Research Ethics Board Members Research Articles

Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study.

BackgroundCluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1) identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2) understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK); (3) elicit the views and experiences of trial participants and cluster representatives; (4) develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5) disseminate the guidelines to researchers, research ethics boards (REBs), journal editors, and research funders.MethodsWe will use a mixed-methods (qualitative and quantitative) approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An Expert Panel of researchers, ethicists, health lawyers, consumer advocates, REB members, and representatives from low-middle income countries will be appointed. A consensus conference will be convened and draft guidelines will be generated by the Panel; an e-consultation phase will then be launched to invite comments from the broader community of researchers, policy-makers, and the public before a final set of guidelines is generated by the Panel and widely disseminated by the research team.

Scientists’ Perspectives on the Ethical Issues of Stem Cell Research

This paper describes findings from an ethics education project funded by the Canadian Stem Cell Network (SCN). The project is part of a larger research initiative entitled "The Stem Cell Research Environment: Drawing the Evidence and Experience Together". The ethics education study began with a series of focus groups with SCN researchers and trainees as part of a "needs assessment" effort. The purpose of these discussions was to identify the main ethical issues associated with stem cell (SC) research from the perspective of the stem cell community. This paper will focus on five prominent themes that emerged from the focus group data including: (1) the source of stem cells; (2) the power of stem cells; (3) working within a charged research environment; (4) the regulatory context; and (5) ethics training for scientists. Additional discussions are planned with others involved in Canadian stem cell research (e.g., research ethics board members, policy makers) to supplement initial findings. These assessment results combined with existing bioethics literature will ultimately inform a web-based ethics education module for the SCN. We believe that our efforts are important for those analyzing the ethical, legal, and social issues (ELSI) in this area because our in depth understanding of stem cell researcher perspectives will enable us to develop more relevant and effective education material, which in turn should help SC researchers address the important ethical challenges in their area.

Students as Members of University-based Academic Research Ethics Boards: A Natural Evolution

University based academic Research Ethics Boards (REB) face the particularly difficult challenge of trying to achieve representation from a variety of disciplines, methodologies and research interests. Additionally, many are currently facing another decision – whether to have students as REB members or not. At Ryerson University, we are uniquely situated. Without a medical school in which an awareness of the research ethics review process might be grounded, our mainly social science and humanities REB must also educate and foster awareness of the ethics review process throughout the academic community. Our Board has had and continues to have students as active members. While there are challenges to having students as Board members, these are clearly outweighed by the advantages, for both the academic community and the future of ethically sound research in the social sciences and humanities. Moreover, the challenges are often based on misconceptions and can be easily overcome through increased education and understanding of the research ethics review process by the academic community at large. The purpose of this paper is to describe and discuss the experiences, advantages and challenges of having students as REB members. The advantages of having students as REB members include the following: (1) Students are the proposed participants in many of our reviewed protocols and student members may illuminate unique issues of participation. (2) Students are active and highly engaged members of the REB. (3) Having students on the REB enhances awareness of research ethics within the University. (4) Student REB members have an opportunity to mentor other students and provide leadership for both undergraduate and graduate students. (5) Students are more vigorously recruited than faculty members and often apply for student positions with enthusiasm and preparation. (6) In creating an atmosphere of excellence in research, engaging students at the beginning of their research career will help in creating tomorrow’s leaders in research and research ethics. The challenges of having students as REB members include the following: (1) Faculty members may be uneasy regarding the prospect of students reviewing protocols. (2) Faculty members may be concerned about confidentiality and respect with students reviewing faculty research protocols. (3) There may be an increased burden for students who serve as members on an REB. (4) There is concern that students will offer less continuous service to the REB. (5) There is a common misconception that students do not have the experience to carry out ethical reviews. While there are challenges from faculty members and others regarding having students as REB members, these challenges are often based on misconceptions about the nature of the REB work and the ethics review process in general. These challenges are also often based on the misconception of the ethics review process as one of peer review and evaluation, instead of a community-based and inclusive process. Having student members is a long-term strategy for both overcoming the misconceptions of the REB as a “necessary evil” and for fostering an awareness of the imperative for ethically sound research in the social sciences and humanities.

A Troubled Dance: Doing the Work of Research Ethics Review

The fast growing interest in the work of university ethics review boards is evident in the proliferation of research and literature in the area. This article focuses on a Research Ethics Board (REB) in the Canadian context. In-depth, open-ended interviews with REB members and findings from a qualitative study designed to examine the ethics review of school-based research are used to illustrate points raised in the paper. The author’s experiences as academic researcher, advisor to student researchers and a 3-year term as an REB member inform the discussion. Macro issues related to the general workings of the board (e.g., maintaining appropriate membership) and micro issues connected to individual REB members’ experiences of reviewing research applications are examined. The author’s goal is to contribute to a fastgrowing conversation related to the issues that influence university ethics review while drawing attention to the contribution that faculty members’ understandings of their work as REB members can make to that conversation.

Protecting the protectors: indemnification agreements for REB members

Liability risk is a serious issue for members of research ethics boards (REBs) at public institutes in Canada. Yet, few Canadian institutes indemnify their REB members. Some simply have not considered the issue; others have deliberated and decided to not indemnify. This paper addresses arguments

Myths about Qualitative Research and the Tri-Council Policy Statement

Myths about Qualitative Research and the Tri-Council Policy Statement Carolyn Ells Shawna Gutfreund It is no secret that qualitative research and Canada's Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) has been an unhappy union. Much in the TCPS is drawn from the research ethics literature that addresses research in the medical context. Although acknowledged, the social sciences and humanities research experience has a low profile in the TCPS. The presence of qualitative research methods within the spectrum of healthcare research has an even lower profile. Some might suggest (incorrectly) that the social sciences, humanities, and qualitative research methods do not appear to influence the policies found in the TCPS at all. Accordingly, in universities and hospitals, in discussions among colleagues at conferences and research venues, and outside the closed doors of research ethics board (REB) meetings, there has been much criticism about the TCPS by those who use different theories and methods than are typical in medical research protocols. While some criticism is justified, some of it is misguided. Despite its emphasis on research ethics in medicine, the TCPS actually allows for more flexibility than some qualitative researchers and REB members sometimes give it credit for. In this paper we address eight common criticisms related to qualitative research and the TCPS, most of which relate to supposed "requirements" surrounding the consent process. It is our contention that these criticisms are not inherent in the TCPS itself, but rather in its interpretation and application. Hence we call these criticisms "myths". By debunking these myths, our aim is to free researchers and REBs from placing undue restrictions on qualitative research. We encourage qualitative researchers and REBs to refer to [End Page 361] the text of the TCPS and interpret it in the context of specific research projects. We advise REBs to think beyond the medical model, and qualitative researchers to quote relevant passages from the TCPS in their protocol submissions to justify the procedures they propose. Tri-Council Policy Statement In August 1998, Canada's three major research funding councils — the Medical Research Council (MRC) (now Canadian Institutes of Health Research (CIHR)), the National Sciences and Engineering Research Council (NSERC) and the Social Sciences and Humanities Research Council (SSHRC) — released their joint policy regarding research involving humans: the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). This joint policy statement replaced previous guidelines of MRC and SSHRC and united the three major research-funding councils under one research ethics umbrella. The TCPS sets out the ethical norms and requirements for conducting research that involves human participants, as well as, requirements for structuring REBs and how they are to operate in their review of research involving human participants. The Councils stipulate that they "will consider funding (or continued funding) only to individuals and institutions which certify compliance with this policy" (TCPS: i.1). Thus, access to funding (or the risk of loss of funding) motivates institutions receiving funding from any of the three Councils, to ensure that all research involving human participants conducted at these institutions or by their researchers complies with the TCPS. This motivation does not reach over privately funded institutions whose research in conducted behind their own closed doors. However, when privately funded institutions collaborate with academic researchers whose institutions receive funding from any of the three Councils, the TCPS is meant to apply to those collaborations. The move from discrepant guidelines that apply to some to a unifying policy that applies to many was (and still is) a challenge, both for individual researchers and the institutions that receive Tri-Council funding. The concerns that we are responding to in this paper could be seen as arising in an era of transition when many institutions were/are formalizing their processes for research ethics review to be in accord with the new TCPS, and other regulations as well. We hope that the myths we address will be dispelled and left behind as qualitative researchers, REBs...

Professional Ethics Considerations of Research Ethics Board Members in Canada

This paper explores issues of professional ethics that are rel evant to those who engage in the ethical review of research with hu man subjects. Codes of ethics of a number of professional groups are examined for guidance offered to research ethics board members. The thought of the philosopher, Mike Martin, is introduced as a way to high light some of the ethical issues that reviewers encounter in their work. Martin believes that ideals contribute to the coherence of an individual's life by shaping character. His discussion of caring, justice, trust, and pro fessional distance offer a resource for reviewers to reflect on the ethical dimensions of their work.

Knowledge of the legislation governing proxy consent to treatment and research

Objective: To assess the knowledge of four groups of individuals regarding who is legally authorised to consent to health care or research involving older patients. Design: A provincewide postal survey....

Judging the Ethical Merit of Clinical Trials: What Criteria Do Research Ethics Board Members Use?

The basic plan was to interview forty members of research ethics boards. Using a standardized approach, these individuals were asked to describe the criteria that they used when assessing the ethical acceptability of research involving human subjects. The responses were elicited during individual interviews conducted by two of the authors (EMM, JVL) and analyzed using qualitative methods. The study was approved by the Human Subjects Review Panel at the University of Toronto.