Biomedical research funding bodies across Europe and North America increasingly encourage—and, in some cases, require—investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what ‘good’ or ‘successful’ public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. (...) The Standards have critical implications for the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public involvement should be undertaken in the first place. We show that presented without this justificatory context, many of the recommendations in the Standards are, at best, fragments that require substantial elaboration by those looking to apply the Standards in their own work and, at worst, subject to potentially harmful misapplication by well-meaning investigators. As funding bodies increasingly push for public involvement in research, the key lesson of our analysis is that future recommendations about how public involvement should be conducted cannot be coherently formulated without a clear sense of the underlying goals and rationales for public involvement. (shrink)

The fourth amendment to the German Medicinal Products Act (Arzneimittelgesetz) states that nontherapeutic research in incompetent populations is permissible under the condition that potential research participants expressly declare their wish to participate in scientific research in an advance research directive. This article explores the implementation of advance research directives in Germany against the background of the international legal and ethical framework for biomedical research. In particular, it addresses a practical problem that arises from the (...) disclosure requirement for advance research directives. We show that, if the disclosure standard for advance research directives is set at a token level, nontherapeutic research in incompetent populations becomes practically impossible. To resolve this issue, we suggest the disclosure standard be set at a type level. (shrink)

This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and (...) significance of the concept of ‘integrating’ empirical methods and ethical argument as a standard for research practice within empirical bioethics. (shrink)

In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (...) (the subjective interpretation). The court's use of the objective interpretation to block studies like the KKI study protects individual children who are worse off than the average child. Unfortunately, this approach also may block research intended to improve the lives of these same individuals. A similar dilemma arises in the context of multinational research, suggesting that a "modified objective standard," proposed to address this dilemma in the multinational setting, may offer a framework for addressing the dilemma in the context of pediatric research as well. (shrink)

: In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given (...) study (the subjective interpretation). The court's use of the objective interpretation to block studies like the KKI study protects individual children who are worse off than the average child. Unfortunately, this approach also may block research intended to improve the lives of these same individuals. A similar dilemma arises in the context of multinational research, suggesting that a "modified objective standard," proposed to address this dilemma in the multinational setting, may offer a framework for addressing the dilemma in the context of pediatric research as well. (shrink)

This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and (...) significance of the concept of ‘integrating’ empirical methods and ethical argument as a standard for research practice within empirical bioethics. (shrink)

BackgroundAdvance research directives (ARD) have been suggested as a means by which to facilitate research with incapacitated subjects, in particular in the context of dementia research. However, established disclosure requirements for study participation raise an ethical problem for the application of ARDs: While regular consent procedures call for detailed information on a specific study (“token disclosure”), ARDs can typically only include generic information (“type disclosure”). The introduction of ARDs could thus establish a double standard in the sense (...) that within the context of ARDs, type disclosure would be considered sufficient, while beyond this context, token disclosure would remain necessary.Main bodyThis paper provides an ethical analysis of ARDs, taking into account the results of numerous empirical studies that have been performed so far. It will be argued that a revised understanding of informed consent can allow for context-sensitive disclosure standards. As a consequence, ARDs that include type disclosure can be acceptable under suitable circumstances. Such an approach raises a number of objections. A thorough examination shows, however, that they are not sufficient to justify a rejection of the approach.ConclusionThe approach presented in this paper avoids introducing a double standard. It is, therefore, more suitable for the implementation of ARDs than established approaches. (shrink)

ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that additional dimensions of (...) the standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

Qualitative research has tended to evoke rather stereotyped objections from the mainstream of social science. Ten standardized responses to the stimulus "qualitative research interview" are discussed: it is not scientific, not objective, not trustworthy, nor reliable, not intersubjective, not a formalized method, not hypothesis testing, not quantitative, not generalizable, and not valid. With the objections to qualitative interviews highly predictable, they may be taken into account when designing, reporting, and defending an interview study. As a help for new (...) qualitative researchers, some of the issues, concepts, and arguments involved are outlined, and the relevancy of the standard objections is discussed. Alternative conceptions of qualitative research, coming from phenomenological and hermeneutical traditions, are suggested. The qualitative interview based on conversation and interaction here appears as a privileged access to a linguistically constituted social world. (shrink)

ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that additional dimensions of (...) the standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

Recent controversy surrounding the Surfactant Positive Airway Pressure and Pulse Oximetry Trial and the Office for Human Resource Protection’s judgment that its informed consent procedures were inadequate has unmasked considerable confusion about OHRP’s definition of research risks. The controversy concerns application of that definition to trials comparing multiple treatments within the existing standard of care. Some have argued that it is impossible for such trials to pose research risks on the grounds that all risks associated with a standard-of-care (...) treatment should instead be considered risks of treatment. However, analysis of OHRP’s definition demonstrates that some risks in such trials can be research risks. (shrink)

This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programmes. The standards that were drafted at the workshop cover the following topics: designer/provider qualifications, learning goals, learning objectives, content, methods, assessment of participants and assessment of (...) the course. The authors invite comments on the draft standards and eventual endorsement of a final version by all stakeholders. (shrink)

. The potential for financial conflicts of interest to influence scientific research has become a significant concern. Some commentators have suggested that the development of standardized study protocols could help to alleviate these problems. This paper identifies two problems with this solution: scientific research incorporates numerous methodological judgments that cannot be constrained by standardized protocols; and standardization can hide significant value judgments. These problems arise because of four weaknesses of standardized guidelines: incompleteness, limited applicability, selective ignorance, and ossification. (...) Therefore, the standardization of study designs should not serve as an alternative to addressing the interests and power relations that pervade science policy-making. Policy makers should take at least two steps to prevent powerful interest groups from co-opting standardized guidelines. First, their development and review should be made as transparent as possible and should be subjected to broadly-based deliberation. Second, standardized guidelines should be supplemented with efforts to scrutinize the conditions under which financial COIs tend to have the most worrisome effects so that additional steps can be taken to eliminate and mitigate those conditions. (shrink)

Criticism of ethical review of research continues and research ethics committees (RECs) need to demonstrate that they are “fit for purpose” by meeting acknowledged standards of process, debate and outcome. This paper reports a workshop in Warsaw in April 2008, organised by the European Forum for Good Clinical Practice, on the problems of setting standards for RECs in the European Union. Representatives from 27 countries were invited; 16 were represented. Problems identified were the limited and variable (...) resources, difficulties of setting standards for ethical debate and its outcomes and that REC members, as volunteers, may resent the imposition of standards. Other ways to set standards were discussed, including analysis of current multicentre review, collecting REC member reports for review, learning from appeals and feedback from applicants, and use of other regional and national meetings. The place of a central, national board or ethics committee was debated as was the need for collaborating with partners in other fields. (shrink)

Nanomaterials have attracted much interest in the medical field and related applications as their distinct properties in the nanorange enable new and improved diagnosis and therapies. Owing to these properties and their potential interactions with the human body and the environment, the impact of nanomaterials on humans and their potential toxicity have been regarded a very significant issue. Consequently, nanomaterials are the subject of a wide range of cutting-edge research efforts in the medical and related fields to thoroughly probe (...) their potential beneficial utilizations and their more negative effects. We posit that the lack of standardization in the field is a serious shortcoming as it has led to the establishment of methods and results that do not ensure sufficient consistency and thus in our view can possibly result in research outputs that are not as robust as they should be. The main aim of this article is to present how NanoDiaRA, a large FP7 European multidisciplinary project that seeks to investigate and develop nanotechnology-based diagnostic systems, has developed and implemented robust, standardized methods to support research practices involving the engineering and manipulation of nanomaterials. First, to contextualize this research, an overview of the measures defined by different regulatory bodies concerning nanosafety is presented. Although these authorities have been very active in the past several years, many questions remain unanswered in our view. Second, a number of national and international projects that attempted to ensure more reliable exchanges of methods and results are discussed. However, the frequent lack of publication of procedures and protocols in research can often be a hindrance for sharing those good practices. Subsequently, the efforts made through NanoDiaRA to introduce standardized methods and techniques to support the development and utilization of nanomaterials are discussed in depth. A series of semi-structured interviews were conducted with the partners of this project, and the interviews were analyzed thematically to highlight the determined efforts of the researchers to standardize their methods. Finally, some recommendations are made toward the setting up of well-defined methods to support the high-quality work of collaborative nanoparticle-based research and development projects and to enhance standardization processes. (shrink)

We proposed the Standards of Conducts to provide a general framework that will serve as the basis for guiding each biostatistician and stem cell researcher to formulate their personal standards, rather than as rules with which they are required to comply. Given the responsibility and characteristics of their work, they are expected to maintain independence and work autonomously as professionals. Each of the Standards of Conducts comprises a preamble, mission and values to uphold, Standards of Conducts, (...) and background. When one internalizes “self-formulated” standards, to make excuses for oneself would be akin to a self-betrayal; responsible actions can be anticipated. If one begins and continues to consider “who I am and what do I work for,” this will become their inner energy, and a source of motivation and pride to inspire oneself. In addition, this aspirational style might help citizens to recognize the autonomous stance of the professional body and that they share the same values. (shrink)

In this essay the ethical issues related to the ‘standard of care’ are discussed together with the implications for the treatment of the control group in transnational clinical trials. It is argued that the human right to health and the duty of justice formulate the moral basis on which this case should be debated.

This paper reports an initiative from the National Research Ethics Service and research ethics committees in the UK to develop a shared ethical debate between committees and to promote standards of ethical review, exploring the problems and practicalities of such an approach.

Next SectionIntensification of poverty and degradation of health infrastructure over recent decades in countries most affected by HIV/AIDS present formidable challenges to clinical research. This paper addresses the overall standard of health care (SOC) that should be provided to research participants in developing countries, rather than the narrow definition of SOC that has characterised the international debate on standards of health care. It argues that contributing to sustainable improvements in health by progressively ratcheting the standard of care (...) upwards for research participants and their communities is an ethical obligation of those in resource-rich countries who sponsor and implement research in poorer ones. (shrink)

During the past decennium, one of the main issues discussed in research ethics has been focused on the care that should be provided to the control group in a clinical trial. This discussion is also called the standard of care debate . Current international research ethics guidelines contain a wide variety of standards for the standard of care—including the provision of the highest attainable, the best available, the best current, a proven , and an established effective treatment. (...) In this article, we systematically review the currently used standards and argue that none of the current standards is adequate to serve as a universal standard for the standard of care. Alex London has made a substantial proposal for a universal standard, but universally adopting his standard is problematic. In this article, we propose a revised version of London's standard. (shrink)

OBJECTIVES: To show that a Local Research Ethics Committee (LREC) can carry out an audit of ethical standards in research. To find out if a researcher met certain ethical standards in recruiting subjects for clinical trials and in obtaining their consent. DESIGN: Postal questionnaire. SETTING: Clinical research by one doctor during one year. SUBJECTS: Eleven patients entered in clinical trials. MAIN OUTCOME MEASURES: Success in ethics committee obtaining data. Achievement of ethical standards in recruitment (...) of subjects and in obtaining consent. RESULTS: The audit was successfully carried out and standards were partly met. CONCLUSIONS: Local Research Ethics Committees can carry out audits of the conduct of research projects which they have approved. Provision for possible audits can be made at the time of application to the committee. Our committee thought the ethical standards in the research which we audited were acceptable. (shrink)

Higher education has been changing radically in recent years, with increasing numbers of students, and complaints about declining standards. This volume brings together leading intellectuals from the US and UK to examine the issues involved.

Much of the public debate over laboratory animal use has focused on either the scientist's demand for absolute freedom of inquiry, or the abolitionist's demand for an end to animal use in science. Yet many recent proposals for reform seek instead to balance the interests of laboratory animals in avoiding harm against the interests of research beneficiaries in continued animal use. This essay is an analysis of the intermediate reform positions and their underlying ethical principles. Keywords: animal research, (...) animal experimentation, ethics CiteULike Connotea Del.icio.us What's this? (shrink)

Committees established for the ethical review of research involving animals have become a widespread legal standard around the world. Despite many differences in their composition, powers, and institutional settings, they share many common problems related to the well-established standards of procedural justice in administrative practice. The paper adapts the general theory of procedural justice to the specific context of ethical review committees. From this perspective, the main concerns over the procedural aspects of the ethical evaluation of research (...) projects are identified and examined. They include in particular the standards of the committees’ composition, impartiality, fair hearing, appeal, transparency, and benevolence. Their proper reflection in the regulatory regimes of animal ethics committees is necessary to secure the standards of fairness of the ethical review itself. This, in turn, is a condition of the moral and social legitimacy of all administrative and quasi-administrative procedures, including the committees’ operations. (shrink)

Federal efforts beginning in the 1990's have successfully increased pediatric research to improve medical care for all children. Since 1997, the FDA has requested 800 pediatric studies involving 45,000 children. Much of this research is "non-beneficial"; that is, it exposes pediatric subjects to risk even though these children will not benefit from participating in the research. Non-beneficial pediatric research (NBPR) seems, by definition, contrary to the best interests of pediatric subjects, which is why one state supreme (...) court has essentially prohibited it. It also appears that the only plausible rationale for this research is utilitarian, as it risks some children for the good of all. But that rationale is troubling. This Article answers two related questions: (1) What is the appropriate legal relationship between NBPR and the "best interests of the child" standard? (2) What is the ethical justification for this research? I argue that courts should hold that the "best interests" standard governs pediatric research. But, contrary to existing case law, courts must consider the benefits to each child, including pediatric subjects, from a policy that permits NBPR, and not simply consider that a non-beneficial protocol presents more risk than potential benefit to a child. Moreover, I argue that the justification for the practice need not be utilitarian. There is no need to appeal to the greater good to justify the research because each child has reason to endorse a policy permitting NBPR where there is a very low ceiling on acceptable risk, and each child has reason to participate in a practice from which she benefits. More controversially, I argue that each child, like other persons, has reason to help others when she can do so at little to no cost to herself. The Article then highlights practical implications of the offered justifications. (shrink)

The revised Common Rule adopts the reasonable person standard to guide research disclosure. Some members of the research community contend that the standard is confusing and ill-suited to the research oversight system. Yet the revised rule is not as radical as it might seem. During the 1970s, judges started using the standard to evaluate negligence claims brought by injured patients who said doctors had failed to obtain informed consent to the harmful procedures. In its influential Belmont Report, (...) the National Commission recommended application of a “reasonable volunteer standard” to guide IRBs evaluating research disclosures. Evidence also suggests that IRBs often invoke the reasonable person standard in deliberations about consent forms. But past application of the standard has been informal and uneven. Robust application of the reasonable person standard will require researchers and IRBs to learn more about what ordinary people want and need to know about the studies they are invited to join. Input from people with personal experience as study participants could be particularly useful to this effort. (shrink)

Hooks et al. note that microbiota-gut-brain research suffers from serious methodological flaws and interpretative issues. We suggest two corrective measures: first, taking more seriously the need of interdisciplinary work; second, interpreting some of the methodological issues as ordinary challenges of standardization, typical of emerging disciplines.

On site monitoring of research is one of the most effective ways to ensure compliance during research conduct. However, it is least carried out primarily for two reasons: presumed high costs both in terms of human resources and finances; and the lack of a clear framework for undertaking site monitoring. In this paper we discuss a model for research site monitoring that may be cost effective and feasible in low resource settings.

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

Application of either the harm principle or the best interest standard to medical decision making conflicts with some types of pediatric research that pose elevated risk without the reasonable prob...

The discussion about complementary and alternative medicine is sometimes rather heated. “Quackery!” the cry goes. A large proportion “of unconventional practices entail theories that are patently unscientific.” “It is time for the scientific community to stop giving alternative medicine a free ride. There cannot be two kinds of medicine — conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work.” “I submit that (...) if these treatments cannot withstand the test of empirical research, … then we have wasted a lot of time and effort. The time has been wasted on all the people who have spent years learning falsehoods about acupuncture points and the principles of homeopathy. And the patients have wasted their time, money, and efforts receiving treatments that were not what they were represented to be or were harmful.”. (shrink)

Recital 33 GDPR has often been interpreted as referring to ‘broad consent’. This version of informed consent was intended to allow data subjects to provide their consent for certain areas of research, or parts of research projects, conditional to the research being in line with ‘recognised ethical standards’. In this article, we argue that broad consent is applicable in the emerging field of Computational Social Science (CSS), which lies at the intersection of data science and social (...) science. However, the lack of recognised ethical standards specific to CSS poses a practical barrier to the use of broad consent in this field and other fields that lack recognised ethical standards. Upon examining existing research ethics standards in social science and data science, we argue that they are insufficient for CSS. We further contend that the fragmentation of European Union (EU) law and research ethics sources makes it challenging to establish universally recognised ethical standards for scientific research. As a result, CSS researchers and other researchers in emerging fields that lack recognised ethical standards are left without sufficient guidance on the use of broad consent as provided for in the GDPR. We conclude that responsible EU bodies should provide additional guidance to facilitate the use of broad consent in CSS research. (shrink)

To determine whether ethical issues concerned with field research are addressed in the peer-review process, instructions to authors and reviewers of 141 (mainly natural science) journals were examined to ascertain how often ethical issues were mentioned. Only one-third (n=41) of responding journals addressed ethical issues in their instructions to authors or reviewers. When ethical issues were considered, most of the journals limited their concerns to ethical issues associated with animal and general human experimentation. No journal mentioned ethical practices in (...) working with indigenous peoples or on traditional lands. Only two journals addressed the ethics of research in sensitive areas in their instructions to authors, only one in its instructions to reviewers. We suggest that peer-reviewed journals respond to an emerging issue in ecological research by formally incorporating research ethics into their instructions to authors and reviewers. Furthermore, these instructions should address the ethical issues associated with field research and in working with indigenous peoples and on traditional lands. (shrink)

Neuroimaging research regularly yields “incidental findings”: observations of potential clinical significance in healthy volunteers or patients, but which are unrelated to the purpose or variables of the study.

While an accurate assessment of risk is always important, it is especially so in pediatric research. Recognizing the pivotal nature of the minimal-risk standard, we set out to determine under what circumstances pediatric magnetic resonance imaging research does or does not meet this standard. We found that while the physical and psychological risks that attend the MRI procedure do not exceed minimal risk, the sedation and contrast enhancement that are sometimes associated with MRI research do, as both (...) exceed the level of risk encountered by typical, healthy children in their everyday experiences. (shrink)

This study delves into the significant ethical criteria in the context of global standards. It addresses the moral wrongdoings and adverse side effects associated with global value chains as discussed in the business ethics literature. The methodology involves theoretical application and synthesis. The study employs ethical principles from deontology, consequentialism, and political cosmopolitanism to establish normative criteria such as “injustice and harm to others” and “bad outcomes.” It further investigates how these criteria should influence consumers' decisions, actions, and responsibilities. (...) These criteria are then used to examine the moral wrongdoings and negative effects mentioned in global standards. The study explores how global standards implicitly express consumers' roles in governing global value chains. It scrutinizes consumers' actions and decisions by applying ethical frameworks to global standards. The study outlines consumers' individual and political responsibilities in achieving the goals of global standards. The research findings have implications for governments, consumers, and organizations in practicing shared responsibility. The aim of this research is to provide normative guidance for responsible actions. (shrink)

Key to precision medicine is the development of expert database projects that gather data, integrate them in the pre-existing database, and publish the product of their processing for others to make use of. Increasingly, it is required that data infrastructure managers and curators pursue and lead research projects on the data so as to learn about new ways data could be used or information that could be potentially generated from them. I call these efforts “data curation-research” and use (...) the case study of COSMIC, the Catalogue of Somatic Mutations in Cancer, to analyze the contextual factors shaping the science of data curation-research. I build on March’s organizational learning categories of exploitation and exploration to place these factors within a theory of organizational change and innovation, and contribute to a richer picture of the social drivers of cancer genomics. (shrink)

Discussion of the ethics of clinical trials in lower income countries has been dominated by concern over double standards. Most prominently, clinical trials of interventions that are less effective than the worldwide best treatment methods typically are not permitted in higher income countries. Commentators conclude that permitting such trials in lower income countries involves an ethical double standard. Despite significant attention to this concern, and its influence over prominent guidelines for research in lower income countries, there has been (...) little analysis of what constitutes an ethical double standard in clinical research. The present article attempts to address this gap in the literature. This analysis finds that ethical double standards involve a kind of disrespect, and yields a three-step decision procedure for evaluating when trials of less than the worldwide best methods raise this concern. Application of this procedure reveals that permitting these trials in lower income countries rarely involves an ethical double standard. Instead, the real challenge is determining when clinical trials of interventions that are less effective than the worldwide best represent a permissible and effective response to differences in access to healthcare between higher income and lower income countries. To protect research subjects, without blocking clinical trials that have the potential to improve health in lower income countries, research review committees and other stakeholders should focus on this issue, not on ethical double standards. (shrink)

Recognizing that students are fundamentally engaged in a process of learning and self-development, ethical review of sub-doctoral student research should be proportionate to that objective. A student's tutor has the pedagogical role and an ethics committee should not interfere with that relationship other than to seek to avoid harms unforeseen by either the student or tutor. Underpowered or other statistically or methodologically flawed sub-doctoral research should not however, in general, be regarded as ethically concerning. With the proviso that (...) no subject is harmed the student can be allowed to learn such lessons as their mistakes may afford them. (shrink)