BMC Medical Ethics is an open access journal publishing original peer-reviewed research articles in relation to medical ethics, heathcare and bioethics.

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  • The challenges of keeping clinicians unaware of their participation in a national, cluster-randomised, implementation trial

    Jex Kuo; Sonja Woodall; Jane Harding; Caroline Crowther; Jane Alsweiler (BMC, 2022-05-01)
    Abstract Background Implementation of recommendations from clinical practice guidelines is essential for evidence based clinical practice. However, the most effective methods of implementation are unclear. We conducted a national, cluster-randomised, blinded implementation trial to determine if midwife or doctor local implementation leaders are more effective in implementing a guideline for use of oral dextrose gel to treat hypoglycaemic babies on postnatal wards. To prevent any conscious or unconscious performance bias both the doctor and midwife local implementation leaders were kept unaware of the trial. This paper reports the ethical dilemmas and practical challenges of ensuring clinicians remained unaware of their involvement in an implementation trial. Methods We sought approval from the National Health and Disability Ethics committee to keep clinicians unaware of the trial by waiving the standard requirement for locality approval usually required for each district health board. The ethics committee did not approve a waiver of consent but advised that we approach the chief executive of each district health board to ask for provisional locality approval. Ultimately it was necessary to seek ethics approval for three separate study designs to keep clinicians unaware of the trial. Results The median (IQR) time for chief executive approval was 16 (6–40) days and for locality approval was 57 (39–84) days. We completed 21 different locality approval forms for 27 hospitals. Conclusions Keeping clinicians unaware of their involvement in a national implementation cluster-randomised trial is feasible. However, despite a national ethics committee, significant logistical challenges were time consuming and delayed trial completion. Co-ordination of the locality approval process would help facilitate multi-centre trials.
  • The genetic technologies questionnaire: lay judgments about genetic technologies align with ethical theory, are coherent, and predict behaviour

    Svenja Küchenhoff; Johannes Doerflinger; Nora Heinzelmann (BMC, 2022-05-01)
    Abstract Background Policy regulations of ethically controversial genetic technologies should, on the one hand, be based on ethical principles. On the other hand, they should be socially acceptable to ensure implementation. In addition, they should align with ethical theory. Yet to date we lack a reliable and valid scale to measure the relevant ethical judgements in laypeople. We target this lacuna. Methods We developed a scale based on ethical principles to elicit lay judgments: the Genetic Technologies Questionnaire (GTQ). In two pilot studies and a pre-registered main study, we validated the scale in a representative sample of the US population. Results The final version of the scale contains 20 items but remains highly reliable even when reduced to five. It also predicts behaviour; for example, ethical judgments as measured by the GTQ predicted hypothetical donations and grocery shopping. In addition, the GTQ may be of interest to policymakers and ethicists because it reveals coherent and ethically justified judgments in laypeople. For instance, the GTQ indicates that ethical judgments are sensitive to possible benefits and harms (in line with utilitarian ethics), but also to ethical principles such as the value of consent-autonomy. Conclusions The GTQ can be recommended for research in both experimental psychology and applied ethics, as well as a tool for ethically and empirically informed policymaking.
  • Screening is not always healthy: an ethical analysis of health screening packages in Singapore

    Sarah Ee Fang Yong; Mee Lian Wong; Teck Chuan Voo (BMC, 2022-06-01)
    Abstract Background Health screening is undertaken to identify individuals who are deemed at higher risk of disease for further diagnostic testing so that they may possibly benefit from interventions to modify the natural course of disease. In Singapore, screening tests are widely available in the form of a package, which bundles multiple tests in one session and commonly includes non-recommended tests. There are various ethical issues associated with such testing as they may not be clinically appropriate and can result in more harm than benefit. This article describes the practice of health screening packages, identifies the ethical issues arising from such packages and discusses the implications of these ethical issues on policy and practice of screening in Singapore. Methods A content analysis of the websites of providers offering general health screening packages to individuals was conducted. A total of 14 health screening package providers were analysed for how packages were conducted and promoted, how clinically appropriate screening tests were, and the price range and composition of screening packages. A normative ethical analysis based on the four principles approach of beneficence, non-maleficence, autonomy and justice in biomedical ethics was used. Results Twelve of the 14 providers included non-recommended tests such as tumour markers, treadmill stress tests and MRI scans in their general health screening packages. Package prices ranged from S$26 to S$10,561, with providers charging higher when more tests were included. Health screening packages were broadly conducted in three stages: (1) the offer and selection of a health screening package; (2) medical assessment and performance of screening tests; (3) a post-screening review. While material provided by all providers was factual, there was no information on the potential risks or harms of screening. Conclusion Several ethical issues were identified that should be addressed with regard to health screening packages in Singapore. A key issue was the information gap between providers and patients, which may result in patients undergoing inappropriate testing that may be more harmful than beneficial. Health screening packages can stimulate unnecessary demand for healthcare and contribute to an inequitable distribution of healthcare resources.
  • Public attitudes towards sharing loyalty card data for academic health research: a qualitative study

    Elizabeth H. Dolan; Kate Shiells; James Goulding; Anya Skatova (BMC, 2022-06-01)
    Abstract Background A growing number of studies show the potential of loyalty card data for use in health research. However, research into public perceptions of using this data is limited. This study aimed to investigate public attitudes towards donating loyalty card data for academic health research, and the safeguards the public would want to see implemented. The way in which participant attitudes varied according to whether loyalty card data would be used for either cancer or COVID-19 research was also examined. Methods Participants (N = 40) were recruited via Prolific Academic to take part in semi-structured telephone interviews, with questions focused on data sharing related to either COVID-19 or ovarian/bowel cancer as the proposed health condition to be researched. Content analysis was used to identify sub-themes corresponding to the two a priori themes, attitudes and safeguards. Results Participant attitudes were found to fall into two categories, either rational or emotional. Under rational, most participants were in favour of sharing loyalty card data. Support of health research was seen as an important reason to donate such data, with loyalty card logs being considered as already within the public domain. With increased understanding of research purpose, participants expressed higher willingness to donate data. Within the emotional category, participants shared fears about revealing location information and of third parties obtaining their data. With regards to safeguards, participants described the importance of anonymisation and the level of data detail; the control, convenience and choice they desired in sharing data; and the need for transparency and data security. The change in hypothetical purpose of the data sharing, from Covid-19 to cancer research, had no impact on participants’ decision to donate, although did affect their understanding of how loyalty card data could be used. Conclusions Based on interviews with the public, this study contributes recommendations for those researchers and the wider policy community seeking to obtain loyalty card data for health research. Whilst participants were largely in favour of donating loyalty card data for academic health research, information, choice and appropriate safeguards are all exposed as prerequisites upon which decisions are made.
  • The red packet phenomenon from the perspective of young Chinese doctors: a questionnaire study

    Hanhui Xu; Mengci Yuan (BMC, 2022-05-01)
    Abstract Background In China, informal payments in the medical profession, which workers in the public health care system receive from patients in the course of performing profession-related activities, are usually referred to as “red packets” (Hongbao 红包). The phenomenon of red packets is widespread and has become one of the most negative factors affecting the doctor-patient relationship in China. Our study aims to explore the situation concerning the phenomenon of red packets in China after the “Red Packet Ban”. Methods A questionnaire was developed including general demographic characteristics, asking whether they had ever been offered red packets, whether they had ever accepted red packets, their reasons for accepting the first red packet and so on. We recruited a total of 413 doctors to complete this questionnaire and conducted in-depth telephone interviews with 18 doctors from the initial group. Results Our data shows that 73 doctors claimed to have accepted red packets, accounting for 17.7% (73/413) of all respondents and 27.8% (73/263) of doctors who had been provided with red packets. 23.2% of red packets were offered after the operation and 67.1% of the doctors declared that the main reason for accepting the red packet was that they “refused the red packets more than once, but the patients/family members were sincere and it was difficult to refuse.” The total amount of the red packets they received each month accounted for no more than 5% of their income. Conclusions (1) The acceptance of red packets does exist among young doctors in China, but shows a significant decrease compared to previous studies. (2) There has been a sharp rise in the proportion of gratitude red packets. (3) Patients should also be educated regarding their behaviour in providing red packets.
  • Patient consent preferences on sharing personal health information during the COVID-19 pandemic: “the more informed we are, the more likely we are to help”

    Sarah Tosoni; Indu Voruganti; Katherine Lajkosz; Shahbano Mustafa; Anne Phillips; S. Joseph Kim; Rebecca K. S. Wong; Donald Willison; Carl Virtanen; Ann Heesters (BMC, 2022-05-01)
    Abstract Background Rapid ethical access to personal health information (PHI) to support research is extremely important during pandemics, yet little is known regarding patient preferences for consent during such crises. This follow-up study sought to ascertain whether there were differences in consent preferences between pre-pandemic times compared to during Wave 1 of the COVID-19 global pandemic, and to better understand the reasons behind these preferences. Methods A total of 183 patients in the pandemic cohort completed the survey via email, and responses were compared to the distinct pre-pandemic cohort (n = 222); all were patients of a large Canadian cancer center. The survey covered (a) broad versus study-specific consent; (b) opt-in versus opt-out contact approach; (c) levels of comfort sharing with different recipients; (d) perceptions of commercialization; and (e) options to track use of information and be notified of results. Four focus groups (n = 12) were subsequently conducted to elucidate reasons motivating dominant preferences. Results Patients in the pandemic cohort were significantly more comfortable with sharing all information and biological samples (90% vs. 79%, p = 0.009), sharing information with the health care institution (97% vs. 83%, p < 0.001), sharing information with researchers at other hospitals (85% vs. 70%, p < 0.001), sharing PHI provincially (69% vs. 53%, p < 0.002), nationally (65% vs. 53%, p = 0.022) and internationally (48% vs. 39%, p = 0.024) compared to the pre-pandemic cohort. Discomfort with sharing information with commercial companies remained unchanged between the two cohorts (50% vs. 51% uncomfortable, p = 0.58). Significantly more pandemic cohort patients expressed a wish to track use of PHI (75% vs. 61%, p = 0.007), and to be notified of results (83% vs. 70%, p = 0.012). Thematic analysis uncovered that transparency was strongly desired on outside PHI use, particularly when commercialization was involved. Conclusions In pandemic times, patients were more comfortable sharing information with all parties, except with commercial entities, where levels of discomfort (~ 50%) remained unchanged. Focus groups identified that the ability to track and receive results of studies using one’s PHI is an important way to reduce discomfort and increase trust. These findings meaningfully inform wider discussions on the use of personal health information for research during global crises.
  • Decision-making approaches for children with life-limiting conditions: results from a qualitative phenomenological study

    Sidharth Vemuri; Jenny Hynson; Katrina Williams; Lynn Gillam (BMC, 2022-05-01)
    Abstract Background For children with life-limiting conditions who are unable to participate in decision-making, decisions are made for them by their parents and paediatricians. Shared decision-making is widely recommended in paediatric clinical care, with parents preferring a collaborative approach in the care of their child. Despite the increasing emphasis to adopt this approach, little is known about the roles and responsibilities taken by parents and paediatricians in this process. In this study, we describe how paediatricians approach decision-making for a child with a life-limiting condition who is unable to participate in decision-making for his/herself. Methods This qualitative phenomenological study involved 25 purposively sampled paediatricians. Verbatim transcripts from individual semi-structured interviews, conducted between mid-2019 and mid-2020, underwent thematic analysis. Interviews were based around a case vignette matched to the clinical experience of each paediatrician. Results Two key themes were identified in the exploration of paediatricians' approach to decision-making for children with life-limiting conditions: (1) there is a spectrum of paediatricians’ roles and responsibilities in decision-making, and (2) the specific influences on paediatricians’ choice of approach for end-of-life decisions. In relation to (1), analysis showed four distinct approaches: (i) non-directed, (ii) joint, (iii) interpretative, and (iv) directed. In relation to (2), the common factors were: (i) harm to the child, (ii) possible psychological harm to parents, (iii) parental preferences in decision-making, and (iv) resource allocation. Conclusions Despite self-reporting shared decision-making practices, what paediatricians often described were physician-led decision-making approaches. Adopting these approaches was predominantly justified by paediatricians’ considerations of harm to the child and parents. Further research is needed to elucidate the issues identified in this study, particularly the communication within and parental responses to physician-led approaches. We also need to further study how parental needs are identified in family-led decision-making approaches. These nuances and complexities are needed for future practice guidance and training around paediatric decision-making. Trial registration: Not applicable.
  • A chronological discourse analysis of ancillary care provision in guidance documents for research conduct in the global south

    Blessings M. Kapumba; Nicola Desmond; Janet Seeley (BMC, 2022-05-01)
    Abstract Introduction Numerous guidelines and policies for ethical research practice have evolved over time, how this translates to global health practice in resource-constrained settings is unclear. The purpose of this paper is to describe how the concept of ancillary care has evolved over time and how it is included in the ethics guidelines and policy documents that guide the conduct of research in the global south with both an international focus and providing a specific example of Malawi, where the first author lives and works, as a case study. Methods Discourse analysis was conducted on 34 international ethics guidelines and policy documents. Documents were purposively selected if they contained a set of key terms that reflect the concept of ancillary care. Following a process of inductive discourse analysis, five key interrelated text phrases relating to ancillary care were extracted from the documents. The evolution of these phrases over time was explored as they represented the development of the concept of ancillary care as a component of ethical health research guidance and practice. Results We found key interrelated phrases that represent discourses regarding the evolution of ancillary care including participant protection; provide care as appropriate; supererogation; patient needs prevail over science; and ancillary care as an obligation. Arguments for the provision of ancillary care were characterised by safeguarding the safety, health rights and well-being of study participants. However, despite the evolution of discourse around ethical obligations to provide ancillary care, this is rarely made explicit within guidance documents, leaving interpretive space for differential application in practice. Conclusion While there have been major changes to the ethics guidance that reflect significant evolution in the ethical conduct of research, the specific vocabulary or language used to explain the ethics of researchers' ancillary care obligations to the health needs of their research participants, lacks clarity and consistency. As a result, the concept of ancillary care continues to be under-represented in local ethical guidelines and regulations, with no clear directives for country-level research ethics committees to apply in regulating ancillary care responsibilities.
  • Asking the right questions: towards a person-centered conception of shared decision-making regarding treatment of advanced chronic kidney disease in older patients

    Wouter R. Verberne; Anne M. Stiggelbout; Willem Jan W. Bos; Johannes J. M. van Delden (BMC, 2022-04-01)
    Abstract An increasing number of older patients have to decide on a treatment plan for advanced chronic kidney disease (CKD), involving dialysis or conservative care. Shared decision-making (SDM) is recommended as the model for decision-making in such preference-sensitive decisions. The aim of SDM is to come to decisions that are consistent with the patient’s values and preferences and made by the patient and healthcare professional working together. In clinical practice, however, SDM appears to be not yet routine and needs further implementation. A shift from a biomedical to a person-centered conception might help to make the process more shared. Shared should, therefore, be interpreted as two persons bringing two perspectives to the table, that both need to be explored during the decision-making process. Starting from the patient’s perspective will enable to determine the mutual goals of care first and, subsequently, determine the best way for achieving those goals. To perform such SDM, the healthcare professional needs to become a skilled companion, being part of the patient’s relational context, and start asking the right questions about what matters to the patient as person. In this article, we describe the need for a person-centered conception of SDM for the setting of older patients with advanced CKD.
  • “Many roads lead to Rome and the Artificial Intelligence only shows me one road”: an interview study on physician attitudes regarding the implementation of computerised clinical decision support systems

    Daan Van Cauwenberge; Wim Van Biesen; Johan Decruyenaere; Tamara Leune; Sigrid Sterckx (BMC, 2022-05-01)
    Abstract Research regarding the drivers of acceptance of clinical decision support systems (CDSS) by physicians is still rather limited. The literature that does exist, however, tends to focus on problems regarding the user-friendliness of CDSS. We have performed a thematic analysis of 24 interviews with physicians concerning specific clinical case vignettes, in order to explore their underlying opinions and attitudes regarding the introduction of CDSS in clinical practice, to allow a more in-depth analysis of factors underlying (non-)acceptance of CDSS. We identified three general themes from the results. First, ‘the perceived role of the AI’, including items referring to the tasks that may properly be assigned to the CDSS according to the respondents. Second, ‘the perceived role of the physician’, referring to the aspects of clinical practice that were seen as being fundamentally ‘human’ or non-automatable. Third, ‘concerns regarding AI’, including items referring to more general issues that were raised by the respondents regarding the introduction of CDSS in general and/or in clinical medicine in particular. Apart from the overall concerns expressed by the respondents regarding user-friendliness, we will explain how our results indicate that our respondents were primarily occupied by distinguishing between parts of their job that should be automated and aspects that should be kept in human hands. We refer to this distinction as ‘the division of clinical labor.’ This division is not based on knowledge regarding AI or medicine, but rather on which parts of a physician’s job were seen by the respondents as being central to who they are as physicians and as human beings. Often the respondents’ view that certain core parts of their job ought to be shielded from automation was closely linked to claims concerning the uniqueness of medicine as a domain. Finally, although almost all respondents claimed that they highly value their final responsibility, a closer investigation of this concept suggests that their view of ‘final responsibility’ was not that demanding after all.
  • Combining rules and dialogue: exploring stakeholder perspectives on preventing sexual boundary violations in mental health and disability care organizations

    Charlotte Kröger; Eva van Baarle; Guy Widdershoven; Roland Bal; Jan-Willem Weenink (BMC, 2022-05-01)
    Abstract Background Sexual boundary violations (SBV) in healthcare are harmful and exploitative sexual transgressions in the professional–client relationship. Persons with mental health issues or intellectual disabilities, especially those living in residential settings, are especially vulnerable to SBV because they often receive long-term intimate care. Promoting good sexual health and preventing SBV in these care contexts is a moral and practical challenge for healthcare organizations. Methods We carried out a qualitative interview study with 16 Dutch policy advisors, regulators, healthcare professionals and other relevant experts to explore their perspectives on preventing SBV in mental health and disability care organizations. We used inductive thematic analysis to interpret our data. Results We found three main themes on how healthcare organizations can prevent SBV in mental health and disability care: (1) setting rules and regulations, (2) engaging in dialogue about sexuality, and (3) addressing systemic and organizational dimensions. Conclusion Our findings suggest that preventing SBV in mental health and disability care organizations necessitates setting suitable rules and regulations and facilitating dialogue about positive aspects of sexuality and intimacy, as well as about boundaries, and inappropriate behaviors or feelings. Combining both further requires organizational policies and practices that promote transparency and reflection, and focus on creating a safe environment. Our findings will help prevent SBV and promote sexual health in mental health and disability care organizations.
  • Travelling to die: views, attitudes and end-of-life preferences of Israeli considering receiving aid-in-dying in Switzerland

    Daniel Sperling (BMC, 2022-04-01)
    Abstract Background Following the increased presence of the Right-to-Die Movement, improved end-of-life options, and the political and legal status of aid-in-dying around the globe, suicide tourism has become a promising alternative for individuals who wish to end their lives. Yet, little is known about this from the perspective of those who engage in the phenomenon. Methods This study applied the qualitative research approach, following the grounded theory tradition. It includes 11 in-depth semi-structured interviews with Israeli members of the Swiss non-profit Dignitas who contemplated traveling to Switzerland for aid-in-dying. Results Seven themes emerged from the data analysis, including health and functioning; feelings regarding survivorship and existence; interacting with the health sector; attitudes regarding death and dying; suicide; choosing death; and choosing suicide tourism. A significant portion of the participants had experienced suicidal thoughts and had even previously attempted suicide, some more than once. Most of them referred to chronic illnesses, functional disability, and social isolation. They understand suffering within the subjective dimension, namely only by the person who is actually subjected to the disease, ailments, and disability. Participants regarded aid-in-dying in Switzerland as positive thanks to its guaranteed outcome: "beautiful death", compared to "disadvantaged dying" which places a burden on the participants' loved ones throughout the prolonged dying. Most of them do not necessarily want to have their loved ones beside them when they die, and they see no significant meaning in dying in a foreign country to which they have no emotional or civil attachment. Conclusion The desirable approval or tragic refusal by Dignitas to participants' requests for suicide tourism enhances the paradox between the perception of aid-in-dying as a mechanism for fulfilling controlled death and its bureaucratic and materialistic characteristics specifically reflected in a paid, formalized approach to aid-in-dying that cultivate dependency and collaboration.
  • Patient-centred care and patient autonomy: doctors’ views in Chinese hospitals

    Zhanming Liang; Min Xu; Guowei Liu; Yongli Zhou; Peter Howard (BMC, 2022-04-01)
    Abstract Background Patient-centred care and patient autonomy is one of the key factors to better quality of service provision, hence patient outcomes. It enables the development of patients’ trusts which is an important element to a better doctor-patient relationship. Given the increasing number of patient disputes and conflicts between patients and doctors in Chinese public hospital, it is timely to ensure patient-centred care is fully and successfully implemented. However, limited studies have examined the views and practice in different aspects of patient-centred care among doctors in the Chinese public hospitals. Methods A quantitative approach was adopted by distributing paper-based questionnaires to doctors and patients in two hospitals (Level III and Level II) in Jinan, Shandong province, China. Results In total, 614 doctors from the surgical and internal medicine units of the two hospitals participated in the survey yielding 90% response rates. The study confirmed the inconsistent views among doctors in terms of their perception and practice in various aspects patient-centred care and patient autonomy regardless of the hospital where they work (category II or category III), their unit speciality (surgical or non-surgical), their gender or seniority. The high proportion of doctors (more than 20%) who did not perceive the importance of patient consultation prior to determining diagnostic and treatment procedure is alarming. This in in part due to the belief held by more than half of the doctors that patients were unable to make rational decisions and their involvement in treatment planning process did not necessarily lead to better treatment outcomes. Conclusion The study calls for the development of system level policy and organisation wide strategies in encouraging and enabling the practice of patient-centred care and patient autonomy with the purposes of improving the quality of the service provided to patients by Chinese hospitals.
  • Ethical and practical considerations for cell and gene therapy toward an HIV cure: findings from a qualitative in-depth interview study in the United States

    Karine Dubé; John Kanazawa; Hursch Patel; Michael Louella; Laurie Sylla; Jeff Sheehy; Lynda Dee; Jeff Taylor; Jen Adair; Kim Anthony-Gonda (BMC, 2022-04-01)
    Abstract Background HIV cure research involving cell and gene therapy has intensified in recent years. There is a growing need to identify ethical standards and safeguards to ensure cell and gene therapy (CGT) HIV cure research remains valued and acceptable to as many stakeholders as possible as it advances on a global scale. Methods To elicit preliminary ethical and practical considerations to guide CGT HIV cure research, we implemented a qualitative, in-depth interview study with three key stakeholder groups in the United States: (1) biomedical HIV cure researchers, (2) bioethicists, and (3) community stakeholders. Interviews permitted evaluation of informants’ perspectives on how CGT HIV cure research should ethically occur, and were transcribed verbatim. We applied conventional content analysis focused on inductive reasoning to analyze the rich qualitative data and derive key ethical and practical considerations related to CGT towards an HIV cure. Results We interviewed 13 biomedical researchers, 5 community members, and 1 bioethicist. Informants generated considerations related to: perceived benefits of CGT towards an HIV cure, perceived risks, considerations necessary to ensure an acceptable benefit/risk balance, CGT strategies considered unacceptable, additional ethical considerations, and considerations for first-in-human CGT HIV cure trials. Informants also proposed important safeguards to developing CGT approaches towards an HIV cure, such as the importance of mitigating off-target effects, mitigating risks associated with long-term duration of CGT interventions, and mitigating risks of immune overreactions. Conclusion Our study identified preliminary considerations for CGT-based HIV cure across three key stakeholder groups. Respondents identified an ideal cure strategy as one which would durably control HIV infection, protect the individual from re-acquisition, and eliminate transmission to others. Known and unknown risks should be anticipated and perceived as learning opportunities to preserve and honor the altruism of participants. Preclinical studies should support these considerations and be transparently reviewed by regulatory experts and peers prior to first-in-human studies. To protect the public trust in CGT HIV cure research, ethical and practical considerations should be periodically revisited and updated as the science continues to evolve. Additional ethics studies are required to expand stakeholder participation to include traditionally marginalized groups and clinical care providers.
  • Pursuing impact in research: towards an ethical approach

    Kristine Bærøe; Angeliki Kerasidou; Michael Dunn; Inger Lise Teig (BMC, 2022-04-01)
    Abstract Background Research proactively and deliberately aims to bring about specific changes to how societies function and individual lives fare. However, in the ever-expanding field of ethical regulations and guidance for researchers, one ethical consideration seems to have passed under the radar: How should researchers act when pursuing actual, societal changes based on their academic work? Main text When researchers engage in the process of bringing about societal impact to tackle local or global challenges important concerns arise: cultural, social and political values and institutions can be put at risk, transformed or even hampered if researchers lack awareness of how their ‘acting to impact’ influences the social world. With today’s strong focus on research impacts, addressing such ethical challenges has become urgent within in all fields of research involved in finding solutions to the challenges societies are facing. Due to the overall goal of doing something good that is often inherent in ethical approaches, boundaries to researchers’ impact of something good is neither obvious, nor easy to detect. We suggest that it is time for the field of bioethics to explore normative boundaries for researchers’ pursuit of impact and to consider, in detail, the ethical obligations that ought to shape this process, and we provide a four-step framework of fair conditions for such an approach. Our suggested approach within this field can be useful for other fields of research as well. Conclusion With this paper, we draw attention to how the transition from pursuing impact within the Academy to trying to initiate and achieve impact beyond the Academy ought to be configured, and the ethical challenges inherent in this transition. We suggest a stepwise strategy to identify, discuss and constitute consensus-based boundaries to this academic activity. This strategy calls for efforts from a multi-disciplinary team of researchers, advisors from the humanities and social sciences, as well as discussants from funding institutions, ethical committees, politics and the society in general. Such efforts should be able to offer new and useful assistance to researchers, as well as research funding agencies, in choosing ethically acceptable, impact-pursuing projects.
  • ‘I feel that injustice is being done to me’: a qualitative study of women’s viewpoints on the (lack of) reimbursement for social egg freezing

    Michiel De Proost; Gily Coene; Julie Nekkebroeck; Veerle Provoost (BMC, 2022-03-01)
    Abstract Background During the last decade, the possibility for women to cryopreserve oocytes in anticipation of age-related fertility loss, also referred to as social egg freezing, has become an established practice at fertility clinics around the globe. In Europe, there is extensive variation in the costs for this procedure, with the common denominator that there are almost no funding arrangements or reimbursement policies. This is the first qualitative study that specifically explores viewpoints on the (lack of) reimbursement for women who had considered to uptake at least one social egg freezing cycle in Belgium. Methods To understand the moral considerations of these women, drawing from twenty-one interviews, this paper integrates elements of a symbiotic empirical ethics approach and thematic analysis. Results We identify four themes: (1) being confronted with unclear information; (2) financial costs as ongoing concern; (3) necessity of coverage; (4) extent of reimbursement. In the first theme, we found that some women were concerned about the lack of clear information about the cost of social egg freezing. In the second theme, we report moral sentiments of injustice and discrimination which some women attributed to their struggles and needs not being recognised. The third theme illustrates diverse views on reimbursement, ranging from viewing social egg freezing as an elective treatment not appropriate for reimbursement to preferences for greater public responsibility and wider access. Finally, we describe the participants’ varying proposals for partial reimbursement and the idea that it should not be made available for free. Conclusions This research adds important empirical insights to the bioethics debate on social egg freezing, in particular by presenting (potential) users’ views on the lack of reimbursement. While there is much more to say about the ethical and political complexities of the reimbursement of this procedure, our study highlighted the voices of (potential) users and showed that at least some of them would welcome the coverage of SEF through the public healthcare insurance.
  • Dealing with sexual boundary violation in mental healthcare institutions by government policies: the case of Flanders, Belgium

    Lara Vesentini; Kim Dewilde; Frieda Matthys; Dirk De Wachter; Hubert Van Puyenbroeck; Johan Bilsen (BMC, 2022-04-01)
    Abstract Background To prevent sexual boundary violations (SBV) in mental health care institutions overall governments require these institutions to report SBV incidents to a central registry and to develop institutional guidelines how to react. In Europe SBV policies are only recently developed or implemented, as is also the case in Flanders (Belgium). The implementation of a new institutional policy is always a challenge and can encounter resistance, especially when it concerns SBV, because they remain delicate and complex. Method This study evaluated the extent to which mandatory policies on SBV have been implemented in mental health care institutions in Flanders, and possible factors for (non-)implementation of these policies. An online survey was sent to the executives of all mental health care institutions in Flanders (N = 162). Results In total 56 executives of mental health care institutions filled out the survey (response rate 35%). Results showed that the implementation of an SBV policy in mental health care institutions is unfortunately inadequate and not all SBV incidents were reported to the central registry. Type of institution and opinions on the SBV policy were related to the (non-)implementation of the requirements. Conclusions It is recommended that governments regularly communicate with mental health care institutions to better understand the concerns and difficulties concerning implementation of the required SBV policy and to support/stimulate an organisational culture of more openness and safety on this topic.
  • Collection and use of human materials during TB clinical research; a review of practices

    Joseph Ochieng; Betty Kwagala; Nelson Sewankambo (BMC, 2022-03-01)
    Abstract Background Human biological materials are usually stored for possible future use in research because they preserve valuable biological information, save time and resources, which would have been spent on collection of fresh samples. However, use of these materials may pose ethical challenges such as unauthorized disclosure of genetic information, which can result in dire consequences for individuals or communities including discrimination, stigma, and psychological harm; has biosecurity implications; and loss of control or ownership of samples or data. To understand these problems better, we evaluated the extent to which tuberculosis (TB) clinical research protocols that were used to collect and store biological materials for future use conform to the requirements stated in the Uganda national guidelines for research involving humans as participants. Methods This was a retrospective review of TB clinical research projects approved by the Uganda National Council for Science and Technology (UNCST) from 2011 to 2015, to examine whether they fulfilled the requirements for ethical collection and use of human materials. Data were abstracted through review of the project protocols using a template developed based on the informed consent and the Materials Transfer Agreement (MTA) requirements in the national guidelines. Results Out of 55 research protocols reviewed, most of the protocols 83.6% had been used to collect the stored samples (sputum, blood and sometimes urine), 28% had a section on specimen collection and 24% mentioned ownership of the biological materials. With respect to review of the consent forms used in the studies that stored materials for future use, only 9% of the protocols had a separate consent form for storage of materials, 4.5% of the consent forms explained the risks, 11.4% explained the purpose of the study while 6.8% mentioned the place of storage for the collected materials. Conclusion Many of the studies reviewed did not meet the requirements for collection and storage of biological materials contained in the national guidelines, which indicates a need to additional training on this topic.
  • Experimenting with modifications to consent forms in comparative effectiveness research: understanding the impact of language about financial implications and key information

    Nyiramugisha K. Niyibizi; Candace D. Speight; Gabriel Najarro; Andrea R. Mitchell; Ofer Sadan; Yi-An Ko; Neal W. Dickert (BMC, 2022-03-01)
    Abstract Background Informed consent forms are intended to facilitate research enrollment decisions. However, the technical language in institutional templates can be unfamiliar and confusing for decision-makers. Standardized language describing financial implications of participation, namely compensation for injury and costs of care associated with participating, can be complex and could be a deterrent for potential participants. This standardized language may also be misleading in the context of comparative effectiveness trials of standard care interventions, in which costs and risk of injury associated with participating may not differ from regular medical care. In addition, the revised U.S. Common Rule contains a new requirement to present key information upfront; the impact of how this requirement is operationalized on comprehension and likelihood of enrollment for a given study is unknown. Methods Two online surveys assessed the impact of (1) changes to compensation for injury language (standard vs. tailored language form) and (2) changes to the key information page (using the tailored compensation language form with standard key information vs. modified key information vs. modified key information plus financial information) on both likelihood of enrollment in and understanding of a hypothetical comparative effectiveness trial. Results Likelihood of enrolling was not observed to be different between the standard and tailored language forms in Study 1 (73 vs. 75%; p = 0.6); however, the tailored language group had a higher frequency of understanding the compensation for injury process specific to the trial (25 vs. 51%; p < 0.0001). Modifications to the key information sheet in Study 2 did not affect likelihood of enrolling (88 vs. 85 vs. 85%; p = 0.6); however, understanding of randomization differed by form (44 vs. 59 vs. 46%; p = 0.002). Conclusions These findings suggest that refining consent forms to clarify key information and tailoring compensation for injury language to the nature of the study, especially in the context of comparative effectiveness trials, may help to improve study comprehension but may not impact enrollment.
  • Indicators and criteria of consciousness: ethical implications for the care of behaviourally unresponsive patients

    Michele Farisco; Cyriel Pennartz; Jitka Annen; Benedetta Cecconi; Kathinka Evers (BMC, 2022-03-01)
    Abstract Background Assessing consciousness in other subjects, particularly in non-verbal and behaviourally disabled subjects (e.g., patients with disorders of consciousness), is notoriously challenging but increasingly urgent. The high rate of misdiagnosis among disorders of consciousness raises the need for new perspectives in order to inspire new technical and clinical approaches. Main body We take as a starting point a recently introduced list of operational indicators of consciousness that facilitates its recognition in challenging cases like non-human animals and Artificial Intelligence to explore their relevance to disorders of consciousness and their potential ethical impact on the diagnosis and healthcare of relevant patients. Indicators of consciousness mean particular capacities that can be deduced from observing the behaviour or cognitive performance of the subject in question (or from neural correlates of such performance) and that do not define a hard threshold in deciding about the presence of consciousness, but can be used to infer a graded measure based on the consistency amongst the different indicators. The indicators of consciousness under consideration offer a potential useful strategy for identifying and assessing residual consciousness in patients with disorders of consciousness, setting the theoretical stage for an operationalization and quantification of relevant brain activity. Conclusions Our heuristic analysis supports the conclusion that the application of the identified indicators of consciousness to its disorders will likely inspire new strategies for assessing three very urgent issues: the misdiagnosis of disorders of consciousness; the need for a gold standard in detecting consciousness and diagnosing its disorders; and the need for a refined taxonomy of disorders of consciousness.

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