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

Individual and institutional conflict of interests in biomedical research have becomes matters of increasing concern in recent years. In the United States, the growth in relationships — sponsored research agreements, consultancies, memberships on boards, licensing agreements, and equity ownership — between for-profit corporations and research universities and their scientists has made the problem of conflicts, particularly financial conflicts, more acute. Conflicts can interfere with or compromise important principles and obligations of researchers and their (...) institutions, e.g., adherence to accepted research norms, duty of care to patients, and open exchange of information. Disclosure is a key component of a successful conflict policy. Commitments which conflict with a faculty member's primary obligations to teaching, research, administrative responsibilities, or patient care also need attention. Institutional conflict of interests present different problems, some of which are discussed in an analysis of an actual problem posed by two proposed clinical trials. (shrink)

In this paper I address the conflict of interest (CoI) issue from a legal point of view at a European level. We will see that the regulatory framework that exists in Europe does state the need for the independence of ethics committee involved in authorisation of research and clinical trials. We will see that CoI is an element that has to be closely monitored at National and International level. Therefore, Member States and Newly Associated States do have to address (...) CoI in the authorisation process of research and clinical protocols of biomedicine. (shrink)

Conflicts of interest held by researchers remain a focus of attention in clinical research. Biases related to these relationships have the potential to directly impact the quality of healthcare by influencing decision-making, yet conflicts of interest remain underreported, inconsistently described, and difficult to access. Initiatives aimed at improving the disclosure of researcher conflicts of interest are still in their infancy but represent a vital reform that must be addressed before potential biases associated with conflicts of (...) interest can be mitigated and trust in the impartiality of clinical evidence restored. In this review, we examine the prevalence of conflicts of interest, evidence of the effects that disclosed and undisclosed conflicts of interest have had on the reporting of clinical evidence, and the emerging approaches for improving the completeness and consistency of disclosures. Through this review of emerging technologies, we recognize a growing interest in publicly accessible registries for researcher conflicts of interest and propose five desiderata aimed at maximizing the value of such registries: mandates for ensuring that researchers keep their records up to date; transparent records that are made available to the public; interoperability to allow researchers, bibliographic databases, and institutions to interact with the registry; a consistent taxonomy for describing different classes of conflicts of interest; and the ability to automatically generate conflicts of interest statements for use in published articles. (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)

Despite the presumed frequency of conflicts of interest in scientific peer review, there is a paucity of data in the literature reporting on the frequency and type of conflicts that occur, particularly with regard to the peer review of basic science applications. To address this gap, the American Institute of Biological Sciences conducted a retrospective analysis of conflict of interest data from the peer review of 282 biomedical research applications via several onsite review panels. The overall (...) conflicted-ness of these panels was significantly lower than that reported for regulatory review. In addition, the majority of identified conflicts were institutional or collaborative in nature. No direct financial conflicts were identified, although this is likely due to the relatively basic science nature of the research. It was also found that 65 % of identified conflicts were manually detected by AIBS staff searching reviewer CVs and application documents, with the remaining 35 % resulting from self-reporting. The lack of self-reporting may be in part attributed to a lack of perceived risk of the conflict. This result indicates that many potential conflicts go unreported in peer review, underscoring the importance of improving detection methods and standardizing the reporting of reviewer and applicant conflict of interest information. (shrink)

This article discusses the establishment of a governance framework for biomedical research in Singapore. It focuses on the work of the Bioethics Advisory Committee , which has been instrumental in institutionalizing a governance framework, through the provision of recommendations to the government, and through the coordination of efforts among government agencies. However, developing capabilities in biomedical sciences presents challenges that are qualitatively different from those of past technologies. The state has a greater role to play in balancing (...) conflicting and potentially irreconcilable economic, social, and political goals. This article analyzes the various ways by which the BAC has facilitated this. (shrink)

Introduction Financial conflicts of interest (fCOI) present well documented risks to the integrity of biomedical research. However, few studies differentiate among fCOI types in their analyses, and those that do tend to use preexisting taxonomies for fCOI identification. Research on fCOI would benefit from an empirically-derived taxonomy of self-reported fCOI and data on fCOI type and payor prevalence.Methods We conducted a content analysis of 6,165 individual self-reported relationships from COI statements distributed across 378 articles indexed with (...) PubMed. Two coders used an iterative coding process to identify and classify individual fCOI types and payors. Inter-rater reliability was κ = 0.935 for fCOI type and κ = 0.884 for payor identification.Results Our analysis identified 21 fCOI types, 9 of which occurred at prevalences greater than 1%. These included research funding (24.8%), speaking fees (20.8%), consulting fees (18.8%), advisory relationships (11%), industry employment (7.6%), unspecified fees (4.8%), travel fees (3.2%), stock holdings (3.1%), and patent ownership (1%). Reported fCOI were held with 1,077 unique payors, 22 of which were present in more than 1% of financial relationships. The ten most common payors included Pfizer (4%), Novartis (3.9%), MSD (3.8%), Bristol Myers Squibb (3.2%), AstraZeneca (3.1%), GSK (3%), Boehringer Ingelheim (2.9%), Roche (2.8%), Eli LIlly (2.5%), and AbbVie (2.4%).Conclusions These results provide novel multi-domain prevalence data on self-reported fCOI and payors in biomedical research. As such, they have the potential to catalyze future research that can assess the differential effects of various types of fCOI. Specifically, the data suggest that comparative analyses of the effects of different fCOI types are needed and that special attention should be paid to the diversity of payor types for research relationships. (shrink)

Secondary use of clinical data in research or learning activities (SeConts) has the potential to improve patient care and biomedical knowledge. Given this potential, the ethical question arises whether physicians have a professional duty to support SeConts. To investigate this question, we analyze prominent international declarations on physicians’ professional ethics to determine whether they include duties that can be considered as good reasons for a physicians’ professional duty to support SeConts. Next, we examine these documents to identify professional (...) duties that might conflict with a potential duty of physicians to support SeConts. (shrink)

Conflict of interest is an issue that has been put in the spotlight by the commercial application of the new biomedical technologies. This paper presents the approach of the Council of Europe and the binding legal instruments to deal with this problem. The main focus is on the Convention on Human Rights and Biomedicine, and its draft additional Protocol on Biomedical Research.

Recently adopted international texts have given a new focus on conflicts of interests and access to information resulting from biomedical research. They confirmed ethical review committees as a central point to guarantee individual rights and the effective application of ethical principles. Therefore specific attention should be paid in giving such committees all the facilities necessary to keep them independent and qualified.

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)

Background The number of coauthors in the medical literature has increased over the past 50 years as authorship continues to have important academic, social and financial implications.Aim and method The study aim was to determine the prevalence of honorary authorship in biomedical publications and identify the factors that lead to its existence. An email with a survey link was sent anonymously to 9283 corresponding authors of PubMed articles published within 1 year of contact.Results A completed survey was obtained from (...) 1246 corresponding authors, a response rate of 15.75%. One-third admitted that they had added authors who did not deserve authorship credit. Origin of the study from Europe and Asia , study type as case report/case series and increasing number of coauthors were found to be the associated factors on multivariate analysis. Journal impact factor was also found to be associated with honorary authorship for those who self-reported honorary authorship and 5.60 for those who did not report unjust authorship, p=0.05). In retrospect, 75% of the authors indicated that they would remove unjustified names from the authorship list. Reasons for adding honorary authors were complimentary , to avoid conflict at work , to facilitate article acceptance , and other .Conclusions Honorary authorship is relatively common in biomedical publications. Researchers should comply with the International Committee of Medical Journal Editors’ criteria for authorship. (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)

Recently adopted international texts have given a new focus on conflicts of interests and access to information resulting from biomedical research. They confirmed ethical review committees as a central point to guarantee individual rights and the effective application of ethical principles. Therefore specific attention should be paid in giving such committees all the facilities necessary to keep them independent and qualified.

Outsourcing clinical trials sponsored by pharmaceutical companies from industrialized countries to low- -income countries – summarized as transnational biomedical research – has lead to many concerns about ethical standards. Whether study participants are particularly vulnerable is one of those concerns. However, the concept of vulnerability is still vague and varies in its definition. Despite the fact that important international ethical guidelines such as the Declaration of Helsinki by the World Medical Association or the Ethical Guidelines for Biomedical (...) Research Involving Human Subjects by the Council of International Organizations of Medical Sciences refer to vulnerability as ethical principle, each of their approaches are different. To overcome these shortcomings, we analyze and unite different approaches of vulnerability and develop practical criteria in order to operationalize the concept especially for the context of TBR. These criteria refer to the context of a study as well as the characteristics and the current living situation of study participants. Based on a case study of an HIV-vaccine-trial conducted in India we demonstrate how those criteria can be applied in a retrospective way to identify potential ethical conflicts. The criteria can also indicate a prospective function for ethical pre-assessment. For this, we provide an outlook for three major topics: 1. Vulnerability as a normative concept: Different ways of protection; 2. The relevance of transparency and 3. Vulnerability as an instrument to increase decision participation of human subjects. (shrink)

_The International Committee of Medical Journal Editors (ICMJE) is a working group of editors of selected medical journals that meets annually. Founded in Vancouver, Canada, in 1978, it currently consists of 11 member journals and a representative of the US National Library of Medicine. The major purpose of the Committee is to address and provide guidance for the conduct and publishing of biomedical research and the ethical tenets underpinning these activities. This advice is detailed in the Committee's _ (...) Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication (URM)._ Recently, the ICMJE has adopted an interventionist role to ensure transparency of conflict of interest revelations in the conduct and publication of industry supported research. It also pursues a policy for the lodgement with trial registries of specified details of Phase III clinical trials. Failure to comply would jeopardise publication of trial outcomes in ICMJE member journals. This policy has resulted in the coming on stream of trial registries, international agreement on trial minimal datasets and compliance with trial registration requirements._. (shrink)

Bibliographic negligence, i.e. omission of citation of the relevant work of other researchers, is possibly the most common type of research misconduct, leading to unfair loss of priority of authorship and undermining the reward system of science. We report a case of bibliographic negligence which we recently suffered from a leading biomedical journal. The case is discussed in the context of the editorial policy of the journal and of relevant ethical guidelines. Scientific journals should develop codes of conduct (...) for citations. In addition, the implications and consequences of bibliographic negligence deserve thorough investigation. (shrink)

The International Committee of Medical Journal Editors is a working group of editors of selected medical journals that meets annually. Founded in Vancouver, Canada, in 1978, it currently consists of 11 member journals and a representative of the US National Library of Medicine. The major purpose of the Committee is to address and provide guidance for the conduct and publishing of biomedical research and the ethical tenets underpinning these activities. This advice is detailed in the Committee's Uniform Requirements (...) for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication . Recently, the ICMJE has adopted an interventionist role to ensure transparency of conflict of interest revelations in the conduct and publication of industry supported research. It also pursues a policy for the lodgement with trial registries of specified details of Phase III clinical trials. Failure to comply would jeopardise publication of trial outcomes in ICMJE member journals. This policy has resulted in the coming on stream of trial registries, international agreement on trial minimal datasets and compliance with trial registration requirements. (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)

Historically, entities with a vested interest in a product that critics have suggested is harmful have consistently used research to back their claims that the product is safe. Prominent examples are: tobacco, lead, bisphenol A, and atrazine. Research literature indicates that about 80–90% of studies with industry affiliation found no harm from the product, while only about 10–20% of studies without industry affiliation found no harm. In parallel to other historical debates, recent studies examining a possible relationship between (...) mercury exposure and autism spectrum disorder show a similar dichotomy. Studies sponsored and supported by industry or entities with an apparent conflict of interest have most often shown no evidence of harm or no “consistent” evidence of harm, while studies without such affiliations report positive evidence of a Hg/autism association. The potentially causal relationship between Hg exposure and ASD differs from other toxic products since there is a broad coalition of entities for whom a conflict of interest arises. These include influential governmental public health entities, the pharmaceutical industry, and even the coal burning industry. This review includes a systematic literature search of original studies on the potential relationship between Hg and ASD from 1999 to August 2015, finding that of the studies with public health and/or industry affiliation, 86% reported no relationship between Hg and ASD. However, among studies without public health and/or industry affiliation, only 21% find no relationship between Hg and ASD. The discrepancy in these results suggests a bias indicative of a conflict of interest. (shrink)

Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union (Eastern EU) and South-East European countries (South-East Europe) that are not members of (...) the European Union.The most common ethical issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors’ conflicts of interest and registration of clinical trialswere the least common ethical policies. Three aspects were significantly morecommon in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation.On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences amongbiomedical journals’ ethical policies calls for further research and active measuresto harmonize policies across journals. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals’ ethical policies calls for further research and active measures to harmonize policies across journals. (shrink)

There is no doubt that industry-sponsored biomedical research is under the microscope. Unfortunately, this new era of skepticism prematurely rushes in doubts of the ethos of science. Skepticism can lead to positive changes, but only when timely and supported by sound reasoning. Snapshot views and theories, especially those that result in costly new regulations and inefficient policies often do more harm than good. Many critics would have the reader doubt scientific integrity because they believe that the relationship between (...) the pharmaceutical industry and biomedical research poses an unavoidable and dangerous conflict of interest. However, these conflicts are neither unavoidable nor dangerous per se. (shrink)

Ethics in participatory research -- Partnership, collaboration and power -- Blurring the boundaries between researcher and researched, academic and activist -- Community rights, conflict and democratic representation -- Co-ownership, dissemination and impact -- Anonymity, privacy, and confidentiality -- Institutional ethical review processes -- Social action for social change.

Re-consent in research, the asking for a new consent if there is a change in protocol or to confirm the expectations of participants in case of change, is an under-explored issue. There is little clarity as to what changes should trigger re-consent and what impact a re-consent exercise has on participants and the research project. This article examines applicable policy statements and literature for the prevailing arguments for and against re-consent in relation to longitudinal cohort studies, tissue banks (...) and biobanks. Examples of re-consent exercises are presented, triggers and non-triggers for re-consent discussed and the conflicting attitudes of commentators, participants and researchers highlighted. We acknowledge current practice and argue for a greater emphasis on ‘responsive autonomy,’ that goes beyond a one-time consent and encourages greater communication between the parties involved. A balance is needed between respecting participants' wishes on how they want their data and samples used and enabling effective research to proceed. (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)

No discussion of academic freedom, research integrity, and patient safety could begin with a more disquieting pair of case studies than those of Nancy Olivieri and David Healy. The cumulative impact of the Olivieri and Healy affairs has caused serious self examination within the biomedical research community. The first part of the essay analyses these recent academic scandals. The two case studies are then placed in their historical context—that context being the transformation of the norms of science (...) through increasingly close ties between research universities and the corporate world. After a literature survey of the ways in which corporate sponsorship has biased the results of clinical drug trials, two different strategies to mitigate this problem are identified and assessed: a regulatory approach, which focuses on managing risks associated with industry funding of university research, and a more radical approach, the sequestration thesis, which counsels the outright elimination of corporate sponsorship. The reformist approach is criticised and the radical approach defended. (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)

Background: In biomedical research, there have been numerous scandals highlighting conflicts of interest (COIs) leading to significant bias in judgment and questionable practices. Academic institutions, journals, and funding agencies have developed and enforced policies to mitigate issues related to COI, especially surrounding financial interests. After a case of editorial COI in a prominent bioethics journal, there is concern that the same level of oversight regarding COIs in the biomedical sciences may not apply to the field of (...) bioethics. In this study, we examined the availability and comprehensiveness of COI policies for authors, peer reviewers, and editors of bioethics journals. Methods: After developing a codebook, we analyzed the content of online COI policies of 63 bioethics journals, along with policy information provided by journal editors that was not publicly available. Results: Just over half of the bioethics journals had COI policies for authors (57%), and only 25% for peer reviewers and 19% for editors. There was significant variation among policies regarding definitions, the types of COIs described, the management mechanisms, and the consequences for noncompliance. Definitions and descriptions centered on financial COIs, followed by personal and professional relationships. Almost all COI policies required disclosure of interests for authors as the primary management mechanism. Very few journals outlined consequences for noncompliance with COI policies or provided additional resources. Conclusion: Compared to other studies of biomedical journals, a much lower percentage of bioethics journals have COI policies and these vary substantially in content. The bioethics publishing community needs to develop robust policies for authors, peer reviewers, and editors and these should be made publicly available to enhance academic and public trust in bioethics scholarship. (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)

Although there is increased recognition of the inevitable--and perhaps sometimes beneficial-- role of values in scientific inquiry, there are also growing concerns about the potential for commercial values to lead to bias. This is particularly evident in biomedical research. There is a concern that conflicts of interest created by commercialization may lead to biased reasoning or methodological choices in testing drugs and medical interventions. In addition, such interests may lead research in directions that are unresponsive to (...) pressing social needs, when it is profitable to do so. Feminist philosophy of science seems particularly well situated to provide resources to help address such concerns because this literature has both 1) theorized about how to minimize biases in science, e.g., sexist or androcentric biases, and 2) generated accounts of objectivity that do not require individual scientists to be value-neutral or disinterested. Two such accounts are assessed in relation to concerns about commercial bias: those offered by feminist empiricism and standpoint feminism. We argue that standpoint feminism is more promising because it has resources to address, not just the epistemological, but also the inescapably ethical dimensions of commercial bias. (shrink)

In his paper “Scientific research is a moral duty”, John Harris argues that individuals have a moral duty to participate in biomedical research by volunteering as research subjects. He supports his claim with reference to what he calls the principle of beneficence as embodied in the “rule of rescue” , and the principle of fairness embodied in the prohibition on “free riding” . His view that biomedical research is an important social good is agreed (...) upon, but it is argued that Harris succeeds only in showing that such participation and support is a moral good, among many other moral goods, while failing to show that there is a moral duty to participate in biomedical research in particular. The flaws in Harris’s arguments are detailed here, and it is shown that the principles of beneficence and fairness yield only a weaker discretionary or imperfect obligation to help others in need and to reciprocate for sacrifices that others have made for the public good. This obligation is discretionary in the sense that the individuals are free to choose when, where, and how to help others in need and reciprocate for earlier sacrifices. That Harris has not succeeded in claiming a special status for biomedical research among all other social goods is shown here. (shrink)

Community engagement is increasingly defended as an ethical requirement for biomedical research. Some forms of community engagement involve asking the consent of community leaders prior to seeking informed consent from community members. Although community consent does not replace individual consent, it could problematically restrict the autonomy of community members by precluding them from research when community leaders withhold their permission. Community consent is therefore at odds with one of the central principles of bioethics: respecting autonomy. This raises (...) the question as to how community consent can be justified or even required. This paper aims to provide an answer to this question by arguing, based on the work of Taylor and Kymlicka, that community practices are important for the identity and autonomy of community members. When these practices are incompatible with a solitary focus on individual informed consent, they need to be protected by making these decision‐making practices (including asking permission to community authorities) part of the consent process. Since these decision‐making practices are important for the autonomy of community members, community consent with the goal of protecting these practices is not necessarily in conflict with autonomy. (shrink)

Background: Biomedical research is influenced by many factors, including the involvement of stakeholder groups invested in research outcomes. Stakeholder involvement in research efforts raises questions of justice as stakeholders’ specific interests and motivations play a role in directing research resources that ultimately produce knowledge, shaping how different conditions (and affected individuals) are understood and treated by society. This issue is highly relevant to child psychiatry research where diagnostic criteria and treatment strategies are often controversial. (...) Biological similarities and stakeholder differences between attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) provide an opportunity to explore this issue by comparing research foci and stakeholder involvement in these conditions. Methods: A subset of ADHD and ASD research articles published between 1970 and 2010 were randomly selected from the PubMed database and coded for research focus, funding source(s), and author-reported conflicts of interest (COIs). Chi-squared analyses were performed to identify differences between and within ADHD and ASD research across time. Results: The proportion of ADHD research dedicated to basic, description, and treatment research was roughly similar and remained stable over time, while ASD research showed a significant increase in basic research over the past decade. Government was the primary research funder for both conditions, but for-profit funders were a notable presence in ADHD research, while joint funding efforts between nonprofit and government funders were a notable presence in ASD research. Lastly, COIs were noted more frequently in ADHD than in ASD research. Conclusions: Our study shows significant differences in research foci and funding sources between the conditions, and identifies the specific involvement of for-profit and nonprofit groups in ADHD and ASD, respectively. Our findings highlight the relationship between stakeholders outside the research community and research trajectories and suggest that examinations of these relationships must be included in broader considerations of biomedical research ethics. (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)

It is correctly asserted that the intensity of the current debate over the use of animals in biomedical research is unprecedented. The extent of expressed animosity and distrust has stunned many researchers. In response, researchers have tended to take a strategic defensive posture, which involves the assertion of several abstract positions that serve to obstruct resolution of the debate. Those abstractions include the notions that the animal protection movement is trivial and purely anti-intellectual in scope, that all science (...) is good (and some especially so), and the belief that an ethical consensus can never really be reached between the parties. (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)

Biomedical ethics in the FRG is still in an embryonic stage. The Hippocratic tradition of paternalism is still dominant, general debates on Weltanschauungen have not yet been replaced by case-study methods and other means of resolving conflicts more effectively in pluralistic societies. Issues such as IVF and embryo research are predominantly treated in legal rather than in moral terms. Some new developments in moral assessment of prenatal care and care of the dying are reported. Allocational disputes over (...) the future of welfare-state health care systems are likely to continue without any major moral or political decision being reached. (shrink)

Scientific and ethical misconduct has increased at an alarming rate as a result of the privatization of knowledge. What began as an effort to stimulate entrepreneurship and increase discovery in biomedical research by strengthening the ties between industry and academics has led to an erosion of confidence in the reporting of research results. Inherent tensions between profit-directed inquiry and knowledge-directed inquiry are instantiated in psychopharmacology, especially in the co-option of academic activity to corporate objectives. The effects of (...) these tensions are visible in research agendas, publication practices, postgraduate education, academic-industry partnerships and product promotion. (shrink)

As Next Generation Sequencing technologies are increasingly implemented in biomedical research and care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice. In a first step we clarify some central concepts such as “raw data”; (...) in a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one’s raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data. In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom. Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects’ legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations. (shrink)

Background As citizen science continues to grow in popularity, there remains disagreement about what terms should be used to describe citizen science activities and participants. The question of how to self-identify has important ethical, political, and practical implications to the extent that shared language reflects a common ethos and goals and shapes behavior. Biomedical citizen science in particular has come to be associated with terms that reflect its unique activities, concerns, and priorities. To date, however, there is scant evidence (...) regarding how biomedical citizen scientists prefer to describe themselves, their work, and the values that they attach to these terms.Methods In 2018, we conducted semi-structured interviews with 35 biomedical citizen scientists in connection with a larger study to understand ownership preferences. Interview data were analyzed to identify the terms that interviewees used and avoided to describe themselves and their work, as well as the reasons for their preferences.Results Biomedical citizen scientists self-identified using three main terms: citizen scientist, biohacker, and community scientist. However, there was a lack of consensus among interviewees on the appropriateness of each term, two of which prompted conflicting responses. Self-identification preferences were based on personal judgments about whether specific terms convey respect, are provocative, or are broad and inclusive, as well as the desirability of each of these messages.Conclusions The lack of consensus about self-identification preferences in biomedical citizen science reflects the diversity of experiences and goals of individuals participating in this field, as well as different perceptions of the values signaled by and implications of using each term. Heterogeneity of preferences also may signal the parallel development of multiple communities in biomedical citizen science. (shrink)

Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests (...) for the sake of society and science. This is the principle of precedence of individual. But there is a problem with how to interpret the principle of precedence of individual in the context of research without prospect of future benefit involving children. There are proposals trying to reconcile non-beneficial research involving children with the concept of the best interests. We assert that this reconciliation is flawed and propose an interpretation of the principle of precedence of individual as follows: not all, but only the most important interests of participants, must be guaranteed; this principle should be interpreted as the secure participant standard. In consequence, the issue of permissible risk ceiling becomes ethically crucial in research with incompetent subjects. (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.

Conflict of interests is a situation when someone is in need of other people’s trust on one the hand and has personal or general interests on the other hand, resulting in conflict with the given responsibility. In this research work, an attempt was made to find the relation between declarations of conflict of interests and reporting positive outcomes in the dental journals in Iran. In this analytical/cross-sectional study, first Health and Biomedical Information was searched and all the Persian (...) and English dental journals published in Iran were collected. Then, all the papers published in the journals from December 2000 to December 2016 were collected and categorized in terms of the year of publication, author or authors’ affiliations, Persian and English journal, type of the substance or the drug used, declarations of conflict of interests and the positive or negative conclusion of the report. Data were analyzed with the Fisher’s exact test and Chi squared test, using the program SPSS 18. In numerical analysis, the significance was set at P < 0.05. Seventeen dental journals in Persian and English were analyzed: 10 in English and 7 in Persian. Reviewing these studies showed that of 1021 articles in Persian, in 128 cases there was no mention of a declaration of conflict of interests and in 11 cases, the COI had been stated. In addition, from 1220 articles in English, in 825 cases there was no mention of declarations of conflict of interests and in 45 cases, the declarations of COI had been mentioned. There was no significant relation between the COI and ‘no’ COI and the reporting of positive outcomes in papers in Iranian dental journals in terms of the journal type, year of publication and the journals’ guarantee form. A total of 83% of studies with declarations of COI had one positive outcome, with a significant relationship in this field; however, in 73% of studies with no COI, there was one positive outcome, too. In general, the society expects that doctors would not consider any incentives except the health of the patients in the efforts made by them. The severity of the consequences of COI is of higher value when the patients’ health is endangered due to it. In addition, COI might change the attitude and approach of other doctors and peers. (shrink)

Non-financial interests, and the conflicts of interest that may result from them, are frequently overlooked in biomedicine. This is partly due to the complex and varied nature of these interests, and the limited evidence available regarding their prevalence and impact on biomedical research and clinical practice. We suggest that there are no meaningful conceptual distinctions, and few practical differences, between financial and non-financial conflicts of interest, and accordingly, that both require careful consideration. Further, a better understanding (...) of the complexities of non-financial conflicts of interest, and their entanglement with financial conflicts of interest, may assist in the development of a more sophisticated approach to all forms of conflicts of interest. (shrink)