Hysterectomy for the Management of Menstrual Hygiene in Women With Intellectual Disability. A Systematic Review Focusing on Standards and Ethical Considerations for Developing Countries.

Background: Menstruation poses particular challenges for women with intellectual disability (ID). In low-and middle-income countries, where these women do not have access to facilities and resources for adequate menstrual care, hysterectomy could be considered as an ethically acceptable procedure. We conducted the first systematic review to identify what constitutes best practice for menstrual hygiene in women with ID and explored the perspectives of actors involved in the hysterectomy decision. Methods: Theory-informed mixed-method thematic systematic review with theory development. Results: Eleven ethical guidelines and 17 studies were included. Respect for autonomy and the patient's best interest were the criteria to determine what constitutes best practice. The actors' values and attitudes expressed some dimensions of existing inequities. In low-and middle-income countries, the main concern of parents was the difficulty to train their daughters about menstrual hygiene. Parents (mothers in particular) also expressed the feeling of being excessively burdened, and complained about the limitations of their support networks. Doctors perceived hysterectomy as a safe procedure and a solution for women with ID, whose menstrual hygiene is problematic. In general, the more severe or profound the level of ID, the more likely the interested parties advocated for a hysterectomy. The women with ID perceived their menstruation as a negative experience. Hence, the three parties supported hysterectomy for menstrual hygiene. Parents and doctors considered informed consent or assent (from the women with ID) as necessary and achievable. Conclusion: The international ethical guidelines suggest that non-therapeutic hysterectomy in women with ID should not and ought not to be recommended as routine and appropriate method to cope with menstrual hygiene even if it is technically safe. Although hysterectomy to cope with menstrual hygiene is still a live issue in high-, middle-, and low-income countries, in high income countries it is performed with authorization from the Court; whilst in low-and middle-income countries there is not an active involvement of the State, or financial or training support for women with ID and their carers. Hence, in low-and middle-income countries there is an urgent need to develop and enact policies and statutes in this area of public health and clinical practice.

[Controversy in the treatment of a critically ill neonate in a rural health service]. / Controversias sobre el tratamiento de un neonato críticamente enfermo en un servicio de salud rural.

Cardiopulmonary resuscitation of newborns with perinatal hypoxia faces serious ethical, moral, medical and legal problems, particularly in rural areas. Ethical and moral issues have to do with the medical-parents relationship; with values, preferences and priorities of each of these groups; and with the scarce resources situation. Medical-technical problems are related to asphyxia complications, and their prognostic and therapeutic implications. Legal considerations arising from the fact of killing or letting die. In this article is analyzed the real case of a neonate with severe perinatal hypoxia in order to enhance the understanding of the incorporation of ethics in everyday clinical practice.

La reanimación cardiopulmonar de recién nacidos con hipoxia perinatal grave enfrenta problemas éticos, morales, médicos y legales, particularmente en áreas rurales. Los problemas éticos y morales tienen que ver con la relación médico-padres; con los valores, preferencias y prioridades de cada uno de estos grupos, y con la situación de la escasez de recursos. Los problemas técnico-médicos están relacionados con las complicaciones relacionadas a la asfixia, así como con sus implicaciones pronósticas y terapéuticas. Mientras que las consideraciones legales derivan del hecho de matar o dejar morir. En este artículo se discute el caso real de un neonato con asfixia perinatal grave con el propósito de fortalecer el entendimiento de la incorporación de la ética de la práctica clínica cotidiana.

[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 issues relating to renal transplantation from prediabetic living donor.

BACKGROUND: In Mexico, diabetes mellitus is the main cause of end - stage kidney disease, and some patients may be transplant candidates. Organ supply is limited because of cultural issues. And, there is a lack of standardized clinical guidelines regarding organ donation. These issues highlight the tension surrounding the fact that living donors are being selected despite being prediabetic. This article presents, examines and discusses using the principles of non-maleficience, autonomy, justice and the constitutionally guaranteed right to health, the ethical considerations that arise from considering a prediabetic person as a potential kidney donor. DISCUSSION: Diabetes is an absolute contraindication for donating a kidney. However, the transplant protocols most frequently used in Mexico do not consider prediabetes as exclusion criteria. In prediabetic persons there are well known metabolic alterations that may compromise the long - term outcomes of the transplant if such donors are accepted. Even so, many of them are finally included because there are not enough donor candidates. Both, families and hospitals face the need to rapidly accept prediabetic donors before the clinical conditions of the recipient and the evolution of the disease exclude him/her as a transplant candidate; however, when using a kidney potentially damaged by prediabetes, neither the donor's nor the recipient's long term health is usually considered.Considering the ethical implication as well as the clinical and epidemiological evidence, we conclude that prediabetic persons are not suitable candidates for kidney donation. This recommendation should be taken into consideration by Mexican health institutions who should rewrite their transplant protocols. SUMMARY: We argue that the decision to use a kidney from a living donor known to be pre-diabetic or from those persons with family history of T2DM, obesity, hypertension, or renal failure, should be considered unethical in Mexico if the donor bases the decision to donate on socially acceptable norms rather than informed consent as understood in modern medicine.

[Physician-patient with AIDS-relationship, as a model of clinical relation within the framework of the social security institutions in Mexico]. / Análisis de la naturaleza de la relación médico-enfermo con SIDA en instituciones de seguridad social en México.

OBJECTIVE: To examine the nature and level of physician involvement during a clinical encounter with a patient with a chronic condition, such as AIDS, and to explore how it is understood and constructed by them. MATERIAL AND METHODS: Qualitative design with participant observation and semi-structured interviews, with physicians and patients, conducted in hospitals of Social Security Institutions in Mexico City Data were analyzed using the constant comparative method developed in the grounded theory tradition. The emergent themes studied were the dynamics of the encounters, levels of participation of the physician, and attitudes of both participants. RESULTS: Irrespective of whether patients were seen for the first time, or subsequently, in outpatient consultation or in hospital, the physician focused on the solution of the biological problem and on the performance of a work commitment with the Institution. CONCLUSION: This study highlights the need to strengthen the incorporation of the ethics into daily clinical practice in order to transform a physician-patient relationship which is merely bureaucratic, focused on the solution of a biological problem and on the fulfillment of an institutional commitment, into a relationship which is truly professional and at the service of the patient.

Ethical issues relating the the banking of umbilical cord blood in Mexico.

BACKGROUND: Umbilical cord banks are a central component, as umbilical cord tissue providers, in both medical treatment and scientific research with stem cells. But, whereas the creation of umbilical cord banks is seen as successful practice, it is perceived as a risky style of play by others. This article examines and discusses the ethical, medical and legal considerations that arise from the operation of umbilical cord banks in Mexico. DISCUSSION: A number of experts have stated that the use of umbilical cord goes beyond the mere utilization of human tissues for the purpose of treatment. This tissue is also used in research studies: genetic studies, studies to evaluate the effectiveness of new antibiotics, studies to identify new proteins, etc. Meanwhile, others claim that the law and other norms for the functioning of cord banks are not consistent and are poorly defined. Some of these critics point out that the confidentiality of donor information is handled differently in different places. The fact that private cord banks offer their services as "biological insurance" in order to obtain informed consent by promising the parents that the tissue that will be stored insures the health of their child in the future raises the issue of whether the consent is freely given or given under coercion. Another consideration that must be made in relation to privately owned cord banks has to do with the ownership of the stored umbilical cord. SUMMARY: Conflicts between moral principles and economic interests (non-moral principles) cause dilemmas in the clinical practice of umbilical cord blood storage and use especially in privately owned banks. This article presents a reflection and some of the guidelines that must be followed by umbilical cord banks in order to deal with these conflicts. This reflection is based on the fundamental notions of ethics and public health and seeks to be a contribution towards the improvement of umbilical cord banks' performance.

[Institutional ethics committees in Mexico: the ambiguous boundary between health care ethics and research ethics]. / Los comités de ética clinica en Mexico: la ambigua frontera entre la ética asistencial y la ética en investigación clínica.

OBJECTIVE: To identify ethics committees in medical practice in Mexico and possible implications stemming from their composition and functions. METHODS: A cross-sectional descriptive study was conducted from January-December 2005. A survey was sent by e-mail to the hospitals and family medicine centers with at 10 practices within the Mexican Institute for Social Security (Instituto Mexicano del Seguro Social) (n=437) and the Institute for Security and Social Services for State Employees (Seguridad y Servicios Sociales de los Trabajadores del Estado) (n=167) and to the Mexican Ministry of Health's most important health care centers (n=15). The following items were analyzed: name of the committee, date of formation, current status, composition, functions, and level of authority. RESULTS: In all, 116 committees were identified, with various names. Of these, 101 (87.1%) were active. The committees were formed from 1985-2006, with a spike occurring in 2004-2005. Of the active committees, 59 (58.4%) were charged with ethical problems/dilemmas related to clinical practice as well as those related to research projects. Of the committee members, 357 (59.0%) held managing positions in the establishment to which the committee pertained; most were medical professionals (71.5%), followed by nursing staff (11.9%). Among the members of the active committees, 77.9% had not received training in ethics. CONCLUSIONS: Legal conflicts can be expected, mainly within the organizations whose committees have the authority to determine a course of action. An integrated plan is needed that will set standards for the composition and proceedings of Mexico's ethics committees and the improved training of committee members.

Ethical behaviours in clinical practice among Mexican health care workers.

The objective of this study was to describe the cultural domain of ethical behaviours in clinical practice as defined by health care providers in Mexico. Structured interviews were carried out with 500 health professionals employed at the Mexican Institute of Social Security in Mexico City. The Smith Salience Index was used to evaluate the relevance of concepts gathered from the free listings of the interviewees. Cluster analysis and factor analysis facilitated construction of the conceptual categories, which the authors refer to as ;dimensions of ethical practice'. Six dimensions emerged from the analysis to define the qualities that comprise ethical clinical practice for Mexican health care providers: overall quality of clinical performance; working conditions that favour quality of care; use of ethical considerations as prerequisites for any health care intervention; values favouring teamwork in the health professional-patient relationship; patient satisfaction scores; and communication between health care providers and patients. The findings suggest that improved working conditions and management practices that promote the values identified by the study's participants would help to improve quality of care.

Los comités de ética clínica en México: la ambigua frontera entre la ética asistencial y la ética en investigación clínica / Institutional ethics committees in Mexico: the ambiguous boundary between health care ethics and research ethics

OBJETIVO: Identificar los comités de ética de la práctica clínica en México y establecer las posibles implicaciones derivadas de su composición y funcionamiento. MÉTODOS: Estudio transversal descriptivo realizado entre enero y diciembre de 2005. Se envió por correo electrónico una encuesta a todos los hospitales y unidades de medicina familiar del Instituto Mexicano del Seguro Social (n = 437) y del Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (n = 167) que contaran con más de 10 consultorios, y a los establecimientos asistenciales más importantes de la Secretaría de Salud de México (n = 15). Los elementos analizados fueron: nombre del comité, fecha en la que fue constituido, estado actual de actividad, composición, funciones y facultades. RESULTADOS: Se identificaron 116 comités con muy diversos nombres, de ellos 101 (87,1 por ciento) estaban activos. Estos comités se crearon entre 1985 y 2006, con un pico entre los años 2004 y 2005. De los comités activos, 59 (58,4 por ciento) se encargaban tanto de los problemas/dilemas éticos relacionados con la práctica clínica como de los proyectos de investigación. De los integrantes, 357 (59,0 por ciento) tenían puestos directivos en el establecimiento al que pertenecía el comité del que eran miembros; predominó la profesión médica (71,5 por ciento), seguida de personal de enfermería (11,9 por ciento). De los integrantes de los comités activos, 77,9 por ciento no había recibido entrenamiento en el campo de la ética. CONCLUSIONES: Puede esperarse que surjan conflictos legales, principalmente en los establecimientos cuyos comités se confieren la autoridad de dictaminar el curso apropiado de una acción. Se requiere un plan integral para estandarizar la composición y los procedimientos de los comités de ética clínica en México y mejorar la preparación de sus miembros.

OBJECTIVE: To identify ethics committees in medical practice in Mexico and possible implications stemming from their composition and functions. METHODS: A cross-sectional descriptive study was conducted from January-December 2005. A survey was sent by e-mail to the hospitals and family medicine centers with at 10 practices within the Mexican Institute for Social Security (Instituto Mexicano del Seguro Social) (n = 437) and the Institute for Security and Social Services for State Employees (Seguridad y Servicios Sociales de los Trabajadores del Estado) (n = 167) and to the Mexican Ministry of Health's most important health care centers (n= 15). The following items were analyzed: name of the committee, date of formation, current status, composition, functions, and level of authority. RESULTS: In all, 116 committees were identified, with various names. Of these, 101 (87.1 percent) were active. The committees were formed from 1985-2006, with a spike occurring in 2004-2005. Of the active committees, 59 (58.4 percent) were charged with ethical problems/dilemmas related to clinical practice as well as those related to research projects. Of the committee members, 357 (59.0 percent) held managing positions in the establishment to which the committee pertained; most were medical professionals (71.5 percent), followed by nursing staff (11.9 percent). Among the members of the active committees, 77.9 percent had not received training in ethics. CONCLUSIONS: Legal conflicts can be expected, mainly within the organizations whose committees have the authority to determine a course of action. An integrated plan is needed that will set standards for the composition and proceedings of Mexico's ethics committees and the improved training of committee members.

[Clinical ethics committees in Mexico: their development in the Mexican Institute of Social Security]. / Comités de ética clínica en México: su desarrollo en el IMSS.

The Mexican Institute of Social Security (IMSS) considers the relevance of ethics in a similar context than other countries have developed. According to these considerations, IMSS implemented formally of system of local committees on clinical ethics (CLEC), not only to provide support when ethical dilemmas emerge, but to facilitate the development of an ethics culture among health professionals. The implementation of the CLEC network started in 2004, and since then, its number has increased across the country. Currently IMSS has 78 CLECs. Their number continues to grow due to the level of awareness about the importance of ethics for making medical decisions. In November 2006 the first CLEC national meeting was held and the need to redefine strategies to improve performance of CLECS emerged. This article reports the current situation of the CLECs in Mexico.

Descriptive ethics: a qualitative study of local research ethics committees in Mexico.

OBJECTIVE: To describe how local research ethics committees (LRECs) consider and apply research ethics in the evaluation of biomedical research proposals. DESIGN: A qualitative study was conducted using purposeful sampling, focus groups and a grounded theory approach to generate data and to analyse the work of the LRECs. SETTING AND PARTICIPANTS: 11 LRECs of the Mexican Institute of Social Security (IMSS). RESULTS: LRECs considered ethics to be implicit in all types of research, but that ethics reviews were only necessary for projects that included the direct participation of human beings. The LRECs appeared to understand the importance of consent, as in the completion of a consent form, but did not emphasise the importance of the process of acquiring 'informed' consent. The committees considered their main roles or functions to be: (a) to improve the methodological quality of research and to verify - if applicable - the ethical aspects; (b) to encourage personnel to undergo research training; (c) to follow-up research to oversee the adherence to norms and compliance with a specified research timetable. CONCLUSIONS: This study provides a valuable insight into how these LRECs understand the ethical review process. The emphasis of the committees was on rules, regulations, improving research methodology and research training, rather than a focus on efforts to protect the rights and well being of research subjects. The results encourage further normative and descriptive lines of investigation concerning education and the development of LRECs.

Understanding the structure and practices of research ethics committees through research and audit: a study from Mexico.

This paper reports on a series of studies that were conducted at the Mexican Institute of Social Security (IMSS) between 2001 and 2002 to determine the role, structure and workings of their local research ethics committees (LRECs). The IMSS, unlike other Mexican health institutions, has a formal system of committees. Such committees operate under a regulatory system and are charged with scrutinising all research proposals in order to ensure their scientific validity and to protect the rights and well being of research subjects [Instituto Mexicano del Seguro Social. Dirección de Prestaciones Médicas (México). Manual de Investigación Médica en el IMSS: Instituto Mexicano del Seguro Social; 1999]. The organisation wanted to know how the committees were functioning and if the work of the committees needed to be improved. The problems that were encountered included issues with the composition of the committees, the process of project assessment, the continuing review process, and a lack of motivation of staff. In addition a qualitative study [Valdez-Martínez E, Turnbull B, Garduño-Espinosa J, Porter JDH. Descriptive ethics: a qualitative study of local research ethics committees in Mexico, Developing World Bioethics, 2005, in press] highlighted the focus of the committees on rules, regulations and the law with little understanding of the important individual role of members in complementing and adding to these structures and perspectives. The paper suggests that, to support staff and to protect research subjects, the organizational structure, management and decision making process of the IMSS's LRECs ought to be assessed regularly through audit cycles. In order to support the further development of the committees, the aim of the audit cycles should be focused on education and development of the vision, perspectives, values, and working processes of each LREC.

Análisis bibliométrico de las publicaciones realizadas por el personal del IMSS / Bibliometric analysis of the publications of Instituto Mexicano del Seguro Social (IMSS) personnel

Objetivo: describir y analizar las características generales y metodológicas de las publicaciones indizadas del personal de salud del Instituto Mexicano del Seguro Social durante 1997.Material y métodos: se evaluaron los artículos originales. Las fuentes primarias incluyeron: Index Medicus, Current Contents e índice CONACYT. En cada artículo se identificó: procedencia y tipo de actividad primordial del primer autor, factor de impacto de la revista, tipo de investigación, área de especialidad, tema del estudio y conducción metodológica, ésta última incluyó: congruencia del diseño con el objetivo, reproducibilidad de los métodos, idoneidad del análisis y pertinencia de las conclusiones.Resultados: se publicó un total de 300 artículos originales, de los cuales 212 (71 por ciento) se encontraron disponibles para el presente estudio; los investigadores de tiempo completo (ITC) generaron 109 artículos y los investigadores con actividades clínicas (IAC) 103. La mediana en el factor de impacto de las revistas donde publicaron los ITC correspondió a 1.337 (0.341 a 37.297), mientras que para los lAC fue de 0.707 (0.400 a 4.237). La investigación biomédica predominó en el primer grupo (41 por ciento); en tanto que la investigación clínica imperó en el segundo (66 por ciento). Al analizar la conducción metodológica se identificaron diferencias estadísticamente significativas entre los grupos de investigadores analizados.Conclusiones: predominaron los estudios descriptivos y las publicaciones en revistas sin factor de impacto. Los ITC conformaron el grupo con mayor producción bibliográfica de artículos originales en revistas indizadas y con factor de impacto.