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.

[Not all published data are reliable: fabricated data in medical research]. / Niet alle gepubliceerde data zijn betrouwbaar.

For a long time, the reliability of medical-scientific research was, without further verification, based on real data. It is becoming increasingly clear that this assumption is unjustified and that probably at least 25% of published randomized clinical trials are based on unreliable and sometimes even fabricated data. After giving a number of examples, it is discussed what the reader can do about this problem. More importantly, editors and publishers should no longer rely on whistle-blowers but take action themselves. If this does not happen, external parties must intervene. Society cannot afford (medical) science that is based on unreliable data.

White House overhauls rules for risky pathogen research.

New policy governs gain-of-function and "dual-use" studies.

Essential data variables for a minimum dataset for head and neck cancer trials and clinical research: HNCIG consensus recommendations and database.

The Head and Neck Cancer International Group (HNCIG) has undertaken an international modified Delphi process to reach consensus on the essential data variables to be included in a minimum database for HNC research. Endorsed by 19 research organisations representing 34 countries, these recommendations provide the framework to facilitate and harmonise data collection and sharing for HNC research. These variables have also been incorporated into a ready to use downloadable HNCIG minimum database, available from the HNCIG website.

The Heart Failure Patient Foundation Position Statement on Research and Patient Involvement.

BACKGROUND: Heart Failure (HF) is a growing global public health problem affecting approximately 64 million people worldwide. OBJECTIVES: The Heart Failure Patient Foundation developed a position statement to advocate for adult patients with HF to be an active participant in research and for HF leaders to integrate patients throughout the research process. METHODS: A review of the literature and best practices was conducted. Based on the evidence, the HF Patient Foundation made recommendations regarding the inclusion of adult patients with HF throughout the research process. RESULTS: Healthcare clinicians, researchers and funding agencies have a role to ensure rigorous quality research is performed and implemented into practice. Inclusion of adult patients with HF throughout the research process can improve the lives of patients and families while advancing HF science. CONCLUSIONS: The HF Patient Foundation strongly advocates that patients with HF be involved in research from inception of the project through dissemination of findings to improve patient outcomes.

Measurement Invariance in Intellectual and Developmental Disability Research.

Measurement invariance (MI) is a psychometric property of an instrument indicating the degree to which scores from an instrument are comparable across groups. In recent years, there has been a marked uptick in publications using MI in intellectual and developmental disability (IDD) samples. Our goal here is to provide an overview of why MI is important to IDD researchers and to describe some challenges to evaluating it, with an eye towards nudging our subfield into a more thoughtful and measured interpretation of studies using MI.

NCI Cancer Research Data Commons: Core Standards and Services.

The NCI Cancer Research Data Commons (CRDC) is a collection of data commons, analysis platforms, and tools that make existing cancer data more findable and accessible by the cancer research community. In practice, the two biggest hurdles to finding and using data for discovery are the wide variety of models and ontologies used to describe data, and the dispersed storage of that data. Here, we outline core CRDC services to aggregate descriptive information from multiple studies for findability via a single interface and to provide a single access method that spans multiple data commons. See related articles by Wang et al., p. 1388, Pot et al., p. 1396, and Kim et al., p. 1404.

Best practices for data management and sharing in experimental biomedical research.

Effective data management is crucial for scientific integrity and reproducibility, a cornerstone of scientific progress. Well-organized and well-documented data enable validation and building on results. Data management encompasses activities including organization, documentation, storage, sharing, and preservation. Robust data management establishes credibility, fostering trust within the scientific community and benefiting researchers' careers. In experimental biomedicine, comprehensive data management is vital due to the typically intricate protocols, extensive metadata, and large datasets. Low-throughput experiments, in particular, require careful management to address variations and errors in protocols and raw data quality. Transparent and accountable research practices rely on accurate documentation of procedures, data collection, and analysis methods. Proper data management ensures long-term preservation and accessibility of valuable datasets. Well-managed data can be revisited, contributing to cumulative knowledge and potential new discoveries. Publicly funded research has an added responsibility for transparency, resource allocation, and avoiding redundancy. Meeting funding agency expectations increasingly requires rigorous methodologies, adherence to standards, comprehensive documentation, and widespread sharing of data, code, and other auxiliary resources. This review provides critical insights into raw and processed data, metadata, high-throughput versus low-throughput datasets, a common language for documentation, experimental and reporting guidelines, efficient data management systems, sharing practices, and relevant repositories. We systematically present available resources and optimal practices for wide use by experimental biomedical researchers.

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.

Implementation of the EQIPD Quality System.

The EQIPD Quality System (QS) was conceptualized and established by an international consortium consisting of academic and industrial partners to ensure that non-regulated biomedical research will be conducted according to Good Research Practice expectations. The QS supports researchers to reflect on and improve internal practices by providing a systematic framework and guidance for implementing the EQIPD QS in a time and cost effective manner. This report describes the content of the EQIPD QS with its key features and 18 Core Requirements (CR) in more detail. It gives a short background on each CR and hands on examples on how they were addressed by two different research labs in their respective laboratory environments. Thereby, this article provides examples and direction for other research labs who aim to implement the QS as well. The final paragraphs discuss the potential benefits of the QS in respect to different user groups and stakeholders within the scientific community and summarize the overall governance structure of the EQIPD framework.

Translating a Culture of Quality to Clinical Research Conduct: Expanding the Clinical Development Quality Framework.

The International Council on Harmonisation E8 Guidance Revision 1 (ICH E8(R1)) calls for creating a Culture of Quality that "values and rewards critical thinking and open, proactive dialogue about what is critical to quality." Across the biopharma landscape, clinical sites, sponsors, and service providers are working to translate this far-reaching guideline into working practices. This manuscript deconstructs key elements that comprise the critical thinking and open, proactive Culture of Quality "enablers." In addition, maturity models are provided so readers can visualize what a Culture of Quality looks like in their clinical research organization. These provide examples of high performing cultures of quality and useful tools for teams or organizations to measure and evolve their respective quality cultures.

Operationalizing Equity, Inclusion, and Access in Research Practice at a Large Academic Institution.

INTRODUCTION: Healthcare advances are hindered by underrepresentation in prospective research; sociodemographic, data, and measurement infidelity in retrospective research; and a paucity of guidelines surrounding equitable research practices. OBJECTIVE: The Joint Research Practices Working Group was created in 2021 to develop and disseminate guidelines for the conduct of inclusive and equitable research. METHODS: Volunteer faculty and staff from two research centers at the University of Pennsylvania initiated a multi-pronged approach to guideline development, including literature searches, center-level feedback, and mutual learning with local experts. RESULTS: We developed guidelines for (1) participant payment and incentives; (2) language interpretation and translation; (3) plain language in research communications; (4) readability of study materials; and (5) inclusive language for scientific communications. Key recommendations include (1) offer cash payments and multiple payment options to participants when required actions are completed; (2) identify top languages of your target population, map points of contact, and determine available interpretation and translation resources; (3) assess reading levels of materials and simplify language, targeting 6th- to 8th-grade reading levels; (4) improve readability through text formatting and style, symbols, and visuals; and (5) use specific, humanizing terms as adjectives rather than nouns. CONCLUSIONS: Diversity, inclusion, and access are critical values for research conduct that promotes justice and equity. These values can be operationalized through organizational commitment that combines bottom-up and top-down approaches and through partnerships across organizations that promote mutual learning and synergy. While our guidelines represent best practices at one time, we recognize that practices evolve and need to be evaluated continuously for accuracy and relevance. Our intention is to bring awareness to these critical topics and form a foundation for important conversations surrounding equitable and inclusive research practices.

An overview of the peer review process in biomedical sciences.

OBJECTIVE: This paper aims to provide an introductory resource for beginner peer reviewers in psychiatry and the broader biomedical science field. It will provide a concise overview of the peer review process, alongside some reviewing tips and tricks. CONCLUSION: The peer review process is a fundamental aspect of biomedical science publishing. The model of peer review offered varies between journals and usually relies on a pool of volunteers with differing levels of expertise and scope. The aim of peer review is to collaboratively leverage reviewers' collective knowledge with the objective of increasing the quality and merit of published works. The limitations, methodology and need for transparency in the peer review process are often poorly understood. Although imperfect, the peer review process provides some degree of scientific rigour by emphasising the need for an ethical, comprehensive and systematic approach to reviewing articles. Contributions from junior reviewers can add significant value to manuscripts.

Virology-the path forward.

In the United States (US), biosafety and biosecurity oversight of research on viruses is being reappraised. Safety in virology research is paramount and oversight frameworks should be reviewed periodically. Changes should be made with care, however, to avoid impeding science that is essential for rapidly reducing and responding to pandemic threats as well as addressing more common challenges caused by infectious diseases. Decades of research uniquely positioned the US to be able to respond to the COVID-19 crisis with astounding speed, delivering life-saving vaccines within a year of identifying the virus. We should embolden and empower this strength, which is a vital part of protecting the health, economy, and security of US citizens. Herein, we offer our perspectives on priorities for revised rules governing virology research in the US.