[Current regulations in the Animal Welfare Act and the significance for animal research]. / Aktuelle Regelungen im Tierschutzgesetz und Bedeutung für die tierexperimentelle Forschung.

Due to the legal implantation of the 3R principle, the number of laboratory animals decreased significantly over the past 10 years. In this article, the historical development of animal experiments over the last decade will be presented in the context of the current regulations of the Animal Welfare Act. It points out bureaucratic obstacles to the approval of animal experiments, which jeopardize Germany as a research location for both academia and industry. The article presents constructive proposals for solutions. This should be done in accordance with the DFG recommendation to ensure efficient biomedical research while maintaining the highest animal welfare standards.

A structured curriculum supporting biomedical trainees' transition into independent academic positions and early career success.

The United States government makes a substantial investment in biomedical training programs each year. However, for most trainees, these opportunities do not translate into career progression in academic research pathways. Only about one-fifth of postdoctoral fellows eventually secure a tenure-track faculty position, and even among these candidates, attrition is high. Although a number of factors govern career choices and career longevity, the transition from trainee to faculty is a challenging process and requires knowledge and skills that are not necessarily developed during a traditional university experience. Many postdoctoral fellows receive adequate training in research skills and scientific communication, but new faculty report not being sufficiently prepared for the job search process and for starting their labs. To address this critical training gap, the ITERT core (Interdisciplinary Translational Education and Research Training) and the Office of Postdoctoral Fellows at the University of Texas MD Anderson Cancer Center implemented a structured course for both postdoctoral fellows and senior PhD students to provide formalized training for successfully navigating academic positions in biomedical research. Here we report on the pilot Navigating Academic Careers course conducted in 2021-2022 for 30 PhD students and postdocs. The nine-module course was conducted over 13 weeks in 25.5 h instructional sessions. The key educational objectives included 1) navigating the job application and the interview/negotiation process, 2) hiring, leading, and mentoring lab personnel and program support staff, 3) project administration and financial stewardship, 4) managing time and work-life balance and 5) developing collaborations, branding, personalized niche, and networking. Survey-based analysis at the time of the course was used to capture the participants' assessment of the course content, organization, and delivery, with a follow-up survey conducted approximately 2 years post-course (2024) to evaluate longer-term impacts of the training. Initial in-course assessment revealed that 89.9% of respondents found the scope and instructional content appropriate, and 91.1% found the course relevant and applicable to their career needs. Longer-term post-course evaluation indicated that 80% of respondents applied the learnings of the course, that 80% reported feeling more confident in navigating an academic job search, and that 66.6% continued to report agreement with the course preparing them for their current role/ongoing job search, with 46.7% already securing jobs in academic research, including as independent faculty. The outcomes of this pilot course suggest that integrating this into the broader postdoctoral training curriculum can enhance both the transition and early-career success of talented scientists-in-training into working professionals in biomedical careers, as faculty and science-trained staff.

[Comparative pathology in oncology-Best practice]. / Vergleichende Pathologie in der onkologischen Forschung.

Comparative experimental pathology is a research field at the interface of human and veterinary medicine. It is focused on the comparative study of similarities and differences between spontaneous and experimentally induced diseases in animals (animal models) compared to human diseases. The use of animal models for studying human diseases is an essential component of biomedical research. Interdisciplinary teams with species-specific expertise should collaborate wherever possible and maintain close communication. Mutual openness, cooperation, and willingness to learn form the basis for a fruitful collaboration. Research projects jointly led by or involving both animal and human pathologists make a significant contribution to high-quality biomedical research. Such approaches are promising not only in oncological research, as outlined in this article, but also in other research areas where animal models are regularly used, such as infectiology, neurology, and developmental biology.

Andragogy in Practice: Applying a Theoretical Framework to Team Science Training in Biomedical Research.

This study is the first to apply the theoretical principles of Malcolm Knowles' theory of andragogy to evaluate data collected from learners who participated in team science training workshops in a biomedical research setting. Briefly, andragogy includes six principles: the learner's self-concept, the role of experience, readiness to learn, orientation to learning, the learner's need to know, and intrinsic motivation. Using an embedded study design, the primary focus was on qualitative data, with quantitative data complementing the qualitative findings. The deductive analysis demonstrated that approximately 85% of the qualitative data could be connected to at least one andragogical principle. Participant responses to positive evaluation questions were largely related to two principles: readiness to learn and problem-based learning orientation. Participant responses to negative questions were largely connected to two different principles: the role of experience and self-direction. Inductive analysis found an additional theme: meeting biological needs. Quantitative survey results supported the qualitative findings. The study findings demonstrate that andragogy can serve as a valuable construct to integrate into the development of effective team science training for biomedical researchers.

Recruitment, Retention, and Training of Citizen Scientists in Translational Medicine Research: A Citizen Science Initiative on Non-Alcoholic Fatty Liver Disease.

Citizen science is a participatory science approach in which members of the public (citizens) collaborate with scientists and professional researchers and become involved in research and innovation activities, resulting in the co-creation of scientific knowledge and innovation. Citizen science has been widely applied in research, particularly in the social sciences, environmental sciences, information and communication technologies, and public health. However, the application of this approach in clinical sciences, particularly in translational medicine research, is still nascent. This exploratory study involved members of the public (citizen scientists) in a translational medicine experiment on non-alcoholic fatty liver disease that incorporated a lifestyle and weight-loss intervention. The aim of this paper is to report successful methods and approaches for the recruitment, retention, and training of citizen scientists. For the citizen scientists' recruitment, online calls placed on the websites of our research project and biomedical research center and targeted emails were the most helpful. Of the 14 members of the public who expressed interest in our study, six were recruited as citizen scientists. Citizen scientists were mostly female (n = 5, 83%), white (n = 3, 50%), over 50 years of age (n = 4, 67%), educated to postgraduate level (n = 5, 83%), and either retired or not in employment (n = 5, 83%). The retention rate was 83% (n = 5), and the dropout rate was 17% (n = 1). We arranged instructor-led interactive online training sessions (an hour-long one-on-one session and two-hour group sessions). Research skills training covered ethics in research and qualitative and quantitative data analysis. Citizen scientists were given several incentives, such as reimbursement of travel and care costs, selection as citizen scientists of the month, publications of their blogs and perspective articles, and co-authorship and acknowledgement in papers and project deliverables. To conclude, members of the public (particularly middle-aged white women with postgraduate education) are interested in becoming citizen scientists in translational medicine research. Their retention rate is higher, and they can contribute to different research activities. However, they need training to develop their research skills and expertise. The training should be simple, comprehensive, and flexible to accommodate the schedules of individual citizen scientists. They deserve incentives as they work on a voluntary basis.

Introducing dynamic consent for improved trust and privacy in research involving human biological material and associated data in South Africa.

Biomedical research using human biological material and data is essential for improving human health, but it requires the active participation of many human volunteers in addition to the distribution of data. As a result, it has raised numerous vexing questions related to trust, privacy and consent. Trust is essential in biomedical research as it relates directly to the willingness of participants to continue participating in research. Privacy and the protection of personal information also influence trust. Informed consent has proven to be insufficient as it cannot overcome the informational deficit between primary and unknown future uses of material and data and is therefore not fully informed and invalid. Broad consent is also problematic as it takes full control of samples and data flow from the research participant and inherently requires that a participant must trust that the researcher will use their material or data in a manner that they would find acceptable. This paper attempts to offer some insight into how these related issues can be overcome. It introduces dynamic consent as a consent model in research involving human biological material and its associated data. Dynamic consent is explained, as well as its claims of superiority in instances where future research is possible. It is also shown how dynamic consent contributes to better control of the samples and data by the research participant, and how trust may be improved by using this consent model. Dynamic consent's co-existence with and support of the South African Protection of Personal Information Act of 2013 is also assessed. The limitations of dynamic consent are also discussed.

A Scalable Pseudonymization Tool for Rapid Deployment in Large Biomedical Research Networks: Development and Evaluation Study.

Background: The SARS-CoV-2 pandemic has demonstrated once again that rapid collaborative research is essential for the future of biomedicine. Large research networks are needed to collect, share, and reuse data and biosamples to generate collaborative evidence. However, setting up such networks is often complex and time-consuming, as common tools and policies are needed to ensure interoperability and the required flows of data and samples, especially for handling personal data and the associated data protection issues. In biomedical research, pseudonymization detaches directly identifying details from biomedical data and biosamples and connects them using secure identifiers, the so-called pseudonyms. This protects privacy by design but allows the necessary linkage and reidentification. Objective: Although pseudonymization is used in almost every biomedical study, there are currently no pseudonymization tools that can be rapidly deployed across many institutions. Moreover, using centralized services is often not possible, for example, when data are reused and consent for this type of data processing is lacking. We present the ORCHESTRA Pseudonymization Tool (OPT), developed under the umbrella of the ORCHESTRA consortium, which faced exactly these challenges when it came to rapidly establishing a large-scale research network in the context of the rapid pandemic response in Europe. Methods: To overcome challenges caused by the heterogeneity of IT infrastructures across institutions, the OPT was developed based on programmable runtime environments available at practically every institution: office suites. The software is highly configurable and provides many features, from subject and biosample registration to record linkage and the printing of machine-readable codes for labeling biosample tubes. Special care has been taken to ensure that the algorithms implemented are efficient so that the OPT can be used to pseudonymize large data sets, which we demonstrate through a comprehensive evaluation. Results: The OPT is available for Microsoft Office and LibreOffice, so it can be deployed on Windows, Linux, and MacOS. It provides multiuser support and is configurable to meet the needs of different types of research projects. Within the ORCHESTRA research network, the OPT has been successfully deployed at 13 institutions in 11 countries in Europe and beyond. As of June 2023, the software manages data about more than 30,000 subjects and 15,000 biosamples. Over 10,000 labels have been printed. The results of our experimental evaluation show that the OPT offers practical response times for all major functionalities, pseudonymizing 100,000 subjects in 10 seconds using Microsoft Excel and in 54 seconds using LibreOffice. Conclusions: Innovative solutions are needed to make the process of establishing large research networks more efficient. The OPT, which leverages the runtime environment of common office suites, can be used to rapidly deploy pseudonymization and biosample management capabilities across research networks. The tool is highly configurable and available as open-source software.

The impact of inclusive mentoring and identity work on self-efficacy in career advancement and career commitment among underrepresented early-career faculty and post-doctoral fellows.

Objective: Researchers from underrepresented groups leave research positions at a disproportionate rate. We aim to identify factors associated with self-efficacy in career advancement and career commitment among underrepresented post-doctoral fellows and early-career faculty. Methods: Building Up is a cluster-randomized trial with 25 academic health institutions. In September-October 2020, 219 Building Up participants completed the pre-intervention assessment, which included questions on demographics, science identity, mentoring, self-efficacy in career advancement (i.e., advancement is open to me, confidence in career progression, confidence in overcoming professional barriers), and career commitment (i.e., intent to continue research training or studying in a field related to biomedical sciences). Using logistic and multinomial logistic regression, we identified characteristics independently associated with self-efficacy in career advancement and career commitment. Results: The cohort is 80% female, 33% non-Hispanic/Latinx Black, and 34% Hispanic/Latinx. Having mentors that address diversity was significantly associated with the belief that advancement is open to them (OR = 1.7). Higher science identity (OR = 4.0) and having mentors that foster independence (OR = 1.8) were significantly associated with confidence in career progression. Higher science identity was also significantly associated with confidence in overcoming professional barriers (OR = 2.3) and intent to continue studying in a field related to biomedical sciences (OR = 3.3). Higher age (OR = 2.3) and higher science identity (OR = 4.2) were significantly associated with intent to continue research training. Discussion: Science identity and mentoring play key roles in self-efficacy in career advancement and career commitment. These factors may contribute to retention of underrepresented early-career biomedical researchers.

Genetic characterization of a captive marmoset (Callithrix jacchus) colony using genotype-by-sequencing.

The marmoset is a fundamental nonhuman primate model for the study of aging, neurobiology, and many other topics. Genetic management of captive marmoset colonies is complicated by frequent chimerism in the blood and other tissues, a lack of tools to enable cost-effective, genome-wide interrogation of variation, and historic mergers and migrations of animals between colonies. We implemented genotype-by-sequencing (GBS) of hair follicle derived DNA (a minimally chimeric DNA source) of 82 marmosets housed at the Southwest National Primate Research Center (SNPRC). Our primary goals were the genetic characterization of our marmoset population for pedigree verification and colony management and to inform the scientific community of the functional genetic makeup of this valuable resource. We used the GBS data to reconstruct the genetic legacy of recent mergers between colonies, to identify genetically related animals whose relationships were previously unknown due to incomplete pedigree information, and to show that animals in the SNPRC colony appear to exhibit low levels of inbreeding. Of the >99,000 single-nucleotide variants (SNVs) that we characterized, >9800 are located within gene regions known to harbor pathogenic variants of clinical significance in humans. Overall, we show the combination of low-resolution (sparse) genotyping using hair follicle DNA is a powerful strategy for the genetic management of captive marmoset colonies and for identifying potential SNVs for the development of biomedical research models.

Mapping the landscape of medical research in the Arab world countries: A comprehensive bibliometric analysis.

OBJECTIVES: To describe the productivity, performance, and impact of medical research in the Arab world countries. METHODS: We carried out a bibliometric analysis using Clarivate Analytics databases from January 2017 to March 2023. We reported research productivity, national and international research collaboration patterns, impact of Arab medical research output compared to the global average, top medical journals publishing Arab-affiliated research, and performance of the most productive Arab institutions. RESULTS: The Arab world contributed 2.72% to global medical research publication, with a citation impact of 11.98 compared to the global impact of 12.02. Qatar, Lebanon, and Saudi Arabia led medical research publications per million population among Arab countries, ranking 26th, 36th, and 37th globally. Medical research publications increased by 87% annually from 2017-2022, with 70% of research originating from Saudi Arabia and Egypt. National collaborations accounted for 15% of Arab world publications, while international collaborations represented 66%. The median impact factor across the top 20 medical journals with Arab-affiliated authors was 5.14, with 50% being quartile one journals. The top 10 Arab-origin medical journals had a median impact factor of 3.13. Approximately 80% of the top 20 Arab institutions were academic, with a median publication count of 3,162.5 and a median citation impact of 14.5. CONCLUSION: The study provides insights into the state of medical research in the Arab countries, indicating room for improvement in the region's medical research.

Multi-activity 3D printed assistive technology in children: a case study.

Congenital limb defects occur when a limb does not develop normally during pregnancy. The quality of each person's everyday life is significantly impacted by any of these defects and there is no concrete treatment. 3D modeling and printing, enables the creation and customization of precise virtual and/or physical models, including models of the human anatomy. These technologies provide a novel method of producing new devices with optimized design and production time, improving adaptability, and incorporating functionality. To this end, we propose a method of designing and producing 3D printed assistive devices and we also present an example of an assistive device, done in the 3D Printing Center for Health, as well as its impact on the patient's daily life. With this device, the patient became able to play the guitar and hold a knife, thus helping on these two activities.

Care, management, and use of ferrets in biomedical research.

The ferret (Mustela putorius furo) is a small domesticated species of the family Mustelidae within the order Carnivora. The present article reviews and discusses the current state of knowledge about housing, care, breeding, and biomedical uses of ferrets. The management and breeding procedures of ferrets resemble those used for other carnivores. Understanding its behavior helps in the use of environmental enrichment and social housing, which promote behaviors typical of the species. Ferrets have been used in research since the beginning of the twentieth century. It is a suitable non-rodent model in biomedical research because of its hardy nature, social behavior, diet and other habits, small size, and thus the requirement of a relatively low amount of test compounds and early sexual maturity compared with dogs and non-human primates. Ferrets and humans have numerous similar anatomical, metabolic, and physiological characteristics, including the endocrine, respiratory, auditory, gastrointestinal, and immunological systems. It is one of the emerging animal models used in studies such as influenza and other infectious respiratory diseases, cystic fibrosis, lung cancer, cardiac research, gastrointestinal disorders, neuroscience, and toxicological studies. Ferrets are vulnerable to many human pathogenic organisms, like severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), because air transmission of this virus between them has been observed in the laboratory. Ferrets draw the attention of the medical community compared to rodents because they occupy a distinct niche in biomedical studies, although they possess a small representation in laboratory research.

Comparative analysis of swine leukocyte antigen gene diversity in Göttingen Minipigs.

Worldwide, pigs represent economically important farm animals, also representing a preferred preclinical large animal model for biomedical studies. The need for swine leukocyte antigen (SLA) typing is increasing with the expanded use of pigs in translational research, infection studies, and for veterinary vaccine design. Göttingen Minipigs (GMP) attract increasing attention as valuable model for pharmacological studies and transplantation research. This study represents a first-time assessment of the SLA gene diversity in Göttingen Minipigs in combination with a comparative metadata analysis with commercial pig lines. As Göttingen Minipigs could harbor private as well as potential novel SLA allele combinations, future research projects would benefit from the characterization of their SLA background. In 209 Göttingen Minipigs, SLA class I (SLA-1, SLA-2, SLA-3) and class II (DRB1, DQB1, DQA) genes were characterized by PCR-based low-resolution (Lr) haplotyping. Criteria and nomenclature used for SLA haplotyping were proposed by the ISAG/IUIS-VIC SLA Nomenclature Committee. Haplotypes were assigned based on the comparison with already known breed or farm-specific allele group combinations. In total, 14 SLA class I and five SLA class II haplotypes were identified in the studied cohort, to manifest in 26 SLA class I but only seven SLA class II genotypes. The most common SLA class I haplotypes Lr-24.0 (SLA-1*15XX or Blank-SLA-3*04:04-SLA-2*06:01~02) and Lr-GMP-3.0 (SLA-1*16:02-SLA-3*03:04-SLA-2*17:01) occurred at frequencies of 23.44 and 18.66%, respectively. For SLA class II, the most prevalent haplotypes Lr-0.21 (DRB1*01XX-DQB1*05XX-DQA*04XX) and Lr-0.03 (DRB1*03:02-DQB1*03:01-DQA*01XX) occurred at frequencies of 38.28 and 30.38%. The comparative metadata analysis revealed that Göttingen Minipigs only share six SLA class I and two SLA class II haplotypes with commercial pig lines. More importantly, despite the limited number of SLA class I haplotypes, the high genotype diversity being observed necessitates pre-experimental SLA background assessment of Göttingen Minipigs in regenerative medicine, allo-transplantation, and xenograft research.

Investigating the Roles and Responsibilities of Institutional Signing Officials After Data Sharing Policy Reform for Federally Funded Research in the United States: National Survey.

BACKGROUND: New federal policies along with rapid growth in data generation, storage, and analysis tools are together driving scientific data sharing in the United States. At the same, triangulating human research data from diverse sources can also create situations where data are used for future research in ways that individuals and communities may consider objectionable. Institutional gatekeepers, namely, signing officials (SOs), are therefore at the helm of compliant management and sharing of human data for research. Of those with data governance responsibilities, SOs most often serve as signatories for investigators who deposit, access, and share research data between institutions. Although SOs play important leadership roles in compliant data sharing, we know surprisingly little about their scope of work, roles, and oversight responsibilities. OBJECTIVE: The purpose of this study was to describe existing institutional policies and practices of US SOs who manage human genomic data access, as well as how these may change in the wake of new Data Management and Sharing requirements for National Institutes of Health-funded research in the United States. METHODS: We administered an anonymous survey to institutional SOs recruited from biomedical research institutions across the United States. Survey items probed where data generated from extramurally funded research are deposited, how researchers outside the institution access these data, and what happens to these data after extramural funding ends. RESULTS: In total, 56 institutional SOs participated in the survey. We found that SOs frequently approve duplicate data deposits and impose stricter access controls when data use limitations are unclear or unspecified. In addition, 21% (n=12) of SOs knew where data from federally funded projects are deposited after project funding sunsets. As a consequence, most investigators deposit their scientific data into "a National Institutes of Health-funded repository" to meet the Data Management and Sharing requirements but also within the "institution's own repository" or a third-party repository. CONCLUSIONS: Our findings inform 5 policy recommendations and best practices for US SOs to improve coordination and develop comprehensive and consistent data governance policies that balance the need for scientific progress with effective human data protections.

Transitioning biomedical research toward human-centric methodologies: systems-based strategies.

Human-centric methodologies like microphysiological systems and in silico methods have shown promise in addressing the limitations of animal models in understanding human biology and responding to public health priorities. However, the prevailing paradigm based on animal research persists. The article proposes a systemic thinking approach, endorsed by the OECD and the EU, as a tool to leverage innovation to reframe the issue and achieve transformative policies. By identifying the complex factors shaping method selection in basic and biomedical research, a simplified model is presented to illuminate the systemic nature of this decision-making process. The goal is not to prescribe solutions but to offer policymakers a new framework for more-effective strategies, emphasizing collaboration among stakeholders and the need for robust data.

Alternatives of Animal Models for Biomedical Research: a Comprehensive Review of Modern Approaches.

Biomedical research has long relied on animal models to unravel the intricacies of human physiology and pathology. However, concerns surrounding ethics, expenses, and inherent species differences have catalyzed the exploration of alternative avenues. The contemporary alternatives to traditional animal models in biomedical research delve into three main categories of alternative approaches: in vitro models, in vertebrate models, and in silico models. This unique approach to artificial intelligence and machine learning has been a keen interest to be used in different biomedical research. The main goal of this review is to serve as a guide to researchers seeking novel avenues for their investigations and underscores the importance of considering alternative models in the pursuit of scientific knowledge and medical breakthroughs, including showcasing the broad spectrum of modern approaches that are revolutionizing biomedical research and leading the way toward a more ethical, efficient, and innovative future. Models can insight into cellular processes, developmental biology, drug interaction, assessing toxicology, and understanding molecular mechanisms.

Diversity supplements: An underutilized opportunity to improve the diversity of the health sciences research workforce.

Purpose: This paper describes the process developed at the University of Pittsburgh to increase the number of NIH-funded Diversity Supplements. Method: The authors formed a Diversity in Academia Workgroup where we created the infrastructure and process to increase the number of Diversity Supplements. Each year, the Office of Sponsored Programs provided a list of grants that would be eligible to submit a Diversity Supplement. We surveyed the Principal Investigators inquiring about their interest in working with a trainee on a Diversity Supplement. If yes, we included their information in a database we built so that trainees could search for eligible research studies. The Diversity Deans then identified underrepresented faculty and postdoctoral researchers. We invited Program Officers from NIH to participate in a panel presentation for trainees, which was well attended. Results: The number of Diversity Supplements awarded to Pitt researchers has significantly increased from 7 in 2020 to 10 in 2021 and to 15 in 2022. Six more have been awarded in the first half of 2023. Conclusions: We created the Diversity in Academia Workgroup with the goal to increase the number of Diversity Supplements at the University of Pittsburgh and in so doing, increase the diversity in the biomedical research workforce. While challenging, we know the critical importance and benefits of increased diversity at the University, and we have made significant strides toward this goal.

Special Operations and Space Medicine for a Joint Future.

This paper is designed to introduce, propose, inform, and advocate enhanced relationships between the medical communities of special operations and space. Although each provides service support in different roles and functions, similarities in both the operational context and in medical care are notable. During a recent interaction, significant relationship potential was discovered by both communities, and recommendations for greater engagement are proposed herein. By identifying and appreciating similarities and understanding history, key actors, and authorities to analyze and realize opportunities will enable us to find synergy for the development of like efforts and goals. Collaboration in research on the limits of human performance and medical support to the most austere and challenging operational environments may benefit both communities in different but productive ways. Establishing and increasing cooperation will also meet command strategic intent, explore and advance a policy concept, initiate a relationship between unique medical communities, and provide a tangible success for the advancement of operational support.