Ethical concerns in e-social science are often raised with respect to privacy, confidentiality, anonymity and the ethical and legal requirements that govern research. In this article, the authors focus on ethical aspects of e-research that are not directly related to ethical regulatory framework or requirements. These frameworks are often couched in terms of benefits or harms that can be incurred by participants in the research. The authors shift the focus to the sources of value in terms of which benefits or (...) harms are understood in real social situations. A central claim of this paper is that the technologies that are used for research are not value neutral, but serve to reinforce some values at the expense of others. The authors discuss databases, modelling and simulation, network analysis as examples of technologies which affect the articulation of values. A view of e-social science as a techno-scientific constellation of researchers, technologies and society, in which values are always already embedded, is put forward as a basis for a view of ethics as reflexive and active engagement, conducted with awareness. Methodological pluralism and proactive openness are also proposed as responses to this view of the ethical dimensions of e-social science. (shrink)

ABSTRACT The ethical aspects of placebo control in clinical trials have been extensively and controversially debated in the last decade. However, a thorough analytical comparison of the different existing international regulations, their terminologies and their ethical principles concerning placebo, is still missing. The central issue in the ongoing controversy is the justification of placebo‐use, if proven treatment exists. All present versions of the examined guidelines propose such justifications, but each guideline differs from the others in relevant details. Therefore the (...) conditions justifying placebo‐use according to each guideline are the focus of our attention. We will first propose a formalized general principle that defines the ethical acceptability of placebo‐use. Then we will analyse three categories of conditions put forward by the different documents: the risk of harm or burden, compelling scientific reasons, and the availability of proven treatment. The analysis shows important normative discrepancies and contradictions between the examined guidelines. Especially striking is the fact that some guidelines allow the participants in clinical trials to be exposed to a risk of serious harm, while others do not. Finally, we try to show how the normative difference of each guideline could influence the decision of researchers or IRBs concerning the ethical acceptabililty of placebo‐use. (shrink)

This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: the data protection regime which follows the application of the European Union General Data Protection Regulation, and 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. (shrink)

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" (§ 45CFR46.404); or 2) no more than a "minor increase over minimal risk" if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition (§ 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations (...) have helped IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations § § 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria. (shrink)

The ethical aspects of placebo control in clinical trials have been extensively and controversially debated in the last decade. However, a thorough analytical comparison of the different existing international regulations, their terminologies and their ethical principles concerning placebo, is still missing. The central issue in the ongoing controversy is the justification of placebo‐use, if proven treatment exists. All present versions of the examined guidelines propose such justifications, but each guideline differs from the others in relevant details. Therefore the conditions (...) justifying placebo‐use according to each guideline are the focus of our attention. We will first propose a formalized general principle that defines the ethical acceptability of placebo‐use. Then we will analyse three categories of conditions put forward by the different documents: the risk of harm or burden, compelling scientific reasons, and the availability of proven treatment. The analysis shows important normative discrepancies and contradictions between the examined guidelines. Especially striking is the fact that some guidelines allow the participants in clinical trials to be exposed to a risk of serious harm, while others do not. Finally, we try to show how the normative difference of each guideline could influence the decision of researchers or IRBs concerning the ethical acceptabililty of placebo‐use. (shrink)

The World Health Assembly adopted the new International Health Regulations on May 23, 2005. The new IHR represent the culmination of a decade-long revision process and an historic development for international law and public health. The new IHR appear at a moment when public health, security, and democracy have become intertwined, addressed at the highest levels of government. The United Nations Secretary-General Kofi Annan, for example, identified IHR revision as a priority for moving humanity toward “larger freedom.” This article (...) analyzes the new IHR and their implications for global health and security in the 21st century.The WHA instructed the WHO Director-General to revise the IHR in 1995 because the Regulations did not provide an effective framework for addressing the international spread of disease. Doubts about the IHR's effectiveness had, however, been present long before 1995. The critiques identified the narrow scope of the regulations, the lack of compliance by states, and the absence of a strategy for responding to rapid changes in public health's global economic and technological environments. (shrink)

Deception is a useful methodological device for studying attitudes and behavior, but deceptive studies fail to fulfill the informed consent requirements in the U.S. federal regulations. This means that before they can be approved by Institutional Review Boards, they must satisfy the four regulatory conditions for a waiver or alteration of these requirements. To illustrate our interpretation, we apply the conditions to a recent study that used deception to show that subjects judged the same wine as more enjoyable when (...) they believed it had a higher price. (shrink)

Business Ethics, the Environment & Responsibility, Volume 31, Issue 2, Page 323-345, April 2022.

The ethical (and philosophical) issues arising in citizen science are fascinating, challenging, and potentially pathbreaking in that they force us to reconsider the conceptual and regulatory catego...

In this paper we examine some of the economic and ethical consequences of different credit market regulations, including usury laws, complete prohibition of interest and providing ease to the borrower upon default. The references to these credit market regulations can be found in many religious and moral philosophy texts. We first examine the effectiveness of these regulations in deterring exploitative lending by developing a model that shows lending can be regulated through either act-based or harm-based regulations. (...) We show that act-based regulations which comprise usury laws and complete prohibition of interest deter lenders more than harm-based regulations which constitute bankruptcy laws. We then analyze that while the regulations may deter certain forms of lending behavior, they may also create certain externalities by contributing towards inequity and societal risk. We propose that a regulator’s choice of implementing credit market regulations maybe dependent on her ethical commitment towards growth and reduction of inequity. We suggest the usury laws are more ethical than bankruptcy laws; however, discouraging the use of debt contracts through prohibition of interest and encouraging the use of risk sharing contracts maybe the most ethical way to regulate the credit markets. (shrink)

In Islamic law paternity is treated as a consequence of a licit sexual relationship. Since DNA testing makes a clear distinction between legal and biological paternity possible, it challenges the continued correlation between paternity and marriage. This article explores the foundations of paternity regulations in the Islamic ethico-legal tradition, with a particular focus on what is termed here “the licit sex principle,” and investigates the extent to which a harm-based argument can be made either by appeal to or against (...) Islamic paternity regulations. It argues that in Islamic bioethics the definition of harm and its boundaries is a function of both: (1) identification of legal and religious rights and the extent to which these rights are violated; and (2) balancing and reconciling perceived harm against both specific principles in relation to a given issue and also the overarching objectives of Islamic law. The article is divided into three main sections addressing the Islamic legal, ethical, and bioethical dimensions of paternity. (shrink)

Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s, international regulatory frameworks defined the paediatric population as vulnerable due to unaddressed public health needs. More recently, ethical recommendations have promoted the active engagement of minors as research partners. In this paper, (...) I adopt a post-structuralist approach to policy analysis to examine deep-seated assumptions and presuppositions underlying the changes in the problematisation of children as biomedical research participants over time. While biomedical research ethics focuses on the autonomy and vulnerability of minors, ethical guidelines are situated in specific sociocultural contexts, shaped, among other things, by contingent public health needs and changing conceptions of the value of research and science for society. In the process, I demonstrate the challenge of moving away from an approach that in taking adults as the model overshadows the complexity of children’s lived experiences as well as their personal, cultural, and social lives. The lack of acknowledgement of this complexity makes children vulnerable to epistemic injustice, which is particularly crucial to address in public involvement initiatives. (shrink)

Because of China’s tremendous increase in foreign direct investment over the past two decades, this method of internationalization has become increasingly significant for companies worldwide. Heavy industry’s dominant role in China’s industrial structure must be modernized to ensure the country’s long-term growth and prosperity. There are 30 provinces in China covered by this dataset, which dates back from 2005 to 2018. Augmented mean group and common correlated effects mean groups estimations demonstrate that China’s industrial upgrading and resource allocation considerably impact (...) FDI inflows. The findings show that FDI inflows appear to be negatively affected by environmental rules. The results show that industrial upgradation and environmental regulations have not had the expected effect on FDI in China without the participation of other stakeholders. For the selected panel, the results from the control variable show that population aging reduces foreign direct investment inflows, whereas, economic growth increases FDI inflows. According to our findings and those of the empirical study, we make some policy proposals to help Chinese provinces attract more foreign direct investment by encouraging and upgrading the screening of such investments. (shrink)

In their 2010 article ‘Research Integrity in China: Problems and Prospects’, Zeng and Resnik challenge others to engage in empirical research on research integrity in China. Here we respond to that call in three ways: first, we provide updates to their analysis of regulations and allegations of scientific misconduct; second, we report on two surveys conducted in Hong Kong that provide empirical backing to describe ways in which problems and prospects that Zeng and Resnik identify are being explored; and (...) third, we continue the discussion started by Zeng and Resnik, pointing to ways in which China's high-profile participation in international academic research presents concerns about research integrity. According to our research, based upon searches of both English and Chinese language literature and policies, and two surveys conducted in Hong Kong, academic faculty and research post-graduate students in Hong Kong are aware of and have a positive attitude towards responsible conduct of research. Although Hong Kong is but one small part of China, we present this research as a response to concerns Zeng and Resnik introduce and as a call for a continued conversation. (shrink)

The study aimed to identify the role of administrative procedures and systems in enhancing the performance of the educational institutions in the Islamic University in Gaza. To achieve the research objectives, the researchers used the analytical descriptive approach to collect information. The researchers used the questionnaire distributed to three categories of employees at the Islamic University (senior management, faculty members, their assistants and members of the administrative board). A random sample of 314 employees was selected and 276 questionnaires were retrieved (...) with a recovery rate of 88.1%. The Statistical Analysis Program (SPSS) was used to enter process and analyze data. The results of the research showed a positive role for the administrative procedures and systems in enhancing the performance of the Islamic University from the point of view of the members (senior management, teaching staff and their assistants and the administrative body), where the relative weight of all the paragraphs (73.728%). The analysis of the results revealed that the administrative procedures at the Islamic University in Gaza are used to an acceptable degree. The relative weight of all the paragraphs is 70%. This indicates a relationship between administrative procedures and regulations and the performance of the Islamic University in the Gaza Strip. The study found that there was a good degree of approval from the sample regarding the administrative procedures and their relationship to the job performance. There exist a sufficient degree of powers to the deans and department managers to carry out their tasks, with the use of plans as control tools. And that there are rules and procedures provided for decision-making in the University Council. It also has full powers to manage the university to improve the teaching and learning environment. The researchers also recommended a number of recommendations, including the need to follow up on the procedures and systems of management and update them continuously in the light of changes that may occur and to ensure the existence of a strong system of electronic information systems within the university. There is a need to provide mechanisms for obtaining information about the surrounding external environment, and effective mechanisms to provide managers with the necessary information in a timely manner. The importance of providing channels of communication that enables staff to communicate information about any violations and breaches. The study also recommended the follow-up, review, procedures and administrative systems, and work to modify them in line with the mission of the university and the objectives that the university seeks to reach. (shrink)

The ideal city of Plato could only come true if three great and unlikely changes were made in the state. Neither Plato's contemporaries nor later generations have been able to breast the second of these ‘waves,’ which brings in a new order of marriage for guardians. The scheme is condemned as not only not good or possible—the Platonic tests—but as inconsistent with itself and with the account given in the Timaeus. The parts under censure are the so-called table of prohibited (...) affinities and the sanction of infanticide. It would be strange to find discrepancies in a proposal so important for Plato's state that details cannot well be left to some Damon, and I hope to show that difficulties arise only when critics do not place themselves exactly at Plato's point of view. He conceived a certain problem with sharp outlines, and his answer is precisely adapted to that. The first wave left the guardians as a family of men and women living in common. How was it possible to preserve this communal life and provide for the future of the guardian class? If the rulers failed to choose aright here, an oracle foretold the decay of the city . Therefore Plato's rigid preoccupation in the second wave is to secure for the archons entire control over the birth of guardian children. Otherwise the community will sink into mere promiscuity and the stock will degenerate. In short, Plato tries to ensure that, apart from the necessary getting of children for the state, the guardians shall be friends and not lovers. Our special problems arise from the two questions—πως παδοποιήσονtαι, καì γεκομÉνους πως θρÉψουσι; . Let us begin with the first of these. (shrink)

The coincident facts among uncivilised peoples.--The nature of a cultural change.--Necessity in human affairs.

The introduction of and the commitment to evidence-based nursing in all care settings have led to a rapid increase of intervention and outcome-based research programs. Yet, the topics of nursing research are not only affected by interventions and outcomes but also affected by the concept of caring derived from humanistic philosophy. Considering this twofold orientation of nursing science, nuanced ethical regulations for nursing research programs are called for. In addition to the different research approaches, further arguments for ethical (...) class='Hi'>regulations are as follows: first, the different degrees of contextualization and the variety of participation models regarding the target groups; second, the capacities and opportunities of participants; and third, the caring relationship between nurses and research subjects. To capture these special features of nursing science, four approaches to fill the gaps in existing ethical regulations for nursing research are proposed: (a) process orientation, (b) community orientation, (c) context orientation, and (d) relation orientation. (shrink)

Organ donation after a circulatory determination of death is possible in selected patients where consent is given to support donation and the patient has been legally declared dead by two doctors. The National Health Act (61 of 2003) and regulations provide strict controls for the certification of death and the donation of organs and tissues after death. Although the National Health Act expressly recognises that brain death is death, it does not prescribe the medical standards of testing for the (...) determination of brain death (neurological determination of death), circulatory death (circulatory determination of death) or for determination of death based on somatic criteria. However, in all cases of organ donation, including after circulatory death, the National Health Act mandates that two doctors certify the death, with one doctor possessing more than 5 years of experience. Additionally, both doctors must be independent from the transplant team. The standard for such determination, as for brain death, aligns with accepted medical standards. The Critical Care Society of Southern Africa has published South African (SA) Guidelines on Death Determination that outline rigorous standards for death determination in hospital settings by either a neurological or circulatory method. Legislation and the Health Professions Council of SA’s (HPCSA) professional guidance direct clinicians on obtaining informed consent for donation either from the patient or in cases of incapacity from their surrogate decision maker. Collectively, the legislation, regulations and professional guidelines in SA provide a robust ethical framework that supports organ donation after circulatory death. (shrink)

The House of Lords majority decision in Matthews v. Kent and Medway Towns Fire Authority overturns the narrow interpretation given to key aspects of the Part-Time Workers (Protection of Less Favourable Treatment) Regulations’ core comparator mechanism in the lower tribunals and the Court of Appeal. It is a contextually astute judgment, which recognises the reductionist implications of an overly narrow approach to establishing comparability for the purposes of a less favourable treatment claim on the grounds of part-time work. The (...) positive aspect of this decision remains overshadowed, however, by the fact that this interpretation provides little consolation to the large majority of part-time women workers whose disadvantage and inequality remains outside the scope of the Regulations’ protection. (shrink)

This is the first re-publication and first English translation of regulations concerning Human Experimentation which were binding law prior to and during the Third Reich, 1931 to 1945. The introduction briefly describes the duties of the Reichsgesundheitsamt, which formulated these regulations. It then outlines the basic concept of the Richtlinien for protecting subjects and patients on the one hand and for encouraging New Therapy and Human Experimentation on the other hand. Major issues, like personal responsibility of the physician (...) or researcher, teaching of ethics of research and therapy, and research and therapy on vulnerable populations, are compared with the regulations in the Nuremberg Code and subsequent regulations influenced by the Nuremberg Code. CiteULike Connotea Del.icio.us What's this? (shrink)

Background We present and discuss the results of a Norwegian survey of medical doctors' views on potential ethical dilemmas in professional practice. Methods The study was conducted in 2015 as a postal questionnaire to a representative sample of 1612 doctors, among which 1261 responded. We provided a list of 41 potential ethical dilemmas and asked whether each was considered a dilemma, and whether the doctor would perform the task, if in a position to do so. Conceptually, dilemmas arise because of (...) tensions between two or more of four doctor roles: the patient’s advocate, a steward of societal interests, a member of a profession and a private individual. Results 27 of the potential dilemmas were considered dilemmas by at least 50% of the respondents. For more than half of the dilemmas, the anticipated course of action varied substantially within the professional group, with at least 20% choosing a different course than their colleagues, indicating low consensus in the profession. Conclusions Doctors experience a large range of ethical dilemmas, of which many have been given little attention by academic medical ethics. The less-discussed dilemmas are characterised by a low degree of consensus in the profession about how to handle them. There is a need for medical ethicists, medical education, postgraduate courses and clinical ethics support to address common dilemmas in clinical practice. Viewing dilemmas as role conflicts can be a fruitful approach to these discussions. (shrink)

Is it necessary to contrast the spreading process of genetic engineering in the agri-food stuff sector? Can EU rules really consider the impact of this brand new technologies on biology and, consequently, on public health? Despite the general trend, a firm opposition is what is happening in some Regions of Italy, where GMOs production and placing on the market are foibidden.

_From Shamanism to Ritual Regulations and Humaneness_ offers an account of the origins and nature of a uniquely Chinese way of thinking that, carried through Confucian tradition, continues to define the character of Chinese culture and society.

Chater & Loewenstein have done a service to the field by raising the fundamental issue of how the political process distorts well-intentioned efforts at behavioral public policy. We connect this argument to broader research on government failure, particularly public choice theory in economics. We further suggest ways that behavioral research can help identify and mitigate such failures.

Investigates the resolution of contradictions and ambiguous derogations in a code, by means of the imposition of partial orderings.