This book is a contribution to the nascent discourse on global health and biomedical research ethics involving Muslim populations and Islamic contexts. It presents a rich sociological account about the ways in which debates and questions involving Islam within the biomedical research context are negotiated - a perspective which is currently lacking within the broader bioethics literature. The book tackles some key understudied areas including: role of faith in moral deliberations within biomedical research ethics, (...) the moral anxiety and frustration experienced by researchers when having to negotiate multiple moral sources and how the marginalisation of women, the prejudice and abuse faced by groups such as sex workers and those from the LGBT community are encountered and negotiated in such contexts. The volume provides a valuable resource for researchers and scholars in this area by providing a systematic review of ethical guidelines and a rich case-based account of the ethical issues emerging in biomedical research in contexts where Islam and the religious moral commitments of Muslims are pertinent. The book will be essential for those conducting research in low and middle income countries that have significant Muslim populations and for those in Muslim-minority settings. It will also appeal to researchers and scholars in religious studies, social sciences, philosophy, anthropology and theology, as well as the fields of biomedical ethics, Islamic ethics and global health.. (shrink)

During the past two decades, Iran has experienced a noteworthy growth in its biomedical research sector. At the same time, ethical concerns and debates resulting from this burgeoning enterprise has led to increasing attention paid to biomedical ethics. In Iran, Biomedical research ethics and research oversight passed through major periods during the past decades, separated by a paradigm shift. Period 1, starting from the early 1970s, is characterized by research paternalism and complete reliance (...) on researchers as virtuous and caring physicians. This approach was in concordance with the paternalistic clinical practice of physicians outside of research settings during the same period. Period 2, starting from the late 1990s, was partly due to revealing of ethical flaws that occurred in biomedical research in Iran. The regulatory and funding bodies concluded that it was not sufficient to rely solely on the personal and professional virtues of researchers to safeguard human subjects' rights and welfare. The necessity for independent oversight, emphasized by international declarations, became obvious and undeniable. This paradigm shift led to the establishment of research ethics committees throughout the country, the establishment of academic research centers focusing on medical ethics and the compilation of the first set of national ethical guidelines on biomedical research–one of the first and most important projects conducted by and in the MEHR. Although not yet arrived, ‘period 3’ is on its way. It is predictable from the obvious trends toward performance of high-quality clinical research and the appearance of a highly educated new generation, especially among women. (shrink)

This article examines the global and worsening problem of research misconduct as it relates to bio-medico-legal education. While research misconduct has serious legal implications, few adequate legal remedies exist to deal with it. With respect to teaching, research ethics education should be mandatory for biomedical students and physicians. Although teaching alone will not prevent misconduct, it promotes integrity, accountability, and responsibility in research. Policies and law enforcement should send a clear message that researchers should adhere (...) to the highest standards of ethics in research. It is vital that researchers and physicians understand basic aspects of law and the legal system in order to develop understanding of the medico-legal issues not just in the legal context, but with a sound grounding in ethics, social and theoretical contexts so that they can practice good medicine. Routine and holistic research ethics education across the curriculum for medical students and resident physicians, and continuing medical education for practicing doctors, are probably the best ways to accomplish this goal. (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)

Shows how international biomedical researchers in Sri Lanka work across cultural, epistemic, economic, and power differences to accomplish clinical trials.

BackgroundGiven that advances in research continuously raise new ethical issues, a multidisciplinary working group of investigators involved in biomedical research has gathered to discuss and compare ethical viewpoints in their daily practice.MethodsThe working group has drafted a Charter for Ethics in Biomedical Research that encompasses all the steps in the research process, i.e. from the initial idea to analysis and publication of the results.ResultsBased on key principles for ethically responsible research, the Charter may (...) serve as a tool for performing research, discussing research issues and training researchers.ConclusionsThe Charter should stimulate researchers to think about their responsibility for research in a progressive, caring society. (shrink)

The role of the Research Ethics Committee (REC) in the design, conduct and dissemination of scientific research is still evolving and many important questions remain unanswered. Hence, the aim of this paper is to address some of the uncertainty that exists around the role and responsibilities of RECs and to discuss some of the controversy that exists over the criteria that RECs should follow when evaluating a research proposal. The discussion is organised around five of the major (...) roles currently performed by RECs when assessing proposals in the biomedical sciences. It will be shown that these five roles need to be critically evaluated and reassessed. The five roles addressed are: assessing the legitimacy and validity of the informed consent process, second, conducting a comprehensive risk/benefit analysis, third, assessing the validity of a research proposal, fourth, ensuring that researchers observe the social norms, values, customs, traditions and laws that prevail in the community or jurisdiction in which the research will be conducted and finally, monitoring the research project as it unfolds and providing an ongoing advisory and consultancy service to both new and experienced researchers. In reassessing the role of the REC, this paper concludes with a set of general recommendations for RECs. These provide some guidance on the minimum criteria that should be followed when RECs evaluate proposals. These guidelines will be beneficial for new and experienced members of REC, and will help to make the process a more objective, efficient and standardised process. The guidelines will also be beneficial for researchers in the biomedical sciences who are preparing proposals for ethical review. (shrink)

We surveyed 1005 postdoctoral fellows by questionnaire about ethical matters related to biomedical research and publishing; 33% responded. About 18% of respondents said they had taken a course in research ethics, and about 31% said they had had a course that devoted some time to research ethics. A substantial majority stated willingness to grant other investigators, except competitors, access to their data before publication and to share research materials. Respondents’ opinions about contributions justifying authorship of (...) research papers were mainly consistent but at variance with those of many biomedical journal editors. More than half said they had observed what they considered unethical research practices. To increase the chances of getting a grant funded, 27% said they were willing to select or omit data to improve their results; to make publication of their work more likely or to benefit their career, 15% would select or omit data and 32% would list an undeserving author. Of respondents who thought they had been unfairly denied authorship on a paper, or been listed with or asked to list an undeserving author, 75% said they would be willing to list an undeserving author (P<0.001). Having taken a course dealing with research ethics had no effect on stated willingness to select or omit data or to fabricate data in the future, but was positively associated with willingness to grant undeserved authorship (P<0.04). Although these results do not controvert research demonstrating the effectiveness of ethics courses during professional education, they indicate that the research environment is a powerful component of a trainee’s experience and ethical development. (shrink)

What is the relationship between scientific research and ethics? Some think that science should be free from ethical and political considerations. _Biomedical Research and Beyond_ argues that ethical guidance is essential for all forms of inquiry, including biomedical and scientific research. By addressing some of the most controversial questions of biomedical research, such as embryonic research, animal research, and genetic enhancement research, the author argues for a rich moral framework for the (...) ethics of inquiry, based on the ideal of human flourishing. He then looks at other areas of inquiry, such as journalistic ethics, and military investigation, to see how similar they are to the ethics of scientific research. Finally, he looks at the virtues that must play a role in any life that is devoted to research and inquiry as a vocational commitment. (shrink)

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

An overview of the key debates in biomedical researchethics, presented through a wide-ranging selection of casestudies.

The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedical research’ as a set of actors, institutions, codes and laws involved in overseeing the ethics (...) of biomedical research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities. (shrink)

The use of human subjects in research comes with lots of ethical challenges. The purpose of this review is to assess the various ethical issues that have been associated with biomedical research in Nigeria. This article also finds out the possible ways of improvement of this scenario. Pubmed/Medline, Google Scholar, JSTOR, and AJOL search were the possible search engine for literature from 2000 to 2020. Key words were used including, ethical issues, biomedical research and Nigeria. (...) Of the 113 publications were found., A total of 18(15.9%) articles fulfilled the study inclusion criteria and were included in this review. Twelve ethical issues were highlighted including Informed consent (12 studies), autonomy and voluntariness (8 studies), beneficence (8 studies), counseling (5 studies), compensation (4 studies), professional behavior and attitudes (2 studies), confidentiality (2 studies), social, cultural and religious practices (2 studies), scientific integrity (1 study), communitarianism (1 study), equity (1 study), and trust (1 study). We found that there are ethical issues in biomedical research in Nigeria of which informed consent is most widely studied. Also, participants had varying degree of understanding of their rights as research subjects. As a result, there is need to enhance the capacity of investigators to better understand these issues and also increase their explanatory skill to help participants achieve complete understanding of their various rights and process. (shrink)

Scientific journals may incur scientific error if articles are tainted by research misconduct. While some journals’ ethical policies, especially those on conflicts of interest, have improved over recent years, with some adopting a uniform approach, only around half of biomedical journals, principally those with higher impact factors, currently have formal misconduct policies, mainly for handling allegations. Worryingly, since a response to allegations would reasonably require an a priori definition, far fewer journals have publicly available definitions of misconduct. While (...) some journals and editors’ associations have taken significant steps to prevent and detect misconduct and respond to allegations, the content, visibility of and access to these policies varies considerably. In addition, while the lack of misconduct policies may prompt and maintain a de novo approach for journals, potentially causing stress, publication delays and even legal disputes, the lack of uniformity may be a matter of contention for research stakeholders such as editors, authors and their institutions, and publishers. Although each case may need an individual approach, I argue that posting highly visible, readily accessible, comprehensive, consistent misconduct policies could prevent the publication of fraudulent papers, increase the number of retractions of already published papers and, perhaps, reduce research misconduct. Although legally problematic, a concerted approach, with sharing of information between editors, which is clearly explained in journal websites, could also help. Ideally, journals, editors’ associations, and publishers should seek consistency and homogenise misconduct policies to maintain public confidence in the integrity of biomedical research publications. (shrink)

Big data techniques, data-driven science and their technological applications raise many serious ethical questions, notably about privacy protection. In this paper, we highlight an entanglement between epistemology and ethics of big data. Discussing the mobilisation of big data in the fields of biomedical research and health care, we show how an overestimation of big data epistemic power – of their objectivity or rationality understood through the lens of neutrality – can become ethically threatening. Highlighting the irreducible non-neutrality at (...) play in big data tools, we insist upon the ethical importance of a critical epistemological approach in which big data are understood as possibly valuable only when coupled with human intelligence and evaluative rationality. (shrink)

Background Q-CEP (Qualificação dos Comitês de Ética em Pesquisa que compõem o Sistema CEP/Conep) is a nationwide project resulting from a partnership between the Brazilian National Research Ethics Commission (Conep), the Ministry of Health and Hospital Moinhos de Vento (HMV). It was developed to consolidate policy for ethical review of research with human beings in all members of the CEP/Conep System, Brazil’s national system of institutional review boards. The aim of this study was therefore to report on the (...) experience and results of the Q-CEP project. Methods An observational, retrospective study includes data from the Q-CEP, obtained from visits to all the institutional research ethics committees (RECs) in the country. The actions implemented by Q-CEP were part of a two-step process: (i) training visits to each REC; (ii) development of distance learning modules on strategic topics pertaining to research ethics evaluation. The data presented herein cover step one (training visits), defined by Q-CEP as the diagnostic stage of the project. For a country with social and economics inequalities such as Brazil, this is a particularly important stage; an accurate picture of reality is needed to inform planning of quality improvement strategies. Results In 2019–2021, Q-CEP visited 832 RECs and trained 11,197 people. This sample covered almost all active RECs in the country; only 4 (0.5%) were not evaluated. Of the 94 items evaluated, 62% did not reach the target of at least 80% compliance and around 1/4 (26%) were below 50% compliance. The diagnostic stage of the process revealed inadequacies on the part of the RECs in their ethical reviews. The analysis of informed consent forms showed compliance in only 131 RECs (15.74%). The description of pending issues made by RECs in their reports was compliant in 19.33% (n = 161). Administrative and operational aspects were also considered inadequate by more than half of the RECs. Conclusions Overall, Brazilian RECs showed poor compliance in several aspects of their operation, both in ethics evaluation and in other processes, which justifies additional training. The Q-CEP project is part of a quality improvement policy promoted by the Brazilian Ministry of Health. The data obtained in the diagnostic step of the project have contributed to the qualification and consolidation of one of the world’s largest research ethics evaluation systems. (shrink)

: Controversy has surrounded the institutions that facilitate discussion and regulation of American biomedical research for years. Recent challenges to the legitimacy of the President's Council on Bioethics have been focused on stem cell research. These arguments represent an opportunity to reconsider the legislation under which stem cell research is regulated, as well as to consider preexisting bodies like the Recombinant DNA Advisory Committee and National Bioethics Advisory Commission. This paper proposes a Federal Life Sciences Policy (...) Commission, a novel commission with advisory and regulatory powers that would benefit from the positive and negative lessons learned under the legislation that currently shapes the formation and institutional characteristics of advisory bodies in the United States. The Federal Life Sciences Policy Commission would have institutional independence not present in previous advisory bodies, while maintaining the tradition of broad societal representation and thoughtful discourse that has developed in the United States. (shrink)

A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.

Cases are, in many ways, the lifeblood of bioethics (Crigger 1998, 15). Moral theory must be checked against the practical experience case studies provide, which experience may engender reasons to...

BackgroundExisting research on perceptions of plagiarism and cultural influences mainly focuses on comparisons between the Western World and the Eastern World. However, possible differences within the Western World have hardly been assessed, especially among biomedical academics. The authors compared perceptions of plagiarism among European biomedical researchers who participated in an online survey.MethodsThe present work is based on the data collected in a previous online survey done in 2018 among biomedical researchers working in leading European and Chinese (...) universities. Respondents based in Europe were grouped into three geographical regions and their responses were analyzed using logistic regression analysis with adjustments for demographic factors.ResultsData were available from 810 respondents. In addition to their generally similar responses, different perceptions of plagiarism were observed among respondents in the three European regions. In summary, among the three European regions, Nordic respondents identified the most types of practices as plagiarism. Compared to the southern respondents, Nordic and northwestern respondents were more likely to consider less evident practices as plagiarism, such as Rephrasing another person’s work without crediting the source [aORN|S 1.99, aORS|NW 0.50 ] and With permission from the original author, using another’s text without crediting the source [aORN|S 3.16, aORS|NW 0.26 ]. In contrast, the southern respondents were the most inclined to recognize recycling of one’s previously rejected research proposal as plagiarism.ConclusionsIn spite of a generally similar response pattern, the present study indicates different perceptions of plagiarism among European biomedical researchers. These intra-European differences should be considered when addressing plagiarism. (shrink)

No other volume has this scope. Students in bioethics, public and international health, and ethics will find this book particularly useful.

In this book, scholars with different disciplinary and national backgrounds argue for possible answers and analyse case studies on current issues of governance in biomedical research. These issues comprise among others the research-care distinction, risk evaluation in early human trials, handling of incidental findings, nocebo effects, cluster randomized trials, publication bias, or consent in biobank research. This book demonstrates how new technologies and research possibilities multiply or intensify already known governance challenges, leaving room for ethical (...) analysis and complex moral choices. Clinical researchers, research ethics committee members and research ethicists have all to deal with such challenges on a daily basis. While general reflection on core concepts of research ethics is seldom pointless, those confronted with hard moral choices do need more practical and contextualized reflection on the said issues. This book particularly provides such contextualized reflections and aims to inform all those who study, conduct, regulate, fund, or participate in biomedical research. (shrink)

We describe the national health research ethics review system of Uzbekistan and identify policy and program gaps that impede the protection of human research subjects. We find that the National Ethic Committee (NEC), functioning at the national level, is solely responsible for conducting research ethics review. There is little evidence that regional ethics committees work as intended, and there is no research ethics review at medical institutes and research centers even though they conduct CDTs (clinical (...) drug trials). There is no national policy for the ethical review of non-clinical trials. We recommend the establishment of institutional review boards (IRBs) at medical institutes and research centers while at the same time building capacity at the national level to oversee and support the research ethics review system of the entire country. (shrink)

This book is a critical examination of certain basic issues and themes crucial to understanding how ethics currently interfaces with health care and biomedical research. Beginning with an overview of the field, it proceeds through a delineation of such key notions as trust and uncertainty, dialogue involving talk and listening, the vulnerability of the patient against the asymmetric power of the health professional, along with professional and individual responsibility. It emphasizes several themes fundamental to ethics and health care: (...) (1) the work of ethics requires strict focus on the specific situational understanding of each involved person. (2) Moral issues, at least those intrinsic to each clinical encounter, are presented solely within the contexts of their actual occurrence; therefore, ethics must not only be practical but empirical in its approach. (3) Each particular situation is in its own way imprecise and uncertain, and the different types and dimensions of imprecision and uncertainty are critical for everyone involved. (4) Finally, medicine and health care more broadly are governed by the effort to make sense of the healer's experiences with the patient, whose own experiences and interpretations are ingredient to what the healer seeks to understand and eventually treat. In addition to providing a way to develop ethical considerations in clinical life and research projects, the book proposes that narratives provide the finest way to state and grapple with these themes and issues, whether in classrooms or real-life situations. It concludes with a prospective analysis of newly emerging issues presented by and within the new genetics, which, together within a focus on the phenomenon of birth, leads to an clearer understanding of human life. (shrink)

Context The conduct of medical research led by Northern countries in developing countries raises ethical questions. The assessment of research protocols has to be twofold, with a first reading in the country of origin and a second one in the country where the research takes place. This reading should benefit from an independent local ethical review of protocols. Consequently, ethics committees for medical research are evolving in Africa. Objective To investigate the process of establishing ethics committees (...) and their independence. Method Descriptive study of 25 African countries and two North American countries. Data were recorded by questionnaire and interviews. Two visits of ethics committee meetings were conducted on the ground: over a period of 3 months in Kigali (Rwanda) and 2 months in Washington DC (USA). Results 22 countries participated in this study, 20 from Africa and two from North America. The response rate was 80%. 75% of local African committees developed into national ethics committees. During the last 5 years, these national committees have grown on a structural level. The circumstances of creation and the general context of underdevelopment remain the major challenges in Africa. Their independence could not be ensured without continuous training and efficient funding mechanisms. Institutional ethics committees are well established in USA and in Canada, whereas ethics committees in North America are weakened by the institutional affiliation of their members. Conclusion The process of establishing ethics committees could affect their functioning and compromise their independence in some African countries and in North America. (shrink)

Intrinsic value and animal integrity are two key concepts in the debate on the ethics of the genetic engineering of laboratory animals. These concepts have, on the one hand, a theoretical origin and are, on the other hand, based on the moral beliefs of people not directly involved in the genetic modification of animals. This ‘external’ origin raises the question whether these concepts need to be adjusted or extended when confronted with the moral experiences and opinions of people directly involved (...) in the creation or use of transgenic laboratory animals. To answer this question, 35 persons from the practice of biomedical research who are directly involved in genetic engineering (scientists, biotechnicians, animal caretakers and laboratory animal scientists) were interviewed. They were asked to give their moral opinion on different aspects of the genetic engineering of animals and to react to statements about the concepts of intrinsic value and animal integrity. Analysis of the interviews showed that, contrary to what is often assumed, the respondents embraced these concepts, even those senses that (more) specifically apply to genetic engineering. And although the respondents raised some objections that go beyond issues of animal welfare, these objections could quite well be expressed in terms of the concepts of intrinsic value and animal integrity. In short, the results of the present study strongly suggest that these concepts do not have to be adjusted or extended in the light of the moral experiences and opinions from practice. (shrink)

Almost all ethical guidelines and legislative policies concerning biomedical research involving human subjects contain provisions about relevance of research for the participating populations, informed consent, adequate care for research induced injuries and several other safeguards but the poor continue to suffer. Globalization has further aggravated poor people’s vulnerability by exposing them to international markets. Since the developing countries are abode of higher population of the poor they have become the unholy mines of this human ore for (...) researchers. In this paper I examine various dimensions of poverty and analyze the international ethical responses in the area of biomedical research involving human subjects in order to determine their adequacy to protect the poor against exploitation and misuse and conclude that in view of the poor’s inherent and extreme vulnerability and the failure of ethical pronouncements to protect them from misuse and exploitation, they should be excluded from being enrolled as research subjects. (shrink)

BackgroundThe use of great apes (GA) in invasive biomedical research is one of the most debated topics in animal ethics. GA are, thus far, the only animal group that has frequently been banned from invasive research; yet some believe that these bans could inaugurate a broader trend towards greater restrictions on the use of primates and other animals in research. Despite ongoing academic and policy debate on this issue, there is no comprehensive overview of the reasons (...) advanced for or against restricting invasive research with GA. To address this gap, we conducted a systematic review of the reasons reported in the academic literature on this topic.MethodsSeven databases were searched for articles published in English. Two authors screened the titles, abstracts, and full texts of all articles. Two journals specialized in animal ethics, and the reference lists of included articles were subsequently also reviewed.ResultsWe included 60 articles, most of which were published between 2006 and 2016. Twenty-five articles argued for a total ban of GA research, 21 articles defended partial restrictions, and 14 articles argued against restrictions. Overall, we identified 110 reason types, 74 for, and 36 against, restricting GA research. Reasons were grouped into nine domains: moral standing, science, welfare, public and expert attitudes, retirement and conservation, respect and rights, financial costs, law and legal status, and longer-term consequences.ConclusionOur review generated five main findings. First, there is a trend in the academic debate in favor of restricting GA research that parallels worldwide policy changes in the same direction. Second, in several domains (e.g., moral standing, and respect and rights), the reasons were rather one-sided in favor of restrictions. Third, some prominent domains (e.g., science and welfare) featured considerable engagement between opposing positions. Fourth, there is low diversity and independence among authors, including frequent potential conflicts of interests in articles defending a strong position (i.e., favoring a total ban or arguing against restrictions). Fifth, scholarly discussion was not the norm, as reflected in a high proportion of non-peer-reviewed articles and authors affiliated to non-academic institutions. (shrink)

Finding an effective microbicide that could substantially lower women’s risk of acquiring HIV infection is an ethical imperative. Women and girls continue to be disproportionally affected by HIV in sub-Saharan Africa. Ethics guidelines for conducting preventive HIV microbicide trials call for steps that intertwine biomedical research and public health. Ethical considerations include adequate studies of the safety of microbicides, the use of placebo controls in future trials once a microbicide is shown to be effective, whether leftover microbicide from (...) a trial that demonstrated efficacy should be made available to the public or used in the control group of a future trial, what preventive measures and treatment should be provided for trial participants during and after the research, and what constitute ‘fair benefits’ to the community or country when a trial is completed. The Global Campaign for Microbicides conducted a study of the benefits being provided to participants in microbicide trials and others, and found substantial evidence that researchers and sponsors are meeting the obligations stated in ethical guidelines. A cautionary tale of an HIV prevention trial that was prematurely halted demonstrates the need for engagement with the community where trials are carried out. (shrink)

Intrinsic value and animal integrity are two key concepts in the debate on the ethics of the genetic engineering of laboratory animals. These concepts have, on the one hand, a theoretical origin and are, on the other hand, based on the moral beliefs of people not directly involved in the genetic modification of animals. This ‘external’ origin raises the question whether these concepts need to be adjusted or extended when confronted with the moral experiences and opinions of people directly involved (...) in the creation or use of transgenic laboratory animals. To answer this question, 35 persons from the practice of biomedical research who are directly involved in genetic engineering (scientists, biotechnicians, animal caretakers and laboratory animal scientists) were interviewed. They were asked to give their moral opinion on different aspects of the genetic engineering of animals and to react to statements about the concepts of intrinsic value and animal integrity. Analysis of the interviews showed that, contrary to what is often assumed, the respondents embraced these concepts, even those senses that (more) specifically apply to genetic engineering. And although the respondents raised some objections that go beyond issues of animal welfare, these objections could quite well be expressed in terms of the concepts of intrinsic value and animal integrity. In short, the results of the present study strongly suggest that these concepts do not have to be adjusted or extended in the light of the moral experiences and opinions from practice. (shrink)

BackgroundEthics in biomedical research is still a fairly new concept in Africa. This work aims to assess the knowledge, attitude and experiences of Beninese researchers with regard to the national ethical regulatory framework of biomedical research in Benin.MethodsThis was a cross-sectional and descriptive study, involving all the researchers fulfilling the inclusion criteria. Data were collected through a face-to-face interview using a questionnaire and analysed. Proportions and means were calculated with their confidence intervals and standard deviations, respectively.ResultsOf (...) the 110 participants included in the study, 40.9% were medical lecturers and 71.1% had been involved in more than 10 biomedical research as researcher. Less than three quarters were able to correctly quote the basic principles from Belmont report. The quarter of them knew the attributions of the National Ethics Committee for Health Research and 38.2%, the content of the legislation on health research ethics in Benin. The common ethical rules were known by 69.1% of the participants. A quarter of participants said they always present the study’s briefing note to their study participants and 62.7% said they systematically request informed consent. For those who do not present the briefing note to participants, the main reasons provided were the researchers’ difficulties in writing the note in plain language and the participants’ limitation in understanding it.ConclusionsThe foundations of a good ethical framework for health research exist in Benin. However, the deployment and use of the various legal texts deserve to be improved. (shrink)

As the recent inaugural Ethical, Legal, and Social Issues 2.0 conference made clear, the effects of information communication technology are pervasive in biomedical research. Data initiatives are arising in all corners of biomedicine. Data sharing efforts already promised to surpass even the ambitious goals of the National Human Genome Research Institute, only 5 years after publication of its 10-year vision. ELSI research was established, in part, to address challenges of open data access and data sharing. However, (...) by and large, ELSI research projects address particular concerns of a given population, jurisdiction, type of research practice or type of data. This does not necessarily facilitate coherent data policy for sustainable data stewardship. Forward-looking, data friendly strategies need to be considered. Orchestration strategies are needed which overcome barriers to collective action. Here we present challenges policymakers face, and suggest three basics steps towards meeting them. First, policymakers must recognise the systematic change that occurs when ICT enables dataflow itself to become an organising principle of biomedical research. Second, methods for identifying and gathering types of metadata suitable for ELSI research ought to be developed and regulated. Third, policymakers need to organise in ways that mirror the new vision for data-enabled research that data technologies are making possible, as ELSI 2.0 encourages researchers to do. Taking these steps will help ensure research evolves in ways that warrants trust of the public while still supporting widespread ethical access to necessary data, research subjects, samples and findings. (shrink)

Digitization of a health record changes its accessibility. An electronic health record (EHR) can be accessed by multiple authorized users. Health information from EHRs contributes to learning healthcare systems’ development. The objective of this systematic review is to answer a question: What are ethical issues concerning research using EHRs in the literature? We searched Medline Ovid, Embase and Scopus for publications concerning ethical issues of research use of EHRs. We employed the constant comparative method to retrieve common ethical (...) themes. We descriptively summarized empirical studies. The study reveals the breadth, depth, and complexity of ethical problems associated with research use of EHRs. The central ethical question that emerges from the review is how to manage access to EHRs. Managing accessibility consists of interconnected and overlapping issues: streamlining research access to EHRs, minimizing risk, engaging and educating patients, as well as ensuring trustworthy governance of EHR data. Most of the ethical problems concerning EHR-based research arise from rapid cultural change. The framing of concepts of privacy, as well as individual and public dimensions of beneficence, are changing. We are currently living in the middle of this transition period. Human emotions and mental habits, as well as laws, are lagging behind technological developments. In the medical tradition, individual patient’s health has always been in the center. Transformation of healthcare care, its digitalization, seems to have some impacts on our perspective of health care ethics, research ethics and public health ethics. (shrink)

Academic medical centers and drug manufacturers have traditionally occupied very distinct positions with regard to public trust. As collaborations among medical researchers and pharmaceutical companies expand, however, worries about the aggressive pursuit of profit that has tarnished the reputation of the pharmaceutical industry may be transferred to medical institutions and clinical investigators, suggesting to some that biomedical research is more about increasing profit than promoting public health. Consequently, when medical institutions forge research collaborations with industry they should (...) be mindful of the potential for these relationships to erode public confidence in the integrity of clinical research.Recent events have heightened concerns about the financing of clinical research. These include the widely publicized deaths of several research volunteers, scandals at the nation's largest funder of biomedical research, and evidence of fabricated research findings in prominent medical journals. These unfortunate events have prompted many to re-examine strategies for managing industry relationships and the financial conflicts of interest they may create. (shrink)

This book deals with the international assessment and regulation of biomedical research. In its chapters, some of the leading figures in today’s bioethics address questions centred on global development, scientific advances, and vulnerability. The series _Values In Bioethics_ makes available original philosophical books in all areas of bioethics, including medical and nursing ethics, health care ethics, research ethics, environmental ethics, and global bioethics.

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by social/communicative difficulties and perseverative behaviours. While research on autism has flourished recently, few studies have been conducted on the disorder in non‐Western contexts. In low‐ and middle‐income countries (LMICs), biomedical research on autism is required to better understand the needs of the population and to develop contextually appropriate interventions. However, autistic individuals are a vulnerable study population and LMICs present with various considerations. While the presentation of autism (...) is heterogeneous, stigma is a common social consequence affecting research. Drawing specifically on the South African context, the ethical intersections of these issues are discussed, along with the limitations of the current informed consent process. Community engagement is recommended as an adjunct to informed consent to ensure that biomedical research is conducted in a more inclusive way. Practical pointers are provided for implementing systematic support for conducting community engagement alongside biomedical research. (shrink)

There is widespread anxiety about the commercialisation and commodification of human tissue. The aims of this paper are: (a) to analyse some of these concerns, and (b) to see whether some of the main ethical arguments that lie behind them are sound. Part 1 looks at 'inducement arguments' against paying individuals for their tissue and concludes that these are generally quite weak. Part 2 examines some ethical objections to third parties (e.g. biotechnology companies and researchers) commercially exploiting human tissue. Firstly, (...) it is argued that prospective tissue donors should be given very full information about the extent to which their tissues will be commercially exploited and about the financial interests of tissue collectors and researchers, since this is an essential component of valid consent. Secondly, some doubt is cast upon the (widely held) view that while 'the human body and its parts shall not, as such, give rise to financial gain', intellectual property based on human tissue research is generally acceptable1. (shrink)