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.

An audit of institutional ethics committee queries raised after initial project submission by a single research department at a tertiary referral center in India.

Introduction: The institutional ethics committees (IECs) raise queries following protocol reviews. The quality of these queries would be a useful metric to assess how well the IEC executes its fundamental role of protecting participants. Methods: Queries received after the initial review and replies sent by a single research department were evaluated. A content analysis was done to identify the domains and categories of queries. We categorized these queries as administrative, ethics related, and scientific. The impact of each query in improving the science or safeguarding the rights and safety of research participants (ethics) was evaluated by two authors of this manuscript: one affiliated and the other nonaffiliated to the institute. Kappa statistics were used to evaluate for agreement between the two. Results: A total of 13 studies (investigator-initiated studies [IISs]: 7 and pharmaceutical industry-sponsored studies [PSSs]: 6) formed the final sample size for analysis. The total number of queries was 364 (IIS: 106 and PSS: 258; P < 0.001). With regard to the categories, we found n = 42 (11.54%) to be irrelevant at that stage of the review process; n = 51 (14.01%) were about information already available which the IEC had missed; n = 67 (18.41%) queries where the IEC needed paraphrasing; n = 50 (13.74%) were entirely relevant with the need for further clarification; and n = 154 (42.31%) had been missed by the investigator during the initial submission. The overall agreement between the affiliated and unaffiliated investigators was just 12.9% (P < 0.001). Conclusions: We found that approximately 25% of the queries raised by the IEC were redundant. It is our opinion that this redundancy could have been channeled into greater focus on scientific and ethical aspects of the protocol. Ongoing dialog between investigators and ethics committees may help address this. Perspectives between the affiliated and the unaffiliated investigators with regard to the relevance of queries were grossly different.

Decisions about College Football during Covid-19: An Ethical Analysis.

This manuscript uses competitive college football as a lens into the complexities of decision-making amid the Covid-19 pandemic. Pulling together what is known about the decision-makers, the decision-making processes, the social and political context, the risks and benefits, and the underlying obligations of institutions to these athletes, we conduct an ethical analysis of the decisions surrounding the 2020 fall football season. Based on this ethical analysis, we provide key recommendations to improve similar decision processes moving forward.

Perceptions on the role of research integrity officers in French medical schools.

Researchers, organizations, and governments are trying to foster research integrity. In France, the law recently permitted the appointment of research integrity officers (RIOs) in each university, to promote research integrity and handle misconducts. Since we assumed that having adequate bodies to deal with research integrity could foster research integrity, we wanted to understand how this might work more concretely. We interviewed 11 newly appointed RIOs in medical schools about how they perceive their role and cope with their responsibilities. We analyzed data following the Paillé and Muchielli's thematic analysis approach. The RIOs report a strong and interesting appropriation of concepts of research integrity, which allows them to warrant their role. Although they report that they did not seek their appointment, they show a real desire to cope with their responsibilities. They are willing to build a role which is currently poorly defined. They assert their legitimacy through their position and experience. They identify themselves with a preventive and corrective role, in an altruistic way. They emphasize their independent and collective role, congruent with other actors. The RIOs intend to be enablers of a responsible conduct of research. These results are encouraging about the potential impact of RIOs to foster research integrity.

Reducing tensions and expediting manuscript submission via an authorship agreement for early-career researchers: A pilot study.

Authorship can be a source of tension on research teams, in academic/industry collaborations, and between mentors/mentees. Authorship misconduct is prevalent among biomedical researchers, and disputes about authorship can generate tensions that have the potential to disrupt professional relationships and damage careers. Early-career researchers may experience particular challenges navigating authorship both because of inexperience and power differentials; in effect, they lack the language and confidence to have these conversations and may feel unwilling to challenge the status quo. The authors implemented an Authorship Agreement for use when collaborating on a manuscript and hypothesized that using this agreement would reduce authorship tensions and speed time to manuscript submission by helping early-career investigators manage authorship conversations more effectively. The authors surveyed trainees (n = 65) on the prevalence of authorship-related tensions and compared the results from the first survey in 2017 to the final survey in 2020. The decrease in tensions around meeting deadlines was significant (z = 2.59, p = 0.010). The authors believe the effect of an Authorship Agreement on authorship-related tensions has not previously been investigated. This work extends what is known about the prevalence of commonly cited authorship tensions, and provides evidence of the effectiveness of steps that can be taken to alleviate them.

A ética na gestão pública / Ethics in public management

Resumo O presente artigo aborda o tema da ética no contexto das organizações públicas, edificada em dois grandes pilares: a Constituição Federal Brasileira e o marco legal do Sistema de Gestão da Ética do Poder Executivo Federal. Para o exercício das funções, os servidores, além da qualificação técnica, necessitam de competências políticas e éticas. Este trabalho é resultante de pesquisa que teve como objetivos: compreender os sentidos da ética e da ética pública para servidores públicos e identificar a importância e as dificuldades para o exercício da ética no processo de trabalho desenvolvido. Trata-se de uma pesquisa exploratória com utilização de abordagem qualitativa. A coleta de dados foi realizada por meio de entrevista semiestruturada e os dados coletados foram analisados por meio da análise de conteúdo, na modalidade de análise temática. Os resultados da pesquisa subsidiaram reflexões para auxiliar futuras decisões relacionadas ao tema estudado, tendo em vista o intuito de disseminar a importância do cumprimento dos preceitos éticos que devem alicerçar a atuação dos servidores. Os argumentos conclusivos reforçam a necessidade de uma ampla discussão do tema "Ética" dentro da esfera pública e a urgência em fomentar posturas que visem à melhoria das relações, cimentando pensamentos críticos e reflexivos no processo de trabalho com base em imperativos éticos.

Abstract This article aims to discuss the subject of ethics in the context of public organizations, built on two main pillars: the Brazilian Federal Constitution and the legal framework of the Ethics Management System of the Federal Executive Power. To carry out their duties, public servants, in addition to technical qualifications, need political and ethical skills. This article is the result of a research that had the following objectives: to understand the meanings of ethics and public ethics for public servants and to identify the importance and difficulties for the exercise of ethics in the work process developed. This is an exploratory research using a qualitative approach. Information collection was carried out with semi-structured interviews, and the data collected analyzed by content analysis, in the thematic analysis mode. The research results supported reflections to help future decisions related to the studied topic, considering the objective of disseminating the importance of complying with the ethical precepts that should underpin the performance of public servants. The conclusive arguments support the need for a broad discussion of the topic of "Ethics" within the public reach and the urgency to promote postures aimed at improving relationships, reinforcing critical and reflective thoughts in the work process based on ethical imperatives.

Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital.

Background: Managing of SAE by all stakeholders i.e. principal investigator (PI), sponsor, and Institutional Ethics Committee (IEC), in an ethical manner is the most important indicator of participant safety during clinical trial. The present study was conducted with the objectives to assess the extent of regulatory compliance in reporting SAEs, relatedness and financial compensation given/recommended by various stakeholders. Methods: This was a retrospective observational study which involved analysis of SAE's reviewed by IEC. Administrative approval for accessing the documents was obtained and complete confidentiality was maintained. A total of 66 SAE of 34 regulatory clinical trials reported from January 2014 to March 2020 were analyzed. Result: When analyzed for relatedness, 16 (24.24%) of the reported SAEs were found related to the clinical trial and out of these, 7 were SAE of death. Among the remaining 50 SAEs, 48 (72.7 %) were not related to clinical trial .65 (98.48%) SAEs, initial report and final report were submitted to EC within timelines. All the 66 SAE reports were sent by EC within stipulated time as required by regulation. Conclusion: The study concludes that 66 SAE reports were identified and there was no deviation in reporting timelines in initial reporting and due analysis report by PI and initial review by IEC in 65 SAE's. Similarly, analysis of SAE by IEC for relatedness, and provision of compensation to participant was achieved in majority of SAE. The study is unique in a way that qualitative and quantitative analysis of SAE reports was performed.

SIMULATED INVESTIGATION OF COMPLAINTS: A COLLABORATIVE EDUCATIONAL STRATEGY FOR LEARNING MEDICAL ETHICS AND BIOETHICS / SINDICÂNCIA SIMULADA: UMA COLABORATIVA ESTRATÉGIA EDUCACIONAL PARA APRENDIZAGEM EM ÉTICA MÉDICA E BIOÉTICA

Medical teaching in Brazil must associate technical matters with ethical education by using active learning methods. It should allow the acquisition of knowledge, the development of attitudes, and critical reflection, for deliberations that could be technically correct and ethically appropriate to each situation. Complaints against possible ethical deviations are investigated in inquiries by Regional Medical Councils. The simulation of the investigation and judgement of ethical complaints is an educational strategy that aims to facilitate the acquisition of knowledge on current ethical, procedural and legal rules that regulate the medical profession in Brazil. Students may also develop skills of group deliberation, after informed reflection and appraisal, on situations with the eventual presence of ethical violations and thus develop ethically justifiable attitudes. The educational strategy could also help prevent future occurrences of ethical infractions and guide doctors to prepare their replies after complaints in Medical Councils. The paper discusses the characteristics of the educational analysis of disciplinary investigations and its potential to help in medical ethics teaching. The method also tries to link the needs of medical schools and graduate medical programs and the legal purpose of Brazilian Medical Councils. It could also allow effective collaboration between the medical profession's educational and regulatory bodies to develop the ethical decision-making process in the students.

O ensino da medicina no Brasil deve associar o conteúdo técnico com a formação ética, valendo-se de métodos ativos de aprendizagem que permitam aquisição de conhecimentos, desenvolvimento de atitudes corretas,  reflexão crítica e consciente para deliberações que sejam tecnicamente acertadas e eticamente adequadas a cada situação. Queixas de usuários de serviços médicos, ou de profissionais da saúde, sobre eventuais desvios éticos são apuradas e depois julgadas em câmaras de sindicâncias nos Conselhos Regionais de Medicina.  O método da sindicância simulada se caracteriza por permitir a cada participante num grupo, de modo ativo e colaborativo, a análise ponderada sobre fatos e circunstâncias relatadas no exercício da profissão médica à luz das normas éticas vigentes no Brasil. A estratégia educacional da simulação de câmaras de sindicâncias visa facilitar a aquisição de conhecimentos sobre as vigentes normas éticas, processuais e legais aplicáveis à profissão médica no Brasil, favorecendo o desenvolvimento de atitudes eticamente justificáveis após reflexão, ponderação e deliberação colegiada  sobre situações descritas para apuração de eventual existência de infrações éticas.  Pode também auxiliar na prevenção de futuras ocorrências de desvios éticos e na preparação de manifestações dos médicos diante de eventuais denúncias. O artigo aborda as características das sindicâncias, possibilidades e limitações da aplicação do método da sindicância simulada e sua importância na conexão entre a finalidade legal dos Conselhos de Medicina e as necessidades de escolas médicas e programas de pós-graduação em medicina, ensejando uma efetiva colaboração entre as instâncias formadoras e reguladoras da profissão médica para desenvolver o processo de tomada de decisões éticas.

Authorship climate: A new tool for studying ethical issues in authorship.

Authorship of academic publications is central to scientists' careers, but decisions about how to include and order authors on publications are often fraught with difficult ethical issues. To better understand scholars' experiences with authorship, we developed a novel concept, authorship climate, which assesses perceptions of the procedural, informational, and distributive justice associated with authorship decisions. We conducted a representative survey of more than 3,000 doctoral students, postdoctoral researchers, and assistant professors from a stratified random sample of U.S. biology, economics, physics, and psychology departments. We found that individuals who tend to have more power on science teams perceived authorship climate to be more positive than those who tend to have less power. Alphabetical approaches for assigning authorship were associated with higher perceptions of procedural justice and informational justice but lower perceptions of distributive justice. Individuals with more marginalized identities also tended to perceive authorship climate more negatively than those with no marginalized identities. These results illustrate how the concept of authorship climate can facilitate enhanced understanding of early-career scholars' authorship experiences, and they highlight potential steps that can be taken to promote more positive authorship experiences for scholars of all identities.

Effect of perioperative intravenous amiodarone on cardioversion of atrial fibrillation early after video-assisted thoracoscopic surgical ablation: Study protocol for a double-blind randomized controlled trial.

Introduction: Video-assisted thoracoscopic surgical (VATS) ablation is widely performed in surgical areas to treat atrial fibrillation (AF), which is minimally invasive and highly effective. Amiodarone, known as a class III antiarrhythmic agent, has the greatest potential to maintain sinus rhythm of AF. At present, few studies focused on the efficacy of perioperative intravenous amiodarone in the VATS ablation of AF. Therefore, the trial is designed to investigate the effect of perioperative amiodarone infusion on cardioversion of AF early after VATS ablation. Methods: and analysis: This will be a prospective, randomized, double-blind, controlled trial. The trial is to enroll 182 patients aged 18-70 years who will undergo VATS ablation of AF. All eligible participants will be randomly allocated to either the amiodarone or placebo group by using the block randomization in a 1:1 ratio. The primary endpoint will be freedom from atrial arrhythmias 24 h after the VATS procedure and be assessed using the Kaplan-Meier method. All data will be analyzed in accordance with the intention-to-treat principle. Discussion: The clinical trial has been designed to investigate the efficacy of perioperative intravenous amiodarone on cardioversion of AF early after VATS ablation. We are hoping to demonstrate that perioperative infusion of amiodarone could improve the maintenance of sinus rhythm 24 h after VATS ablation.

Audit of principal investigator's compliance for submission of continue review application and decisions taken on lapses in validity of approval by the Institutional Ethics Committee at tertiary oncology center in Navi Mumbai.

Context: A failure to obtain continued Institutional Ethics Committee (IEC) approval for the study before the expiry date assigned by the IEC is considered as "lapse of the IEC approval" to continue the study at the site by the Investigator. Considering this, we had conducted an audit of principal investigators (PI ') compliance for Continuing Review Application (CRA) submission timelines and decision taken on the lapses in the validity of IEC approval continuation. Aim: The aim of this study is to assess the pre- and post-policy trends of non-compliance management of delayed CRA submission and compare the PI's compliance for submission of CRA between Investigator Initiated trial (IIT) and Pharma studies. Setting and Design: The present study was a retrospective audit of CRAs of ongoing projects submitted by PIs to IEC, ACTREC. Materials and Methods: The data from total 199 CRAs submitted for review to the IEC between the year January 2016 and December-2017 were collected and maintained in Microsoft Excel sheet, and later, the data were exported into the SPSS software version 21 for the analysis. Statistical Analysis: All categorical data were presented in numbers and percentage. The first primary objective was assessed by calculating the duration between the dates of approval for any study to the date of next CRA submission. The CRAs submitted after the project expiry date were considered as a lapse in following the IEC SOP. Results: This retrospective audit revealed that CRA reminder sent by the IEC to the PI played an important role in compliance w. r. t timely in following the IEC SOPof the CRA by the PI. As a result, overall, 90% of CRAs showed compliance in submitting CRAs to IEC in both IIT and Pharma study. The number of lapses were reduced to 7 in the postpolicy period as compared to 15 lapses in the prepolicy period. Conclusion: This retrospective audit reveals that CRA reminder sent by the IEC to the PI played an important role in improving the compliance of PIs in submitting CRA to IEC. Each IEC should develop the policy to minimize the delays in CRA submission by the PI and prevent lapses in following the IEC SOP.

Los exámenes de ayuda diagnóstica y los conflictos de interés en nuestros hospitales: ¿Corrupción enmascarada?

Introducción: En los hospitales públicos, las dificultades surgidas por el déficit de recursos logísticos en el laboratorio clínico, dificultan aún más una atención de calidad. La carencia de una gestión por procesos y los conflictos de interés surgidos por la proliferación de laboratorios no certificados ni acreditados, hacen necesaria una nueva visión sobre este tema. La Medicina del Laboratorio Basado en la Evidencia, es una herramienta de la cual clínicos, tecnólogos y biólogos pueden beneficiarse. Por otro lado, es necesario que, a partir del estado, se consensuen los esfuerzos realizados por los distintos actores de este problema: UNAGESP, IETSI, SIS, INACAL, SUSALUD, Defensoría del Pueblo, Contraloría General de la República, Colegios profesionales y Empresa privada para mejorar la gestión del laboratorio clínico.

Background: In public hospitals, the difficulties arising from the lack of logistical resources in the clinical laboratory make quality care even more difficult. The lack of management by processes and the conflicts of interest arising from the proliferation of laboratories that are not certified or accredited make a new vision on this subject necessary. Evidence-Based Laboratory Medicine is a tool from which clinicians, technologists and biologists can benefit. On the other hand, it is necessary that, from the state, the efforts made by the UNAGESP, IETSI, SIS, INACAL, SUSALUD, the Ombudsman's Office, the Comptroller General's Office of the Republic, professional associations and private companies to improve the management of the clinical laboratory be agreed upon.

Industry effects on evidence: a case study of long-acting injectable antipsychotics.

A vigorously debated issue in the psychiatric literature is whether long-acting injectable antipsychotics (LAIs) show clinical benefit over antipsychotics taken orally. In addressing this question, it is critical that systematic reviews incorporate risk of bias assessments of trial data in a robust way and are free of undue industry influence. In this paper, we present a case analysis in which we identify some of the design problems in a recent systematic review on LAIs vs oral formulations. This case illustrates how evidence syntheses that are shaped by commercial interests may undermine patient-centered models of recovery and care. We offer recommendations that address both the bioethical and research design issues that arise in the systematic review process when researchers have financial conflicts of interest.

Development and Retrospective Review of a Pediatric Ethics Consultation Service at a Large Academic Center.

The primary objective was to review pediatric ethics consultations (PECs) at a large academic health center over a nine year period, assessing demographics, ethical issues, and consultant intervention. The secondary objective was to describe the evolution of PECs at our institution. This was a retrospective review of Consultation Summary Sheets compiled for PECs at our Academic Health Center between January 2008 and April 2017. There were 165 PECs reviewed during the study period. Most consult requests came from the inpatient setting, with the Pediatric and Neonatal Intensive Care Units being the highest utilizers. Consultation utilization increased over the study period. The most common patient age was less than one year. Physicians were most likely to request consultation. Patient Best Interest, Withholding/Withdrawing of Life Sustaining Therapy, and Provider Moral Distress were ethical issues most commonly identified by the consultants. Making recommendations was the most common consultant intervention. The ethics consultation process evolved over time from informal provider discussions, to a hospital infant care review committee, to a pediatric only consultation service, to a combined adult/pediatric consultation service, with variable levels of salary support for consultants. Ethics consultation requests are growing at our institution. Similarities in identified ethical issues exist between our findings and existing literature, however meaningful comparisons remains elusive secondary to variability in approaches to investigation and reporting. A combined paid/volunteer/trainee ethics consultation service model appears sustainable and real time ethics consultation is feasible using this approach.

Current status of standardized, quality and ethical oversight of clinical research in the country: An audit of the Central Drugs Standard Control Organization (registration of ethics committees) and national accreditation board for hospital and healthcare providers (accreditation) databases.

PURPOSE: The Prof. Ranjit Roy Chaudhury committee report recommended the accreditation of Institutional Ethics Committees (IECs). Rule 122DD of the Drugs and Cosmetics Act (and Rules) mandates that only registered ECs can accord approval for regulatory studies. We evaluated the current status of registered, reregistered, and accredited ECs in the country to assess the impact of both the recommendation and rule. MATERIALS AND METHODS: Websites of stakeholders-the Central Drugs Standard Control Organization (CDSCO), National Accreditation Board for Hospitals and Healthcare Providers (NABH) were assessed. Information on registration status was then compared with regulatory clinical trials in the Clinical Trials Registry of India, population demographics of all states, and the Medical Council of India recognized postgraduate medical colleges in the various states. RESULTS: A total of 1268 ECs were registered with CDSCO. Of these, 1008 (79.5%) were institutional and 256 (20.18%) independent ECs. A total of 499/1268 (39.4%) ECs were reregistered. Of which 449/499 (90%) were institutional and 50/499 (10%) were independent. Institutional ECs were five times more likely to be reregistered with CDSCO relative to independent ECs (cOR 4.52 [3.12, 6.54], P < 0.0001). A total of 15/233 (7%) applications to NABH had received accreditation. A wide skew was seen in the distribution of ECs across various states as also their oversight of regulatory clinical trials. CONCLUSIONS: Registration and reregistration of ECs along with accreditation is not commensurate with the needs of the country at this time and must be vigorously promoted.

Central institutional ethics committee needed to facilitate timely review of multicenter clinical trials.

A multicenter trial in India undergoes review by Institutional Ethics Committees (IECs) of all participating institutions. The failure to obtain approval even from a single institution's IEC creates a situation of inequitable access to clinical trials. The dichotomy in decisions of different IECs is attributed to lack of standardization and accountability in their functioning. The registration of IECs with Central Drugs Standard Control Organization notwithstanding, the current model of IEC review has failed to ensure uniformity in IEC decisions in multicenter trials. Alternative models that allow central review of multicenter clinical trials should be explored.

'Text-work' in Research Ethics Review: The significance of documents in and beyond committee meetings.

This article analyzes how a formal text (the Ethics Review Form) available at National Health Service Research Ethics Committees (NHSRECs) in the United Kingdom was used in meetings. Derived from the work of Dorothy Smith on incorporating texts into institutional ethnography (IE), it proposes the concept of "text work" as a way into understanding more about decision-making in ethics review and describes the extent to which this formal text shaped and influenced review work. The research study used observations of committee meetings, field-notes and interviews to produce an ethnographic mapping of Research Ethics Committees' (RECs) work. This article draws on one aspect of the research which was the process of isolating a particular, ubiquitous text and analyzing how it worked and was worked on in the meetings. The analysis contributes to contemporary discussion offering an alternative to ongoing debates about idealized ways of conducting ethics review. Finally, some tentative suggestions are made about improving training, based on and starting from the work which reviewers undertake.

Which will Trump: human rights and professional ethics, or torture redux?

Recent political developments in the United States raise concerns about the potential return of aggressive interrogation strategies, particularly in the event of another large-scale terror attack on the U.S. mainland. This essay reviews various legal, ethical and policy responses to revelations of torture during the Bush administration. It asks whether they improve the prospect that, in future, human rights will trump torture, not vice versa. The essay argues that physicians could help prevent further abuses - especially given their access, social status and expertise - but that insufficient steps have been taken to empower them to do so.

The Georges Pompidou University Hospital Clinical Data Warehouse: A 8-years follow-up experience.

BACKGROUND: When developed jointly with clinical information systems, clinical data warehouses (CDWs) facilitate the reuse of healthcare data and leverage clinical research. OBJECTIVE: To describe both data access and use for clinical research, epidemiology and health service research of the "Hôpital Européen Georges Pompidou" (HEGP) CDW. METHODS: The CDW has been developed since 2008 using an i2b2 platform. It was made available to health professionals and researchers in October 2010. Procedures to access data have been implemented and different access levels have been distinguished according to the nature of queries. RESULTS: As of July 2016, the CDW contained the consolidated data of over 860,000 patients followed since the opening of the HEGP hospital in July 2000. These data correspond to more than 122 million clinical item values, 124 million biological item values, and 3.7 million free text reports. The ethics committee of the hospital evaluates all CDW projects that generate secondary data marts. Characteristics of the 74 research projects validated between January 2011 and December 2015 are described. CONCLUSION: The use of HEGP CDWs is a key facilitator for clinical research studies. It required however important methodological and organizational support efforts from a biomedical informatics department.