this concept (through self-interest and apprehension), it is because the debate has become more complex. Formerly, the dilemma was between respect for life versus quality of life. Today, although this dilemma is still with us, the questions raised by French physicians show us that autonomy is given increasing importance. The equation to be solved now contains three variables: respect for life, well-being, autonomy. So we find ourselves between three positions and no longer two: respect for life (the ethics of conviction), quality of life based on autonomy (rationalist and secular deontologism), and quality of life based on the differential between well-being and suffering (utilitarianism).
A solution could lie in consequentialism, which integrates the consequences for future generations in terms of both safeguarding of autonomy and quality of life, and puts the sacredness of life in second place but without sacrificing it. By evaluating their future quality of life, we can better respond to the needs of these children.
PMCID: PMC4512037  PMID: 26204881
Autonomy; Ethics; Neonatology; Quality of life; Perception; Prematurity; Responsability
5.  Population attitudes towards research use of health care registries: a population-based survey in Finland 
BMC Medical Ethics  2015;16:48.
Register-based research can provide important and valuable contributions to public health research, but involves ethical issues concerning the balance of public health benefits and individual autonomy. This study aimed to describe the opinions of the Finnish public about these issues.
Mail survey questionnaire sent to a random sample of 1000 Finns.
Participation proportion was 42 %, with 258 women and 160 men. The majority of the participants (61 %) were willing to provide their identifiable health information for research. Almost half of the participants (48 %) would, nevertheless, like to be informed when their information is used. A third (30 %) indicated no need for informed consent in register-based research, a similar proportion felt it should be obtained for every study, and 40 % thought it necessary in some situations, such as studies addressing a sensitive study topic. As for the best policy for obtaining consent, the majority (86 %) favoured broader consent methods: one consent covering a certain register or a research topic. Half of the participants (55 %) desired a required ethical evaluation from register-based research addressing a sensitive issue. Privacy protection was the most common concern for register-based research. More than half of the participants were either content with the current Finnish laws concerning register-based research or wanted to liberalize them to advance research.
The Finnish public is supportive of register-based research, but the requirement for informed consent divides opinions and many would at least like to be informed of the research use of their information.
Electronic supplementary material
The online version of this article (doi:10.1186/s12910-015-0040-x) contains supplementary material, which is available to authorized users.
PMCID: PMC4504396  PMID: 26183438
Informed consent; Medical records; Personal health records; Privacy; Research ethics
6.  Giving samples or “getting checked”: measuring conflation of observational biospecimen research and clinical care in Latino communities 
BMC Medical Ethics  2015;16:49.
Expectations of receiving personal health information as a fringe benefit of biospecimen donation—termed diagnostic misconception—are increasingly documented. We developed an instrument measuring conflation of observational biospecimen-based research and clinical care for use with Latino communities, who may be particularly affected by diagnostic misconception due to limited health care access.
The instrument was developed using prior qualitative research, revised through cognitive interviewing and expert review, and field tested in a convenience sample of 150 Latino adults in Eastern Washington State. It was further refined through exploratory factor analysis and validated against existing measures of genetic knowledge and researcher trust.
The final instrument demonstrated high internal consistency, evidence of content and construct validity, and no floor and ceiling effects. Individuals who were unemployed, spoke only Spanish, had no health insurance, received health care outside of traditional venues, and had good self-rated health received higher scores, indicating greater conflation of biospecimen-based research and clinical care.
The ability to systematically measure beliefs related to diagnostic misconception will help facilitate ethically-informed efforts to recruit Latinos into biospecimen-based research studies.
Electronic supplementary material
The online version of this article (doi:10.1186/s12910-015-0041-9) contains supplementary material, which is available to authorized users.
PMCID: PMC4504441  PMID: 26183580
Hispanic/Latino; Diagnostic misconception; Psychometrics; Measure construction; Biospecimen donation
7.  A risk screening tool for ethical appraisal of evidence-generating initiatives 
BMC Medical Ethics  2015;16:47.
The boundaries between health-related research and practice have become blurred as initiatives traditionally considered to be practice (e.g., quality improvement, program evaluation) increasingly use the same methodology as research. Further, the application of different ethical requirements based on this distinction raises concerns because many initiatives commonly labelled as “non-research” are associated with risks to patients, participants, and other stakeholders, yet may not be subject to any ethical oversight. Accordingly, we sought to develop a tool to facilitate the systematic identification of risks to human participants and determination of risk level across a broad range of projects (e.g., clinical research, laboratory-based projects, population-based surveillance, and program evaluation) and health-related contexts. This paper describes the development of the Public Health Ontario (PHO) Risk Screening Tool.
Development of the PHO Risk Screening Tool included: (1) preparation of a draft risk tool (n = 47 items); (2) expert appraisal; (3) internal stakeholder validation; (4) external validation; (5) pilot testing and evalution of the draft tool; and (6) revision after 1 year of testing.
A risk screening tool was generated consisting of 20 items organized into five risk domains: Sensitivity; Participant Selection, Recruitment and Consent; Data/Sample Collection; Identifiability and Privacy Risk; and Commercial Interests. The PHO Risk Screening Tool is an electronic tool, designed to identify potential project-associated risks to participants and communities and to determine what level of ethics review is required, if any. The tool features an easy to use checklist format that generates a risk score (0–3) associated with a suggested level of ethics review once all items have been completed. The final score is based on a threshold approach to ensure that the final score represents the highest level of risk identified in any of the domains of the tool.
The PHO Risk Screening Tool offers a practical solution to the problem of how to maintain accountability and appropriate risk oversight that transcends the boundaries of research and practice. We hope that the PHO Risk Screening Tool will prove useful in minimizing the problems of over and under protection across a wide range of disciplines and jurisdictions.
Electronic supplementary material
The online version of this article (doi:10.1186/s12910-015-0039-3) contains supplementary material, which is available to authorized users.
PMCID: PMC4494793  PMID: 26149410
Risk screening tool; Risk assessment; Risk; Ethics; Research; Quality improvement; Program evaluation; Evidence generating; Learning healthcare; Public Health
8.  The importance of reliable information exchange in emergency practices: a misunderstanding that was uncovered before it was too late 
BMC Medical Ethics  2015;16:46.
Many medical emergency practices are regulated by written procedures that normally provide reliable guidelines for action. In some cases, however, the consequences of following rule-based instructions can have unintended negative consequences. The article discusses a case - described on a type level - where the consequences of following a rule formulation could have been fatal.
Case presentation
A weak and elderly patient has cardiac arrest, and a Do Not Resuscitate (DNR) clause is written in the patient’s medical record. Paramedics at the scene cannot see that the patient’s general appearance match conditions which would indicate the DNR clause, so they start cardiopulmonary resuscitation (CPR), and the patient survives. This turns out to be a crucial decision. The DNR clause is from an earlier bout with serious disease from which the patient has recovered, against all odds, and someone has forgotten to remove the clause from the medical record.
In order to be able to interpret the validity of written guidelines, paramedics and other health workers need to develop personal skills that transcend the ability simply to follow written instructions. Within traditional virtue ethics, personal judgment is conceived of as crucial for being able to make ‘good’ autonomous decisions. Virtue ethical analyses, decision-making abilities and non-technical communication skills are important as conceptual tools when health workers need to make difficult clinical decisions.
The case study accentuates the significance of prudent judgment in medical practice. In the case described, the consequence of trusting the written advance directive could have been fatal, but the point is general: for the purpose of achieving excellent organizational performance, it is insufficient for health workers to rely uncritically on rules and procedures. Even the clearest rule formulations must be interpreted contextually in order to determine ethically correct behavior and avoid potential negative consequences that are not in the patient’s best interests.
PMCID: PMC4494799  PMID: 26149274
Cardiac arrest; Prehospital work; Resuscitation; Advance directives; Clinical judgment; Rule-based ethics; Virtue ethics
9.  Exploring researchers’ experiences of working with a researcher-driven, population-specific community advisory board in a South African schizophrenia genomics study 
BMC Medical Ethics  2015;16:45.
Community engagement within biomedical research is broadly defined as a collaborative relationship between a research team and a group of individuals targeted for research. A Community Advisory Board (CAB) is one mechanism of engaging the community. Within genomics research CABs may be particularly relevant due to the potential implications of research findings drawn from individual participants on the larger communities they represent. Within such research, CABs seek to meet instrumental goals such as protecting research participants and their community from research-related risks, as well as intrinsic goals such as promoting the respect of participants and their community. However, successful community engagement depends on the degree to which CABs legitimately represent and engage with communities targeted for research. Currently, there is little literature describing the use of CABs in genomics research taking place in developing countries, and even less in the field of genomics research relating to mental illness. The aim of this article is to describe and consider the contributions made by a researcher-driven, population-specific CAB in a genomics of schizophrenia research project taking place in South Africa, from the perspective of the research team.
Four broad discussion topics emerged during the CAB meetings namely: 1) informed consent procedures, 2) recruitment strategies, 3) patient illness beliefs and stigma experiences, and 4) specific ethical concerns relating to the project. The authors consider these discussions in terms of their contributions to instrumental and intrinsic goals of community engagement.
The CAB gave valuable input on the consent processes and materials, recruitment strategies and suggested ways of minimizing the potential for stigma and discrimination. All of these contributions were of an instrumental nature, and helped improve the way in which the research took place. In addition, and perhaps more importantly, the CAB made a unique and important contribution relating to intrinsic functions such as promoting the respect and dignity of research participants and their community. This was particularly evident in ensuring sensitivity and respect of the community’s traditional beliefs about schizophrenia and its treatment, and in this way promoting a respectful relationship between the research team and the participants.
PMCID: PMC4487967  PMID: 26135122
Community engagement; Genomics research; Community advisory board; Schizophrenia; Xhosa
10.  Evaluating community engagement in global health research: the need for metrics 
BMC Medical Ethics  2015;16:44.
Community engagement in research has gained momentum as an approach to improving research, to helping ensure that community concerns are taken into account, and to informing ethical decision-making when research is conducted in contexts of vulnerability. However, guidelines and scholarship regarding community engagement are arguably unsettled, making it difficult to implement and evaluate.
We describe normative guidelines on community engagement that have been offered by national and international bodies in the context of HIV-related research, which set the stage for similar work in other health related research. Next, we review the scholarly literature regarding community engagement, outlining the diverse ethical goals ascribed to it. We then discuss practical guidelines that have been issued regarding community engagement. There is a lack of consensus regarding the ethical goals and approaches for community engagement, and an associated lack of indicators and metrics for evaluating success in achieving stated goals. To address these gaps we outline a framework for developing indicators for evaluating the contribution of community engagement to ethical goals in health research.
There is a critical need to enhance efforts in evaluating community engagement to ensure that the work on the ground reflects the intentions expressed in the guidelines, and to investigate the contribution of specific community engagement practices for making research responsive to community needs and concerns. Evaluation mechanisms should be built into community engagement practices to guide best practices in community engagement and their replication across diverse health research settings.
PMCID: PMC4488111  PMID: 26126899
Research ethics; Community engagement; Participatory research; Global health; Evaluation; Metrics
11.  How much dentists are ethically concerned about overtreatment; a vignette-based survey in Switzerland 
BMC Medical Ethics  2015;16:43.
Overtreatment (or unnecessary treatment) is when medical or dental services are provided with a higher volume or cost than is appropriate. This study aimed to investigate how a group of dentists in Switzerland, a wealthy country known to have high standards of healthcare including dentistry, evaluated the meaning of unnecessary treatments from an ethical perspective and, assessed the expected frequency of different possible behaviors among their peers.
A vignette describing a situation that is susceptible for overtreatment of a patient was presented to a group of dentists. The vignette was followed by five options. A questionnaire including the vignette was posted to 2482 dentists in the German-speaking areas of Switzerland. The respondents were asked to rate each option according to their estimation about its prevalence and their judgment about the degree to which the behavior is ethically sound.
732 completed questionnaires were returned. According to the responses, the most ethical and the most unethical options are considered to be the most and the least prevalent behaviors among dentists practicing in Switzerland, respectively.
Suggesting unnecessary treatments to patients seems to be an ethically unacceptable conduct in the eyes of a sample of dentists in Switzerland. Although the respondents believed their colleagues were very likely to behave in an ethical way in response to a situation that is susceptible to overtreatment, they still seemed to be concerned about the prevalence of unethical behaviors in this regard.
PMCID: PMC4474445  PMID: 26088562
Overtreatment; Undertreatment; Ethical issues; Dental care; Dentists
12.  Understandings of genomic research in developing countries: a qualitative study of the views of MalariaGEN participants in Mali 
BMC Medical Ethics  2015;16:42.
Obtaining informed consent for participation in genomic research in low-income settings presents specific ethical issues requiring attention. These include the challenges that arise when providing information about unfamiliar and technical research methods, the implications of complicated infrastructure and data sharing requirements, and the potential consequences of future research with samples and data. This study investigated researchers’ and participants’ parents’ experiences of a consent process and understandings of a genome-wide association study of malaria involving children aged five and under in Mali. It aimed to inform best practices in recruiting participants into genomic research.
A qualitative rapid ethical assessment was undertaken. Fifty-five semi-structured interviews were conducted with the parents of research participants. An additional nine semi-structured interviews were conducted with senior research scientists, research assistants and with a member of an ethics committee. A focus group with five parents of research participants and direct observations of four consent processes were also conducted. French and translated English transcripts were descriptively and thematically coded using OpenCode software.
Participants’ parents in the MalariaGEN study had differing understandings of the causes of malaria, the rationale for collecting blood samples, the purposes of the study and the kinds of information the study would generate. Genomic aspects of the research, including the gene/environment interaction underlying susceptibility or resistance to severe malaria, proved particularly challenging to explain and understand.
This study identifies a number of areas to be addressed in the design of consent processes for genomic research, some of which require careful ethical analysis. These include determining how much information should be provided about differing aspects of the research and how best to promote understandings of genomic research. We conclude that it is important to build capacity in the design and conduct of effective and appropriate consent processes for genomic research in low and middle-income settings. Additionally, consideration should be given to the role of review committees and community consultation activities in protecting the interests of participants in genomic research.
Electronic supplementary material
The online version of this article (doi:10.1186/s12910-015-0035-7) contains supplementary material, which is available to authorized users.
PMCID: PMC4469103  PMID: 26077875
Consent; Research ethics; Bioethics; Children; Genomic research; Mali; Malaria; Qualitative research
13.  Eating and drinking interventions for people at risk of lacking decision-making capacity: who decides and how? 
BMC Medical Ethics  2015;16:41.
Some people with progressive neurological diseases find they need additional support with eating and drinking at mealtimes, and may require artificial nutrition and hydration. Decisions concerning artificial nutrition and hydration at the end of life are ethically complex, particularly if the individual lacks decision-making capacity. Decisions may concern issues of life and death: weighing the potential for increasing morbidity and prolonging suffering, with potentially shortening life. When individuals lack decision-making capacity, the standard processes of obtaining informed consent for medical interventions are disrupted. Increasingly multi-professional groups are being utilised to make difficult ethical decisions within healthcare. This paper reports upon a service evaluation which examined decision-making within a UK hospital Feeding Issues Multi-Professional Team.
A three month observation of a hospital-based multi-professional team concerning feeding issues, and a one year examination of their records. The key research questions are: a) How are decisions made concerning artificial nutrition for individuals at risk of lacking decision-making capacity? b) What are the key decision-making factors that are balanced? c) Who is involved in the decision-making process?
Decision-making was not a singular decision, but rather involved many different steps. Discussions involving relatives and other clinicians, often took place outside of meetings. Topics of discussion varied but the outcome relied upon balancing the information along four interdependent axes: (1) Risks, burdens and benefits; (2) Treatment goals; (3) Normative ethical values; (4) Interested parties.
Decision-making was a dynamic ongoing process with many people involved. The multiple points of decision-making, and the number of people involved with the decision-making process, mean the question of ‘who decides’ cannot be fully answered. There is a potential for anonymity of multiple decision-makers to arise. Decisions in real world clinical practice may not fit precisely into a model of decision-making. The findings from this service evaluation illustrate that within multi-professional team decision-making; decisions may contain elements of both substituted and supported decision-making, and may be better represented as existing upon a continuum.
PMCID: PMC4462006  PMID: 26062801
Decision-making capacity; Healthcare decisions; Multi-professional; Artificial nutrition; Eating and drinking interventions; Progressive neurological disease
14.  “It scares me to know that we might not have been there!”: a qualitative study into the experiences of parents of seriously ill children participating in ethical case discussions 
BMC Medical Ethics  2015;16:40.
All hospital trusts in Norway have clinical ethics committees (CEC). Some of them invite next of kin/patients to be present during the discussion of their case. This study looks closer at how parents of seriously ill children have experienced being involved in CEC discussions.
Ten next of kin of six seriously ill children were interviewed. Their cases were discussed in two CECs between April of 2011 and March of 2014. The main ethical dilemma was limitation of life-prolonging treatment. Health care personnel who could elucidate the case were also present in the discussion. The interviewer observed each discussion and then interviewed the next of kin shortly after the meeting, following a structured interview guide.
All next of kin emphasized that it had been important for them to be present. They stressed the important role of the CEC chair and appreciated that their case was discussed in a systematic way. Some next of kin appreciated that the child’s impending death was discussed openly, and believed that this would facilitate their future grieving. Having had an opportunity to hear all the arguments behind the decision to be made would probably help them to accept the road ahead.
All of them felt that they were taken seriously and listened to. They felt that they had added vital information to the discussion. All but one couple did not want any decision-making responsibility, some of them even worried that they might have influenced the discussion too much.
None of the next of kin felt that being present during the CEC discussion had been too heavy a burden. On the contrary, they claimed that their presence in a CEC discussion may add vital information to the discussion and may improve the quality of the decision. It is important that the CEC’s role is explained to them so they are well prepared for what to expect. They need to be followed up after the discussion.
PMCID: PMC4464619  PMID: 26048681
Ethics consultation; Committee; End-of-life; Parents; Discussion
15.  Engaging with Community Advisory Boards (CABs) in Lusaka Zambia: perspectives from the research team and CAB members 
BMC Medical Ethics  2015;16:39.
The use of a Community Advisory Board (CAB) is one method of ensuring community engagement in community based research. To identify the process used to constitute CABs in Zambia, this paper draws on the perspectives of both research team members and CAB members from research groups who used CABs in Lusaka. Enabling and restricting factors impacting on the functioning of the CAB were identified.
All studies approved by the University of Zambia Bioethics Research Committee (UBNZABREC) from 2008 – 2012 were reviewed to identify those studies that were likely to include a CAB. Eight teams with studies that included a CAB were identified. For each of these studies, consent was obtained to conduct an informal interview with a research team member and to obtain contact details for one CAB member. In total 14 interviews were conducted with 8 research team members and 6 CAB members from 12–30 August 2013.
Identification of potential CAB members from the community and their participation in developing the terms of reference for CABs was perceived to have contributed to the success of the CAB. Due to the trust that the community had in members of their community the CABs were then in a stronger position to influence community participation in the research. Training of CAB members was identified as a factor that enhanced the functioning of a CAB. Lack of commitment and low literacy levels of CAB members posed a threat to the role of the CAB. Although compensation in the form of a stipend was not provided, CAB members were provided with transport reimbursements for attending meetings.
Selection of CAB members from within the community contributed to community confidence in the CAB, enhancing its ability to act as an effective link between study team and community. This contributed positively to the conduct of the study and enhanced community awareness and acceptance of the research. However, establishment of study specific CABs has the potential to compromise CAB independence due to support provided by the research team in the form of transport reimbursements and other forms of support. Consideration should be given to establishing community wide Community Advisory Boards that could function across a range of studies to increase independent objective decision-making.
PMCID: PMC4453219  PMID: 26037507
Community engagement; Community advisory board; Community based participatory research; research team
16.  “Losing the tombola”: a case study describing the use of community consultation in designing the study protocol for a randomised controlled trial of a mental health intervention in two conflict-affected regions 
BMC Medical Ethics  2015;16:38.
Community consultation is increasingly recommended, and in some cases, required by ethical review boards for research that involves higher levels of ethical risk such as international research and research with vulnerable populations. In designing a randomised control trial of a mental health intervention using a wait list control, we consulted the community where the research would be undertaken prior to finalising the study protocol. The study sites were two conflict-affected locations: Grozny in the Chechen Republic and Kitchanga in eastern Democratic Republic of Congo.
Group discussions with a range of community members were held in both study sites. Facilitators used a prepared set of questions to guide the discussions and to solicit feedback on the value of the research as well as on the study design. Specific questions were asked about enablers and barriers to participation in the research.
Six groups were held in Grozny and thirteen in Kitchanga. The majority of individuals and groups consulted supported the research, and understood the purpose. In Grozny, the main concern raised was the length of the waiting period. Barriers to both waiting and returning for follow up were identified. In Kitchanga, there was a strong reaction against the wait list control and against randomisation. The consultations provided information on unanticipated harms to the community, allowing changes to the study design to mitigate these harms and increase acceptability of the study. It also served to inform the community of the study, and through engaging with them early, helped promote legitimacy and joint responsibility.
Community consultation prior to finalising the study design for a mental health intervention trial in two humanitarian settings proved feasible. Our experience reinforces the importance of community consultation before the study design is finalised and the importance of broad consultation that includes both community leaders and the potential study participants.
Electronic supplementary material
The online version of this article (doi:10.1186/s12910-015-0032-x) contains supplementary material, which is available to authorized users.
PMCID: PMC4450849  PMID: 26032480
Community consultation; Randomisation; Mental health; Democratic Republic of Congo (DRC); Chechen Republic; Médecins Sans Frontières (MSF); Conflict
17.  Ethical deliberations about involuntary treatment: interviews with Swedish psychiatrists 
BMC Medical Ethics  2015;16:37.
Involuntary treatment is a key issue in healthcare ethics. In this study, ethical issues relating to involuntary psychiatric treatment are investigated through interviews with Swedish psychiatrists.
In-depth interviews were conducted with eight Swedish psychiatrists, focusing on their experiences of and views on compulsory treatment. In relation to this, issues about patient autonomy were also discussed. The interviews were analysed using a descriptive qualitative approach.
The answers focus on two main aspects of compulsory treatment. Firstly, deliberations about when and why it was justifiable to make a decision on involuntary treatment in a specific case. Here the cons and pros of ordering compulsory treatment were discussed, with particular emphasis on the consequences of providing treatment vs. refraining from ordering treatment. Secondly, a number of issues relating to background factors affecting decisions for or against involuntary treatment were also discussed. These included issues about the Swedish Mental Care Act, healthcare organisation and the care environment.
Involuntary treatment was generally seen as an unwanted exception to standard care. The respondents’ judgments about involuntary treatment were typically in line with Swedish law on the subject. However, it was also argued that the law leaves room for individual judgments when making decisions about involuntary treatment. Much of the reasoning focused on the consequences of ordering involuntary treatment, where risk of harm to the therapeutic alliance was weighed against the assumed good consequences of ensuring that patients received needed treatment. Cases concerning suicidal patients and psychotic patients who did not realise their need for care were typically held as paradigmatic examples of justified involuntary care. However, there was an ambivalence regarding the issue of suicide as it was also argued that risk of suicide in itself might not be sufficient for justified involuntary care. It was moreover argued that organisational factors sometimes led to decisions about compulsory treatment that could have been avoided, given a more patient-oriented healthcare organisation.
Electronic supplementary material
The online version of this article (doi:10.1186/s12910-015-0029-5) contains supplementary material, which is available to authorized users.
PMCID: PMC4446957  PMID: 26016885
Psychiatry; Bioethics; Personal autonomy; Paternalism; Coercion; Involuntary commitment
18.  Research partnerships between high and low-income countries: are international partnerships always a good thing? 
BMC Medical Ethics  2015;16:36.
International partnerships in research are receiving ever greater attention, given that technology has diminished the restriction of geographical barriers with the effects of globalisation becoming more evident, and populations increasingly more mobile.
In this article, we examine the merits and risks of such collaboration even when strict universal ethical guidelines are maintained. There has been widespread examples of outcomes beneficial and detrimental for both high and low –income countries which are often initially unintended.
The authors feel that extreme care and forethought should be exercised by all involved parties, despite the fact that many implications from such international work can be extremely hard to predict. However ultimately the benefits gained by enhancing medical research and philanthropy are too extensive to be ignored.
PMCID: PMC4447022  PMID: 26017015
International Health; Development; Nigeria; Collaborative research; Global Partnership
19.  A first online intervention to increase patients’ perceived ability to act in situations of abuse in health care: reports of a Swedish pre-post study 
BMC Medical Ethics  2015;16:35.
Efforts to counteract abuse in health care, defined as patient-experienced abuse, have mainly focused on interventions among caregivers. This study is the first to test an online intervention focusing on how patients can counteract such abuse. The intervention aimed at increasing patients’ intention and perceived ability to act in future situations where they risk experiencing abuse.
Participants were recruited through a nephrology clinic in Sweden. The intervention consisted of an online program that aimed to stimulate patients to think of possible actions in situations in which they risk experiencing abuse. The program comprised stories and exercises in text and comic form. The participants filled out a questionnaire immediately before and after going through the program, as well as during follow-up four to eight weeks later.
Forty-eight patients (39 %) participated in the study and spent, on average, 41 min responding to questions and going through the program. Both men and women, of various ages and educational backgrounds, participated. An increase in participants' self-reported ability to identify opportunities to act in a given situation was seen immediately afterwards, as well as during follow up.
The current study suggests that it is feasible and most likely useful to a variety of patients to work with the provided material that has the aim of counteracting abuse in health care. It would be of interest to further develop ways of using comics and to test similar interventions in other health care settings.
PMCID: PMC4448297  PMID: 26003674
Abuse in health care; Patient intervention; Online intervention; Patient empowerment; Comics
20.  Conceptions of decision-making capacity in psychiatry: interviews with Swedish psychiatrists 
BMC Medical Ethics  2015;16:34.
Decision-making capacity is a key concept in contemporary healthcare ethics. Previous research has mainly focused on philosophical, conceptual issues or on evaluation of different tools for assessing patients’ capacity. The aim of the present study is to investigate how the concept and its normative role are understood in Swedish psychiatric care. Of special interest for present purposes are the relationships between decisional capacity and psychiatric disorders and between health law and practical ethics.
Eight in-depth interviews were conducted with Swedish psychiatrists. The interviews were analysed according to descriptive qualitative content analysis in which categories and sub-categories were distilled from the material.
Decision-making capacity was seen as dependent on understanding, insight, evaluation, reasoning, and abilities related to making and communicating a choice. However, also the actual content of the decision was held as relevant. There was an ambivalence regarding the relationship between psychiatric disorders and capacity and a tendency to regard psychiatric patients who made unwise treatment decisions as decisionally incapable. However, in cases relating to patients with somatic illnesses, the assumption was rather that patients who made unwise decisions were imprudent but yet decisionally capable.
The respondents’ conceptions of decision-making capacity were mainly in line with standard theories. However, the idea that capacity also includes aspects relating to the content of the decision clearly deviates from the standard view. The tendency to regard imprudent choices by psychiatric patients as betokening lack of decision-making capacity differs from the view taken of such choices in somatic care. This difference merits further investigations.
Electronic supplementary material
The online version of this article (doi:10.1186/s12910-015-0026-8) contains supplementary material, which is available to authorized users.
PMCID: PMC4447019  PMID: 25990948
Psychiatry; Bioethics; Mental capacity; Personal autonomy; Paternalism; Involuntary commitment
21.  Actual implementation of sick children’s rights in Italian pediatric units: a descriptive study based on nurses’ perceptions 
BMC Medical Ethics  2015;16:33.
Several charters of rights have been issued in Europe to solemnly proclaim the rights of children during their hospital stay. However, notwithstanding such general declarations, the actual implementation of hospitalized children’s rights is unclear. The purpose of this study was to understand to which extent such rights, as established by the two main existing charters of rights, are actually implemented and respected in Italian pediatric hospitals and the pediatric units of Italian general hospitals, as perceived by the nurses working in them.
Cross-sectional study. A 12-item online questionnaire was set up and an invitation was sent by email to Italian pediatric nurses using professional mailing lists and social networks. Responders were asked to score to what extent each right is respected in their hospital using a numeric scale from 1 (never) to 5 (always).
536 questionnaires were returned. The best implemented right is the right of children to have their mothers with them (mean score 4.47). The least respected one is the right of children to express their opinion about care (mean 3.01). Other rights considered were the right to play (4.29), the right to be informed (3.95), the right to the respect of privacy (3.75), the right to be hospitalized with peers (3.39), the right not to experience pain ever (3.41), and the right to school (3.07). According to the majority of nurses, the most important is the right to pain relief.
Significant differences in the implementation of rights were found between areas of Italy and between pediatric hospitals and pediatric units of general hospitals.
According to the perception of pediatric nurses, the implementation of the rights of hospitalized children in Italian pediatrics units is still limited.
PMCID: PMC4455682  PMID: 25964120
Children; Hospital; Charter of rights
22.  IRB practices and policies regarding the secondary research use of biospecimens 
BMC Medical Ethics  2015;16:32.
As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented.
This paper reports on data from a survey of IRB Administrative Directors from 60 institutions affiliated with the Clinical and Translation Science Awards (CTSAs) about their policies and practices regarding secondary use and sharing of biospecimens. Specifically, IRB ADs were asked about consent for future use of biospecimens, assignment of risk for studies using biobanked specimens, and sharing of biospecimens/data.
Our data indicate that IRBs take varying approaches to protocol review, risk assessment, and data sharing, especially when specimens are not anonymized.
Unclear or divergent policies regarding biospecimen research among IRBs may constitute a barrier to advancing genetic studies and to inter-institutional collaboration, given different institutional requirements for human subjects protections.
Electronic supplementary material
The online version of this article (doi:10.1186/s12910-015-0020-1) contains supplementary material, which is available to authorized users.
PMCID: PMC4426182  PMID: 25953109
IRBs; Policy; Biobanks; Biospecimens; Data sharing; Genetic research
23.  Ultrasound’s ‘window on the womb’ brings ethical challenges for balancing maternal and fetal health interests: obstetricians’ experiences in Australia 
BMC Medical Ethics  2015;16:31.
Obstetric ultrasound has become a significant tool in obstetric practice, however, it has been argued that its increasing use may have adverse implications for women’s reproductive freedom. This study aimed to explore Australian obstetricians’ experiences and views of the use of obstetric ultrasound both in relation to clinical management of complicated pregnancy, and in situations where maternal and fetal health interests conflict.
A qualitative study was undertaken as part of the CROss-Country Ultrasound Study (CROCUS). Interviews were held in November 2012 with 14 obstetricians working in obstetric care in Victoria, Australia. Data were analysed using qualitative content analysis.
One overall theme emerged from the analyses: The ethical challenge of balancing maternal and fetal health interests, built on four categories: First, Encountering maternal altruism’ described how pregnant women’s often ‘altruistic’ position in relation to the health and wellbeing of the fetus could create ethical challenges in obstetric management, particularly with an increasing imbalance between fetal benefits and maternal harms. Second, ‘Facing shifting attitudes due to visualisation and medico-technical advances’ illuminated views that ultrasound and other advances in care have contributed to a shift in what weight to give maternal versus fetal welfare, with increasing attention directed to the fetus. Third, ‘Guiding expectant parents in decision-making’ described the difficult task of facilitating informed decision-making in situations where maternal and fetal health interests were not aligned, or in situations characterised by uncertainty. Fourth, ‘Separating private from professional views’ illuminated divergent views on when the fetus can be regarded as a person. The narratives indicated that the fetus acquired more consideration in decision-making the further the gestation progressed. However, there was universal agreement that obstetricians could never act on fetal grounds without the pregnant woman’s consent.
This study suggests that medico-technical advances such as ultrasound have set the scene for increasing ethical dilemmas in obstetric practice. The obstetricians interviewed had experienced a shift in previously accepted views about what weight to give maternal versus fetal welfare. As fetal diagnostics and treatment continue to advance, how best to protect pregnant women’s right to autonomy requires careful consideration and further investigation.
PMCID: PMC4429903  PMID: 25953252
Australia; Decision-making; Ethics; Fetus; Maternal rights; Obstetric ultrasound; Obstetricians; Obstetrics; Pregnant women; Qualitative studies
24.  Reconsidering ‘ethics’ and ‘quality’ in healthcare research: the case for an iterative ethical paradigm 
BMC Medical Ethics  2015;16:21.
UK-based research conducted within a healthcare setting generally requires approval from the National Research Ethics Service. Research ethics committees are required to assess a vast range of proposals, differing in both their topic and methodology. We argue the methodological benchmarks with which research ethics committees are generally familiar and which form the basis of assessments of quality do not fit with the aims and objectives of many forms of qualitative inquiry and their more iterative goals of describing social processes/mechanisms and making visible the complexities of social practices. We review current debates in the literature related to ethical review and social research, and illustrate the importance of re-visiting the notion of ethics in healthcare research.
We present an analysis of two contrasting paradigms of ethics. We argue that the first of these is characteristic of the ways that NHS ethics boards currently tend to operate, and the second is an alternative paradigm, that we have labelled the ‘iterative’ paradigm, which draws explicitly on methodological issues in qualitative research to produce an alternative vision of ethics. We suggest that there is an urgent need to re-think the ways that ethical issues are conceptualised in NHS ethical procedures. In particular, we argue that embedded in the current paradigm is a restricted notion of ‘quality’, which frames how ethics are developed and worked through. Specific, pre-defined outcome measures are generally seen as the traditional marker of quality, which means that research questions that focus on processes rather than on ‘outcomes’ may be regarded as problematic. We show that the alternative ‘iterative’ paradigm offers a useful starting point for moving beyond these limited views.
We conclude that a ‘one size fits all’ standardisation of ethical procedures and approach to ethical review acts against the production of knowledge about healthcare and dramatically restricts what can be known about the social practices and conditions of healthcare. Our central argument is that assessment of ethical implications is important, but that the current paradigm does not facilitate an adequate understanding of the very issues it aims to invigilate.
PMCID: PMC4493950  PMID: 25952678
Quality; Research ethics committees; Health research; UK
25.  Caring for quality of care: symbolic violence and the bureaucracies of audit 
BMC Medical Ethics  2015;16:23.
This article considers the moral notion of care in the context of Quality of Care discourses. Whilst care has clear normative implications for the delivery of health care it is less clear how Quality of Care, something that is centrally involved in the governance of UK health care, relates to practice.
This paper presents a social and ethical analysis of Quality of Care in the light of the moral notion of care and Bourdieu’s conception of symbolic violence. We argue that Quality of Care bureaucracies show significant potential for symbolic violence or the domination of practice and health care professionals. This generates problematic, and unintended, consequences that can displace the goals of practice.
Quality of Care bureaucracies may have unintended consequences for the practice of health care. Consistent with feminist conceptions of care, Quality of Care ‘audits’ should be reconfigured so as to offer a more nuanced and responsive form of evaluation.
PMCID: PMC4493962  PMID: 25952931
Care; Quality of care; Ethics of care; Bourdieu; Symbolic violence; Audit

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