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)

In this context, the UAE enacted federal law authorizing the UAE Cabinet to grant temporary licenses for testing innovations that use future technologies and its applications such as Artificial Intelligence. The law aims at providing a safe test environment for legislation that meet the technological revolution. This is done in collaboration with “Regulations Lab” that was set up in January 2019 in Dubai Future Foundation.

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)

The recent global increase in environmental regulation does not necessarily signal improvement in firms’ ecological imprints. Like many markets, the Arab world is struggling to implement environmental compliance measures among local firms. For Arab countries, the reliance solely on formal policies to improve local firms’ ecological footprints may be risky given the evident institutional challenges to enforce environmental regulations, specially post the Arab Spring. Drawing from the literature highlighting the merits of combining formal and informal controls to ensure successful (...) implementation of a strategy, we argue that the emphasis for regulation must be accompanied by an emphasis for developing environmental ethics of individuals, who are the expected implementers of any environmental policy. In that light, we propose that the Eco-Islam phenomenon can serve as an influential and effective foundation for building organizational cultures with stronger environmental ethics among local small and medium enterprises. We explain the underlying maxims of Eco-Islam then conduct qualitative research among experts preaching or practicing the concept to gain better insights into the potential of leveraging it in Muslim-majority Arab countries. Finally, we conclude with insightful implications for local SMEs in the region. (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)

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)

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...

We examined differences in the knowledge and beliefs that exist among nurse researchers in the USA (n = 119) regarding informed consent and the use of data from patients’ medical records. Using a mail survey, two domains of ethical knowledge and beliefs were assessed: the legal right to privacy and the moral right to privacy. More than half of the participants were very confident in their knowledge of institutional review board procedures, research ethics, informed consent, the legal right to privacy, (...) and the moral right to privacy. In contrast, most rated themselves as uncertain about US federal research regulations and there was wide variation in knowledge about current federal guidelines. Those who were more confident in their knowledge of or had more practical experience with research ethics, were no more likely to answer correctly a question about current federal guidelines regulating the use of patient data from medical records than those who reported less confidence or experience. (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)

Product configuration is a key enabling technology for mass customization production. Previous studies mainly focus on the solving technologies for obtaining a feasible configuration or optimal configuration but ignore environmental factors like CO2 emissions, especially the environmental regulations from international organizations. In this article, we address product configuration optimization problems considering both carbon cap and carbon tax regulations. A two-stage approach that combines both Particle Swarm Optimization and a greedy algorithm is presented to solve the product configuration problems (...) with carbon emission concerns. A case study of a configurable ranger-drilling machine is illustrated to demonstrate the effectiveness of the presented approach. The impacts of carbon cap and carbon tax regulations on configuration results are compared. Further, the models are extended to analyze the effects of single-sourcing and multisourcing on product configuration. The analysis shows that multisourcing in combination with carbon tax regulation can facilitate a manufacturer to provide more green and low-carbon customized products for customers. Numerical experiments are conducted to validate the effectiveness of the model and the efficiency of the proposed solution method. (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)

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

Considering recent theoretical discussions about the concept of moral legitimacy, this study advances our understanding of its performance consequences. Specifically, it uncovers the mediating role of moral legitimacy in the relationship between regulations and industry performance. Our analysis of the U.S. state-level data on regulations in a controversial industry between 1994 and 2010 yields four significant findings. The results show that regulations not only decrease performance but also negatively impact moral legitimacy. Moreover, this study provides empirical evidence (...) that moral legitimacy is positively related to industry performance, providing much-needed direct support for this premise. Importantly, the results indicate that moral legitimacy mediates the effect of regulations on performance, but only when regulations are aligned with moral values. Overall, this study extends our understanding of how regulations influence moral legitimacy, and in turn impact industry performance. (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)

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.

In ‘Obesity, equity and choice’ (J Med Ethics2018;0:1–7. doi:10.1136/medethics-2018-104848), Timothy Wilkinson argues that preventive regulations to address obesity, such as taxes on sugary drinks, are at worst inequitable and at best fail to increase or improve equity. He concludes that we do not yet have good reasons to adopt them. I argue that equity considerations are not as problematic for preventive regulations as Wilkinson suggests.

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)

The second of five commentaries on “Bloomberg's Health Legacy: Urban Innovator or Meddling Nanny?” from the September‐October 2013.

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)

The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some less (...) so. For example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:When OPRR Comes Calling:Enforcing Federal Research RegulationsCharles R. Mccarthy (bio)In an update following this article, Ruth Macklin responds to the revelation that the controversial Hall-Stillman embryo-splitting experiment at George Washington University was conducted—contrary to federal regulations—without prior institutional review board (IRB) review. This revelation altered Dr. Macklin's view of the ethical status of the research. Undoubtedly such revelations also raise general questions for administrators and researchers in many (...) institutions, including, for example: How do allegations of noncompliance with federal regulations arise? When should allegations of infractions of the regulations be reported? Who has an obligation to report? To whom should reports be made? What sort of inquiry should take place? Who should conduct the inquiry? If a determination is made that infractions have occurred, what sanctions are appropriate? And, what publicity is given to the allegations, before, during, and after an evaluation?Some of these questions can be answered in a straightforward manner, while the answers to others depend on the circumstances of the case. This article provides some general answers to these questions.1BackgroundThe Department of Health and Human Services (DHHS) is the largest supporter of biomedical and behavioral research in the world. Somewhere between 25 and 33 percent of its medical research budget is devoted to the support of research involving human subjects. In accordance with the Public Health Service Act, DHHS has issued Regulations for the Protection of Human Subjects (45 CFR 46). The DHHS Secretary has delegated responsibility for promulgating and administering the regulations to the Office for Protection from Research Risks (OPRR), which is located within the National Institutes of Health.When an institution receives an award from a DHHS agency to carry out research involving human subjects, it is required to negotiate, or to have on file, an "assurance of compliance" document that provides detailed information [End Page 51] specifying how the institution plans to comply with the regulations for the protection of human subjects. Most major research institutions in the country have on file a "multiple project assurance" (MPA) document, which extends DHHS regulations to all human subjects research conducted or sponsored by that institution, irrespective of the source of funding. The regulations and the assurance of compliance require any research project involving human subjects to be reviewed and approved by an institutional review board (IRB) prior to initiation of the research. In addition, the project must be re-reviewed by the IRB at appropriate intervals—in no case, less than once a year. Institutional compliance with these and other requirements of the regulations has improved during the last 30 years and appears to be at a high level. However, from time to time, allegations of noncompliance arise, as they did in the George Washington University embryo-splitting experiment, and set in motion the review process described below.How do Allegations of Noncompliance Arise?Allegations or indications of noncompliance with federal regulations for the protection of human subjects may come from a variety of sources. Most commonly, the institution's IRB discovers that research involving humans is going forward without the required prior IRB review and approval, or that approved research is being conducted in a way that is contrary to the stipulations of the IRB. The Hall-Stillman case came to the attention of George Washington University's IRB because the research protocol was submitted to the IRB after the research had been carried out. In this case, there could be no doubt that an infraction had occurred.Information about possible noncompliance also frequently derives from a funding agency's Initial Review Group (IRG) (commonly called a Study Section) when it has reason to suspect noncompliance in a project it is reviewing for possible funding. An actual case that occurred some years ago involved a research application that proposed to perform brain biopsies on normal volunteers. The IRG that reviewed the application lost little time in questioning whether an IRB had approved the protocol. In this case, it was not enough for the IRG to recommend disapproval of the proposal for funding; it also was obliged to report the possible infraction to OPRR.Whistleblowers, including research subjects, nurses, students, members of the... (shrink)

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 a nationwide study of state legislative Web sites, Narro, Mayo, and Miller found that the communication tools (i.e., weblogs, electronic newsletters, online polling) that state legislators offer vary more from state to state than legislator to legislator. Taking their information into account, this article addresses regulations put on legislators’ home pages.The author interviewed Webmasters in 44 states and found that having less limitations and allowing legislators freedom to manipulate their home pages encourage them to use these home pages (...) for active communication. Although most states do not allow state legislators to use home pages as a campaign tool, some allow free flow of communication between legislators and constituents. The researcher found that legislators would use their home pages more as a communication tool if given the freedom. However, change begins with legislators, who are the policy makers. Whether they have freedom is their own choice. (shrink)

There is a little explored tension between the regulations called for by environmentalists and the predominant liberal political theory. The latter says that laws are only legitimate when publicly defensible to all who must follow them and thus does not support the state adoption of particular values. Environmental concerns frequently fall under the category of particular values. I explore ways that liberalism does in fact support environmental regulations as furthering universal rights and justice within and between generations. However, (...) some forms of environmental preservation are clearly government pursuits of particular values. I explore possible liberal justifications of publicly fostering environmental values and conclude by arguing for a deliberative democratic approach. (shrink)

Recent state regulations require women, before undergoing abortions, to be subjected to unwanted and nonmedically necessary sonograms, often requiring an intrusive vaginal probe. Physicians, for their part, are forced to turn the viewing screens toward the faces of their patients and to describe to them the details on the screen. In this commentary, I explain these current laws and the various court responses to them to date. Further, I demonstrate why these abortion regulations violate the ethical principles governing (...) informed consent and why they should be declared unconstitutional based on women’s constitutional rights as settled by Planned Parenthood of Southeastern Pennsylvania v. Casey and physicians’ First Amendment rights. (shrink)