This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and (...) commodification in research have shed light on the importance of transparency. The repercussions of Belmont's emphasis on the protection of vulnerable populations is also explored, as is the relationship between the report's ethical principles and their applications. It is concluded that while the Belmont Report was an impressive response to the ethical issues of its day, the field of research ethics involving human subjects may have outgrown it. (shrink)

The Belmont Report’s distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole (...) exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. (shrink)

Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at (...) what we know about IRB decision-making in relation to protecting and including “vulnerable” groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight. (shrink)

Our primary focus is on analysis of the concept of voluntariness, with a secondary focus on the implications of our analysis for the concept and the requirements of voluntary informed consent. We propose that two necessary and jointly sufficient conditions must be satisfied for an action to be voluntary: intentionality, and substantial freedom from controlling influences. We reject authenticity as a necessary condition of voluntary action, and we note that constraining situations may or may not undermine voluntariness, depending on the (...) circumstances and the psychological capacities of agents. We compare and evaluate several accounts of voluntariness and argue that our view, unlike other treatments in bioethics, is not a value-laden theory. We also discuss the empirical assessment of individuals? perceptions of the degrees of noncontrol and self-control. We propose use of a particular Decision Making Control Instrument. Empirical research using this instrument can provide data that will help establish appropriate policies and procedures for obtaining voluntary consent to research. (shrink)

Medical tourism is a form of medical travel wherein patients move across borders from their home country to another for the purpose of seeking medical trea tmen t tha t is unavailable or unaffordable at home, for the privacy of a transnational location, or for the tourist destination attractions. Medical tourist may seek procedures not approved at home, such as stem cell treatments, or physician assisted suicide. International travel for procedures legal at home and in the destination c oun t (...) r y a re p red omina tely m o tiva ted by affordability and shorter wait-time. In the U.S. some insurance agencies offer reimbursement if a patient goes abroad and has a procedure that is drastically cheaper. Globalization of health care is becoming a fact of life and medical tourism is only one facet of the picture. This paper will examine what we know about medical tourism from a literature survey and evaluate ethical concerns including welfare of pa tien ts, impact on healthcare systems in destination countries, and effect of medical travel on public health. (shrink)

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, are a product of their time. Born in the aftermath of wartime atrocities committed by Nazi doctors, and influenced by domestic research scandals like the Willowbrook and Tuskegee studies, the regulations express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. Requirements for informed consent, risk minimization, equitable subject selection, and peer review of proposed research rest on (...) the presumption that the research enterprise owes subjects a duty of protection. (shrink)

Rapid advances in high throughput genomic technologies and next generation sequencing are making medical genomic research more readily accessible and affordable, including the sequencing of patient and control whole genomes and exomes in order to elucidate genetic factors underlying disease. Over the next five years, the Human Heredity and Health in Africa (H3Africa) Initiative, funded by the Wellcome Trust (United Kingdom) and the National Institutes of Health (United States of America), will contribute greatly towards sequencing of numerous African samples for (...) biomedical research. (shrink)

Traffic research shares a fundamental dilemma with other areas of empirical research in which humans are potentially put at risk. Research is justified because it can improve safety in the long run. Nevertheless, people can be harmed in the research situation. Hence, we need to balance short-term risks against long-term safety improvements, much as in other areas of research with human subjects. In this paper we focus on ethical issues that arise when human beings are directly affected in the performance (...) of research by examining how the ethical requirements in biomedical research can inform traffic research. After introducing the basic ethical requirements on biomedical research, each of the major requirements is discussed in relation to traffic research. We identify the main areas where biomedical research and traffic research differ, and where the ethical requirements from the former cannot easily be transferred to the latter. Finally, we argue that there is a need for systematic studies of the ethics of traffic research and point to some of the issues that need to be addressed. (shrink)

: The standard bioethics account is that respecting patient autonomy means ensuring patients make their own decisions. In fact, respecting patient autonomy often has more to do with the overall shape and meaning of patients' health care regimes, and sometimes, at least, patients will very reasonably defer to medical authority.

The rapid growth of pharmaceutical markets in the 20th century has increased the demand for human research participants in clinical trials. However, with the globalization of clinical research, most clinical trials are conducted in low-income countries (LICs) with political and economic instability, and lack of basic healthcare, but easy access to human subjects. This paper explores the unique ethical challenges faced during the pre-enrollment phase of cross-cultural research in a country like Pakistan, and how these challenges make the Pakistani population (...) vulnerable to exploitation. It also outlines recommendations regarding conducting research in Pakistan within ethical parameters adopted according to local culture. This discussion is important because researchers must focus on the pre-enrollment phase of the research process for it’s cultural suitability and acceptability so that the research conducted is credible and valid and has social value for the research population. (shrink)

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. Because very few subjects (...) with research-related injuries can meet the financial or evidentiary requirements associated with a successful legal claim to recover the costs associated with their injuries, most injured subjects must shoulder the burden of those expenses alone. For 40 years, national advisory panels have concluded that this result is out of step with the Common Rule's otherwise protectionist promise. When the Department of Health and Human Services released an Advance Notice of Proposed Rulemaking (ANPRM) in 2011, suggesting potential changes to the Common Rule, the time seemed ripe to address research-related injuries. The ANPRM, however, makes no mention of compensation for research-related injuries, and the federal government once again seems poised to stop short of addressing what has arguably become the most longstanding, frequent, and consistent plea for regulatory reform of research: protections for injured subjects. This article asks why, despite decades of federal-level panels recommending no-fault compensation for research-related injuries, the United States has so strongly resisted change. I suggest that a central reason for our current impasse is that, despite consensus among federal advisory committees that there is an obligation to compensate injured subjects, the committees have not coalesced around a moral justification for that duty. Although multiple justifications can support and even strengthen a single ethical obligation, the reverse has occurred in this context. I demonstrate that the committees' articulation of multiple ethical principles – including humanitarianism, professional beneficence, and compensatory justice – results in incongruent obligations that favor different kinds of compensation systems. This outcome, which I call “moral gridlock,” makes it extremely difficult to determine what kind of compensation scheme to implement. Recognizing that each moral argument for compensation creates a slightly different trajectory is, however, an important first step in moving toward a more systematic approach to compensating injured research subjects. (shrink)

This article offers a narrative dimension to the evolution of professional ethics in psychology in Israel. The similarities and differences with ethics in the United States frame the discussion. The author's viewpoint and involvement in promoting ethics in academic and professional settings opens the article. This is followed by consideration of the licensing of the profession in 1977, and the ethics requirements that followed. Cultural developments that influenced Israeli society in the direction of greater individual autonomy and disillusionment with paternalism (...) are discussed. The Patient's Rights Law of 1996, the Ethiopian Blood crisis of 1996, and the sexual boundary violations of psychologist Falach in 1992 have had important implications for psychology in Israel. Examining ethics education, the requirements for ethical research, and current ethics resources for psychologists show that although much has been accomplished, there still remains a great deal to be done. (shrink)

Bioethics provides various models of fair allocation of scarce health resources like COVID-19 vaccines. Even though these models are grounded in some ethical principles like justice and beneficence, there were severe inequalities in global access to COVID-19 vaccines. In Ghana, about 21.5 million COVID-19-doses have been administered but comprise mainly members of the adult population. As a result, ethical issues related to vaccinating children have been largely ignored in the country. This paper explores some of the ethical implications related to (...) children’s exclusion in the initial COVID-19 vaccination programs in Ghana. It provides a general overview of the COVID-19 pandemic in Ghana and how it related to children and discusses the risks to which Ghanaian children were exposed by delaying their COVID-19 vaccination. A guide to facilitating the full rollout of COVID-19 vaccination in Ghana for children has been proposed that indicates that a fair vaccine distribution for children should prioritize children on admission at health facilities, those diagnosed with severe underlying health conditions, and children who could play an instrumental role in promoting vaccine uptake. It concludes that children must not be placed at the peripheries of the COVID-19 vaccination program in Ghana. (shrink)

Anderson and Dyck claim that the current trend of almost exclusively using citation-based evaluative metrics to assess the research output of scholars is unsound. I agree with them in this, but I feel that, for practical reasons, this system will not disappear in the near future, so we must concentrate on making it fairer. Both commentators doubt whether numerically expressing each contributor's relative contribution is feasible. I admit that an important precondition for this task is the possibility of an informed, (...) democratic debate among equals about the relative contribution of each contributor to the article. Mechanisms should be established to protect vulnerable researchers in the academic field in the same way as safeguards exist today to protect vulnerable research participants. Theoretically, however, I think that the fair allocation of authorship credit is possible, and much of this task is already being performed routinely when contributors determine the order of their names in the byline, being well aware of the widespread assumption that this order mostly mirrors the order of their relative contributions. All they would have to do as an additional task is to express this order in numbers. If they cannot reach a consensus, they could always choose not to express their relative contribution in numbers, in which case the presumption would be that they contributed equally. My proposal could, at best, make the system fairer and, at worst, not reduce the options that evaluators already have. (shrink)