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.     

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.     

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).     

Letter to the editor: On plurality and authorship in science

Moffatt argues that the “plurality of distinct accounts of scientific authorship” necessitates caution in attempts to identify unethical authorship practices, and urges that considerations be given to establishing a “single consensus account of authorship.” The revised International Committee of Medical Journal Editors (ICMJE) criteria do capture the essential features of authorship in terms of “intellectual contribution” and “responsibility and accountability,” which would clearly demarcate academically legitimate authorship from the common misdemeanors of ghost writing and honorary authorship. However, plurality in the practice of science and credit-sharing culture at the ground would likely render universal adoption or compliance of a single consensus account of authorship untenable.     

The role of federal regulations in assuring research integrity

The federal government has a proper interest in research integrity. Regulations have had effects on scientists and institutions; some appear to have been beneficial, such as recent educational efforts; others have augmented bureaucracy and sowed divisiveness. The federal oversight bureaucracy should be subject to the sunset provision.

Participation by the community is essential to the development of effective regulations, but ethical issues should be dealt with by professional standards, not laws. It is argued that the scientific community had begun to respond to public concerns when change was accelerated by regulation, and that change from within is most effective.     

Giving Voice to Research Participants: Should IRBs Hear From Research Participant Representatives?

The current decision-making model for the review of human research contains inadequate mechanisms to ensure that the interests and perspectives of research participants are considered by Institutional Review Boards, whose decisions may profoundly affect the safety and well-being of participants. As a result, this model is far from being optimized to realize Institutional Review Boards' principal mandate and undermines the credibility of the research review process. This article proposes a procedural mechanism that would ameliorate these systemic deficiencies by allowing “research participant representatives” to give voice to participants during the research review process.     

Ideological Expectations for Value Consensus in Chinese Society

Surveys have shown that popular ideology has tended to move from pluralism to clustering around dualism at this sensitive and critical moment for the formation of value consensus in contemporary China. The formation of a “value consensus” or “common values” must answer three questions: “What is ‘common’ about this consensus?” How can ‘consensus’ be reached?” “How can ‘values’ be legitimated?” On the basis of survey information, this paper presents the basic argument that what is common lies in ethics; consensus in spirit; and value legitimacy in our national cultural home. Ordinary people have three major ideological expectations of value consensus in contemporary China: expectation of ethical enlightenment with the theme of turning “I” into “we”; expectation of a spiritual baptism with the value “unity of the individual and the universal” and expectation of the endeavor to “return home.” Specifically, their content is as follows: to protect ethical existence and undertake the re- enlightenment of ethical consciousness at the national, family and group levels; to sublate “atomistic exploration” of the theory and mode of rationalistic ethics and carry out the “spiritual’ construction of the three great ethical entities of society, state and family; and to “go back home” to national cultural traditions and ethics and build value legitimacy. These three major expectations can be condensed into three ideas: protecting ethics, reviving “spirit” and going back “home.”     

Can self-regulation deliver an ethical commercial literature? A critical reading of the “Good Publication Practice” (GPP3) guidelines for industry-financed medical journal articles

Much medical journal literature is developed by the pharmaceutical and device industries, sometimes with assistance from marketing agencies, writers, and academics. This literature is vulnerable to commercial bias. The publications trade issues self-regulatory ethical guidelines for its production, called “Good Publication Practice” (GPP). I evaluated the most recent iteration, GPP3. The most progressive recommendations in GPP3 call for complete publication of all clinical trials, and full data sharing. GPP3 makes numerous further recommendations more directly concerning the publications trade. Many of these repeat existing editorial requirements, chiefly those of the International Committee of Medical Journal Editors, but readers are not adequately advised of this. Despite its emphasis on ethical and transparent reporting, the detail of GPP3 enables continued use of academic medical literature for drug marketing, on the basis of commercial steerage of content, coupled with the attribution of published articles to collaborating academic authors. As such, GPP3 provides a de facto manual for how marketing through academic journal content can be conducted in compliance with contemporary editorial standards. Consequently, the self-regulatory GPP3 guidelines are not a sound basis for the production of unbiased industry-financed medical journal literature. I suggest improvements for future iterations of these influential guidelines.     

Revisiting demand,politicization and externalization in authoritarian political regimes: policy advisory system in Russian practices

ABSTRACT

This study contributes to debate on three related questions in Policy Advisory System research. Is the Policy Advisory System concept applicable in countries other than developed democracies? How does it function in a state-centred authoritarian regime? How does the authoritarian environment affect tendencies such as “politicization” and “externalization”? These questions are addressed using materials on the current Russian governance structure and advisory practices, focusing on two broadly defined “governance subsystems” in the Presidential Administration of Russia, “Political Bloc” and “Economic Bloc”, both acting as regular customers for advisory communities. One finding is the phenomenon of “Dual Demand” from the same centre of power—“stability” for “Political Bloc” and “innovation” for “Economic Bloc”—which contributed to creation of two different clusters of policy advisory agencies with different statuses. Other findings include transformation of “politicization” to policy control mechanisms and attempted “externalization” turning into the reverse—“internalization”—bringing independent advisory organizations under the supervision of government structures.     

Toward increased public representation on bioethics committees: Lessons from Judging the cold war human radiation experiments∗

The process of judging the Cold War Human Radiation Experiments illuminates a need to develop a model for an appropriate public role on bioethics committees. A citizen representative was appointed to the President's Advisory Committee on Human Radiation Experiments, and the Committee solicited broad public participation in their investigation. However, many members of the affected and interested public desired further representation on the Committee, as they tended towards stronger ethical condemnations of the experiments than the Committee expressed. I offer an account of a testimony before the Committee by a radiation experiment subject's survivor to illustrate this contrast in moral perspective. I consider some the contributions that “non‐expert”; public members can add to committee deliberations, and suggest that concerns about public representatives may be overcome with the guidance of clearer principles for selecting public members. Further efforts to increase membership by the general and affected public on bioethics committees will enhance deliberations and help realize the democratic ideals of bioethics.     

'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.     

Malaysian researchers talk about the influence of culture on research misconduct in higher learning institutions

Based on a previous survey by the Office of Research Integrity (ORI) in the USA, a considerable number of foreign research scientists have been found guilty of research misconduct. However, it remains unclear as to whether or not cultural factors really contribute to research misconduct. This study is based on a series of interviews with Malaysian researchers from the local universities regarding their own professional experiences involving working with researchers or research students from different countries or of different nationalities. Most of the researchers interviewed agreed that cultures do shape individual character, which influences the way that such individuals conduct research, their decision-making, and their style of academic writing. Our findings also showed that working culture within the institution also influences research practices, as well as faculty mentorship of the younger generation of researchers. Given the fact such misconduct might be due to a lack of understanding of research or working cultures or practices within the institution, the impact on the scientific community and on society could be destructive. Therefore, it is suggested that the institution has an important role to play in orienting foreign researchers through training, mentoring, and discussion with regard to the “does” and “don’ts” related to research, and to provide them with an awareness of the importance of ethics when it comes to conducting research.     

The nature and quality of engineering research

Engineering is the application oí science to design and development of products intended for useful social purposes. Engineering research consists of a wide variety of activities ranging from study of material properties for possible future application to the testing necessary to establish design parameters or to verify the adequacy of new design concepts. Professors of engineering are generally expected to conduct research, preferably in the “engineering sciences”; (e.g. thermodynamics, metallurgy), to publish their results, and find their own sources of funding. Many private corporations maintain departments of research and development, the findings of which are often proprietary and not subject to peer review. Managers of engineering research projects attempt to assure the quality of their results by “instrumental”; or “organizational”; methods. Instrumental methods assure accuracy in data collection and processing, while organization methods maintain a work environment conducive to creativity and integrity among researchers. Organizational conditions can affect research quality adversely, by giving rise to ethical problems associated with conflicts between corporate interests and those of individuals.     

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.     

Studying democratic innovations: toward a problem-driven approach to case study research

ABSTRACT

Hajer and Wagenaar (2003. Deliberative Policy Analysis: Understanding Governance in the Network Society. Cambridge: Cambridge University Press, xiv, 16) advanced a conception of policy analysis – “Deliberative Policy Analysis” – that “rests on three pillars: interpretation, practice and deliberation.” This form of policy analysis, they argued, supports “more direct, participatory forms of democracy” involving “democratic deliberation on concrete issues” (xv, 29). Since their writing, empirical research on such initiatives – “democratic innovations,” for short – has blossomed. However, while deliberative policy analysis is itself post-positivist in orientation, many researchers bring a (quasi-) positivist orientation to their work on democratic innovations. A key challenge for deliberative policy analysts is, then, how to participate in this field of inquiry while maintaining a post-positivist orientation. Pragmatist philosophy, I submit, can help them to meet this challenge. Pragmatism rejects a number of positivist assumptions about the nature of empirical inquiry. Relatedly, it supports the claim that policy analysis should be interpretive, practice-oriented, and deliberative. Indeed, it suggests that policy analysis cannot avoid being so. By way of illustration, I indicate how pragmatism points to an approach to case study research that rests on the three pillars.     

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.     

From fun to fraught: marketing to kids and regulating “risky foods” in Canada

ABSTRACT

In an era of industrialized food production, ultra-processed foods, “Big Food” marketing, and growing obesity rates, food has come to be framed as an object of risk – and as an object of regulation. Such reframing has fascinating implications related to issues of responsibility and decision making, especially when it comes to children’s food. This article probes the relationship between representation, regulation and “risky” consumption with respect to children’s food. I examine how child-targeted foods become framed as “risky” and what counts as “risky” food messaging under Health Canada’s commitment to restrict the marketing of unhealthy foods to children. Detailing the tension between food as a risk object and food as a child object, I suggest how issues of semantic provisioning and the politics of the unseen work to complicate and destabilize the (seemingly) straightforward process of prohibiting unhealthy food marketing to children.     

National,independent oversight: Reinforcing the safety net for human subjects research*

National, independent oversight is vital to resolve the problems and inconsistencies in oversight of human subjects research. Three key functions that must be considered in any proposal for such a mechanism are (1) issue spotting, (2) guidance on identified issues, and (3) sampling and follow‐up. The 1998 report and recommendations of the National Bioethics Advisory Commission concerning research involving persons with mental disorders that may affect decisionmaking capacity address these functions in part, but application is limited to a small segment of the research population. Incorporation of these three key functions in a formal, national, independent oversight process is necessary in order to ensure accountability and maintain public trust in research.     

Research Misconduct Definitions Adopted by U.S. Research Institutions

In 2000, the U.S. federal government adopted a uniform definition of research misconduct as fabrication, falsification, or plagiarism (FFP), which became effective in 2001. Institutions must apply this definition of misconduct to federally-funded research to receive funding. While institutions are free to adopt definitions of misconduct that go beyond the federal standard, it is not known how many do. We analyzed misconduct policies from 183 U.S. research institutions and coded them according to thirteen different types of behavior mentioned in the misconduct definition. We also obtained data on the institution’s total research funding and public vs. private status, and the year it adopted the definition. We found that more than half (59%) of the institutions in our sample had misconduct policies that went beyond the federal standard. Other than FFP, the most common behaviors included in definitions were “other serious deviations” (45.4%), “significant or material violations of regulations” (23.0%), “misuse of confidential information” (15.8%), “misconduct related to misconduct” (14.8%), “unethical authorship other than plagiarism” (14.2%), “other deception involving data manipulation” (13.1%), and “misappropriation of property/theft” (10.4%). Significantly more definitions adopted in 2001 or later went beyond the federal standard than those adopted before 2001 (73.2% vs. 26.8%), and significantly more definitions adopted by institutions in the lower quartile of total research funding went beyond the federal standard than those adopted by institutions in the upper quartiles. Public vs. private status was not significantly associated with going beyond the federal standard.