The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting.

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

Impact of institutional review board stipulations on turnaround time for approvals of surgical studies.

BACKGROUND: We have examined the number and types of stipulations received following the submission of surgical study protocols to the Institutional Review Boards (IRBs) for review, and their effect on turnaround time for approval. This analysis will enable our organization to improve the quality of applications and design of study protocols, which can streamline the approval process and increase efficiency of the startup phase for clinical research. METHODS: IRB stipulations for 48 surgical studies were analyzed. Various factors were assessed: surgical specialty, type of study by design, clinical trial phase, type of investigational product, type of IRB utilized (local or centralized), study complexity score, type of review (e.g., exempt, expedited, or full board), turnaround time, and number of stipulations received. Statistical analyses were performed to examine associations between the number/type of stipulations received during the IRB review process and any of the aforementioned study-related factors. RESULTS: For analyzed surgical studies, the number of stipulations allotted to a study and time taken for approval had moderate association with the complexity of the study. The turnaround time for approval was the highest for randomized, controlled trials and studies undergoing full board review. CONCLUSION: This study elucidates characteristics that are associated with increased time for IRB approval. Analysis of IRB stipulations can help improve the turnaround time for the approval process, increase efficiency of startup phase, and transition to execution phase faster, which will allow more time for enrollment of research subjects, and increase return on investment made into research and development programs.

Hard to reach? Methodological challenges researching vulnerable, gang-involved, young people.

INTRODUCTION: Research with young people (YP) is ethically challenging and bound in a complex maze of issues relating to power, voice and representation. Such sensitivities mean that the challenges raised in researching marginalised YP are often hard to navigate. This paper reports on research carried out with YP to explore links between mental health, school exclusion and involvement in criminal gangs. It aims to provide a practical guide to negotiating some of the methodological and ethical challenges experienced. METHOD: In-depth interviews conducted with 28 YP (aged 14-24 years) who were gang involved or seen to be at risk of gang involvement. Research was conducted in youth clubs, alternative provision and youth justice settings. RESULTS: OBSERVATIONS/REFLECTIONS: We reflect on how navigating ethics can create barriers to involving YP as primary informants in research. We consider why it is important to overcome these hurdles and how public engagement work with recognised gatekeepers and the use of creative interview methods can facilitate meaningful encounters, where YP feel able to share valuable insights into their lives. CONCLUSION: Alongside a number of specific learning points, the paper reflects on theories behind research with YP, including the need for recognition of power imbalances and reflexivity. It concludes with thoughts on the practical realities of achieving meaningful participation or an 'authentic voice' with marginalised groups and the importance of this in informing policy and practice. PATIENT OR PUBLIC CONTRIBUTION: The focus of this work was to collect experiences of YP who are recognised as gang-involved or at risk of being so, with a view to informing health and education policies. The scoping study for the project involved extensive public engagement work with YP exploring and trialling suitable methods of accessing, recruiting and ultimately interviewing this target group. This is central to the discussion within the body of the paper.

A scoping review of ethics review processes during public health emergencies in Africa.

BACKGROUND: The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). METHODS: We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. RESULTS: Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. CONCLUSIONS: There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics.

Government Initiatives for Research Ethics During COVID-19 Pandemic in Korea.

BACKGROUND: Despite the growing necessity for government-led policy changes on clinical research ethics during pandemic, the scope of previous literature is limited to Korean government's pandemic response strategies or reflections of research ethics at the level of institutions and academic societies. This paper examines the proactive policy changes and responses by the South Korean government in addressing the challenges and issues of research ethics against the backdrop of the urgency of rapid development and emergency supply of medical products during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: We conducted searches of various government documents, using predetermined keywords related to research ethics and integrity during the COVID-19 pandemic. Only documents issued by governments or public institutions were included. A total of 24 documents were selected for analysis. They were divided into two phases: the first phase for urgent response (January 2020-February 2021) and the second phase (March 2021-February 2023) for long-term preparedness. RESULTS: The Korean government recommended several measures of research governance to accelerate the ethical review of COVID-related research to be shortened less than one week: the joint operation of Institutional Review Boards (IRBs), exempted or expedited review by a special review committee, guidelines for urgent reviews, and designation of the Korean Academy of Medical Sciences as the supervising agency for the Clinical Trial Safety Support Institution as well as the Central IRB. It allowed temporary non-face-to-face methods for informed consent process (telephone explanations and a photo of the original signed consent) and clinical trials (telephone counselling and prescription, proxy prescription, and drug delivery and supply to clinical trial participants, and online ethics training). CONCLUSION: As a result of South Korea's commitment to ethical principles in their pandemic response, the medical system did not experience collapses due to the pandemic, and pandemic research was conducted with careful ethical considerations. The pandemic ethics immunization during the Middle East respiratory syndrome epidemic in 2015 laid the foundation for prompt government initiatives that ensured both pandemic research ethics and pandemic response ethics.

The Structure of Clinical Ethical Decision-Making: A Hospital System Needs Assessment.

Bioethical dilemmas can emerge in research and clinical settings, from end-of-life decision-making to experimental therapies. The COVID-19 pandemic raised serious ethical challenges for healthcare organizations, highlighting the need to conduct needs assessments of the bioethics infrastructures of healthcare organizations. Clinical ethics committees (CECs) also create equitable policies, train staff on ethics issues, and play a consultative role in resolving the difficulty of complex individual cases. The main objective of this project was to conduct a needs assessment of the bioethics infrastructure within a comprehensive hospital system. A cross-sectional anonymous online survey, including quantitative and qualitative formatted questions. The survey was sent to five key leaders from the organization's hospitals. Survey questions focused on the composition, structure, function, and effectiveness of their facilities' bioethics infrastructure and ethics-related training and resources. Positive findings included that most facilities have active CECs with multidisciplinary membership; CECs address critical issues and encourage team members to express clinical ethics concerns. Areas of concern included uncertainty about how CECs function and the process for resolving clinical ethics dilemmas. Most reported no formal orientation process for CEC members, and many said there was no ongoing ethics education process. The authors conclude that if CECs are a critical institutional resource where the practice of medicine and mission intersect, having well-functioning ethics committees with trained and oriented members demonstrates an essential commitment to the mission. The survey revealed that more needs to be done to bolster the bioethics infrastructure of this institution.

Specific Trends in Pediatric Ethical Decision-Making: An 18-Year Review of Ethics Consultation Cases in a Pediatric Hospital.

This is a qualitative examination of ethics consultation requests, outcomes, and ethics committee recommendations at a tertiary/quaternary pediatric hospital in the U.S. The purpose of this review of consults over an 18-year period is to identify specific trends in the types of ethical dilemmas presented in our pediatric setting, the impact of consultation and committee development on the number and type of consults provided, and any clinical features and/or challenges that emerged and contributed to the nature of ethical situations and dilemmas. Furthermore, in reviewing clinical ethics consultation trends for nearly two decades, we can identify topic areas for further ethics education and training for ethics consultants, ethics committee members, and pediatric healthcare teams and professionals based on our experiences. Our study with nearly two decades of data prior to the COVID-19 pandemic can serve as groundwork for future comparisons of consultation requests and ethics support for pediatric hospitals prior to, during, and following a pandemic.

Assessing the Variability in Interpretation of the Catholic Directives Pertaining to Reproductive Health Services: An Exploratory Qualitative Study of Two Hospitals on the American East Coast.

The ethics in Catholic hospitals are guided by the Ethical and Religious Directives for Catholic Health Care Services, which provide direction on many topics, including family planning. Previous research has demonstrated there is variability in the availability of prohibited family planning services at Catholic hospitals. This study aims to research a potential source of variability in interpretation and application of the directives through interviewing ethics committee members. Participants were recruited from two different hospitals on the east coast with a total sample size of eight. Ethics committee members were asked questions regarding their personal approach to ethics, their hospital's approach to ethics, and the permissibility of specific family planning methods at their hospital. Most ethics committee members stated that the Catholic faith and/or directives were important in their hospitals' approach to ethics. Most participants stated that they had instances in which their personal approach to ethics conflicted with their hospital's approach, citing women's health and end-of-life care as common causes of conflict. All but one ethics committee member stated that hormonal contraception was forbidden under the directives; however, many members stated that this was either a gray area or permissible under certain circumstances. Reproductive health issues rarely came before the ethics committee at either site with one participant referring to them as "black and white issues." This research suggests that ethics committee members did not see the directives governing family planning services to be ambiguous. However, given the low frequency in which these issues come to the attention of the ethics committee, it is difficult to determine whether the opinions expressed by our participants contribute to the variability between Catholic hospitals when it comes to reproductive healthcare provision. An interesting topic for future research would be interviewing executives at Catholic hospitals to determine where this variability arises.

Preclinical efficacy in investigator's brochures: Stakeholders' views on measures to improve completeness and robustness.

AIMS: Research ethics committees and regulatory agencies assess whether the benefits of a proposed early-stage clinical trial outweigh the risks based on preclinical studies reported in investigator's brochures (IBs). Recent studies have indicated that the reporting of preclinical evidence presented in IBs does not enable proper risk-benefit assessment. We interviewed different stakeholders (regulators, research ethics committee members, preclinical and clinical researchers, ethicists, and metaresearchers) about their views on measures to increase the completeness and robustness of preclinical evidence reporting in IBs. METHODS: This study was preregistered (https://osf.io/nvzwy/). We used purposive sampling and invited stakeholders to participate in an online semistructured interview between March and June 2021. Themes were derived using inductive content analysis. We used a strengths, weaknesses, opportunities and threats matrix to categorize our findings. RESULTS: Twenty-seven international stakeholders participated. The interviewees pointed to several strengths and opportunities to improve completeness and robustness, mainly more transparent and systematic justifications for the included studies. However, weaknesses and threats were mentioned that could undermine efforts to enable a more thorough assessment: The interviewees stressed that current review practices are sufficient to ensure the safe conduct of first-in-human trials. They feared that changes to the IB structure or review process could overburden stakeholders and slow drug development. CONCLUSION: In principle, more robust decision-making processes align with the interests of all stakeholders and with many current initiatives to increase the translatability of preclinical research and limit uninformative or ill-justified trials early in the development process. Further research should investigate measures that could be implemented to benefit all stakeholders.

Reimagining Thriving Ethics Programs without Ethics Committees.

With the increasing professionalization of clinical ethics, some hospitals and health systems utilize both ethics committees and professional clinical ethicists to address their ethics needs. Drawing upon historical critiques of ethics committees and their own experiences, the authors argue that, in ethics programs with one or more professional clinical ethicists, ethics committees should be dissolved when they fail to meet minimum standards of effectiveness. The authors outline several criteria for assessing effectiveness, describe the benefits of a model that places primary responsibility for ethics work with professional clinical ethicists-the PCE-primary model, and offer suggestions for alternative ethics program structures that empower healthcare professionals to contribute to ethics work in ways more tailored to their strengths and skills while minimizing the shortcomings of ethics committees.

Ethical and coordinative challenges in setting up a national cohort study during the COVID-19 pandemic in Germany.

With the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), global researchers were confronted with major challenges. The German National Pandemic Cohort Network (NAPKON) was launched in fall 2020 to effectively leverage resources and bundle research activities in the fight against the coronavirus disease 2019 (COVID-19) pandemic. We analyzed the setup phase of NAPKON as an example for multicenter studies in Germany, highlighting challenges and optimization potential in connecting 59 university and nonuniversity study sites. We examined the ethics application process of 121 ethics submissions considering durations, annotations, and outcomes. Study site activation and recruitment processes were investigated and related to the incidence of SARS-CoV-2 infections. For all initial ethics applications, the median time to a positive ethics vote was less than two weeks and 30 of these study sites (65%) joined NAPKON within less than three weeks each. Electronic instead of postal ethics submission (9.5 days (Q1: 5.75, Q3: 17) vs. 14 days (Q1: 11, Q3: 26), p value = 0.01) and adoption of the primary ethics vote significantly accelerated the ethics application process. Each study center enrolled a median of 37 patients during the 14-month observation period, with large differences depending on the health sector. We found a positive correlation between recruitment performance and COVID-19 incidence as well as hospitalization incidence. Our analysis highlighted the challenges and opportunities of the federated system in Germany. Digital ethics application tools, adoption of a primary ethics vote and standardized formal requirements lead to harmonized and thus faster study initiation processes during a pandemic.

Perspectives of agriculture, nutrition and health researchers regarding research governance in Malawi. Using a leadership, ethics, governance and systems framework.

BACKGROUND: Research ethics is intertwined with and depends on building robust and responsive research governance systems alongside researchers. Globally there has been substantial investment in agriculture, nutrition, and health (ANH) research motivated by the need to improve health outcomes, such as micronutrient deficiencies in Sub-Saharan Africa. Although there has been a notable focus on ethical issues inherent in ANH studies, there has been scanty research examining researchers' attitudes related to ANH research. This study was conducted to explore the perspectives of researchers who conducted an agronomic biofortification study in Malawi. METHODOLOGY: In-depth interviews were conducted with a purposive sample of ten ANH researchers. Interviews were conducted online via Zoom, audio-recorded, transcribed verbatim, and thematically analysed using the Leadership, Ethics, Governance and Systems Framework. RESULTS: Four core aspects emerged: Leadership: The relevance of building ethics leadership and ethical competence among researchers. ETHICS: There is a need to develop a framework that operationalises core ethical values that can guide the implementation of ANH research. Governance: Research guidelines were perceived to be too generic to guide ANH research. Systems: Researchers' recommended the establishment of a specialised ANH research ethics committee. CONCLUSIONS: The findings highlight the significance of building ethics leadership and supporting ethical competency amongst researchers. Researchers recommended the development of tailored approaches rather than utilising generic governance systems and frameworks that are drawn from medical research and thus not fit for purpose in this field. In Malawi, specialised ethics review committees are needed to guide ANH research.

Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations.

BACKGROUND: Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia. METHOD: This was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions. RESULTS: Twenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review. CONCLUSION: Saudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies.

Surveying the Indian research ethics committee response to the COVID-19 pandemic.

Research ethics committees (RECs) have played a crucial role in expediting the review of research protocols amidst the COVID-19 pandemic. To improve their performance and identify areas of enhancement, a multicentric study was conducted in India by the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP). The study aimed to evaluate the preparedness of Indian RECs during the COVID-19 outbreak while conducting protocol reviews and comprehend the challenges they encountered. After obtaining ethics committee approval, a cross-sectional observational study was conducted using two validated questionnaires, one for REC member secretaries/chairpersons and another for REC members. The questionnaires consisted of 13 multiple-choice questions, 10 yes or no questions, and 2 open-ended questions each. The study was distributed to multiple RECs. A total of 109/200 participants, including 13 REC member secretaries, 12 chairpersons and 84 REC members from a total of 34 REC's, consented to participate in the study. During the COVID-19 pandemic, 23/25 (92%) of the RECs conducted online meetings. The most common challenges faced by RECs included risk-benefit analysis (12/25 RECs), review of informed consent (12/25 RECs), and protocols involving vulnerable populations (10/25 RECs). 65% of the REC members reported the need for ethics review training, and 66/84 REC members agreed or strongly agreed that RECs require training in COVID-19 protocol review. Additionally, 62/84 REC members agreed or strongly agreed that central/joint RECs should review multicenter COVID-19 protocols. RECs in India encountered difficulties while reviewing risk-benefit analyses, informed consent documents (ICDs), and COVID-19 protocols and they suggested providing training on these topics.

A Survey Study on Knowledge and Attitude Toward the Ethics Committee and Research Ethical Practices Among Researchers From Kuwait.

The integrity of research findings and the safety of participants who voluntarily consent to participate in research studies must be assured through ethical approaches. Additionally, ethical guidelines and the ethics committee protect participants from unfair practices by the research team. Therefore, this study aims to assess the knowledge and attitudes toward the ethics committee and research ethical practices among the researchers of a diabetes institute in Kuwait. An anonymous survey was conducted through an online questionnaire using Microsoft Forms. The study had a response rate of 86%. Among the 55 participants in this study, 43 (78%) had ethics training. Researchers involved in more than four research projects were shown to have a much higher awareness of the ethics committee and its role than researchers involved in no projects. Approximately 90% of researchers had training in research ethics and were knowledgeable about informed consent forms and assent, as well as additional protections for vulnerable populations. Ninety-eight percent of respondents were of the view that an ethics committee was necessary. Our study concluded that most of the researchers at the institute were aware of the role of the ethics committee, and ethical principles. However, we recommend that continuous and customized training on research ethics should be provided.

Clinical Ethics Committee in an Oncological Research Hospital: two-years Report.

RESEARCH QUESTION AND AIM: Clinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020, a CEC was established in an Oncology Research Hospital in the North of Italy. This paper describes the development process and the activities performed 20 months from the CEC's implementation, to increase knowledge about CEC's implementation strategy. RESEARCH DESIGN: We collected quantitative data related to number and characteristics of CEC activities carried out from October 2020 to June 2022 using the CEC internal database. Data were reported descriptively and compared with data from the literature to provide a complete overview of the CEC's development and implementation process. PARTICIPANTS AND RESEARCH CONTEXT: The study has been conducted at the local health authority (LHA) of Reggio Emilia. It is a report of the activities provided by the CEC, where no HPs or patients were involved. ETHICAL CONSIDERATIONS: The report is part of a larger study named EVAluating a Clinical Ethics Committee implementation process (EvaCEC), which has been approved by the Local Ethics Committee (AUSLRE Protocollo n° 2022/0026554 of 24/02/2022). EvaCEC is also the first author's PhD project. FINDINGS: In total, the CEC performed 7 ethics consultations (EC), published three policies related to particular ethical questions of clinical and organizational practice, provided one educational online course on ethics consultation targeting employed HPs, and promoted a specific dissemination process among the different departments of the LHA. According to our results, the CEC widely fulfilled the standard threefold set of clinical ethics support services tasks (namely, ethics consultation, ethics education, and policy development), but further investigations are needed to evaluate the CEC's impact on clinical practice. CONCLUSION: Our findings may increase knowledge regarding the composition, role, and tasks of a CEC in an Italian setting, informing future strategies and efforts to regulate these institutions officially.

Observing resuscitative practice. A novice researcher's experience of obtaining ethics approval.

Undertaking research involving vulnerable groups, such as those requiring resuscitation involves careful analysis during the ethical review process. When a person lacks the capacity to make an informed choice about their participation in a research study, a waiver of consent offers an alternative. This paper is based on a doctoral research study using ethnography to explore the resuscitative practices and experiences of rural nurses through observation and interviews. This paper aims to explore the ethical issues raised by the Human Research Ethics Committee relating to consent of vulnerable patients requiring resuscitation within a rural context. In particular, the challenges of addressing risk (privacy) vs benefit (public) associated with a waiver of consent. This paper will consider why the rural context should be championed during the ethical review process, when decisions about public benefit are being deliberated. Utilising a communitarianism approach that advocates for greater rural representation during the ethical review processes will ensure that rural research involving vulnerable groups can be addressed safely and benefit not only the experiences and practices of rural nurses but also the wider rural communities they serve.

[Evaluation of clinical trials on medicinal products by ethics committees: changes due to the new EU Regulation 536/2014 (CTR) and necessary harmonization measures]. / Bewertung klinischer Arzneimittelprüfungen durch Ethikkommissionen: Änderungen durch die neue EU-Verordnung 536/2014 (CTR) und nötige Harmonisierungsmaßnahmen.

After Regulation (EU) No. 536/2014 (Clinical Trial Regulation, CTR) of the European Parliament and of the Council took effect on 31 January 2022, the application process for clinical trials fundamentally changed. This article describes the fundamental procedural changes and the resulting changes for Germany and, in particular, for the ethics committees. The harmonization efforts of the ethics committees at the EU level are discussed.According to the new EU regulation, only one ethics committee is involved in the approval of a clinical trial of medicinal products in Germany. The previous consultation procedure involving several locally competent ethics committees has been replaced. Instead, there is now closer cooperation between the ethics committees and the federal authorities through the preparation of a joint assessment report as well as with the other EU member states as part of the consolidation of the respective country-specific requirements. The regular mutual exchange between the ethics committees that had previously accompanied the consultation procedure helped to harmonize the decision criteria but also the discretionary decisions. Due to the discontinuation of this exchange, more detailed procedural recommendations are required but also other regular exchange possibilities in order to not only maintain but also to advance harmonizations already in place. The Working Group of Medical Ethics Committees (AKEK), as the representative of the individual ethics committees, also maintains an intensive exchange with federal authorities, applicants, other European ethics committees and European institutions.

Psychiatric Hospital Ethics Committee Discussions Over a Span of Nearly Three Decades.

Various types of health settings use clinical ethics committees (CEC) to deal with the ethical issues that confront both healthcare providers and their patients. Although these committees are now more common than ever, changes in the content of ethical dilemmas through the years is still a relatively unexplored area of research. The current study examines the major topics brought to the CEC of a psychiatric hospital in Israel and explores whether there were changes in their frequency across nearly three decades. The present paper reports on a thematic analysis of the written verbatim transcripts from 466 ethical topics brought to the CEC between the years 1991 and 2016. The following major topics related to ethical dilemmas were identified: confidentiality (30%), patient autonomy (23%), health records (14%), dual relationship (12%), allocation of resources (11%), inappropriate professional and personal conduct (9%), and multicultural sensitivity (1%). Topics related to confidentiality increased significantly over the years, as did inappropriate professional and personal conduct. In addition, the analysis showed that the content of the ethical cases and the resolutions suggested by the CEC also varied over the years. In conclusion, although most ethical topics have remained relatively stable over time, the discourse around them has evolved, requiring a dynamic assessment and reflection by the mental health practitioners serving as members of a CEC.

A Revised Moral Appraisal of Early Induction of Labor in Cases of Anencephaly.

The central concern of this article is whether early induction of labor for an anencephalic fetus can ever be morally justified, particularly by a Catholic healthcare ethics committee. By revisiting and refining arguments in articles by Drane (1992) and Bole (1992) published in this journal, a revised argument - consistent with the Catholic moral tradition - can seemingly be constructed that a Catholic healthcare ethics committee might use to justify early induction of labor in some pregnancies involving an anencephalic fetus. Such a revised argument depends upon two central claims; first, that the anencephalic fetus in question is necessarily in the process of dying when early induction of labor occurs, and second, that the fetus is judged to be undergoing extraordinary or disproportionate means of preserving their life as a result of receiving ongoing maternal support of a mother's womb. The revised argument developed in this article aims to utilize the doctrine of double effect in conjunction with these two central claims to justify early induction of labor for anencephalic fetal persons in some circumstances. Unfortunately, the revised argument - if successful - would be at odds with a stance taken in the United States Conference of Catholic Bishops (USCCB) 1996 statement "Moral Principles Concerning Infants with Anencephaly." However, there is reason to believe the revised argument offered in this article is well aligned with other guidance from the USCCB, contained in the publication Ethical and Religious Directives for Catholic Healthcare Services (2018). This article concludes by noting some important limitations of the argument and offering hope that consideration of the argument ultimately helps to strengthen the Catholic moral tradition.