This study aimed to explore stakeholders’ perspectives on the ethical considerations for returning individual pharmacogenomics research results to people living with HIV. A qualitative approach to investigation involved five focus group discussions with 30 Community representatives, 12 key informant interviews with researchers, and 12 in-depth interviews with research ethics committee members. In total, 54 stakeholders who were involved in pharmacogenomics research and HIV treatment and care contributed to the data collection between September 2021 and February 2022. The study explored five (...) prominent themes: (i) defining the nature of research results to return to participants; (ii) preparing research participants to receive their results; (iii) obtaining informed consent for the return of results; (iv) opinions on health personnel to return the results to participants; and (v) opinions on how research results should be communicated to participants. Respondents identified various strategies for the return of individual results with minimal ethical risks including the setting up of a diverse and independent committee to undertake a risk-benefit assessment based on local context; ongoing discussions about the possible kinds of results and their implications throughout the study; and employing genetic counsellors to communicate results to participants. The strategies identified in this study should be further studied and independently verified. (shrink)

Background The globalization of clinical research in the last two decades has led to a significant increase in the volume of clinical research in developing countries. As of 2016, Uganda was the third largest destination for clinical trials in Africa. This requires adequate capacity and systems to facilitate ethical practice. Methods This was a retrospective study involving review of laws, guidelines, policies and records from 1896 to date. Results Modern medicine evolved from 1896 and by the time of Uganda's independence (...) in 1962, a 1500 bed national referral hospital was in place and a fully‐fledged medical school was established at the Makerere University. As the practice of medicine evolved in the country, so did medical research that addressed priority health issues. The growth in modern medicine was not matched with development of research infrastructure and regulatory systems. The first documented regulation of research activities was in 1970 while the first research ethics committee established in 1986 was to facilitate review of research related to the HIV/AIDs pandemic. In 1990 an Act of Parliament was passed to facilitate development and implementation of policies, hence the development of the national guidelines in 1997, training, establishment and accreditation of research ethics committees, conferences and research site monitoring. Conclusion Over the past 120 years, the implementation and structural aspects of research ethics in Uganda have evolved through 70 years of no regulation, followed by 30 years of rudimentary regulation while the last 20 years have shown significant growth in the regulatory system associated with supportive laws, institutionalization of regulatory and training processes. (shrink)

BackgroundIn response to COVID-19 pandemic, the Government of Uganda adopted public health measures to contain its spread in the country. Some of the initial measures included refusal to repatriate citizens studying in China, mandatory institutional quarantine, and social distancing. Despite being a public health emergency, the measures adopted deserve critical appraisal using an ethics and human rights approach. The goal of this paper is to formulate an ethics and human rights criteria for evaluating public health measures and use it to (...) reflect on the ethical propriety of those adopted by the government of Uganda to contain the spread of COVID-19.Main bodyWe begin by illustrating the value of ethics and human rights considerations for public health measures including during emergencies. We then summarize Uganda’s social and economic circumstances and some of the measures adopted to contain the spread of COVID-19. After reviewing some of the ethics and human rights considerations for public health, we reflect upon the ethical propriety of some of Uganda’s responses to COVID-19. We use content analysis to identify the measures adopted by the government of Uganda to contain the spread of COVID-19, the ethics and human rights considerations commonly recommended for public health responses and their importance. Our study found that some of the measures adopted violate ethics and human rights principles. We argue that even though some human rights can sometimes be legitimately derogated and limited to meet public health goals during public health emergencies, measures that infringe on human rights should satisfy certain ethics and human rights criteria. Some of these criteria include being effective, strictly necessary, proportionate to the magnitude of the threat, reasonable in the circumstances, equitable, and least restrictive. We reflect on Uganda’s initial measures to combat the spread of COVID-19 and argue that many of them fell short of these criteria, and potentially limit their effectiveness.ConclusionThe ethical legitimacy of public health measures is valuable in itself and for enhancing effectiveness of the measures. Such legitimacy depends on the extent to which they conform to ethics and human rights principles recommended for public health measures. (shrink)

Genetic results are usually not returned to research participants in Uganda despite their increased demand. We report on researchers’ perceptions and experiences of return of individual genetic research results. The study involved 15 in-depth interviews of investigators involved in genetics and/or genomic research. A thematic approach was used to interpret the results. The four themes that emerged from the data were the need for return of individual results including incidental findings, community engagement and the consenting process, implications and challenges to (...) return of individual results. While researchers are willing to return clinically significant genetic results to research participants, they remain unsure of how this should be implemented. Suggestions to aid implementation of return of results included reconsenting of participants before receiving individual genetic results and increasing access to genetic counseling services. Community engagement to determine community perceptions and individual preferences for the return of results, and also prepare participants to safely receive results emerged as another way to support return of results. Researchers have a positive attitude toward the return of clinically significant genetic results to research participants. There is need to develop national guidance on genetic research and also build capacity for clinical genetics and genetic counseling. (shrink)

Research Ethics, Volume 18, Issue 3, Page 193-209, July 2022. This study aimed to explore experiences and practices of key research team members in obtaining informed consent for pharmacogenetics research and to identify the approaches used for enhancing understanding during the consenting process. Data collection involved 15 qualitative, in-depth interviews with key researchers who were involved in obtaining informed consent from HIV infected individuals in Uganda for participation in pharmacogenetic clinical trials. The study explored two prominent themes: approaches used to (...) convey information and enhance research participants’ understanding and challenges faced during the consenting process. Several barriers and facilitators for obtaining consent were identified. Innovative and potentially effective consenting strategies were identified in this study that should be studied and independently verified. (shrink)

BackgroundThe return of genetics and genomics research results has been a subject of ongoing global debate. Such feedback is ethically desirable to update participants on research findings particularly those deemed clinically significant. Although there is limited literature, debate continues in African on what constitutes appropriate practice regarding the return of results for genetics and genomics research. This study explored perspectives and ethical considerations of Ugandan genomics researchers regarding the return of genetics and genomics research results.MethodsThis was a qualitative study that (...) employed in-depth interviews. Thirty participants were purposively selected based on their expertise as genomics researchers in Uganda. Data were analysed through content analysis along the main themes of the study using a comprehensive thematic matrix, to identify common patterns arising from the narratives. NVivo software 12 was used to support data analysis.ResultsThe return of genetics and genomics research results was generally acceptable to researchers, and some indicated that they had previously returned individual or aggregate results to participants and communities. The main reasons cited for sharing research results with participants included their clinical utility, actionability and overall benefit to society. Ethical considerations for appropriate return of results included a need for effective community engagement, genetic counselling prior to disclosure of the results, adequate informed consent, and proper assessment of the implications of, or consequences of returning of results. However, the approaches to return of results were perceived as unstandardized due to the lack of appropriate regulatory frameworks.ConclusionsThe return of genetic and genomic research results is generally acceptable to researchers despite the lack of appropriate regulatory frameworks. Ethical considerations for return of genetics and genomics research results are highly divergent, hence the need for national ethical guidelines to appropriately regulate the practice. (shrink)

BackgroundGenetics and genomics research (GGR) is increasingly being conducted around the world; yet, researchers and research oversight entities in many countries have struggled with ethical challenges. A range of ethics and regulatory issues need to be addressed through comprehensive policy frameworks that integrate with local environments. While important efforts have been made to enhance understanding and awareness of ethical dimensions of GGR in Africa, including through the H3Africa initiative, there remains a need for in-depth policy review, at a country-level, to (...) inform and stimulate local policy development and revision on the continent.MethodsTo identify and characterize existing ethics-related guidelines and laws applicable to GGR across much of Africa, we conducted a scoping review of English language policy documents identified through databases, repositories, and web searches. Thirty-six documents were included and coded using a framework that contained a range of themes across five analytical categories: (1) respect, (2) beneficence, (3) justice, (4) independent oversight, and (5) bans and prohibitions. Data analysis software (NVivo 12) was used to organize, code, and tabulate information according to document characteristics and topics. Illustrative examples of policy requirements were selected for inclusion.ResultsDocuments that met inclusion criteria spanned 20 years; published between 1996 and 2018, with the majority (58%) published after 2009. About two-thirds were denoted as “guidelines,” and slightly more than half were non-exclusive to GGR. Very few (six) country-level documents identified were specific to GGR. Requirements related to the principle of “respect” appeared most often across all documents, relative to other principles and processes. The most commonly stated ban was on reproductive cloning. Other prohibitions applied to germline editing, undue inducements in research, sample use for commercial purposes, employee mandatory DNA testing, fetal sex selection, stem cell use, eugenics, and research without public health benefits.ConclusionsEnforceable policies that are indispensable to the ethical conduct and review of GGR are either deficient or missing in many African countries. Existing international, GGR-specific ethics guidelines can be used to inform GGR policy development at a country-level, in conjunction with insight from country specific ethics committees and other local stakeholders. (shrink)

Informed consent in medical practice is essential and a global standard that should be sought at all the times doctors interact with patients. Its intensity would vary depending on the invasiveness and risks associated with the anticipated treatment. To our knowledge there has not been any systematic review of consent practices to document best practices and identify areas that need improvement in our setting. The objective of the study was to evaluate the informed consent practices of surgeons at University teaching (...) Hospitals in a low resource setting. (shrink)

In July 2020, the H3Africa Ethics and Community Engagement (E&CE) Working Group organised a webinar with ethics committee members and biomedical researchers from various African institutions throughout the Continent to discuss the issue of whether and how biological samples for scientific research may be accessed by commercial entities when broad consents obtained for the samples are silent. 128 people including Research Ethics Committee members (10), H3Africa researchers (46) including members of the E&CE working group, biomedical researchers not associated with H3Africa (...) (27), representatives from the National Institutes of Health (16) and 10 other participants attended the webinar and shared their views. Several major themes emerged during the webinar, with the topics of broad versus explicit informed consent, defining commercial use, legacy samples and benefit sharing prevailing in the discussion. This report describes the consensus concerns and recommendations raised during the meeting and will be informative for future research on ethical considerations for genomic research in the African research context. (shrink)

In Campbell Soup Co. v. Allstate Insurance Co. ), the United States District Court for the Western District of Michigan, Southern Division, held that a health plan's coordination of benefits clause, covered under the Employee Retirement Income Security Act, does not preempt a similar no-fault automobile insurance clause in the absence of irreconcilable conflict. The court found that ERISA's policy of shielding plans from unanticipated claims could only be furthered when the plan had expressly disavowed such claims. Because the (...) ERISA plan in this case did not specifically subordinate itself to the no-fault policy, the district court found that the no-fault COB clause controlled. However, to escape this ruling, ERISA plans need only redraft their COB clauses specifically to disclaim liability in case of conflict with provisions of no-fault insurance policies. This caveat substantially limits the scope of the court's ruling. (shrink)

The risk of tort liability for health maintenance organizations and other managed care plans has dramatically increased in recent years. This is due in part to the growing percentage of health care rendered through managed care plans. The cost-containment mechanisms commonly used by managed care plans, such as limiting access to services and/or choice of providers, creates a climate ripe for disputes that may end up in court. As dissatisfied patients and providers seek recourse in the courts, tort doctrines are (...) extended and new legal theories emerge as needed. For example, the concepts of direct and vicarious tort liability developed in the hospital context have been extended by courts to encompass HMOs. vicarious liability claims, based on ostensible agency or respondeat superior doctrines, have been brought against HMOs and managed care plans for negligent treatment by physicians selected to provide care to members. (shrink)

The risk of tort liability for health maintenance organizations and other managed care plans has dramatically increased in recent years. This is due in part to the growing percentage of health care rendered through managed care plans. The cost-containment mechanisms commonly used by managed care plans, such as limiting access to services and/or choice of providers, creates a climate ripe for disputes that may end up in court. As dissatisfied patients and providers seek recourse in the courts, tort doctrines are (...) extended and new legal theories emerge as needed. For example, the concepts of direct and vicarious tort liability developed in the hospital context have been extended by courts to encompass HMOs. vicarious liability claims, based on ostensible agency or respondeat superior doctrines, have been brought against HMOs and managed care plans for negligent treatment by physicians selected to provide care to members. (shrink)

The Employee Retirement Income Security Act of 1974 , a federal law regulating private employer-sponsored employee benefit plans, was primarily designed for pension plans, but has had a profound impact on state health care reform efforts. ERISA's broad preemption language has been judicially interpreted to preclude states from most forms of regulation of employer health plans, including benefit design and incorporating employer expenditure requirements in state health reform financing. But since 1974, Congress has never seriously returned to reexamine several (...) fundamental questions: Should employers be required to offer or contribute to employee health coverage? Should ERISA preempt state efforts to take such actions? Or should ERISA incorporate more comprehensive regulation of health plans in these areas? Although the politics of ERISA preemption have thus far blocked federal reform, while allowing state reform activity to be simultaneously curtailed, new health reform efforts may force Congress to address these questions. (shrink)

For most of the first two decades after the enactment of the Employee Retirement Income Security Act of 1974, health policymakers did not seem to recognize the full impact that ERISA would have on regulation of health insurance and health care coverage. Perhaps the early court decisions in which the courts clarified that states could regulate insurance companies and the products they sold to ERISA plan sponsors gave them false comfort that because Congress appeared to recognize the role (...) of the states in regulating insurance, ERISA might have only a tangential impact on health care reform efforts. (shrink)

As the shield preempting state suits under the Employee Retirement Income Security Act has been successfully pierced and Duke v. U.S. Healthcare, Inc., 57 F.3d 350 ), plaintiff attorneys have begun to use the ERISA statute itself to further litigation against managed care organizations. The court in Shea v. Esensten, 107 F.3d 625, held in a landmark decision that an HMO's failure to disclose financial incentives that discourage a treating physician from providing essential health care referrals for conditions covered (...) under the plan benefit structure is a breach of ERISA's fiduciary duties. (shrink)

As the shield preempting state suits under the Employee Retirement Income Security Act has been successfully pierced and Duke v. U.S. Healthcare, Inc., 57 F.3d 350 ), plaintiff attorneys have begun to use the ERISA statute itself to further litigation against managed care organizations. The court in Shea v. Esensten, 107 F.3d 625, held in a landmark decision that an HMO's failure to disclose financial incentives that discourage a treating physician from providing essential health care referrals for conditions covered (...) under the plan benefit structure is a breach of ERISA's fiduciary duties. (shrink)

The United States Court of Appeals for the Eighth Circuit held that ERISA did not preempt a Minnesota tort claim alleging fraud and negligent misrepresentation against primary-care physicians who failed to disclose their financial incentives to minimize specialist referrals. The original action was filed in state court after the plaintiff's husband died of heart failure, alleging that his family doctors had assured him that referral to a cardiologist was unnecessary. The plaintiff filed a wrongful death suit against the doctors, (...) their clinic, and her husband's HMO. Her complaint against the HMO alleged that certain financial incentives built into the HMO-physician contract were designed to minimize referrals to specialists. The HMO removed the case to the District of Minnesota, contending that ERISA preempted the plaintiff's wrongful death claim. (shrink)

The United States Court of Appeals for the Eighth Circuit held that ERISA did not preempt a Minnesota tort claim alleging fraud and negligent misrepresentation against primary-care physicians who failed to disclose their financial incentives to minimize specialist referrals. The original action was filed in state court after the plaintiff's husband died of heart failure, alleging that his family doctors had assured him that referral to a cardiologist was unnecessary. The plaintiff filed a wrongful death suit against the doctors, (...) their clinic, and her husband's HMO. Her complaint against the HMO alleged that certain financial incentives built into the HMO-physician contract were designed to minimize referrals to specialists. The HMO removed the case to the District of Minnesota, contending that ERISA preempted the plaintiff's wrongful death claim. (shrink)

On December 7, 1994, the U.S. District Court of the Northern District of Illinois ruled that ERISA preempts a participant in an ERISA plan from suing the plan's administrator under a state common law theory of respondeat superior ) : at 208). On September 12, 1995, the Seventh Circuit of the U.S. Court of Appeals reversed this decision and ordered that the case be tried in state court ). The court held that the case had been improperly removed (...) to federal court. The court of appeals stated that the federal court did not have jurisdiction because the plaintiff's claim did not fall within ERISA's provisions.In this case, plaintiff David Rice brought a medical malpractice suit against two doctors who provided treatment to him in accordance with his ERISA insurance plan. (shrink)

On August 29, 2006, the United States Court of Appeals for the District of Columbia Circuit held that an injured ERISA plan beneficiary need not be “made whole” by any injury-related recovery from a third party in order for her ERISA plan to assert subrogation or reimbursement rights if the plan's terms either 1) “unambiguously establish a plan priority” to any funds a beneficiary recovers from a third party, or 2) are reasonably interpreted to establish such a priority (...) by an ERISA plan fiduciary clearly authorized to do so.In 1991, appellants William and Judith Moore purchased an ERISA health insurance policy from Blue Cross Blue Shield of the National Capital Area and its wholly-owned subsidiary CapitalCare. On September 10, 1992, the Moores’ daughter Alistaire, a plan beneficiary, was seriously injured in an automobile accident. (shrink)

In its recent opinion in Intel v. Sulyma, the U.S. Supreme Court clarified what qualifies as the “actual knowledge” required to trigger ERISA’s three-year statutory period. The Court’s opinion, however, left open whether establishing “actual knowledge” by a plaintiff in one case serves to time-bar otherwise timely suits that challenge subsequent breaches of the same character. This article argues that, under the continuing fiduciary duty analysis that the Court set forth in Tibble v. Edison, such suits should not be (...) deemed untimely. (shrink)

On August 29, 2006, the United States Court of Appeals for the District of Columbia Circuit held that an injured ERISA plan beneficiary need not be “made whole” by any injury-related recovery from a third party in order for her ERISA plan to assert subrogation or reimbursement rights if the plan's terms either 1) “unambiguously establish a plan priority” to any funds a beneficiary recovers from a third party, or 2) are reasonably interpreted to establish such a priority (...) by an ERISA plan fiduciary clearly authorized to do so.In 1991, appellants William and Judith Moore purchased an ERISA health insurance policy from Blue Cross Blue Shield of the National Capital Area and its wholly-owned subsidiary CapitalCare. On September 10, 1992, the Moores’ daughter Alistaire, a plan beneficiary, was seriously injured in an automobile accident. (shrink)

On April 26, 1995, the United States Supreme Court limited the reach of the preemption provision of ERISA in New York State Conference of Blue Cross & Blue Shield Plans v. Tavelers Insurance Co. ). In Travelers, the Supreme Court upheld the validity of a New York statute requiring hospitals to collect surcharges from patients covered by commercial insurers and requiring health maintenance organizations to pay a surcharge to the state's general fund that varies depending on the number of (...) Medicaid-eligible HMO members enrolled. Neither patients insured by Blue Cross/Blue Shield plans nor the plans themselves are similarly charged under the statute. Several commercial insurers and HMOs claimed the surcharges should be preempted under ERISA because they are levied on patients whose insurance or HMO membership premiums are purchased by an ERISA plan.The ERISA preemption clause means that federal regulation, or lack thereof, supersedes state regulation that is related to employee pension and benefit plans. This preemption clause prevents states from changing health care and benefit law for a significant portion of state residents. (shrink)

Although the ethical and legal worlds are often at odds, a wealth of information is gained by evaluating legal decisions from an ethical perspective. Evaluating court decisions from an ethical viewpoint, increases our knowledge, and helps to beneficially influence future court precedent. Of particular importance to the relationship between the law, business, and ethics, is the ideal of beneficence and non-maleficence. It is the court’s role to protect the rights of individuals, especially with regards to their health care provision. These (...) issues are especially present in conflicts that relate to the availability and access to health care and insurance coverage. Patient autonomy, physician malpractice and informed consent are all influenced by such current court precedent as addressed bythe Employee Retirement Income and Security Act of 1974 (ERISA). This leads us to the central theme of this discussion on the ethical implications of the Supreme Court precedent on ERISA. (shrink)

On August 29, 2006, the United States Court of Appeals for the District of Columbia Circuit held that an injured ERISA plan beneficiary need not be “made whole” by any injury-related recovery from a third party in order for her ERISA plan to assert subrogation or reimbursement rights if the plan's terms either 1) “unambiguously establish a plan priority” to any funds a beneficiary recovers from a third party, or 2) are reasonably interpreted to establish such a priority (...) by an ERISA plan fiduciary clearly authorized to do so.In 1991, appellants William and Judith Moore purchased an ERISA health insurance policy from Blue Cross Blue Shield of the National Capital Area and its wholly-owned subsidiary CapitalCare. On September 10, 1992, the Moores’ daughter Alistaire, a plan beneficiary, was seriously injured in an automobile accident. (shrink)

This volume gathers together for the first time are all the key texts in a crucial debate in modern philosophy, centered on Leibniz's famous 1695 essay, the "New System of the Nature of Substances and their Communication," in which he introduced his strikingly original theory of metaphysics. His "system" became increasingly famous and drew him into discussion and development of these ideas, both in public and in private, with a variety of thinkers, most notably the great French philosopher Pierre Bayle. (...) Woolhouse's and Francks's new English edition gives the only full representation of this debate, and will therefore be essential reading for anyone who wishes to gain a proper understanding of Leibniz's philosophy and its intelletual context. All the texts are newly translated and extensively annotated; many appear in English for the first time. (shrink)

Plato's dialogues frequently criticize traditional Greek myth, yet Plato also integrates myth with his writing. Daniel S. Werner confronts this paradox through an in-depth analysis of the Phaedrus, Plato's most mythical dialogue. Werner argues that the myths of the Phaedrus serve several complex functions: they bring nonphilosophers into the philosophical life; they offer a starting point for philosophical inquiry; they unify the dialogue as a literary and dramatic whole; they draw attention to the limits of language and the limits of (...) knowledge; and they allow Plato to co-opt cultural authority as a way of defining and legitimating the practice of philosophy. Platonic myth, as a species of traditional tale, is thus both distinct from philosophical dialectic and similar to it. Ultimately, the most powerful effect of Platonic myth is the way in which it leads readers to participate in Plato's dialogues and to engage in a process of self-examination. (shrink)

t. 1. Apo ton prōto skeptomeno anthrōpo mechri ton 6. aiōna M.Ch. -- t. 2. Apo ton 7. aiōna M.Ch. mechri to sēmera.

We propose a formal framework for interpretable machine learning. Combining elements from statistical learning, causal interventionism, and decision theory, we design an idealised explanation game in which players collaborate to find the best explanation for a given algorithmic prediction. Through an iterative procedure of questions and answers, the players establish a three-dimensional Pareto frontier that describes the optimal trade-offs between explanatory accuracy, simplicity, and relevance. Multiple rounds are played at different levels of abstraction, allowing the players to explore overlapping causal (...) patterns of variable granularity and scope. We characterise the conditions under which such a game is almost surely guaranteed to converge on a optimal explanation surface in polynomial time, and highlight obstacles that will tend to prevent the players from advancing beyond certain explanatory thresholds. The game serves a descriptive and a normative function, establishing a conceptual space in which to analyse and compare existing proposals, as well as design new and improved solutions. (shrink)

Ariès traces Western man's attitudes toward mortality from the early medieval conception of death as the familiar collective destiny of the human race to the modern tendency, so pronounced in industrial societies, to hide death as if it were an embarrassing family secret.

The main objective of this paper is to define a logic for reasoning about distributed time-stamped claims. Such a logic is interesting for theoretical reasons, i.e. as a logic per se, but also because it has a number of practical applications, in particular when one needs to reason about a huge amount of pieces of evidence collected from different sources, where some of the pieces of evidence may be contradictory and some sources are considered to be more trustworthy than others. (...) We introduce the time-stamped claim logic including a sound and complete sequent calculus. In order to show how time-stamped claim logic can be used in practice, we consider a concrete cyber-attribution case study. (shrink)

Capital punishment—the legally authorized killing of a criminal offender by an agent of the state for the commission of a crime—stands in special need of moral justification. This is because execution is a particularly severe punishment. Execution is different in kind from monetary and custodial penalties in an obvious way: execution causes the death of an offender. While fines and incarceration set back some of one’s interests, death eliminates the possibility of setting and pursuing ends. While fines and incarceration narrow (...) one’s routes to happiness, death eliminates its possibility. Not surprisingly, there is much debate about the moral permissibility of capital punishment. This entry maps the terrain of this debate. The first section discusses justifications of the death penalty as they appear in major theories of punishment. The second section surveys moral objections to execution that apply to most justifications. The third addresses procedural criticisms, which do not target the morality of execution so much as the justice of its implementation. (shrink)