Ethics committees in the time of COVID-19.

BACKGROUND: ethics committees (ECs) protect the rights, safety, and well-being of research participants and ensure the scientific correctness of clinical research. COVID-19 pandemic and the lockdown from 9 March to 16 May 2020 have potentially influenced several activities, including ECs. OBJECTIVES: to assess the impact of COVID-19 outbreak on Italian ECs and their performance during the lockdown. DESIGN: cross-sectional survey. SETTING AND PARTICIPANTS: the survey was conducted in mid-June 2020 in Italy contacting all the 90 local ECs. MAIN OUTCOME MEASURES: amount and kind of activities performed during the lockdown, characteristics of submitted studies and adoption of standard protocols of evaluation of research applications during the pandemic. Chi-square test was used to estimate the differences between territories with higher incidence (HI) and lower incidence (LI) of COVID-19. RESULTS: 258 questionnaires were collected from 46 ECs that participated in the study. Ten were excluded due to missing substantial data. Responses were divided into two groups according to location of EC: the HI (125 responses) and the LI (123 responses). Seventy-five percent of the HI describe an increase in the number of studies submitted, while 53% of the LI does not (p=0.001). Due to the pandemic and its effects on research, the 15% of participants belonging to HI territories reported that consideration and respect of research-related and general ethical principles could have decreased, as well the adoption of standard protocols of evaluation of research applications. EC secretariats located in HI Regions moved to smart working more than in LI ones (75% vs 59%; p=0.001). Where the EC workload increased significantly, it was reported that it was impossible to perform an accurate analysis of the submitted documentation, with the effect of providing a favorable opinion to studies of not excellent quality, though always ensuring the respect of ethical principles and patients' safety. CONCLUSIONS: COVID-19 impact on ECs has been heavier in HI territories, but smart working has been effective in ensuring EC activities and the subsequent activation of clinical studies potentially useful to face the pandemic. Clear differences arise between ECs belonging to the Italian Regions that have recorded a HI of COVID-19 cases compared to those located in Regions with a LI of cases. In some EC members' perception, the high number of studies in the most affected Regions together with the emergency experienced during the lockdown may have exposed ECs to the risk of decreasing the adoption of ethical principles and standard protocols of evaluation of research applications.

Non-commercial trials on medicines submitted to the Ethics Committee of the University Hospital of Bologna (Italy) along 8 years of activity: time to update rules and recommendations.

PURPOSE: In Italy, the non-commercial trials on medicines are regulated by the Ministry Decree 17 December, 2004. Its intent is of encouraging the independent research for the improvement of clinical practice. We aimed to analyze the main features of the proposals of non-commercial clinical trials on medicines submitted to the Independent Ethics Committee (IEC) of the University Hospital of Bologna in the period 2010-2017. METHODS: Data were extracted from IEC registry and were organized with an ad hoc database. The relationships between the variables were examined using contingency tables. When appropriate, we applied the chi-square statistical test for the comparison of the categorical variables. RESULTS: Over the 8-year period, the IEC evaluated 2931 studies, of which 1156 (39.4%) related to clinical trials on medicines; 245 (21.2%) out of the latter were non-commercial ones. A percentage of 49.8 of the trials were of phase II; 137 trials (55.9%) were promoted by hospitals, medical schools or institutes for research, hospitalization and health care. Non-profit organizations and scientific societies were promoters of 88 trials (35.9%). Most phase I and phase II trials received additional support from pharmaceutical companies. CONCLUSIONS: Our results show a not negligible industrial influence on non-commercial trials through additional support, mostly to those of phase II. An update of the present legislation on this matter is desirable, adopting clearer rules on the relations sponsor-industry.

Ethics committee registration and re-registration with the regulatory authority in India.

Background: All ethics committees (ECs) that review and monitor clinical trials in India must be registered with the regulatory authority. We ascertained the status of registration and re-registration of ECs till December 2017. Methods: The ECs registered and re-registered with the Indian regulatory authority till December 2017 were extracted. The status of ECs was analysed according to the state, institute category and registration. Results: A total of 1260 ECs were registered, of which 14% were based in medical colleges, 2% in dental colleges, 61.2% in hospitals other than medical colleges and 8% as independent ECs. Of the recognized medical and dental colleges, only 37.3% and 10.9%, respectively, and 45.9% of ECs from teaching hospitals (other than medical and dental colleges) had registered with the regulatory authority. Of the 911 ECs eligible for re-registration, 516 (56.5%) had reregistered. Conclusion: A low proportion of registrations ofECs from eligible academic health institutions raises concern about adherence to regulatory guidelines and conduct of clinical trials in India. The lower re-registration of ECs helps in the identification of factors which should be addressed to facilitate clinical research in India.

A Survey of Hospital Ethics Structures in Ontario.

In response to the growing recognition of the prevalence of ethical issues in clinical care, hospitals in Canada began forming ethics committees in the 1980s. Studies showed significant growth in the prevalence of ethics committees over the ensuing decade. Although the limited studies available suggest that ethics committees have become very prevalent in Canadian hospitals, hospital ethics services have evolved in recent years to include a wider range of structures. In some cases, these structures may work in conjunction with an ethics committee, but in other cases they may replace ethics committees. They include on-staff ethicists, external ethics consultants, "hub-and-spokes" structures and regional ethics programs. What is not known, however, is how prevalent these other structures are and whether ethics committees continue to function as the main delivery mechanism for ethics services in Canadian hospitals. This paper reports on the results of a survey of hospitals in Ontario to answer those questions.

Proyecto para la creación de un comité de ética médica u hospitalaria de nivel local en el hospital San Miguel Arcángel, distrito de San Miguelito, provincia de Panamá. Año 2013 / Project for the creation of a medical or hospital ethical committee at a local level in the San Miguel Arcangel Hospital, district of San Miguelito, province of panamá. Year 2013

El siguiente proyecto se basa en el diseño para la creación de un comité de ética médica asistencial a nivel hospitalario. Se elaboró en el Hospital San Miguel Arcángel, Distrito de San Miguelito, Provincia de Panamá, durante el año 2013. Dado que la creación de proyectos sociales requiere parámetros unificados a nivel internacional, se toma como formato las guías de creación y funcionamiento de los comités de bioética de la Unesco, adaptadas al contexto socioeconómico, político y cultural del Distrito de San Miguelito, Provincia de Panamá. Además de adaptarlo al aspecto socio-ecológico donde se realiza el proyecto de investigación, se abarca el aspecto teórico desde la bioética ontológica personalista, donde el eje fundamental es la dignidad de la persona humana. Se elaboró un estudio de percepción del personal médico y de enfermería, sobre el manejo de los dilemas éticos más frecuentes en el Hospital San Miguel Arcángel. El instrumento de medición utilizado fue una encuesta de percepción previamente validada a través de una prueba piloto. La confiabilidad se midió con el coeficiente alfa de Cronbach y la validez se obtuvo del contenido. Se obtiene resultados estadísticos satisfactorios que comprueban las hipótesis de trabajo sobre el reconocimiento de la importancia de la autonomía, confidencialidad, protección a la población vulnerada, bienestar laboral del personal de salud e integración de la bioética en la agenda institucional. Sin embargo, hubo aspectos particulares que indican algunas dudas en cuanto al manejo de algunas realidades que se presentan en el contexto de la atención sanitaria

The next project was based on the design on the creation of a medical ethical Committee at a hospital. It was developed at the San Miguel Arcangel Hospital, District of San Miguelito, Province of Panama, in 2013. Insomuch as the creation of social projects requires unified international parameters, format is taken from the Unesco’s guides for the establishing and working of bioethics committees; adapted to the socio-economic, political and cultural context of the San Miguelito District, Panama Province. Furthermore to adapting to socioecological aspect where the research project is carried out, the theoretical aspect includes from the ontological personalistic bioethics, where the cornerstone is the dignity of the human person. A study of perceptions of medical staff and nursing was developed on the management of the most common ethical dilemmas in the Hospital San Miguel Arcángel. The instrument used was a previously validated perception survey through a pilot test. Reliability was measured using Cronbach’s alpha coefficient, and validity was obtained from the content. Satisfactory statistical results, that verify the working hypotheses on the recognition of the importance of autonomy, confidentiality, protection of vulnerable population, occupational health staff welfare and integration of bioethics at the institutional agenda, were obtained. However, there were particular aspects that indicate some doubt as to the management of some realities that are presented in the context of health care

[Ethics committees in the experience of the IMSS: a Latin American instance]. / Los comités de ética en la experiencia del IMSS: una instancia en Latinoamérica.

BACKGROUND: The aim of this article is to identify the current state of hospital bioethics committees and local research ethics committees of the Mexican Institute of Social Security (IMSS). METHODS: A descriptive cross-sectional study was performed that included all hospitals of the IMSS (N = 262). Two self-administered questionnaires were e-mailed between october and november 2014 to the hospital directors: one for hospital bioethics committees and another for local research ethics committees. Both questionnaires had five sections: committee location, date of committee set up, activity situation, composition, functions, and experience. RESULTS: The response rate was 85 %. It was reported 150 active hospital bioethics committees and 67 active local research ethics committees. In both groups physicians and executive directors dominated committees' membership, and lay people were reported only in seven hospital bioethics committees. The primary function of hospital bioethics committees was case consultation, and their primary goal "to improve the quality of medical care". Local Research Ethics Committees reported as primary function "to evaluate health research protocols and rule of them", and as their primary goal "to protect the rights and wellbeing of the research subjects". CONCLUSIONS: Both groups of committees ought to be assessed regularly through audit cycles in order to identify the educative actions that enhance their efficiency.

Introducción: el objetivo es examinar la situación actual de los comités hospitalarios de bioética (CHB) y de los comités locales de investigación y ética en investigación en salud (CLIEIS) del Instituto Mexicano del Seguro Social (IMSS). Métodos: estudio cuantitativo, transversal descriptivo, realizado entre octubre y noviembre de 2014. Se enviaron por correo electrónico dos cuestionarios, autoadministrados o de autorreporte, a todos los hospitales del IMSS (N = 262): uno para los CHB y otro para los CLIEIS. Cinco apartados contenían ambos cuestionarios: localización del comité, fecha en la que fue constituido, estado actual de actividad, composición, funciones y experiencia. Resultados: la tasa de respuesta fue de 85 %. Se identificaron 150 CHB activos y 67 CLIEIS activos. En ambos grupos predominó la profesión médica y el personal directivo entre sus integrantes. Los representantes de la ciudadanía sólo fueron reportados en siete CHB. La función primaria reportada por los CHB fue la consultiva, y su meta primaria: "mejorar la calidad de la atención médica". Los CLIEIS señalaron como función primaria: "evaluar y dictaminar protocolos de investigación en salud" y dentro de sus metas el "proteger los derechos y el bienestar de los sujetos de investigación". Conclusiones: ambos grupos de comités debieran ser evaluados regularmente a través de ciclos de auditoría con el propósito de identificar las acciones educativas que promuevan su eficiencia.

Ethical procedures and patient consent differ in Europe.

BACKGROUND: Research ethics approvals, procedures and requirements for institutional research ethics committees vary considerably by country and by type of organisation. OBJECTIVE: To evaluate the requirements and procedures of research ethics committees, details of patient information and informed consent based on a multicentre European trial. DESIGN: Survey of European hospitals participating in the prospective observational study on chronic postsurgical pain (euCPSP) using electronic questionnaires. SETTING: Twenty-four hospitals in 11 European countries. PARTICIPANTS: From the 24 hospitals, 23 local investigators responded; 23 answers were analysed. OUTCOME MEASURES: Comparison of research ethics procedures and committee requirements from the perspective of clinical researchers. Comparison of the institutions' procedures regarding patient information and consent. Description of further details such as costs and the duration of the approval process. RESULTS: The approval process lasted from less than 2 weeks up to more than 2 months with financial fees varying between 0 and 575 &OV0556;. In 20 hospitals, a patient information sheet of variable length (half page up to two pages) was provided. Requirements for patients' informed consent differed. Written informed consent was mandatory at 12, oral at 10 and no form of consent at one hospital. Details such as enough time for consideration, possibility for withdrawal and risks/benefits of participation were provided in 25 to 30% of the institutions. CONCLUSION: There is a considerable variation in the administrative requirements for approval procedures by research ethics committees in Europe. This results in variation of the extent of information and consent procedures for the patients involved. TRIAL REGISTRATION: euCPSP in Clinicaltrials.gov identifier: NCT01467102; PAIN-OUT in Clinicaltrials.gov identifier: NCT02083835.

Liberalism, authority, and bioethics commissions.

Bioethicists working on national ethics commissions frequently think of themselves as advisors to the government, but distance themselves from any claims to actual authority. Governments however may find it beneficial to appear to defer to the authority of these commissions when designing laws and policies, and might appoint such commissions for exactly this reason. Where does the authority for setting laws and policies come from? This question is best answered from within a normative political philosophy. This paper explains the locus of moral authority as understood within one family of normative political theories--liberal political theories--and argues that most major "liberal" commentators have understood both the source and scope of ethics commissions' authority in a manner at odds with liberalism, rightly interpreted. The author argues that reexamining the implications of liberalism for bioethics commissions would mean changing what are considered valid criticisms of such commissions and also changing the content of national bioethics commission mandates. The author concludes that bioethicists who participate in such commissions ought to carefully examine their own views about the normative limits of governmental authority because such limits have important implications for the contribution that bioethicists can legitimately make to government commissions.

Education and the improvement of clinical ethics services.

The proliferation of clinical ethics in health care institutions around the world has raised the question about the qualifications of those who serve on ethics committees and ethics consultation services. This paper discusses some of weaknesses associated with the most common educational responses to this concern and proposes a complementary approach. Since the majority of those involved in clinical ethics are practicing health professionals, the question of qualification is especially challenging as the role of ethics committees and, increasingly, ethics consultation services are becoming increasingly important to the functioning of health care institutions. Since the challenging nature of health care finances often leads institutions to rely on voluntary participation of committed health professional with only token administrative or clerical support to provide the needed ethics services, significant challenges are created for attaining competence and functional effectiveness. The article suggests that a complementary approach should be adopted for sustaining and building capacity in clinical ethics. Ethics committees and consultation services should systematically adopt quality improvement techniques to effect designed changes in clinical ethics performance and to build ethical capacity within targeted clinical units and services. Demonstrating improvements in functioning can go a long way to build confidence and capacity for clinical ethics and can help in justifying the need for support. To do so, however, requires that ethics committees and consultation services first shift attention to those areas that demonstrate weak or questionable ethical performance, including the established practices of the ethics committee and consultation service, and second seek collaboration with the involved health care providers to pursue demonstrable change. Such an approach has a much better chance of improving the capacity for clinical ethics in health care institutions than relying on educational approaches alone.

Aspectos éticos en la investigación en Radiología / Ethical aspects of research in radiology

La investigación clínica con seres humanos es imprescindible para el desarrollo de la medicina, pero debe siempre salvaguardar la autonomía del participante, su dignidad y la justicia. Diversos documentos de consenso han sido creados a tal efecto, destacando el Código de Nüremberg, la Declaración de Helsinki, el Informe Belmont y el Convenio de Oviedo. Además de conocer estos documentos fundamentales, todo radiólogo que desee realizar un trabajo de investigación debe conocer la existencia de los Comités de Ética y consultar con ellos la metodología de su estudio, que debe ajustarse a los códigos éticos referidos y a la legislación vigente (AU)

Clinical research on human beings is essential for progress in medicine; however, it is also essential to safeguard research subjects’ autonomy, dignity, and rights. Diverse documents have been developed in consensus to address these issues: some of the most relevant are the Nuremberg Code, the Helsinki Declaration, and the Oviedo Convention. In addition to being familiar with these fundamental documents, all radiologists who conduct research should know about Ethics Committees and consult them about the methodology of their studies, which must fulfill the conditions stipulated in the above-mentioned guidelines as well as in the legislation in force (AU)

Capacity mapping of national ethics committees in the Eastern Mediterranean Region.

BACKGROUND: Ethics issues in the areas of science, technology and medicine have emerged during the last few decades. Many countries have responded by establishing ethics committees at the national level. Identification of National Ethics Committees (NECs) in the Eastern Mediterranean (EM) region and the extent of their functions and capacity would be helpful in developing capacity building programs that address the needs of these committees. Accordingly, we conducted a survey to determine the characteristics of existing NECs in the EM region. METHODS: We developed a questionnaire to collect information on different aspects of NECs. The questionnaire was sent to the WHO country office in each of the 22 Member States in the EM region. We used descriptive statistics to analyze the data. RESULTS: We obtained responses from 77% (17/22) of the EM countries; 88% (15/17) of the countries stated they had NECs. Of these NECs, 40% (6/15) were involved in the ethics of science and technology, 73% (11/15) in medical ethics, and 93% (14/15) in medical research ethics; 10 NECs stated they reviewed research protocols. Of the respondent NECs, 25% (4/15) met at least on a monthly basis. Regarding training, 21% of the members from all of the NECs had received formal training in ethics; 53% (8/15) of the NECs had none of their members with formal training in ethics. Regarding support, 33% (5/15) received financial support and 60% (9/15) had administrative support. CONCLUSION: While many countries in the EM region report the existence of NECs, many meet infrequently, many have members without formal training in ethics, and many lack important financial and administrative resources. Further efforts should be directed towards capacity building programs that include ethics training and provision of important infrastructure resources for these committees.

Ensayos clínicos: valoración del tipo de aclaraciones solicitadas y homogeneidad en la revisión por los comités éticos de investigación clínica / Clinical assays: requested explanations and homogeneity of ethics and clinical

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Informed consent in Sri Lanka: a survey among ethics committee members.

BACKGROUND: Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. METHODS: We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. RESULTS: Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. CONCLUSION: The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent.

The NJ SEED project: evaluation of an innovative initiative for ethics training in nursing homes.

OBJECTIVES: This article reports the results of an evaluation of the New Jersey Stein Ethics Education and Development (NJ SEED) project--a statewide initiative to create, organize and educate a statewide network of regional long-term care ethics committees. The main focus of the evaluation was to measure utilization of the committees, describe how facilities have benefited from the project, and identify potential barriers to the use of this resource. METHODS: Based on administrative records from the NJ SEED project, 225 facilities were identified and asked to complete a facility survey. Ninety-three surveys were received, resulting in a 41% response rate. An additional survey of the regional ethics committees (RECs), as well as several focus groups and individual interviews were conducted to supplement the survey data. RESULTS: Fifty-eight percent of the facility respondents reported current participation in an NJ regional ethics committee. About one third (30%) of participating facilities had requested a formal case consultation (on at least one occasion) on behalf of a resident, but two thirds had consulted with their RECs on a more informal basis. Facilities that reported participating in the REC Network were more likely to have formally written policies than nonparticipants. CONCLUSIONS: Many NJ nursing homes find the statewide REC Network to be an important resource; however continued efforts need to be expended for recruiting and training facilities that are not taking full advantage of this important source of peer support and professional expertise.

Parto vaginal o cesárea: el dilema persiste / Vaginal or caesarean delivery: the dilemma persists

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Encuesta sobre bioetica en un hospital de pediatria: bases para futuras estrategias / Survey on bioethics in a pediatric hospital: basis for new strategies

La ética médica (EM) forma parte de la medicina desde sus comienzos pero recién en las últimas décadas se la reconoce como disciplina independiente. Se realizó un estudio observacional y descriptivo a médicos del Hospital de Niños Ricardo Gutiérrez para determinar: a) el conocimiento de conceptos básicos de EM entre sus miembros, b) la inserción y función del comité de bioética (CB) en dicha institución. Se repartieron 150 encuestas, se recuperaron 90 (60%). Los conceptos teóricos de EM (definiciones de bioética, paciente terminal, autonomía, justicia, beneficencia, y consentimiento informado) fueron respondidos correctamente por el 75.2%. Conocía la existencia del CB el 97.8%. Lo había consultado alguna vez el 61.1%. De aquellos que consultaron, la recomendación sugerida por el CB para resolver el dilema ético presentado fue: totalmente útil, para el 23.6%, parcialmente útil para el 45.5%, y no útil para el 27.3%. Nunca había consultado al CB el 37.8%, del cual el 64.7% refería no haber tenido dilema, el 11.7% consideraba no útil ¶a priori÷ la posible respuesta del CB, el 11.7% no justificó la causa, el 2.9% no distinguió los dilemas y a otro 2.9% no se le ocurrió consultar. La mayoría de los que respondieron tenía información adecuada sobre conceptos básicos de EM. Tanto el índice de consultas al CB como la valoración de sus dictámenes como total o parcialmente útiles (69.1%) avalan la acción del mismo. Es llamativo que el principal argumento por el cual no se consultó al CB fue el no tener dilemas éticos. Tanto el CB en el HNRG como las universidades deberían intensificar la docencia en EM, fundamentalmente en los aspectos prácticos, que facilitaría a los integrantes del equipo de salud detectar dilemas éticos.(AU)

The impact of committee characteristics on the success of healthcare ethics committees.

Despite the increase in number and importance of healthcare ethics committees (HECs), little is known about how successful HECs are and what characteristics contribute to their success. The current study attempted: (1) to examine the effect of respondent backgrounds on the self-reported success and characteristics of HECs, (2) to describe the current success status of HECs, and (3) to explore how committee characteristics are related with the success. Questionnaires on characteristics of respondents and committees as well as the rating of success were distributed to 962 acute care hospitals with 300 beds or more across the United States in the calendar year 2000. A total number of 294 chairpersons and 223 members from 334 ethics committees responded to the survey, yielding a 35% response rate. Statistical analyses on the survey data found that the length of services on committees (seniority) and the size of committees were significant contributors to the perceived success of committees. The significant association of seniority suggests that future studies should control for the effect of seniority, possibly using multivariate modeling methods. The more success perceived by large committees indicates a need for small committees to increase the size of their committees so that they can expand their expertise to resolve the wide variety of current issues.

Healthcare ethics committees and managed care.

OBJECTIVES: Healthcare ethics committees (HECs) play an important role in medical decision making in US hospitals, but no study has determined whether HECs deal with managed care, in any form. This pilot study was performed to evaluate the activities and perceptions of HECs about managed care. STUDY DESIGN: Forty-five hospitals in the Philadelphia area were selected at random, and comprised 36.6% of area institutions and 47% of area inpatient beds. Surveys were administered to ethics committee representatives by the authors in 1998. PATIENTS AND METHODS: Survey responses were coded, and both tabulated responses and analyzed data are presented. Correlations were analyzed with the unpaired 2-tailed t test. RESULTS: HECs devoted 7.6% of committee time to managed care issues, and the remainder to education, policy development, and case consultation. Time spent on managed care issues depended on the size of the institution (small hospitals spent twice the time on managed care as did large institutions); composition of the committee (presence of clergy and retirees on HECs correlated with the likelihood that HECs would address managed care issues); and whether the HEC was requested to help with managed care issues. Of the HECs surveyed, 18% had formal but disparging discussions of ethical concerns in managed care. The impact of changing insurance programs on the hospital and HECs was a concern. CONCLUSIONS: HECs arbitrate ethical conflicts in managed care when asked. As the presence of managed care increases, ethics committees will increasingly be called on to resolve the resulting ethical dilemmas. To be effective in this role, HECs must become knowledgeable about managed care principles and policies.