Search

Copyright of Dinbilimleri Journal is the property of Dinbilimleri Journal and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s, international regulatory frameworks defined the paediatric population as vulnerable due to unaddressed public health needs. More recently, ethical recommendations have promoted the active engagement of minors as research partners. In this paper, I adopt a post-structuralist approach to policy analysis to examine deep-seated assumptions and presuppositions underlying the changes in the problematisation of children as biomedical research participants over time. While biomedical research ethics focuses on the autonomy and vulnerability of minors, ethical guidelines are situated in specific sociocultural contexts, shaped, among other things, by contingent public health needs and changing conceptions of the value of research and science for society. In the process, I demonstrate the challenge of moving away from an approach that in taking adults as the model overshadows the complexity of children's lived experiences as well as their personal, cultural, and social lives. The lack of acknowledgement of this complexity makes children vulnerable to epistemic injustice, which is particularly crucial to address in public involvement initiatives. [ABSTRACT FROM AUTHOR]

Background. The assessed reproduction technologies (ART) often involve a range of controversial ethical and legal issues that are inspiring for research. Purpose. Comprehensive study on ways to use certain types of technologies. Materials. This paper provides with research of a legal framework of the ART based on the legislation of 13 Muslim countries: Oman, Saudi Arabia, Bahrain, Morocco, Jordan, the UAE, Malaysia, Iran, Lebanon, Egypt, Algeria, Tunisia and Turkey. Results. Due to a range of religious, ethical, legal and social reasons access to the ART was prohibited, but in recent decades mujtahids and fakihs have come to conclusion that for the sake of national prosperity and sustainable development of the ummah medically assisted reproduction may be permissible under certain conditions and must be regulated by laws and correspond to fatwas. The limits of usage of certain technologies have common tendency in gulf countries and the Northern Africa. Nevertheless, some other Muslim countries (e.g., Iran and Malaysia) address this issue in a more detailed and open-minded way. Conclusion. Although there’re legal mechanisms and tools for a broader interpretation and a wider interpretation despite critical opinion of theologies and restricted nature of so-called «gates of al-ijtihad», because they are based on established years ago institutes an, in fact, don’t contradict the foundations of Qur’an and Sunnah. However, features of Muslim law remain.

Background: The impetus for policies promoting medical data sharing in China has gained significant traction. Nonetheless, the present legal and ethical framework governing the research use of medical data in China, is characterized by a more restrictive rather than permissive approach. The proportion of Chinese medical data being leveraged for scientific research still has room for improvement at present, indicating a significant untapped potential for advancing medical knowledge and improving healthcare outcomes. Building upon this research, we aim to delve deeper into the challenges researchers encounter in the sharing of medical data through focus group interviews., Methods: We conducted two focus group interviews study with researchers representing diverse disciplines to explore their perspectives on 21 June 2021 and 28 July 2021. A total of seventeen researchers willingly participated in this study, representing various professional backgrounds. Similar codes were merged. Research team discussions were also utilized to select interviewees' statements that were regarded as typical or representative., Results: The respondents demonstrated a strong understanding that medical data should not be disseminated arbitrarily, recognizing the importance of sharing data in compliance with laws. Through the interview, we found that although respondents stressed the importance of careful consideration regarding if and when this information can be responsibly released, none of the respondents raised the issue of necessitating consent from data subjects for the research use of medical data. This observation sharply contrasts with the stringent separate consent provisions for secondary data use outlined in the PIPL., Conclusions: The findings from the focus group studies shed light on researchers' barriers and ethical challenges towards medical data sharing for scientific research, highlighting their deep concern for data security and cautious approach to sharing. The key objectives aimed at facilitating and enabling the reuse of medical data encompass enhancing interoperability, harmonizing data standards, improving data quality, safeguarding privacy, ensuring informed consent, incentivizing patients, and establishing explicit regulations pertaining to data access and utilization., Competing Interests: Declarations Ethical approval and consent to participate This investigation was reviewed and approved by the Health Science Center of Peking University IRB (No IRB00001052-19013). To safeguard the privacy of the respondents, we proactively requested them to mask any identifying characteristics that could potentially lead to recognition. Moreover, all respondents provided informed consent, having received comprehensive written and oral information about the project. This information included details about the objectives and topics of the focus group interviews, the confidentiality measures in place to protect their data, the storage and use of the data for scientific papers and presentations, as well as the option to withdraw from the study at any point without providing a specific reason. Throughout the transcription process, careful consideration was given to protecting the identities of individuals, institutions, and locations involved in the study. Names were changed, and any information that posed a risk of identifying individuals was handled with utmost caution. Consent for publication Not applicable. Competing interests The authors declare no competing interests., (© 2024. The Author(s).)

Internationally, governments and scientists are bound by legal and treaty rights when working with Indigenous nations. These rights include the right of Indigenous people to control the conduct of science with Indigenous nations. Unfortunately, in some cases, individual scientists and scientific teams working with biological and genetic data collected from Indigenous people have not respected these international rights. Here, we argue that the scientific community should understand and acknowledge the historical harms experienced by Indigenous people under the veil of scientific progress (truth) and implement existing standards for ethical conduct of research and sovereign control of data collected within Indigenous communities (reconciliation). Specifically, we outline the rationale for why scientists, scientific journals and research integrity and institutional review boards/ethics committees should adopt, and be held accountable for upholding, current international standards of Indigenous data sovereignty and ethical use of Indigenous biological samples., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Research data mismanagement (RDMM) is a serious threat to accountability, reproducibility, and re-use of data. In a recent article in this journal, it was argued that RDMM can take two forms: intentional research misconduct or unintentional questionable research practice (QRP). I disagree because the scale for severity of consequences of research misbehavior is not bimodal. Furthermore, intentionality is difficult to prove beyond doubt and is only one of many criteria that should be taken into account when deciding on the severity of a breach of research integrity and whether a sanction is justified. Making a distinction between RDMM that is research misconduct and RDMM which not puts too much emphasis on intentionality and sanctioning. The focus should rather be on improving data management practices by preventive actions, in which research institutions should take a leading role.

The COVID-19 pandemic forced Principal Investigators (PIs) to make rapid and unprecedented decisions about ongoing research projects and research teams. Confronted with vague or shifting guidance from institutional administrators and public health officials, PIs nonetheless had to decide whether their projects were "essential," who could conduct on-site "essential" research, how to continue research activities by remote means if possible, and how to safely and effectively manage personnel during the crisis. Based on both narrative comments from a federally sponsored survey of over a thousand NIH- and NSF-funded PIs and their personnel, as well as follow-up interviews with over 60 survey participants, this study examines various ways PI and institutional decisions raised issues of procedural and distributive fairness. These fairness issues include the challenge of treating research personnel fairly in light of their disparate personal circumstances and inconsistent enforcement of COVID-19-related directives. Our findings highlight aspects of fairness and equitability that all PIs and research administrators should keep in mind for when future research disruptions occur.

Serious and continuing research noncompliance and integrity violations undermine the quality of research and trust in science. When researchers engage in these behaviors, institutional officials (IOs) often develop corrective action plans. Ideally, such plans address the root causes so noncompliance or research integrity violations discontinue. The aim of this study was to identify what IOs perceive as causes and action plan activities typically prescribed. We conducted semi-structured in-depth interviews with 47 IOs at research institutions across the U.S. including: institutional review board and institutional animal care and use committee chairs and directors, chief research officers, research compliance and integrity officers, and institutional conflicts of interest chairs and directors. The most common root causes identified were: 1) lack of knowledge or training, 2) failure to provide research team supervision, and 3) researcher attitudes toward compliance. The most common action plan activities include: 1) retraining in compliance or research integrity, 2) follow-up and hands-on involvement with the researcher, and 3) mandated oversight or mentoring. Because the most commonly identified action plan activities fail to adequately address the majority of root causes, our findings suggest a need for IOs to rethink existing approaches to action plan development to more effectively target root causes.

The words integrity, ethics, and governance are used interchangeably in relation to research. This masks important differences that must be understood when trying to address concerns regarding research culture. While progress has been made in identifying negative aspects of research culture (such as inequalities in hiring/promotion, perverse incentives, etc.) and practical issues that lead to research waste (outcome reporting bias, reproducibility, etc.), the responsibility for addressing these problems can be unclear due to the complexity of the research environment. One solution is to provide a clearer distinction between the perspectives of "Research Integrity," "Research Ethics," and "Research Governance." Here, it is proposed that Research Integrity should be understood as focused on the character of researchers, and consequently the responsibility for promoting it lies primarily with researchers themselves. This is a different perspective from Research Ethics, which is focused on judgments on the ethical acceptability of research, and should primarily be the responsibility of research ethics committees, often including input from the public as well as the research community. Finally, Research Governance focuses on legal and policy requirements, and although complementary to research integrity and ethics, is primarily the responsibility of expert research support officers with the skills and experience to address technical compliance.

Institutions are increasingly employing algorithms to provide performance feedback to individuals by tracking productivity, conducting performance appraisals, and developing improvement plans, compared to traditional human managers. However, this shift has provoked considerable debate over the effectiveness and fairness of algorithmic feedback. This study investigates the effects of negative performance feedback (NPF) on the attitudes, cognition and behavior of medical researchers, comparing NPF from algorithms versus humans. Two scenario-based experimental studies were conducted with a total sample of 660 medical researchers (algorithm group: N1 = 411; human group: N2 = 249). Study 1 analyzes the differences in scientific misconduct, moral disengagement, and algorithmic attitudes between the two sources of NPF. The findings reveal that NPF from algorithms shows higher levels of moral disengagement, scientific misconduct, and negative attitudes towards algorithms compared to NPF from humans. Study 2, grounded in trait activation theory, investigates how NPF from algorithms triggers individual's egoism and algorithm aversion, potentially leading to moral disengagement and scientific misconduct. Results indicate that algorithm aversion triggers individuals' egoism, and their interaction enhances moral disengagement, which in turn leads to increased scientific misconduct among researchers. This relationship is also moderated by algorithmic transparency. The study concludes that while algorithms can streamline performance evaluations, they pose significant risks to scientific misconduct of researchers if not properly designed. These findings extend our understanding of NPF by highlighting the emotional and cognitive challenges algorithms face in decision-making processes, while also underscoring the importance of balancing technological efficiency with moral considerations to promote a healthy research environment. Moreover, managerial implications include integrating human oversight in algorithmic NPF processes and enhancing transparency and fairness to mitigate negative impacts on medical researchers' attitudes and behaviors., (© 2024. The Author(s).)

'Ethics first' reform in China significantly changes the governance framework for the research of emerging technologies. The misapplication of human genome editing technology reflects the urgent need to reform the governance framework. Strengthening ethics governance in medical research has become a consensus in China, where legal and ethical reforms are proceeding in parallel. The protection of human dignity, the prevention of biosafety risks, as well as the regulation of technological crimes are at the core of the legal system, which has been embodied in numerous fundamental legislations following the CRISPR-babies incident. Establishing a national ethics committee to coordinate ethics governance, and reinforcing ethics review and external oversight are significant steps in ethical reform. Essentially, ethics governance requires implementing the basic concept of 'ethics first', focusing on forward-looking and preventive governance rather than delayed intervention, while maintaining openness and collaboration., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

The Code of Health and Disability Services Consumers' Rights (the Code)1 and the Health and Disability Commissioner Act (the Act)2 are up for review. The Code currently applies to clinical care, teaching and research. When it was introduced, there were no national mechanisms to govern research, but since then the National Ethics Advisory Committee (NEAC) has developed detailed guidelines and established a network of ethics committees at various institutional levels. As currently written, the Code prohibits research on a patient who lacks capacity unless it is in their "best interests." This precludes some important research. The NEAC guidelines are more nuanced and measured, designed to balance the risks to the patient with the benefits to the community. We argue that the Code and the Act should be amended to allow decisions about research proposals on people who lack capacity to be made by an ethics committee set up by NEAC., Competing Interests: Ben Gray and Angela Ballantyne are not and have not been members of the National Ethics Advisory Committee., (© PMA.)

The working group set up by the SEAP-IAP addresses in this Part II some general considerations and five particular considerations to be taken into account when a biological sample of human origin, coming from our archives, acquires a different destination from the usual one, in this case for research. From this moment on, we must follow mandatory legal and ethical rules, and the different recitals provide us with guidelines to ensure good practice, both for biological material and its associated data. The traditional task of custody given to the Pathological Anatomy is approached, as always, from the point of view of responsibility and, in this article, adjusted to its time., (Copyright © 2024 Sociedad Española de Anatomía Patológica. All rights reserved.)

This article reviews the implementation challenges to the American Society of Clinical Oncology's ethical framework for including research biopsies in oncology clinical trials. The primary challenges to implementation relate to the definitions of secondary endpoints, the scientific and regulatory framework, and the incentive structure that encourages inclusion of biopsies. Principles of research stewardship require that the clinical trials community correctly articulate the scientific goals of any research biopsies, especially those that are required for the patient to enroll on a trial and receive an investigational agent. Furthermore, it is important to sufficiently justify the characterization of secondary (as distinguished from exploratory) endpoints, protect the interest of research participants, and report accurate and complete information to ClinicalTrials.gov and the published literature., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: L.A.L. and E.G.-M. declare no potential conflicts of interest. J.P.—GSK, employment (spouse). M.J.R.—Stock and Other Ownership Interests: SAB Biotherapeutics; Honoraria: Emerson Lake Safety; Consulting or Advisory Role: Aptevo Therapeutics, Apotex, Genentech, Arvinas, Ayala Pharmaceuticals, Oncovalent Therapeutics, EQRx, Bluebird Bio, Bayer, Cantex Pharmaceuticals, Eagle Pharmaceuticals, and EMD Serono; Research Funding: AbbVie (Inst), Genentech/Roche (Inst), Xencor (Inst), Corvus Pharmaceuticals (Inst), Bristol Myers Squibb (Inst), Incyte (Inst); Patents, Royalties, Other Intellectual Property: Royalties related to UGT1A1 genotyping for irinotecan, royalties related to UGT1A1 genotyping for irinotecan (Inst), Provisional patent application for method of treating viral pneumonitis with low-dose tocilizumab (Inst); Expert Testimony: Multiple generic companies (defendants in patent litigation); Other Relationship: Credit Suisse, Optimal Cancer Care Alliance (OCCA), and William Blair.

In this paper, we explore how the concepts of autonomy and autonomous choice are understood in the context of spinal cord injury in the academic literature, both in reporting on research results and more broadly on outcomes and quality of life. We find inconsistent, framework-absent portrayals of autonomy as well as an absence of discourse that draws upon ethical constructs and theory. In response, we advance a person-centered framework for spinal cord injury research that combines both lived experience and a disability ethics approach to fill this gap., (© 2024 The Authors. PM&R published by Wiley Periodicals LLC on behalf of American Academy of Physical Medicine and Rehabilitation.)

This study investigated the ethical landscape of aging research amid the increasing global focus on extending the human lifespan and health span. Our global survey of 180 researchers across 38 jurisdictions revealed divergent perceptions of aging, a consensus regarding the feasibility of delaying aging, and multiple perspectives regarding lifespan extension. The present findings underscore a paradigm shift toward inclusive and ethically sound research, emphasizing the need for an approach that strikes a balance between basic and clinical research. In addition, this study highlighted key ethical concerns in aging research, including the effects of misleading advertising, potential inequality in access to aging interventions, and risks pertaining to the extrapolation of research findings from lower-model organisms to humans. The insights presented in this paper call for an integrated approach for overcoming the complex ethical and societal challenges in aging research to ensure responsible and equitable advancements in this burgeoning field., (© 2024. Science China Press.)

A novel advantage of the use of machine learning (ML) systems in medicine is their potential to continue learning from new data after implementation in clinical practice. To date, considerations of the ethical questions raised by the design and use of adaptive machine learning systems in medicine have, for the most part, been confined to discussion of the so-called "update problem," which concerns how regulators should approach systems whose performance and parameters continue to change even after they have received regulatory approval. In this paper, we draw attention to a prior ethical question: whether the continuous learning that will occur in such systems after their initial deployment should be classified, and regulated, as medical research? We argue that there is a strong prima facie case that the use of continuous learning in medical ML systems should be categorized, and regulated, as research and that individuals whose treatment involves such systems should be treated as research subjects.

Academic global surgery consists of collaborative partnerships that address surgical inequities through research, training, education, advocacy, and diplomacy. It has been characterized by increased scholastic production through global surgery publications, dedicated global surgery sessions within scientific conferences, global surgery-specific research grants, database development to support global surgery research, global surgery research fellowships, and global surgery-based academic promotion paradigms. The increased emphasis on global surgery research has been accompanied by multiple ethical challenges. This article reviews critical ethical dilemmas presented by global surgery research efforts and proposes interventions on the partnership, infrastructural, and policy levels to enhance fidelity within research partnerships., (Copyright © 2024 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Health-related innovation in biotechnology requires anticipating potential bioethical implications. In this article, we present a strategy to embed ethics in a group of early-stage researchers performing research in gene therapy and regenerative medicine in the laboratory phase. We conducted a series of focus group meetings with early-stage researchers who work in biotechnology laboratories. The objective was to reflect on the bioethical challenges of their own work and to promote the integration of research ethics with laboratory practice. The activity was assessed with questionnaires completed by the researchers before and after the meetings, and the analyses of the focus groups' content. As a result of the focus group series, all participants changed their perspectives about ethical issues regarding their planned research, developed the ability to reflect and debate on research ethics and had increased awareness of ethical issues in their own research activities. Half of them made changes in their research work. The study provides a concrete strategy to embed ethics and to strengthen responsibility in laboratory research. It is a strategy that allows to perform ethics reflection "on site" and in "real time" and complements the classic strategy of ethics assessment of the research protocol before starting the research procedure.

People with disorders of consciousness (DoC) are characteristically unable to synchronously participate in decision-making about clinical care or research. The inability to self-advocate exacerbates preexisting socioeconomic and geographic disparities, which include the wide variability observed across individuals, hospitals, and countries in access to acute care, expertise, and sophisticated diagnostic, prognostic, and therapeutic interventions. Concerns about equity for people with DoC are particularly notable when they lack a surrogate decision-maker (legally referred to as "unrepresented" or "unbefriended"). Decisions about both short-term and long-term life-sustaining treatment typically rely on neuroprognostication and individual patient preferences that carry additional ethical considerations for people with DoC, as even individuals with well thought out advance directives cannot anticipate every possible situation to guide such decisions. Further challenges exist with the inclusion of people with DoC in research because consent must be completed (in most circumstances) through a surrogate, which excludes those who are unrepresented and may discourage investigators from exploring questions related to this population. In this article, the Curing Coma Campaign Ethics Working Group reviews equity considerations in clinical care and research involving persons with DoC in the following domains: (1) access to acute care and expertise, (2) access to diagnostics and therapeutics, (3) neuroprognostication, (4) medical decision-making for unrepresented people, (5) end-of-life decision-making, (6) access to postacute rehabilitative care, (7) access to research, (8) inclusion of unrepresented people in research, and (9) remuneration and reciprocity for research participation. The goal of this discussion is to advance equitable, harmonized, guideline-directed, and goal-concordant care for people with DoC of all backgrounds worldwide, prioritizing the ethical standards of respect for autonomy, beneficence, and justice. Although the focus of this evaluation is on people with DoC, much of the discussion can be extrapolated to other critically ill persons worldwide., (© 2024. Springer Science+Business Media, LLC, part of Springer Nature and Neurocritical Care Society.)

Background: The growing diffusion of artificial intelligence, data science and digital health has highlighted the role of collection of data and biological samples, thus raising legal and ethical concerns regarding its use and dissemination. Further, the expansion of biobanking, from the basic collection of frozen specimens to the virtual biobanks of specimens and associated data that exist today, has given a revolutionary potential on healthcare systems, particularly in the field of neurological diseases, due to the inaccessibility of central nervous system and the need of non-invasive investigation approaches. Informed Consent (IC) is considered mandatory in all research studies and specimen collections, and must specifically take into account the ethical respect to the individuals to whom the used biological material and data belong., Methods: We evaluated the attitudes of patients with neurological diseases (NP) and healthy volunteers (HV) towards the donation of biological samples to a biobank for future research studies on neurological diseases, and limitations on the use of data, related to the requirements set by the General Data Protection Regulation (GDPR). The study involved a total of 1454 subjects, including 502 HVs and 952 NPs, recruited at Santa Lucia Foundation IRCCS, Rome, from 2020 to 2024., Results: We found that (i) almost all subjects agreed with the participation in biobanking (ii) and authorization to genetic studies (HV = 99.1%; NP = 98.3%); Regarding the return of results, (iii) we found a statistically significant difference between NP and HV, the latter preferring not to be informed of potential results (HV = 43%; NP = 11.3%; p < 0.0001); (iv) a small number limited the sharing inside European Union (EU) (HV = 4.6%; NP = 6.6%), whereas patients were more likely to refuse transfer outside EU (HV = 7.4%; NP = 10.7% p = 0.05); (v) nearly all patients agreed with the use of additional health data from EMR for research purposes (98.9%)., Conclusions: Consent for the donation of material for research purposes is crucial for biobanking and biomedical research studies that use biological material of human origin. Here, we have shown that choices regarding participation in a neurological biobank can be different between HVs and NPs, even if the benefit for research and scientific progress is recognized. NP have a strong interest in being informed of possible results but limit sharing of samples, highlighting a perception of greater individual or relative benefit, while HV prefer a wide dissemination and sharing of data but not to have the return of the results, favoring a possible benefit for society and knowledge. The results underline the need to carefully manage biological material and data collected in biobanks, in compliance with the GDPR and the specific requests of donors., (© 2024. The Author(s).)

Competing Interests: None declared.

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., (© 2024. The Author(s).)

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/., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Tijdink et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

The Willowbrook Hepatitis Study is one of the best-known examples of unethical medical research, but the research has always had defenders. One of the more intriguing defenses continually used was that critics did not know the researchers on the study and, therefore, could not assess their ethics. This essay traces the appeal to the researchers' characters across published research and archival sources from the 1960s through today. These appeals reflect the observation as old as Aristotle that one of the most potent modes of persuasion is ethos or character. The specific types of character in these appeals develop out of the paternalistic nature of clinical and research practice in the mid-twentieth century. If the individual physician is the locus of medical judgment, then the physician's character becomes a key concern for bioethics. These appeals still appear and have implications for bioethics in the present day., (© The Author(s) 2024. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

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., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

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., (© 2024 The Authors. Ethics & Human Research, published by Wiley Periodicals LLC on behalf of The Hastings Center.)

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., (Copyright 2024 American Medical Association. All Rights Reserved.)

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., (Copyright 2024 American Medical Association. All Rights Reserved.)

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., (Copyright 2024 American Medical Association. All Rights Reserved.)

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., (Copyright 2024 American Medical Association. All Rights Reserved.)

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., (Copyright 2024 American Medical Association. All Rights Reserved.)

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., (Copyright 2024 American Medical Association. All Rights Reserved.)

Biobanks' activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first-hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four-step checklist aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU., (© 2023 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.)

Research ethics committees (RECs) have played a crucial role in expediting the review of research protocols amidst the COVID-19 pandemic. To improve their performance and identify areas of enhancement, a multicentric study was conducted in India by the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP). The study aimed to evaluate the preparedness of Indian RECs during the COVID-19 outbreak while conducting protocol reviews and comprehend the challenges they encountered. After obtaining ethics committee approval, a cross-sectional observational study was conducted using two validated questionnaires, one for REC member secretaries/chairpersons and another for REC members. The questionnaires consisted of 13 multiple-choice questions, 10 yes or no questions, and 2 open-ended questions each. The study was distributed to multiple RECs. A total of 109/200 participants, including 13 REC member secretaries, 12 chairpersons and 84 REC members from a total of 34 REC's, consented to participate in the study. During the COVID-19 pandemic, 23/25 (92%) of the RECs conducted online meetings. The most common challenges faced by RECs included risk-benefit analysis (12/25 RECs), review of informed consent (12/25 RECs), and protocols involving vulnerable populations (10/25 RECs). 65% of the REC members reported the need for ethics review training, and 66/84 REC members agreed or strongly agreed that RECs require training in COVID-19 protocol review. Additionally, 62/84 REC members agreed or strongly agreed that central/joint RECs should review multicenter COVID-19 protocols. RECs in India encountered difficulties while reviewing risk-benefit analyses, informed consent documents (ICDs), and COVID-19 protocols and they suggested providing training on these topics., (© 2023 John Wiley & Sons Ltd.)

We advocate in this little assay for the concept of active retirement. We feel the need to broadcast our experience to younger professionals. Mentor, Telemachus' advisor in the Odyssey, has evolved greatly into the 21st century. From an ideal point of view, we consider that clinical practice is inextricably linked to research. Within the public health system there is an ethical space for volunteering. Perhaps it is what Anglo-Saxon primary care calls "vocational training"., (Copyright © 2024 SEGG. Publicado por Elsevier España, S.L.U. All rights reserved.)