[Implementation of a multimodal strategy for information and collection of advance directives in a comprehensive cancer center]. / Mise en place d'une stratégie multimodale d'information et de recueil des directives anticipées dans un Centre de lutte contre le cancer (CLCC).

INTRODUCTION: In France, advance directives (AD) remain unknown and underused by healthcare users and professionals. This is particularly true in oncology. This work was carried out with patients and caregivers of a Comprehensive Cancer Center to improve their appropriation and information. METHODS: The project, built by the Ethics Committee, the Patients Committee and the Palliative Care Team, made it possible to develop over 6 months a training program, an information procedure and several original documents. RESULTS: A total of 34 one-hour training courses for all professionals were organized. A procedure for making information available, including the right to draft ADs, has been implemented. This procedure is personalized, gradual and multi-professional. When a patient wishes to write his AD, he is accompanied by a dedicated team and benefits from a specific form, which enlighten values and preferences before addressing the desired level of therapeutic commitment. Communication elements were diffused, and a specific training on "anticipated discussions" was created. A dedicated space in the computerized chart makes it possible to locate the existence of ADs and to display them instantaneously. DISCUSSION - CONCLUSION: Based on the observation of the obstacles to the use of ADs, the strategy we implemented aims to provide information that is both efficient and ethically respectful for both patients and caregivers. ADs are only one element facilitating autonomy and anticipation, and must be associated with a shared continuous definition of the project and of the goals of care.

The challenges of keeping clinicians unaware of their participation in a national, cluster-randomised, implementation trial.

BACKGROUND: Implementation of recommendations from clinical practice guidelines is essential for evidence based clinical practice. However, the most effective methods of implementation are unclear. We conducted a national, cluster-randomised, blinded implementation trial to determine if midwife or doctor local implementation leaders are more effective in implementing a guideline for use of oral dextrose gel to treat hypoglycaemic babies on postnatal wards. To prevent any conscious or unconscious performance bias both the doctor and midwife local implementation leaders were kept unaware of the trial. This paper reports the ethical dilemmas and practical challenges of ensuring clinicians remained unaware of their involvement in an implementation trial. METHODS: We sought approval from the National Health and Disability Ethics committee to keep clinicians unaware of the trial by waiving the standard requirement for locality approval usually required for each district health board. The ethics committee did not approve a waiver of consent but advised that we approach the chief executive of each district health board to ask for provisional locality approval. Ultimately it was necessary to seek ethics approval for three separate study designs to keep clinicians unaware of the trial. RESULTS: The median (IQR) time for chief executive approval was 16 (6-40) days and for locality approval was 57 (39-84) days. We completed 21 different locality approval forms for 27 hospitals. CONCLUSIONS: Keeping clinicians unaware of their involvement in a national implementation cluster-randomised trial is feasible. However, despite a national ethics committee, significant logistical challenges were time consuming and delayed trial completion. Co-ordination of the locality approval process would help facilitate multi-centre trials.

[What place for an Ethics committee in a comprehensive cancer centre? For an ethics embodied in real life]. / Quelle place pour un comité d'éthique dans un Centre de lutte contre le cancer ? Pour une éthique incarnée.

The Ethics committee of Gustave Roussy cancer center is devoted to both reflection and action. The group has 40 members, professionals, patients and outside experts. These meet in plenary meetings or in specific working sessions and intervene at the request of any professional faced with ethical questions in the care. This Ethics Committee has voluntarily a double vocation: on one hand, a reflective group on major issues of ethics in health and its involvement in hospital life; on the other hand, a working group embedded in the daily lives of the care. The themes addressed at the meetings (plenary sessions, annual meetings) include shared-decision making, advance directives, refusal of care, religious aspects, or biomedical research… Daily activity centered on the care revolves around several times a week meetings, in various services, "Supportive Collegial Meetings" such as proposed in the 3rd French Cancer Plan; these include nursing staff members, oncologists, intensive and palliative care specialists, psychologist, around difficult medical and/or ethical situations. In case of situation requiring an urgent discussion, a referral to the Ethics Committee brings together within 24hours four to five members of the Committee and the care team. Moreover, the Ethics Committee helped develop Aid to Decision making Form upon care gradation for hospitalized cancer patients. Through these interventions on a daily basis, assistance of professionals, reflexive vocation or even delivery of training, the Ethics Committee contributes to an acculturation around anticipation and collegiality in the care. Its double polarity aims to reconcile "philosophical time' for the ethics process, and the connection with the routine issues raised by patients, their families and caregivers.

Ethics Committees: Team Perspectives and Organizational Responses.

Healthcare ethics committees can be valuable resources but are largely underutilized by nurses. The purpose of this project was to review ethics concerns and educational needs of nurses in a large, integrated healthcare delivery system. Seven themes were identified: organizational issues, nonbeneficial care, withdrawing life-sustaining therapies, discharge disposition, challenging patients and families, communication with physicians, and capacity versus competence. A process was then developed to better engage nurses in ethical discussions.

Avances y retos de las Comisiones Estatales de Bioética en México / State Bioethics Commissions in Mexico, Achievements and Challenges

Se han realizado estudios comparativos sobre comisiones nacionales de bioética, comités hospitalarios de bioética y de ética en investigación de diversos países; sin embargo existen pocos datos sobre la aplicación de la bioética a nivel subnacional. Este trabajo ofrece una aproximación a la evolución de las Comisiones Estatales de Bioética en México, se identifican como actividades de su quehacer acciones de capacitación, difusión, asesoría y promoción de la bioética en la atención médica y la vinculación con la Comisión Nacional de Bioética y otras instituciones de salud y educativas. Las Comisiones Estatales ayudan a fomentar la bioética a nivel subnacional y a extender la atención integral en situaciones complejas en el ámbito médico e investigativo (AU)

Comparative studies have been developed on the infrastructure on bioethics of different countries, comprised mainly by national commissions, hospital bioethics and research ethics committees; however, there are few data on the application of bioethics at the subnational level. This work offers an approximation to the evolution of the State Commissions of Bioethics in Mexico and accounts for their work in outreach, education, and counseling, as well as entrenching a culture of bioethics in medical care and networking with the National Bioethics Commission and other health and educational institutions. State Commissions help to promote bioethics at the subnational level and to foster comprehensive care in complex medical and research settings (AU)

Using video in childbirth research.

BACKGROUND: Conducting video-research in birth settings raises challenges for ethics review boards to view birthing women and research-midwives as capable, autonomous decision-makers. AIM: This study aimed to gain an understanding of how the ethical approval process was experienced and to chronicle the perceived risks and benefits. RESEARCH DESIGN: The Birth Unit Design project was a 2012 Australian ethnographic study that used video recording to investigate the physical design features in the hospital birthing space that might influence both verbal and non-verbal communication and the experiences of childbearing women, midwives and supporters. Participants and research context: Six women, 11 midwives and 11 childbirth supporters were filmed during the women's labours in hospital birth units and interviewed 6 weeks later. Ethical considerations: The study was approved by an Australian Health Research Ethics Committee after a protracted process of negotiation. FINDINGS: The ethics committee was influenced by a traditional view of research as based on scientific experiments resulting in a poor understanding of video-ethnographic research, a paradigmatic view of the politics and practicalities of modern childbirth processes, a desire to protect institutions from litigation, and what we perceived as a paternalistic approach towards protecting participants, one that was at odds with our aim to facilitate situations in which women could make flexible, autonomous decisions about how they might engage with the research process. DISCUSSION: The perceived need for protection was overly burdensome and against the wishes of the participants themselves; ultimately, this limited the capacity of the study to improve care for women and babies. CONCLUSION: Recommendations are offered for those involved in ethical approval processes for qualitative research in childbirth settings. The complexity of issues within childbirth settings, as in most modern healthcare settings, should be analysed using a variety of research approaches, beyond efficacy-style randomised controlled trials, to expand and improve practice-based results.

Time required to start multicentre clinical trials within the Italian Medicine Agency programme of support for independent research.

BACKGROUND AND AIM: Time allowed for independent ethics committees (IECs) and administrative offices to assess and activate clinical trials is regulated by law. This study aims to describe time spent activating two multicentre non-profit trials supported by the Italian Medicines Agency (AIFA). Five non-AIFA supported (NAS) trials were used as a benchmark. METHODS: The two AIFA-supported trials were FATA-GIM3 (optimal adjuvant hormonal treatment for breast cancer) and TOSCA (duration of adjuvant FOLFOX in colorectal cancer). The five NAS trials focused on lung or ovarian cancer. The following were measured for all trials: date of submission of trial documentation to peripheral IEC, date of IEC opinion and date trial contracts were signed. Times are reported in months. RESULTS: 106 centres applied to participate in FATA-GIM3 and 137 in TOSCA. An IEC opinion was issued by 100/106 (1 negative opinion) and 137/137 (2 negative opinions) centres, with a median time from submission of 3.6 months (range 0.1-60.2). After a positive IEC opinion, the median time before signing the trial contract was 3.3 months (0.1-59.2). Contracts were signed with 93/99 and 135/135 centres, with a median time from submission of study documentation of 8.4 months (0.5-61.1). Times for NAS trials were not substantially different. CONCLUSIONS: FATA-GIM3 and TOSCA centres were opened after a median of 8 months, consisting of nearly 4 months each for IEC opinion and administrative signature, similar to the NAS trials. The process of trial activation in Italy remains inefficient and takes far longer than legally allowed.

[Ethical issues of artificial nutritional support]. / Ethische Fragen der künstlichen Ernährung.

This review article discusses some ethical issues of clinical nutrition according to the Beauchamp and Childress principles of bioethics: "respect for autonomy, nonmaleficence, beneficence, and justice".

Problems related to the use of animals for therapeutic and care purposes. The Document of the National Committee for Bioethics.

The Italian Ministry of Health, in 2002, instructed the National Committee for Bioethics to carefully review and ultimately provide evidence for future legislative bills in various aspects. One such matter was that of the subject of "Pet Therapy", generically viewed as a "man-animal" relationship, with the purpose of proving beneficiary to both human health and welfare. The necessity of a bioethical approach was deemed important in establishing the concrete benefits for mankind (and the research required to demonstrate this) whilst also considering any possible malaise inflicted on those animals participating. The final recommendations decided upon, took into consideration effectiveness, cost, suitable alternatives, discussion of the intervention with the patient.

Centralized national ethical review of clinical trials in Croatia.

AIM: To present the Croatian system of ethical review of clinical trials and assessment outcomes of the applications reviewed by the Croatian Central Ethics Committee. METHODS: Clinical trial applications reviewed by the Croatian Central Ethics Committee, which has the legal mandate to review clinical trials of medicinal products and medical devices, were retrospectively analyzed from May 2004 to the end of 2008 according to the number, research area, and type of opinion issued. Applications from 2008 were analyzed separately according to the study phase, participants (adult trials vs pediatric trials), and sponsor (commercial trials vs academic trials). Data were analyzed by descriptive statistics. RESULTS: Since its establishment in 2004, the Croatian Central Ethics Committee has reviewed 407 trials. The greatest number of clinical trials was in the field of oncology (n = 69), mental and behavioral disorders (n = 52), and endocrine, nutritional, and metabolic diseases (n = 50). In the initial assessment of clinical trials, 60% applications received a conditionally positive opinion. In 28% of applications, the opinion had to be postponed because additional documentation or explanations were required. In 2008, the Croatian Central Ethics Committee reviewed 99 trials, most of which were phase III trials (n = 57). Five clinical trials included pediatric population and 3 were academic clinical trials. CONCLUSION: The model of centralized clinical trial review seems to be appropriate for the current number of clinical trials conducted in Croatia. The efficient and standardized review process of clinical trials by the Central Ethics Committee may positively affect the increasing number of clinical trials conducted in Croatia. Future development includes the transparency of the clinical trials through a publically available database and establishing the basis for conducting academic clinical trials.

Ethical dilemmas in palliative care in traditional developing societies, with special reference to the Indian setting.

BACKGROUND: There are intriguing and challenging ethical dilemmas in the practice of palliative care in a traditional developing society. OBJECTIVE: To review the different ethical issues involved in cancer and palliative care in developing countries, with special reference to India. METHODS: Published literature on pain relief and palliative care in the developing countries was reviewed to identify ethical issues and dilemmas related to these, and ways in which ethical principles could be observed in delivery of palliative care in such countries are discussed. RESULTS: The literature review revealed a number of ethical dilemmas and challenges that professionals, cancer patients and their families encountered during palliative care. It was noted that patients' preferences and decisions are influenced by family members. Dilemmas leave the professionals and families confused about how ethical their actions have been. Specific ethical issues were noted in relation to the availability and use of oral morphine for pain relief, spiritual care, lack of adequate palliative care services, and palliative care education. CONCLUSIONS: The four principles of ethics posed difficulties in understanding the complex ethical issues in a developing country with a traditional background. Ethical issues need to be handled delicately and sensitively in palliative care settings, within the framework of the traditions and culture of the society and financial constraints. The possible role of ethics committees in palliative care settings to help decision-making needs to be studied and discussed.

The role of psychosomatic-medicine psychiatrists in bioethics: a survey study of members of the academy of psychosomatic medicine.

The Bioethics Subcommittee of The Academy of Psychosomatic Medicine developed a survey to assess the involvement of psychosomatic-medicine psychiatrists in bioethics and the extent of their participation on bioethics committees and in the teaching of bioethics. Of 599 Academy members surveyed, 122 (20.4%) responded. The majority of respondents reported that the management of bioethical dilemmas had a significant impact on their work in psychosomatic medicine. Many respondents were involved in teaching bioethics and in serving on ethics committees. The majority of respondents reported psychiatry-resident involvement on ethics committees. Bioethics work is an integral part of the fabric of psychosomatic medicine.

Consultation-liaison psychiatrists on bioethics committees: opportunities for academic leadership.

OBJECTIVE: This article briefly reviews the history of the relationship between psychiatry and the leadership of ethics committees as a background for examining appropriate educational initiatives to adequately prepare residents and early career psychiatrists to serve as leaders of ethics committees. METHOD: A Medline review of literature on psychiatry and ethics committees and consultation as well as recent survey data from the Academy of Psychosomatic Medicine indicate that psychosomatic medicine psychiatrists are particularly qualified and interested in serving as chairs of ethics committees. The authors compare knowledge and skills obtained in psychiatric training with the Society for Heath and Human Values and the Society for Bioethics Consultation Task Force on standards for ethics consultation proposed as core competencies for ethics committee leadership. RESULTS: Psychiatric residency and fellowship training in psychosomatic medicine can provide the knowledge and skill sets to meet the standards for ethics consultation. Further professional development through pursuit of formal ethics training, advance degrees in bioethics, mentoring, and residency and felloships focus on ethics and enhance competency, confidence, and the skills required for ethics committee leadership. CONCLUSIONS: Academic psychiatrists, particularly those in psychosomatic medicine, have historically made a significant contribution as chairs of ethics committees. Continuation and expansion of this leadership may require interested psychiatrists to obtain additional training in bioethics.

Calidad de los estudios postautorización de tipo observacional registrados en España antes de su regulación / Quality of observational post-authorization studies registered in Spain before their regulation

Fundamento y objetivo: En julio de 2002, los estudios postautorización de tipo observacional quedaron definitivamente regulados en España. La justificación de dicha regulación ha sido cuestionada. El objetivo de este trabajo es evaluar la calidad científica y ética de los estudios registrados el año previo a la entrada en vigor de la normativa, así como el valor social de sus resultados utilizando su publicación como indicador. Material y método: Se ha recogido los datos de carácter administrativo, metodológico, ético y de seguimiento de los estudios postautorización presentados en la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) durante el año 2001. Resultados: En 2001 se presentó en la AEMPS un total de 162 estudios postautorización que pretendían incluir un total de 306.539 pacientes. El diseño más habitual fue el de «seguimiento prospectivo no controlado» (122 estudios [75%]) y prácticamente en su totalidad (99%) el médico fue la única fuente de información. En un 43% no se especifica el tamaño muestral o no se justifica. La duración de los estudios fue inferior a 12 meses en el 83%. Sólo en el 13% de los estudios se solicitó la revisión por un comité ético de investigación clínica y sólo en el 44% se preveía algún procedimiento de información a los sujetos de investigación. Once estudios se publicaron como originales en revistas (el 10% de los finalizados), 1 de ellos en una revista internacional, y 13 (el 12% de los finalizados) en forma de comunicaciones a congresos, 2 de ellos internacionales. Conclusiones: Los estudios postautorización presentados en la AEMPS durante el año 2001 tuvieron escasa calidad metodológica y ética. La mayoría de ellos no se publicó, lo cual pone en cuestión el valor de esas investigaciones al tiempo que alimenta las dudas sobre su verdadera finalidad. La regulación de esos estudios parecía, pues, justificada

Background and objective: In July, 2002, observational post-authorization studies were subjected to regulation in Spain, giving rise to an uproar among sponsors and investigators. The aim of the present report was to assess the scientific and ethical quality of the studies presented during the year before the regulation came into force. In addition, we explored how many of them reached publication. Material and method: We extracted information relative to administrative procedures, methods, follow-up and ethical issues from the protocol of the studies presented to the Spanish Agency for Medicines and Healthcare Products (AEMPS) during 2001. Results: A total of 162 studies intended to recruit 306,539 patients were registered as post-authorization studies in 2001. The most widely used design was the «non-controlled prospective follow-up study» (122 studies; 75%). Physicians were the only source of information in 99% of the studies. In 43% of them, the sample size was neither specified nor justified. In 83% of the studies the observation period per patient was less than 12 months. An ethical review was requested for only 13% of the studies while a procedure to inform patients was planned in 44%. Eleven studies (10% of those finalized) had been published in scientific journals (1 of them international) and 13 (12% of those finalized) were reported as a communication to a national (11) or international (2) congress. Conclusions: Most post-authorization studies presented to the AEMPS in 2001 had poor methodological and ethical quality. Only a few became published, raising doubts about their scientific aims. These results give empirical support to the regulation adopted