Multisite Research Ethics Review: Problems and Potential Solutions

Article

Expedited Ethics Review Form for Student Projects

Form to be completed and discussed with your tutor for submission to the ethics committee as appropriate

Ethics Committee Student Project Expedited Review Checklist

checklist for fast track review of student project by ECS ethics committee

Ethical review in creative industries and other practice-based research

The processes used in Australian universities for reviewing the ethics of research projects are based on the traditions of research and practice from the medical and health sciences. The national guidelines for ethical conduct in research are heavily based on presumptions that the researcher–participant relationship is similar to a doctor–patient relationship. The National Health and Medical Research Council, Australian Research Council and Australian Vice-Chancellors’ Committee have made a laudable effort to fix this problem by releasing the National Statement on Ethical Conduct in Human Research in 2007, to replace the 1999 National Statement on Ethical Conduct in Research Involving Humans. The new statement better encompasses the needs of the humanities, social sciences and creative industries. However, this paper argues that the revised National Statement and ethical review processes within universities still do not fully encompass the definitions of ‘research’ and the requirements, traditions, codes of practice and standards of the humanities, social sciences and creative industries. The paper argues that scholars within these disciplines often lack the language to articulate their modes of practice and risk management strategies to university-level ethics committees. As a consequence, scholars from these disciplines may find their research is delayed or stymied. The paper focuses on creative industries researchers, and explores the issues that they face in managing the ethical review process, particularly when engaging in practice-based research. Although the focus is on the creative industries, the issues are relevant to most fields in the humanities and social sciences.

Does research into sensitive areas do harm? Experiences of research participation after a child’s diagnosis with Ewing’s Sarcoma

Objective: To investigate family members’ experiences of involvement in a previous study (conducted August 1995 to June 1997) following their child’s diagnosis with Ewing’s sarcoma. Design: Retrospective survey, conducted between 1 November and 30 November 1997, using a postal questionnaire. Participants: Eighty-one of 97 families who had previously completed an in-depth interview as part of a national case–control study of Ewing’s sarcoma. Main outcome measures: Participants’ views on how participation in the previous study had affected them and what motivated them to participate. Results: Most study participants indicated that taking part in the previous study had been a positive experience. Most (n = 79 [97.5%]) believed their involvement would benefit others and were glad to have participated, despite expecting and finding some parts of the interview to be painful. Parents whose child was still alive at the time of the interview recalled participation as more painful than those whose child had died before the interview. Parents who had completed the interview less than a year before our study recalled it as being more painful than those who had completed it more than a year before. Conclusions: That people suffering bereavement are generally eager to participate in research and may indeed find it a positive experience is useful information for members of ethics review boards and other “gatekeepers”, who frequently need to determine whether studies into sensitive areas should be approved. Such information may also help members of the community to make an informed decision regarding participation in such research.

Clinical trials in pediatrics

“Children are not little adults.” Almost all aspects of children's health including clinical trials and drug development are poor cousins of adult health. Over the years, pediatricians worldwide caution against blind extrapolation of adult data to children as it may result in considerable harm [1,2]. Also, it is increasingly recognized that the roots of many chronic diseases in adulthood stem from childhood and tackling health issues in children lead to improved health in adults [3,4]. Furthermore, investment in early childhood has long-term benefits in adults not only in health but also in other aspects of life such as education and crime reduction [4,5]. Arguably, health at birth is the single most important predictor of health in adulthood as the inequality of an infant at birth has intergenerational effects [5]. The Carolina Abecedarian Project showed that early childhood programs that are of high quality result in substantial societal benefits (e.g., reduction of crime, increased earnings, better education) [4,5]. A recent publication from this project found that this benefit also translated into improved adult health outcomes [4]. In a randomized trial, Campbell and colleagues described that disadvantaged children who were randomized to the intervention group (early education, health screenings and nutrition program) had significantly lower rates of metabolic syndrome, obesity and hypertension, when aged in their mid-30s, compared with the control group [4]...

Identification des pratiques, défis et solutions rencontrés dans l’évaluation de protocoles de recherche en neuroimagerie

Les récents progrès en neuroimagerie ont permis, au cours des dernières années, de faire avancer les connaissances sur les maladies neurologiques et psychiatriques en offrant la possibilité de mieux comprendre l’évolution des maladies neurodégénératives et la nature du comportement, des émotions, de la personnalité, et de la cognition. Plusieurs défis éthiques ont émergés suite à l’utilisation de ces nouvelles technologies d’imagerie cérébrale. La perspective des chercheurs concernant les pratiques d’évaluation des protocoles de recherche en neuroimagerie ainsi que les défis éthiques, sociaux et légaux auxquels font face les chercheurs n'ont pas encore été étudiés, même s’ils constituent des acteurs clés. Nous avons entrepris une étude empirique sur les perspectives des chercheurs quant au processus d'évaluation par les comités d’éthique de la recherche (CÉR) afin d’examiner les enjeux éthiques, légaux et sociaux liés à la pratique de la neuroimagerie au Canada. Pour ce faire, nous avons expédié un questionnaire en ligne et réalisé des entrevues semi-structurées avec des chercheurs en neuroimagerie et des présidents des CÉR. Les entrevues ont été transcrites et analysées à l'aide du logiciel d'analyse qualitative Nvivo. Nos résultats ont mis en lumière plusieurs aspects éthiques légaux et sociaux suscitant une attention particulière afin de remédier aux défis actuels dans la recherche en neuroimagerie ainsi qu’au processus d’évaluation de la recherche par les CÉR. Nos données comportent également des recommandations provenant des chercheurs eux-mêmes afin d'améliorer le processus d'évaluation. Finalement, notre propre expérience avec cette étude multicentrique nous a permis de constater plusieurs des défis mentionnés par les chercheurs.

Un projet de recherche exempté d’évaluation éthique : Réflexions et questionnements sur l’article 2.1 de l’Énoncé de politique des trois Conseils

Étude de cas / Case study

Un projet de recherche exempté d’évaluation éthique : une suggestion de clarification sur le processus d’évaluation éthique

Lettre à l'éditeur / Letter to the Editor

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

Lettre à l'éditeur / Letter to the Editor

La relación entre los conceptos de relación estratégica comunitaria de las organizaciones con las comunidades y la responsabilidad social

Para maximizar los beneficios, una compañía fundamenta sus acciones en ciertas estrategias que ayudan a cumplir su objetivo de generar utilidades. Entre las diferentes acciones que una organización puede utilizar, están las de responsabilidad social y las de relaciones estratégicas con la comunidad. Partiendo de la definición de comunidad, pasando por una descripción de responsabilidad social y sus diferentes formas de aplicabilidad dentro de una empresa, hasta la definición de relación estratégica con la comunidad; esta investigación dirige sus esfuerzos a determinar el vínculo que existe entre los conceptos de responsabilidad social y relación estratégica comunitaria. Adicionalmente, se plantea que otras estrategias de relacionamiento con clientes, como el mercadeo relacional o el CRM, las cuales enfocan sus esfuerzos en conocer a cada uno de los clientes de una compañía para plantear una oferta acorde a sus necesidades, no son muy efectivas a la hora de crear un vínculo emocional con la comunidad.

Do Editorial Policies Support Ethical Research? A Thematic Text Analysis of Author Instructions in Psychiatry Journals

Introduction: According to the Declaration of Helsinki and other guidelines, clinical studies should be approved by a research ethics committee and seek valid informed consent from the participants. Editors of medical journals are encouraged by the ICMJE and COPE to include requirements for these principles in the journal's instructions for authors. This study assessed the editorial policies of psychiatry journals regarding ethics review and informed consent. Methods and Findings: The information given on ethics review and informed consent and the mentioning of the ICMJE and COPE recommendations were assessed within author's instructions and online submission procedures of all 123 eligible psychiatry journals. While 54% and 58% of editorial policies required ethics review and informed consent, only 14% and 19% demanded the reporting of these issues in the manuscript. The TOP-10 psychiatry journals (ranked by impact factor) performed similarly in this regard. Conclusions: Only every second psychiatry journal adheres to the ICMJE's recommendation to inform authors about requirements for informed consent and ethics review. Furthermore, we argue that even the ICMJE's recommendations in this regard are insufficient, at least for ethically challenging clinical trials. At the same time, ideal scientific design sometimes even needs to be compromised for ethical reasons. We suggest that features of clinical studies that make them morally controversial, but not necessarily unethical, are analogous to methodological limitations and should thus be reported explicitly. Editorial policies as well as reporting guidelines such as CONSORT should be extended to support a meaningful reporting of ethical research.

Review of Dr. Richard Shapcott's International Ethics : A Critical Introduction. 2010. London: Polity Press. ISBN-13: 978-0-7456-3142-4.

This work by Richard Shapcott is, as the title provides, an introduction to international ethics. By taking a quick glance at the table of contents (see Figure 1) we see that he has systematically divided this particular discourse into its normative areas of concern (in other words its major areas of argument or research). When reading, we also see that a great deal of work has gone into the publication because the narrative is flowing, the arguments continuous, and because the tone of the work maintained its critical position throughout.