Critical dialogue method of ethics consultation: making clinical ethics facilitation visible and accessible.

In clinical ethics consultations, clinical ethicists bring moral reasoning to bear on concrete and complex clinical ethical problems by undertaking ethical deliberation in collaboration with others. The reasoning process involves identifying and clarifying ethical values which are at stake or contested, and guiding clinicians, and sometimes patients and families, to think through ethically justifiable and available courses of action in clinical situations. There is, however, ongoing discussion about the various methods ethicists use to do this ethical deliberation work. In this paper, we make visible and accessible seven steps of facilitation used in the critical dialogue method of ethics consultation.We describe how the facilitation techniques serve two overall purposes. First, to identify ethically justified responses to ethical questions. Second, to assist participants to gain greater moral clarity, understanding and confidence to respond to ethical challenges as independent moral agents.By describing in detail facilitation steps for clinical ethics consultation, we aim to advance the scholarship of 'clinical ethics facilitation methods' and to demystify the ethical deliberation work undertaken by clinical ethicists.

Ethical regulation of biomedical research in Brazil: a quality improvement initiative.

BACKGROUND: Q-CEP (Qualificação dos Comitês de Ética em Pesquisa que compõem o Sistema CEP/Conep) is a nationwide project resulting from a partnership between the Brazilian National Research Ethics Commission (Conep), the Ministry of Health and Hospital Moinhos de Vento (HMV). It was developed to consolidate policy for ethical review of research with human beings in all members of the CEP/Conep System, Brazil's national system of institutional review boards. The aim of this study was therefore to report on the experience and results of the Q-CEP project. METHODS: An observational, retrospective study includes data from the Q-CEP, obtained from visits to all the institutional research ethics committees (RECs) in the country. The actions implemented by Q-CEP were part of a two-step process: (i) training visits to each REC; (ii) development of distance learning modules on strategic topics pertaining to research ethics evaluation. The data presented herein cover step one (training visits), defined by Q-CEP as the diagnostic stage of the project. For a country with social and economics inequalities such as Brazil, this is a particularly important stage; an accurate picture of reality is needed to inform planning of quality improvement strategies. RESULTS: In 2019-2021, Q-CEP visited 832 RECs and trained 11,197 people. This sample covered almost all active RECs in the country; only 4 (0.5%) were not evaluated. Of the 94 items evaluated, 62% did not reach the target of at least 80% compliance and around 1/4 (26%) were below 50% compliance. The diagnostic stage of the process revealed inadequacies on the part of the RECs in their ethical reviews. The analysis of informed consent forms showed compliance in only 131 RECs (15.74%). The description of pending issues made by RECs in their reports was compliant in 19.33% (n = 161). Administrative and operational aspects were also considered inadequate by more than half of the RECs. CONCLUSIONS: Overall, Brazilian RECs showed poor compliance in several aspects of their operation, both in ethics evaluation and in other processes, which justifies additional training. The Q-CEP project is part of a quality improvement policy promoted by the Brazilian Ministry of Health. The data obtained in the diagnostic step of the project have contributed to the qualification and consolidation of one of the world's largest research ethics evaluation systems.

Oversight of Dual-Use Research: What Role for Ethics Committees?

The World Health Organization (WHO) Global Guidance Framework for the Responsible Use of the Life Sciences addresses the governance of biorisks, including dual-use research, for countries. It emphasizes engaging multisectoral stakeholders such as governments, scientific bodies, health and research institutes, standard-setting organizations, funding bodies, and others. Ethics constitutes a key component of the framework. Given the high social impact of such research and the importance of trust, risk, and benefit, national ethics committees could make a valuable contribution by providing ethical guidance in the decisionmaking process. The purpose of this study was to examine the role of national ethics committees in the context of governance and oversight of dual-use research at the national level. We conducted a landscape analysis of the activities of ethics committees in dual-use research oversight. We also searched the WHO database on National Ethics Committees for publications related to dual-use research and/or misuse of life sciences research and gathered additional documentation from national ethics committees websites and through author contacts. Results showed that in the context of the wide range of oversight mechanisms for dual-use research in countries, national ethics committees have contributed to guiding policy and assessing dual-use research risks in only a limited number of countries. Recommendations from those countries include establishing a multistakeholder, coordinated oversight mechanism at the country level; strengthening international linkages to guide, harmonize, and reinforce national and international efforts; and involving ethics committees as an expert resource in the governance and oversight process.

Nippon Medical School's Ethical Review Processes for Studies Involving Human Subjects.

All life science and medical research involving human subjects must be conducted in compliance with the Declaration of Helsinki and the relevant laws and guidelines. Additionally, its scientific and ethical suitability must be reviewed by a committee well versed in the nature and content of the research. Failure to comply with these requirements when conducting research involving human subjects is a serious violation of Japanese laws, guidelines, and local regulations, so several ethics committees and institutional review boards have been established within the Nippon Medical School (NMS) Foundation and its affiliated institutions. It is essential for investigators to keep up to date with the latest developments in the ethical review process and to ensure that any projects they propose to embark on are subjected to an appropriate ethical review before the research is initiated. To help researchers and other staff affiliated with the NMS Foundation keep abreast of these developments, this report outlines NMS's current ethical review processes for research involving human subjects.

Data from the Indian drug regulator and from Clinical Trials Registry-India does not always match.

Introduction: In India, regulatory trials, which require the drug regulator's permission, must be registered with the Clinical Trials Registry-India (CTRI) as of 19 March 2019. In this study, for about 300 trials, we aimed to identify the CTRI record that matched the trial for which the regulator had given permission. After identifying 'true pairs', our goal was to determine whether the sites and Principal Investigators mentioned in the permission letter were the same as those mentioned in the CTRI record. Methods: We developed a methodology to compare the regulator's permission letters with CTRI records. We manually validated 151 true pairs by comparing the titles, the drug interventions, and the indications. We then examined discrepancies in their trial sites and Principal Investigators. Results: Our findings revealed substantial variations in the number and identity of sites and Principal Investigators between the permission letters and the CTRI records. Discussion: These discrepancies raise concerns about the accuracy and transparency of regulatory trials in India. We recommend easier data extraction from regulatory documents, cross-referencing regulatory documents and CTRI records, making public the changes to approval letters, and enforcing oversight by Institutional Ethics Committees for site additions or deletions. These steps will increase transparency around regulatory trials running in India.

Case study on communicating with research ethics committees about minimizing risk through software: an application for record linkage in secondary data analysis.

Objective: In retrospective secondary data analysis studies, researchers often seek waiver of consent from institutional Review Boards (IRB) and minimize risk by utilizing complex software. Yet, little is known about the perspectives of IRB experts on these approaches. To facilitate effective communication about risk mitigation strategies using software, we conducted two studies with IRB experts to co-create appropriate language when describing a software to IRBs. Materials and Methods: We conducted structured focus groups with IRB experts to solicit ideas on questions regarding benefits, risks, and informational needs. Based on these results, we developed a template IRB application and template responses for a generic study using privacy-enhancing software. We then conducted a three-round Delphi study to refine the template IRB application and the template responses based on expert panel feedback. To facilitate participants' deliberation, we shared the revisions and a summary of participants' feedback during each Delphi round. Results: 11 experts in two focus groups generated 13 ideas on risks, benefits, and informational needs. 17 experts participated in the Delphi study with 13 completing all rounds. Most agreed that privacy-enhancing software will minimize risk, but regardless all secondary data studies have an inherent risk of unexpected disclosures. The majority (84.6%) noted that subjects in retrospective secondary data studies experience no greater risks than the risks experienced in ordinary life in the modern digital society. Hence, all retrospective data-only studies with no contact with subjects would be minimal risk studies. Conclusion: First, we found fundamental disagreements in how some IRB experts view risks in secondary data research. Such disagreements are consequential because they can affect determination outcomes and might suggest IRBs at different institutions might come to different conclusions regarding similar study protocols. Second, the highest ranked risks and benefits of privacy-enhancing software in our study were societal rather than individual. The highest ranked benefits were facilitating more research and promoting responsible data governance practices. The highest ranked risks were risk of invalid results from systematic user error or erroneous algorithms. These societal considerations are typically more characteristic of public health ethics as opposed to the bioethical approach of research ethics, possibly reflecting the difficulty applying a bioethical approach (eg, informed consent) in secondary data studies. Finally, the development of privacy-enhancing technology for secondary data research depends on effective communication and collaboration between the privacy experts and technology developers. Privacy is a complex issue that requires a holistic approach that is best addressed through privacy-by-design principles. Privacy expert participation is important yet often neglected in this design process. This study suggests best practice strategies for engaging the privacy community through co-developing companion documents for software through participatory design to facilitate transparency and communication. In this case study, the final template IRB application and responses we released with the open-source software can be easily adapted by researchers to better communicate with their IRB when using the software. This can help increase responsible data governance practices when many software developers are not research ethics experts.

[ChatGPT: aid to medical ethics decision making?] / ChatGPT: Hilfe bei der medizinethischen Entscheidungsfindung?

BACKGROUND: Physicians have to make countless decisions every day. The medical, ethical and legal aspects are often intertwined and subject to change over time. Involving an ethics committee or arranging an ethical consultation are examples of potential aids to decision making. Whether and how artificial intelligence (AI) and the large language model (LLM) of the company OpenAI (San Francisco, CA, USA), known under the name ChatGPT, can also help and support ethical decision making is increasingly becoming a matter of controversial debate. MATERIAL AND METHODS: Based on a case example, in which a female physician is confronted with ethical and legal issues and presents these to ChatGPT to come up with answers, the first indications of the strengths and weaknesses are ascertained. CONCLUSION: Due to the rapid technical development and access to ever increasing quantities of data, the utilization should be closely observed and evaluated.

Is the UN receiving ethical approval for its research with human participants?

This paper examines the institutional mechanisms supporting the ethical oversight of human participant research conducted by the United Nations (UN). The UN has served an instrumental role in shaping international standards on research ethics, which invariably require ethical oversight of all research studies with human participants. The authors' experiences of conducting research collaboratively with UN agencies, in contrast, have led to concern that the UN frequently sponsors, or participates in, studies with human participants that have not received appropriate ethical oversight. It is argued that the institutional mechanisms in place to prevent research with human participants from being undertaken by the UN without ethical oversight do not, at present, extend substantively beyond the provision of guidelines and online training offered by a minority of UN bodies. The WHO and UNICEF are identified as notable exceptions, having implemented various measures to prevent health research with human participants from being undertaken without ethical oversight. Yet, it is highlighted that the WHO and UNICEF are not the only UN bodies that undertake health research with human participants and there are countless actors under the umbrella of the UN system that are regularly involved in non-health research with human participants. Arguments for the pursuit of the highest standard of ethical oversight by UN bodies are presented. Moving forward, the paper asks the question: is it time for the UN to set the standards for the oversight of ethical oversight?

Which Benefits Can Justify Risks in Research?

Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs.

Future pandemics and the urge to 'do something'.

Research with enhanced potential pandemic pathogens (ePPP) makes pathogens substantially more lethal, communicable, immunosuppressive or otherwise capable of triggering a pandemic. We briefly relay an existing argument that the benefits of ePPP research do not outweigh its risks and then consider why proponents of these arguments continue to confidently endorse them. We argue that these endorsements may well be the product of common cognitive biases-in which case they would provide no challenge to the argument against ePPP research. If the case against ePPP research is strong, the views of professional experts do little to move the needle in favour of ePPP research.

Researchers' Perspectives Regarding Ethical Issues of Biobank Research in the Arab Region.

Background: The recent expansion of genomic biobank research in the Arab region in the Middle East North Africa has raised complex ethical and regulatory issues. However, there is a lack of studies regarding the views of Arab researchers involved in such research. We aimed to assess the perceptions and attitudes of Arab researchers regarding these issues in biobank research. Methods: We developed a questionnaire to assess the perceptions and attitudes regarding genetic research of researchers from Egypt, Sudan, Morocco, and Jordan. The questionnaire requested demographic data, perceptions, and attitudes regarding the collection, storage, and use of biospecimens and data, the use of broad consent, data security, data sharing, and community engagement. We used multiple linear regressions to identify predictors of perceptions and attitudes. Results: We recruited 383 researchers. Researchers favored equally the use of broad and tiered consent (44.1% and 39.1%, respectively). Most respondents agreed with the importance of confidentiality protections to ensure data security (91.8%). However, lower percentages were seen regarding the importance of community engagement (64.5%), data sharing with national colleagues and international partners (60.9% and 41.1%, respectively), and biospecimen sharing with national colleagues and international partners (59.9% and 36.2%, respectively). Investigators were evenly split on whether the return of individual research results should depend on the availability or not of a medical intervention that can be offered to address the genetic anomaly (47.5% and 46.4%, respectively). Predictors of attitudes toward biospecimen research included serving on Research Ethics Committees, prior research ethics training, and affiliation with nonacademic institutions. Conclusions: We recommend further exploratory research with researchers regarding the importance of community engagement and to address their concerns about data sharing, with researchers within and outside their countries.

Challenges Faced by "Young" Ethics Committees under the Mode of Collaborative Review / 中国医学伦理学

In the process of exploring standardized and efficient ethical review models for multi-center drug clinical trials, the ethical review alliance emerged as the times require. Compared with mature ethics committees, higher requirements have been put forward for the "young" ethics committees. By analyzing problems existing in review work of "young" ethics committees in the ethics review alliance, this paper discussed the measures to improve the review quality of "young" ethics committees and promote the standardized and efficient operation of the alliance, and put forward countermeasures and suggestions for improving the homogenization of ethics review and accelerating the clinical research process of innovative drugs.

If it walks like a duck : Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI) is research.

Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI) is an ethical framework developed by the WHO for using unproven interventions in public health emergencies outside the context of medical research. It is mainly intended for use when medical research would be impracticable, but there is still a need to systematically gather data about unproven interventions. As such, it is designed as something of a middle ground between clinical and research ethical frameworks.However, I argue that MEURI does not truly lie at the intersection of clinical care and research. Due to its intent, structure and oversight requirements, it takes on most of the crucial features of research, to the point that it is best understood as a form of research. As a result, cases where MEURI could practicably be applied should instead make use of existing research frameworks. For those circumstances where research is truly impracticable, a more straightforward oversight system than MEURI is needed. While existing practices of compassionate use have some applicability, proposals to make use of clinical ethics committees to oversee unproven interventions may help achieve the right balance in acting in a patient's best interests when the relevant evidence base is weak.

What Ethics Support for Resolving Ethical Conflicts Do Internists Use in Spanish Hospitals?

Background Ethical conflicts generate difficulties in daily clinical activity. Which methods of ethical advice are most frequently used to resolve them among Spanish doctors has not been studied. The objective of this study is to describe what methods hospital internal medicine physicians in Spain use to resolve their ethical doubts and which they consider most useful. Design A cross-sectional observational study was conducted through a voluntary and anonymous survey and distributed through an ad hoc platform of the Spanish Society of Internal Medicine. Measures We measured methods by which to resolve doubts, types of tools sought, frequency of consulting the Clinical Ethics Committees, and satisfaction with resolution of ethical issues. Results Of 261 internists surveyed, 86 per cent resolve their ethical doubts with assistance, the most frequently used method being consultation with colleagues (58.6 per cent), followed by using specific protocols or guides (11.8 per cent) and consultation with experts in bioethics (9.6 per cent). The most preferred tools are the creation of protocols (30.3 per cent) and the establishment of a consultant/expert in bioethics (27.8 per cent). Conclusions Internists in Spain usually seek assistance to resolve their ethical doubts. Consulting colleagues is the most frequently adopted method. The majority regard tools to resolve ethical conflicts as necessary, seeking above all protocols and consultants/experts in bioethics.

The Physician-Assisted Suicide Pathway in Italy: Ethical Assessment and Safeguard Approaches.

Although in Italy there is currently no effective law on physician-assisted suicide or euthanasia, Decision No. 242 issued by the Italian Constitutional Court on September 25, 2019 established that an individual who, under specific circumstances, has facilitated the implementation of an independent and freely-formed resolve to commit suicide by another individual is exempt from criminal liability. Following this ruling, some citizens have submitted requests for assisted suicide to the public health system, generating a situation of great uncertainty in the application processes. As a matter of fact, shared and defined procedures are lacking as Decision 242/2019 merely added some principles on which the legislature will have to base its future intervention. This paper analyses the advisory role that the Decision attributes to territorial ethics committees with the aim of stimulating discussions on their role in oversight mechanisms. The proposed conclusion is that the envisaged role does not appear consistent with the functions of these bodies and is ultimately substantially undefined and unjustified.

[ChatGPT: aid to medical ethics decision making?] / ChatGPT: Hilfe bei der medizinethischen Entscheidungsfindung?

BACKGROUND: Physicians have to make countless decisions every day. The medical, ethical and legal aspects are often intertwined and subject to change over time. Involving an ethics committee or arranging an ethical consultation are examples of potential aids to decision making. Whether and how artificial intelligence (AI) and the large language model (LLM) of the company OpenAI (San Francisco, CA, USA), known under the name ChatGPT, can also help and support ethical decision making is increasingly becoming a matter of controversial debate. MATERIAL AND METHODS: Based on a case example, in which a female physician is confronted with ethical and legal issues and presents these to ChatGPT to come up with answers, the first indications of the strengths and weaknesses are ascertained. CONCLUSION: Due to the rapid technical development and access to ever increasing quantities of data, the utilization should be closely observed and evaluated.