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 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.

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.

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.

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.

Ethics committees in state mental hospitals: a national survey.

OBJECTIVE: The goals of the study were to examine the composition, operation, and purpose of ethics committees in state mental hospitals, to determine whether committees were accessible to patients and family members, and to identify frequently addressed ethical issues. METHODS: In June 1992 a 41-item survey questionnaire was mailed to chief executive officers of 204 state-operated general psychiatric inpatient facilities. Survey items asked about the facility's attributes, composition of the ethics committee, how the committee functioned, and the issues it addressed. RESULTS: A total of 145 facilities from 46 states responded to the survey, for a response rate of 71 percent. Nearly half the facilities had ethics committees, most of which were recently established. Physicians accounted for the plurality of committee membership, followed by nurses and administrators. Although several facilities gave patients access to committee meetings, few patients or their family members actually attended these meetings. Issues such as patients' danger to others, resuscitation policies, and scarce resources were frequently addressed by many committees but were never addressed by others. CONCLUSIONS: Although many state mental hospitals have established ethics committees in the past few years, these committees may not meet patients' needs because of inadequate representation by patient advocates and family members. Numerous concerns were heard by committees, but no obvious patterns of pressing issues were revealed.

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?

Ethics committees in Japanese medical schools.

The present features and functions of ethics committees in 80 Japanese medical schools were surveyed by employing questionnaires. Seventy-nine schools had already established committees on each campus (however, the ethics committee at Kitasato Medical University was formally established after the completion of this survey). The major role of Japanese ethics committees may be said roughly to correspond to that of Institutional Review Boards (IRB) in the U.S., although ethics committees have other functions as well. Among the ethics committees' many problems, two significant weaknesses should be underscored. The first is the inappropriate composition of the membership of the committees: more non-campus members, younger professionals, and women should be invited to participate. The second concern is the committees' essentially closed review process: this process has not been adequately open to the public even in cases in which the issue of the patient's confidentiality does not arise. However, several schools are now preparing to open their meetings to non-members and this policy should improve the present situation. It is fortunate, however, that the ethics committees in Japan's medical schools were established by members from each campus and not as a response to national directives or legislation.