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)

In Grimes v. Kennedy Krieger Institute, the Maryland Court of Appeals considered whether it is possible for investigators or research entities to have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. The research under review, the Lead Abatement and Repair & Maintenance Study, was conducted from 1993 to 1996 by investigators at the Kennedy Krieger Institute, an affiliate of Johns Hopkins University.After briefly discussing the case at (...) the center of this ruling, I consider how ambiguities within the federal research regulations at 45 C.F.R. § 46 contribute to disagreements among reasonable and informed people of good will about what studies should be approved. I argue that Grimes may be understood as placing restrictions on how these regulations may be interpreted and used. (shrink)

World Athletics have introduced regulations preventing female athletes with certain differences in sex development from competing in the female category. We argue these regulations are not justified and should be removed. Firstly, we examine the reasoning and evidence underlying the position that these athletes have a substantial mean difference in performance from other female athletes such that it constitutes an advantage, and argue it is not sufficient. Secondly, if an advantage does exist, it needs to be demonstrated it (...) is unfair. We argue the advantage would not be unfair because to say otherwise relies on a presupposition about whether these athletes are female, which involves contradictory and inconsistent definitions of sex. Thirdly, we contend that even if it is established that there is an advantage and it is unfair, the response of requiring athletes to take testosterone-suppressing medication is not appropriate and is unfair. (shrink)

Ethical principles play an important part not only in the promulgation of regulations but also in their application, i.e., enforcement and adjudication. While traditional ethical principles – promotion of welfare, freedom, and fairness – play an important role in both elements of regulation, some other kinds of ethical principles are significant as well. Principles governing the structure of decision processes should shape the structure and actions of agencies; principles of wise application should govern the work of those whose responsibility (...) it is to apply regulatory language to particular situations. These points are demonstrated by investigating a case study: federal regulations designed to protect children involved in scientific research applied to a placebo study of the effects of recombinant human growth hormone on children of extremely short stature. Keywords: ethics, interpretation, regulation, research CiteULike Connotea Del.icio.us What's this? (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.

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 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)

In order to design and implement electronic institutions that incorporate norms governing the behavior of the participants of those institutions, some crucial steps should be taken. The first problem is that human norms are (on purpose) specified on an abstract level. This ensures applicability of the norms over long periods of time in many different circumstances. However, for an electronic institution to function according to those norms, they should be concrete enough to be able to check them run time. A (...) second problem is that norms describe which behavior is desirable and permitted, but not how this is achieved in an institution. In the “real world" regulations often indicate procedures for implementing and enforcing the law. Likewise we should devise means to annotate the norms with practical aspects such as enforcement mechanisms, sanctions, etc. in order to get requirements for an institution that will enforce norms (by either constraining behavior within the norms or reacting to violation of the norms). The choice of which kind of mechanism is chosen is not a normative one, but usually based on criteria of efficiency and/or feasibility of the mechanism. In this paper we present our view on how to approach these problems and other related issues to be solved in order to develop e-institutions capable to operate in complex, highly regulated scenarios. (shrink)

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)

The purpose of the present discussion is to present, reflect upon, and evaluate the effective legal regulations concerning the obligation to terminate a medical experiment. The considerations made herein aim at providing an answer to the question whether the aforesaid legal regulations are clear and sufficient. The said analysis is based on the following source: The Act of 5 December 1996 concerning the Professions of General Practitioner and Dental Practitioner. The regulations concerning the obligation to discontinue a (...) medical experiment, both by the will of the participant and on the physician’s initiative, are of great importance owing to the fact that they guarantee protection of the patients taking part in the experimental study. The provisions implicitly oblige the physician to monitor the patients’ state of health and conduct constant assessment whether or not further carrying on the experiment is expedient and admissible. The legal regulations effective in Poland are explicit and sufficient. Their wording does not raise any considerable reservations. As it appears, the legislature managed to work out appropriate rules so as to minimize the danger zone for the participants of clinical tests and at the same time implement a guarantee that participants’ rights shall be respected. (shrink)

The risks of uncontrolled dissemination of GMOs has made it clear that biosafety is a very relevant matter that goes beyond the State boundaries. This approach has had its corresponding reflection at the policy level, which reveals that the public powers and the legislators have been sensitive to this existing preoccupation in ever-growing sectors of society. From the European regulations, one can deduce a set of principles, which must guide the decisions of the public powers in matters related to (...) biosafety: precaution, authorisation and inspection, “step by step”, “case by case”, traceability and transparency, among other. (shrink)

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

This research examines the comparison between Qanuns and Regional Regulations (Perda) in the context of Aceh, with a focus on the uniqueness possessed by Aceh as an autonomous region. Qanuns, as the term for provincial regulations in Aceh, are formed through a collaborative process between the Governor and the Aceh Regional Representative Council (DPRA) within the framework of the Regional Legislation Program (Prolega). Aceh is recognized as having a special status based on Law Number 11 of 2006 concerning (...) the Governance of Aceh (UUPA), which grants the right and authority to independently manage government affairs, as a result of the Helsinki MoU. This research also identifies an exception to the obligation to include an Academic Manuscript in the formation of Qanuns, which is a mandate from a higher regulation, to avoid conflicts. However, challenges in the implementation of Qanuns arise due to constraints in the guidance and supervision by the government, which creates injustice for Aceh. The research methodology combines empirical and normative approaches, involving interviews and field observations to analyze the differences and specifications between Qanuns and Perdas, as well as their implications for regional governance. The research found that Qanuns in Aceh have a different formation process compared to Regional Regulations (Perdas) in other provinces, with the specifics regulated in the Law on the Governance of Aceh (UUPA). There is an exception to the obligation of an Academic Manuscript for Qanuns, which is a direct mandate from a higher regulation. Despite being granted special autonomy, challenges in the implementation of Qanuns arise due to constraints in the guidance and supervision by the central government. (shrink)

Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional (...) regulatory protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research. (shrink)

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)

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 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...

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)

We conducted a scoping review to ascertain the landscape of ethics regulations for AD/ADRD research in Africa using Arksey and O'Malley's framework. We sourced regulations from the International Compilation of Human Research Standards. We included regulations from 14 countries published between 1997 and 2020. Provisions in the regulations applicable to research in AD/ADRD were part of broader sub-provisions for research such as with persons under legal disability. Regulations mostly required the appointment of Legally Authorised Representatives, (...) as a major protection for persons with AD/ADRD. Provisions supporting capacity assessment and advance directives were only provided in regulations from five and two countries respectively. No regulation cited the Convention on the Rights of Persons with Disabilities as a foundational instrument for its provisions. In conclusion, regulations specifically applicable to research among AD/ADRD or other cognitively impaired persons in Africa are scarce and provisions in existing regulations mostly lack specificity for practical implementation. (shrink)

Traditionally, corruption is seen as a rational pursuit of profit, focusing on personal gain. However, this view overlooks behavioral, social, and systemic influences. This paper focuses on the behavioral aspects of corruption, providing a deeper understanding of its complexities by addressing the factors overlooked by conventional approaches. Reviewing some of the literature, we highlight how researchers have approached the study of corruption from the perspective of behavioral sciences. Additionally, we examine how the emerging discipline of Behavioral Public Policy (BPP) employs (...) innovative methods to reduce corrupt practices, offering new insights and strategies that transcend traditional approaches. The core contribution of our paper lies in its novel approach: showing a path for corruption decrease by replacing traditional regulations and bureaucratic burdens, which research shows can increase its likelihood, with non-regulatory behavioral tools such as nudges and sludge audits. By reducing regulations and administrative red tape, these tools simplify processes minimizing opportunities for corrupt behavior in certain contexts, while aligning with liberal principles. In this article, we aim to infuse corruption research with a behavioral twist and a liberal perspective, offering policymakers alternative strategies to foster transparency, accountability, and ethical governance. While this approach will not completely eradicate corruption, it strives to show how BPP can reduce its occurrences. (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)

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)

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)

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)

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)

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)