Tackling Predatory Journals in Oncology: Training Is Key!

Predatory journal is a global threat endangering the integrity of oncology research, where guidelines and recommendations are evidence-based. In this correspondence, we question regarding the problem while also providing some pertinent solutions.

Conflicts of interest in clinical practice: lessons learned from cardiovascular medicine.

Cardiovascular diseases represent a major burden worldwide, and clinical trials are critical to define treatment improvements. Since various conflicts of interest (COIs) may influence trials at multiple levels, cardiovascular research represents a paradigmatic example to analyze their effects and manage them effectively to re-establish the centrality of evidence-based medicine.Despite the manifest role of industry, COIs may differently affect both sponsored and non-sponsored studies in many ways. COIs influence may start from the research question, data collection and adjudication, up to result reporting, including the spin phenomenon. Outcomes and endpoints (especially composite) choice and definitions also represent potential sources for COIs interference. Since large randomized controlled trials significantly influence international guidelines, thus impacting also clinical practice, their critical assessment for COIs is mandatory. Despite specific protocols aimed to mitigate COI influence, even scientific societies and guideline panels may not be totally free from COIs, negatively affecting their accountability and trustworthiness.Shared rules, awareness of COI mechanisms and transparency with external data access may help promoting evidence-based research and mitigate COIs impact. Managing COIs effectively should preserve public trust in the cardiovascular profession without compromising the positive relationships between investigators and industry.

A transformative solution to build effective, transparent, and resilient "fit-for-purpose" national health research ethics systems.

The current research ethics review systems are composed of isolated institutional Research Ethics Committees (RECs) that develop their own standard operating procedures (SOPs), templates and so on, with low adoption of digital solutions to manage submission and review processes. This poses several challenges, such as delays, higher costs, and hindering multi-site research. We propose an online national research ethics platform that all RECs can use, with common review processes and documentation requirements following national policy. The system will scale up adoption of digital solutions to all RECs. It will reduce administrative burden and harmonize review procedures. It will also obviate the need for separate and isolated interventions such as national REC registries or clinical trial registries, as these can be generated as transactional outputs of the system. The harmonized procedures and possibility of single submission will facilitate multi-site research. Sharing of resources and expertise among RECs on the platform will enhance resilience. An e-EC system developed in India and a Regional Health research portal developed by the WHO South-East Asia office offer proof of concepts to demonstrate the feasibility of developing and using such systems. The proposed solution is ambitious but feasible. Developing the proposed system will be a vital cost-effective investment in national health infrastructure to strengthen the research ecosystem and accelerate delivery of improved healthcare innovations by reducing unnecessary delays in conducting research. To maximize benefits, concurrent efforts are needed to build researchers' capacity and enhance the quality and efficiency of human reviews of the research proposals by REC.

Ethical Considerations for Enrolling "Invested Parties" in Large-Scale Clinical Studies: Insights from the RECOVER Initiative.

Research institutions often lack policies addressing the risks and benefits of enrolling "invested parties" such as investigators, research staff, and patient, caregiver, and community representatives (groups most affected by a disease or intervention) in studies where they have direct involvement. Invested parties may have both strong motivations to study the condition or intervention and to participate as study subjects. More guidance is needed to promote appropriate access to research participation and mitigate potential risks. This article addresses the gap in guidance by presenting an ethical framework and practical guidelines for the enrollment of invested parties. Drawing from experiences with the Researching COVID to Enhance Recovery (RECOVER) Initiative, a large multisite observational cohort study, we argue that invested parties should not be categorically excluded from enrollment in their own research studies if certain criteria are met and appropriate safeguards are in place. We underscore the need to balance inclusion with fairness, promote valid voluntary informed consent, ensure data privacy, protect scientific validity, and mitigate unique risks to invested parties as participants. Additionally, we recommend regular reporting and empirical assessment to evaluate the impact of enrolling invested parties on participants and study outcomes.

How Should Clinician-Researchers Model Regard for Nonhuman Animals Bred for and Used in Human-Centered Science?

If we assume that nonhuman animals experience pain or distress, then ethically justifying human-centered research with only nonhuman animals as subjects likely requires that the research's benefits to humans must, at least, outweigh harms suffered by the nonhuman animals. Yet this reasoning does not seem to account well for the ethical view that nonhuman animals are morally valuable in their own right. This commentary on a case considers this ethical tension and discusses how clinician-researchers should navigate it. This commentary also suggests why clinician-researchers' reasoning about the nature and scope of their obligations to nonhuman animals extends beyond governing regulations and federal oversight, which is silent on or ambiguous about nonhuman animals as morally valuable in their own right.

According to Which Criteria Should We Determine Whether and When IACUCs Are Sufficient for Protecting the Welfare of Nonhuman Animals Used in Research?

Nonhuman animals used in biomedical research frequently suffer and are harmed as part of their use as experimental models. The Institutional Animal Care and Use Committee (IACUC) of a given institution is meant to ensure that research protocols follow federal guidelines, but research protocols such as those described in this case can generate unnecessary suffering; this problem suggests limitations of IACUCs' capacity to protect nonhuman animals' welfare. This commentary on the case considers how to more fully protect nonhuman animals used in scientific research and identifies barriers to more comprehensive protection of nonhuman animals' welfare.

Should Nonhuman Animals Be Recognized Legally as Persons?

This article explores the legal status of nonhuman animals used in biomedical research. While acknowledging that, presently, nonhuman animals in research settings hold no personal legal rights, this article explores what a legal person is and proposes that it is possible for nonhuman animals to become legal persons and receive better protections under the federal Animal Welfare Act.

With What Should We Replace Nonhuman Animals in Biomedical Research Protocols?

Historically, most discussions about nonhuman animal experimentation consider what has become known as the 3 R's: refinement, reduction, and replacement. Refinement and reduction receive the most attention, but recent modeling advances suggest that suitable replacement of nonhuman animal testing would bolster human research and increase translatability to human health outcomes. This article discusses these modeling advances and advocates their use, especially as replacements to nonpredictive nonhuman animal protocols, and discusses growing momentum in biomedical research communities and federal agencies that favors replacement of animal testing.

Which Concepts Are Key to Transitioning From Nonhuman Animal Models to Engineered Microphysiological Systems in Biomedical Research?

A transition from nonhuman animal models to engineered microphysiological systems (MPS), such as organoids and organ-on-a-chip technologies, would signal a paradigm shift in biomedical research. Despite MPS' potential to more accurately model human physiology, reduce high failure rates of drugs in clinical trials, and limit unnecessary animal use, widespread adoption is hampered by public opinion and lack of scalability, standardization, and current regulatory uptake. This article suggests how 5 key concepts (awareness, access, education, application, and rewards) could help address these barriers. These concepts are part of a framework that underscores a need to integrate MPS into mainstream biomedical research and to better promote ethical responsibility for the means of biomedical innovation.

Humanity and Inhumanity of Nonhuman Primate Research.

This illustration depicts important biomedical advancements generated by nonhuman primate (NHP) research. NHPs' value in human-centered research is their unique evolutionary proximity to humans.

Relational responsibilities: Researchers perspective on current and progressive assessment criteria: A focus group study.

INTRODUCTION: The focus on quantitative indicators-number of publications and grants, journal impact factors, Hirsch-index-has become pervasive in research management, funding systems, and research and publication practices (SES). Accountability through performance measurement has become the gold standard to increase productivity and (cost-) efficiency in academia. Scientific careers are strongly shaped by the push to produce more in a veritable 'publish or perish' culture. To this end, we investigated the perspectives of biomedical researchers on responsible assessment criteria that foster responsible conduct of research. METHODS: We performed a qualitative focus group study among 3 University medical centers in the Netherlands. In these centers, we performed 2 randomly selected groups of early career researchers (PhD and postdoc level & senior researchers (associate and full professors) from these 3 institutions and explored how relational responsibilities relate to responsible conduct of research and inquired how potential (formal) assessment criteria could correspond with these responsibilities. RESULTS: In this study we highlighted what is considered responsible research among junior and senior researchers in the Netherlands and how this can be assessed in formal assessment criteria. The participants reflected on responsible research and highlighted several academic responsibilities (such as supervision, collaboration and teaching) that are often overlooked and that are considered a crucial prerequisite for responsible research. As these responsibilities pertain to intercollegiate relations, we henceforth refer to them as relational. After our systematic analysis of these relational responsibilities, participants suggested some ideas to improve current assessment criteria. We focused on how these duties can be reflected in multidimensional, concrete and sustainable assessment criteria. Focus group participants emphasized the importance of assessing team science (both individual as collective), suggested the use of a narrative in researcher assessment and valued the use of 360 degrees assessment of researchers. Participants believed that these alternative assessments, centered on relational responsibilities, could help in fostering responsible research practices. However, participants stressed that unclarity about the new assessment criteria would only cause more publication stress and insecurity about evaluation of their performance. CONCLUSION: Our study suggests that relational responsibilities should ideally play a more prominent role in future assessment criteria as they correspond with and aspire the practice of responsible research. Our participants gave several suggestions how to make these skills quantifiable and assessable in future assessment criteria. However, the development of these criteria is still in its infancy, implementation can cause uncertainties among those assessed and consequently, future research should focus on how to make these criteria more tangible, concrete and applicable in daily practice to make them applicable to measure and assess responsible research practices in institutions. TRIAL REGISTRATION: Open Science Framework https://osf.io/9tjda/.