Multisite Research Ethics Review: Problems and Potential Solutions

ArticleLes essais cliniques multicentriques à grande échelle ont augmenté en fréquence. À l’heure actuelle, un projet de recherche réalisé dans plusieurs institutions nécessite une évaluation éthique pour chaque établissement. Bien que l’évaluation (institutionnelle) locale peut être nécessaire dans certains cas, les évaluations répétitives peuvent nécessiter des changements inutiles et ne servent pas à protéger davantage les participants. Il a été démontré que le fait d’avoir plusieurs évaluations éthiques d’une seule étude retarde la recherche et exige, dans certains cas, des ressources importantes afin de satisfaire aux demandes des différents comités d’éthique. Cette revue de la littérature aborde les questions conceptuelles et présente les recherches empiriques entourant l’évaluation éthique multicentrique de différentes juridictions. Elle aborde également les méthodes alternatives pour rationaliser le processus d’évaluation éthique, y compris l’évaluation réciproque et l’évaluation centralisée, ainsi qu’une proposition de modification du processus d’évaluation centralisé.Large scale, multisite clinical research trials have been increasing in frequency. As it stands currently, a research project performed at multiple institutions requires ethics review at each institution. While local (institutional) review may be necessary in some instances, repetitive reviews may require unnecessary changes and not serve to further protect participants. Multiple ethics reviews of a single study have been shown to delay research and require, in some cases, significant resources in order to fulfill the requests of individual ethics boards. This literature review discusses the conceptual issues and outlines empirical research surrounding multisite ethics review from different jurisdictions, as well as alternative methods to streamline the ethics review process including reciprocal review, centralized review, and a proposed modification to the centralized review process

Authorship ethics in global health research partnerships between researchers from low or middle income countries and high income countries

Background. Over the past two decades, the promotion of collaborative partnerships involving researchers from low and middle income countries with those from high income countries has been a major development in global health research. Ideally, these partnerships would lead to more equitable collaboration including the sharing of research responsibilities and rewards. While collaborative partnership initiatives have shown promise and attracted growing interest, there has been little scholarly debate regarding the fair distribution of authorship credit within these partnerships. Discussion. In this paper, we identify four key authorship issues relevant to global health research and discuss their ethical and practical implications. First, we argue that authorship guidance may not adequately apply to global health research because it requires authors to write or substantially revise the manuscript. Since most journals of international reputation in global health are written in English, this would systematically and unjustly exclude non-English speaking researchers even if they have substantially contributed to the research project. Second, current guidance on authorship order does not address or mitigate unfair practices which can occur in global health research due to power differences between researchers from high and low-middle income countries. It also provides insufficient recognition of “technical tasks” such as local participant recruitment. Third, we consider the potential for real or perceived editorial bias in medical science journals in favour of prominent western researchers, and the risk of promoting misplaced credit and/or prestige authorship. Finally, we explore how diverse cultural practices and expectations regarding authorship may create conflict between researchers from low-middle and high income countries and contribute to unethical authorship practices. To effectively deal with these issues, we suggest: 1) undertaking further empirical and conceptual research regarding authorship in global health research; 2) raising awareness on authorship issues in global health research; and 3) developing specific standards of practice that reflect relevant considerations of authorship in global health research. Summary. Through review of the bioethics and global health literatures, and examination of guidance documents on ethical authorship, we identified a set of issues regarding authorship in collaborative partnerships between researchers from low-middle income countries and high income countries. We propose several recommendations to address these concerns

Prescribing unproven cancer drugs: Physician perspectives on expanded access and right to try

BACKGROUND: For gravely ill patients who have no treatment options and who are ineligible for clinical trials, the US Food and Drug Administration (FDA) established the Expanded Access Program (EAP). Motivated by efforts to weaken FDA regulation and sold as providing greater access to experimental drugs, the federal Right to Try Act (RTT) was passed in 2017. It reduces FDA oversight by not requiring physicians to report safety data and foregoes approval of protocols by local institutional review boards. METHODS: This study explored the views of 17 neuro-oncologists from 15 different academic medical centers with varying experience with EAP and RTT using convenience sampling. We conducted semi-structured interviews and qualitative analysis to identify emerging themes. RESULTS: Most oncologists were confused between the two pathways, had little familiarity with RTT, and had little knowledge about experimental medicine available through either pathway. Oncologists reported a preference of enrolling patients in clinical trials over off-trial preapproval pathways with scant data. As a result, oncologists revealed concerns over properly evaluating risks for their patients. CONCLUSION: Our findings suggest that neuro-oncologists need better resources and clearer mechanisms at their institutions to help navigate EAP and RTT in order to counsel patients interested in experimental medicine

Canada\u27s assisted human reproduction act: Pragmatic reforms in support of research

Canada\u27s Assisted Human Reproduction Act is long overdue for Parliamentary review. We argue that the current regulation of research using human reproductive materials is not proportionate, not responsive to the uncertain threats posed to human and environmental health and safety, and is not considerate of diverse values in a democratic society. We propose tailored regulatory carve-outs for in vitro research for currently prohibited activities, such as gene editing, and for the exercise of Ministerial Discretion for access by Canadians to experimental in vivo interventions that are currently prohibited, such as mitochondrial replacement therapy. Our recommendations are bounded by constitutional constraints that recognize political and practical challenges in keeping oversight of this research under Federal jurisdiction, whether conducted in academic or private sectors. The proposed nuanced regulatory scheme should be overseen by a new national Agency, modeled on a blend of the Canadian Stem Cell Oversight Committee and Assisted Human Reproduction Canada

Professional Regulation: A Potentially Valuable Tool in Responding to “Stem Cell Tourism”

The growing international market for unproven stem cell-based interventions advertised on a direct-to-consumer basis over the internet (“stem cell tourism”) is a source of concern because of the risks it presents to patients as well as their supporters, domestic health care systems, and the stem cell research field. Emerging responses such as public and health provider-focused education and national regulatory efforts are encouraging, but the market continues to grow. Physicians play a number of roles in the stem cell tourism market and, in many jurisdictions, are members of a regulated profession. In this article, we consider the use of professional regulation to address physician involvement in stem cell tourism. Although it is not without its limitations, professional regulation is a potentially valuable tool that can be employed in response to problematic types of physician involvement in the stem cell tourism market

Researchers’ perceptions of ethical authorship distribution in collaborative research teams

Authorship is commonly used as the basis for the measurement of research productivity. It influences career progression and rewards, making it a valued commodity in a competitive scientific environment. To better understand authorship practices amongst collaborative teams, this study surveyed authors on collaborative journal articles published between 2011 and 2015. Of the 8364 respondents, 1408 responded to the final open-ended question, which solicited additional comments or remarks regarding the fair distribution of authorship in research teams. This paper presents the analysis of these comments, categorized into four main themes: (1) disagreements, (2) questionable behavior, (3) external influences regarding authorship, and (4) values promoted by researchers. Results suggest that some respondents find ways to effectively manage disagreements in a collegial fashion. Conversely, others explain how distribution of authorship can become a "blood sport" or a "horror story" which can negatively affect researchers' wellbeing, scientific productivity and integrity. Researchers fear authorship discussions and often try to avoid openly discussing the situation which can strain team interactions. Unethical conduct is more likely to result from deceit, favoritism, and questionable mentorship and may become more egregious when there is constant bullying and discrimination. Although values of collegiality, transparency and fairness were promoted by researchers, rank and need for success often overpowered ethical decision-making. This research provides new insight into contextual specificities related to fair authorship distribution that can be instrumental in developing applicable training tools to identify, prevent, and mitigate authorship disagreement

BioéthiqueOnline : Moving to Peer-Review = BioéthiqueOnline : Passage à l’évaluation par les pairs

Éditoral / Editoria

Health Misinformation and the Power of Narrative Messaging in the Public Sphere

Numerous social, economic and academic pressures can have a negative impact on representations of biomedical research. We review several of the forces playing an increasingly pernicious role in how health and science information is interpreted, shared and used, drawing discussions towards the role of narrative. In turn, we explore how aspects of narrative are used in different social contexts and communication environments, and present creative responses that may help counter the negative trends. As traditional methods of communication have in many ways failed the public, changes in approach are required, including the creative use of narratives