Ethical Regulation Research Articles

Empowering the Research Community to Investigate Misconduct and Promote Research Integrity and Ethics: New Regulation in Scandinavia

Researchers sometimes engage in various forms of dishonesty and unethical behavior, which has led to regulatory efforts to ensure that they work according to acceptable standards. Such regulation is a difficult task, as research is a diverse and dynamic endeavor. Researchers can disagree about what counts as good and acceptable standards, and these standards are constantly developing. This paper presents and discusses recent changes in research integrity and ethics regulation in Norway, Denmark, and Sweden. Recognizing that research norms are developed through practice and are therefore unsuited for comprehensive national regulation, the Scandinavian countries focus on empowering the research community to regulate itself instead, except for the most severe cases of misconduct. This empowerment takes the form of giving research institutions tools and investigatory powers while also holding them responsible for ensuring that both the institution and individual researchers are up to date on relevant norms. In this way, the Scandinavian governments seek to avoid some of the challenges found in more legalistic approaches, which risk lagging behind the continuous development of research norms and can be insensitive to the fact that different disciplines have different norms. While the new approach in Scandinavian has several potential benefits, it also involves potential trade-offs and limitations. The new laws can create confusion about what researchers are allowed to do. Another issue is that it only addresses the fundamental drivers of misconduct to a limited extent.

Change of the profession or form of its practice from the perspective of the professional ethics of attorneys-at-law

The article discusses issues related to the professional mobility of attorneys-at-law in light of the Code of Ethics of Attorneys-at-Law. The author discusses changes in the profession or form of its practicing in terms of movement between the public and private sectors as well as within the private sector itself. The article also addresses the issue of changing the form of practicing the profession or the entity where the profession is practiced. These phenomena, though partially regulated by law, escape ethical regulation; the Code covers them only to a narrow extent (professional secrecy and conflict of interest). The question is, therefore, whether this and the indirect application of several other principles of professional ethics (independence, dignity of the profession, loyalty, and trust) can be considered appropriate. The author analyzes if the application of the above ethical principles is sufficient in terms of safeguarding against the unethical use of relationships or networks from the professional past as well as avoiding the related reduction in independence, conflicts of interest, breach of professional secrecy, or loyalty.

Are we ready for the revision of the 14-day rule? Implications from Chinese legislations guiding human embryo and embryoid research.

The ISSCR recently released new guidelines that relaxed the 14-day rule taking away the tough barrier, and this has rekindled relevant ethical controversies and posed a fresh set of challenges to each nation's legislations and policies directly or indirectly. To understand its broad implications and the variation and impact of China's relevant national policies, we reviewed and evaluated Chinese laws, administrative regulations, departmental rules, and normative documents on fundamental and preclinical research involving human embryos from 1985 to 2022 in this paper. We have historically examined whether these regulations, including a 14-day rule, had restrictions on human embryo research, and whether and how these policies affected human embryo and embryoid research in China. We also discussed and assessed the backdrop in which China has endeavored to handle such as the need for expanding debates among justice practice, academia, and the public, and the shifting external environment influenced by fast-developing science and technology and people's culture and religions. In general, Chinese society commonly opposes giving embryos or fetuses the legal status of humans, presumably due to the Chinese public not seeming to have any strong religious beliefs regarding the embryo. On this basis, they do not strongly oppose the potential expansion of the 14-day rule. After the guidelines to strengthen governance over ethics in science, and technology were released by the Chinese government in 2022, Chinese policymakers have incorporated bioethics into the national strategic goals using a "People-Centered" approach to develop and promote an ecological civilization. Specifically, China follows the "precautionary principle" based on ethical priority as it believes that if scientific research carries any potential technological and moral risks on which no social ethical consensus has been attained, there would be a need to impose oversight for prevention and precaution. At the same time, China has adopted a hybrid legislative model of legislation and ethical regulations with criminal, civil and administrative sanctions and a 14-day limit specified within its national hESCs guidelines. This would certainly be a useful example for other countries to use when considering the possibility of developing a comprehensive, credible and sustainable regulatory framework.

Ethical perspectives of the involvement of vulnerable populations in health research

Abstract Background Public involvement in research has potential to transform public health research processes and outcomes, as well as contribute to sustainable collaborations between academia and the civil society. However, this all relies on public involvement being conducted in an ethical and inclusive way, especially when involving representatives from vulnerable populations. Methods In this empirically informed theoretical reflection, ethical perspectives on involvement of vulnerable populations in health research were explored using data collected within a public involvement evaluation project. By analysing observational and longitudinal qualitative data from research projects involving public representatives from vulnerable groups, ethical aspects were identified. Results Responsibility and decision-making appeared as important ethical aspects, where laws and regulations conflicted with involvement ideals. Similarly, reimbursement and recognition for public contributors became an ethical issue when facing legislation and bureaucracy, especially when involving children or refugees. Another ethical aspect concerned researchers’ concerns in balancing involvement and protection of vulnerable groups, especially when involving contributors living under unstable circumstances. Finally, effectively communicating around research and involvement in an accessible way, for contributors to be involved but not burdened, was a challenge for researchers. Conclusions Public involvement of vulnerable populations led to ethical challenges related to conflicting ideals and practical realities, including balancing involvement and protection of contributors. This highlighted a need for ethical guidance to support ethical decision-making and practice. The findings are used to guide the development of an ethical framework for decision-making in public involvement. Key messages • Researchers involving public contributors from vulnerable groups face ethical challenges which causes barriers to involvement. • There is need for guidance on ethical decision-making for researchers involving representatives from vulnerable groups in research.

International Research and Philanthropy

International Research and Philanthropy

The Concept of «Traditional Russian Spiritual and Moral Values» in the context of Ensuring Media Security on the Internet

The paper is devoted to the definition of the special legal term «traditional Russian spiritual and moral values» / «traditional spiritual and moral values of the peoples of Russia». The relevance of the study is due to its role in the field of legal provision of information security (as the underlying system for ensuring relevant strategic national priorities). This interdisciplinary scientific research is carried out at the intersection of such legal sciences as information law, criminology, theory of forensic examinations (forensic expert science) and judicial speech. According to the results of the study, the authors conclude that the use of the category «morality» in normative acts does not mean at all that it is permissible to substitute ethical legal regulation. The analysis of the content of the term «traditional Russian spiritual and moral values» as a composite special legal term that generalizes and designates an extensive group of legal concepts, the development of an appropriate list and its consolidation in legal acts should be carried out based on the legal nature of the listed phenomena, and based on their comprehensive legal assessment (establishing the degree of compliance / non-compliance with the law, the presence/absence of public danger). Based on this approach, the authors propose their understanding of the term «traditional Russian spiritual and moral values» and list them. The authors propose an approach based on the ranking of values according to the degree of their social significance and compliance with the norms of law, expressed in the division of the entire set of traditional Russian spiritual and moral values into the so-called core and periphery. Nuclear values are the most significant, at the same time uniform for the whole society, supported, and stimulated by the existing system of law. Around the core of the essential values, there is a belt of secondary, that is, separate, less widespread traditions, values and foundations of individual social groups of our society.

Democratising Ethical Regulation and Practice in Educational Research

This paper sets the context for questions covered in the Education Sciences Special Issue: Regulation and Ethical Practice for Educational Research: What are appropriate ethical appraisal and approval practices for particular contexts? How can ethics committees effectively support educational researchers and educational research? To do so, the paper argues for a democratising of ethical regulation and practice in educational research, which includes the decolonization agenda, to break away from enduring power imbalances in knowledge production. A key focus is on the regulation of educational research through ethics committees (whether institutional, regional and/or national) and how this affects research practice. While intended to help researchers to protect and benefit potential research participants, ethics committees themselves can have an important part to play in recognizing and removing barriers to inclusivity, as well as in erecting them, to maximise the benefits of educational research. To overturn the dominance of global North knowledge, for post-colonial research ethics regulation, broader conversations of researcher values and experiences in different parts of the world are needed. This paper explores how ethics committees’ expectations do and could shape researcher decision-making. It presents examples of approaches to ethical appraisal which would support empowerment and participation, not only for gatekeepers and participants but also for the research community, whether experienced researcher, ethics committee member or neophyte researcher. Evidence of ethical research practice which paves the way forward is drawn from a range of contexts to help acknowledge the enduring and wide-ranging impact of colonialism, neo-liberalism and neo-imperialism.

Ethical Models for Regulating the Visual Environment of a Digital City

The article considers mutual influence of ethics and visual environment of the city on the basis of descriptive models of ethical values and mechanisms of regulation. The historical aspect of the moral component of the urban environment is analyzed. Ethical collisions in the digital city are questioned. Mechanisms of ethical regulation of the visual environment of the digital city are systematized. Ways of increasing the role of social control, civic activity and digital culture of the population are suggested, to form moral responsibility for improving the quality of life of the citizens, their sustainable, prosperous future.

Can We Justify Military Enhancements? Some Yes, Most No.

The United States Department of Defense has, for at least 20years, held the stated intention to enhance active military personnel ("warfighters"). This intention has become more acute in the face of dropping recruitment, an aging fighting force, and emerging strategic challenges. However, developing and testing enhancements is clouded by the ethically contested status of enhancements, the long history of abuse by military medical researchers, and new legislation in the guise of "health security" that has enabled the Department of Defense to apply medical interventions without appropriate oversight. This paper aims to reconcile existing legal and regulatory frameworks on military biomedical research with ethical concerns about military enhancements. In what follows, we first outline one justification for military enhancements. The authors then briefly address existing definitional issues over what constitutes enhancement before addressing existing research ethics regulations governing military biomedical research. Next, they argue that two common justifications for rapid military innovation in science and technology, including enhancement, fail. These justifications are (a) to satisfy a compelling military need and (b) strategic dominance. The authors then turn to an objection that turns on the idea that we need not have these justifications if warfighters are willing to adopt enhancement, and argue that laissez-faire approaches to enhancement fail in the context of the military due to pressing and historically significant concerns about coercion and exploitation. The paper concludes with what is referred to as the "least-worst" justification: Given the rise of untested enhancements in civilian and military life, we have good reason to validate potential enhancements even if they do not satisfy reasons (a) or (b) above.

GASTROPROTECTIVE EFFECT OF CRUDE SERICIN POWDER, AGAINST ASPIRIN INDUCED GASTRIC MUCOSAL INJURIES IN RATS

Crude Sericin Powder, derived from the silk gland of silkworm (Bombyx mori) has many biomedical applications due to its antioxidant properties. In this present study , to evaluate the gastro-protective consequences of hydroxyl amino acid rich sericin solution on aspirin induced gastric mucosal injuries in albino rat models were tested following Institutional Ethical committee rules and regulations .In our experiments, 36 male Holtzman strain adult rats were considered and divided into Control group, Crude sericin treated group, Crude Sericin Pre-treated control group, Crude Sericin Pre-treated Aspirin treated group, Omeprazole treated control group and Omeprazole Pre-treated experiment group. AST, ALT and ALP, SOD, CAT, LPO, and GSH were measured of all groups. Crude Sericin Pre-treated group shows increase in UI, GSH, ALT ALP and AST activities, whereas it shows decrease in CAT and SOD activities.

Medico-Legal Cases Registered in the Casualty Department of a Teaching Hospital in Nepal

Medico-Legal Case (MLC) refers to any case of injury or ailment where some criminality is involved. The injury cases suggestive of criminal offense, burn injuries, vehicular accidents, suspected homicide, poisoning, and sexual assault are medico-legal cases. We conducted a descriptive study in Casualty Department of Teaching Hospital, Kathmandu, Nepal from May 1, 2019 to October 31, 2020. A total of 487 cases were registered. The cases were categorized according to the type of treatment they required. The record was obtained after informed consent of participants and with due assurance of confidentiality, ethical regulations and repute of the institution and individual. The data obtained was analyzed in SPSS version 21. Out of the total, 317 were male and 170 were female. The highest recorded cases were due to road traffic accidents (RTA) accounting for 167 (34.3%). The second highest was physical assault comprising 146 cases (30%) followed by fall injury 81 cases (16.6%). The study showed 48 poisoning cases (9.6%), followed by 14 cases (2.9%) of electric shock. Alcohol intoxication and trauma were eight (1.6%) each. Similarly, suicide and blast cases were six (1.2%) each. Likewise, occupational hazard and sexual assault were found one (0.2%) each, during this study period. The most common age group for medico-legal cases was 21-30 years and above 60 years were the least common. RTAs account the major part of Medico-legal cases in our study. By imparting proper education and awareness among public and medical students the frequency of these cases can be reduced.

The Impact of Scientific and Technological Progress in Biotechnology on Human Rights and Principles of Law

The paper raises ethical and social problems of biolaw, consideration of which is necessary to improve its principles and norms. The authors are convinced that biolaw is designed to take into account both the advantages and problematic aspects associated with the impact of new technologies on the human body that can change a person as a physical individual and, accordingly, transform society and humanity as a whole. The paper touches upon two key aspects of biolaw: the development of biorights or rights related to the human body in the system of rights of a new generation and the definition of principles of biolaw that ensure the unity of legal and ethical-social regulators in biotechnology. One of the important conclusions is that, although human biorights and the principles of biolaw are interrelated institutions, in the system of legal regulation they have features of content and action. Having identified the need to develop a new approach to understanding the principles of biolaw, the authors emphasize the need to create a theory of biolaw taxonomy or biotaxonomy, within which special importance should be given to the principles of biolaw as a dogmatic and sustainable means of legal regulation that form a systemic relationship with the principles of bioethics, constituting a single, dialectically interrelated homological series. Thus, the paper gives an opportunity to think about the development of the theory of biopraw and the prospects for its development in the paradigm of interaction with ethical and other social regulators.

LEGAL AND ETHICAL ASPECTS OF SOCIAL MEDIA USER PROVISION OF INFORMATION TO THE PUBLIC REGULATION: THE VIEW OF MEDIA REGULATORY AND SELF-REGULATORY BODIES IN LITHUANIA

Social media users are recognised to be a new actor in the field of public information. Their activities along with professional journalists’ activities of providing information to the public differ. The changing field of public information and peculiarities of providing information to the public by social media users prompt scientific discussions on social media regulation in relation to information provision to the public. The aim of the research is to determine the criteria for equating activities of information provision to the public by social media users with activities of public information professionals in the context of legal and ethical regulation of professional media. The research is carried out by analysing legal documents regulating the activities of Lithuanian media and social media, as well as decisions adopted by self-regulatory bodies and other institutions. Having conducted the research, it was established that in Lithuania the criteria for equating SM users to journalists are the criteria of journalistic activity (functionality) and journalistic professionalism. For acknowledgment that SM users provide information to the public like journalists, criteria of information publicity, dissemination, accessibility, and possibility of information control are raised.

Global Ethical Consideration and Accounting Practices in Nigeria

The poor culture of accounting practices in Nigeria, as well as manipulation of financial statements have attracted the attention of scholars’ overtime to question the role of global ethics on accounting practices in Nigeria. In view of this, the main objective of this study dealt on the conceptual review of global ethical consideration and accounting practices in Nigeria. The study employed a review of literature by past researchers on the discourse. In conclusion, the study found that in Nigeria the culture of accounting promotes creative accounting practices, income smoothing and window dressing. Based on the findings, the study recommended that culture should be given adequate consideration in enforcement of global ethical rules and regulation among practicing accountants in Nigeria. Furthermore, professional bodies like Institute of Chartered Accountants of Nigeria ICAN, Association of National Accountants of Nigeria and financial reporting council of Nigeria. Should work in concensus in order to comply effectively with IFRS and global ethical rules and regulations.

Practical aspects of the organization of ethical review of clinical trials in the context of the COVID-19 pandemic

The COVID-19 pandemic has greatly affected all spheres of life, including biomedical research. The ethical regulation of clinical trials has a long history in international and domestic practice. An efficient infrastructure of international and national legislation has been created. At the same time, there are features of the organization of ethical review of clinical trials that arise under the restrictions associated with COVID-19. Healthcare of all countries is faced with the need to develop new approaches caused by the speed of the spread of the disease, its severe consequences for the life and health of people, the excessive burden on the medical worker, not only physical, but also psychological, including those associated with ethical problems. The purpose of this research was to study and analyze the experience of ethical review of clinical trials in the context of the COVID-19 epidemic, its regulatory framework in international and domestic practice. For high-quality and lawful conduct of clinical trials in Russia in the context of the COVID-19 epidemic, appropriate conditions were created, namely, a vertical base: the central ethical committee of the Ministry of Health of the Russian Federation local ethical committees based in clinical institutions and research centers. They are provided with sufficient and high-quality legal support in the form of laws of the Russian Federation, country standards and by-laws. The work of local ethics committees is built in accordance with strict ethical international and domestic standards. Standard operating procedures implemented in local ethics committees provide for all the nuances of situations, including those implemented using modern telecommunication technologies and other end-to-end information technologies. Even if many restrictions are imposed, biomedical research must continue, and accordingly, it must be carried out under the strict control and monitoring of research ethics committees. The article presents an overview of legal sources, an analysis of the main approaches in domestic and foreign literature, taking into account historical retrospective.

Limitations and ethical reflection on the application of big data in museum visitor research

ABSTRACT In the past two decades, big data has been gradually introduced into visitor research of museums globally. However, there are technical limitations in data collection, such as sample deviation and data quality in data collection, and data analysis limitations, such as weakening causality and inaccurate judgement of human emotions. This has also raised many ethical issues, such as human subjectivity, privacy, and social justice in applying big data in museum visitor research. Thus, it is imperative to clarify the application scope of big data and formulate ethical regulations to promote the development of extensive data research methods for museum visitors.

In Vitro Models of Biological Barriers for Nanomedical Research.

Nanoconstructs developed for biomedical purposes must overcome diverse biological barriers before reaching the target where playing their therapeutic or diagnostic function. In vivo models are very complex and unsuitable to distinguish the roles plaid by the multiple biological barriers on nanoparticle biodistribution and effect; in addition, they are costly, time-consuming and subject to strict ethical regulation. For these reasons, simplified in vitro models are preferred, at least for the earlier phases of the nanoconstruct development. Many in vitro models have therefore been set up. Each model has its own pros and cons: conventional 2D cell cultures are simple and cost-effective, but the information remains limited to single cells; cell monolayers allow the formation of cell–cell junctions and the assessment of nanoparticle translocation across structured barriers but they lack three-dimensionality; 3D cell culture systems are more appropriate to test in vitro nanoparticle biodistribution but they are static; finally, bioreactors and microfluidic devices can mimicking the physiological flow occurring in vivo thus providing in vitro biological barrier models suitable to reliably assess nanoparticles relocation. In this evolving context, the present review provides an overview of the most representative and performing in vitro models of biological barriers set up for nanomedical research.

Development and validation of prognostic models for anal cancer outcomes using distributed learning: protocol for the international multi-centre atomCAT2 study

BackgroundAnal cancer is a rare cancer with rising incidence. Despite the relatively good outcomes conferred by state-of-the-art chemoradiotherapy, further improving disease control and reducing toxicity has proven challenging. Developing and validating prognostic models using routinely collected data may provide new insights for treatment development and selection. However, due to the rarity of the cancer, it can be difficult to obtain sufficient data, especially from single centres, to develop and validate robust models. Moreover, multi-centre model development is hampered by ethical barriers and data protection regulations that often limit accessibility to patient data. Distributed (or federated) learning allows models to be developed using data from multiple centres without any individual-level patient data leaving the originating centre, therefore preserving patient data privacy. This work builds on the proof-of-concept three-centre atomCAT1 study and describes the protocol for the multi-centre atomCAT2 study, which aims to develop and validate robust prognostic models for three clinically important outcomes in anal cancer following chemoradiotherapy.MethodsThis is a retrospective multi-centre cohort study, investigating overall survival, locoregional control and freedom from distant metastasis after primary chemoradiotherapy for anal squamous cell carcinoma. Patient data will be extracted and organised at each participating radiotherapy centre (n = 18). Candidate prognostic factors have been identified through literature review and expert opinion. Summary statistics will be calculated and exchanged between centres prior to modelling. The primary analysis will involve developing and validating Cox proportional hazards models across centres for each outcome through distributed learning. Outcomes at specific timepoints of interest and factor effect estimates will be reported, allowing for outcome prediction for future patients.DiscussionThe atomCAT2 study will analyse one of the largest available cross-institutional cohorts of patients with anal cancer treated with chemoradiotherapy. The analysis aims to provide information on current international clinical practice outcomes and may aid the personalisation and design of future anal cancer clinical trials through contributing to a better understanding of patient risk stratification.

Principlism and citizen science: the possibilities and limitations of principlism for guiding responsible citizen science conduct

Citizen science (CS) has been presented as a novel form of research relevant for social concerns and global challenges. CS transforms the roles of participants to being actively involved at various stages of research processes, CS projects are dynamic, and pluralism arises when many non-professional researchers take an active involvement in research. Some argue that these elements all make existing research ethical principles and regulations ill-suited for guiding responsible CS conduct. However, while many have sought to highlight such challenges from CS, few have discussed principles per se providing the foundation for regulations. In this article we will investigate the possibilities of midlevel principlism in guiding responsible CS conduct. Principlism has the potential of accommodating many of the concerns taken to reduce the relevance of existing principles.

The Relationship of Pragmatic Language Competency and Self-Esteem in Hearing-Impaired Children

Background and aim: It is suggested that hearing impaired children with hearing aids and cochlear implant, showed poor pragmatic abilities. Pragmatic is the most related language component to social interaction. Further, it has effect on personality development and self-esteem. The main aim of the present study is investigating the relationship between pragmatic abilities and self-esteem in hearing impaired children. Materials and methods: sixty hearing impaired children with hearing aids or cochlear implant were included into this study according to inclusion and exclusion criteria. Then parents or other caregivers were asked to fulfill Children’s Communication Checklist (CCC) and self-esteem questionnaire. The participants were divided into three groups based on hearing impairment severity, including: severe, moderate and mild. The relationship between pragmatic ability and self-esteem was examined in three groups and without considering categorization, by Pearson correlation coefficient, significant level was 0.05. Ethical considerations: This project is approved in Arak university of medical sciences with ethical registration code IR.ARAKMU.REC.1399.150. All parents gave written informed consent form. findings: the results illustrated that there is significant relationship between pragmatic abilities and self-esteem in all hearing impairment children without considering categorization (p<0.05). By considering categorization, significant relationship was showed in self-esteem and pragmatic abilities in moderate and mild groups (p<0.05). Conclusion: according to our analysis, pragmatic abilities and self-esteem are related. This relationship is more obvious in low severity impairment.