Research ethics committees: values and power in higher education

The rise of research governance structures in universities has created huge disquiet amongst academic researchers. The unquestioning adoption of a medical model of ethical review based upon positivist methodological assumptions has created for many a mismatch between their own ongoing ethical research practice and the process of obtaining clearance from Research Ethics Committees (REC). This paper examines the issues that have contributed to dissatisfaction with the ethical review model that is prevalent within the modern university. Using examples from the authors’ own experiences, the dynamics of values, interests and power in research governance is examined from multiple perspectives including that of REC member and applicant; lecturer/student supervisor; researcher; and
university administrator. The paper reveals a rift between the values and objectives of the key players in research governance within the modern university and concludes by asking whether differences can be resolved so that a collaborative approach to ethical review may be incorporated into a renewed academic research culture. It is suggested that the alternative is increasing alienation from anything to do with ‘ethics’, with potentially serious consequences for the ethical standards of social research.

Multi-centre research in Australia:analysis of a recent National Health and Medical Research Council-funded project

BACKGROUND AND OBJECTIVE: Human research ethics committees provide essential review of research projects to ensure the ethical conduct of human research. Several recent reports have highlighted a complex process for successful application for human research ethics committee approval, particularly for multi-centre studies. Limited resources are available for the execution of human clinical research in Australia and around the world.

METHODS: This report overviews the process of ethics approval for a National Health and Medical Research Council-funded multi-centre study in Australia, focussing on the time and resource implications of such applications in 2007 and 2008.

RESULTS: Applications were submitted to 16 hospital and two university human research ethics committees. The total time to gain final approval from each committee ranged between 13 and 77 days (median = 46 days); the entire process took 16 months to complete and the research officer's time was estimated to cost $A34 143.

CONCLUSIONS: Obstacles to timely human research ethics committee approval are reviewed, including recent, planned and potential initiatives that could improve the ethics approval of multi-centre research.

The World Health Organization Multi-Professional Patient Safety Curriculum : implementation of key modules and its impact on patient safety knowledge, skills, and attitudes of medical students at the University of Algarve

ABSTRACT - Objectives: We attempted to show how the implementation of the key elements of the World Health Organization Patient Safety Curriculum Guide Multi-professional Edition in an undergraduate curriculum affected the knowledge, skills, and attitudes towards patient safety in a graduate entry Portuguese Medical School. Methods: After receiving formal recognition by the WHO as a Complementary Test Site and approval of the organizational ethics committee , the validated pre-course questionnaires measuring the knowledge, skills, and attitudes to patient safety were administered to the 2nd and3rd year students pursuing a four-year course (N = 46). The key modules of the curriculum were implemented over the academic year by employing a variety of learning strategies including expert lecturers, small group problem-based teaching sessions, and Simulation Laboratory sessions. The identical questionnaires were then administered and the impact was measured. The Curriculum Guide was evaluated as a health education tool in this context. Results: A significant number of the respondents, 47 % (n = 22), reported having received some form of prior patient safety training. The effect on Patient Safety Knowledge was assessed by using the percentage of correct pre- and post-course answers to construct 2 × 2 contingency tables and by applying Fishers’ test (two-tailed). No significant differences were detected (p < 0.05). To assess the effect of the intervention on Patient Safety skills and attitudes, the mean and standard deviation were calculated for the pre and post-course responses, and independent samples were subjected to Mann-Whitney’s test. The attitudinal survey indicated a very high baseline incidence of desirable attitudes and skills toward patient safety. Significant changes were detected (p < 0.05) regarding what should happen if an error is made (p = 0.016), the role of healthcare organizations in error reporting (p = 0.006), and the extent of medical error (p = 0.005). Conclusions: The implementation of selected modules of the WHO Patient Safety Curriculum was associated with a number of positive changes regarding patient safety skills and attitudes, with a baseline incidence of highly desirable patient safety attitudes, but no measureable change on the patient safety knowledge, at the University of Algarve Medical School. The significance of these results is discussed along with implications and suggestions for future research.

Helping medical students to acquire a deeper understanding of truth-telling.

PROBLEM: Truth-telling is an important component of respect for patients' self-determination, but in the context of breaking bad news, it is also a distressing and difficult task. INTERVENTION: We investigated the long-term influence of a simulated patient-based teaching intervention, integrating learning objectives in communication skills and ethics into students' attitudes and concerns regarding truth-telling. We followed two cohorts of medical students from the preclinical third year to their clinical rotations (fifth year). Open-ended responses were analysed to explore medical students' reported difficulties in breaking bad news. CONTEXT: This intervention was implemented during the last preclinical year of a problem-based medical curriculum, in collaboration between the doctor-patient communication and ethics programs. OUTCOME: Over time, concerns such as empathy and truthfulness shifted from a personal to a relational focus. Whereas 'truthfulness' was a concern for the content of the message, 'truth-telling' included concerns on how information was communicated and how realistically it was received. Truth-telling required empathy, adaptation to the patient, and appropriate management of emotions, both for the patient's welfare and for a realistic understanding of the situation. LESSONS LEARNED: Our study confirms that an intervention confronting students with a realistic situation succeeds in making them more aware of the real issues of truth-telling. Medical students deepened their reflection over time, acquiring a deeper understanding of the relational dimension of values such as truth-telling, and honing their view of empathy.

Examining discourses on the ethics and public understanding of cognitive enhancement with methylphenidate

L’émergence de l’utilisation du méthylphénidate (MPH; Ritalin) par des étudiants universitaires afin d’améliorer leur concentration et leurs performances universitaires suscite l’intérêt du public et soulève d’importants débats éthiques auprès des spécialistes. Les différentes perspectives sur l’amélioration des performances cognitives représentent une dimension importante des défis sociaux et éthiques autour d’un tel phénomène et méritent d’être élucidées. Ce mémoire vise à examiner les discours présents dans les reportages internationaux de presse populaire, les discours en bioéthique et en en santé publique sur le thème de l’utilisation non médicale du méthylphénidate. Cette recherche a permis d’identifier et d’analyser des « lacunes » dans les perspectives éthiques, sociales et scientifiques de l’utilisation non médicale du méthylphénidate pour accroître la performance cognitive d’individus en santé. Une analyse systématique du contenu des discours sur l’utilisation non médicale du méthylphénidate pour accroître la performance cognitive a identifié des paradigmes divergents employés pour décrire l’utilisation non médicale du méthylphénidate et discuter ses conséquences éthiques. Les paradigmes « choix de mode de vie », « abus de médicament » et « amélioration de la cognition » sont présents dans les discours de la presse populaire, de la bioéthique et de la santé publique respectivement. Parmi les principales différences entre ces paradigmes, on retrouve : la description de l’utilisation non médicale d’agents neuropharmacologiques pour l’amélioration des performances, les risques et bénéfices qui y sont associés, la discussion d’enjeux éthiques et sociaux et des stratégies de prévention et les défis associés à l’augmentation de la prévalence de ce phénomène. La divergence de ces paradigmes reflète le pluralisme des perceptions de l’utilisation non médicale d’agents neuropharmacologiques Nos résultats suggèrent la nécessité de débats autour de l’amélioration neuropharmacologique afin de poursuivre l’identification des enjeux et de développer des approches de santé publique cohérentes.

Who has responsibility for access to essential medical drugs in the developing world?

L’accès aux traitements de base est un enjeu crucial pour la santé, la pauvreté et le développement. La responsabilité en matière d’accès est alors une question essentielle. Le huitième Objectif du Millénaire pour le Développement postule qu’en coopération avec les firmes pharmaceutiques, l’accès aux traitements essentiels doit être assuré. Les principales parties prenantes qui doivent engager leur responsabilité pour l’accès aux médicaments sont (1) l’industrie pharmaceutique, (2) les gouvernements, (3) la société au sens large, et (4) les individus (qu’ils soient ou non malades). Quatre approches permettent d’appréhender la responsabilité: (a) l’approche déontologique; (b) l’utilitarisme; (c) l’égalitarisme; (b) l’approche basée sur les droits de l’homme. Ces quatre arguments peuvent être utilisés pour assigner une responsabilité aux gouvernements dans l’accès aux médicaments. Le papier conclut qu’il est parfois difficile de distinguer entre ces quatre approches et qu’un « glissement-d’échelle » de la responsabilité est une voie utile pour appréhender les rôles des quatre principales parties prenantes dans l’accès aux médicaments, dépendant du pays ou de la région et de son environnement interne.

Ethics in Health Policy for Allergy : A Practical Approach for Decision-Makers

Comme à l’approche d’un tsunami, l’incidence grandissante des allergies affecte maintenant plus de 30% de la population des pays développés. Étant la cause de nombreuses morbidités et un risque significatif de mortalité, les allergies nécessitent des dépenses exorbitantes au système de santé et constituent une des plus importantes sources d’invalidité. Cette thèse a pour but de contribuer à faciliter la prise de décision éclairée dans le développement de politiques en santé en lien avec cette maladie immunitaire chronique en utilisant des principes d’éthique comme outils pour guider le développement de politiques en santé. Le premier chapitre démontre le présent déficit d’analyses des enjeux éthiques en allergologie et démontre de quelle façon les réflexions en éthique peuvent guider le développement de politiques et l’élaboration de stratégies appliquées aux allergies. Les chapitres qui suivront présentent des applications spécifiques des principes d’éthiques ciblant des contextes précis comme des méthodes qui fournissent des outils de réflexion et des cadres théoriques qui peuvent être appliqués par les décideurs pour guider des interventions en santé concernant les allergies et les conditions de co-morbidité reliées. Le second chapitre présente un cadre théorique pour l’évaluation et la priorisation d’interventions en santé publique par la diminution des allergènes présents dans l’environnement basées sur des théories de justice sociale. Les critères entourant les politiques d’évaluation se concentrent sur les enjeux éthiques référant aux populations vulnérables, sur une distribution plus égale des bénéfices pour la santé, et sur le devoir d’éviter la stigmatisation. Le troisième chapitre offre aux administrateurs et au personnel infirmier du réseau scolaire un cadre décisionnel pour guider le développement de politiques efficaces et éthiquement justifiables concernant les allergies alimentaires pour les écoles. Dans ce contexte, les principes de base d’éthique en santé publique et en bioéthique - par exemple, l’empowerment des populations vulnérables dans la prise en charge de leur santé et la protection de la confidentialité du dossier médical - servent d’outils pour évaluer les politiques. Le dernier chapitre emploie les principes de base de recherche en éthique comme méthode pour développer un argumentaire en faveur de la réforme des réglementations entourant la production de médicaments immunothérapeutiques. La nécessité éthique d’éviter les risques de méfait à l’endroit du sujet humain dans la recherche permettra de servir de guide pour structurer de futures politiques en santé publique en égard à la production d’immunothérapeutiques à l’échelle mondiale.

Bob and Jane go to Argentina: The Ethics of Cross-Border Care

Étude de cas / Case study

Bioethics through the telescope: institutional ethics in the NHS

The article argues for a broader conception of bioethics. The principles that dominate current thinking are generally individualistic and do not represent the real world inhabited by patients, doctors, hospitals and the NHS as a whole. Rather than focus almost exclusively on the micro-end of the analytical spectrum, bioethics, and medical lawyers in particular, should take the institutional dimensions of health and health care more seriously, ie use a telescope to understand the dynamics that drive the subject, not just a microscope.

Construction of ethics in clinical research - Clinical trials registration

Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong conclusions) led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE), supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO) created the International Clinical Trial Registry Platform (ICTRP), which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

Why medical schools are tolerant of unethical behavior

The exposure to unethical and unprofessional behavior is thought to play a major role in the declining empathy experienced by medical students during their training. We reflect on the reasons why medical schools are tolerant of unethical behavior of faculty. First, there are barriers to reporting unprofessional behavior within medical schools including fear of retaliation and lack of mechanisms to ensure anonymity. Second, deans and directors do not want to look for unethical behavior in their colleagues. Third, most of us have learned to take disrespectful circumstances in health care institutions for granted. Fourth, the accreditation of medical schools around the world does not usually cover the processes or outcomes associated with fostering ethical behavior in students. Several initiatives promise to change that picture.

How to progress from discourse to practice? a new agenda for change in medical schools into the next decade

In the context of medical school instruction, the segmented approach of a focus on specialties and excessive use of technology seem to hamper the development of the professional-patient relationship and an understanding of the ethics of this relationship. The real world presents complexities that require multiple approaches. Engagement in the community where health competence is developed allows extending the usefulness of what is learned. Health services are spaces where the relationship between theory and practice in health care are real and where the social role of the university can be revealed. Yet some competencies are still lacking and may require an explicit agenda to enact. Ten topics are presented for focus here: environmental awareness, involvement of students in medical school, social networks, interprofessional learning, new technologies for the management of care, virtual reality, working with errors, training in management for results, concept of leadership, and internationalization of schools. Potential barriers to this agenda are an underinvestment in ambulatory care infrastructure and community-based health care facilities, as well as in information technology offered at these facilities; an inflexible departmental culture; and an environment centered on a discipline-based medical curriculum.

Specifying the effects of religion on medical helpseeking: The case of infertility

Several recent studies have examined the connection between religion and medical service utilization. This relationship is complicated because religiosity may be associated with beliefs that either promote or hinder medical helpseeking. The current study uses structural equation modeling to examine the relationship between religion and fertility-related helpseeking using a probability sample of 2183 infertile women in the United States. We found that, although religiosity is not directly associated with helpseeking for infertility, it is indirectly associated through mediating variables that operate in opposing directions. More specifically, religiosity is associated with greater belief in the importance of motherhood, which in turn is associated with increased likelihood of helpseeking. Religiosity is also associated with greater ethical concerns about infertility treatment, which are associated with decreased likelihood of helpseeking. Additionally, the relationships are not linear throughout the helpseeking process. Thus, the influence of religiosity on infertility helpseeking is indirect and complex. These findings support the growing consensus that religiously-based behaviors and beliefs are associated with levels of health service utilization.

Bioethics and medical/legal considerations on cochlear implants in children

Cochlear implants are the best treatment for congenital profound deafness. Pediatric candidates to implantation are seen as vulnerable citizens, and the decision of implanting cochlear devices is ultimately in the hands of their parents/guardians. The Brazilian Penal Code dictates that deaf people may enjoy diminished criminal capacity. Many are the bioethical controversies around cochlear implants, as representatives from the deaf community have seen in them a means of decimating their culture and intrinsic values. Objective: This paper aims to discuss, in bioethical terms, the validity of implanting cochlear hearing aids in children by analyzing their vulnerability and the social/cultural implications of the procedure itself, aside from looking into the medical/legal aspects connected to their criminal capacity. Materials and Methods: The topic was searched on databases Medline and Lilacs; ethical analysis was done based on principialist bioethics. Results: Cochlear implants are the best therapeutic option for people with profound deafness and are morally justified. The level of criminal capacity attributed to deaf people requires careful analysis of the subject's degree of understanding and determination when carrying out the acts for which he/she has been charged. Conclusion: Cochlear implants are morally valid. Implantations must be analyzed on an each case basis. ENT physicians bear the ethical responsibility for indicating cochlear implants and must properly inform the child's parents/guardians and get their written consent before performing the procedure.