Now showing items 1-20 of 694

    • The ethics of practicing defensive medicine in Jordan: a diagnostic study

      Qosay A. E. Al-Balas; Hassan A. E. Al-Balas (BMC, 2021-07-01)
      Abstract Background Defensive medicine (DM) practice refers to the ordering or prescription of unnecessary treatments or tests while avoiding risky procedures for critically ill patients with the aim to alleviate the physician’s legal responsibility and preserve reputation. Although DM practice is recognized, its dimensions are still uncertain. The subject has been highly investigated in developed countries, but unfortunately, many developing countries are unable to investigate it properly. DM has many serious ramifications, exemplified by the increase in treatment costs for patients and health systems, patients’ exposure to risks, and negative effects on the psychological health of both health providers and recipients. Ultimately, the most serious consequence is the ethical consequences. Methods This work is based on a review of the literature related to DM worldwide and a comparison with the available knowledge found in Jordan. It is qualitative with a descriptive nature, aiming to diagnose the current DM practice in Jordan. Results This is the first published article that discusses DM in Jordan by diagnosing its ethical and economic consequences for the health system as well as for patients. Despite the knowledge of the reasons that support its practice, little is being done to solve this issue. The absence of agreeable medical malpractice law, the dearth of unified medical protocols, the overwhelming pressure imposed by patients on medical staff, and the deteriorating patient-physician relationship are some of the causes of DM practice. Surely, the solution to these issues is to focus on fortifying the ethical and humanitarian aspects on the side of both the physician and the patient to ensure positive collaboration. The ethical aim of the physician to treat the patient faithfully and do what is possible to help combined with the appreciation of the physician’s efforts and the choice to not take advantage of the physician through litigation could be the most reasonable solution in the near future. Conclusion Jordan is suffering from DM due to the limited financial expenditure on the health sector and the impracticality of medical malpractice law. The authors highlight that the cardinal step in solving this dilemma is restoring the ethical dimension of the patient-physician relationship.
    • Stakeholder perspectives on the ethico-legal dimensions of biobanking in South Africa

      Shenuka Singh; Keymanthri Moodley (BMC, 2021-07-01)
      Abstract Background Biobanking provides exciting opportunities for research on stored biospecimens. However, these opportunities to advance medical science are fraught with challenges including ethical and legal dilemmas. This study was undertaken to establish perspectives of South African stakeholders on the ethico-legal dimensions of biobanking. Methods An in-depth exploratory study was conducted with 25 purposively selected biobankers, clinicians, researchers, postgraduate students in biobanking research, and research ethics committee (REC) members in South Africa. Potential study participants were recruited through known hubs for biobanking in the country, online searches and the snowball sampling technique. A semi-structured face-to-face or Skype interview was arranged. Data was analysed using thematic analysis. Results The emergent themes included: inconsistency in understanding consent models, disconnect between biobank researchers and biosample donors, inadequate processes to support re-consenting minors, inconsistent governance processes for biobanking research; challenges with sample and data sharing, and suboptimal strategies for benefit sharing and return of results. Biobanking practice in general appeared to be inconsistent and fragmented. While the need for consent in research is explicitly outlined in legislative documents, some respondents were unclear on the type of consent model to apply in biosample collection. They also reported inconsistencies in research participants’ understanding of consent. Furthermore, these respondents’ own understanding of consent and consent models were dependent on where they were positioned in biobanking practice (roles occupied). Respondents were unsure about the process to follow to re-consent child participants once the age of majority (≥ 18 years) was reached. It was not surprising that consent was identified as one of the major ethical challenges in biobanking practice. In certain settings, some respondents reported suboptimal governance processes for sample collection. Participants were generally unsure about how to operationalise benefit sharing and how to approach the idea of returning results to research participants and biobank donors. Conclusion The study findings indicated inconsistencies in stakeholder understanding of ethico-legal considerations related to biobanking in South Africa. A need for ongoing ethics capacity development among stakeholders was identified. Improving understanding of the ethics of biobanking could be facilitated by acknowledging the disconnect created by biosamples in the relationship between biobank researchers and donors.
    • Documentation of ethically relevant information in out-of-hospital resuscitation is rare: a Danish nationwide observational study of 16,495 out-of-hospital cardiac arrests

      Louise Milling; Lars Grassmé Binderup; Caroline Schaffalitzky de Muckadell; Erika Frischknecht Christensen; Annmarie Lassen; Helle Collatz Christensen; Dorthe Susanne Nielsen; Søren Mikkelsen; The Danish Cardiac Arrest Registry Group (BMC, 2021-06-01)
      Abstract Background Decision-making in out-of-hospital cardiac arrest should ideally include clinical and ethical factors. Little is known about the extent of ethical considerations and their influence on prehospital resuscitation. We aimed to determine the transparency in medical records regarding decision-making in prehospital resuscitation with a specific focus on ethically relevant information and consideration in resuscitation providers’ documentation. Methods This was a Danish nationwide retrospective observational study of out-of-hospital cardiac arrests from 2016 through 2018. After an initial screening using broadly defined inclusion criteria, two experienced philosophers performed a qualitative content analysis of the included medical records according to a preliminary codebook. We identified ethically relevant content in free-text fields and categorised the information according to Beauchamp and Childress’ four basic bioethical principles: autonomy, non-maleficence, beneficence, and justice. Results Of 16,495 medical records, we identified 759 (4.6%) with potentially relevant information; 710 records (4.3%) contained ethically relevant information, whereas 49 did not. In general, the documentation was vague and unclear. We identified four kinds of ethically relevant information: patients’ wishes and perspectives on life; relatives’ wishes and perspectives on patients’ life; healthcare professionals’ opinions and perspectives on resuscitation; and do-not-resuscitate orders. We identified some “best practice” examples that included all perspectives of decision-making. Conclusions There is sparse and unclear evidence on ethically relevant information in the medical records documenting resuscitation after out-of-hospital cardiac arrests. However, the “best practice” examples show that providing sufficient documentation of decision-making is, in fact, feasible. To ensure transparency surrounding prehospital decisions in cardiac arrests, we believe that it is necessary to ensure more systematic documentation of decision-making in prehospital resuscitation.
    • Ethics of HIV cure research: an unfinished agenda

      Karine Dubé; John Kanazawa; Jeff Taylor; Lynda Dee; Nora Jones; Christopher Roebuck; Laurie Sylla; Michael Louella; Jan Kosmyna; David Kelly (BMC, 2021-06-01)
      Abstract Background The pursuit of a cure for HIV is a high priority for researchers, funding agencies, governments and people living with HIV (PLWH). To date, over 250 biomedical studies worldwide are or have been related to discovering a safe, effective, and scalable HIV cure, most of which are early translational research and experimental medicine. As HIV cure research increases, it is critical to identify and address the ethical challenges posed by this research. Methods We conducted a scoping review of the growing HIV cure research ethics literature, focusing on articles published in English peer-reviewed journals from 2013 to 2021. We extracted and summarized key developments in the ethics of HIV cure research. Twelve community advocates actively engaged in HIV cure research provided input on this summary and suggested areas warranting further ethical inquiry and foresight via email exchange and video conferencing. Discussion Despite substantial scholarship related to the ethics of HIV cure research, additional attention should focus on emerging issues in six categories of ethical issues: (1) social value (ongoing and emerging biomedical research and scalability considerations); (2) scientific validity (study design issues, such as the use of analytical treatment interruptions and placebos); (3) fair selection of participants (equity and justice considerations); (4) favorable benefit/risk balance (early phase research, benefit-risk balance, risk perception, psychological risks, and pediatric research); (5) informed consent (attention to language, decision-making, informed consent processes and scientific uncertainty); and (6) respect for enrolled participants and community (perspectives of people living with HIV and affected communities and representation). Conclusion HIV cure research ethics has an unfinished agenda. Scientific research and bioethics should work in tandem to advance ethical HIV cure research. Because the science of HIV cure research will continue to rapidly advance, ethical considerations of the major themes we identified will need to be revisited and refined over time.
    • Why should HCWs receive priority access to vaccines in a pandemic?

      Xavier Symons; Steve Matthews; Bernadette Tobin (BMC, 2021-06-01)
      Abstract Background Viral pandemics present a range of ethical challenges for policy makers, not the least among which are difficult decisions about how to allocate scarce healthcare resources. One important question is whether healthcare workers (HCWs) should receive priority access to a vaccine in the event that an effective vaccine becomes available. This question is especially relevant in the coronavirus pandemic with governments and health authorities currently facing questions of distribution of COVID-19 vaccines. Main text In this article, we critically evaluate the most common ethical arguments for granting healthcare workers priority access to a vaccine. We review the existing literature on this topic, and analyse both deontological and utilitarian arguments in favour of HCW prioritisation. For illustrative purposes, we focus in particular on the distribution of a COVID-19 vaccine. We also explore some practical complexities attendant on arguments in favour of HCW prioritisation. Conclusions We argue that there are deontological and utilitarian cases for prioritising HCWs. Indeed, the widely held view that we should prioritise HCWs represents an example of ethical convergence. Complexities arise, however, when considering who should be included in the category of HCW, and who else should receive priority in addition to HCWs.
    • Analyzing the paradigmatic cases of two persons with a disorder of consciousness: reflections on the legal and ethical perspectives

      Mario Picozzi; Lino Panzeri; Davide Torri; Davide Sattin (BMC, 2021-07-01)
      Abstract Background Media have increasingly reported on the difficulties associated with end-of-life decision-making in patients with Disorders of Consciousness (DOC), contextualizing such dilemma in detailed accounts of the patient’s life. Two of the first stories debated in the scientific community were those related to the cases of two women, one American, the other Italian, who captured attention of millions of people in the first years of this third millennium. Methods Much has been written about the challenges of surrogate decision-making for patients in DOC, but less has been written comparing these challenges across legal systems and cultures. In our paper, we propose a systematic analysis of the final legal documents written by the American and Italian Courts in relation to the two cases, developing our discussion around three areas: the level of certainty/reliability of diagnosis and prognosis, the reconstruction of self-expression, time of illness and time of care. They are examples of the typical issues discussed by legal authors and allow us to understand the link and the difference between the legal and ethical perspectives. Results The legal approach to the two cases has some common elements: the need to be certain about the diagnosis and prognosis and the fact that the clinical criteria are necessary in determining the most appropriate treatments, although these criteria are not sufficient unless they are supplemented by the patient’s will. The issue of relations takes on importance both from a legal and an ethical point of view, but from two different perspectives. While ethics safeguards relationships by guaranteeing their differences and makes them reconcilable, law safeguards relationships by guaranteeing the cold forms of respect, equality, impartiality, symmetry, reciprocity, and irreversibility. In this perspective, the link between the time of care and the decision of the family members assumes importance. Conclusions The most interesting point that emerges from our analysis is the issue of relationships and how they affect decisions, both from a legal and ethical point of view. For this reason, during the patients’ hospitalization, it is necessary to identify ways in which they might give their opinion about the moral issues underlying their choices.
    • Solitary death and new lifestyles during and after COVID-19: wearable devices and public health ethics

      Eisuke Nakazawa; Keiichiro Yamamoto; Alex John London; Akira Akabayashi (BMC, 2021-07-01)
      Abstract Background Solitary death (kodokushi) has recently become recognized as a social issue in Japan. The social isolation of older people leads to death without dignity. With the outbreak of COVID-19, efforts to eliminate solitary death need to be adjusted in line with changes in lifestyle and accompanying changes in social structure. Health monitoring services that utilize wearable devices may contribute to this end. Our goals are to outline how wearable devices might be used to (1) detect emergency situations involving solitary older people and swiftly connect them with medical treatment, to (2) reduce the frequency of deaths that remain undiscovered and (3) to reduce social isolation by promoting social interaction. Methods Theoretical and philosophical approaches were adopted to examine ethical issues surrounding the application of wearable devices and cloud-based information processing systems to prevent solitary death in the world with/after COVID-19. Main body (1) Technology cannot replace social connections; without social support necessary to foster understanding of the benefits of health management through wearable devices among older adults, such devices may remain unused, or not used properly. (2) Maturity of the technology; systems face the difficult task of detecting and responding to a wide range of health conditions and life-threatening events in time to avert avoidable morbidity and mortality. (3) Autonomy and personhood; promoting the voluntary use of wearable devices that are a part of larger efforts to connect isolated individuals to a community or social services might be effective. Legal force should be avoided if possible. There is some concern that landlords may require an older person to sign a contract agreeing to wear a device. The autonomy of solitary older people should be respected. (4) Governance: policies must be developed to limit access to data from wearables and the purposes for which data can be used. Conclusion If thoughtfully deployed under proper policy constraints, wearable devices offer a way to connect solitary older people to health services and could reduce cases of solitary death while respecting the personhood of the user.
    • How ethics committees and requirements are structuring health research in the Philippines: a qualitative study

      Gideon Lasco; Vincen Gregory Yu; Lia Palileo-Villanueva (BMC, 2021-07-01)
      Abstract Background The last few decades have seen the rising global acknowledgment of the importance of ethics in the conduct of health research. But research ethics committees or institutional review boards (IRBs) have also been criticized for being barriers to research. This article examines the case of the Philippines, where little has been done to interrogate the health research and IRB culture, and whose circumstances can serve as reflection points for other low- and middle-income countries. Methods Semi-structured interviews were conducted from July to October 2020 to elicit health researchers’ perspectives and experiences regarding IRBs and the ethics approval process in the country, as well as counterpoint narratives from researchers who have also worked for IRBs. Results Across the fields of clinical, public health, and social science research, the issue of ethics review revealed itself to be foremost an issue of inequity. IRB processes serve as a barrier for those outside the academe; those belonging to institutions, cities, or entire regions without their own accredited IRBs; and researchers working independently, without ample budget, or on highly specialized topics—more so for non-clinical researchers who must grapple with the primarily biomedical framework of most IRBs. Consequently, the research landscape invariably favors those with the resources to do research, and researches that tend to attract funding. Conclusion The broader challenge of equity in health research will entail more fundamental reforms, but proximal interventions can be done to make the ethics approval process more equitable, such as enhancing institutional oversight, regulating IRB fees, and enabling a more supportive and welcoming environment for early-career, student, independent, and non-clinical health researchers. This article ends by reflecting on the implications of our findings toward the larger research culture.
    • Adherence with reporting of ethical standards in COVID-19 human studies: a rapid review

      Lydia O’Sullivan; Ronan P. Killeen; Peter Doran; Rachel K. Crowley (BMC, 2021-06-01)
      Abstract Background Patients with COVID-19 may feel under pressure to participate in research during the pandemic. Safeguards to protect research participants include ethical guidelines [e.g. Declaration of Helsinki and good clinical practice (GCP)], legislation to protect participants’ privacy, research ethics committees (RECs) and informed consent. The International Committee of Medical Journal Editors (ICMJE) advises researchers to document compliance with these safeguards. Adherence to publication guidelines has been suboptimal in other specialty fields. The aim of this rapid review was to determine whether COVID-19 human research publications report compliance with these ethical safeguards. Methods A rapid systematic literature review was conducted in MEDLINE using the search term ‘COVID-19’. The search was performed in April 2020 with no start date and repeated to include articles published in November 2020. Filters were ‘Full free text available’ and ‘English Language’. Two reviewers assessed article title, abstracts and full texts. Non-COVID-19 articles and non-clinical studies were excluded. Independent reviewers conducted a second assessment of a random 20% of articles. The outcomes included reporting of compliance with the Declaration of Helsinki and GCP, REC approval, informed consent and participant privacy. Results The searches yielded 1275 and 1942 articles of which 247 and 717 were deemed eligible, from the April  search and November respectively. The majority of journals had editorial policies which purported to comply with ICMJE ethical standards. Reporting of compliance with ethical guidelines was low across all study types but was higher in the November search for case series and observational studies. Reporting of informed consent for case studies and observational studies was higher in the November search, but similar for case series. Overall, participant confidentiality was maintained but some case studies included a combination of details which would have enabled participant identification. Reporting of REC approval was higher in the November search for observational studies. Conclusions While the majority of journal’s editorial policies purported to support the ethical safeguards, many COVID-19 clinical research publications identified in this rapid review lacked documentation of these important safeguards for research participants. In order to promote public trust, ethical declarations should be included consistently.
    • Trends in Swedish physicians’ attitudes towards physician-assisted suicide: a cross-sectional study

      Niels Lynøe; Anna Lindblad; Ingemar Engström; Mikael Sandlund; Niklas Juth (BMC, 2021-07-01)
      Abstract Aims To examine attitudes towards physician-assisted suicide (PAS) among physicians in Sweden and compare these with the results from a similar cross-sectional study performed in 2007. Participants A random selection of 250 physicians from each of six specialties (general practice, geriatrics, internal medicine, oncology, surgery and psychiatry) and all 127 palliative care physicians in Sweden were invited to participate in this study. Setting A postal questionnaire commissioned by the Swedish Medical Society in collaboration with Karolinska Institute in Stockholm. Results The total response rate was 59.2%. Slightly fewer than half [47.1% (95% CI 43.7–50.5)] of the respondents from the six specialties accepted PAS, which is significantly more than accepted PAS in the 2007 study [34.9% (95% CI 31.5–38.3)]. Thirty-three percent of respondents were prepared to prescribe the needed drugs. When asked what would happen to the respondent’s own trust in healthcare, a majority [67.1% (95% CI 63.9–70.3)] stated that legalizing PAS would either not influence their own trust in healthcare, or that their trust would increase. This number is an increase compared to the 2007 survey, when just over half [51.9% (95% CI 48.0–55.2)] indicated that their own trust would either not be influenced, or would increase. Conclusions The study reveals a shift towards a more accepting attitude concerning PAS among physicians in Sweden. Only a minority of the respondents stated that they were against PAS, and a considerable proportion reported being prepared to prescribe the needed drugs for patient self-administration if PAS were legalized.
    • Meta-consent for the secondary use of health data within a learning health system: a qualitative study of the public’s perspective

      Annabelle Cumyn; Adrien Barton; Roxanne Dault; Nissrine Safa; Anne-Marie Cloutier; Jean-François Ethier (BMC, 2021-06-01)
      Abstract Background The advent of learning healthcare systems (LHSs) raises an important implementation challenge concerning how to request and manage consent to support secondary use of data in learning cycles, particularly research activities. Current consent models in Quebec were not established with the context of LHSs in mind and do not support the agility and transparency required to obtain consent from all involved, especially the citizens. Therefore, a new approach to consent is needed. Previous work identified the meta-consent model as a promising alternative to fulfill the requirements of LHSs, particularly large-scale deployments. We elicited the public’s attitude toward the meta-consent model to evaluate if the model could be understood by the citizens and would be deemed acceptable to prepare for its possible implementation in Quebec. Methods Eight focus groups, with a total of 63 members of the general public from various backgrounds were conducted in Quebec, Canada, in 2019. Explicit attention was given to literacy levels, language spoken at home and rural vs urban settings. We assessed attitudes, concerns and facilitators regarding key components of the meta-consent model: predefined categories to personalized consent requests, a dynamic web-based infrastructure to record meta-consent, and default settings. To analyse the discussions, a thematic content analysis was performed using a qualitative software. Results Our findings showed that participants were supportive of this new approach of consent as it promotes transparency and offers autonomy for the management of their health data. Key facilitators were identified to be considered in the implementation of a meta-consent model in the Quebec LHSs: information and transparency, awareness campaigns, development of educational tools, collaboration of front-line healthcare professionals, default settings deemed acceptable by the society as well as close partnerships with recognized and trusted institutions. Conclusions This qualitative study reveals the openness of a sample of the Quebec population regarding the meta-consent model for secondary use of health data for research. This first exploratory study conducted with the public is an important step in guiding decision-makers in the next phases of implementing the various strategies to support access and use of health data in Quebec.
    • Association between knowledge and attitudes towards advance directives in emergency services

      Silvia Poveda-Moral; Pilar José-Maria de la Casa; Pere Sánchez-Valero; Núria Pomares-Quintana; Mireia Vicente-García; Anna Falcó-Pegueroles (BMC, 2021-06-01)
      Abstract Background Implementing the routine consultation of patient advance directives in hospital emergency departments and emergency medical services has become essential, given that advance directives constitute the frame of reference for care personalisation and respect for patients’ values and preferences related to healthcare. The aim of this study was to assess the levels and relationship of knowledge and attitudes of nursing and medical professionals towards advance directives in hospital emergency departments and emergency medical services, and to determine the correlated and predictor variables of favourable attitudes towards advance directives. Methods Observational, descriptive, and cross-sectional study. The study was conducted in the emergency department of a second-level hospital and in the emergency medical service. Data collection was performed from January 2019 to February 2020. The STROBE guidelines were followed for the preparation of the study. Results A total of 173 healthcare professionals responded to the questionnaire. Among them, 91.3% considered that they were not sufficiently informed about advance directives, and 74% acknowledged not having incorporated them into their usual practice. Multinomial analysis indicated a statistically significant relationship between the variable emergency medical service and having more favourable attitudes towards consulting the advance directives in their practical application (OR 2.49 [95% CI 1.06–5.88]; p = 0.037) and compliance in complex scenarios (OR 3.65 [95% CI 1.58 − 8.41]; p = 0.002). Working the afternoon and night shift was a predictor variable for obtaining a higher score with respect to attitudes in complex scenarios. Conclusion There is an association between the level of knowledge that nursing and medical professionals have about advance directives and the scores obtained on the attitude scales at the time of practical implementation and in complex scenarios. This shows that the more knowledge professionals have, the more likely they are to consult patients' advance directives and to respect their wishes and preferences for care and/or treatment.
    • Moral distress and ethical climate in intensive care medicine during COVID-19: a nationwide study

      Moniek A. Donkers; Vincent J. H. S. Gilissen; Math J. J. M. Candel; Nathalie M. van Dijk; Hans Kling; Ruth Heijnen-Panis; Elien Pragt; Iwan van der Horst; Sebastiaan A. Pronk; Walther N. K. A. van Mook (BMC, 2021-06-01)
      Abstract Background The COVID-19 pandemic has created ethical challenges for intensive care unit (ICU) professionals, potentially causing moral distress. This study explored the levels and causes of moral distress and the ethical climate in Dutch ICUs during COVID-19. Methods An extended version of the Measurement of Moral Distress for Healthcare Professionals (MMD-HP) and Ethical Decision Making Climate Questionnaire (EDMCQ) were online distributed among all 84 ICUs. Moral distress scores in nurses and intensivists were compared with the historical control group one year before COVID-19. Results Three hundred forty-five nurses (70.7%), 40 intensivists (8.2%), and 103 supporting staff (21.1%) completed the survey. Moral distress levels were higher for nurses than supporting staff. Moral distress levels in intensivists did not differ significantly from those of nurses and supporting staff. “Inadequate emotional support for patients and their families” was the highest-ranked cause of moral distress for all groups of professionals. Of all factors, all professions rated the ethical climate most positively regarding the culture of mutual respect,  ethical awareness and support. “Culture of not avoiding end-of-life-decisions” and “Self-reflective and empowering leadership” received the lowest mean scores. Moral distress scores during COVID-19 were significantly lower for ICU nurses (p < 0.001) and intensivists (p < 0.05) compared to one year prior. Conclusion Levels and causes of moral distress vary between ICU professionals and differ from the historical control group. Targeted interventions that address moral distress during a crisis are desirable to improve the mental health and retention of ICU professionals and the quality of patient care.
    • Assessing research misconduct in Iran: a perspective from Iranian medical faculty members

      Erfan Shamsoddin; Zahra Torkashvand-Khah; Ahmad Sofi-Mahmudi; Leila Janani; Payam Kabiri; Ehsan Shamsi-Gooshki; Bita Mesgarpour (BMC, 2021-06-01)
      Abstract Background Research misconduct is a global concern in biomedical science. There are no comprehensive data regarding the perception and situation of scientific misconduct among the Iranian medical faculty members. We conducted a nationwide survey to assess the research misconduct among the medical faculty members in Iran. Methods We used the Persian version of the research misconduct questionnaire (PRMQ) on the Google Forms platform. We sent the survey link to a systematic random sample of medical faculty members in Iran (N = 4986). Descriptive analyses were performed on the individual items of the PRMQ, with frequencies and percentages for categorical and Likert-type response items, and means and standard deviation (S.D.) for continuous variables. Chi-square analysis was conducted to test hypotheses examining differences in the frequency of responses related to factors influencing misconduct. We also defined four tenure categories (TC) based on the working years of the participants as tenured faculty members. All the analyses were performed using R 3.6.0. Results The response rate was 13.8% (692 responses). Nearly 70% of the respondents agreed that their publication output would be of higher quality if there were no publication pressure. Approximately three-quarters (N =499, 72.1%) of the respondents had been aware of some instances of research misconduct during the previous year according to their understanding of misconduct. Among the participants, 18.5% perceived the effectiveness of their associated organisation’s rules for reducing research misconduct to be high or very high. Pressure for tenure was identified as the item most frequently perceived with a strong behavioural influence on engaging in research misconduct (80.2%). Conclusions This study confirms that research misconduct needs to be actively addressed among the medical faculty members. Making policies with a focus on boosting awareness regarding the occasions of scientific misconduct and its management seems to be indispensable in the future in Iran.
    • Principles for pandemics: COVID-19 and professional ethical guidance in England and Wales

      Helen Smith; Peta Coulson-Smith; Mari-Rose Kennedy; Giles Birchley; Jonathan Ives; Richard Huxtable (BMC, 2021-06-01)
      Abstract Background During the arrival of the COVID-19 pandemic, various professional ethical guidance was issued to (and for) health and social care professionals in England and Wales. Guidance can help to inform and support such professionals and their patients, clients and service users, but a plethora of guidance risked information overload, confusion, and inconsistency. Methods During the early months of the pandemic, we undertook a rapid review, asking: what are the principles adopted by professional ethical guidance in England and Wales for dealing with COVID-19? We undertook thematic content analysis of the 29 documents that met our inclusion criteria. Results The 29 documents captured 13 overlapping principles: respect, fairness, minimising harm, reciprocity, proportionality, flexibility, working together, inclusiveness, communication, transparency, reasonableness, responsibility, and accountability. Conclusions We intend this attempt to collate and outline the prominent principles to be helpful, particularly, for healthcare practice during the COVID-19 pandemic and, hopefully, for future pandemic planning. We also offer some reflections on the guidance and the principles therein. After describing the principles, we reflect on some of the similarities and differences in the guidance, and the challenges associated not only with the specific guidance reviewed, but also with the nature and import of “professional ethical guidance”.
    • What does engagement mean to participants in longitudinal cohort studies? A qualitative study

      Cynthia A. Ochieng; Joel T. Minion; Andrew Turner; Mwenza Blell; Madeleine J. Murtagh (BMC, 2021-06-01)
      Abstract Background Engagement is important within cohort studies for a number of reasons. It is argued that engaging participants within the studies they are involved in may promote their recruitment and retention within the studies. Participant input can also improve study designs, make them more acceptable for uptake by participants and aid in contextualising research communication to participants. Ultimately it is also argued that engagement needs to provide an avenue for participants to feedback to the cohort study and that this is an ethical imperative. This study sought to explore the participants’ experiences and thoughts of their engagement with their birth cohort study. Methods Participants were recruited from the Children of the 90s (CO90s) study. Qualitative semi-structured interviews were conducted with 42 participants. The interviews were transcribed verbatim, and uploaded onto Nvivo software. They were then analysed via thematic analysis with a constant comparison technique. Results Participants’ experiences of their engagement with CO90s were broadly based on three aspects: communication they received from CO90s, experiences of ethical conduct from CO90s and receiving rewards from CO90s. The communication received from CO90s, ranged from newsletters explaining study findings and future studies, to more personal forms like annual greeting cards posted to each participant. Ethical conduct from CO90s mainly involved participants understanding that CO90s would keep their information confidential, that it was only involved in ‘good’ ethical research and their expectation that CO90s would always prioritise participant welfare. Some of the gifts participants said they received at CO90s included toys, shopping vouchers, results from clinical tests, and time off from school to attend data collection (Focus) days. Participants also described a temporality in their engagement with CO90s and the subsequent trust they had developed for the cohort study. Conclusion The experiences of engagement described by participants were theorized as being based on reciprocity which was sometimes overt and other times more nuanced. We further provide empirical evidence of participants’ expectation for a reciprocal interaction with their cohort study while highlighting the trust that such an interaction fosters. Our study therefore provides key insights for other cohort studies on what participants value in their interactions with their cohort studies.
    • Who should be tested in a pandemic? Ethical considerations

      Sven Ove Hansson; Gert Helgesson; Niklas Juth (BMC, 2021-06-01)
      Abstract Background In the initial phase of the Covid-19 pandemic, difficult decisions had to be made on the allocation of testing resources. Similar situations can arise in future pandemics. Therefore, careful consideration of who should be tested is an important part of pandemic preparedness. We focus on four ethical aspects of that problem: how to prioritize scarce testing resources, the regulation of commercial direct-to-consumer test services, testing of unauthorized immigrants, and obligatory testing. Main text The distribution of scarce resources for testing: We emphasize the use of needs-based criteria, but also acknowledge the importance of choosing a testing strategy that contributes efficiently to stopping the overall spread of the disease. Commercial direct-to-consumer test services: Except in cases of acute scarcity, such services will in practice have to be allowed. We propose that they should be subject to regulation that ensures test quality and adequate information to users. Testing of unauthorized immigrants, their children and other people with unclear legal status: Like everyone else, these individuals may be in need of testing, and it is in society’s interest to reach them with testing in order to stop the spread of the disease. A society that offers comprehensive medical services to unauthorized immigrants is in a much better position to reach them in a pandemic than a society that previously excluded them from healthcare. Obligatory testing: While there are often strong reasons for universal testing in residential areas or on workplaces, there are in most cases better ways to achieve testing coverage than to make testing mandatory. Conclusion In summary, we propose (1) decision-making primarily based on needs-based criteria, (2) strict regulation but not prohibition of direct-to-consumer test services, (3) test services offered to unauthorized immigrants, preferably as part of comprehensive medical services, and (4) broad outreach of testing services whenever possible, but in general not obligatory testing.
    • Consent for withholding life-sustaining treatment in cancer patients: a retrospective comparative analysis before and after the enforcement of the Life Extension Medical Decision law

      Yu Jin Chung; Incheol Park; Junho Cho; Jin Ho Beom; Ji Eun Lee (BMC, 2021-06-01)
      Abstract Background The Life Extension Medical Decision law enacted on February 4, 2018 in South Korea was the first to consider the suspension of futile life-sustaining treatment, and its enactment caused a big controversy in Korean society. However, no study has evaluated whether the actual implementation of life-sustaining treatment has decreased after the enforcement of this law. This study aimed to compare the provision of patient consent before and after the enforcement of this law among cancer patients who visited a tertiary university hospital's emergency room to understand the effects of this law on the clinical care of cancer patients. Methods This retrospective single cohort study included advanced cancer patients aged over 19 years who visited the emergency room of a tertiary university hospital. The two study periods were as follows: from February 2017 to January 2018 (before) and from May 2018 to April 2019 (after). The primary outcome was the length of hospital stay. The consent rates to perform cardiopulmonary resuscitation (CPR), intubation, continuous renal replacement therapy (CRRT), and intensive care unit (ICU) admission were the secondary outcomes. Results The length of hospital stay decreased after the law was enforced from 4 to 2 days (p = 0.001). The rates of direct transfers to secondary hospitals and nursing hospitals increased from 8.2 to 21.2% (p = 0.001) and from 1.0 to 9.7%, respectively (p < 0.001). The consent rate for admission to the ICU decreased from 6.7 to 2.3% (p = 0.032). For CPR and CRRT, the consent rates decreased from 1.0 to 0.0% and from 13.9 to 8.8%, respectively, but the differences were not significant (p = 0.226 and p = 0.109, respectively). Conclusion After the enforcement of the Life Extension Medical Decision law, the length of stay in the tertiary university hospital decreased in patients who established their life-sustaining treatment plans in the emergency room. Moreover, the rate of consent for ICU admission decreased.
    • A Q methodology study on divergent perspectives on CRISPR-Cas9 in the Netherlands

      Mirjam Schuijff; Menno D. T. De Jong; Anne M. Dijkstra (BMC, 2021-04-01)
      Abstract Background CRISPR-Cas9, a technology enabling modification of the human genome, is developing rapidly. There have been calls for public debate to discuss its ethics, societal implications, and governance. So far, however, little is known about public attitudes on CRISPR-Cas9. This study contributes to a better understanding of public perspectives by exploring the various holistic perspectives Dutch citizens have on CRISPR-Cas9. Methods This study used Q methodology to identify different perspectives of Dutch citizens (N = 30) on the use of CRISPR-Cas9. The Q-sort method aims at segmenting audiences based on the structural characteristics of their perspectives. Participants individually ranked 32 statements about CRISPR-Cas9 and discussed their rankings in small groups. By-person factor analysis was performed using PQMethod. Participants’ contributions to the discussions were used to further make sense of the audience segments identified. Results Five perspectives on CRISPR-Cas9 were identified: (1) pragmatic optimism (2) concerned scepticism; (3) normative optimism; (4) enthusiastic support; and (5) benevolent generalism. Each perspective represents a unique position motivated by different ranking rationales. Sorting rationales included improving health, preventing negative impacts on society, and fear of a slippery slope. Overall, there is broad, but not universal support for medical uses of CRISPR-Cas9. Conclusions Research on CRISPR-Cas9 should prioritise the broadly supported applications of the technology. Research and public debates on CRISPR-Cas9, its uses, its broader implications, and the governance of CRISPR-Cas9 are recommended. A discourse that includes all perspectives can contribute to the embedding of future uses of CRISPR-Cas9 in society. This study shows that Q methodology followed by group discussions enables citizens to contribute meaningfully to discourses about research.
    • Correction to: Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian Research Ethics Committees

      G. Benfatto; Regulatory Group; Ethics Committee Catania 1 (Group); F. Drago (BMC, 2021-04-01)
      An amendment to this paper has been published and can be accessed via the original article.