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

In this paper we make a proposal for reforming biomedical research that is aimed to align re-search more closely with the so-called fair-share principle according to which the proportions of global resources as-signed to different diseases should agree with the ratios of human suffering associated with those diseases.

Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the establishment of standards for the protection of communities. We have developed such a strategy, based on five steps. (i) Identification of community characteristics relevant to the biomedical research setting, (ii) delineation of a typology of different types of communities using these characteristics, (iii) (...) determination of the range of possible community protections, (iv) creation of connections between particular protections and one or more community characteristics necessary for its implementation, and (v) synthesis of community characteristics and possible protections to define protections appropriate for each type of community. Depending on the particular community, consent and consultation, consultation alone, or no added protections may be required for research. (shrink)

This volume assesses the ethical, quantitative, and qualitative questions posed by the current financing of biomedical research.

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

The current situation in medicine has been described as a crisis of credibility, as the profit motive of industry has taken control of clinical trials and the dissemination of data. Pharmaceutical companies maintain a stranglehold over the content of medical journals in three ways: (1) by ghostwriting articles that bias the results of clinical trials, (2) by the sheer economic power they exert on journals due to the purchase of drug advertisements and journal reprints, and (3) by the threat of (...) legal action against those researchers who seek to correct the misrepresentation of study results. This paper argues that Karl Popper's critical rationalism provides a corrective to the failure of academic freedom in biomedical research. (shrink)

In this paper we make a proposal for reforming biomedical research that is aimed to align re-search more closely with the so-called fair-share principle according to which the proportions of global resources as-signed to different diseases should agree with the ratios of human suffering associated with those diseases.

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)

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)

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)

This paper addresses the appropriate role for public input into priority setting for federal funding of biomedical research and development. The public should be involved in priority setting because researchers should be publicly accountable, because the public has a right to oversee government activities, and because public input is needed to assess normative questions related to the burden of disease and health care needs. On the other hand, political factors arising from public input can also hamper the governmentÕs (...) ability to allocate funds according to the burden of disease or to promote the progress of biomedical science. When it comes to public input into R & D priority setting, more is not necessarily better. What is needed is the right balance of public and expert decision making with respect to the setting of biomedical R & D priorities. (shrink)

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot (...) end the debate about the merits of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless. (shrink)

Biomedical deployments of data science capitalise on vast, heterogeneous data sources. This promotes a diversified understanding of what counts as evidence for health-related interventions, beyond the strictures associated with evidence-based medicine. Focusing on COVID-19 transmission and prevention research, I consider the epistemic implications of this diversification of evidence in relation to: (1) experimental design, especially the revival of natural experiments as sources of reliable epidemiological knowledge; and (2) modelling practices, particularly the recognition of transdisciplinary expertise as crucial to (...) developing and interpreting data models. Acknowledging such shifts in evidential, experimental and modelling practices helps avoid harmful applications of data-intensive methods. (shrink)

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)

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)

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)

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

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)

Authors endure considerable hardship carrying out biomedical research, from generating ideas to completing their manuscripts and submitting their findings and data to a journal. When researchers submit to journals, they entrust their findings and ideas to editors and peer reviewers who are expected to respect the confidentiality of peer review. Inherent trust in peer review is built on the ethical conduct of authors, editors and reviewers, and on the respect of this confidentiality. If such confidentiality is breached by (...) unethical reviewers who might steal or plagiarize the authors’ ideas, researchers will lose trust in peer review and may resist submitting their findings to that journal. Science loses as a result, scientific and medical advances slow down, knowledge may become scarce, and it is unlikely that increasing bias in the literature will be detected or eliminated. In such a climate, society will ultimately be deprived from scientific and medical advances. Despite a rise in documented cases of abused peer review, there is still a relative lack of qualitative and quantitative studies on reviewer-related misconduct, most likely because evidence is difficult to come by. Our paper presents an assessment of editors’ and reviewers’ responsibilities in preserving the confidentiality of manuscripts during the peer review process, in response to a 2016 case of intellectual property theft by a reviewer. Our main objectives are to propose additional measures that would offer protection of authors’ intellectual ideas from predatory reviewers, and increase researchers’ awareness of the responsible reviewing of journal articles and reporting of biomedical research. (shrink)

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

Authors, reviewers, and editors have critical responsibilities to ensure the validity and utility of published biomedical research.

This paper discusses the hazards of regulating controversial biomedical research in light of the emergence of powerful, multi-national biotechnology corporations. Prohibitions on the use of government funds can simply force controversial research into the private sphere, and unilateral or multilateral research bans can simply encourage multi-national companies to conduct research in countries that lack restrictive laws. Thus, a net effect of government regulation is that research migrates from the public to the private sphere. Because (...) private research receives less oversight and external scrutiny than public research, it can threaten the welfare and rights of human subjects, scientific progress and openness, and the quality of the approval process for new biomedical technologies. In order to avoid the harmful effects of government regulation of biotechnology, society should promote meaningful discussion and dialogue among scientists, industry leaders, and the public before resorting to regulatory solutions. Legislative or executive initiatives should be applied with great discretion and care, and should be crafted in such a way that they protect public health and safety, promote scientific progress, and avoid the hazards of privatized research and polarized debates. (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)

Extramural funding provides major support for biomedical research in academia, and National Institutes of Health (NIH) grants often constitute direct evaluation criteria for promotions and tenure. Therefore, NIH budget trends influence long‐term scientific strategies and career decisions, as well as the progress of science itself. Our analysis of the last 37 years of NIH awards, however, reveals that the success rate of grant applications submitted for funding is negatively related to the total yearly amount of (inflation‐adjusted) NIH extramural (...) expenditure. Instead, as might be expected, the ratio between available funding and the number of submission directly predicts the probability of winning support in any given year. We purport that the considerable success rate variability can be parsimoniously explained by a proportional but delayed reaction of the number of applications to budget fluctuations. As a counterintuitive consequence, grant proposals conceived during lean periods might stand the best chance of success. BioEssays 29:933–936, 2007. © 2007 Wiley Periodicals, Inc. (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)

The advancement of science requires the publication of research results so other scientists may examine, confirm, and build upon them, and the publishing ecosystem that mediates this process has undergone dramatic change over recent decades. This article takes a broad view of the biomedical research publishing system from its origins in the 17th century to the present day. It begins with a story from the author’s lab that illustrates a scientist’s complex interactions with the publishing system and (...) then reviews the history, growth, and evolution of scientific publishing, including several recent disruptive developments: the digital transformation, the open access (OA) movement, the creation of “predatory journals,” and the emergence of preprint archives. Each has influenced scientific peer review and editorial decision-making, two processes critical to the conduct of medical and scientific research and culture. After briefly discussing concerns about the impact of politics on editorial decision-making, the article closes with thoughts on the future evolution of this publishing ecosystem, which will impact the biomedical research ecosystem that depends upon it. Beyond accelerated speed and improved access to publications, the community should prioritize research aimed at further enhancing the quality and impact of published research, the core goal of the scientific enterprise. [End Page 358]. (shrink)

Several feminist philosophers of science have argued that social and political values are compatible with, and may even enhance, scientific objectivity. A variety of normative recommendations have emerged regarding how to identify, manage, and critically evaluate social values in science. In particular, several feminist theorists have argued that scientific communities ought to: 1) include researchers with diverse experiences, interests, and values, with equal opportunity and authority to scrutinize research; 2) investigate or "study up" scientific phenomena from the perspectives, interests, (...) and conditions of marginalized stakeholders potentially affected by the research; and 3) make gender, ethnicity, class, and geographical location "visible," or use them as categories of analysis when appropriate. Yet, more work is needed to determine what exactly these recommendations would require, and the benefits they would yield, in specific research contexts. Using the recent development of the human papillomavirus (HPV) vaccines, we examine how these three feminist recommendations would have applied. We argue that these principles would have yielded several epistemic and social benefits in the HPV case, as well as in biomedical research more generally. That is, biomedical research guided by these principles would not only be epistemically superior, but also more socially responsible. (shrink)

Biomedical research on human subjects involves exposing individuals to risks and burdens for the benefit of others, and therefore raises concerns about exploitation. While the concept of exploitation has received significant attention in recent research ethical literature, its relevance and implications in this area remain unclear and contested. This chapter explains how this concept is nonetheless important for understanding the ethical complexities of human subject research and the proper design of subject protections. The chapter provides an (...) overview of research practices often thought to raise exploitation concerns and introduces philosophical exploitation theory, focusing on aspects relevant to research ethics. Against this background, the obligations of non-exploitation held by researchers, sponsors, and third parties such as ethics committees and regulators are outlined. The chapter ends by considering how exploitative research in the past can be retroactively remediated. (shrink)

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)

Recent empirical evidence has demonstrated that research misconduct occurs to a substantial degree in biomedical research. It has been suggested that scientific integrity is also of concern in China, but this seems to be based largely on anecdotal evidence. We, therefore, sought to explore the Chinese situation, by making a systematic review of published empirical studies on biomedical research integrity in China. One of our purposes was also to summarize the existing body of research (...) published in Chinese. We searched the China National Knowledge Infrastructure, Wanfang Data, PubMed and Web of Science for potentially relevant studies, and included studies meeting our inclusion criteria, i.e. mainly those presenting empirically obtained data about the practice of research in China. All the data was extracted and synthesized using an inductive approach. Twenty-one studies were included for review. Two studies used qualitative methods and nineteen studies used quantitative methods. Studies involved mainly medical postgraduates and nurses and they investigated awareness, attitudes, perceptions and experiences of research integrity and misconduct. Most of the participants in these 21 studies reported that research integrity is of great importance and that they obey academic norms during their research. Nevertheless, the occurrence of research misbehaviors, such as fabrication, falsification, plagiarism, improper authorship and duplicate submission was also reported. Strengthening research integrity training, developing the governance system and improving the scientific evaluation system were areas of particular attention in several studies. Our review demonstrates that a substantial number of articles have been devoted to research integrity in China, but only a few studies provide empirical evidence. With more safeguard measures of research integrity being taken in China, it would be crucial to conduct more research to explore researchers’ in-depth perceptions and evaluate the changes. (shrink)

Throughout much of the world, universities have driven towards industrial partnerships. This collaboration, which, in the biochemical field at least, has to continue if potential benefits for patients are to be realised, has brought with it a number of problems. These include the neglect of long-term research in favour of short-term projects, the curtailing of free dissemination of research information within university departments and the biasing of results of clinical trials by the financial interests of the investigators.It is (...) very important that governments, universities, and industry itself address these problems. Universities should monitor the amount of basic, curiosity-driven research that is being carried on, compared with that which is more short-term goal orientated. PhD students and post-doctoral fellows should be exposed to the principles of bioethics early on in their careers. Further work is necessary on the terms of research contracts to protect, on the one hand, the rights of individual scientists and, on the other, industry from rogue scientists. Where problems arise, procedures should be in place for independent reviews to be conducted by bodies such as the Medical Research Council in the UK or the National Institutes of Health in the USA. The conflict-of-interest rules recently introduced for publication in medical journals should be extended to all branches of science. (shrink)

Current debates surrounding the virtues and shortcomings of randomization are symptomatic of a lack of appreciation of the fact that causation can be inferred by two distinct inference methods, each requiring its own, specific experimental design. There is a non-statistical type of inference associated with controlled experiments in basic biomedical research; and a statistical variety associated with randomized controlled trials in clinical research. I argue that the main difference between the two hinges on the satisfaction of the (...) comparability requirement, which is in turn dictated by the nature of the objects of study, namely homogeneous or heterogeneous populations of biological systems. Among other things, this entails that the objection according to which randomized experiments fail to provide better evidence for causation because randomization cannot guarantee comparability is mistaken. (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)

One way to make philosophy of science more socially relevant is to attend to specific scientific practises that affect society to a great extent. One such practise is biomedical research. This paper looks at contemporary U.S. biomedical research in particular and argues that it suffers from important epistemic, moral and socioeconomic failings. It then discusses and criticises existing approaches to improve on the status quo, most prominently by Thomas Pogge (a political philosopher), Joseph Stiglitz (a Nobel-prize (...) winning economist) and James Robert Brown (a philosopher of science). Finally, it sketches an alternative proposal and argues for its superiority. The proposal has four components: changing the intellectual property regime; instituting independent clinical research; aligning innovators' and patients' interests; and enacting additional regulation. (shrink)

ABSTRACT This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze – as an example – the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, (...) either in the US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non‐uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries. (shrink)

Recent proposals to improve public communication about animal-based biomedical research have been narrowly focused on reforming biomedical journal submission guidelines. My suggestion for communication reform is broader in scope reaching beyond the research community to healthcare communicators and ultimately the general public. The suggestion is for researchers to provide journalists and public relations practitioners with concise summaries of their ‘animal use data’. Animal use data is collected by researchers and intended for the public record but is (...) rarely, if ever, given significant media exposure. By providing healthcare communicators with specific details about their animal use, researchers can play a role informing people about a matter of serious public interest and help to promote a more open and publicly accountable animal research culture. (shrink)