Quelle régulation pour l’arrêt d’un protocole de recherche clinique de thérapie génique somatique ? État des lieux auprès des cliniciens-chercheurs européens

Depuis 2002, le débat sur les risques associés à la thérapie génique est initié suite à l’annonce que deux enfants inclus dans un essai thérapeutique impliquant une thérapie génique ont développé des effets indésirables important. En Janvier 2005, le débat sur les risques reprit suite à l’interruption du protocole sur les enfants bulle du Pr Fischer à l’hôpital Necker de Paris. Nous avons donc étudié le processus impliqué ainsi que la réflexion éthique associée aux décisions d’arrêt de protocole de recherche. Notre travail a été mené par une équipe pluridisciplinaire combinant chercheurs en santé, généticiens et éthiciens. Nous avons étudié la participation des chercheurs, des patients, des institutions officielles, des comités d’éthique ainsi que des associations de patients dans le processus de décision d’interruption d’un protocole de recherche.Nous avons également analysé les critères jugés les plus pertinents dans l’arrêt d’un protocole de recherche. Enfin nous avons analysé le point de vue des personnes directement impliquées dans la thérapie génique au moyen d’un questionnaire. Toutes les personnes contactées ont présenté un poster de recherche au congrès de la Société Européenne de Thérapie Génique. 62 personnes d’autant d’équipes de recherche différentes, de 17 pays, sur les 350 contactés ont répondu. Selon eux, la décision d’arrêt d’un protocole de recherche doit être prise suite à une consultation des chercheurs, des patients, du ministère de tutelle, d’une agence nationale de régulation ou d’un comité d’éthique ; la légitimité étant accordée à des décisions prises en commun par les chercheurs, les patients et les comités d’éthique. Les incidents sérieux et de façon plus surprenante, les incidents moins graves sont jugés comme étant des critères suffisants pour interrompre un essai. Nous avons fini par analyser les conséquences éthiques, telles que balance bénéfice/risque, processus de régulation ou responsabilité, de ces critères sur l’arrêt d’un protocole de recherche.

Un projet de recherche exempté d’évaluation éthique : quelques précisions

Lettre à l'éditeur / Letter to the Editor

La collaboration chez Pierre Perrault : étude comparative de Pour la suite du monde et La bête lumineuse.

Ce mémoire propose une analyse de la collaboration à l’intérieur de projets cinématographiques dans l’œuvre de Pierre Perrault. Comme la collaboration entre cinéaste et participants soulève des questions éthiques, cette recherche étudie deux films pivots dans la carrière de ce cinéaste soit Pour la suite du monde et La bête lumineuse. Tout en contrastant le discours du cinéaste avec celui d’un protagoniste nommé Stéphane-Albert Boulais, cette étude détaille les dynamiques de pouvoir liées à la représentation et analyse l’éthique du créateur. Ce mémoire présente une description complète de la pensée de Pierre Perrault, ainsi que sa pratique tant au niveau du tournage que du montage. Cette étude se consacre à deux terrains cinématographiques pour soulever les pratiques tant au niveau de l’avant, pendant, et après tournage. Ce mémoire se penche ensuite sur Stéphane-Albert Boulais, qui grâce à ses nombreux écrits sur ses expériences cinématographiques, permet de multiplier les regards sur la collaboration. Après une analyse comparative entre les deux terrains cinématographiques, ce mémoire conclut sur une analyse détaillée de l’éthique du créateur à l’intérieur de projets collaboratifs.

L’Homme en question

Travail créatif: pièce de théâtre / Creative Work: Play

Big Data: Wrongs and Rights by Andrew Cormack (WAIS Seminar)

Abstract: Big Data has been characterised as a great economic opportunity and a massive threat to privacy. Both may be correct: the same technology can indeed be used in ways that are highly beneficial and those that are ethically intolerable, maybe even simultaneously. Using examples of how Big Data might be used in education - normally referred to as "learning analytics" - the seminar will discuss possible ethical and legal frameworks for Big Data, and how these might guide the development of technologies, processes and policies that can deliver the benefits of Big Data without the nightmares. Speaker Biography: Andrew Cormack is Chief Regulatory Adviser, Jisc Technologies. He joined the company in 1999 as head of the JANET-CERT and EuroCERT incident response teams. In his current role he concentrates on the security, policy and regulatory issues around the network and services that Janet provides to its customer universities and colleges. Previously he worked for Cardiff University running web and email services, and for NERC's Shipboard Computer Group. He has degrees in Mathematics, Humanities and Law.

The relevance to international mergers of the ethical perspectives of participants

International mergers are becoming more widespread among medium-sized companies that for decades have held a prime position in their home country market, but who now feel threatened that they may not be of a significant size to continue to be viable in the international marketplace. The purpose of this paper is to examine the merger of one Australian company and one of its former competitors in the international marketplace from the perspective of the congruence between their espoused ethical cultures in business prior to the merger. A questionnaire comprising 46 questions was sent to the public relations manager of each organization prior to the merger. These managers were asked to fill in the questionnaire and to provide a copy of their code of ethics. The research found that organizations need to not only have a code of ethics, but also need to focus especially on the area of code augmentation to ensure that they communicate the ethos of their code to their employees.

Developing a placebo-controlled trial in surgery : issues of design, acceptability and feasibility

Background: Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK.
Methods: Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons); plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists); three focus groups with anaesthetists (one national, two regional; 58 anaesthetists); two focus groups with members of the patient organisation Arthritis Care (7 participants); telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants); interviews with Chairs of UK ethics committees (6 individuals); postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons) and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists); two centre pilot (49 patients assessed).
Results: There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions) proved easier than the method of anaesthesia (general anaesthesia). General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot. Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully.
Conclusions: Our study illustrated the opposing and often strongly held opinions about surgical placebos, the ethical issues underpinning this controversy, and the challenges that exist even when ethics committee approval has been granted. It showed that a placebo-controlled trial could be conducted in principle, albeit with difficulty. It also highlighted that not only does a placebo-controlled trial in surgery have to be ethically and scientifically acceptable but that it also must be a feasible course of action. The place of placebo-controlled surgical trials more generally is likely to be limited and require specific circumstances to be met. Suggested criteria are presented.

Patient and nurse preferences for nurse handover-using preferences to inform policy: a discrete choice experiment protocol

INTRODUCTION: Nursing bedside handover in hospital has been identified as an opportunity to involve patients and promote patient-centred care. It is important to consider the preferences of both patients and nurses when implementing bedside handover to maximise the successful uptake of this policy. We outline a study which aims to (1) identify, compare and contrast the preferences for various aspects of handover common to nurses and patients while accounting for other factors, such as the time constraints of nurses that may influence these preferences.; (2) identify opportunities for nurses to better involve patients in bedside handover and (3) identify patient and nurse preferences that may challenge the full implementation of bedside handover in the acute medical setting. METHODS AND ANALYSIS: We outline the protocol for a discrete choice experiment (DCE) which uses a survey design common to both patients and nurses. We describe the qualitative and pilot work undertaken to design the DCE. We use a D-efficient design which is informed by prior coefficients collected during the pilot phase. We also discuss the face-to-face administration of this survey in a population of acutely unwell, hospitalised patients and describe how data collection challenges have been informed by our pilot phase. Mixed multinomial logit regression analysis will be used to estimate the final results. ETHICS AND DISSEMINATION: This study has been approved by a university ethics committee as well as two participating hospital ethics committees. Results will be used within a knowledge translation framework to inform any strategies that can be used by nursing staff to improve the uptake of bedside handover. Results will also be disseminated via peer-reviewed journal articles and will be presented at national and international conferences.

Ética na pesquisa em Administração

Ethics on scientific research is approached and often discussed in several areas of knowledge connected to health. In the Administration area there are very few studies which approach the topic of ethics on research. The present paper tried to fill in this gap in the production of knowledge about the topic, investigating how the ethical principles found in the literature and in the codes of conduct are noticed and taken into account in Administration research activities developed by acting researchers in Administration Post Graduation Programs. Theoretically speaking, the study was based mainly on the approaches by Creswell (2007) and Bell and Bryman (2007), which discuss the research ethical principles. Methodologically speaking it was all about an exploratory kind of study, with qualitative research approach. Upon data collection, personal interviews were made aiming at its depth and focus groups were formed. The first stage had interviews with four experienced researchers who took part on a teaching and researching event and on the second stage we used the focus group technique. The focus groups were done in four college institutions along with the post graduation programs in Administration in the states of Rio Grande do Norte, Paraíba and Pernambuco, in Brazil. The results suggest the existence of general principles and parameters for the scientific research recommended in the literature and on official resolution. However, in the Administration area, there are only a few recommendations of good practices when it comes to submitting articles for scientific publications but we found no guidance with ethical principles and parameters which cover all the activities in the scientific research and which specifically meet the research particularities in Administration. The main ethical dilemma pointed by the researchers refers to ethical questions which arise at the time of data collection and on disclosing the results. Most researchers do not know the guidelines and the ethical norms on ethics about research that we have in our country neither do they send in their projects to the research ethics committee. When dilemma arises, they decide the ethical question based on their values and common sense. These elements confirm the thesis that the researcher s procedure in the research activities in Administration is predominantly signed by personal values or by common sense and less by ethical principles, whether by not knowing the normative instruments related to ethics or by disagreeing with any disciplining rules on ethical behavior in the research

Significados e percepções do homem diante da gravidez de sua companheira com síndromes hipertensivas

The general aim of the research was to comprehend the Social Representations constructed by the man in the face of his companion s risk pregnancy caused by hypertensive syndromes. The study is of exploratory and descriptive character in a qualitative approach developed at two public maternity hospitals, both located in Natal-RN, with 65 men whose wives had undergone high-risk pregnancy. The project was submitted to the Ethics on Research Committee of the Federal University of Rio Grande do Norte, Brazil (CEP-UFRN), with favorable report no. 81/07. For data collection, the following multimethods were employed: a word free association test; a projective test for registering mental images; and a semistructured interview schedule. The speech contents were analyzed in accordance with the Theory of Social Representations and complemented by the Central Nucleus Theory. The discussion of the results was grounded on literary findings of the companion s participation in pregnancy as well as in risk pregnancy associated with hypertensive syndromes. The data showed fear as representation s central nucleus, while recollections of that feeling referred to death of both companion and child in addition to fear of the unknown. The categories preoccupation and carefulness, other feelings, and clinical picture of the disease represented components of the peripheral nucleus. The results concerning mental images followed the same category criteria of the word free association test fear, other feelings, preoccupation, carefulness, and clinical picture of the disease. After being processed in accordance with the principles of content analysis, the statements originated three thematic unities: fear and insecurity in the presence of the companion s risk pregnancy; attitudes of carefulness to the risk pregnancy of the partner; and humanized assistance during the companion s risk pregnancy. Considering the results, the conclusion is that the partner s risk pregnancy caused by hypertensive syndromes represents, for the man, feelings of fear, preoccupation, insecurity, lack of acceptance and information, as well as attitudes of carefulness. The results reveal necessity of reorganizing the obstetric assistance with an eye to including the man as participant in the reproductive process. That demands extension of humanized carefulness to the companion with a view to make him an active coadjutor in the assistance of high-risk pregnant

Interação competitiva do zinco e ferro após administração oral e venosa de zinco em crianças eutróficas

The aim of this study was to assess the acute and chronic effects of zinc in serum iron profile of children aged 6-9 years in relation to nutritional status and dietary intake. The study participants were 11 children regardless of sex, aged 6-9 years. They were selected from three public schools of the city of Natal, Brazil. Body mass index was used to assess nutritional status. In order to determine the patterns of childhood growth and ideal weight we used the standards of the World Health Organization. The dietary intake assessment was based on information from a three-day prospective food survey. The variables were energy intake, protein, lipids, carbohydrates, fiber, calcium, iron and zinc. All children underwent an intravenous administration of zinc (IVAZn) before and after oral administration of zinc (OAZn) (5 mg Zn / day) for three months. We measured serum iron, hematocrit, hemoglobin and total protein, before and after the use of oral zinc. The analysis of hematocrit, hemoglobin and total protein was performed using standard methods of clinical laboratory. Zinc levels and serum iron were measured by atomic absorption spectrophotometry. The project was evaluated and approved by the Ethics in Research Committee of Federal University of Rio Grande do Norte. Results: All children had normal weight. The consumption of energy, fat, fiber, calcium and iron were below recommended levels. However, the levels of protein and carbohydrates were high. Protein and zinc increased significantly after OAZn. Carbohydrate and protein were elevated in the blood. After OAZn, both protein and zinc increased, being statistically significant. Conclusion: The potential inhibitory effect of physiological or pharmacological doses of zinc on the profile of serum iron was observed in children with healthy weight and aged between 6 and 9 years. This negative effect of zinc did not affect the levels of hematocrit or hemoglobin, and therefore did not cause anemia. This was a multidisciplinary study, involving researchers from medicine, nutrition and pharmacy. This met the requirements of multidisciplinarity of the Post Graduate Program in Health Sciences of Federal University of Rio Grande do Norte.

A fragilidade e suas representações para idosos domiciliados no contexto da estratégia de Saúde da Família

This study aims to analyze social representations of elders to their fragile situation at home, with the presence of one or more characteristics, as defined by the Brazilian Ministry of Health. It is a descriptive and qualitative study, based on methodological -principles of the Theory of Social Representations. Setting was the homes of elderly residents in the area ascribed to a Family Health Unit (FHU) in the city of Natal. A total of 10 elderly subjects, whose choice was intentional and according to the need for USF home visit in a period of time, considering the saturation process of the information. As collection procedures were used the semi-structured interview and participant observation in accordance with the ethical rules of Resolution No. 196/96, with the assent of the Ethics and Research UFRN. To analyze the results, it was used the thematic content analysis in the aspect of preparation of representations, focusing on the totality of the discourse of the subjects. The results indicate that most study participants felt difficult to give meaning to the terms weakness and to be weak, although many present one or more aspects of the syndrome of frailty. From the content analysis of participants speeches in this study, we achieved the following categories: fragility as illness and disease as aging, aging and frailty as causes of changes and difficulties in daily life, the presence of family life in the fragile elderly, fragility as weakness and the risk for falls, the perception of being weak like a different person in addition to the absence of fragility in elderly life. Thus, through the processes of anchoring and objectification, the "fragile being" became familiar and concrete, showing that the meaning of weakness, besides the scientific definition found in the reified universes, can be reinterpreted and built within the consensus universes. About the care received by the staff of Family Health, from the viewpoint of older people there seems to be an understanding about the role of professional nurses; on the other hand, older people often mention the role of the Community Health Agent

Custo-efetividade da terapia compressiva no processo de cicatrização de úlceras venosas

Analytical study of therapeutic nonrandomized intervention type, intra-group controlled, with the aim of analyzing the cost-effectiveness of compression therapy with manipulated Unna boot in relation to conventional therapy in the healing of venous ulcers (VU) of patients treated in ambulatory clinic. The study population was composed by patients with VU treated by angiologists in Surgical Clinic Ambulatory of the Onofre Lopes University Hospital (HUOL) with a sample of 18 patients. It obtained the assent of the HUOL Ethics in Research Committee (Protocol 276/09). Data collection was performed over a period of four months by the own master's student and 34 nursing students, through the application of the research instrument in the admission of patients to the study and in the ten subsequent evaluations, performed at the time of changing Unna boot, weekly, for a maximum period of 10 weeks. The data were analyzed with SPSS 15.0 software, using descriptive and inferential statistics, and presented as tables, charts and graphs. Among those surveyed, prevailed: females, mean age 57.6 years, low education and income levels, most retired, unemployed or off work, with the standing position more than six hours per day and up to eight hours daily of domestic or occupational activities. In health status profile of respondents there were predominantly sleep, rest and inadequate elevation of the lower limbs, no smoking and/or alcohol use, presence of hypertension and no use of drugs. Most presented the first VU for over 10 years, recurrences, present VU for more than five years, involvement of left leg, in malleolar and / or distal leg region, mild edema, hyperpigmentation, lipodermatosclerosis, telangiectasies, reticular and varicose veins, mild pain, serous exudate in moderate quantity, small lesions (up to 50cm2), with predominance of granulation tissue and / or epithelialization and demarcated, elevated and irregular borders, with crusts and macerated. Most patients reported that in the 10 weeks prior to admission, made bandages at home and / or Basic Health Unit and / or ambulatory, with nursing aides or technicians, daily, and on weekends or holidays, performed by patients themselves, using healing ointment on the lesion, being observed granulation / epithelialization and increase in VU prevalent in the 10 weeks of traditional treatment. After follow up with manipulated Unna boot, was observed a decrease of lesions in all study patients, with complete healing in 27.8% of those between 1 and 5 weeks of treatment, with satisfactory evolution of the lesions, pain and ankle and calf circumferences, and unsatisfactory development of the borders of ulcers, edema, sleep, rest and elevation of the lower limbs, especially in more chronic patients. Furthermore, patients who achieved total healing and exhibited the greatest percentage reduction of lesions had a higher number of wound healing factors (ρ = 0.01 and ρ = 0.027, respectively). The manipulated Unna boot showed better results in those patients with shorter duration of injury, leading them to a satisfactory outcome within a short period of treatment. After the cost-effectiveness analysis, we conclude that the manipulated Unna boot is more effective than conventional therapy in the healing process of VU and is more cost-effective in patients with shorter lesions (ρ = 0.001), shorter treatment (ρ = 0.000) and greater number of wound healing factors (ρ = 0.005).

Assistência aos portadores de úlceras venosas: proposta de protocolo

Venous ulcers (VU), recurrent chronic wounds resulting from Chronic Venous Insufficiency (CVI), affect different age groups and would severely affect ambulation of patients. The lesions require treatment lasting and complex and are responsible for significant morbidity and mortality. Thus, this study aims to identify the important aspects covered in the scientific literature protocol for assisting patients with venous ulcers, identifying the issues to be proposed by the judges of the study (nurses, doctors and physiotherapists) to the protocol of care provided to patients venous ulcers and present the structure of protocol proposed by the judges of the study to assist patients with venous ulcers treated at a referral hospital of Rio Grande do Norte. This is a descriptive study using a quantitative approach, carried out at the dressings, located in the outpatient surgical clinic of the Hospital University Onofre Lopes (HUOL), located in East Sanitary District, Natal-RN. The sample consisted of 39 professionals, 30 nurses, seven doctors and two physical therapists, team members HUOL surgical clinic and other public and private institutions of Rio Grande do Norte and Jequié/Bahia. These professionals were the judges responsible for selecting the guidelines already proposed in the literature on VU protocols. Approved by the Ethics in Research HUOL (Report n.o 081/07), began the first stage of the study which consisted of reviewing the scientific literature about the relevant aspects to be included in a protocol for assisting patients with VU. These aspects were organized into a proposed questionnaire to the judges of the study. Following examination, held on the content validation with application of the Kappa (K), accepting a score higher than 0.80 and the Likert Scale, whereas rates from 4.0 to 5.0. The data collected were organized in Microsoft Excel and exported into Statistical Package for Social Sciences (SPSS) 15.0. The literature review included national and international scientific articles, thesis, dissertation and institutional protocols. Regarding the characterization of professional nurses predominated (76.1%), between 34 and 45 years (41.0%), female (79.5%), married/consensual union (46.2%), with specialization in VU care (61.5%), working in the hospital network (46.1%), with up to 5 years experience in VU (69.2%) and claiming to feel prepared to care for these injuries (92.3 %). With regard to aspects that had very good agreement (K ≥ 0.81), remained the items found in the literature with some modifications. In the analysis of the proposed evaluation items had very important, ranging from 4.1 (drug treatment) to 4.9 (patient assessment and care of the injury and the injured and perilesional skin). The proposition of the protocol is arranged in eleven items: A) Evaluation of patient and lesion, B) Registration and documentation, C) the wound and perilesional skin, D) an indication of coverage, E) Use of antibiotic and pain treatment, F) Surgical treatment of CVI, G) Drug treatment, H) Improving venous return and prevetion of recurrence, I) Referral of patients, J) Training and K) Reference and counter reference