The anti-gender threat: An ethical, democratic, and scientific imperative for NIH research/ers.

Anti-gender campaigns in the United States and globally have promoted policies and legislation that significantly limit bodily autonomy for women, transgender, and nonbinary people. This attack on the human rights of women and gender-diverse communities not only reflects implicit and explicit bias but also detrimentally impacts population health and well-being. We outline the domestic and global rise of anti-gender campaigns and their deep historical connections to broader forms of discrimination and inequality to argue that there is an ethical, democratic, and scientific imperative to more critically center and contextualize gender in health research. While the inclusion of gender as a complex concept in research design, implementation, and dissemination is important, we emphasize that gender inequities must be understood as inextricable from other systems of discrimination and exclusion. To that end, this commentary outlines two actions: for researchers to advance critical approaches to gender as part of a broader landscape of discrimination, and for the US National Institutes of Health to integrate both sex and gender into funded research.

Informed consent of the patient for medical intervention for conducting biomedical research.

OBJECTIVE: Aim: is to find out the peculiarities of informed consent of the patient for medical intervention during biomedical research. PATIENTS AND METHODS: Materials and Methods: The dialectical method was used as a universal and general scientific method, which made it possible to consider the peculiarities of the content of the patient's informed consent. Using the logico-semantic method, the essence and features of biomedical research with the patient's participation were determined. The formal-legal method is used to analyze adaptation processes of biomedical research. System-structural method were applied when comparing the content of the patient's informed consent in separate legislation. The work also used such methods of cognition as comparative-legal, systemic-logical, and logical-legal. CONCLUSION: Conclusions: "Informed consent" includes not only the concept of consent itself, i.e. the free decision of a person, but also an explanation of a specific case or research procedure. And it largely depends on the specialist. Will he be able to convey and explain the patient's problem, illness, actions correctly, fully and in an accessible form? Yes, free consent is given by a person, but the doctor also influences this decision to some extent. Patients' freedom in choosing medical care methods is somewhat limited.

Research on emerging infectious diseases: pros and cons of centralised government controls.

As the world grapples with the constant threat of new pathogens, the role of government oversight in research and response efforts has become a topic of considerable debate in the academic community. In the recently released "SOP [standard operating procedure] for Nipah virus research in Kerala for studies involving human participants / human samples" by the Government of Kerala, the SOP, apart from administrative permission, requires the proposal to be cleared by the Institutional Research Committee at a Government Medical College, and the inclusion of an investigator from a government institution [1]. In these challenging times, it is crucial to weigh the pros and cons of stringent administrative controls to ensure an effective and ethical approach to tackling emerging infectious diseases.

Publish and perish: New issues in publication ethics.

The expression "Publish or perish," first appeared in 1942. It signified the rising importance of publication as a means to obtain research funds and establish a secure academic career. The expression is still highly relevant, but increasingly problematic. Perhaps it should be revised to read "Publish and Perish". We have reached a point where researchers, especially in non-English speaking countries, are no longer able to afford to publish their research. There seems little point in undertaking research if we can no longer disseminate or, indeed, apply the wisdom gained from it.

Nippon Medical School's Ethical Review Processes for Studies Involving Human Subjects.

All life science and medical research involving human subjects must be conducted in compliance with the Declaration of Helsinki and the relevant laws and guidelines. Additionally, its scientific and ethical suitability must be reviewed by a committee well versed in the nature and content of the research. Failure to comply with these requirements when conducting research involving human subjects is a serious violation of Japanese laws, guidelines, and local regulations, so several ethics committees and institutional review boards have been established within the Nippon Medical School (NMS) Foundation and its affiliated institutions. It is essential for investigators to keep up to date with the latest developments in the ethical review process and to ensure that any projects they propose to embark on are subjected to an appropriate ethical review before the research is initiated. To help researchers and other staff affiliated with the NMS Foundation keep abreast of these developments, this report outlines NMS's current ethical review processes for research involving human subjects.

Poxviruses as Agents of Biological Warfare: The Importance of Ensuring Ethical Standards for Research with Viruses.

Historically, biological agents have been used to target various populations. One of the earliest examples could be the catastrophic effect of smallpox in Australia in the eighteenth century (as alleged by some historians). Modern biological techniques can be used to both create or provide protection against various agents of biological warfare. Any microorganism (viruses, bacteria, and fungi) or its toxins can be used as biological agents. Minnesota Department of Health has listed Smallpox (variola major) as a category A bioterrorism agent, even though it has been eradicated in 1980 through an extensive vaccination campaign. Category A agents are considered the highest risk to public health. Laboratory-associated outbreaks of poxviruses could cause unprecedented occupational hazards. Only two WHO-approved BSL-4 facilities in the United States and Russia are allowed to perform research on the variola virus. So, poxviruses present themselves as a classical case of a dual-use dilemma, since research with them can be used for both beneficial and harmful purposes. Although the importance of ethics in scientific research requires no further elaboration, ethical norms assume greater significance during experimentation with poxviruses. In this chapter, we will update the readers on the sensitive nature of conducting research with poxviruses, and how these viruses can be a source of potential biological weapons. Finally, specified ethical guidelines are explored to ensure safe research practices in virology.

Do Physicians Have a Duty to Support Secondary Use of Clinical Data in Biomedical Research? An Inquiry into the Professional Ethics of Physicians.

Secondary use of clinical data in research or learning activities (SeConts) has the potential to improve patient care and biomedical knowledge. Given this potential, the ethical question arises whether physicians have a professional duty to support SeConts. To investigate this question, we analyze prominent international declarations on physicians' professional ethics to determine whether they include duties that can be considered as good reasons for a physicians' professional duty to support SeConts. Next, we examine these documents to identify professional duties that might conflict with a potential duty of physicians to support SeConts.

Ethical guidance for conducting health research with online communities: A scoping review of existing guidance.

Online research methods have grown in popularity due in part to the globalised and far-reaching nature of the internet but also linked to the Covid-19 pandemic whereby restrictions to travel and face to face contact necessitated a shift in methods of research recruitment and data collection. Ethical guidance exists to support researchers in conducting online research, however this is lacking within health fields. This scoping review aims to synthesise formal ethical guidance for applying online methods within health research as well as provide examples of where guidance has been used. A systematic search of literature was conducted, restricted to English language records between 2013 and 2022. Eligibility focused on whether the records were providing ethical guidance or recommendations, were situated or relevant to health disciplines, and involved the use or discussion of online research methods. Following exclusion of ineligible records and duplicate removal, three organisational ethical guidance and 24 research papers were charted and thematically analysed. Four key themes were identified within the guidance documents, 1) consent, 2) confidentiality and privacy, 3) protecting participants from harm and 4) protecting researchers from harm with the research papers describing additional context and understanding around these issues. The review identified that there are currently no specific guidelines aimed at health researchers, with the most cited guidance coming from broader methodological perspectives and disciplines or auxiliary fields. All guidance discussed each of the four key themes within the wider context of sensitive topics and vulnerable populations, areas and issues which are often prominent within health research thus highlighting the need for unifying guidance specific for health researchers. Further research should aim to understand better how online health studies apply ethical principles, to support in informing gaps across both research and guidance.

Advancing primatology through ethical and scientific perspectives on rhesus monkey (Macaca mulatta) cloning.

A critical turning point was reached in research with the recent success in cloning rhesus monkeys (Macaca mulatta), a major advancement in primatology. This breakthrough marks the beginning of a new age in biomedical research, ushered by improved somatic cell nuclear transfer techniques and creative trophoblast replacement strategies. The successful cloning of rhesus monkeys presents the possibility of producing genetically homogeneous models that are highly advantageous for studying complex biological processes, testing drugs, and researching diseases. However, this achievement raises important ethical questions, particularly regarding animal welfare and the broader ramifications of primate cloning. Approaching the future of primate research with balance is critical, as the scientific world stands on the brink of these revolutionary breakthroughs. This paper aims to summarise the consequences, ethical challenges and possible paths forward in primatology arising from rhesus monkey cloning.

Global health reciprocal innovation: ethical, legal and regulatory considerations.

Global health reciprocal innovation (GHRI) is a recent and more formalised approach to conducting research that recognises and develops innovations (eg, medicines, devices, methodologies) from low- and middle-income countries (LMICs). At present, studies using GHRI most commonly adapt innovations from LMICs for use in high-income countries (HICs), although some develop innovations in LMICs and HICs. In this paper, we propose that GHRI implicitly makes two ethical commitments: (1) to promote health innovations from LMICs, especially in HICs, and (2) to conduct studies on health innovations from LMICs in equitable partnerships between investigators in LMICs and HICs. We argue that these commitments take a significant step towards a more equal global health research enterprise while helping to ensure that populations and investigators in LMICs receive equitable benefits from studies using GHRI. However, studies using GHRI can raise potential ethical concerns and face legal and regulatory barriers. We propose ethical, legal and regulatory considerations to help address these concerns and barriers. We hope our recommendations will allow GHRI to move the global health research enterprise forward into an era where all people are treated equally as knowers and learners, while populations in both LMICs and HICs benefit equitably from studies using GHRI.

Accounting for future populations in health research.

The research we fund today will improve the health of people who will live tomorrow. But future people will not all benefit equally: decisions we make about what research to prioritize will predictably affect when and how much different people benefit from research. Organizations that fund health research should thus fairly account for the health needs of future populations when setting priorities. To this end, some research funders aim to allocate research resources in accordance with disease burden, prioritizing illnesses that cause more morbidity and mortality. In this article, I defend research funders' practice of aligning research funding with disease burden but argue that funders should aim to align research funding with future-rather than present-disease burden. I suggest that research funders should allocate research funding in proportion to aggregated estimates of disease burden over the period when research could plausibly start to yield benefits until indefinitely into the future.

Weighing the moral status of brain organoids and research animals.

Recent advances in human brain organoid systems have raised serious worries about the possibility that these in vitro 'mini-brains' could develop sentience, and thus, moral status. This article considers the relative moral status of sentient human brain organoids and research animals, examining whether we have moral reasons to prefer using one over the other. It argues that, contrary to common intuitions, the wellbeing of sentient human brain organoids should not be granted greater moral consideration than the wellbeing of nonhuman research animals. It does so not by denying that typical humans have higher moral status than animals, but instead by arguing that none of the leading justifications for granting humans higher moral status than nonhuman animals apply to brain organoids. Additionally, it argues that there are no good reasons to be more concerned about the well-being of human brain organoids compared to those generated from other species.

A comparative ethical analysis of the Egyptian clinical research law.

BACKGROUND: In this study, we examined the ethical implications of Egypt's new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country with a robust healthcare infrastructure and predominantly treatment-naïve patients. METHODS: We conducted a comparative analysis of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise to ensure rigorous analysis and interpretation of the laws. RESULTS: On the rating of the seven different principles (social and scientific values, scientific validity, fair selection of participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France, and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than explicitly stated ones. CONCLUSION: The analysis underscores Egypt's alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the critical need for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity. Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda for enhancing research ethics in Egypt and beyond.

Determining the state of guidance on pediatric biobanking for researchers, HRECS, and families: Regulatory mapping of international guidance.

Biobanking-the storage of human biological samples, including tissue, blood, urine, and genetic data-raises many ethical, legal, and social issues, including confidentiality and privacy. Pediatric biobanking is more complicated, with difficulties arising because children lack capacity to consent and acquire this capacity upon maturity when the research is still ongoing. Yet given the limited availability of pediatric samples, the translational nature of biobanking presents a unique opportunity to share samples and produce clinically necessary information about pediatric development and diseases. Guidance on navigating these legal and ethical difficulties is needed for those involved in pediatric biobanking-including researchers, participants, and families, and those involved in biobank governance. This paper seeks to map the current regulatory framework governing pediatric biobanking to determine what guidance is currently offered. Regulatory mapping of current international and national guidelines on pediatric biobanking addressing the ethical, legal, and social nuances of pediatric biobanking was undertaken. This paper finds that international guidelines around biobanking are mostly for adults, and even when pediatric-specific, documents are non-binding, inconsistent, or only limited guidance is offered on a range of important issues specific to pediatric biobanks.   Conclusion: This paper shows a need for consistent, comprehensive, and clear regulation on pediatric biobanking so that research can more quickly, efficiently, and ethically be translated to useful information and treatment in pediatric care. What is Known: • Pediatric biobanking presents new opportunities to conduct valuable translational research to benefit pediatric populations. However, the storage of pediatric biological samples raises many ethical, legal and social issues-in part because child participants may be considered to lack capacity to consent but can acquire this capacity upon maturity when the research is still ongoing. Pediatric biobanks must grapple with issues of consent, confidentiality and privacy, and long-term participation regarding child participants. What is New: • Regulatory guidance on these ethical, legal, and social issues is needed for researchers, participants, and families and those involved in biobank governance. This paper identifies nationally specific and international guidance on biobanking and summarizes the guidance provided in relation to these pediatric specific issues. It finds that most guidance is non-binding and inconsistent between guidance documents and may offer only limited guidance to stakeholders. A need for consistent, comprehensive, and clear regulation on pediatric biobanking is needed at an international level to enable research.

Research opportunities and ethical considerations for heart and lung xenotransplantation research: A report from the National Heart, Lung, and Blood Institute workshop.

Xenotransplantation offers the potential to meet the critical need for heart and lung transplantation presently constrained by the current human donor organ supply. Much was learned over the past decades regarding gene editing to prevent the immune activation and inflammation that cause early organ injury, and strategies for maintenance of immunosuppression to promote longer-term xenograft survival. However, many scientific questions remain regarding further requirements for genetic modification of donor organs, appropriate contexts for xenotransplantation research (including nonhuman primates, recently deceased humans, and living human recipients), and risk of xenozoonotic disease transmission. Related ethical questions include the appropriate selection of clinical trial participants, challenges with obtaining informed consent, animal rights and welfare considerations, and cost. Research involving recently deceased humans has also emerged as a potentially novel way to understand how xeno-organs will impact the human body. Clinical xenotransplantation and research involving decedents also raise ethical questions and will require consensus regarding regulatory oversight and protocol review. These considerations and the related opportunities for xenotransplantation research were discussed in a workshop sponsored by the National Heart, Lung, and Blood Institute, and are summarized in this meeting report.

ChatGPT for Automated Cross-Checking of Authors' Conflicts of Interest Against Industry Payments.

OBJECTIVE: The Centers for Medicare & Medicaid Services "OpenPayments" database tracks industry payments to US physicians to improve research conflicts of interest (COIs) transparency, but manual cross-checking of articles' authors against this database is labor-intensive. This study aims to assess the potential of large language models (LLMs) like ChatGPT to automate COI data analysis in medical publications. STUDY DESIGN: An observational study analyzing the accuracy of ChatGPT in automating the cross-checking of COI disclosures in medical research articles against the OpenPayments database. SETTING: Publications regarding Food and Drug Administration-approved biologics for chronic rhinosinusitis with nasal polyposis: omalizumab, mepolizumab, and dupilumab. METHODS: First, ChatGPT evaluated author affiliations from PubMed to identify those based in the United States. Second, for author names matching 1 or multiple payment recipients in OpenPayments, ChatGPT undertook a comparative analysis between author affiliation and OpenPayments recipient metadata. Third, ChatGPT scrutinized full article COI statements, producing an intricate matrix of disclosures for each author against each relevant company (Sanofi, Regeneron, Genentech, Novartis, and GlaxoSmithKline). A random subset of responses was manually checked for accuracy. RESULTS: In total, 78 relevant articles and 294 unique US authors were included, leading to 980 LLM queries. Manual verification showed accuracies of 100% (200/200; 95% confidence interval [CI]: 98.1%-100%) for country analysis, 97.4% (113/116; 95% CI: 92.7%-99.1%) for matching author affiliations with OpenPayments metadata, and 99.2% (1091/1100; 95% CI: 98.5%-99.6%) for COI statement data extraction. CONCLUSION: LLMs have robust potential to automate author-company-specific COI cross-checking against the OpenPayments database. Our findings pave the way for streamlined, efficient, and accurate COI assessment that could be widely employed across medical research.

Research integrity and academic medicine: the pressure to publish and research misconduct.

CONTEXT: This narrative review article explores research integrity and the implications of scholarly work in medical education. The paper describes how the current landscape of medical education emphasizes research and scholarly activity for medical students, resident physicians, and faculty physician educators. There is a gap in the existing literature that fully explores research integrity, the challenges surrounding the significant pressure to perform scholarly activity, and the potential for ethical lapses by those involved in medical education. OBJECTIVES: The objectives of this review article are to provide a background on authorship and publication safeguards, outline common types of research misconduct, describe the implications of publication in medical education, discuss the consequences of ethical breaches, and outline possible solutions to promote research integrity in academic medicine. METHODS: To complete this narrative review, the authors explored the current literature utilizing multiple databases beginning in June of 2021, and they completed the literature review in January of 2023. To capture the wide scope of the review, numerous searches were performed. A number of Medical Subject Headings (MeSH) terms were utilized to identify relevant articles. The MeSH terms included "scientific misconduct," "research misconduct," "authorship," "plagiarism," "biomedical research/ethics," "faculty, medical," "fellowships and scholarships," and "internship and residency." Additional references were accessed to include medical school and residency accreditation standards, residency match statistics, regulatory guidelines, and standard definitions. RESULTS: Within the realm of academic medicine, research misconduct and misrepresentation continue to occur without clear solutions. There is a wide range of severity in breaches of research integrity, ranging from minor infractions to fraud. Throughout the medical education system in the United States, there is pressure to publish research and scholarly work. Higher rates of publications are associated with a successful residency match for students and academic promotion for faculty physicians. For those who participate in research misconduct, there is a multitude of potential adverse consequences. Potential solutions to ensure research integrity exist but are not without barriers to implementation. CONCLUSIONS: Pressure in the world of academic medicine to publish contributes to the potential for research misconduct and authorship misrepresentation. Lapses in research integrity can result in a wide range of potentially adverse consequences for the offender, their institution, the scientific community, and the public. If adopted, universal research integrity policies and procedures could make major strides in eliminating research misconduct in the realm of academic medicine.