For decades a debate has played out in the literature about who bioethicists are, what they do, whether they can be considered professionals qua bioethicists, and, if so, what professional responsibilities they are called to uphold. Health care ethics consultants are bioethicists who work in health care settings. They have been seeking guidance documents that speak to their special relationships/duties toward those they serve. By approving a Code of Ethics and Professional Responsibilities for Health Care Ethics Consultants, (...) the American Society for Bioethics and Humanities (ASBH) has moved the professionalization debate forward in a significant way. This first code of ethics focuses on individuals who provide health care ethics consultation (HCEC) in clinical settings. The evolution of the code's development, implications for the field of HCEC and bioethics, and considerations for future directions are presented here. (shrink)

When conducting health and medical research it is important to do the research ethically and to apply for prior ethical approval from the relevant authorities. The latter requirement is true for developed countries as well as developing countries. The authors argue that simply applying for research ethics approval from an institutional review board at a university based in a developed country is not enough to start a health research project in a developing country. The paper also suggests (...) a number of reasons why researchers may fail to seek local research ethics permission in developing countries. The authors use a recent paper reporting research conducted in Nepal and published in an international journal as a case study to highlight the importance of being sensitive to local requirements regarding applying for and registering health and medical research. (shrink)

Although ethical guidelines for doing Internet research are available, most prominently those of the Association of Internet Researchers, ethical decision-making for research on publ...

Objectives—To assess the process involved in obtaining ethical approval for a single-centre study involving geographically dispersed subjects with an uncommon genetic disorder. Design—Observational data of the application process to 53 local research ethics committees (LRECs) throughout Wales, England and Scotland. The Multicentre Research Ethics Committee (MREC) for Wales had already granted approval. Results—Application to the 53 LRECs required 24,552 sheets of paper and took two months of the researcher's time. The median time taken for approval (...) was 39 days with only seven (13%) of committees responding within the recommended 21 days. In at least nineteen cases (36%) a subcommittee considered the application. Thirty-three committees (62%) accepted the proposal without amendments but, of the remainder, four (8%) requested changes outside of the remit of LRECs. Discussion—Difficulties still exist with the system for obtaining ethical approval for studies involving a single centre but with patients at multiple sites, as is often required for genetic observational research. As such studies differ from true multicentre studies, it may be advantageous to develop a separate and specific process of application to ensure that resources are not unnecessarily expended in the quest for ethical approval. (shrink)

BackgroundWe conducted a survey to identify what types of health/medical research could be exempt from research ethics reviews in Australia.MethodsWe surveyed Australian health/medical researchers and Human Research Ethics Committee members. The survey asked whether respondents had previously changed or abandoned a project anticipating difficulties obtaining ethics approval, and presented eight research scenarios, asking whether these scenarios should or should not be exempt from ethics review, and to provide comments. Qualitative data were analysed thematically; quantitative data (...) in R.ResultsWe received 514 responses. Forty-three per cent of respondents to whom the question applied, reported changing projects in anticipation of obstacles from the ethics review process; 25% reported abandoning projects for this reason. Research scenarios asking professional staff to provide views in their area of expertise were most commonly exempted from ethics review ; scenarios involving surplus samples and N-of-1 studies were most commonly required to undergo ethics review. HREC members were 26% more likely than researchers to require ethics review. Need for independent oversight, and low risk, were most frequently cited in support of decisions to require or exempt from ethics review, respectively.ConclusionsConsiderable differences exist between researchers and HREC members, about when to exempt from review the research that ultimately serves the interests of patients and the public. It is widely accepted that evaluative research should be used to reduce clinical uncertainties—the same principle should apply to ethics reviews. (shrink)

BackgroundPrevious studies have indicated that failure to report ethical approval is common in health science articles. In social sciences, the occurrence is unknown. The Swedish Ethics Review Act requests that sensitive personal data, in accordance with the EU General Data Protection Regulation (GDPR), should undergo independent ethical review, irrespective of academic discipline. We have explored the adherence to this regulation. MethodsUsing the Web of Science databases, we reviewed 600 consecutive articles from three domains (health sciences with and without (...) somatic focus and social sciences) based on identifiable personal data published in 2020. ResultsInformation on ethical review was lacking in 12 of 200 health science articles with somatic focus (6%), 21 of 200 health science articles with non-somatic focus (11%), and in 54 of 200 social science articles (27%; p < 0.001 vs. both groups of health science articles). Failure to report on ethical approval was more common in (a) observational than in interventional studies (p < 0.01), (b) articles with only 1–2 authors (p < 0.001) and (c) health science articles from universities without a medical school (p < 0.001). There was no significant association between journal impact factor and failure to report ethical approval.ConclusionsWe conclude that reporting of research ethics approval is reasonably good, but not strict, in health science articles. Failure to report ethical approval is about three times more frequent in social sciences compared to health sciences. Improved adherence seems needed particularly in observational studies, in articles with few authors and in social science research. (shrink)

This paper attempts to open debate about the nature of and need for ethical review of health-related social science research. Drawing upon personal experience and anecdotal reports we describe some of the problems social scientists and ethics committee members may encounter when social science research is reviewed by Multicentre and Local Research Ethics Committees. We argue that the boundary between research methods and ethics is ambiguous and flexible, and that ethics therefore permeates research at all levels (...) from the construction of the research question to the ways in which data are collected and disseminated. We suggest that the dissatisfaction both sides may experience may be mitigated by more communication and a willingness to understand the others' definition of what counts as ethics and how research is organized and executed. We conclude that ethical review has great potential to strengthen research, and that we must work hard to avoid a situation in which ethical review is seen as just a bureaucratic exercise. (shrink)

Background Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals. Methods This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI (...) Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review. Results A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies discussed informed consent. Only half of those reported that written informed consent had been obtained; few reported oral consent, and few used other methods such as online consent or completion and return of data collection to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “consent was obtained from participants or participants agreed to join in the research”. Furthermore, whilst most of clinical studies mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received. Conclusion The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required. (shrink)

During the set-up phase of an international study of genetic influences on outcomes from sepsis, we aimed to characterise potential differences in ethics approval processes and outcomes in participating European countries. Between 2005 and 2007 of the FP6-funded international Genetics Of Sepsis and Septic Shock project, we asked national coordinators to complete a structured survey of research ethic committee approval structures and processes in their countries, and linked these data to outcomes. Survey findings were reconfirmed or modified (...) in 2017. Eighteen countries participated in the study, recruiting 2257 patients from 160 ICUs. National practices differed widely in terms of composition of RECs, procedures and duration of the ethics approval process. Eight countries used a single centralised process for approval, seven required approval by an ethics committee in each participating hospital, and three required both. Outcomes of the application process differed widely between countries because of differences in national legislation, and differed within countries because of interpretation of the ethics of conducting research in patients lacking capacity. The RECs in four countries had no lay representation. The median time from submission to final decision was 1.5 months; in nine approval was received within 1 month; six took over 6 months, and in one 24 months; had all countries been able to match the most efficient approvals processes, an additional 74 months of country or institution-level recruitment would have been available. In three countries, rejection of the application by some local RECs resulted in loss of centres; and one country rejected the application outright. The potential benefits of the single application portal offered by the European Clinical Trials Regulation will not be realised without harmonisation of research ethics committee practices as well as national legislation. (shrink)

We argue that developing a human ethics application is an effective method for refining the intent and design of research studies. Our study aimed to investigate the delivery of end-of-life and palliative care nursing to residents of an aged care unit in a Multi-purpose Service/centre in rural Victoria. We used the ethics application process as a strategy to focus the study, and to refine the data collection and analysis techniques. It is our contention that the process of completing (...) the application and gaining ethics approval is laborious; however, the intellectualising that occurs provides researchers with an opportunity to reflect upon and refine their studies, thus ensuring the ultimate success and timely completion of research investigations. (shrink)

This paper examines the institutional mechanisms supporting the ethical oversight of human participant research conducted by the United Nations (UN). The UN has served an instrumental role in shaping international standards on research ethics, which invariably require ethical oversight of all research studies with human participants. The authors’ experiences of conducting research collaboratively with UN agencies, in contrast, have led to concern that the UN frequently sponsors, or participates in, studies with human participants that have not received appropriate ethical (...) oversight. It is argued that the institutional mechanisms in place to prevent research with human participants from being undertaken by the UN without ethical oversight do not, at present, extend substantively beyond the provision of guidelines and online training offered by a minority of UN bodies. The WHO and UNICEF are identified as notable exceptions, having implemented various measures to prevent health research with human participants from being undertaken without ethical oversight. Yet, it is highlighted that the WHO and UNICEF are not the only UN bodies that undertake health research with human participants and there are countless actors under the umbrella of the UN system that are regularly involved in non-health research with human participants. Arguments for the pursuit of the highest standard of ethical oversight by UN bodies are presented. Moving forward, the paper asks the question: is it time for the UN to set the standards for the oversight of ethical oversight? (shrink)

Small-scale research projects involving human subjects have been identified as being effective in developing critical appraisal skills in undergraduate students. In deciding whether to grant ethical approval to such projects, university research ethics committees must weigh the benefits of the research against the risk of harm or discomfort to the participants. As the learning objectives associated with student research can be met without the need for human subjects, the benefit associated with training new healthcare professionals cannot, in itself, (...) justify such risks. The outputs of research must be shared with the wider scientific community if it is to influence future practice. Our survey of 19 UK universities indicates that undergraduate dissertations associated with the disciplines of medicine, dentistry and pharmacy are not routinely retained in their library catalogues, thus closing a major avenue to the dissemination of their findings. If such research is unlikely to be published in a peer-reviewed journal, presented at a conference, or otherwise made available to other researchers, then the risks of harm, discomfort or inconvenience to participants are unlikely to be offset by societal benefits. Ethics committees should be satisfied that undergraduate research will be funnelled into further research that is likely to inform clinical practice before granting ethical approval. (shrink)

We analysed research ethics committee (REC) letters. We found that RECs frequently identify process errors in applications from researchers that are not deemed “favourable” at first review. Errors include procedural violations (identified in 74% of all applications), missing information (68%), slip-ups (44%) and discrepancies (25%). Important questions arise about why the level of error identified by RECs is so high, and about how errors of different types should be handled.

Background: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied.Methods: The protocols of clinical research projects submitted to the research ethics committee of the University of Freiburg in 2000 (...) were analysed. Published full articles in several databases were searched and investigators contacted. Data on study and publication characteristics were extracted from protocols and corresponding publications.Results: 299 study protocols were included. The most frequent study design was randomised controlled trial , followed by uncontrolled studies , laboratory studies and non-randomised studies . 182 were multicentre studies including 97 international collaborations. 152 of 299 had commercial funding and 46 non-commercial funding. 109 of the 225 completed protocols corresponded to at least one full publication ; the publication rate was 48%. 168 of 210 identified publications were cited in articles indexed in the ISI Web of Science. The median was 11 citations per publication .Conclusions: Results of German clinical research projects conducted are largely underreported. Barriers to successful publication need to be identified and appropriate measures taken. Close monitoring of projects until publication and adequate support provided to investigators may help remedy the prevailing underreporting of research. (shrink)

This paper provides advice for the supervision of PhD students during the research ethics approval process written from the perspective of a PhD student. This advice is for supervisors – to be aware of the level of experience their student has regarding applying for ethical approval and conducting research with human participants; to ensure clarity as to whether the student or the supervisor has responsibility for the ethical storage of research materials after the end of the PhD; (...) and finally, and most important, to advise the student on the issues to cover in their ethics approval form, go through their completed form thoroughly, and meet them to discuss feedback. (shrink)

Undertaking research involving vulnerable groups, such as those requiring resuscitation involves careful analysis during the ethical review process. When a person lacks the capacity to make an informed choice about their participation in a research study, a waiver of consent offers an alternative. This paper is based on a doctoral research study using ethnography to explore the resuscitative practices and experiences of rural nurses through observation and interviews. This paper aims to explore the ethical issues raised by the Human Research (...) Ethics Committee relating to consent of vulnerable patients requiring resuscitation within a rural context. In particular, the challenges of addressing risk (privacy) vs benefit (public) associated with a waiver of consent. This paper will consider why the rural context should be championed during the ethical review process, when decisions about public benefit are being deliberated. Utilising a communitarianism approach that advocates for greater rural representation during the ethical review processes will ensure that rural research involving vulnerable groups can be addressed safely and benefit not only the experiences and practices of rural nurses but also the wider rural communities they serve. (shrink)

While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over (...) the period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research. (shrink)

Background: Authors are required to describe in their manuscripts ethical approval from an appropriate committee and how consent was obtained from participants when research involves human participants.Objective: To assess the reporting of these protections for several study designs in general medical journals.Design: A consecutive series of research papers published in the Annals of Internal Medicine, BMJ, JAMA, Lancet and The New England Journal of Medicine between February and May 2003 were reviewed for the reporting of ethical approval and (...) patient consent. Ethical approval, name of approving committee, type of consent, data source and whether the study used data collected as part of a study reported elsewhere were recorded. Differences in failure to report approval and consent by study design, journal and vulnerable study population were evaluated using multivariable logistic regression.Results: Ethical approval and consent were not mentioned in 31% and 47% of manuscripts, respectively. 88 papers failed to report both approval and consent. Failure to mention ethical approval or consent was significantly more likely in all study designs than in randomised controlled trials . Failure to mention approval was most common in the BMJ and was significantly more likely than in The New England Journal of Medicine. Failure to mention consent was most common in the BMJ and was significantly more likely than in all other journals. No significant differences in approval or consent were found when comparing studies of vulnerable and non-vulnerable participants.Conclusion: The reporting of ethical approval and consent in RCTs has improved, but journals are less good at reporting this information for other study designs. Journals should publish this information for all research on human participants. (shrink)

Allocating access to unapproved COVID-19 drugs available via Pre-Approval Access pathways or Emergency Use Authorization raises unique challenges at the intersection of clinical care and research....

Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research. Whether or not T1 has these features, translational research beyond approval is (...) unlikely to and, when conducted on the global poor, may support development. Therefore, insofar as T1 is morally problematic, and no independent objections to T2 exist, the ethics of translational research is diverse: while some translational research is problematic, some is not. Funding and oversight should reflect this diversity, and T2 should be encouraged, particularly when conducted among the global poor. (shrink)

BackgroundInternational guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka.MethodsWe obtained ERC approval in Sri Lanka and the United Kingdom. Theses (...) from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized.ResultsOf 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent.ConclusionOnly one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal. (shrink)

University human research ethics application procedures can be complicated and daunting, especially for international students unfamiliar with the process and the language. We conducted focus groups and interviews with four research higher degree and 21 Master’s coursework international students at an Australian university to gain their views on the human ethics application process. We found the most important influences on their experience were: the time it took to do an application; support from supervisors, peers and others; their own (...) language skills; and their lack of familiarity with research ethics procedures. To improve the experience of international students undertaking research involving human research ethics applications, we recommend universities provide guidance on institutional ethics review processes, concepts and terminology, with translations in a range of languages, together with guidance on how to conduct research ethically within and outside the students’ own countries. We also recommend curricula be developed to further students’ understanding of the importance of ethical research practice, and that these curricula be embedded in undergraduate and postgraduate degree programs and reflected in course learning outcomes. (shrink)

Despite significant scholarly debate about knowledge production in the management discipline through the peer-review journal processes, there is minimal discussion about the ethical treatment of the research subject in these publication processes. In contrast, the ethical scrutiny of management research processes within research institutions is often highly formalized and very focused on the protection of research participants. Hence, the question arises of how management publication processes should best account for the interests of the research subject, both in the narrow sense (...) of specific research participants and in the broader understanding of the subject of the research. This question is particularly pertinent in light of significant codification of research ethics within academic institutions, and increasing self-reflection within the management discipline about the “good” of management research and education. Findings from a survey and interviews with management journal editors reveal a complex scenario; many editors believe that a formalized requirement within the journal publication process may have detrimental outcomes and, in fact, diminish the ethical integrity of management scholarship. Building on these findings, this paper argues that ethical concern for the research subject merely in terms of institutional rule compliance and avoidance of harm to individual participants is insufficient, and calls for explicitly positive engagement with both the individual and the collective subject of management research should receive due ethical consideration. An alternative model involving reflexive ethical consideration of research subjects across the publication process—with implications for role of authors, reviewers, editors, and research subjects—is outlined. (shrink)

Book reviewed in this article: Ethical Issues in Drug Testing, Approval and Pricing: The Clot‐Dissolving Drugs. By Baruch Brody.

COVID-19 vaccination of children has begun in various high-income countries with regulatory approval and general public support, but largely without careful ethical consideration. This trend is expected to extend to other COVID-19 vaccines and lower ages as clinical trials progress. This paper provides an ethical analysis of COVID-19 vaccination of healthy children. Specifically, we argue that it is currently unclear whether routine COVID-19 vaccination of healthy children is ethically justified in most contexts, given the minimal direct benefit that COVID-19 (...) vaccination provides to children, the potential for rare risks to outweigh these benefits and undermine vaccine confidence, and substantial evidence that COVID-19 vaccination confers adequate protection to risk groups, such as older adults, without the need to vaccinate healthy children. We conclude that child COVID-19 vaccination in wealthy communities before adults in poor communities worldwide is ethically unacceptable and consider how policy deliberations might evolve in light of future developments. (shrink)

This article examines the ethical thought of the prominent French philosopher, Alain Badiou. His work is placed in the context of discussions of the sources of normativity in relation to Kant and Levinas and then the central category of the event in Badiou's work is critically discussed. The article claims that Badiou's talk of truth in relation to event is misplaced and argues that there is a residual heroism behind Badiou's political thinking.

(2002). 'Target Approval Delays Cost Air Force Key Hits': Law, Policy, Ethics and the Warfighter's Dilemma. Journal of Military Ethics: Vol. 1, No. 2, pp. 113-124.

Drugs addressing unmet medical needs can change the lives of millions. Developing and validating new drugs can, however, take many years. To streamline the assessment of new drugs, regulatory agencies have long established shortened review pathways. Among these programs, Accelerated Approval (AA) has recently come under scrutiny due to the U.S. Food and Drug Administration's decision to authorize Aducanumab, the first Alzheimer's disease drug. This decision attracted fierce criticism due to the allegedly insufficient evidence about the safety and efficacy (...) of the drug. While considerable scholarly attention has been devoted to this case, the ethical aspects of the AA regulatory pathway have so far remained relatively unexplored. In this paper, we set out to fill this gap. We illustrate six conditions that should be met for AA to be ethically acceptable: moral solicitude, evidence, risk mitigation, impartiality, sustainability, and transparency. We discuss such conditions and suggest practical steps to implement them in regulatory and oversight processes. Taken together, our six conditions represent a benchmark for assessing the ethical validity of AA processes and decisions. (shrink)

The function of local research ethics committees is to consider the ethics of research proposals using human participants. After approval has been given, there is no comprehensive system in place to monitor research and ensure that recommendations are carried out. Some suggest that research ethics committees are ideally placed to fulfil this function by carrying out random monitoring of research they have reviewed. The health service guideline creating local research ethics committees is under review.1 This (...) paper suggests that increasing the monitoring role of ethics committees in the present climate would be inappropriate. This is due to the large workload of the committees, their voluntary nature and the change a monitoring role might cause to the relationship between researcher and ethics committee, which might herald an increasing recourse to judicial review. A radical overhaul of the system would be necessary in order for ethics committees adequately to fulfil a monitoring function. (shrink)

In Canada, all institutions that conduct publicly funded, animal-based research are expected to comply with the standards of the Canadian Council on Animal Care (CCAC). The CCAC promotes the use of animal alternatives, and uses the “3Rs” principles of Replacement, Reduction, and Refinement as a guiding ethical framework. To ensure these standards are strictly enforced, internal ethics committees at each institution are tasked with creating “Animal Use Protocol” (AUP) forms to be filled out by researchers and evaluated by the (...) committees. In this paper, we assess AUP forms from Canada’s top research universities to identify the extent to which they conform to, or advance, the 3Rs framework. Our results show various deficiencies that call into question the quality of information elicited by these forms. To remedy this, we recommend that the CCAC assume responsibility for creating a standardized 3Rs section to be used on all AUP forms. In addition, proposal forms and experimental results for all research at CCAC-certified institutions should be digitized and uploaded into a national database. We argue that this would offer higher quality information for researchers at the experimental design stage, while strengthening the CCAC’s mandate to be accountable to the Canadian public. (shrink)

BackgroundMulti-centre studies generally cost more than single-centre studies because of larger sample sizes and the need for multiple ethical approvals. Multi-centre studies include clinical trials, clinical quality registries, observational studies and implementation studies. We examined the costs of two large Australian multi-centre studies in obtaining ethical and site-specific approvals.MethodsWe collected data on staff time spent on approvals and expressed the overall cost as a percent of the total budget.ResultsThe total costs of gaining approval were 38 % of the budget (...) for a study of 50 centres (mean cost AUD $6960 per site) and 2 % for a study of 11 centres (mean cost AUD $2300 per site). Seventy-five and 90 % of time was spent on repeated tasks, respectively, and many time-consuming tasks, such as reformatting documents, did nothing to improve the study design or participant safety.ConclusionsImprovements have been made to the ethical approval application system, but more gains could be made without increasing risks of harm to research participants. We propose that ethical review bodies and individual sites publish statistics on how long they take to process approvals which could then be nationally benchmarked. (shrink)

The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service procedures and the electronic Integrated Research Application System. We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on (...) the substantive research, and suggest directions for radical system change. We have recorded 491 exchanges with 89 individuals involved in research ethics and governance approvals, generating 193 pages of email text excluding attachments. These are conservative estimates. The exchanges were conducted outside IRAS, expected to be the platform where all necessary documents are provided and questions addressed. Importantly, the figures exclude the actual work of preparing the ethics documentation. We propose six areas of work to enable system change: 1. Support the development of a broad range of customised research ethics and governance templates to complement generic, typically clinical trials orientated, ones; 2. Develop more sophisticated and flexible frameworks for study classification; 3. Link with associated processes for assessment, feedback, monitoring and reporting, such as ones involving funders and patient and public involvement groups; 4. Invest in a new generation IT infrastructure; 5. Enhance system capacity through increasing online reviewer participation and training; and 6. Encourage researchers to quantify the approvals processes for their studies. Ethics and governance approvals are burdensome for historical reasons and not because of the nature of the task. There are many opportunities to improve their efficiency and analytic depth in an age of innovation, increased connectivity and distributed working. If we continue to work under current systems, we are perpetuating, paradoxically, an unethical system of research approvals by virtue of its wastefulness and impoverished ethical debate. (shrink)

In this paper, I focus on Edmund Husserl’s analyses of the act of approval and the role he attributes to it in his ethics. I show that we can deepen our understanding of both if we rely on his critical reflections on Shaftesbury’s theory of affections in his lecture course Einleitung in die Ethik. The sections of this course devoted to Shaftesbury are the only place in Husserl’s later philosophical production where he addresses the need to clarify the (...) nature of approval from a phenomenological point of view and provides precise indications about the role that such emotions play in our life. I thereby examine Husserl’s criticisms of Shaftesbury’s account of reflective emotions, and I compare these criticisms with Husserl’s account of approval in the texts from the Konvolut über Billigung collected in the Studien zur Struktur des Bewusstseins. I argue that, according to Husserl, approval is an essential but not sufficient component in the pursuit of virtue. The upshot is that crucial parts of Husserl’s ethics come from a radical and original reworking of central notions of the early modern sentimentalist tradition. (shrink)

Alzheimer’s disease (AD), the devastating and most prevailing underlying cause for age-associated dementia, has no effective disease-modifying treatment. The last approved drug for the relief of AD symptoms was in 2003. The recent approval of sodium oligomannate (GV-971, 2019) in China and the human antibody aducanumab in the USA (ADUHELM, 2021) therefore represent significant breakthroughs, albeit ones that are fraught with controversy. Here, we explore potential scientific ethics issues associated with GV-971 and aducanumab’s development and approval. While (...) these issues may be belied by socioeconomic and political complexities in the heady business of commercial drug development, they are of fundamental importance to scientific integrity and ultimately, welfare of patients. We posit that the push for approval of both AD drugs based on incomplete research and unconvincing marginal effectiveness is ethically unsound. Regardless of how both these drugs shall perform in the market for the years to come, the scientific ethics issues and potentially questionable research practices should therefore be duly noted and lessons learned. (shrink)

The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study’s investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of research regulatory structures, arranging a (...) site visit from a U.S. research ethics committee (REC) becomes difficult, thus creating a potential barrier to regulatory oversight by the parent REC. However, this barrier may be overcome through the use of digital technologies, since much of the world has at least remote access to the Internet. Empirical research is needed to pilot test the use of these technologies for research oversight to ensure the protection of human subjects taking part in research worldwide. (shrink)