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.

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.

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.

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.

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.

[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.

Ethics complaints against female psychiatrists.

OBJECTIVE: The purpose of this study was to assess the prevalence and nature of investigated ethics complaints against female psychiatrists and to compare them with those against male psychiatrists. METHOD: The author, a member of the APA Ethics Committee, reviewed informal records kept by her during a period of just under 5 years. RESULTS: The Ethics Committee reviewed 259 complaints against men and 30 against women, constituting a prevalence rate of about 1.1% against male members and 0.4% against female members. Thirty-nine percent of the complaints against men and 60% against women were dismissed. Eighty-five sexual complaints against male psychiatrists and eight against female psychiatrists (of which two and six, respectively, were for homosexual behavior) were investigated. Also investigated were 19 complaints involving discourtesy or poor judgment against men and two against women, 21 of breach of confidentiality against men and three against women, and 23 involving financial matters against men and four against women. CONCLUSIONS: In this study of informal records, there were fewer investigated ethics complaints against female than against male psychiatrists, and more of these were dismissed after investigation. A greater proportion of the complaints of sexual exploitation made against women were for homosexual involvement. Cultural power differentials between genders may in part explain some of the data.

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.

Nursing ethics committees--where are they?

When establishing Nursing Ethics Committees (NECs), statewide nursing organizations play an important role in developing and disseminating resources. The Connecticut Nurses Association Ethics and Human Rights Committee surveyed 85 healthcare facilities to identify active NECs. Representatives facilitated other committees by providing guidelines and assistance to those agencies developing NECs--the ultimate goal.

Constraints on the moral agency of nurses.

Awareness of nurses' ethical concerns has increased greatly over the last few years. In response to this awareness, the Canadian Nurses Association revised the Code of Ethics to provide direction for the implementation of ethical standards for nursing. Yet, a growing body of literature suggests that situational constraints make it difficult for nurses to uphold these standards. Overcoming these constraints will take concerted efforts in nursing education, administration, practice and research.

Long-term care survey reveals challenges. Facilities grapple with five broad issues, including changes in leadership and AIDS.

The Catholic Health Association's 1992 survey of Catholic long-term care (LTC) facilities identified five broad issues LTC facilities face in the 1990s: leadership, system affiliation, community programs, resident issues, and care of persons with AIDS. The transition to lay leadership presents new challenges to the relationship between LTC facilities and their sponsors. Despite the dominance of religious sponsors, an increasing number of laypersons are serving as healthcare administrators both in long-term and acute care. Thirty percent of respondents reported being affiliated with a multi-institutional system. This percentage has changed little in the past few years, although the number of facilities that are system members continues to increase at the fastest rate of any type of LTC facility. Only 27 percent of survey respondents said they provide educational or informational programs for persons in their communities. Thirty-nine percent of system-affiliated LTC facilities reported offering such programs. One encouraging finding shows that 80 percent of facilities have written policies for living wills, 64 percent for designated proxy, and 86 percent for durable power of attorney for healthcare. LTC providers are struggling to determine their role in caring for persons with HIV and AIDS. Only 3.6 percent of respondents care for residents with AIDS. A major problem LTC administrators face is a fear of potential infection of staff or residents.

Today's ethics committees face varied issues. A CHA survey reveals committees' functions, authority, and structure.

In a survey of Catholic Health Association member hospitals, 92 percent indicated they have formal ethics committees at their institutions. Sixty-two percent said their ethics committees were formed between 1983 and 1989. The survey found that current ethics committees are still committed to their traditional roles--education, policy development, and case review--but the education is directed to more diverse audiences than in the past. Support for medical and nursing staffs may be emerging as another possible function of ethics committees. The issues that precipitated the formation of institutional ethics committees have become more complex. In particular, questions involving the appropriate use of technology, the renewed awareness of patients' rights, changing relationships among healthcare providers, and conflicting social values have continued to require the intervention of ethics committees. However, the frequency with which respondents said their committees provide case consultations seems lower than it should be if committees were used to their full advantage. The institutional ethics committee can play a part in enlarging the current healthcare reform debate and promoting moral values. It can address such important questions as, Should the well-being of individuals take precedence over the well-being of communities?

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.