The clinical trial activation process: a case study of an Italian public hospital.

BACKGROUND/AIMS: In order to make the centers more attractive to trial sponsors, in recent years, some research institutions around the world have pursued projects to reorganize the pathway of trial activation, developing new organizational models to improve the activation process and reduce its times. This study aims at analyzing and reorganizing the start-up phase of trials conducted at the Research and Innovation Department (DAIRI) of the Public Hospital of Alessandria (Italy). METHODS: A project was carried out to reorganize the trial authorization process at DAIRI by involving the three facilities responsible for this pathway: clinical trial center (CTC), ethics committee secretariat (ESC), and administrative coordination (AC). Lean Thinking methodology was used with the A3 report tool, and the analysis was carried out by monitoring specific key performance indicators, derived from variables representing highlights of the trials' activation pathway. The project involved phases of analysis, implementation of identified countermeasures, and monitoring of timelines in eight 4-month periods. The overall mean and median values of studies activation times were calculated as well as the average times for each facility involved in the process. RESULTS: In this study, 298 studies both sponsored by research associations and industry with both observational and interventional study design were monitored. The mean trial activation time was reduced from 218 days before the project to 56 days in the last period monitored. From the first to the last monitoring period, each facility involved achieved at least a halving of the average time required to carry out its activities in the clinical trials' activation pathway (CTC: 55 days vs 23, ECS: 25 days vs 8, AC 29 days vs 10). Average activation time for studies with agreement remains longer than those without agreement (100 days vs. 46). CONCLUSIONS: The reorganization project emphasized the importance of having clinical and administrative staff specifically trained on the trial activation process. This reorganization led to the development of a standard operating procedure and a tool to monitor the time (KPIs of the process) that can also be implemented in other clinical centers.

Planned oocyte cryopreservation to preserve future reproductive potential: an Ethics Committee opinion.

Planned oocyte cryopreservation is an ethically permissible procedure that may help individuals avoid future infertility. Because planned oocyte cryopreservation is new and evolving, it is essential that those considering using it be informed about the uncertainties regarding its efficacy and long-term effects. This replaces the document of the same name, last published in 2017.

[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.

Trends in COPD mortality from 1983 to 2018: protocol for a population-based cohort study in Denmark.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death worldwide, which is partly contributed to the increasing prevalence of COPD owning to a demographic shift towards an older population. Conversely, recent studies on COPD mortality that take this demographic shift in age into account find decreasing overall age-standardised COPD mortality rates over time. This decrease in the age-standardised COPD mortality rate is contributed advances in COPD diagnostics and treatment, decreasing smoking prevalence and general advances in medical care particularly in western countries. However, it is unknown if patients with COPD have experienced a comparable relative increase in survival in line with the general population.Hence, there is a need for longitudinal studies comparing trends in mortality in patients with COPD compared with matched non-COPD individuals from the background population. METHODS AND ANALYSES: This is a cohort study with a matched non-COPD comparator cohort. Data are retrieved from the Danish national registers. Data from multiple registries from 1983 to 2018 will be merged on an individual level using the 10-digit Civil Registration numbers that are unique to each citizen in Denmark. Time trends in mortality in patients with COPD compared with the matched comparator cohort will be examined in three study periods: 1983-1993, 1994-2007 and 2008-2018. ETHICS AND DISSEMINATION: The study is entirely based on registry data and ethical approval is not required according to Danish Law and National Ethics Committee Guidelines. The results will be published in peer-reviewed journals and reported at appropriate national and international conferences.

Randomised controlled trial of early magnetically controlled capsule endoscopy for the prevention of gastrointestinal bleeding in patients at high bleeding risk scheduled for percutaneous coronary intervention: MACE-GPS study protocol.

INTRODUCTION: Limited data are available regarding the decision-making process for preventing gastrointestinal bleeding in patients at high risk of bleeding scheduled for percutaneous coronary intervention (HBPCI), especially due to the lack of a simple, accurate and sensitive methods for gastrointestinal injury detection. This randomised trial aims to assess the effects of early magnetically controlled capsule endoscopy (MCE) in patients with HBPCI for the prevention of gastrointestinal bleeding compared with conventional management. METHODS AND ANALYSIS: The Magnetic-Assisted Capsule Endoscopy Gastrointestinal bleeding Protection Strategy (MACE-GPS) is a multicentre, open-label, randomised controlled trial. Patients admitted for HBPCI will be randomised and placed into two study groups. In the early MCE group, 1228 patients will undergo MCE following admission to the hospital. If necessary, these patients may further undergo a multidisciplinary approach to determine treatment based on the MCE findings. A total of 1228 patients in the control group will undergo conventional treatment based on the attending cardiologist's interpretation of their clinical presentations. The primary end point is the incidence of gastrointestinal bleeding within 12 months of enrolment. ETHICS AND DISSEMINATION: The MACE-GPS trial has been approved by the ethics committees of all participating sites. Participant recruitment began in April 2023 and will be completed in April 2025, and the 1-year follow-up will be completed in April 2026. The study results will be disseminated through conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: ChiCTR2300070025.

Assessing the impact of diverse mask types on COPD patients: a randomised controlled trial study protocol.

INTRODUCTION: Wearing masks has proven beneficial in preventing respiratory pathogen infections in individuals with chronic obstructive pulmonary disease (COPD). However, the impact of different mask types on physiological indicators and daily physical activity in COPD patients remains uncertain. This study aims to assess the immediate effects of various mask types on cardiopulmonary function indicators, subjective perceptions and the 6-minute walking distance (6MWD) in individuals with COPD. METHODS AND ANALYSIS: This randomised controlled trial will enrol 129 stable COPD patients. Participants will be randomly divided into three groups: control, N95 mask and surgical mask groups. Each group will undergo both a 6-minute seated test and a 6-minute walk test (6MWT), without or with their respective masks. A 10-minute interval will be provided between the two phases. The primary indicators of the study include the 6MWD and blood oxygen saturation. Secondary outcomes encompass blood pressure, pulse rate, Borg score, Rate of Perceived Exertion (RPE) score and subjective perception score. Oxygen saturation, pulse rate and blood pressure will be recorded four times during the trial, while Borg and RPE scores will be compared before and after the 6MWT. Additionally, subjective perception scores will be collected after each mask-wearing stage. ETHICS AND DISSEMINATION: This study has received approval from the Ethics Committee of the Affiliated Hospital of Gansu University of Chinese Medicine (approval number: 202335). We plan to disseminate research results through publication in a peer-reviewed journal or presentation at a conference. TRIAL REGISTRATION NUMBER: ChiCTR2300074554.

Potential Issues in Mandating a Disclosure of Institutional Investigation in Retraction Notices.

A retraction notice is a formal announcement for the removal of a paper from the literature, which is a weighty matter. Xu et al. (Science and Engineering Ethics, 29(4), 25 2023) reported that 73.7% of retraction notices indexed by the Web of Science (1927-2019) provided no information about institutional investigations that may have led to the retractions, and recommended that Committee on Publication Ethics (COPE) retraction guidelines should make it mandatory to disclose institutional investigations leading to retractions in such notices. While this recommendation would add to the transparency of the retraction process, a blanket mandate as such could be potentially problematic. For research misconduct (RM)-positive cases, a mandatory investigative disclosure may be abused by some to deflect responsibility. More importantly, a mandatory disclosure could harm authors and institutions in RM-negative cases (i.e. those stemming from honest errors with no misconduct). I illustrate with case vignettes the potential epistemic injustice and confusion that a mandate for investigation disclosure in retraction notices could incur, and suggest a more nuanced approach to its implementation.

Global matters of epidemiology and the ethical challenges of addressing the health of populations.

PURPOSE: The American College of Epidemiology (ACE) held its 2022 Annual Meeting, September 8-11, with a conference theme of 'Pandemic of Misinformation: Building Trust in Epidemiology'. The ACE Ethics Committee hosted a symposium session in recognition of the global spotlight placed on epidemiology and public health due to the COVID-19 crisis. The ACE Ethics Committee invited previous Chairs of the Ethics Committee and current President of the International Epidemiological Association to present at the symposium session. This paper aims to highlight the ethical challenges presented during the symposium session. METHODS: Three speakers with diverse backgrounds representing expertize from the fields of ethics, epidemiology, public health, clinical trials, pharmacoepidemiology, statistics, law, and public policy, covering perspectives from the U.S., Europe, and Southeast Asia were selected to present on the ethical challenges in epidemiology and public health applying a global theme. Dr. D. Weed presented on 'Causation, Epidemiology and Ethics'; Dr. C.M. Pandey presented on the 'Ethical Challenges in the Practice of Digital Epidemiology'; and Dr. J. Acquavella presented on 'Departures from Scientific Objectivity: A Cause of Eroding Trust in Epidemiology.' RESULTS: The collective goal to improve the public's health was a mutually shared theme across the three distinct areas. We highlight the common ethical guidance and principle-based approaches that have served epidemiology and public health in framing and critical analysis of novel challenges, including autonomy, beneficence, justice, scientific integrity, duties to the profession and community, and developing and maintaining public trust; however, gaps remain in how best to address health inequalities and the novel emergence and pervasiveness of misinformation and disinformation that have impacted the health of the global community. We introduce an ethical framework of translational bioethics that places considerations of the social determinants of health at the forefront. CONCLUSIONS: The COVID-19 pandemic required an expedited public health response and, at the same time, placed the profession of epidemiology and public health, its system, and structures, under the microscope like never before. This article illustrates that revisiting our foundations in research and practice and orienting contemporary challenges using an ethical lens can assist in identifying and furthering the health of populations globally.

Ethical obligations in fertility treatment when intimate partners withhold information from each other: an Ethics Committee opinion.

Clinicians should encourage disclosure between intimate partners but should maintain confidentiality in cases where there is no prospect of harm to the partner and/or offspring. In cases where a member of a couple refuses to disclose relevant health information to the other partner and there exists a risk of harm to the unaware partner and/or offspring, clinicians may refuse to offer care and should decline to treat if full informed consent is not possible because of the lack of disclosure. This document replaces the previously published document of the same name, last published in 2018.

Providing ethics advice in a pandemic, in theory and in practice: A taxonomy of ethics advice.

The pandemic significantly raised the stakes for the translation of bioethics insights into policy. The novelty, range and sheer quantity of the ethical problems that needed to be addressed urgently within public policy were unprecedented and required high-bandwidth two-way transfer of insights between academic bioethics and policy. Countries such as the United Kingdom, which do not have a National Ethics Committee, faced particular challenges in how to facilitate this. This paper takes as a case study the brief career of the Ethics Advisory Board (EAB) for the NHS Covid-19 App, which shows both the difficulty and the political complexity of policy-relevant bioethics in a pandemic and how this was exacerbated by the transience and informality of the structures through which ethics advice was delivered. It analyses how and why, after EAB's demise, the Westminster government increasingly sought to either take its ethics advice in private or to evade ethical scrutiny of its policies altogether. In reflecting on EAB, and these later ethics advice contexts, the article provides a novel framework for analysing ethics advice within democracies, defining four idealised stances: the pure ethicist, the advocate, the ethics arbiter and the critical friend.

Ethical considerations for telemedical delivery of fertility care: an Ethics Committee opinion.

Telemedicine has the potential to increase access to and decrease the cost of care. However, it also alters the nature of the physician-patient relationship and the interaction of patients with the healthcare system, which may limit access to care in some circumstances. Regardless of the modality of care delivery, the basic tenets of medical ethics and the obligations of physicians to their patients still hold.

Using Ethics Committees to Justify Force-Feeding Political Prisoners in Israel.

Thousands of Palestinian prisoners are held in Israeli prisons without trial. For some of them, engaging in hunger strikes is the last resort in opposing unlawful detention and inhumane prison conditions. While mainstream bioethics deliberation, reasonable arguments, and international legal and medical professional declarations prohibit force-feeding, local ethical deliberations, professional medical guidelines, and legislation allow the use of medical judgment and clinical ethics committees to force-feed these prisoners. Until now, Israeli physicians have refused to do so, but this may change in the future. The international medical and bioethics communities need to stand behind these medical professionals, as well as prisoners. Clinical ethics committees in Israel must choose whether they serve the interests of these prisoner-patients and perhaps their political or human rights agenda, or whether they are subservient to an unjust, oppressive regime.

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.

[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.

Feasibility, effectiveness and acceptability of two perturbation-based treadmill training protocols to improve reactive balance in fall-prone older adults (FEATURE): protocol for a pilot randomised controlled trial.

INTRODUCTION: Perturbation-based balance training (PBT) targets the mechanism of falls (eg, slipping, tripping) to specifically train the recovery actions needed to avoid a fall. This task-specific training has shown great promise as an effective and efficient intervention for fall prevention in older adults. However, knowledge about the dose-response relationship of PBT, as well as its feasibility and acceptability in older adults with increased risk of falling is still limited. Thus, the aim of this study is to compare the effectiveness of two different treadmill PBT protocols for improving reactive balance control in fall-prone older adults, and to evaluate the feasibility and acceptability of these protocols. METHODS AND ANALYSIS: The study is designed as a pilot randomised controlled trial with a 6-week intervention and 6-week follow-up period. Thirty-six community-dwelling, fall-prone (Timed Up and Go >12 s, habitual gait speed <1.0 m/s and/or fall history) older adults will be randomised (1:1) to receive six (weeks 1-6) or two treadmill PBT sessions (weeks 1+6) plus four conventional treadmill training sessions (weeks 2-5). Training sessions are conducted 1×/week for 30 min. Each PBT will include 40 perturbations in anterior-posterior and mediolateral directions. Reactive balance after perturbations in standing (Stepping Threshold Test (STT)) and walking (Dynamic Stepping Threshold Test (DSTT)) will be assessed as the primary outcome for effectiveness. Secondary outcomes are spatiotemporal and kinematic parameters collected during STT, DSTT and PBT, maximum perturbation magnitude for each PBT session, static and dynamic balance, physical capacity, physical activity, concerns with falling and executive functions. Feasibility will be assessed via training adherence, drop-out rate, perturbations actually performed and adverse events; and acceptability via self-designed questionnaire and focus groups. ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee of the Medical Faculty Heidelberg (S-602/2022). Findings will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: DRKS00030805.

Misconduct in third-party assisted reproductive technology by participants and nonmedical professionals or entities: an Ethics Committee opinion.

Physicians involved in third-party assisted reproductive technology arrangements who discover material misconduct or other undisclosed information by a party to the arrangement (such as a gamete or embryo donor, gestational carrier, or intended parent) or by a nonmedical professional participant or entity (such as a recruiting program, gamete or embryo bank, or lawyer) should encourage that party or professional participant to disclose such misconduct or information. In some instances, it is ethically permissible for the physician to either disclose material information to the affected party or to decline to provide or continue to provide care. In all cases involving the legal status or rights of the parties, physicians should recommend that patients seek independent legal professional advice. This document replaces the document "Misconduct in third-party assisted reproduction," last published in 2018. The use of a physician's own gametes for the purpose of reproduction without the informed consent of the recipient(s) is unethical and illegal, as well as never permissible.

O Sistema CEP/Conep e as pesquisas em ciências humanas e sociais: outras éticas, outras semânticas / The CEP/Conep System and research in human and social sciences: other ethics, other semantics / El Sistema CEP/Conep y las investigaciones en ciencias humanas y sociales: otras éticas, otras semánticas

Esta nota de conjuntura tem o objetivo de evidenciar algumas questões importantes sobre como se configura o Sistema CEP/Conep e as implicações dessa regulação no campo das ciências humanas e sociais. Primeiro, explicito o que consiste esse sistema para, em seguida, esboçar as controvérsias provenientes desse controle, que tem como aspecto central, ser regido pelo que a análise do Estado e sua organização burocrática chamam de lógica cartorial

This note aims to highlight some important questions about the configuration of the CEP/CONEP System and the implications of this regulation in the field of human and social sciences. First, I will explain what is this system, and then I will outline the controversies resulting from this control, which has as central aspect, to be governed by the so-called notarial logic, according to the analysis of the State and its bureaucratic organization

Esta nota de coyuntura tiene como objetivo poner en evidencia algunas cuestiones importantes sobre como es configurado el Sistema CEP/CONEP y las implicaciones de esta normativa para el campo de las ciencias humanas y sociales. Primero explicaré en que consiste ese sistema y, en seguida, esbozaré las controversias que surgen de ese control, que tiene como aspecto central ser regido por lo que el análisis del Estado y su organización burocrática denominan lógica notarial

Adherence to the AAP's Institutional Ethics Committee Policy Recommendations.

OBJECTIVES: In 2019, the American Academy of Pediatrics (AAP) outlined 8 operational recommendations for pediatric institutional ethics committees (IECs). The study purpose was to quantify the extent to which pediatric IECs adhere to the AAP IEC Policy Statement recommendations. METHODS: A convenience sample of ethics points of contact from Children's Hospital Association membership were invited to complete an electronic survey on their ethics programs and practices in spring 2022. Nineteen survey questions were preidentified as reflecting measures specific to best practice standards previously published by the AAP. This subset of questions was analyzed using frequencies and categorized to assess for adherence to the AAP IEC policy recommendations. RESULTS: A total of 117 out of 181 surveys were completed (65%). Stark IEC practice gaps include: lack of diversity of membership, training needs to maintain members' competencies, quality improvement within the organization, and scope of ethics service. Over one-quarter of IECs do not have a systematic way of informing hospital staff about ethics consultancy services and how to place an ethics consult. Nineteen percent of responding IEC services do not inform patients or families about the existence of ethics consult services. One-third of responding children's hospitals do not provide resources for the IECs to engage in ethics education at the facility. CONCLUSIONS: IECs in children's hospitals are not consistently abiding by operational recommendations. Next steps should include assessment of recommendation barriers and enablers with a goal of enhancing strong practices across IECs in children's hospitals.

Review of diversity, equity, and inclusion by ethics committees: A Delphi consensus statement.

The appropriate representation of diverse populations in interventional trials remains problematic. A Delphi process was used to affirm the central role that ethics committees and institutions play in this process and to establish consensus upon 25 consolidated recommendations across four themes to promote diversity and inclusion in interventional clinical research.

What do Retraction Notices Reveal About Institutional Investigations into Allegations Underlying Retractions?

Academic journal publications may be retracted following institutional investigations that confirm allegations of research misconduct. Retraction notices can provide insight into the role institutional investigations play in the decision to retract a publication. Through a content analysis of 7,318 retraction notices published between 1927 and 2019 and indexed by the Web of Science, we found that most retraction notices (73.7%) provided no information about institutional investigations that may have led to retractions. A minority of the retraction notices (26.3%) mentioned an institutional investigation either by journal authorities (12.1%), research performing organizations (10.3%), joint institutions (1.9%), research integrity and ethics governing bodies (1.0%), third-party institutions (0.5%), unspecified institutions (0.4%), or research funding organizations (0.1%). Comparing retraction notices issued before and after the introduction of retraction guidelines by the Committee on Publication Ethics (COPE) in 2009 revealed that those published after the guidelines' publication were more likely to report investigations by journal authorities. Comparing retraction notices from different disciplines revealed that those from social sciences and the humanities were more likely to disclose investigations by research performing organizations than those from biomedical and natural sciences. Based on these findings, we suggest that the COPE retraction guidelines in the future make it mandatory to disclose in retraction notices institutional investigations leading to retractions.