Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science, and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions. Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also (...) requires limiting the risks of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved. (shrink)

Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international (...) collaborative trials of drugs in developing countries, especially expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research. Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research. (shrink)

In November 2016, the Council for International Organizations of Medical Sciences published its revised International Ethical Guidelines for Health-related Research Involving Humans. In relation to earlier versions, the scope of the new guidelines has been expanded to include public-health research. While successful to some extent, the document does not take into sufficient account the differences between public-health research and other types of health research. It is silent on some issues of importance to public-health research, (...) such as its definition, health inequities and novel research methodologies. Its treatment of some other issues, including the need for researchethics committee approval, consent, community involvement and dissemination of research results, are deficient in some respects. The guidelines that are particularly applicable to and useful for public-health research deal with social value, the health needs of communities and populations, community engagement, disasters and disease outbreaks, cluster randomised trials and data sharing. Much further development of the foundations and applications of public-health research ethics is needed to inform future revisions of the guidelines and of other international and national research-ethics documents. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.4 (2004) 411-425 [Access article in PDF] Vulnerability, Vulnerable Populations, and Policy Mary C. Ruof "Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are selected, the means of protecting their rights and welfare must be strictly applied."Guideline 13: Research Involving Vulnerable Persons International Ethical Guidelines for Biomedical Research Involving Human Subjects Council for (...) class='Hi'>International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO) Geneva, Switzerland, 2002 Within medical research and healthcare certain groups are afforded special protections and services because of their designation as vulnerable. The vulnerable require special justification to participate in human subject research in order to eliminate potential human rights abuses. The Nuremberg Code of 1947 was written in response to the extreme human subject abuses that occurred under the Nazi regime, and, although the intent of the 1947 Code was to protect human rights, rigid voluntary consent requirements deprived some individuals of the right to participate in clinical trials. Recent human research guidelines, such as the CIOMS/WHO guidelines referenced above and the guidelines referenced in Section V of this Scope Note, attempt to balance both protection from abuse in research and access to new, experimental treatments for the vulnerable.Although various protective guidelines stipulate special protections for vulnerable populations, the concept of vulnerability and consequently the criteria designating vulnerable populations remain vague. Precisely who are the vulnerable? The word "vulnerability" stems from the Latin vulnerare, "to wound." (Oxford Encyclopedic English Dictionary 1995). In clinical research, the term [End Page 411] vulnerable generally is applied to individuals who are unable to give informed consent or who are susceptible to coercion. The Common Rule (45 CFR 46, Subpart A) includes as vulnerable research subjects: children, prisoners, pregnant women, and persons who are handicapped, mentally disabled, economically disadvantaged, or educationally disadvantaged. Although the Common Rule specifies certain vulnerable categories, the guidelines were not intended to be exclusive, leaving open the interpretation of vulnerability.In medical research and health policy, vulnerability is an abstract concept that has concrete effects both for those labeled vulnerable and for those not. Clinical researchers, healthcare workers, ethical reviewers, and policymakers must be able to identify vulnerable subjects to establish how healthcare resources will be allocated and who will qualify for special protections and socialized benefits. Attempts to quantify vulnerability in clear, measurable ways have met little if any consensus. As Alexander Morawa (II, 2003, p. 150) states, "There is no single approach to definition of vulnerability. In fact, there is no purposeful categorisation at all."Difficulties in defining vulnerability have prompted discourse surrounding its utility as a qualifying factor in the allocation of health resources and its appropriateness as a guiding principle in bioethics. Some of the authors cited in this Scope Note argue against the labeling and categorization of vulnerable individuals and populations. "Labeling individuals as 'vulnerable' risks viewing vulnerable individuals as 'others' worthy of pity, a view rarely appreciated" (III, Danis and Patrick 2002, p. 320). The categories of vulnerable groups listed under the Common Rule have been the source of controversy, "for example, many find the suggestion that pregnant women are vulnerable to be quite sexist" (IV, DeBruin 2001, p. 7). Instead of creating categories of vulnerable populations, would it not be better to derive an account of just treatment from a just social policy at large that encompasses human vulnerabilities (II, Brock 2002, p. 283).For some of the authors listed here, the concept of vulnerability is essential to bioethics. Robert Goodin (I, 1985, p. 107) writes that the vulnerability of other human beings is the source of our special responsibilities to them. In contrast to the four American principles of biomedical ethics—autonomy, nonmaleficence, beneficence, and justice—the four principles of European bioethics and biolaw include vulnerability along with autonomy, dignity, and integrity. According to, Jacob Dahl Rendtorff and Peter Kemp (I, 2000, p. 274) "the principle of vulnerability is ontologically prior to the other [European] principles, it expresses better than all of the other ethical principles... the finitude of the human condition."Some of the... (shrink)

In exploring the concept of vulnerability, we do not begin with a blank slate. In research involving human subjects, ethics guidelines typically provide a rough definition of the concept. For example, the commentary on Guideline 13 in the International Ethical Guidelines for Biomedical Research Involving Human Subjects, issued by the Council for International Organizations of Medical Sciences (CIOMS), says that "vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. (...) More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests" (CIOMS 2002). Because the CIOMS guidelines .. (shrink)

One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal (...) regulations require that the “risks to subjects” be “reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge” to be gained from the .. (shrink)

Health‐related data uses and data sharing have been in the spotlight for a while. Since the beginning of the big data era, massive data mining and its inherent possibilities have only increased the debate about what the limits are. Data governance is a relevant aspect addressed in ethics guidelines. In this context, the European project BRIDGE Health (BRidging Information and Data Generation for Evidence‐based Health policy and research) strove to achieve a comprehensive, integrated and sustainable EU health‐information system. One of (...) the aims of the project was to evaluate the requirements to construct a data‐linkage infrastructure for the secure management of health information. In a blueprint provided for this infrastructure, the topics ethics and the intimately related governance occupied a whole section, where the recent ethics guidelines by the Council for International Organizations of Medical Sciences (CIOMS) and the World Medical Association (WMA) were referenced. We explore what has changed in the latest versions of the ethics documents adopted by CIOMS and WMA regarding the management of health data and human tissues, the appropriateness of their application in new forms of research and infrastructures as the proposed in the BRIDGE Health project, and whether society should be so concerned about this topic, in the digital era of social exchange. (shrink)

We consider the implications for the ethical evaluation of research programs of two fundamental changes in the revised research ethical guideline of the Council for International Organizations of Medical Sciences. The first is the extension of scope that follows from exchanging “biomedical” for “health‐related” research, and the second is the new evaluative basis of “social value,” which implies new ethical requirements of research. We use the example of antibiotic resistance interventions to explore the need to (...) consider the instances of what we term the pragmatic risks of such interventions to evaluate the social value of certain kinds of health‐related research. These (pragmatic) risks severely threaten the social value of interventions in every area where human and social responses significantly impact on their effectiveness. Thus, the social value of health‐related research needed to demonstrate its effectiveness depends on the extent and successful management of such risks. Research designed to take into account the management of pragmatic risks also gives rise to similar types of risks, and the potential for social value in light of those risks needs to be considered in ethical reviews based on the new guidelines. We argue that, to handle this new expanded task, the international system of research ethical review addressed by the guidelines needs institutional development. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Religious Perspectives on Bioethics, Part ILaura Jane Bishop (bio) and Mary Carrington Coutts (bio)This is Part One of a two part Scope Note on Religious Perspectives on Bioethics. Part Two will be published in the December 1994 issue of this Journal. This Scope Note has been organized in alphabetical order by the name of the religious tradition.Contents for Parts 1 and 2Part 1Part 2I.GeneralI.Native AmericanII.African Religious TraditionsReligious TraditionsIII.Bahá'í FaithII.Protestantism—willIV.Buddhism (...) and Confucianisminclude a general sectionV.Eastern Orthodoxyand sections focused onVI.Hinduismspecific denominations.VII.IslamIII.Roman CatholicismVIII.JainismIX.JudaismIntroductionThe many religions of the world bring diverse, and occasionally divergent, attitudes to bioethical issues. These beliefs may guide patients and health care professionals as they seek or provide health care. In an attempt to facilitate understanding of and access to information about these beliefs in our pluralistic and global society, this Scope Note identifies literature by the world's major religious groups on topics relating to bioethics.Topics covered by this Scope Note include general attitudes to health and [End Page 155] health care, the physician-patient relationship, treatment refusal, abortion, contraception, sterilization, reproductive technologies, genetics, mental health, human experimentation, organ transplantation and donation, death, euthanasia, suicide, and prolongation of life. Material was not available on all of these topics for each religion.The literature gathered here represents only a small portion of the available writing on religion and medicine, and is limited to that which comments explicitly on bioethical issues. Some faiths have a rich tradition of writing in bioethics; for others the literature is more limited. Variation in coverage is not intended to indicate the relative importance of a faith, but reflects accessibility and space constraints. Individuals interested in obtaining additional information are encouraged to contact the National Reference Center for Bioethics Literature.Specific citations about a region or country were chosen because of the predominance of a religious tradition within the population. In all cases, variation in spelling represents author usage. This Scope Note treats only the literature published in English, and every attempt has been made to identify English language sources for these faiths.It is important to remember that doctrinal and theological differences exist even within the same denomination and that views of individual patients, family members, and health care providers should be sought.Dictionaries and EncyclopediasMelton, J. Gordon, ed. Encyclopedia of American Religions. Fourth edition. Detroit: Gale Research, 1993. 1217 p. Basic information about the history, sacred texts, membership, educational facilities, publications, and North American addresses are provided for 1,730 churches, denominations, sects, and cults. Bibliographies for many faiths supplement this extensive resource.Reich, Warren T., ed. Encyclopedia of Bioethics. New York: Free Press, Macmillan, 1978. 4 volumes. Articles on all the major religions as they relate to bioethics are included in this highly-regarded encyclopedia. In addition, many of the topical essays feature a section on the views of various faiths on the topic under discussion. For the best use of the Encyclopedia, see the subject index in volume 4. (Note: a revised, second edition is due to be published by Macmillan in late 1994.)GeneralAmerican Psychiatric Association. Committee on Religion and Psychiatry. Guidelines Regarding Possible Conflict Between Psychiatrists' Religious Commitment and Psychiatric Practice. American Journal of Psychiatry 147 (4): 542, April 1990. The American Psychiatric Association recommends that psychiatrists respect their patients' religious beliefs and that they not impose their own [End Page 156] beliefs on their patients.Bankowski, Z., and Bryant, J. H. Health Policy, Ethics and Human Values: Proceedings of the XVIIth CIOMS Round Table Conference, Athens Greece. Geneva: Council for International Organizations of Medical Sciences, 1985. 336 p. Many sections of this volume address issues where religion impacts health policymaking. Africa, the Middle East, Europe, Latin America, and Asia are highlighted for the varied ways in which their religions and cultures are integrated into the provision of health care.Batchelor, Edward, ed. Abortion: The Moral Issues. New York: Pilgrim Press, 1982. 246 p. Batchelor compiles a collection of essays by experts on religious ethics as they relate to abortion. Includes... (shrink)

Background. Responsible clinical research drives the advancement of healthcare. Despite tremendous improvements in the globalresearch and development environment since the 1950s, low- and middle-income countries (LMICs) are often left behind. There are several reasons for this. Firstly, operational, social, ethical and regulatory challenges in LMICs make it difficult for researchers to conduct clinical studies in those settings in line with international requirements. Secondly, many people living in low-resource settings distrust research because some past studies have not benefited the participants (...) or the communities involved.Objectives. To present the consensus recommendations by a Council for International Organizations of Medical Sciences (CIOMS) Working Group on how to advance good-quality, ethical clinical research in resource-limited settings.Methods. CIOMS convened a Working Group of senior scientists from drug regulatory authorities, the pharmaceutical industry, publicprivate partnerships for product development, and academia.Results. This article summarises the Working Group’s report.Conclusion. The report recommendations can foster the creation of a more enabling ecosystem for clinical research and promotecollaboration between policymakers, regulators, researchers and funders. (shrink)

Public statements by various international groups emphasize that decisions to undergo genetic screening, either for disease-carrier status or for predisposition-to-disease status, and decisions about the use of the resulting information should be made voluntarily by the party to be screened. For example, the World Medical Association, in its Declaration on the Human Genome Project, says, “One should respect the will of persons screened and their right to decide about participation and about the use of the information obtained.” Giving (...) this principle a name, “voluntarism,” the Council for International Organizations of Medical Sciences, in its Declaration of Inuyama , announced that “voluntarism should be the guiding principle in the provision of genetic services. (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 October 2005, UNESCO (the United Nations Educational, Scientific and Cultural Organization) adopted the Universal Declaration on Bioethics and Human Rights. This was the culmination of nearly 2 years of deliberations and negotiations. As a non-binding instrument, the declaration must be incorporated by UNESCO’s member states into their national laws, regulations or policies in order to take effect. Based on documentary evidence and data from interviews, this paper compares the declaration’s universal principles with national bioethics guidelines and practice in Kenya (...) and South Africa. It concentrates on areas of particular relevance to developing countries, such as protection of vulnerable persons and social responsibility. The comparison demonstrates the need for universal principles to be contextualised before they can be applied in a meaningful sense at national level. The paper also assesses the ‘added value’ of the declaration in terms of biomedical research ethics, given that there are already well-established international instruments on bioethics, namely the World Medical Association Declaration of Helsinki and the CIOMS (Council for International Organizations of Medical Sciences) guidelines on biomedical research. It may be that the added value lies as much in the follow-up capacity building activities being initiated by UNESCO as in the document itself. (shrink)

ABSTRACT A complex problem exists about how to promote the best interests of children as a group through research while protecting the rights and welfare of individual research subjects. The Nuremberg Code forbids studies without consent, eliminating most children as subjects, and the Declaration of Helsinki disallows non-therapeutic research on non-consenting subjects. Both codes are unreasonably restrictive. Another approach is represented by the Council for the International Organizations of Medical Science, the U.S. Federal Research Guidelines, and (...) many other national policies. They allow research ethics committees or institutional review boards to authorize studies with acceptable balances of likely benefits and harms, but neither clarify how to balance them nor explain the meaning of pivotal concepts, like “minimal risk.” Paths to the improvement of balancing or consequentialist approaches include improving standardizing of risk assessment, rejecting crude utilitarianism, identifying and justifying normative or moral judg-ments, and acknowledging extra-regulatory thresholds and deontological or non-negotiable duties to children. (shrink)

This article compares two science advisory organizations: the Intergovernmental Panel for Climate Change (IPCC) and the International Council for the Exploration of the Seas (ICES), with a special focus on how their respective policy systems absorb the knowledge delivered for use in decision processes. The science-policy processes of these two organizations differ in important respects; ICES delivers highly specified knowledge to a specified uptake mechanism, while the IPCC produces unspecified knowledge for an unspecified uptake mechanism. Since (...) both environmental governance areas are criticized for lack of needed action, a comparison is of interest asking how this might relate to the organization of science advice. As theoretical resources for this explorative comparison we utilize two approaches from the field of science and technology studies: the co-production approach, which focuses on the entanglements of scientific and political processes, and the systems-theory-oriented multiple-worlds model, which assumes a clear difference in institutional logics between the scientific and the political field. Since the IPCC has been critically analysed by several studies utilizing resources from the two approaches, we contribute with new insights by bringing in ICES, which is a much less studied organization exposing a different science-policy structure. One important finding is that the two theoretical approaches focus on different aspects, exposing ‘links’ and ‘integration’, both of which we argue are important for analysing and assessing science advisory organizations. Moreover, these aspects can be advantageously integrated into a single theoretical framework. (shrink)

The concept of death and its relationship to organ transplantation continue to be sources of debate and confusion among academics, clinicians, and the public. Recently, an international group of scholars and clinicians, in collaboration with the World Health Organization, met in the first phase of an effort to develop international guidelines for determination of death. The goal of this first phase was to focus on the biology of death and the dying process while bracketing legal, ethical, cultural, and (...) religious perspectives. The next phase of the project will include a broader group of stakeholders in the development of clinical practice guidelines and will use expert consensus on biomedical criteria for death from the first phase as scientific input into normative deliberation about appropriate policies and practices. Surely, science alone cannot resolve the normative and philosophical questions intertwined in debates about moral status, legal and moral rights, the ethics of killing, and personhood and the nature of the self; however, scientific input is necessary for informed moral deliberation. An objective and unbiased investigation of the biology of death is independent of, and should be undertaken prior to, an analysis of the normative questions engendered by debate about determination of death. This strategy is explicitly endorsed by the International Guidelines for Determination of Death and reflects the prevailing view of these issues in the mainstream medical literature. However, this mainstream literature, exemplified by the IGDD group's recent report, does not exhibit any of the characteristics usually associated with a scientifically rigorous investigation, such as making empirically testable and falsifiable claims, a commitment to evidence and logic over authoritative assertion, or a willingness to revise hypotheses and theories in light of new evidence. Indeed, the core claims and methodologies of the mainstream medical literature on death, both of which are represented by the IGDD report, are not merely scientifically unjustified; they are not science at all. This situation creates a problem for the integrity of science and the academy, and it unjustly obscures and prevents legitimate democratic and moral deliberation about issues that, at bottom, are normative, not scientific. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 13.1 (2003) 53-64 [Access article in PDF] Incentives for Providing Organs Patricia Milmoe McCarrick and Martina Darragh After a contentious debate at its 2002 annual meeting, the American Medical Association's House of Delegates voted to endorse the opinion of its Council on Ethical and Judicial Affairs that the impact of financial incentives on organ donation should be studied (Josefson 2002). The shortage (...) of organs for transplantation has been an ongoing problem for more than 20 years. In June1981, Representative Philip Crane (R-IL) introduced legislation in the U.S. House of Representatives proposing a $25,000 income tax deduction and a $25,000 estate tax exclusion for donating an organ (Tax Incentives 1981). Still the National Organ Transplant Act enacted in October 1984 prohibited the offering of any "valuable consideration" in return for organs (United States 1984).The developments of a legal market for tissues in the United States and a black market for organs around the world have raised the question of whether donation without compensation is the only ethically viable option. Some critics of the current system claim reliance on donation actually promotes a black market in organs (Kaserman and Barnett 2002, p. 38; Palmer 1999, p. 36). In addition, a new set of compensation issues has arisen as living kidney donor transplantations begin to rival those performed with cadaveric organs (United States 2001).As a result, current suggestions for incentives go far beyond the traditional death benefit payment to include such ideas as medals of honor for donors, reimbursement for funeral expenses, exchange programs for organ donation, and special medical insurance for living organ donors. Numerous bills introduced into the 107th Congress have proposed such incentives (Delmonico et al. 2002.) In October 2002, the U.S. Department of Health and Human Services awarded $5.2 million in grants to study both clinical and behavioral interventions for increasing organ donations that do not involve incentives. The inspiration for some of the funded proposals comes from the successes of Spain's social services and the United Kingdom's clinical administration of organ procurement programs (Robeznieks 2002). [End Page 53]With a nod to evidence-based medicine, the underlying concern expressed in much of the current literature is that no idea for increasing the supply of organs should be discounted before it is studied. This bibliography provides a short introduction to the range of opinions expressed on the issue of incentives for providing organs.al-Mousawi, M.; Samhan, M.; al-Mezairee I.; Razzak, M.A.; and Khawari, F. Cadaver Organ Procurement in Kuwait. Transplantation Proceedings 31 (8): 3375-76, 1999.The authors describe a protocol that significantly increased cadaveric organ donation and credit it with fostering the expansion of an organ sharing program among the Arab Gulf states. Developed by Kuwaiti neurologists and anesthetists after a continuing education course on transplantation, the protocol places a special emphasis on the role of local transplant coordinators who facilitate the investigation of brain death cases by neurologists.Arnold, Robert; Bartlett, Steven; Bernat, James; et al. [Ethics Committee of the American Society of Transplant Surgeons] Financial Incentives for Cadaver Organ Donation: an Ethical Reappraisal. Transplantation 73 (8): 1361-67, 27 April 2002.To prepare for proposed studies of financial incentives for organ donation, the American Society of Transplant Surgeons convened a panel to develop a methodology for evaluating the ethics of such research. Comprised of organ procurement organization executives, physicians, surgeons, and ethicists, the panel generated a list of nine criteria for use in judging any incentives proposal. While opposed to direct payment or tax incentives for organ donation, a majority of the members support funeral expense reimbursement or charitable contributions as incentives that would not violate or undermine the ideal of altruism.Cameron, J. Stewart, and Hoffenberg, Raymond. The Ethics of Organ Transplantation Reconsidered: Paid Organ Donation and the Use of Executed Prisoners as Donors. Kidney International 55 (2): 724-32, February 1999.After reviewing arguments for and against payment for organ procurement, the authors apply these arguments to the specific case of obtaining organs from executed... (shrink)

The Research Excellence Framework of the Higher Education Funding Council for England is taking place in 2013, its three key elements being outputs, impact, and “quality of the research environment”. Impact will be assessed using case studies that “may include any social, economic or cultural impact or benefit beyond academia that has taken place during the assessment period.”1 Medical ethics in the UK still does not have its own cognate assessment panel—for example, bioethics or applied ethics—unlike in, for (...) example, Australia. Several researchers in medical ethics have reported to the Institute of Medical Ethics that during the internal preliminary stage of the Research Excellence Framework several medical schools have decided to include only research that entails empirical data gathering. Thus, conceptual papers and ethical analysis will be excluded. The arbitrary exclusion of reasoned discussion of medical ethics issues as a proper subject for medical research unless it is based on empirical data gathering is conceptually mistaken. “Empirical ethics” is, of course, a legitimate component of medical ethics research, but to act as though it is the only legitimate component suggests, at best, a partial understanding of the nature of ethics in general and medical ethics in particular. It also mistakenly places medicine firmly on only one side of the science/humanities “two cultures” divide instead of in its rightful place bridging the divide. Given the emphasis by the General Medical Council on medical ethics in properly preparing “tomorrow’s doctors,” we urge medical schools to find a way of using the upcoming Research Excellence Framework to highlight the expertise residing in their ethicist colleagues. We are confident that appropriate assessment will reveal work of high quality that can be shown to have social and cultural impact and benefit beyond academia, as required by the framework. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Editorial changes at PPPWelcomes and ThanksJohn Z. Sadler, MDAfter 30 years of co-editing (with Bill Fulford) and editing Philosophy, Psychiatry, & Psychology, I thought it was time for me to step down, and last fall the Association for the Advancement of Philosophy and Psychiatry Executive Council assembled an international search team to select a new Editor-in-Chief. This thoughtful and efficient group, led by Robyn Bluhm, completed the (...) search and selection in a matter of a few months! All of us in the field are grateful to the search committee members for their congenial, disciplined, and fruitful work: Derek Bolton, David Crepaz-Keay, Anthony Fernandez, Brent Kious, Guilherme Messas, and Michael Wong. We are excited about the future of the journal with our new Editor-in-Chief, Professor Werdie van Staden. Briefly, Werdie is the Nelson Mandela Professor of Philosophy and Psychiatry and Director of the Centre for Ethics and Philosophy of the Health Sciences, the University of Pretoria, South Africa.Students, trainees, and early career scholars in our field often ask about how senior scholars found their way to, and through, the field of philosophy/psychiatry. The reading of Werdie's biography, in chronological order, would befuddle a reader trying to predict where he would end up by 2024. In the youth of his adulthood, Werdie was heading toward a career in music, collecting several degrees in music theory, composition, and performance. Indeed, music would occupy a big piece of his life over the decades. Dr. van Staden has continued his musical career as a composer of two symphonies, a concerto, as well as multiple choral and chamber works. He has performed as a flautist for the Pretoria Symphony Orchestra since 2006, and was the Principal for 8 years.However, he was also an individual directed toward service to his fellow human beings. He completed his MBChB medical degree in 1990 and went on to several degree qualifications in medicine, psychiatry, and philosophy. Most significant for us was his early experience with Bill Fulford's master's degree program in the Philosophy of Mental Health at the University of Warwick, later completing a doctoral degree. His Mandela Professorship at Pretoria was the first endowed Professorship in our philosophy/psychiatry multidisciplinary field. Since then his intellectual work has ranged over clinical and research ethics, philosophy of language and psychopathology, Ubuntu virtue theory, person-centered medicine, medical education, and many more areas, making him a most versatile scholar. Over the past three [End Page 91] decades he has functioned as a practicing clinician, a department chair, a clinical trialist, a partner to Bill Fulford in developing and disseminating the Values-Based Practice approach to clinical medicine, a leader in many professional organizations, an editor of the South African Journal of Psychiatry, not to overlook serving as an author, reviewer, and Senior Editor at PPP at various points since the journal's inception. His professional and intellectual activities and accomplishments are too numerous to recount; suffice to say we are delighted to have him bring his vision, creativity, and vigor to us by adding PPP to his to-do list!We congratulate and thank Professor Nancy Potter on her retirement from academia as well as one of our first Senior Editors of PPP. Nancy's path to philosophy/psychiatry was by way of work in the correctional system in her youth, followed by philosophical field work in the emergency psychiatry department at the University of Louisville Hospital, with her psychiatrist colleague Rafi El-Mallakh, MD. However, philosophy has been her first priority, with work in feminist theory, philosophy of peace, virtue theory, and standpoint/social epistemology over her career. Never satisfied with armchair philosophy, Dr. Potter has immersed herself in settings, traditions, and practices to understand them from inside as well as out. As a PPP Senior Editor, Nancy was instrumental in developing the service-user voice, as well as diversifying our authorship in many other ways. I will miss her even-tempered, yet rigorous editorial voice in the journal.My last appointment of a Senior Editor turned out to be one of Dr. van Staden's students. I welcome Dr. Mohammed Abouelleil Rashed as our newest... (shrink)

Bioethics has been in existence now for more than twenty years. Much has changed, however, since Van Rensselaer Potter2 first used the term bioethics in 1971. For Potter, bioethics was an applied science with its roots in the biological sciences and its orientation towards the betterment of human life. Today the concept is used in a different context. It has become the name given to the ethical research that has become necessary in light of the new possibilities created by (...) revolutionary developments in medical science. Generally speaking, bioethics is concerned with the beginning and the end of life. In a certain sense, however, this is merely a de facto definition which does not possess a great deal of internal logical consistency.If we attempt to reconstruct the incredibly rapid evolution of bioethics we quickly realize how the times were truly ripe for this new discipline to begin to mature. In a very short space of time bioethics was taken seriously in just about every University and medical centre the world over. There is no part of the world which has not organised a colloquium or developed a study programme or created a Centre for Biomedical Ethics. Yet this advance is hardly surprising if we consider the fact that there have been revolutionary developments in themedical world in the 1960’s which have made it necessary to engage in serious ethical reflection on the borderline questions of human life.From the start, bioethicists have concerned themselves primarily with ethical problems related to reproductive technology such as in vitro fertilization, medically assisted fertilization with donor gametes, pregnancy termination, and the status of the embryo. More recently, however, questions concerning the end of life have entered the bioethicist’s field of interest, e.g. ethical questions related to euthanasia and the problems surrounding the artificial nutrition and hydration of persistently vegetative patients. In the meantime, of course, bioethics has broadened its field of interest beyond questions related to the beginning and end of life. Serious ethical and juridical reflection has resulted from the problems surrounding organ transplantation, transplantation of brain tissue, and the problem of AIDS.With the many recent developments in genetics, the first applications of gene therapy, and the world-wide human genome research project bioethics is assured an exciting future. It is clear that the issues which grab the bioethicist’s attention are rather disparate. Moreover, we are now beginning to realize that a whole gamut of specific questions cannot be addressed unless the broader context of the ethics of health care in general is taken into account. Such a realization has led to something of a new movement within the bioethical sphere which is interested in widening the notion of ‘medical ethics’ or ‘ethics of health’.The purpose of this article is to help familiarize the reader with the world of bioethics. Such a task is both simple and complex; bioethics has become a house with many rooms, a house, furthermore, which is being constantly renovated and rebuilt. By way of introduction, we shall take an investigative and evaluative stroll through the broad landscape bioethics has traced in the first twenty years of its existence. (shrink)

Bioethics has been in existence now for more than twenty years. Much has changed, however, since Van Rensselaer Potter2 first used the term bioethics in 1971. For Potter, bioethics was an applied science with its roots in the biological sciences and its orientation towards the betterment of human life. Today the concept is used in a different context. It has become the name given to the ethical research that has become necessary in light of the new possibilities created by (...) revolutionary developments in medical science. Generally speaking, bioethics is concerned with the beginning and the end of life. In a certain sense, however, this is merely a de facto definition which does not possess a great deal of internal logical consistency.If we attempt to reconstruct the incredibly rapid evolution of bioethics we quickly realize how the times were truly ripe for this new discipline to begin to mature. In a very short space of time bioethics was taken seriously in just about every University and medical centre the world over. There is no part of the world which has not organised a colloquium or developed a study programme or created a Centre for Biomedical Ethics. Yet this advance is hardly surprising if we consider the fact that there have been revolutionary developments in themedical world in the 1960’s which have made it necessary to engage in serious ethical reflection on the borderline questions of human life.From the start, bioethicists have concerned themselves primarily with ethical problems related to reproductive technology such as in vitro fertilization, medically assisted fertilization with donor gametes, pregnancy termination, and the status of the embryo. More recently, however, questions concerning the end of life have entered the bioethicist’s field of interest, e.g. ethical questions related to euthanasia and the problems surrounding the artificial nutrition and hydration of persistently vegetative patients. In the meantime, of course, bioethics has broadened its field of interest beyond questions related to the beginning and end of life. Serious ethical and juridical reflection has resulted from the problems surrounding organ transplantation, transplantation of brain tissue, and the problem of AIDS.With the many recent developments in genetics, the first applications of gene therapy, and the world-wide human genome research project bioethics is assured an exciting future. It is clear that the issues which grab the bioethicist’s attention are rather disparate. Moreover, we are now beginning to realize that a whole gamut of specific questions cannot be addressed unless the broader context of the ethics of health care in general is taken into account. Such a realization has led to something of a new movement within the bioethical sphere which is interested in widening the notion of ‘medical ethics’ or ‘ethics of health’.The purpose of this article is to help familiarize the reader with the world of bioethics. Such a task is both simple and complex; bioethics has become a house with many rooms, a house, furthermore, which is being constantly renovated and rebuilt. By way of introduction, we shall take an investigative and evaluative stroll through the broad landscape bioethics has traced in the first twenty years of its existence. (shrink)

The Concussion in Sport Group guidelines have successfully brought the attention of brain injuries to the global medical and sport research communities, and has significantly impacted brain injury-related practices and rules of international sport. Despite being the global repository of state-of-the-art science, diagnostic tools and guides to clinical practice, the ensuing consensus statements remain the object of ethical and sociocultural criticism. The purpose of this paper is to bring to bear a broad range of multidisciplinary challenges to the (...) processes and products of sport-related concussion movement. We identify lacunae in scientific research and clinical guidance in relation to age, disability, gender and race. We also identify, through multidisciplinary and interdisciplinary analysis, a range of ethical problems resulting from conflicts of interest, processes of attributing expertise in sport-related concussion, unjustifiably narrow methodological control and insufficient athlete engagement in research and policy development. We argue that the sport and exercise medicine community need to augment the existing research and practice foci to understand these problems more holistically and, in turn, provide guidance and recommendations that help sport clinicians better care for brain-injured athletes. (shrink)

Several influential ethical guidelines and frameworks endorse the view that research with human participants is ethically acceptable only when it has “social value,” meaning that it generates knowledge which can be used to benefit society. For example, the Nuremberg Code requires that medical experiments on human beings “yield fruitful results for the good of society, unprocurable by other methods or means of study”. The Council for International Organizations of Medical Sciences guidelines hold that “health-related (...) research with humans... must have social value” or the “prospect of generating the knowledge and the means necessary to protect and promote people’s health” (CIOMS... (shrink)

Recent developments of three-dimensional printing of biomaterials in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular (...) ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article considers whether there is a limit as to what should be bioprinted in medicine; examines key risks of significant harm associated with testing 3D bioprinting for humans; investigates the clinical trial paradigm used to test 3D bioprinting; analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments. (shrink)

Guideline 20 of the updated International Ethics Guidelines for Health‐related Research Involving Humans (2016) by the Council for International Organizations of Medical Sciences (CIOMS) provides guidance on research in disasters and disease outbreaks against the background of the need to generate knowledge quickly, overcome practical impediments to implementing such research, and the need to maintain public trust. The guideline recommends that research ethics committees could pre‐screen study protocols to expedite ethical reviews in a situation (...) of crisis, that pre‐arrangements be made regarding data sharing and biomedical sample sharing, and that sponsors and research ethics committees seek to minimize risk to researchers conducting research during a disaster. This paper critiques these recommendations against the background of the findings of a survey of public health officials and chairs of research ethics committees in the Caribbean during 2016, which sought to determine the best template for the expeditious ethical review of research proposals in emergency and epidemic situations in the Caribbean, and whose findings can serve as a model for other low‐ and middle‐income countries. (shrink)

Human rights legislation pertaining to applications of human genetic science is still lacking at an international level. Three international human rights documents now serve as guidelines for countries wishing to develop such legislation. These were drafted and adopted by the United Nations Educational, Scientific and Cultural Organization, the Human Genome Organization, and the Council of Europe. It is critically important that the international nursing community makes known its philosophy and practice-based knowledge relating to ethics and human (...) rights, and contributes to the globalization of genetics. Nurses have particular expertise because they serve in a unique role at grass roots level to mediate between genetic science and its application to public health policies and medical interventions. As a result, nurses worldwide need to focus a constant eye on human rights ideals and interpret these within social, cultural, economic and political contexts at national and local levels. The purpose of this article is to clarify and legitimate the need for an international declaration on nursing, human rights, human genetics and public health policy. Because nurses around the world are the professional workforce by which genetic health care services and genetic research protocols will be delivered in the twenty-first century, members of the discipline of nursing need to think globally while acting locally. Above all other disciplines involved in genetics, nursing is in a good position to articulate an expanded theory of ethics beyond the principled approach of biomedical ethics. Nursing is sensitive to cultural diversity and community values; it is sympathetic to and can introduce an ethic of caring and relational ethics that listen to and accommodate the needs of local people and their requirements for public health. (shrink)

Benefiting from a widely recognised experience of the field of bioethics, the Council of Europe which represents all the democratic countries of Europe, has embarked on the ambitious task of drafting a European Convention on bioethics. The purpose of this text is to set out fundamental values, such as respect for human dignity, free informed consent and non-commercialisation of the human body. In addition to this task, protocols will provide specific standards for the different fields concerned with the application (...) of biomedical sciences. The convention and the first two protocols (human experiments and organ transplants) are due to be ready for signature by mid 1994. (shrink)

BackgroundThe International Committee of Medical Journal Editors Recommendations set ethical and editorial standards for article publication in most leading medical journals. Here, I examine the strengths and weaknesses of the Recommendations in the prevention of commercial bias in industry-financed journal literature, on three levels – scholarly discourse, article content, and article attribution.DiscussionWith respect to overall discourse, the most important measures in the ICMJE Recommendations are for enforcing clinical trial registration and controlling duplicate publication. With respect to article (...) content, the ICMJE promotes stringent author accountability and adherence to established reporting standards. However, the ICMJE accepts the use of commercial editorial teams to produce manuscripts, which is a potential source of bias, and accepts private company ownership and analysis of clinical trial data. New ICMJE guidance on data sharing will address but not eliminate problems of commercial data access. With respect to attribution, the Recommendations oppose guest authorship and encourage clear documentation of author contributions. However, they exclude writers from coauthorship; provide no specific advice on the attribution of commercial literature, for instance with respect to company authorship, author sequence or prominent commercial labeling; and endorse the use of fine print and euphemism. The ICMJE requires detailed author interest disclosures, but overlooks the interests of non-authors and companies, and does not recommend that interests most salient to the publication are highlighted. Together, these weaknesses facilitate “advocacy”-based marketing, in which literature planned, financed and produced by companies is fronted by academics, enabling commercial messages to be presented to customers by their respected clinical peers rather than companies themselves.ConclusionsThe ICMJE Recommendations set important research and reporting standards, without which commercial bias would likely be a significantly greater problem than it is today. However, they also support practices of commercial data control, content development and attribution that run counter to science’s values of openness, objectivity and truthfulness. These weaknesses could be addressed with appropriate modifications to the Recommendations. The ICMJE should also disclose its own commercial interests and funding – not least because publishing organizations that finance it and pay the salaries of some member editors derive substantial revenues from industry. (shrink)

Recent advances in neuroscience lead to a wider realm for philosophy to include the science of the Darwinian-evolved computational brain, our inner world producing organ, a non-recursive super- Turing machine combining 100B synapsing-neuron DNA-computers based on the genetic code. The whole system is a logos machine offering a world map for global context, essential for our intentional grasp of opportunities. We start from the observable contrast between the chaotic universe vs. our orderly inner world, the noumenal cosmos. So far, philosophy (...) has been rehearsing our thoughts, our human-internal world, a grand painting of the outer world, how we comprehend subjectively our experience, worked up by the logos machine, but now we seek a wider horizon, how humans understand the world thanks to Darwinian evolution to adapt in response to the metaphysical gap, the chasm between the human animal and its environment, shaping the organism so it can deal with its variable world. This new horizon embraces global context coded in neural structures that support the noumenal cosmos, our inner mental world, for us as denizens of the outer environment. Kant’s inner and outer senses are fundamental ingredients of scientific philosophy. Several sections devoted to Heidegger, his lizard debunked, but his version of the metaphysical gap & his doctrine of the logos praised. Rorty and others of the behaviorist school discussed also. (shrink)

Background: Even in countries with an opt-out or presumed consent system, relatives have a considerable influence on the post-mortem organ harvesting decision. However, their reflection capacity may be compromised by grief, and they are, therefore, often prone to choose refusal as default option. Quite often, it results in late remorse and dissatisfaction. So, a high-quality reflection support seems critical to enable them to gain a stable position and a long-term peace of mind, and also avoid undue loss of potential grafts. (...) In practice, recent studies have shown that the ethical aspects of reflection are rarely and often poorly discussed with relatives and that no or incomplete guidance is offered. No review of the literature is available to date, although it could be of value to improve the quality of the daily practice. Objectives: The objective was to review and synthesize the main concepts and approaches, theories and practices of ethical reflection support of the relatives or surrogates of potential post-mortem organ donors. Research design: A narrative review was performed in the medical, psychological and ethical fields using PubMed, PsycArticles and Web of Science databases (1980–2020). Results: Out of 150 papers, 25 were finally retained. Four themes were drawn: the moral status of the potential post-mortem organ donor, the principlistic approach with its limits and critics, the narrative approach and the transcendental approach. Discussion: This review suggests an extension of psychological support towards ethical reflection support. The process of helping relatives in their ethical exploration of post-mortem organ donation is psychologically and morally characterized. The need for specialized professionals educated and experienced both in clinical psychology and in health ethics to carry out this task is discussed. Practical impact: This review could contribute to optimize the quality of the ethical reflection support by initiating an evolution from an empirical, partial and individual-dependent support to a more systematized, professionalized and exhaustive support. (shrink)

The theory of boundary organizations was developed to address an important group of institutions in American society neglected by scholarship in science studies and political science. The long-term stability of scientific and political institutions in the United States has enabled a new class of institutions to grow and thrive as mediators between the two. As originally developed, this structural feature of these new institutions—that is, their location on the boundary between science and politics—dominated theoretical frame-works for explaining their behavior. (...) Applying the theory of boundary organizations to international society requires a refocusing of some of the theory’s central features, however. In this article, I introduce a new framework—hybrid management—to explain the activities of boundary organizations in the more complex, contingent, and contested settings of global politics. I develop the framework of hybrid management using the specific example of the U.N. Framework Convention on Climate Change’s Subsidiary Body for Scientific and Technological Advice. (shrink)

What happens in the world’s most advanced life sciences laboratories, why those activities are important, and whether and how they can be brought under a uniform governance framework might be considered exquisitely esoteric matters in the context of the great geopolitical questions of our time. Nonetheless, the emerging issues in biotechnology—the use of living organisms to create new products and especially in the control of the human genome—represent a useful stress test for the future of the norms inherent in (...) the liberal international order (LIO). My case study will be the nearly universal public outrage following the announcement by a Chinese scientist that he had engaged in the first gene editing of several embryos that survived to birth, an episode that has created an opportunity to assess the global consensus about the ethics of biotechnology with regard to human DNA. Although not as explicit or well understood or enforced as weapons treaties, trade arrangements, or monetary institutions, the norms around biotechnology are very much a product of the post-World War II liberal consensus. (shrink)

This paper argues that two characteristics of social life impinge importantly upon medical attempts to maintain high ethical standards. The first is the tension between the role of ethics in protecting the patient and maintaining the solidarity of the profession. The second derives from the observation that the foundations of contemporary medical ethics were laid at a time of one-to-one doctor-patient relations while nowadays most doctors work in or are associated with large-scale organisations. Records cease to be the (...) property of individual doctors, become available not only to other doctors but also to educational and social work personnel. Making records openly available to patients is suggested as the only antidote to this irreversible loss of individual practitioner control. The importance for doctors of understanding the nature of professional and bureaucratic organisations in order to deal with the hazards involved is stressed as is the responsibility of the General Medical Council to regulate medical competence as well as personal behaviour. (shrink)

Currently one of the main goals of editors is to attain a higher visibility for their journals. On the other hand, authors strive to publish their research in journals indexed in eminent databases such as Scopus, Thompson Reuters’ Web of Science, Medline, etc. Therefore, clarifying the standards of indexing is of great importance. One of the most important issues in publication is the ethical considerations, which are mainly described by organizations, such as the International Committee of Medical (...) Journal Editors and the Committee on Publication Ethics. In this study, we examined the ethical requirements of high impact databases for indexing journals to investigate whether they mention or mandate journals to adhere to publication ethics. We found that only Scopus mandated journals to state clear ethical policies on their website as a criterion for being indexed while Medline and Directory of Open Access Journals advised journals to adhere to ethics, not mandated, and Web of Science and PubMed Central made no mention of ethics as a required criterion for indexing. Based on this short review, there seems to be a gap between the requirements of indexing systems and international guidelines for publication ethics. Currently, most indexing systems have only partially recommended journals to consider ethical issues. In such an atmosphere, we cannot expect journals or as a result, authors to professionally, completely, and whole heartedly implement ethical guidelines as a mandatory rule in their journals and research, when the indexing systems that most editors want to be indexed in and most authors want to be cited in do not mandate such guidelines. (shrink)

ArgumentThis paper explores the links between the competing scientific, disciplinary, and institutional identifications of social scientists working for international organizations and the nature of the work produced in these establishments. By examining the case of UNESCO's Social Science Department from 1946 to 1955, the paper shows how the initial lack of organizational identification diminished the efficiency and productivity of the Department and slowed down the creation of an international system for research in the social sciences. It (...) then examines how the elaboration of such identification resulted from a period of trial and error during which several national, academic, and scientific models were explored. The paper concludes that only the discourse of “moral sensitivity” kept the Department together at a time when disillusions regarding internationalism, the destabilization of the meaning of nation, and suspicion towards some Western disciplines rendered unacceptable the universalization of a single international social scientific identification. (shrink)

This book contains a collection of treaty documents and soft law on health care rights and health ethics which are used in health law training programs. Regional documents and explanatory reports on health care rights, which are derived from international human rights law, provide a way of "unwrapping" government obligations in health care, making rights more specific, accessible, and (judicially) accountable. In addition, soft law declarations and medical ethics contribute to understanding the moral meaning of human rights in (...) health care. As such, the principles and standards provide practical guidance for States when dealing with equal access to health care services, the rights of patients, biomedical research, organ donations and transplants, genetics, and public health. The book covers the basic documents, while general comments and explanatory reports amplify the principles embodied in the human rights treaties. The authoritative interpretations clarify a 'European approach' on a State's obligations concerning health care rights and ethics. (shrink)

In this article we analyse the ideas of outstanding Armenian thinker of X century Gregory of Narek and their connection with ideas of V. Potter. The power of Narek as a remedy for diseases is explained also by the viewpoint of Word Remedy.

The revision of the Council of International Organizations of Medical Sciences (CIOMS) International ethical guidelines for health‐related research (2016) heralds a paradigm shift from the ‘protectionist’ policies that emerged following historical research atrocities of the 20th century, towards a more nuanced and inclusive approach to research participation. Adopting this modified approach will enable countries to secure the benefits of research for individuals and for society as a whole, while at the same time minimizing the (...) potential for exploitation and research‐related harms. This article considers the potential impact of Guideline 16 of the CIOMS 2016 from a New Zealand perspective, with respect to research involving adults with impaired capacity and who are incapable of giving informed consent. While the CIOMS 2016 apply a ‘minimal risk’ threshold to guide research involving adults who lack capacity to consent, New Zealand law currently adopts a ‘best interests’ standard which significantly restricts the scope of permissible research that may be performed in this context. This article argues that the CIOMS 2016 should influence change to New Zealand’s legal framework for ethical review of research. CIOMS 2016 provides useful guidance for the necessary standards and processes to enable the responsible and ethical inclusion of adults with impaired capacity in research. (shrink)

The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically modified organisms remains high. Gene drive open field research thus raises important questions regarding what is owed to those who may not consent to such research, or those could be affected by the proposed research, but whose consent is not solicited. (...) The precise circumstances under which informed consent must be obtained, and from whom, requires careful consideration. Furthermore, appropriate engagement processes should be central to any introduction of genetically modified mosquitos in proposed target settings. In this work, international guidance documents on informed consent and engagement are reviewed and applied to the genetically modified mosquito research context. Five analogous research endeavours that involve area-wide / open field experiments are reviewed. The approach of each in respect to the solicitation of individual informed consent and community engagement are highlighted. While the solicitation of individual informed consent in host settings of gene drive field trials may not be possible or feasible in some instances, local community and stakeholder engagement will be key to building trust towards the proposed conduct of such research. In this regard, the approaches taken by investigators and sponsors of political science field research and weather modification field research should be avoided. Rather, proponents of gene drive field research should look to the Eliminate Dengue field trials, cluster randomised trials, and pragmatic clinical trials for guidance regarding how the solicitation of individual informed consent of host communities ought to be managed, and how these communities ought to be engaged. (shrink)

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences, the International Conference on Harmonization's standards for industry, and the CONSORT group's reporting norms, in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's body of regulations, (...) and information sheets by the Department of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”. (shrink)

There are longstanding calls for international organizations to be more inclusive of the voices and interests of people whose lives they affect. There is nevertheless widespread disagreement among practitioners and political theorists over who ought to be included in IO decision-making and by what means. This paper focuses on the inclusion of IOs’ ‘intended beneficiaries,’ both in principle and practice. It argues that IOs’ intended beneficiaries have particularly strong normative claims for inclusion because IOs can affect their vital (...) interests and their political agency. It then examines how these claims to inclusion might be feasibly addressed. The paper proposes a model of inclusion via representation and communication, or ‘mediated inclusion.’ An examination of existing practices in global governance reveals significant opportunities for the mediated inclusion of IOs’ intended beneficiaries, as well as pervasive obstacles. The paper concludes that the inclusion of intended beneficiaries by IOs is both appropriate and feasible. (shrink)

There is a fairly closed circle between culture, language, meaning, and truth such that the world of a given culture is a world understood in terms of the meanings produced in that culture. Medicine is, in fact, a subculture of a powerful type and has its own language and understanding of the range of illnesses that affect human beings. So how does medicine get at the truth of people and their ills in such a way as to escape its own (...) limited constructions? There is a way out of the closed circle implicit in the idea of a praxis and the engagement with reality that is central to it and the further possibility introduced by Jacques Lacan that signification is never comprehensive in relation to the subject's encounter with the real. I will explore both of these so as to develop a conception of truth that is apt for the knowledge that arises in the clinic. (shrink)

This paper examines the crowded landscape of conferences and organizations within which the International Foundation for Science (IFS) was shaped in the early 1970s. The IFS aimed to support scientists from developing countries, circumventing the bureaucracy of established international organizations such as UNESCO and the Organization for Economic Co-operation and Development (OECD). The new foundation was a potential rival to such institutions, which ironically provided the conditions essential to its emergence. Their conferences, board meetings and assemblies, (...) where scientists and policy makers convened, provided key infrastructure for the development of the IFS. This infrastructure appears simultaneously both as an almost invisible feature of international science policy, and as a political problem. The solution to this problem was Stockholm: a geographical place that was also placeless, occupying both national and international status, desirable in its political, scientific and geographical neutrality. In an organizational context, academies and scientific societies who found their role circumscribed by existing international institutions used the IFS to argue for their particular role and expertise in funding and promoting scientific development. Geographically and politically, neutral Sweden provided a setting which was located between East and West, and which added to the country's own reputation for championing the causes of developing nations. (shrink)

The potential of psychiatry as an integrative science has been impeded by an internal schism that derives from the duality of mental and physical. Organic unity theory is proposed as a conceptual framework that brings together the terms of the mind-body duality in one coherent perspective. Organic unity theory is braided of three strands: identity, which describes the relationship between mentally described events and corresponding physically described events; continuity, which describes the linguistic-conceptual system that contains both mental and physical terms; (...) and dialectic, which describes the relationship between the empirical way of knowing that is associated with the physical domain of the linguistic-conceptual system and the hermeneutic way of knowing that is associated with the mental domain. Each strand represents an integrative formulation that resolves an aspect of mental-physical dualism into an underlying unity. After the theory is presented, its implications for psychiatry are briefly considered. (shrink)

Neuroethics applies cognitive neuroscience for prescribing alterations to conceptions of self and society, and for prescriptively judging the ethical applications of neurotechnologies. Plentiful normative premises are available to ground such prescriptivity, however prescriptive neuroethics may remain fragmented by social conventions, cultural ideologies, and ethical theories. Herein we offer that an objectively principled neuroethics for international relevance requires a new meta-ethics: understanding how morality works, and how humans manage and improve morality, as objectively based on the brain and social (...) class='Hi'>sciences. This new meta-ethics will simultaneously equip neuroethics for evaluating and revising older cultural ideologies and ethical theories, and direct neuroethics towards scientifically valid views of encultured humans intelligently managing moralities. Bypassing absolutism, cultural essentialisms, and unrealistic ethical philosophies, neuroethics arrives at a small set of principles about proper human flourishing that are more culturally inclusive and cosmopolitan in spirit. This cosmopolitanism in turn suggests augmentations to traditional medical ethics in the form of four principled guidelines for international consideration: empowerment, non-obsolescence, self-creativity, and citizenship. (shrink)

The main varieties of scientific misconduct are fabrication, falsification, misquoting and plagiarism. Considering the "improvement" of fraudulent skills, scientists, editors, and authorities must jointly combat the misconduct. Also, it is important that whistleblowers must be protected from revenge. The response to scientific misconduct requires national and international bodies to provide leadership and guidelines. Whistleblowers need a safe, confidential place to report misconduct. The quality of research and hidden conflicts of interest should be taken into account deciding which studies are (...) to be included into reviews. Forged publications and speculative theories have been used for promotion of drugs, dietary supplements and treatments without proven effectiveness. Marketing of placebos in the guise of evidence-based medications seems to be on the increase. Patients can be misinformed not only by the advertising but also by publications supposed to be scientific. Furthermore, it has become usual practice to disregard published criticism in spite of personal communications and debates at conferences. Some scientists seem to make use of critical comments without citing them, or just continue publications ignoring the criticism. The same scientists continue working sometimes in cooperation with renowned researchers; and it is possible that some later articles are more reliable than earlier ones. However, it is insufficient to hope that reliable publications would be shortly confirmed while forgeries would fall into oblivion. Fake papers are misleading for research and practice, cost time and money. Wrong concepts are persisting and reappearing, which may result in useless experimentation and application of invasive methods without sufficient indications. An international cooperation of bona fide scientists, editors and authorities is needed to eradicate the scientific misconduct and fraude in medicine. The book contains an overview of misconduct in medical research and practice mainly from the former Soviet Union. Ample documentary evidence is provided as illustrations. (shrink)

The apartheid ideology in South Africa had a pervasive influence on all levels of education including medical undergraduate training. The role of the health sector in human rights abuses during the apartheid era was highlighted in 1997 during the Truth and Reconciliation Commission hearings. The Health Professions Council of South Africa subsequently realised the importance of medical ethics education and encouraged the introduction of such teaching in all medical schools in the country. Curricular reform at the (...) University of Stellenbosch in 1999 presented an unparalleled opportunity to formally introduce ethics teaching to undergraduate students. This paper outlines the introduction of a medical ethics programme at the Faculty of Health Sciences from 2003 to 2006, with special emphasis on the challenges encountered. It remains one of the most comprehensive undergraduate medical ethics programmes in South Africa. However, there is scope for expanding the curricular time allocated to medical ethics. Integrating the curriculum both horizontally and vertically is imperative. Implementing a core curriculum for all medical schools in South Africa would significantly enhance the goals of medical education in the country. (shrink)