Knowledge, Attitude and Practice of Research Ethics among Researchers in Nepal.

INTRODUCTION: The universal health research ethical principles must be adhered to ensure a balance between science and safeguarding participants' rights, safety and dignity. A cross-sectional study was conducted to assess the knowledge, attitude, and practice of research ethics among researchers in Nepal. METHODS: The study was carried out among 449 researchers who submitted proposals for ethical review and approval from the Ethical Review Board of the Nepal Health Research Council between January 2017 to August 2021. Simple random sampling was done ensuring a proportional representation of researchers from all areas of health research. A structured questionnaire was administered online for data collection. RESULTS: The participants aged between 23-80 years old consented to complete the survey questionnaire. The median age of the respondents was 35 (23-80) years. Among all the respondents, 52 (11.58%) were unaware about the National Ethical Guideline for Health Research. Similarly, 110 (24.50%) respondents strongly agreed that the ethical review process impairs research and makes it harder for researchers to conduct research; 372 (82.85%) respondents had pursued research activity only after obtaining ethical approval. CONCLUSIONS: Half of the respondents had knowledge on different aspects of research ethics.

[SEAP-IAP recommendations for the collection, storage and use of biological materials of human origin and related data intended for research. Generic biobank consideration and ethical-legal review (Part II)]. / Recomendaciones de la SEAP-IAP para la recolección, el almacenamiento y el uso de materiales biológicos de origen humano y los datos relacionados, destinados a la investigación. Consideración genérica de biobanco y revisión ético-legal (Parte II).

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.

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

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

Biobanking, digital health and privacy: the choices of 1410 volunteers and neurological patients regarding limitations on use of data and biological samples, return of results and sharing.

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.

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

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

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

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

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

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

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

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

Should Nonhuman Animals Be Recognized Legally as Persons?

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

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

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

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

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

Humanity and Inhumanity of Nonhuman Primate Research.

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