Through mystery, literature reveals to us the Great Unknown. While we are absorbed by the matters at hand with the present enactment of our life, groping for clues to handle them, it is through literature that we discover the hidden strings underlying their networks. Hence our fascination with literature. But there is more. The creative act of the human being, its proper focus, holds the key to the Sezam of life: to the great metaphysical/ontopoietic questions which literature may disclose. First, (...) it leads us to the sublimal grounds of transformation in the human soul, source of the specifically human significance of life (Analecta Husserliana, Volume III, XIX, XXIII, XXVII) Second, it leads us to the unveiling of the hidden workings of life in the twilight of knowing in a dialectic between The Visible and the Invisible, (Volume LXXV, 2002, Analecta Husserliana) down to the ontopoietic truth. (Volume LXXVI, 2002, Analecta Husserliana) This prying into the unknown which provokes the human being as he or she attempts to conquer, step by step, a space of existence, finds its culmination in the phenomenon of mystery as the subject of the present collection. Its formulation brings us to the greatest question of all: the enigmatic solidarity -in-distinctiveness of human cognition and existence. Papers are written by: Tony E. Afejuku, Gary Backhaus, Paul G. Beidler, Matthew J. Duffy, Raffaela Giovagnoli, Jennifer Anna Gosetti-Ferencei, Matti Itkonen, Lawrence Kimmel, Catherine Malloy, Vladimir L. Marchenkov, Nancy Mardas, Howard Pearce, Bernadette Prochaska, Victor Gerald Rivas, M.J. Sahlani, Dennis Skocz, Jadwiga S. Smith, Mara Stafecka, Max Statkiewicz, Mariola Sulkowska, Anna-Teresa Tymieniecka, Leon U. Weinman, Tim Weiss. (shrink)

In an era of unrivalled sequencing, computation and networking capability, international sharing of genomic samples and data is becoming a modus operandi for modern medical research. Researchers are collaborating to establish large collections with global scale. Having never before set foot outside the cell, the molecules that shape us are being digitized and launched across the globe. Protecting individual privacy interests in this information is a central challenge of the genomic research era. This article reviews international (...) privacy norms governing human genomic biobanks and databases. It will not directly consider biobanks established for other health-related purposes, such as screening or therapy. A genomic biobank is “a hybrid infrastructure,” an organized collection of human biological material combined with associated health information: physical measurements, outcome data in medical records, and epidemiological information, as well as genomic data derived from the samples. (shrink)

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently (...) or are not expressed in local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently (...) or are not expressed in local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

Canada’s Tri-Council Policy Statement: Ethical conduct for research involving humans, first published in 1998, has recently been updated.1 The US Department of Health and Human Services has just issued an Advance Notice of Proposed Rulemaking that would substantially change the 20-year-old Common Rule governing most federally funded research involving human participants.2 A comparison of the two countries’ systems for protecting human research participants is therefore timely. This analysis situates the Canadian system in an international context, with (...) particular attention to its similarities and differences to the US system and their shared challenges going forward with their changes. (shrink)

"The Bush administration and Congress are in concert on the goal of developing a fleet of unmanned aircraft that can reduce both defense costs and aircrew losses in combat by taking on at least the most dangerous combat missions. Unmanned combat aerial vehicles (UCAVs) will be neither inexpensive enough to be readily expendable nor-- at least in early development-- capable of performing every combat mission alongside or in lieu of manned sorties. Yet the tremendous potential of such systems is widely (...) recognized, and allies as well as potential adversaries are moving quickly to mount their own research and development programs. The United States is committed to fielding UCAV capabilities by 2010, principally for the missions of suppression of enemy air defense and deep strike, which are among the highest risk tasks for the Air Force and naval aviation."--Overview. (shrink)

Human embryo models formed from stem cells—known as embryoids—allow scientists to study the elusive first stages of human development without having to experiment on actual human embryos. But clear ethical guidelines for research involving embryoids are still lacking. Previously, a handful of researchers put forward new recommendations for embryoids, which they hope will be included in the next set of International Society for Stem Cell Research guidelines. Although these recommendations are an improvement over the default (...) approach, they are nonetheless unworkable, because they rely on a poorly conceived notion of an embryoid’s ‘potential’ to trigger stringent research regulations. (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)

The increasing possibilities for using tissue for research and development in genetics and biotechnology have made stored human biological materials more important than ever. Using stored human biological materials raises many legal and ethical questions. On an international level however, the use of these materials has not been regulated in a detailed manner so far. The Council of Europe recently declassified the text of the proposal for an instrument on the use of archived human biological materials in biomedical (...) research for public consultation. The purpose of this paper is to comment on this document regarding its primary goal, which is to protect the rights and fundamental freedoms of the individual whose biological materials could be included in a research project. The guidelines offer good basic protection for sources of identifiable human biological materials but, surprisingly, offer no protection to sources of anonymous or anonymised materials. (shrink)

In this article we examine ethical aspects of the involvement of children in clinical research, specifically those who are incapable of giving informed consent to participate. The topic is, of course, not a new one in medical ethics but there are some tensions in current guidelines that, in our view, need to be made explicit and which need to be responded to by the relevant official bodies. In particular, we focus on tensions between the World Medical Association Declaration (...) of Helsinki, and the guidance offered by the British Medical Association, the Royal College of Paediatrics and Child Health , and the Council for International Organizations of Medical Sciences. We conclude with a call for these organisations to make their guidance explicit in relation to the World Medical Association Declaration. (shrink)

American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines (...) conflict or come to different but compatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways. AAP/ACMG analyzes risks and benefits using best interests of the child and recommends that, absent ameliorative interventions available during childhood, clinicians should generally decline to order testing. Parents authorize focused tests. ACMG analyzes risks and benefits using the interests of the child and other family members and recommends that sequencing results be examined for additional variants that can lead to ameliorative interventions, regardless of age, which laboratories should report to clinicians who should contextualize the results. Parents must accept additional analysis. The ethical arguments in these statements appear to be in tension with each other. (shrink)

Diese Abhandlung untersucht die Frage, ob internationale Richtlinien für die Gentechnologie, insbesondere im Hinblick auf "genetische Verbesserungen" , wünschenswert und machbar erscheinen. Es wird die Auffassung vertreten, daß die Forderung nach solchen internationalen Richtlinien sich unüberwindlichen praktischen Hindernissen gegenübersieht. Den Hintergrund für diese Auffassung bilden die Ambivalenz des Richtlinienkonzepts, das Fehlen einer Autorität, die solche Richtlinien in Kraft setzen könnte, mangelnder Konsens über zentrale Normen oder Werte, die in die Richtlinien einbezogen werden könnten, der Widerstand sowohl von Seiten der Wissenschaft (...) als auch der privaten Wirtschaft gegen solche Richtlinien und schließlich die öffentliche Forderung nach der Einführung von Methoden "genetischer Verbesserung". Die Forschung über Methoden "genetischer Verbesserung" hat schon begonnen und wird sich ohne Zweifel fortsetzen. Es wird daher in diesem Beitrag vorgeschlagen, daß öffentliche Mittel zur Unterstützung der Forschung über "genetische Verbesserung" zur Verfügung gestellt werden, um sicher zu stellen, daß Forschung dieser Art angemessene vorhergehende Begutachtung und andauernde Überwachung erfährt. Öffentlichkeit, Vorausschau und Kritik können uns helfen, vom Mißbrauch des Menschen als Forschungsobjekt und rücksichtslosem Forscherdrang weg und hin zu akzeptablen Formen der "genetischen Verbesserung" zu kommen. This essay explores whether international guidelines in genetics, specifically regarding genetic enhancement, are desirable and feasible. It is argued that the quest for international guidelines faces insuperable practical obstacles. These include the ambiguity of the concept of guidelines, no authoritative body to issue guidelines, lack of consensus about substantive norms or values to be incorporated into guidelines, resistance from the scientific as well as the private business sector to guidelines, and public demand for genetic enhancement. Genetic enhancement research has already begun and will no doubt continue. It is proposed that public funding for genetic enhancement research be provided to ensure that such research receives adequate prior review and continual monitoring. Publicity, oversight, and critique can help steer us away from abuses of human research subjects and reckless science toward acceptable forms of genetic enhancement. (shrink)

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

Structural interventions to historic stone masonry buildings require that both structural and heritage values be considered simultaneously. The absence of one of these value systems in implementation can be regarded as an unethical professional action. The research objective of this article is to prepare a guideline for ensuring ethical structural interventions to small-scale stone historic masonry buildings in the conservation areas of Northern Cyprus. The methodology covers an analysis of internationally accepted conservation documents and national laws related to the (...) conservation of historic buildings, an analysis of building codes, especially Turkish building codes, which have been used in Northern Cyprus, and an analysis of the structural interventions introduced to a significant historic building in a semi-intact state in the walled city of Famagusta. This guideline covers issues related to whether buildings are intact or ruined, the presence of earthquake risk, the types of structural decisions in an architectural conservation project, and the values to consider during the decision making phase. (shrink)

Brain-computer Interface (BCI) research is rapidly expanding, and it engages domains of human experience that many find central to our current understanding of ourselves. Ethical principles or guidelines can provide researchers with tools to engage in ethical reflection and to address practical problems in research. Though researchers have called for clearer ethical principles or guidelines, there is little existing data on what form these should take. We developed a prospective set of ethical principles for BCI (...) class='Hi'>research with specific guidelines and shared them, via a survey, to participants at the 6th International BCI Meeting at the Asilomar Conference Center in 2016. Respondents were broadly supportive of principles of Care for Subjects, Modesty, Participation, Inclusivity, Relationality, Justice, and Social Impact. Principles more traditionally aligned with responsible conduct of research showed higher levels of endorsement. Researcher support for specific principle-based ethical guidelines varied with respect to stringency of researcher obligations. (shrink)

The International Panel on Social Progress is an independent association of top research scholars with the goal of assessing methods for improving the main institutions of modern societies. The IPSP has produced a report consisting of twenty-two chapters in three volumes that distills the research of these scholars and outlines what the best social science has to say about positive social change. Written in accessible language by scholars across the social sciences and humanities, these volumes assess the (...) achievements of world societies in past centuries, the current trends, the dangers that we are now facing, and the possible futures in the twenty-first century. It covers the main socio-economic, political, and cultural dimensions of social progress, global as well as regional issues, and the diversity of challenges and their interplay around the world. The authors offer a cautious optimistic conclusion: multiple ideas for social progress and better policies are already available and deserve to be tested and implemented. (shrink)

Bauer, Taub, and Parsi's review of an international sample of standards on informed consent, confidentiality, commercialization, and quality of research in tissue banking reveals that no clear national or international consensus exists for these issues. The authors' response to the lack of uniformity in the meaning, scope, and ethical significance of the policies they examined is to call for the creation of uniform ethical guidelines. This raises questions about whether harmonization should consist of voluntary international (...) standards or international regulations that include an official oversight mechanism and sanctions for noncompliance, and about who should participate in the harmonization process. Moreover, the normative assumptions and political dynamics that shape global policymaking need to be addressed. This commentary explores the policy implications and normative questions raised by the idea of international ethical guidelines for the use of biotechnologies and biotechnological resources such as stored samples of human tissue. (shrink)

This article shows how funding research on Alzheimer's disease became a priority for the British Medical Research Council in the late 1970s and 1980s, thanks to work that isolated new pathological and biochemical markers, and showed that the disease affected a significant proportion of the elderly population. In contrast to histories that focus on the emergence of new and competing theories of disease causation in this period, I argue that concerns over the use of different assessment methods ensured (...) the MRC's immediate priority was standardising the ways in which researchers identified and recorded symptoms of Alzheimer's disease in potential research subjects. I detail how the rationale behind the development of standard assessment guidelines was less about arriving at a firm diagnosis and more about facilitating research by generating data that could be easily compared across the disciplines and sites that constitute modern biomedicine. Drawing on criticism of specific tests in the MRC's guidelines, which some psychiatrists argued were "middle class biased", I also show that debates over standardisation did not simply reflect concerns specific to the fields or areas of research that the MRC sought to govern. Questions about the validity of standard assessment guidelines for Alzheimer's disease embodied broader concerns about education and social class, which ensured that distinguishing normal from pathological in old age remained a contested and historically contingent process. (shrink)

This is the first of three volumes containing a report from the International Panel on Social Progress. The IPSP is an independent association of top research scholars with the goal of assessing methods for improving the main institutions of modern societies. Written in accessible language by scholars across the social sciences and humanities, these volumes assess the achievements of world societies in past centuries, the current trends, the dangers that we are now facing, and the possible futures in (...) the twenty-first century. It covers the main socio-economic, political, and cultural dimensions of social progress, global as well as regional issues, and the diversity of challenges and their interplay around the world. This particular volume covers topics such as economic inequality and growth, finance and corporations, labor, capitalism, and social justice. (shrink)

This is the third of three volumes containing a report from the International Panel on Social Progress. The IPSP is an independent association of top research scholars with the goal of assessing methods for improving the main institutions of modern societies. Written in accessible language by scholars across the social sciences and humanities, these volumes assess the achievements of world societies in past centuries, the current trends, the dangers that we are now facing, and the possible futures in (...) the twenty-first century. It covers the main socio-economic, political, and cultural dimensions of social progress, global as well as regional issues, and the diversity of challenges and their interplay around the world. This particular volume covers topics such as world cultures and religions, families, global health, education, and the contributions of social sciences to institutional change. (shrink)

BackgroundWhen conducting research with Indigenous populations consent should be sought from both individual participants and the local community. We aimed to search and summarise the literature about methods for seeking consent for research with Indigenous populations.MethodsA systematic literature search was conducted for articles that describe or evaluate the process of seeking informed consent for research with Indigenous participants. Guidelines for ethical research and for seeking consent with Indigenous people are also included in our review.ResultsOf 1447 (...) articles found 1391 were excluded ; 56 were relevant and included. Articles were categorised into original research that evaluated the consent process or publications detailing the process of seeking consent and guidelines for ethical research. Guidelines were categorised into international ; national and state/regional/local guidelines. In five studies based in Australia, Canada and The United States of America the consent process with Indigenous people was objectively evaluated. In 13 other studies interpreters, voice recording, videos, pictures, flipcharts and “plain language” forms were used to assist in seeking consent but these processes were not evaluated. Some Indigenous organisations provide examples of community-designed resources for seeking consent and describe methods of community engagement, but none are evaluated. International, national and local ethical guidelines stress the importance of upholding Indigenous values but fail to specify methods for engaging communities or obtaining individual consent. In the ‘Grey literature’ concerns about the consent process are identified but no solutions are offered.ConclusionConsultation with Indigenous communities is needed to determine how consent should be sought from the community and the individual, and how to evaluate this process. (shrink)

BackgroundIn research ethics, the most basic question would always be, “which is an ethical issue, which is not?” Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus. In this manuscript, we attempted (...) to do just that.MethodsWe extracted the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative.ResultsWe found that there is no consensus on the majority of the imperatives and that in only 8.2 % of the imperatives were there at least moderate consensus. Of the 12 clusters, Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least.ConclusionThere was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences. (shrink)

Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s, international regulatory frameworks defined the paediatric population as vulnerable due to unaddressed public health needs. More recently, ethical recommendations have promoted the active engagement of minors as (...) class='Hi'>research partners. In this paper, I adopt a post-structuralist approach to policy analysis to examine deep-seated assumptions and presuppositions underlying the changes in the problematisation of children as biomedical research participants over time. While biomedical research ethics focuses on the autonomy and vulnerability of minors, ethical guidelines are situated in specific sociocultural contexts, shaped, among other things, by contingent public health needs and changing conceptions of the value of research and science for society. In the process, I demonstrate the challenge of moving away from an approach that in taking adults as the model overshadows the complexity of children’s lived experiences as well as their personal, cultural, and social lives. The lack of acknowledgement of this complexity makes children vulnerable to epistemic injustice, which is particularly crucial to address in public involvement initiatives. (shrink)

In 2006, the Indian Council of Medical Research (ICMR) published its ‘Ethical guidelines for Biomedical Research on human participants’. The intention was to translate international ethical standards into locally and culturally appropriate norms and values to help biomedical researchers in India to conduct ethical research and thereby safeguard the interest of human subjects. Unfortunately, it is apparent that the guideline is not fit for purpose. In addition to problems with the structure and clarity of the (...) guidelines, there are several serious omissions and contradictions in the recommendations. In this paper, we take a close look at the two key chapters and highlight some of the striking flaws in this important document. We conclude that ethics committees and national authorities should not lose sight of international ethical standards while incorporating local reality and cultural and social values, as focusing too much on the local context could compromise the safety of human subjects in biomedical research, particularly in India. (shrink)

There is currently no international consensus around post-trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post-trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post-trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes (...) towards post-trial access and participants and community members. Given that clinical trials conducted in low-income countries will likely continue, there is an urgent need for consideration of post-trial benefits for participants, communities, and citizens of host countries. While this issue may not be as pressing in countries where participants have access to healthcare and medicines through public schemes, it is particularly important in regions where this may not be available. (shrink)

BackgroundThere is general consensus internationally that unfair distribution of the benefits of research is exploitative and should be avoided or reduced. However, what constitutes fair benefits, and the exact nature of the benefits and their mode of provision can be strongly contested. Empirical studies have the potential to contribute viewpoints and experiences to debates and guidelines, but few have been conducted. We conducted a study to support the development of guidelines on benefits and payments for studies conducted (...) by the KEMRI-Wellcome Trust programme in Kilifi, Kenya.MethodsFollowing an initial broad based survey of cash, health services and other items being offered during research by all programme studies (n = 38 studies), interviews were held with research managers (n = 9), and with research staff involved in 8 purposively selected case studies (n = 30 interviewees). Interviews explored how these ‘benefits’ were selected and communicated, experiences with their administration, and recommendations for future guidelines. Data fed into a consultative workshop attended by 48 research staff and health managers, which was facilitated by an external ethicist.FindingsThe most commonly provided benefits were medical care (for example free care, and strengthened quality of care), and lunch or snacks. Most cash given to participants was reimbursement of transport costs (for example to meet appointments or facilitate use of services when unexpectedly sick), but these payments were often described by research participants as benefits. Challenges included: tensions within households and communities resulting from lack of clarity and agreement on who is eligible for benefits; suspicion regarding motivation for their provision; and confusion caused by differences between studies in types and levels of benefits.ConclusionsResearch staff differed in their views on how benefits should be approached. Echoing elements of international benefit sharing and ancillary care debates, some research staff saw research as based on goodwill and partnership, and aimed to avoid costs to participants and a commercial relationship; while others sought to maximise participant benefits given the relative wealth of the institution and the multiple community needs. An emerging middle position was to strengthen collateral or indirect medical benefits to communities through collaborations with the Ministry of Health to support sustainability. (shrink)

Background: There is general consensus internationally that unfair distribution of the benefits of research is exploitative and should be avoided or reduced. However, what constitutes fair benefits, and the exact nature of the benefits and their mode of provision can be strongly contested. Empirical studies have the potential to contribute viewpoints and experiences to debates and guidelines, but few have been conducted. We conducted a study to support the development of guidelines on benefits and payments for studies (...) conducted by the KEMRI-Wellcome Trust programme in Kilifi, Kenya. Methods: Following an initial broad based survey of cash, health services and other items being offered during research by all programme studies (n = 38 studies), interviews were held with research managers (n = 9), and with research staff involved in 8 purposively selected case studies (n = 30 interviewees). Interviews explored how these ‘benefits’ were selected and communicated, experiences with their administration, and recommendations for future guidelines. Data fed into a consultative workshop attended by 48 research staff and health managers, which was facilitated by an external ethicist.FindingsThe most commonly provided benefits were medical care (for example free care, and strengthened quality of care), and lunch or snacks. Most cash given to participants was reimbursement of transport costs (for example to meet appointments or facilitate use of services when unexpectedly sick), but these payments were often described by research participants as benefits. Challenges included: tensions within households and communities resulting from lack of clarity and agreement on who is eligible for benefits; suspicion regarding motivation for their provision; and confusion caused by differences between studies in types and levels of benefits. Conclusions: Research staff differed in their views on how benefits should be approached. Echoing elements of international benefit sharing and ancillary care debates, some research staff saw research as based on goodwill and partnership, and aimed to avoid costs to participants and a commercial relationship; while others sought to maximise participant benefits given the relative wealth of the institution and the multiple community needs. An emerging middle position was to strengthen collateral or indirect medical benefits to communities through collaborations with the Ministry of Health to support sustainability. (shrink)

Now that stem cell scientists are clamouring for human eggs for cloning-based stem cell research, there is vigorous debate about the ethics of paying women for their eggs. Generally speaking, some claim that women should be paid a fair wage for their reproductive labour or tissues, while others argue against the further commodification of reproductive labour or tissues and worry about voluntariness among potential egg providers. Siding mainly with those who believe that women should be financially compensated for providing (...) eggs for research, the new stem cell guidelines of the International Society for Stem Cell Research (ISSCR) legitimise both reimbursement of direct expenses and financial compensation for many women who supply eggs for research. In this paper, the authors do not attempt to resolve the thorny issue of whether payment for eggs used in human embryonic stem cell research is ethically legitimate. Rather, they want to show specifically that the ISSCR recommended payment practices are deeply flawed and, more generally, that all payment schemes that aim to avoid undue inducement of women risk the global exploitation of economically disadvantaged women. (shrink)

Conducting marine mammal research can raise several important ethical issues. For example, the continuation of whaling for commercial purposes despite the international moratorium provides opportunities for scientists to obtain data and tissue samples. In 2021 we analysed 35 peer-reviewed papers reporting research based on collaborations with Icelandic whalers. Results highlighted little consideration or understanding of the legal and ethical issues associated with the deliberate killing of whales amongst those researchers, funding bodies, universities and journals involved. Ethical statements (...) were rarely provided. Those that were written were incomplete. Whilst research using whaling data may seem acceptable to some, it often becomes hard to justify when subject to scrutiny by the media and the public. Thus, there is a particular danger of reputational harm for early career researchers who may become unwittingly involved in such activities. Here we also consider the broader variety of ethical issues raised by non-lethal research (both historical and recent) on marine mammals including tagging and biopsy. We discuss instances where study animals were harmed or even killed and where the public mistook tags for harpoons. Without clear guidelines, reviewers and journal editors are put in an impossible position when considering whether to reject papers on ethical grounds. We propose that for such studies, universities, funders, journals, and permit issuers must require ethical assessments and that journals more effectively implement their existing policies on publishing ethical statements. The professional marine mammal societies need to work together to produce modern ethical guidance. Such guidance should require transparency in the provenance of data and samples while including advice on law, welfare issues, involvement of local scientists, and offshoring. Furthermore, it should require appraisal of and justification for the absolute necessity of invasive procedures. As is already the case in biomedical disciplines, ethical statements should be required in marine mammal science. (shrink)

Refugees and asylum seekers may experience challenges related to pre-arrival experiences, structural disadvantage after migration and during resettlement requiring the need for special protection when participating in research. The aim was to review if and how people with refugee and asylum seeker backgrounds have had their need for special protection addressed in national and international research ethics guidelines. A systematic search of grey literature was undertaken. The search yielded 2187 documents of which fourteen met the inclusion (...) criteria. Few guidelines addressed specific ethical considerations for vulnerable groups much less people with refugee and asylum seeker backgrounds. One guideline explicitly addressed vulnerability for refugees and asylums seekers. To ensure members of ethics committees and researchers consider the potential challenges of conducting research with these groups, guidelines may need to be supplemented with a refugee and asylum seeker specific research ethics framework. Such a framework may be necessary to optimally protect people with refugee and asylum seeker backgrounds in research. (shrink)

Research ethics guidelines grew out of several infamous episodes where research subjects were exploited. There is significant international synchronization of guidelines. However, indigenous groups in New Zealand, Canada and Australia have criticized these guidelines as being inadequate for research involving indigenous people and have developed guidelines from their own cultural perspectives. Whilst traditional research ethics guidelines place a lot of emphasis on informed consent, these indigenous guidelines put much greater (...) emphasis on interdependence and trust. This article argues that traditional guidelines are premised on relationships of equal power, and that often the researcher has more power that is not fully equalized by providing information. Where there is a relationship of unequal power, then focusing on interdependence and trust is more likely to achieve ethical safety. We illustrate this thesis by describing the detail of a research project looking at the use of interpreters, where we video-recorded live consultations and then interviewed the patient, interpreter and doctor. We conclude by suggesting that mainstream research ethics guidelines should pay more attention to the development of a trustworthy relationship between subject and researcher, and that, following the lead from clinical medicine, we should develop a culturally competent ethical framework for research on human subjects. (shrink)

This book uses the example of informed consent guidelines for international research on human subjects to demonstrate how a philosophical analysis can assist in understanding how underlying concepts affect public policy; how and why such policies are exclusionary; and what methodology can be used to remedy injustices in public policy and practice. Epidemics, such as AIDS, have resulted in an increase in medical research in less developed countries. In an attempt to be more globally applicable, current (...) international guidelines for research on human subjects have attempted to acknowledge the importance of community. This book explains how these attempts fail to adequately acknowledge the importance community has for many people in less developed countries, and how these guidelines fail to attend to constraints to autonomy that oftentimes get magnified once community is involved in the informed consent process. The book further explains how these problems can be traced to a mistaken underlying notion of autonomy and what policymakers can do to remedy these problems . (shrink)

BackgroundConcurrent with efforts to establish national and regional biorepositories in Africa is widespread endorsement of ethics committees as stewards of the interests of individual donors and their communities. To date, ethics training programs for IRB members in Botswana have focused on ethical principles and international guidelines rather than on the ethical dimensions of specific medical technologies and research methodologies. Little is known about the knowledge and concerns of current and prospective IRB members in Botswana with respect to (...) export, reuse, storage, and benefit-sharing of biospecimens.MethodsThis qualitative study examined perspectives of IRB members in Botswana about the collection and use of biospecimens in research. Forty-one IRB members representing five committees in Botswana participated in discussions groups in March 2013. Transcriptions of audiotapes and field notes were analyzed to identify issues of concern that might be alleviated through education and capacity-building, and areas that required ongoing discussion or additional regulatory guidance.ResultsAreas of concern included lack of understanding among patients and providers about the use of biospecimens in clinical care and research; reuse of biospecimens, particularly issues of consent, ownership and decision-making; export of specimens and loss of control over reuse and potential benefits; and felt need for regulatory guidance and IRB-member training. Local belief systems about bodily integrity and strong national identity in the construct of benefits may be at odds with initiatives that involve foreign biorepositories or consider such collections to be global public goods.ConclusionEducation is needed to strengthen IRB-member capacity to review and monitor protocols calling for the collection and use of biospecimens, guided by clear national policy on priority-setting, partnerships, review, and oversight. Engagement with local stakeholders is needed to harmonize fundamentally different ways of understanding the human body and community identity with the aims of contemporary biomedicine. (shrink)

This paper argues that international development research should be submitted to the oversight of research ethics committees from the countries where data will be collected. This includes research conducted by individuals who may fall outside the jurisdictions of most ethics guidelines or policies, such as individuals contracted by non-governmental organizations. The argument is grounded in an understanding of social justice that recognizes that not seeking local ethics approval can be an affront to the decolonization movement, (...) and may lead to significant direct harms to participants. Local ethics oversight can help ensure projects appropriately take into consideration local laws, regulations, priorities and context. For example, a local research ethics committee may be in a better position than a foreign one to assess whether any given proposed project carries context-specific risks. In addition, submitting to a local research ethics committee is to acknowledge the legitimacy of local authorities, thereby taking a stance against the history of colonizing disempowerment. Local oversight is a mechanism to increase the accountability of researchers working abroad: if respect for local authority and tailoring to local context are to be upheld, there must be mechanisms to ensure that research that does not meet these requirements does not proceed. Objections based on the limited oversight capacity in some countries and on concerns related to the politicization of the review process are discussed. Finally, the roles and responsibilities of the various stakeholders in the implementation of greater local ethics oversight are laid out. (shrink)

The practice of assigning authorship for a scientific publication tends to raise two normative questions: 1) ‘who should be credited as an author?’; 2) ‘who should not be credited as an author but should still be acknowledged?’. With the publication of the revised version of The European Code of Conduct for Research Integrity (ECCRI), standard answers to these questions have been called into question. This article examines the ways in which the ECCRI approaches these two questions and compares these (...) approaches to standard definitions of ‘authorship’ and ‘acknowledgment’ in guidelines issued by the International Committee of Medical Journal Editors (ICMJE) and the World Association of Medical Editors (WAME). In light of two scenarios and the problems posed by these kinds of ‘real-world’ examples, we recommend specific revisions to the content of the ECCRI in order not only to provide a more detailed account of the tasks deserving of acknowledgment, but to improve the Code’s current definition of authorship. (shrink)

There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects research in developing countries, but many developing countries do not have such committees . Theoretical and practical uncertainties encountered by an IRB on the Caribbean island of Grenada offer insight into ethical review of research in developing countries. Theoretical uncertainties include questions about whether means of ensuring confidentiality and obtaining informed consent will be effective in local settings, (...) and whether deviations from Western norms are justifiable. International guidelines are helpful in addressing these concerns, but are subject to interpretation. Guidelines are less helpful in practical areas like selecting members or chairs. They do not address what sort of procedures and paperwork will work in a developing country, or IRBs’ relationships to governments that have no mandate for them. Experiences presented here show that IRBs in developing countries can sustainably adhere to international standards. Sustainability requires knowledge, personal commitment, and an official mandate to uphold international standards. Capacity building must therefore focus on educational programs to make developing country leaders knowledgeable about the value of international guidelines to their nations. Such knowledge is needed before people will become motivated to promote, implement, and uphold the guidelines. People in developing countries must help design bridges to help their nations put international standards into practice. The structure of such bridges may, of necessity, vary in different settings. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 175-188 [Access article in PDF] Scope Note 38 Bioethics Resources on the Web * Once described as an "enormous used book store with volumes stacked on shelves and tables and overflowing onto the floor" (Pool, Robert. 1994. Turning an Info-Glut into a Library. Science 266 (7 October): 20-22, p. 20), Internet resources now receive numerous levels of organization, from basic directory listings (...) to elaborate "links" (cross-references to other Internet documents) that flash and glow in the dark. In many ways, the Internet functions as a direct extension of the traditional library. Following linked references across various sites is an electronic version of browsing library stacks, and the serendipitous discoveries made while "surfing the Net" recall the wonders of physically going "book-to-book." Although many of the Internet's best aspects augment library strengths by eliminating physical distance from sources, Net resources pose unique problems for researchers. It is not always clear who is responsible for the content of Web documents, when the document was produced, or how often (if ever) it is updated. Internet resource tools, then, must enable researchers to identify appropriate resources and to evaluate what they find when they get there. Web Research as Taking "Snapshots" Given the Internet's visual nature and fluid content, the process of conducting research on the Web has been likened to taking an informal picture of information on a specific date at a particular time. This metaphor also conveys the "zoom-in" aspect of searching through Web pages by going from general to specific categories. In the first section of this Scope Note, National Reference Center for Bioethics Literature (NRCBL) staff present a snapshot of bioethics resources taken during the spring months of 2000. Entries are divided into the categories of directories, electronic journals, full-text documents, news/current awareness, and teaching resources. In the two subsequent sections, this series of categories is repeated for entries on a specific topic within bioethics-genetics-and again for general search and evaluation tools. Where a Web site may contain pages applicable [End Page 175] to more than one category, multiple entries are made for that site with appropriate information for each category.Much as telecommunication advances have strengthened the relationship of patients and providers as partners, the dynamic nature of the Internet acknowledges that the researcher functions as a librarian whenever accessing the Web. It is our hope that BIOETHICSLINE and the other NRCBL databases not only will enable researchers to search the Web more efficiently, but also will help them to evaluate what they find when they get there. Bioethicsline on the Web: An International Plan in Progress Once only available through libraries, the U.S. National Library of Medicine (NLM), the funding agency for the ongoing development of the BIOETHICS LINE® database from the Kennedy Institute, has provided free Web access to that database of 63,000 citations since September 1998 through Internet Grateful Med. Plans are now underway to eliminate such specialty databases and incorporate all citations into PubMed (for journal articles) or LOCATORplus (for book-like materials and chapters in books). Both of these databases are likewise available at no cost on the Web. In the transition to PubMed and LOCATORplus some features of BIOETHICSLINE that presently are available may be lost. Researchers are encouraged to contact the National Reference Center for Bioethics Literature with search requests or for search strategy assistance with either the current or the future system ([email protected]).The inclusion of bioethics citations in PubMed and LOCATORplus will have several advantages. First, unique keywords from the Bioethics Thesaurus will be considered for inclusion in Medical Subject Headings (MeSH), the indexing vocabulary for PubMed and LOCATORplus, thereby enhancing retrieval of relevant clinical literature by offering more precise terminology covering ethical issues. Second, it will be easier to identify foreign-language materials, which are not currently included in the scope of BIOETHICSLINE. Third, the updating schedule will become more frequent. On the other hand, there may be some loss of searching precision because certain specialized features... (shrink)