Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network

PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.     

National Scientific Misconduct Policies in Argentina: Two Definitions of Research Misconduct

ABSTRACT

In “An International Study of Research Misconduct Policies”, Resnik et al. count Argentina in the list of countries without national research misconduct policies. In this paper, we clarify that Argentina has national policies of research misconduct and present the research misconduct definitions of two official science organisms: the National Scientific and Technical Research Council (CONICET) and the Ethics Committee of the Argentine Ministry of Science (MINCyT).     

Person-oriented research ethics: integrating relational and everyday ethics in research

Research ethics is often understood by researchers primarily through the regulatory framework reflected in the research ethics review process. This regulatory understanding does not encompass the range of ethical considerations in research, notably those associated with the relational and everyday aspects of human subject research. In order to support researchers in their effort to adopt a broader lens, this article presents a “person-oriented research ethics” approach. Five practical guideposts of person-oriented research ethics are identified, as follows: (1) respect for holistic personhood; (2) acknowledgement of lived world; (3) individualization; (4) focus on researcher-participant relationships; and (5) empowerment in decision-making. These guideposts are defined and illustrated with respect to different aspects of the research process (e.g., research design, recruitment, data collection). The person-oriented research ethics approach provides a toolkit to individual researchers, research groups, and research institutions in both biomedical and social science research wishing to expand their commitment to ethics in research.     

Why the tolerance of potential harms? Research ethics in Alzheimer disease

This article summarizes the history of presentations to the National Bioethics Advisory Commission (NBAC) by representatives of the Alzheimer's Disease and Related Disorders Association, Inc., on the topic of human subjects research ethics. The interactions between these two bodies presents a useful profile of a public commission and a voluntary association working to clarify issues of great importance to the association's constituency. The context of epidemiology and ongoing research is also briefly presented. The author is a member of the Alzheimer's Disease and Related Disorders Association, Inc., National Ethics Advisory Panel, and in that role presented the Association position before NBAC and at the Friends Research Institute conference.     

Canadian policy on reporting breaches of research integrity: When should Research Ethics Boards be informed?

ABSTRACT

In Canada, institutions that receive research funding from the three federal granting agencies must establish research ethics boards (REBs) to review the ethical acceptability of research involving humans. Institutions are also expected to promote the responsible conduct of research, fostering researchers’ abilities to act with integrity in the conduct of their research. Where a researcher fails to act with integrity in research with humans, institutional policies and procedures of the U15, Canada’s most research-intensive universities, vary in the extent to which they involve their REBs in response to such breaches. Some make no mention of the REB, whereas others state that their REB should be provided with information relating to upheld allegations. In this paper, we argue that when allegations of research integrity breaches are corroborated, the institution’s REB should be identified as a party required to receive that information. Only then can REBs ensure compliance with research ethics standards, which is essential to maintain the public’s trust.     

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.     

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.     

Ethical Beliefs of Social Work Researchers

Abstract

The purpose of this study is to examine the beliefs of social work researchers about ethical practices. Surveys were mailed to a random sample of 240 members of the Society for Social Work and Research (SSWR) to elicit their views about ethical practices in social work research. Responses from 160 members (67% response rate) yielded information regarding the appropriateness of dual relationships, authorship practices, informed consent procedures, and other conduct in social work research. Age, gender, educational level, years of social work research experience, and current teaching of social work research were related to respondents' ethical views about practices with students and sexual relationships with research subjects. The need for additional resources on ethics in social work research is highlighted.     

论中国公共行政伦理的核心任务 ——从"距离悖论"的中国式表现说起

应用伦理学是伦理学的现代发展形式之一,也是最富有生命力的理论前沿,有着重大的现实价值。本期所刊发的四篇文章是国内青年学者近期在应用伦理学的不同领域中所取得的阶段性成果。《市场经济与分配正义》一文重申了分配与生产、交换的同等地位,从社会伦理的角度阐述了分配正义与合理市场经济秩序构建的问题。《论环境伦理学中的整体主义》一文则围绕环境保护的道德责任归属的问题进行了深入分析,指出个体主义和整体主义虽然都有其历史渊源,并且可以部分地解决环境伦理的规范问题,但都缺乏内在的自洽性,这就暴露了环境伦理学作为学科之不成熟性的事实。《论中国公共行政伦理的核心任务》一文探讨了公共行政的一般特性以及在中国的特殊问题,从而揭示了中国公共行政建设的重点所在。《论当代宗教的伦理化趋势》一文考察了全球化视阈下的宗教的新变化,特别是信仰伦理成分的加重使它在今日社会发展中扮演着越来越重要的角色。     

市场经济与分配正义

应用伦理学是伦理学的现代发展形式之一,也是最富有生命力的理论前沿,有着重大的现实价值。本期所刊发的四篇文章是国内青年学者近期在应用伦理学的不同领域中所取得的阶段性成果。《市场经济与分配正义》一文重申了分配与生产、交换的同等地位,从社会伦理的角度阐述了分配正义与合理市场经济秩序构建的问题。《论环境伦理学中的整体主义》一文则围绕环境保护的道德责任归属的问题进行了深入分析,指出个体主义和整体主义虽然都有其历史渊源,并且可以部分地解决环境伦理的规范问题,但都缺乏内在的自洽性,这就暴露了环境伦理学作为学科之不成熟性的事实。《论中国公共行政伦理的核心任务》一文探讨了公共行政的一般特性以及在中国的特殊问题,从而揭示了中国公共行政建设的重点所在。《论当代宗教的伦理化趋势》一文考察了全球化视阈下的宗教的新变化,特别是信仰伦理成分的加重使它在今日社会发展中扮演着越来越重要的角色。     

Disclosure of Unknown Harms in Magnetic Resonance Imaging Research

Unknown harms are by their nature difficult to communicate. While magnetic resonance imaging (MRI) has known risks (e.g., metal projectiles, dislodgement of medical implants), this imaging modality also has potential unknown long-term negative health effects associated with its static magnetic fields. We carried out a research ethics board (REB) file review of previously approved MRI research studies and found that unknown risks were either left undisclosed or were inadequately disclosed to research participants and REBs. This article outlines issues raised by our REB file review and suggests steps that should be taken in order to satisfactorily communicate information about potential unknown harms of MRI.     

Enriching our understanding of vulnerability through the experiences and perspectives of individuals living with mental illness

ABSTRACT

Vulnerability is a central concept in research ethics and typically serves to identify individuals or groups whose participation in research prompts specific concerns or warrants special consideration. While theoretical discussions on vulnerability have contributed valuable insights to discussions of mental health research and care, they have not been enriched thus far by stakeholder perspectives. This oversight has important consequences for the ways in which we frame vulnerability. It misses the far-reaching insights and experiential knowledge of mental health research participants whose experiences this ethics concept ultimately seeks to capture. In view of this gap, our study combines a pragmatist ethics framework and interpretive phenomenological analysis of qualitative interviews to explore user perspectives on the notion of vulnerability through the lived experiences of mental health research participants and patient-advocates. Importantly, these perspectives offer essential clues to address the difficulties of operationalizing concerns for vulnerability in concrete and practical ways. They help refine our understanding of this key ethics concept.     

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.     

Inaction over retractions of identified fraudulent publications: ongoing weakness in the system of scientific self-correction

Published articles may be retracted when their findings are no longer considered reliable due to honest error, publication misconduct, or research misconduct. This article focuses on the case of a single serial violator of research and publication ethics in anesthesiology and critical care, which is widely publicized. A chain of events led to detection of misconduct that had substantial impact on the evidence base for the safety of hydroxyethyl starch, an intravenous artificial colloid solution, which is reflected in current guidelines on fluid management and volume resuscitation. As citations to retracted works continue to be a cause for concern, this article reviews the retraction status of this author’s published articles to determine whether sufficient action has been taken to retract his body of work. Results show that retraction practices are not uniform and that guidelines for retraction are still not being fully implemented, resulting in retractions of insufficient quantity and quality. As retractions continue to emerge for the author’s publications, with ten more since 2011, and as they are generally increasing, these data on retractions not only provide findings of misconduct, but also allow us to make inferences about ongoing weaknesses in the system of scientific literature.     

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.     

Reflexive Research Ethics in Fetal Tissue Xenotransplantation Research

For biomedical research in which the only involvement of the human subject is the provision of tissue or organ samples, a blanket consent, i.e., consent to use the tissue for anything researchers wish to do, is considered by many to be adequate for legal and Institutional Review Board (IRB) requirements. Alternatively, a detailed informed consent provides patients or study participants with more thorough information about the research topic. We document here the beliefs and opinions of the research staff on informed consent and the discussion-based reflexive research ethics process that we employed in our fetal tissue xenotransplantion research on the impact of environmental exposures on fetal development. Reflexive research ethics entails the continued adjustment of research practice according to relational and reflexive understandings of what might be beneficent or harmful. Such reflexivity is not solely an individual endeavor, but rather a collective relationship between all actors in the research process.     

Trends in Domestic and International Social Work Research: A 10-Year Review of American Research Journals

ABSTRACT

This article presents a typology of international social work research and analyzes trends over a 10-year period (1995–2004) based on reviews of 707 articles from three major American social work research journals: Social Work Research, Journal of Social Service Research, and Research on Social Work Practice. The analysis revealed there was a considerable increase (3.5%) in the total amount of research articles, particularly a higher increase in international social work research (2.8%) than national social work research (0.8%). A small decline was detected in transnational comparative research (?0.4%).     

Honesty and method

A client must rely on the integrity of the professional money manager through the stages of the investment process: research, recommendation of specific securities, selection of investments appropriate to the investor, trading of the securities, and reporting of how successful the decisions have been. Throughout this process, the investment manager may be confronted with conflicts of interest. The Association for Investment Management and Research (AIMR) is a nonprofit association of money managers that has developed a code of ethics and standards of professional conduct. Its code contains governing principles; its standards provide the minimum rules of conduct. The AIMR Standards work on the assumption that investors will be adequately protected if the appropriate processes are in place and they provide full disclosure. Since the late 1980s, AIMR has been leading an industry effort to include in the Standards guidelines for presenting a money manager's historical performance.