Ethical Regulation Research Articles

Relational research ethics and disengagement from collaborative research projects in higher education: A conceptual analysis

Research collaboration is a common practice in higher education, and so is the discourse of research ethics. However, the colonial orientation of some research as well as the managerial models of higher education practices undermine the connectedness and relationality of collaborative research. In this article, I argue this point with a focus on disengagement or withdrawal of collaborators from research projects before they are completed. I argue that this practice has ethical implications at various levels, especially the level of the researched or colonised communities. Drawing from multi-disciplinary literature, I follow a conceptual analysis method, focusing on research collaboration, research ethics and disengagement. The article identifies the types and benefits of collaborative research, as well as common reasons and ethical implications of disengagement from such projects. It concludes by recommending an extension of research ethics regulations to incorporate disengagement, in consideration of the relationality of collaborative research projects. Keywords: collaborative research, disengagement, relational ethics, managerialism, higher education

ПСИХОЛОГІЧН ІВИТОКИ КОРУПЦІЇ

Considering the fact, that the vast majority of research on corruption is carried out in the field of law and economics, the purpose of this article is to single out the psychological origins of corruption, which are directly related to the problem of the effectiveness of overcoming it. A deep interrelationship of existential and psychological factors of corruption, which in the context of the spiritual situation of society act as synonyms, has been established. It is noted that in modern studies of corruption, there is a tendency to consider this phenomenon as a "problem of macropsychology", which not only reveals its social, political, and economic aspects, but also sees in it a general spiritual and civilizational problem. It is emphasized that corruption occurs at the intersection of economic, existential and psychological factors. The theoretical approaches of philosophers and psychologists (A. Bandura, E. Fromm, J. Lypovetsky, etc.) to the study of the nature of modern consumer society and the spiritual sense of well-being of a person in such a society are analyzed. Emphasized is the position that excessive consumption acts as a compensator for anxiety. The need for this type of consumption comes from a feeling of inner emptiness, hopelessness, mental confusion, and tension. The direct connection between consumption and spiritual instability of a person is emphasized. The relentless growth of needs while minimizing ethical regulators stimulates the finding of various (unethical and illegal) forms of meeting these needs, which opens a wide path for corruption. It is noted that consideration of the psychological mechanisms of the formation of corrupt behavior contributes to a deeper penetration into the essence of this phenomenon; and the psychological analysis of corruption reveals its important aspect, which is rooted in dependence on consumption. Such a spiritual illness of modern society contributes to the development of corrupt motives and, accordingly, corrupt acts. Three main psychological origins of corrupt behavior are singled out: deprivation; frustration and deviance. Moreover, it is stated that the study of corruption within the framework of deviantology gives the greatest positive effect, because in this case, the negative methods of fighting corruption can be opposed by a positive method.

IMPLEMENTATION OF GOOD GOVERNANCE BUSINESS SHARIA (GGBS) IN ISLAMIC BANKING IN INDONESIA

In the development of Sharia banking with the merger of several Sharia Banks to become Bank Indonesia Shariah (BIS), is hoped that it can progress very rapidly, as is the case of Islamic banking in Indonesia which has grown significantly. The development of Sharia banking must be accompanied by good governance so that it is not only a tag line for Islamic financial institutions. The Standard Operating Procedure of Islamic banking must be carried out properly based on Sharia principles. Therefore, Bank Indonesia issued Bank Indonesia Regulation No. 11/33/ PBI 2009 concerning the Implementation of Sharia Business Governance (GGBS) for Sharia Commercial Banks (BUS/ Bank Umum Syariah) and Sharia Business Units (UUS/ Unit Usaha Syariah). The five principles are: Transparency, Accountability, Responsibility, Professionalism and Fairness or equality. GGBS is a banking management system designed to improve compliance with the prevailing moral ethics laws and regulations. According to Chapra, the implementation of Good Corporate Governance is a requirement for Sharia Banks to develop properly and in accordance with Sharia compliance. The implementation of GGBS in Sharia banking is expected to create a business that is healthy, conducive, transparent and efficient and a blessing.

CRISPER/cas9-Human Germline Gene Editing: Study of Islamic Ethical and Scientific Perspectives

The advancement of technology in medical science has just changed human lives, as well as biomedical innovations are making human lives better but lesser harmful. In past, scientifically and religiously approved techniques such as testtube baby & human stem cells therapy have served humanity especially infertile and connubial parents. Nowadays, the advancement in CRISPER/cas9 technology which is about human germline gene editing, just rekindled the religious and ethical concerns, especially in Islamic perspectives. Although, human germline genome editing and modification have been started decades ago claims about disease prevention strategies have raised many religious concerns such as tampering with God’s creation, human dignity, safety and efficacy of the technology, and human genetic enhancement. This kind of editing might result in inheritable changes in the human genome. So, questions about its status whether it should be allowed or not, need deep & serious study from religious and ethical perspectives. This study will encompass Islamic perspectives on these concerns in the light of ethical principles of Islam while considering and assessing the permissibility or lawful status of CRISPR/Cas9 mediated human germline gene editing. This research study also aims to address the controversial discussions among Muslim jurists regarding human germline gene editing as well as to comprise the related ethical regulations and concerns.

Galleria mellonella as a Suitable Model of Bacterial Infection: Past, Present and Future.

The increasing interest for Galleria mellonella larvae as an infection model is evidenced by the number of papers reporting its use, which increases exponentially since the early 2010s. This popularity was initially linked to limitation of conventional animal models due to financial, technical and ethical aspects. In comparison, alternative models (e.g. models using Caenorhabditis elegans, Drosophila melanogaster or G. mellonella) were cheap, simple to use and not limited by ethical regulation. Since then, similar results have been established with G. mellonella model comparatively to vertebrates, and it is more and more often used as a robust model per se, not only as an alternative to the murine model. This review attempts to summarize the current knowledge supporting the development of this model, both on immunological and microbiological aspects. For that, we focus on investigation of virulence and new therapies for the most important pathogenic bacteria. We also discuss points out directions for standardization, as well as recent advances and new perspectives for monitoring host-pathogen interactions.

在中國的科研倫理規範體系建設中重視公眾參與

LANGUAGE NOTE | Document text in Chinese; abstract also in English.
 It is an inspiring idea that public participation should be the key factor for determining the human embryo research policy. However, public participation is missing from the Chinese government's vision of an ethics regulation system for scientific research. This article argues that to develop human embryo research policy for China and a new regulation system globally, the most important tasks may be to set rules for public participation and to understand the views on human embryo and cell-based embryo research ethics held by different stakeholders and the Chinese public.

Етичні кодекси міських рад як важливі засоби регулювання службової поведінки депутатів та посадовців

Виокремлено основні відмінності кодексів поведінки та етики. На основі аналізу змісту та структури окремих кодексів етики депутатів та етичної поведінки посадовців, ухвалених міськими радами, виявлено їх переваги та недоліки. Наголошено на потребі удосконалення порядку розгляду повідомлень про порушення депутатами та посадовцями норм поведінки та акцентовано на необхідності запобігання проявам неетичної поведінки шляхом організації регулярних тренінгів на етичну тематику, спрямованих на формування очікуваних стандартів поведінки.

Ethical regulation of economic relations: agenda change and values correction

The article deals with the current situation in the field of ethical regulation of economic relations. The author shows that interest in the ethical regulation of the economy increases during the transitional historical periods, which are characterized by a fundamental transformation of all aspects of societys life, both the formation of capitalism and the formation of Industry 4.0. The idea of replenishing ethical standards in the field of professional labor activity is substantiated on the open data of sociological research, the theoretical separation of market and ethical thinking, the contraction of the sphere of pure ethical regulation (М. Sandel). It is expressed in the transition from the recognition ethics to the trust ethics, the latter goes beyond the boundaries of interpersonal relations, forming a culture of institutional trust. Modern practices of ethical codification of companies activities are greatly influenced by the problems of the value dimension of digitalization, automation, artificial intelligence, green economy, inclusion in the business culture of organizations.

Legal and ethical regulation of genetic research

The paper deals with the problems of genetic research regulation stemming from the peculiarities of this area of knowledge where research is practically inseparable from patient treatment, and cognitive practices are connected with the development and implementation of new devices, methodologies, and technologies to a much greater extent than in other areas of human activity. The issues of genetic research regulation are analyzed in the context of the concept suggested by Helga Nowotny and Giuseppe Testa distinguishing three human technologies of standardization through which control over the development of knowledge about genes is exercised. These three technologies are law, governance and bioethics, and the efficiency of their interaction is declared a necessary and sufficient condition for the successful development of molecular genetic sciences. The paper examines all the three technologies one by one, identifies the specifics and difficulties of their implementation in present-day Russian science, and assesses the genetic research prospects assuming the implementation of the aforementioned technologies. Particular attention is paid to institutionalization of ethics committees as an element of the genetic research regulation system. Substantiation is provided for the thesis that ethical committees should act as an institution combining rulemaking, management, and expert functions rather than as a structure capable of performing advisory and recommendatory functions only. The ability of the Russian society and state to withstand the grand challenges of our time is associated with the success in solving this problem.

The doctrine of double effect in ethics education

Ethics education is a vast term for learning experiences aimed to assist students in developing ethically, whether in terms of increased ethical awareness and understanding or greater motivation to act ethically in the world. The article discusses the doctrine of double effect in the context of ethical education between deontology and consequentialism. The authors note that it is impossible to agree the doctrine of double effect with contrarian normative positions. In the first part of the article, authors argue in favor of the doctrine of the double effect as an independent ethical principle. In the second part of the article, authors consider the doctrine of double effect by using the example of an armed conflict situation in the terms of international humanitarian law. The main thesis of the article is that the doctrine of double effect should be considered as a universal presupposition of both ethical and educational regulation.

From Neuroethics to Neo-romanticism. Aldous Huxley in Response to Current Proposals for Ethical and Legal Regulation of Neuroscience

The neuroethics field emerged in the early 2000s in an effort to face important philosophical dilemmas and anticipate disruptive social changes linked to the use of neurotechnology (Safire, 2002). From very early on, this field grew out of two core issues, namely inquiries into the ethics of neuroscience –concerning the moral use of knowledge and technology– and inquiries into the neuroscience of ethics –on how new brain function evidence can change human self-understanding (Roskies 2002). Similarly, neurolaw is now on a parallel path with two main pillars as Chandler (2018) suggested, (1) “self-reflexive inquiry” (the neuroscience of law) and (2) “inquiry into the development and use of brain science and technologies” (the law of neuroscience). In this paper, I suggest that these two lines of research are still excessively disconnected from one another and, to support this claim, I analyze the three potential point-of-no-return risks that Aldous Huxley associated with technological challenges, namely centralization of power, bureaucratic alienation, and scientific idealism. In addition, I show how Huxley shifted analysis of technological problems from a focus on the rights of potential victims to the duties of potential aggressors. Finally, I argue that Aldous Huxley’s view on how to build a bridge that brings pillars 1) and 2) closer together also helps prevent the technological point-of-no-return. According to Huxley, the key is found in paying particular attention to understanding contemplative activity, reinforcing its role in the study of reality, and, eventually, returning the romantic gaze updated to academia.

When journalists lose their foothold

The global #MeToo movement exposed the widespread structural problem of sexual harassment, which was also the case in Sweden and Norway. Across the various sectors of working life, women were able to identify with the call. This perspective, however, was under- mined in the public sphere when person-centred scandal stories about a few powerholders and media celebrities took over. In addition, a lack of verifiable documentation – and uncritical use of anonymous sources – ignited renewed debates about the ethical standards of professional journalism. This article discusses two alleged #MeToo cases: Aftonbladet’s dramatic and unfounded accusations against the theatre CEO Benny Fredriksson and VG’s misuse and manipulation of a “bar-dance” episode involving the Norwegian Labour politician Trond Giske. Both media stories developed into “critical incidents”, resulting in public criticism, self-examination and discussions around ethical rules and regulation.

SNMMI Clinical Trials Network Research Series for Technologists: Ethical Issues and Regulations in the Medical Workplace.

Ethical principles and laws have developed as medical practice and research have grown. This article discusses regulatory policies in patient care and the governing bodies that provide oversight. These include but are not limited to the Food and Drug Administration, Office for Human Research Protection, Code of Federal Regulations, Nuclear Regulatory Commission, Joint Commission, Health Insurance Portability and Accountability Act, Occupational Safety and Health Administration, World Health Organization, and International Conference on Harmonization. This article reviews ethical requirements in clinical research and provides examples of medical mistreatment that forced the development of these rules and regulations. Some include the Nuremberg Code, Declaration of Helsinki, and Belmont Report; good clinical practice; and the Common Rule. Several specific research documents are discussed further in this continuing education series. These guiding documents and principles are important because every patient and research subject deserves a safe environment with safe products and protection of privacy. Individuals deserve to understand their role in medicine and clinical research, have the right to refuse care, make informed decisions, know the risks and benefits included, and ultimately have their individual choices respected.

Level of exclusive breastfeeding and its enabling factors among lactating women who delivered in health facilities of Asosa town, Ethiopia: a cross sectional study

BackgroundDespite the enormous benefit of exclusive breastfeeding (EBF) to mothers and infants, the practice of exclusive breastfeeding is globally low. In sub-Saharan Africa and Ethiopia, the prevalence of EBF stands at 35% and 59%, respectively. The low EBF practice in Ethiopia as well as in the studied region calls for further study and thus we studied the EBF practice in the study area since little is known about its current magnitude and factors influencing its practice for some programmatic improvements.MethodsA facility based cross-sectional study linked to a community was conducted from June-July 2019 among 412 mothers who had antenatal follow-up and delivered in health facilities of Asosa town over a period of one year prior to the study. Data on socio demographic characteristics and other important variables were collected through face to face interview while gestational age in weeks was recorded from their medical chart by trained health extension workers in accordance with relevant ethical guidelines and regulations. The collected data were then cleaned and entered into Epi-data software version 3.02. Analysis was done by SPSS version 20. Binary and multivariate logistic regression were performed to identify the contributing factors. P-value of less than 0.05 and 95% confidence interval was considered to determine statistical significance.ResultsOf the 412 respondents, the majority (88.1%) were multi-gravida and above. Slightly higher than a quarter (26.0%) and over half (55.4%) had neither received antenatal nor postnatal care. The proportion of mothers who exclusively breastfed their children was 76.0% and the overall aggregated good practice of EBF score was 64.1%. Mothers who completed primary school [AOR = 4.5; 95% CI = 1.1,18.2], had four or more ANC [AOR = 1.8;95CI = 0.79–0.98], and postnatal follow-up [AOR = 0.21;95% CI = 0.07–0.67], and had male infants [AOR = 2.3; 95% CI = 1.0–4.95] were among the factors influencing the exclusive breastfeeding practice score.ConclusionWhile three in four mothers exclusively breastfed their newborns and about two-thirds had good EBF score, the observed women’s retention on the continuum of the maternal care pathway is low with one in four had no antenatal and over half had no postnatal care which are important derivers for EBF practice. To improve the EBF score and narrow the observed maternal and child health disparities, it is essential to promote maternal education and increase the recomended coverage of antenatal and postnatal care for mothers.

P048 A NEW MODALITY FOR BIOMECHANICAL VALIDATION OF CLOSURE TECHNIQUES OF LAPAROTOMIES

Abstract Aim Incisional hernia remains one of the most frequent complications after abdominal surgery. Several closure techniques exist. However, fundamental biomechanical understanding of these techniques and of the differences in clinical outcomes are still lacking. It is thought that distribution of lateral forces on the midline plays a role. Testing in a clinical setting is limited by sample sizes, costs and ethical regulations. We propose a preclinical ex vivo model in which multiple closure configurations can be tested in a controlled setting, eliminating interfering variables existing in previously published, more complex abdominal wall models. Consequently, this allows a valid comparison between closure modalities based on biomechanical merits. Material and Methods The experimental set-up is represented by a vertical tensile load tester, in which a sutured tissue sample is clamped. The tissue samples are covered with a fine, random speckle pattern via miniscule ink droplets. A high-resolution camera captures the speckles as the tissue is subjected to linear pulling forces. Image analysis documenting relative movement of speckles as a means for measuring tissue deformation is performed in ex-vivo tissue samples, resulting in specific objective biomechanical characteristics for each closure configuration. Results Local tissue strain fields are visualized, and compared between closure modalities and correlated to known linear forces applied to the tissue. The latest results will be shared and discussed. Conclusions A new modality for biomechanical evaluation of closure techniques has been developed. Further validation and serial experiments with different closure modalities with and without mesh reinforcement can be performed in order to determine the biomechanically optimal suture-technique for fascial closure.

Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road.

This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: (a) the data protection regime which follows the application of the European Union General Data Protection Regulation (GDPR), and (b) the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper.

Bioethics: from Enlightenment to return

Based on the concept adopted by the Russian legislator in the field of bioethics, the articleanalyzes aspects of the formation of moral and ethical regulations as a subject of legal regulation, a historical review of the features of the perception by the individual and society of ethical norms as criteria for self-restraint of the possibility of choosing options for lawful or unlawful behavioris given. The transformation of law from the age of enlightenment to the era of return to ethical institutions is shown both in the historical periods of the outgoing era and in the examples of negative law-making of contemporaries, in order to leave the norms of ethics outside the national order.The traditional explanation of the dominance of such an approach to the legal regulation of ethical institutions is reduced to the absence of objects of legal support due to the fact that ethics is not a legal, but a moral one. De facto ethical norms are introduced into the modern legal order of the Russian Federation at the level of law enforcement activities, for example, through the adoption of Codes of Professional Ethics. The expediency of formation in Russia of the National Council on Bioethics and Biosafety is substantiated.

The informed consent in the mature minor: Understanding and decision-making capacity

IntroductionThe informed consent of the minor is a fundamental requirement of paediatric research. There is a lack of harmonisation as regards the age of the mature minor to consent, and there are no systematic tools available to assess competence in decision-making capacity. The objective of this work is to analyse the ethical and legal situation of consent by minors, as well as studies that use an objective assessment tool in the mature minor. Material and methodsSystematic review of scientific articles in PubMed, Embase and the Grey Literature, published with keywords “informed consent minors”, without date restriction until March 2019. Abstracts and a selection of complete articles were reviewed following a protocol including identification, screening, eligibility, and inclusion. ResultsOf the 260 records identified, 139 were excluded. After categorising the resulting 121 publications, 13 were finally selected following the eligibility criteria, including 7 articles on international ethical and legal regulations and 6 on understanding and decision- making capacity assessment. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) semi-structured interview was used in 4 studies, including different age ranges (6–21 years) in healthy and sick children. ConclusionsThe semi-structured MacArthur interview adapted to adolescents could be an appropriate tool with robust psychometric measures for assessing competence for the informed consent of minors between 9 and 12 years of age. The regulation of informed consent in paediatric research should consider this evidence.

REGIONAL OPPORTUNITIES AND ETHICAL RISKS OF MEDICAL TOURISM (ON THE EXAMPLE OF THE VOLGOGRAD REGION)

Abstract. The article examines medical tourism as a promising area of modern health care within the framework of the federal project "Development of the export of medical services", part of the national project "Health". The authors examine the possibilities of regional health care within the framework of the project "Development of medical services export in the Volgograd region". The data on the number and geography of visitors, financial revenues to the regional budget for the ensuring, paid medical services are presented. The risks of regional health care that hinder the development of medical tourism are described and the ways to avoid them are indicated. At the present stage of the development of Russian healthcare, the provision of medical tourism services is not legally formalized, so more attention should be paid to ethical regulation in this area.

A randomized clinical trial of hyaluronic acid gel pulpotomy in primary molars with 1 year follow-up

Objective This randomized clinical study aimed to evaluate the success of hyaluronic acid (HA) as a pulpotomy medicament of human primary molars and to compare it with formocresol (FC) and ferric sulphate (FS) pulpotomy treatments up to 12 months. Materials and methods The study was conducted with 130 primary molars of 44 children. The ethical approval and registration to clinical trials (No: NCT04115358) were completed. After the removal of all the coronal pulp tissue, a 0.5% HA gel, or a FC, or a 20% FS solution were applied randomly to the radicular pulp tissues of the primary molars. Then, the pulp chambers were filled with a zinc oxide eugenol cement and restored either with a composite filling material or with a stainless-steel crown. The treatment success rates of the 3 groups were followed and compared clinically and radiographically at 1st-, 3rd-, 6th- and 12th-months. Results Primary molars treated with FC, FS and HA dressings were clinically successful 77.5%, 86.8% and 87.5% respectively after 12th-month follow-up (p > .05). Radiographic successes of FC, FS and HA groups were lower than clinical successes (57.6%, 68.8%, 57.9% respectively at the 12th-month) but the difference between the groups was not statistically significant (p > .05). Equivalence analysis assuming not more than 10% difference between the materials suggested that HA was not inferior to FC or FS. Conclusions Within the limitations of this study, our randomized clinical trial shows that HA is a promising pulpotomy medicament in primary molars. However, further studies are justified to further improve the HA material success.