'Text-work' in Research Ethics Review: The significance of documents in and beyond committee meetings

ABSTRACT

This article analyzes how a formal text (the Ethics Review Form) available at National Health Service Research Ethics Committees (NHSRECs) in the United Kingdom was used in meetings. Derived from the work of Dorothy Smith on incorporating texts into institutional ethnography (IE), it proposes the concept of “text work” as a way into understanding more about decision-making in ethics review and describes the extent to which this formal text shaped and influenced review work. The research study used observations of committee meetings, field-notes and interviews to produce an ethnographic mapping of Research Ethics Committees’ (RECs) work. This article draws on one aspect of the research which was the process of isolating a particular, ubiquitous text and analyzing how it worked and was worked on in the meetings. The analysis contributes to contemporary discussion offering an alternative to ongoing debates about idealized ways of conducting ethics review. Finally, some tentative suggestions are made about improving training, based on and starting from the work which reviewers undertake.     

Qualitative Evaluation Methods in Ethics Education: A Systematic Review and Analysis of Best Practices

Although qualitative research offers some unique advantages over quantitative research, qualitative methods are rarely employed in the evaluation of ethics education programs and are often criticized for a lack of rigor. This systematic review investigated the use of qualitative methods in studies of ethics education. Following a review of the literature in which 24 studies were identified, each study was coded based on 16 best practices characteristics in qualitative research. General thematic analysis and grounded theory were found to be the dominant approaches used. Researchers are effectively executing a number of best practices, such as using direct data sources, structured data collection instruments, non-leading questioning, and expert raters. However, other best practices were rarely present in the courses reviewed, such as collecting data using multiple sources, methods, raters, and timepoints, evaluating reliability, and employing triangulation analyses to assess convergence. Recommendations are presented for improving future qualitative research studies in ethics education.     

The Canadian Agency for the Oversight of Research Involving Humans: A Reform Proposal

In this paper, I propose the creation of a Canadian agency for the oversight of research involving humans. I describe first a series of significant problems with Canada’s current system of oversight. I then argue for the creation of a national-level agency, covering all research involving humans, with three branches (policy and standards, education, and compliance). Of particular note, the proposed compliance branch consists of a number of independent national and regional Research Ethics Boards (i.e., REBs no longer reside within institutions). There is also an Audit Committee and a Non-compliance Committee (with supporting staff of auditors and compliance officers) to ensure compliance with the policies and standards set by the Policy and Standards Branch. Finally, I answer a series of “frequently asked questions” about the proposed agency design such as “What about ‘local context’?” and “Why not have a system of accreditation of institutional REBs instead?” In sum, radical reform is needed and, in this paper, I present a proposal for such reform.     

Effective Practices in the Delivery of Research Ethics Education: A Qualitative Review of Instructional Methods

In order to delineate best practices for courses on research ethics, the goal of the present effort was to identify themes related to instructional methods reflected in effective research ethics and responsible conduct of research (RCR) courses. By utilizing a qualitative review, four themes relevant to instructional methods were identified in effective research ethics courses: active participation, case-based activities, a combination of individual and group approaches, and a small number of instructional methods. Three instructional method themes associated with less effective courses were also identified: passive learning, a group-based approach, and a large number of instructional methods. Key characteristics of each theme, along with example courses relative to each theme, are described. Additionally, implications regarding these instructional method themes and recommendations for best practices in research ethics courses are discussed.     

The Therapeutic Misconception: A Threat to Valid Parental Consent for Pediatric Neuroimaging Research

Neuroimaging research has brought major advances to child health and well-being. However, because of the vulnerabilities associated with neurological and developmental conditions, the parental need for hope, and the expectation of parents that new medical advances can benefit their child, pediatric neuroimaging research presents significant challenges to the general problem of consent in the context of research involving children. A particular challenge in this domain is created by the presence of therapeutic misconception on the part of parents and other key research stakeholders. This article reviews the concept of therapeutic misconception and its role in pediatric neuroimaging research. It argues that this misconception can compromise consent given by parents for the involvement of their children in research as healthy controls or as persons with neurological and developmental conditions. The article further contends that therapeutic misconception can undermine the research ethics review process for proposed and ongoing neuroimaging studies. Against this backdrop, the article concludes with recommendations for mitigating the effects of therapeutic misconception in pediatric neuroimaging research.     

The Expanding Purview: Institutional Review Boards and the Review of Human Subjects Research

The implications of the institutional review board (IRB) system's growing purview are examined. Among the issues discussed are whether IRBs are censoring research and whether the IRB review process fundamentally alters the research that is being conducted. The intersection between IRB review and free speech is also explored. In general, it is argued that the review system for human subjects research (HSR) should be modified in order to limit the scope of IRB review.     

Building a More Connected DSMB: Better Integrating Ethics Review and Safety Monitoring

Data and Safety Monitoring Boards (DSMBs) have become an increasingly common feature of clinical trial oversight, yet a paucity of legal or ethical frameworks govern these Boards’ composition or operation, or their relationship with other actors with monitoring responsibilities. This paper argues that prevailing structural gaps are impeding harmonized systems for monitoring the ongoing ethical acceptability of clinical trials. Particular tensions stem from DSMBs’ sweeping discretion in deciding whether and when to recommend that a trial should be terminated or amended based on safety and efficacy information. This discretion becomes especially challenging in light of DSMBs’ monopoly over emerging trial data, which prevents Institutional Review Boards, sponsors, and investigators from participating in certain pivotal and ethically charged decisions. To address these disconnects, I advocate for strengthened pre-trial and post-trial communication in addition to innovative strategies to support DSMB decision making through the life of a trial.     

Asian Public Concern over the Ethics of Scientists: Predictors and Implications for Research Ethics

The following two research questions were examined in this study: 1) What is the public's level of concern with ethics in science; and 2) Are religious affiliation, religious involvement, and education predictors of that concern in Asia? The sample includes 7,963 men and women between the ages of 20 and 59 from ten Asian countries. An overall low level of relative concern toward ethics in science was reported. Lower educational attainment was associated with lower odds of concern. Christian religious affiliation and moderate religious involvement were also associated with lower odds of concern. This article highlights the importance of more active research into social perspectives on ethics in science.     

Research ethics review for the use of anonymized samples and data: A systematic review of normative documents

While the anonymization of biological samples and data may help protect participant privacy, there is still debate over whether this alone is a sufficient safeguard to ensure the ethical conduct of research. The purpose of this systematic review is to examine whether the review of an ethics committee is necessary in the context of anonymized research, and what the considerations in said ethics review would be. The review of normative documents issued by both national and international level organizations reveals a growing concern over the ability of anonymization procedures to prevent against reidentification. This is particularly true in the context of genomic research where genetic material’s uniquely identifying nature along with advances in technology have complicated previous standards of identifiability. Even where individual identities may not be identifiable, there is the risk of group harm that may not be protected by anonymization alone. We conclude that the majority of normative documents support that the review of an ethics committee is necessary to address the concerns associated with the use of anonymized samples and data for research.     

Biomedical Research and the Commercialization Agenda: A Review of main Considerations for Neuroscience

This article reviews a range of issues associated with the commercialization of biomedical research and speculates on how these issues might apply to the neuroscience context. Drawing on existing studies of the impact of research commercialization activities on various areas of biotechnology research, the authors explore normative benchmarks for assessing and resolving issues likely to arise from the commercialization of neuroscientific research, including such topics as patenting, marketing pressures, and representations of research prospects.     

Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia

The review of clinical trials with human participants in Malaysia is governed by a decentralized control system. The clinical trial protocols are reviewed by 13 registered research ethics committees (RECs) in Malaysia. A governmental body, the National Pharmaceutical Control Bureau, is responsible for the inspection and oversight of these registered RECs to ensure that they comply with the regulatory requirements. However, this study highlights that each REC in Malaysia has a different standard operating procedure and ethical review process. Other procedural challenges identified include inadequate membership, poor mechanism for research monitoring after ethical approval, and insufficient resources. Establishments of a national standard of REC and a central ethics committee are suggested to ensure procedural compliance in the oversight of clinical trials in Malaysia. While there is a growing concern that procedural compliance may not have a direct impact on the protection of human subjects, our key point is that an ethical review system compliant with the national standards could serve as a strong framework to support and enhance the ethical quality of decision-making and judgement. We believe that being aware of how influential procedural compliance can be would help committees improve the ethical quality of their research review.     

Dealing with Misconduct in Biomedical Research: A Review of the Problems and the Proposed Methods for Improvement

The increasing complexity of scientific research has been followed by increasing varieties of research misconduct. Dealing with misconduct involves the processes of detection, reporting, and investigation of misconduct. Each of these steps is associated with numerous problems which need to be addressed. Misconduct investigation should not stop with inquiries and disciplinary actions in specific episodes of misconduct. It is necessary to decrease the personal price paid by those who expose misconduct and to protect the personal and professional interests of honest researchers accused of misconduct unfairly or mistakenly. There is no dearth of suggestions to improve the objectivity and fairness of investigations. What is needed is the willingness to test the various options and implement the most suitable ones.     

Validation of the CoRE Questionnaire for a Medical Journal Peer Review

If a peer review instrument asks concrete questions (defined as items that can only generate disagreement if reviewers have different degrees of expertise), then questionnaires could become more meaningful in terms of resolving subjectivity thus leading to more reviewer agreement. A concrete item questionnaire with well-chosen questions can also help resolve disagreement when reviewers have the same level of expertise. We have recently created the core-item reviewer evaluation (CoRE) questionnaire for which decision-threshold score levels have been created, but which have not been validated. This prospective validation of these thresholds for the CoRE questionnaire demonstrated strong agreement between reviewer recommendations and their reported score levels when tested prospectively at Clinical Medicine and Research. We conclude that using the CoRE questionnaire will help reduce peer reviewer disagreement. More importantly, when reviewer expertise varies, editors can more easily detect this and decide which opinion reflects the greater expertise.     

Too Many Rationales,Not Enough Reason: A Call to Examine the Goals of Including Lay Members on Institutional Review Boards

Every major U.S. commission appointed to review Institutional Review Boards (IRBs) as well as numerous reports and scholarly articles have recommended increasing the number of lay (nonscientist and unaffiliated) members on IRBs. Meanwhile, qualitative studies have shown that lay IRB members experience confusion about their roles, including ambiguity whether their roles are different from other members of the board. Without articulating the unique reasons why unaffiliated and nonscientist members are needed, IRBs have little guidance on how to recruit and train these members, and how many should be at the table. By looking back through the history of IRB regulations, policies, and commentaries we can articulate unique contributions these members can make. Only with these contributions in mind can we make arguments for how to best achieve them and make the case that increasing their numbers is necessary.     

Researching Vulnerable Groups: Ethical Issues and the Effective Conduct of Research in Local Authorities

The Data Protection Act 1998 and Research Governance Frameworkfor Health and Social Care (Department of Health, 2003a) havebrought consideration of ethical issues in the conduct of researchinto sharper focus. This paper, based primarily on the authors’experiences of conducting research on children in need and outcomesfor vulnerable children, examines the impact these changes havehad on the research process. The difficulties experienced byresearchers in gaining access to research participants in orderto develop evidence-based policy and practice are explored.Finally, the paper outlines some practical steps that can betaken to facilitate the effective conduct of research.     

Quality and Peer Review of Research: An Adjudicating Role for Editors

Peer review gives research a stamp of approval, but the reviews themselves can be flawed. This is potentially serious for the writer, the journal, and journal user. This study describes shortcomings of the peer review process and condenses them into an explanatory framework involving situational, personal, social, and ethical factors. Some proposals to improve matters are impractical and may make them worse. Some data is offered which illustrates the problem and suggests a potential solution. Informed editors who avoid mechanical approaches engage cautiously and critically with reviews and guard against bias, even in themselves, could make a significant difference.     

Grading Gems: Appraising the Quality of Research for Social Work and Social Care

The impetus towards basing practice and policy decisions moreexplicitly on sound research requires tools to facilitate thesystematic appraisal of the quality of research encompassinga diverse range of methods and designs. Five exemplar toolswere developed and assessed in terms of their usefulness inselecting studies for inclusion in a systematic review. Thewidely used ‘hierarchy of evidence’ was adaptedand used to appraise internal validity. Four tools were thendeveloped to appraise the external validity dimensions of generalizability(two scales) and methods of data collection (two scales). Methodsof combining the scores generated by each tool were explored.Qualitative and quantitative studies were appraised, not separatedinto two spheres but by using complementary tools developedto appraise different aspects of rigour. There was a high levelof agreement between researchers in applying the tools to twenty-twostudies on decision making by professionals about the long-termcare of older people. The scales for internal validity and generalizabilitydiscriminated between the qualities of studies appropriately.The two tools to appraise data collection gave diverse results.Excluding studies that scored in the lowest category on anyscale appeared to be the scoring system that was most justifiable.This approach is presented to stimulate debate about the practicalapplication of the evidence-based initiative to social workand social care. This study may assist in developing clearerdefinitions and common language about appraising rigour thatshould further the process of selecting robust research forsynthesis to inform practice and policy decisions.     

Reforming the Oversight of Multi-Site Clinical Research: A Review of Two Possible Solutions

The current system for the ethical oversight of clinical research suffers from structural, procedural, and performance assessment problems. Initially conceived primarily to handle local investigator-initiated single-site studies, the system of institutionally-based committee review has become progressively more inefficient given the increased prevalence of commercially or federally sponsored multi-center trials. To date, proposed solutions do not adequately address these problems.

Beginning with a review of these structural, procedural, and performance assessment problems, this article will then consider two proposals for addressing these deficiencies: (a) regional ethics organizations; and (b) IRBNet?, a newly developed web-based program for cooperative IRB review. The strengths and weaknesses of these two approaches will be evaluated in light of recent experience with centralized review. The proposal to establish a system of regional ethics organizations presents a comprehensive approach to many of the problems faced by the current system. However, IRBNet? offers an immediate and feasible solution to many of the problems faced by the review of multi-site clinical studies.     

Research as Profession and Practice: Frameworks for Guiding the Responsible Conduct of Research

Programs in the responsible conduct of research (RCR) vary between institutions, demonstrated by disparate structures and goals. These variations may be attributed to the absence of grounding frameworks within which to examine research and RCR education programs. This article examines research as a practice and a profession, using these frames to draw out defining features of research and the moral obligations entailed. Situating research within virtue ethics can clarify how researchers might cultivate the virtues necessary for meeting its obligations and aims. By elucidating these features, these perspectives can serve to guide the development of RCR education programs.     

三十年来北京近代市政建设研究述评

近三十年来,北京近代市政建设问题逐渐为学界所重视并取得了一系列的研究成果,使近代北京城市史的研究不断深化。本文从社会史的视角,对三十年来北京近代市政建设的研究加以总结和梳理,评述了学界在探讨市政建设与城市社会运行、市民生活变迁,以及城市文化演进之间的关系等方面所取得的成果和存在的问题。