Scientific Research Ethics

L'éthique des mégadonnées implique l'adhésion aux concepts de bons et mauvais comportements concernant les données, en particulier les données personnelles. L'éthique des mégadonnées se concentre sur les collecteurs et diffuseurs des données structurés ou non structurés. L'éthique des mégadonnées est soutenue, au niveau de l'UE, par une documentation complète, qui cherche à trouver des solutions concrètes pour maximiser la valeur des mégadonnées sans sacrifier les droits humains fondamentaux. Le Contrôleur européen de la protection des données (CEPD) soutient le droit à (...) la vie privée et le droit à la protection des données personnelles dans le respect de la dignité humaine. DOI: 10.13140/RG.2.2.25877.96480 . (shrink)

Preston Greene (2020) argues that we should not conduct simulation investigations because of the risk that we might be terminated if our world is a simulation designed to research various counterfactuals about the world of the simulators. In response, we propose a sequence of arguments, most of which have the form of an "even if” response to anyone unmoved by our previous arguments. It runs thus: (i) if simulation is possible, then simulators are as likely to care about simulating simulations (...) as they are likely to care about simulating basement (i.e. non-simulated) worlds. But (ii) even if simulations are interested only in simulating basement worlds the discovery that we are in a simulation will have little or no impact on the evolution of ordinary events. But (iii) even if discovering that we are in a simulation impacts the evolution of ordinary events, the effects of seeming to do so could also happen in a basement world, and might be the subject of interesting counterfactuals in the basement world Finally, (iv) there is little reason to think that there is a catastrophic effect from successful simulation probes, and no argument from the precautionary principle can be used to leverage the negligible credence one ought have in this. Thus, if we do develop a simulation probe, then let’s do it. (shrink)

Reprint of an article that first appeared in Theoretical Medicine and Bioethics (2017).

During the COVID-19 pandemic, ethics centers were forced to reimagine program delivery. In a tumultuous time with rampant social isolation, the need for ethics education and dialogue was also critical. The authors, members of the directorship team of the Kegley Institute of Ethics, discuss how KIE met these challenges through organizing over fifty online events during the pandemic, including webinars, pedagogy workshops, ethics bowls, intercollegiate student conversations, colloquia, film viewings, and podcasts. The article describes both the opportunities and challenges that (...) different types of virtual events present and argues that innovation in online programming can help ethics centers show ethical leadership in their communities. As one example, we discuss how online events can both enhance and hinder accessibility for participants. We also describe how online programming presents both barriers and opportunities for community building and can prompt ethics centers to reflect on their identities and missions. (shrink)

Given the sordid history of injustices linking genetics to race and ethnicity, considerations of justice are central to ensuring the responsible development of precision medicine programmes around the world. While considerations of justice may be in tension with other areas of concern, such as scientific value or privacy, there are also be tensions between different aspects of justice. This paper focuses on three particular aspects of justice relevant to this context: social justice, distributive justice and human rights. The implications of (...) each for the use of race and ethnicity in precision medicine is described, along with how they intersect and potentially conflict with one another. By attending to these intersections, we aim to enrich and add nuance to debates over how best to proceed with precision medicine initiatives. (shrink)

Research Ethics, Ahead of Print. Interview-based research in multilingual situations can present researchers with specific ethical challenges relating to language-based power play, data handling and presentation. Studies indicate favouring the L1 as an interviewing language may produce better quality data, but external pressures can favour English as the dominant research language. This article examines researcher perceptions and experiences of the ethical consequences of language choice and the practical issues involved. Interviews were conducted with five European researchers working on an interview-based (...) project with experiences of diverse interviewing scenarios. The four moral principles of respect for autonomy, justice, beneficence and non-maleficence were used as a framework for analysis. The analysis revealed a nuanced picture of ethical issues in both L1- and English-oriented scenarios. This included potential misrepresentation and deculturalisation of the data in the former, and language-based power asymmetries in the latter. The findings highlight the importance of documenting ethics-related methodological details of language use, and advocates publication practices favouring the inclusion and foregrounding of L1 data. (shrink)

Philosophers of science now broadly agree that doing good science involves making non-epistemic value judgments. I call attention to two very different normative standards which can be used to evaluate such judgments: standards grounded in ethics and standards grounded in political philosophy. Though this distinction has not previously been highlighted, I show that the values in science literature contain arguments of each type. I conclude by explaining why this distinction is important. Seeking to determine whether some value-laden determination meets substantive (...) ethical standards is a very different endeavor from seeking to determine if it is politically legitimate. (shrink)

This paper considers the responsibilities of the FDA with regard to disseminating information about the benefits and harms of e-cigarettes. Tobacco harm reduction advocates claim that the FDA has been overcautious and has violated ethical obligations by failing to clearly communicate to the public that e-cigarettes are far less harmful than cigarettes. We argue, by contrast, that the FDA’s obligations in this arena are more complex than they may appear at first blush. Though the FDA is accountable for informing the (...) public about the health risks and benefits of products it regulates, it also has other roles (and attendant responsibilities) that inform when and how it should disseminate information. In addition to being a knowledge purveyor, it is also a knowledge producer, an advisor to the public, and a practical agent shaping the material conditions in which people make health-related choices. In our view, those other roles call for caution in the way the FDA interprets and communicates the available evidence. (shrink)

This study aimed to explore experiences and practices of key research team members in obtaining informed consent for pharmacogenetics research and to identify the approaches used for enhancing unde...

In today’s online data-driven world, people constantly shed data and deposit digital footprints. When individuals access health services, governments and health providers collect and store large volumes of health information about people that can later be retrieved, linked and analysed for research purposes. This can lead to new discoveries in medicine and healthcare. In addition, when securely stored and de-identified, the privacy risks are minimal and manageable. In many jurisdictions, ethics committees routinely waive the requirement for researchers to obtain consent (...) from data subjects before using and linking these datasets in an effort to balance respect for individuals with research efficiency. In this paper, I explore the ethical justification for using routinely collected health data for research without consent. I conclude that, not only is this morally justified but also that data subjects have a moral obligation to contribute their data to such research, which would obviate the need for ethics committees to consider consent waivers. In justifying this argument, I look to the duty of easy rescue, distributive justice and draw analogies with vaccination ethics. (shrink)

Learning about research ethics and research integrity is greatly facilitated by case studies, which illuminate, ground and personalise abstract questions. This paper argues that fiction can provide similar learning experiences, incarnating ethical dilemmas through a medium that is highly accessible yet sophisticated in its depictions of how researchers behave. Examples of fictional illustrations are given to illustrate various themes such as animal experimentation, exploitation of the vulnerable, researcher bias and research fraud.

Criticism is a staple of the scientific enterprise and of the social epistemology of science. Philosophical discussions of criticism have traditionally focused on its roles in relation to objectivity, confirmation, and theory choice. However, attention to criticism and to criticizability should also inform our thinking about scientific pursuits: the allocation of resources with the aim of developing scientific tools and ideas. In this paper, we offer an account of scientific pursuitworthiness which takes criticizability as its starting point. We call this (...) the apokritic model of pursuit. Its core ideas are that pursuits are practices governed by norms for asking and answering questions, and that criticism arises from the breach of these norms. We illustrate and advertise our approach using examples from institutional grant review, neuroscience, and sociology. We show that the apokritic model can unify several indices of criticizability, that it can account for the importance of criticizing pursuits in scientific practice, and that it can offer ameliorative advice to erstwhile pursuers. (shrink)

ABSTRACT The purpose of this paper is to argue that social science is an inherently moral enterprise. There are four reasons to see science as a moral endeavor based on the neo-Aristotelian recognition that morality is centered on human goods, not just right action. First, science is guided by epistemic values and underwritten by pro-science traits. Second, the outcomes of applied science are valued by scientists and others. Third, attempting to eliminate values from science is counterproductive because it leads to (...) smuggling in moral commitments that are very difficult to critically evaluate, particularly in the social sciences. Finally, the goal of science is knowledge, which is a vital human good. Therefore, science is a thoroughly moral enterprise because human goods are moral aims. I conclude with three implications of this argument for science education. (shrink)

Limited research has been done among pregnant people participating in investigational drug trials. To enhance the ethical understanding of pregnant people’s perspectives on research participation, we sought to describe motives and risk perceptions of participants in a phase 1 trial of ledipasvir/sofosbuvir treatment for chronic Hepatitis C virus during pregnancy. Pregnant people with chronic HCV infection enrolled in an open-label, phase 1 study of LDV/SOF participated in semi-structured, in-depth interviews to explore their reasons for participation and experiences within the study. (...) Pregnant people took 12 weeks of LDV/SOF and were interviewed at enrollment and at the end of study. We recorded the interviews, transcribed them verbatim, coded them using NVivo software, and performed inductive thematic analysis. Nine women completed the study yielding 18 interview transcripts. We identified two themes regarding motives and one regarding risk perception. Motives— Women conceptualized study participation as part of the caregiving role they associate with motherhood; participating was viewed as an act of caregiving for their infants, their families, themselves, and other pregnant women with chronic HCV. Women also noted that they faced multiple barriers to treatment prior to pregnancy that created a desire to receive therapy through trial participation. Risk perception— Women acknowledged personal and fetal risk associated with participation. Acceptance of risk was influenced by women’s concepts of motherhood, preexisting knowledge of HCV and medical research, family members, intimate partners, or by the study design. Women enrolled in a phase 1 trial for chronic HCV therapy during pregnancy acknowledged risks of participation and were motivated by hopes for fetal and personal benefit and by lack of prenatal access to treatment. Ethical inclusion of pregnant people in research should acknowledge structural factors that contribute to vulnerability and data deficiencies for treatment in pregnancy. (shrink)

Research Ethics, Volume 18, Issue 2, Page 93-113, April 2022. Twitter is an increasingly common source of rich, personalized qualitative data, as millions of people daily share their thoughts on myriad topics. However, questions remain unclear concerning if and how to quote publicly available social media data ethically. In this study, focusing on 136 education manuscripts quoting 2667 Tweets, we look to investigate the ways in which Tweets are quoted, the ethical discussions forwarded and actions taken, and the extent to (...) which quoted Tweets are “discoverable.” A concerning result is that in almost all manuscripts, and for around half of all quoted Tweets, the original author could be identified. Drawing on our findings we share some ethical dilemmas, including those that arise from an apparent lack of understanding of the technical aspects of the platform, and offer suggestions for promoting ethically-informed practice. (shrink)

Research Ethics, Volume 18, Issue 2, Page 163-168, April 2022. Citation is an essential practice in scientific publishing. However, it is mandatory that citing the sources in a scientific work is performed in a proper manner. Manipulating citations in research articles is one form of academic research misconduct that violates publication ethics. Citation manipulation simply occurs for the purpose of increasing the number of citations of a researcher or a journal. Unfortunately, there has been a growing trend for this type (...) of misconduct recently and this has not received much attention from the science community. The most effective solution to prevent the growth of such unethical practices is for reputable journals to impose stricter rules on reference evaluation criteria in order to emphasize on the appropriateness of the citations. (shrink)

ABSTRACT Science is an ethical community whose practitioners aim to discover information about the natural world and to explain discernible patterns that might be detected. Those who pursue science generally embrace certain epistemic values that help establish the moral boundaries of the community, while the twin pillars of rationality and empiricism serve as the foundations upon which scientists establish their truth claims. Yet however robust the assertions might appear, they nevertheless are the by-products of an exclusively human endeavor directly impacted (...) by those sociological forces that apply throughout the social universe, including the scientist’s social location and the importance of enhancing one’s reputation. The current paper identifies key sociological factors that help shape scientific bias and the nature of the justifications used to defend truth claims. A case study of one community committed to a sociological paradigm demonstrates the utility of the explanatory framework advanced. A more self-conscious awareness of the forces at play that create such biases can help mitigate their deleterious impacts that subvert the quest for explanatory knowledge and valid truth claims about observable phenomena. (shrink)

The trolley problem is one of the liveliest research frameworks in experimental ethics. In the last decade, social neuroscience and experimental moral psychology have gone beyond the studies with mere text-based hypothetical moral dilemmas. In this article, I present the rationale behind testing the actual behaviour in more realistic scenarios through Virtual Reality and summarize the body of evidence raised by the experiments with virtual trolley scenarios. Then, I approach the argument of Ramirez and LaBarge (2020), who claim that the (...) virtual simulation of the Footbridge version of the trolley dilemma is an unethical research practice, and I raise some objections to it. Finally, I provide some reflections about the means and ends of trolley-like scenarios and other sacrificial dilemmas in experimental ethics. (shrink)

Scientists have the ability to influence policy in important ways through how they present their results. Surprisingly, existing codes of scientific ethics have little to say about such choices. I propose that we can arrive at a set of ethical guidelines to govern scientists’ presentation of information to policymakers by looking to bioethics: roughly, just as a clinician should aim to promote informed decision-making by patients, a scientist should aim to promote informed decision-making by policymakers. Though this may sound like (...) a natural proposal, I show it offers guidance that conflicts with standard scientific practices. I conclude by considering one cost of the proposal: that it would prevent scientists from acting as advocates in a way that is currently common in certain fields. I accept that the proposal would restrict scientists’ political advocacy rights, but argue that the benefits of adopting it — promoting democratic governance — justify the restriction. (shrink)

What makes science trustworthy to the public? This chapter examines one proposed answer: the trustworthiness of science is based at least in part on its independence from the idiosyncratic values, interests, and ideas of individual scientists. That is, science is trustworthy to the extent that following the scientific process would result in the same conclusions, regardless of the particular scientists involved. We analyze this "idiosyncrasy-free ideal" for science by looking at philosophical debates about inductive risk, focusing on two recent proposals (...) which offer different methods of avoiding idiosyncrasy: the high epistemic standards proposal and the democratic values proposal. (shrink)

ABSTRACTCOVID-19 is compromising all aspects of society, with devastating impacts on health, political, social, economic and educational spheres. A premium is being placed on scientific research as the source of possible solutions, with a situational imperative to carry out investigations at an accelerated rate. There is a major challenge not to neglect ethical standards, in a context where doing so may mean the difference between life and death. In this paper we offer a rubric for considering the ethical challenges in (...) COVID-19 related research, in the form of an ethics toolkit for global research developed at the University of Edinburgh in collaboration with more than 200 global researchers from around the world. This toolkit provides a framework to support confrontation of ethical conflicts through the integrated and iterative analysis of Place, People, Principles and Precedents, throughout the research journey. Two case analyses are offered to exemplify the utility of the toolkit as a flexible and dynamic tool to promote ethical research in the context of COVID-19. (shrink)

Ethics dumping is the practice of undertaking research in a low- or middle-income setting which would not be permitted, or would be severely restricted, in a high-income setting. Whilst Kenya operates a sophisticated research governance system, resource constraints and the relatively low number of accredited research ethics committees limit the capacity for ensuring ethical compliance. As a result, Kenya has been experiencing cases of ethics dumping. This article presents 11 challenges in the context of preventing ethics dumping in Kenya, namely (...) variations in governance standards, resistance to double ethics review, resource constraints, unresolved issues in the management of biological samples, unresolved issues in the management of primary data, unsuitable informed consent procedures, cultural insensitivity, differing standards of care, reluctance to provide feedback to research communities, power differentials which facilitate the exploitation of local researchers and lack of local relevance and/or affordability of the resultant products. A reflective approach for researchers, built around the values of fairness, respect, care and honesty, is presented as a means of taking shared responsibility for preventing ethics dumping. (shrink)

Research Ethics, Volume 18, Issue 2, Page 114-125, April 2022. Learning about research ethics and research integrity is greatly facilitated by case studies, which illuminate, ground and personalise abstract questions. This paper argues that fiction can provide similar learning experiences, incarnating ethical dilemmas through a medium that is highly accessible yet sophisticated in its depictions of how researchers behave. Examples of fictional illustrations are given to illustrate various themes such as animal experimentation, exploitation of the vulnerable, researcher bias and research (...) fraud. (shrink)

Codes of ethics currently offer no guidance to scientists acting in capacity of expert. Yet communicating their expertise is one of the most important activities of scientists. Here I argue that expert communication has a specifically ethical dimension, and that experts must face a fundamental trade-off between "actionability" and "transparency" when communicating. Some recommendations for expert communication are suggested.

The success of precision medicine depends on obtaining large amounts of information about at-risk populations. However, getting consent is often difficult. Why? In this commentary I point to the differentials in social status involved. These differentials are inevitable once personal information is surrendered, but are particularly intense when the studied populations are socioeconomically or socioculturally disadvantaged and/or ethnically stigmatized groups. I suggest how the deep distrust of the latter groups can be partially justified as a lack of confidence that their (...) core values or interests will sufficiently be taken into account. Hence, the ethical challenge here lies not in avoiding status differentials, but in dealing with them appropriately. Scientists should not assume trust from others but adopt a norm of “demonstrating trustworthiness”. (shrink)

In the past decade, policy-makers in science have been concerned with harmonizing research integrity standards across Europe. These standards are encapsulated in the European Code of Conduct for Research Integrity. Yet, almost every European country today has its own national-level code of conduct for research integrity. In this study we document in detail how national-level codes diverge on almost all aspects concerning research integrity – except for what constitutes egregious misconduct. Besides allowing for potentially unfair responses to joint misconduct by (...) international collaborations, we argue that the divergences raise questions about the envisaged self-regulatory function of the codes of conduct. (shrink)

Background Professional communities such as the medical community are acutely concerned with negligence: the category of misconduct where a professional does not live up to the standards expected of a professional of similar qualifications. Since science is currently strengthening its structures of self-regulation in parallel to the professions, this raises the question to what extent the scientific community is concerned with negligence, and if not, whether it should be. By means of comparative analysis of medical and scientific codes of conduct, (...) we aim to highlight the role of negligence provisions in codes of conduct for scientists, and to discuss the normative consequences for future codes of conduct. -/- Methods We collected scientific and medical codes of conduct in a selection of OECD countries, and submitted each code of conduct to comparative textual analysis. -/- Results Negligence is invariably listed as an infraction of the norms of integrity in medical codes of conduct, but only rarely so in the scientific codes. When the latter list negligence, they typically do not provide any detail on the meaning of ‘negligence’. -/- Discussion Unlike codes of conduct for professionals, current codes of conduct for scientists are largely silent on the issue of negligence, or explicitly exclude negligence as a type of misconduct. In the few cases where negligence is stipulated to constitute misconduct, no responsibilities are identified that would help prevent negligence. While we caution against unreasonable negligence provisions as well as disproportionate sanctioning systems, we do argue that negligence provisions are crucial for justified trust in the scientific community, and hence that there is a very strong rationale for including negligence provisions in codes of conduct. (shrink)

Qualitative fieldwork research on sensitive topics sometimes requires that interviewees be granted confidentiality and anonymity. When qualitative researchers later publish their findings, they must ensure that any statements obtained during fieldwork interviews cannot be traced back to the interviewees. Given these protections to interviewees, the integrity of the published findings cannot usually be verified or replicated by third parties, and the scholarly community must trust the word of qualitative researchers when they publish their results. This trust is fundamentally abused, however, (...) when researchers publish articles reporting qualitative fieldwork data that they never collected. Using only publicly available information, I argue that a 2017 article in an Elsevier foreign policy and international relations journal presents anonymised fieldwork interviews that could not have occurred as described. As an exercise in post-publication peer review (PPPR), this paper examines the evidence that calls into question the reliability of the putative fieldwork quotations. I show further that the 2017 article is not a unique case. The anonymity and confidentiality protections common in some areas of research create an ethical problem: the protections necessary for obtaining research data can be used as a cover to hide substandard research practices as well as research misconduct. (shrink)

Many are calling for concrete mechanisms of oversight for health research involving artificial intelligence (AI). In response, institutional review boards (IRBs) are being turned to as a familiar model of governance. Here, we examine the IRB model as a form of ethics oversight for health research that uses AI. We consider the model's origins, analyze the challenges IRBs are facing in the contexts of both industry and academia, and offer concrete recommendations for how these committees might be adapted in order (...) to provide an effective mechanism of oversight for health‐related AI research. (shrink)

First introduced in 2015, Contributor Role Ontologies and Taxonomies are the most recent innovation developed to address ethical issues of scholarly authorship. By providing a standard list of roles to specify individual contributions to publications, CROTs enhance transparency and consistency about the reporting of conducted tasks, and accordingly, improve the attribution of credit and responsibilities. Although various parties such as academic journals and universities are increasingly adopting CROTs, thus far no study has evaluated them from an ethical perspective. To fill (...) this gap, this study develops an assessment instrument and subsequently analyses three major CROTs including CRediT, CRO and TaDiRAH, and provides recommendations for improving them from an ethical perspective. This study uses a bottom-up approach comprised of two literature reviews, combined with a review of non-conventional sources to collate concerns about authorship and use of CROTs, and generate candidate assessment criteria. Then with a top-down approach and using David Resnik’s 12 principles of research ethics, developed candidate assessment criteria are further analysed, and an assessment instrument consisting of 25 justified criteria is compiled. This instrument is used to identify the ethical strengths and weaknesses of CRediT, CRO and TaDiRAH. Finally, using current best practices and available technology in publication processes, recommendations are provided for further development and improvement of CROTs. Results show that CRediT satisfies more criteria than other CROTs. In relation to the attribution of credit and usability, CRediT provides unique options. However, unlike TaDiRAH that is translated into languages other than English, and CRO that has revised its roles, CRediT is only available in English and has not been updated yet. Improving CROTs benefits almost all parties involved in the development, production, or use of academic publications such as researchers, journal editors, librarians, hiring and promotion committees and funders. (shrink)

Building, restoring and maintaining well-placed trust between scientists and the public is a difficult yet crucial social task requiring the successful cooperation of various social actors and institutions. Kitcher’s takes up this challenge in the context of liberal democratic societies by extending his ideal model of “well-ordered science” that he had originally formulated in his. However, Kitcher nowhere offers an explicit account of what it means for the public to invest epistemic trust in science. Yet in order to understand how (...) his extended model and its implementation in the actual world address the problem of trust as well as to evaluate it critically, an explicit account of epistemic public trust in science needs to be given first. In this article we first present such an account and then scrutinize his project of building public trust in science in light of it. We argue that even though Kitcher’s ideal model and his proposals for its implementation in the real world face a number of problems, they can be addressed with the resources of our account. (shrink)

BackgroundThe areas of Research Ethics and Research Integrity are rapidly evolving. Cases of research misconduct, other transgressions related to RE and RI, and forms of ethically questionable behaviors have been frequently published. The objective of this scoping review was to collect RE and RI cases, analyze their main characteristics, and discuss how these cases are represented in the scientific literature.MethodsThe search included cases involving a violation of, or misbehavior, poor judgment, or detrimental research practice in relation to a normative framework. (...) A search was conducted in PubMed, Web of Science, SCOPUS, JSTOR, Ovid, and Science Direct in March 2018, without language or date restriction. Data relating to the articles and the cases were extracted from case descriptions.ResultsA total of 14,719 records were identified, and 388 items were included in the qualitative synthesis. The papers contained 500 case descriptions. After applying the eligibility criteria, 238 cases were included in the analysis. In the case analysis, fabrication and falsification were the most frequently tagged violations. The non-adherence to pertinent laws and regulations, such as lack of informed consent and REC approval, was the second most frequently tagged violation, followed by patient safety issues and plagiarism. 80.8% of cases were from the Medical and Health Sciences, 11.5% from the Natural Sciences, 4.3% from Social Sciences, 2.1% from Engineering and Technology, and 1.3% from Humanities. Paper retraction was the most prevalent sanction, followed by exclusion from funding applications.ConclusionsCase descriptions found in academic journals are dominated by discussions regarding prominent cases and are mainly published in the news section of journals. Our results show that there is an overrepresentation of biomedical research cases over other scientific fields compared to its proportion in scientific publications. The cases mostly involve fabrication, falsification, and patient safety issues. This finding could have a significant impact on the academic representation of misbehaviors. The predominance of fabrication and falsification cases might diverge the attention of the academic community from relevant but less visible violations, and from recently emerging forms of misbehaviors. (shrink)

ABSTRACT There is limited guidance about whether and how to provide psychological assessment results to research participants. This paper considers several ethical challenges associated with offering individual research results in psychological assessment research. Additionally, the process used to return individual results within a study examining neurodevelopmental effects of anesthesia exposure in children and adolescents is described. Almost all participants requested to know if results were concerning; however, only around a third of those with concerning findings sought additional feedback. Ongoing research (...) and guidance are necessary to establish evidence-based practices and manage challenges that may emerge when disclosing such results. (shrink)

ABSTRACT Digital mental health interventions have emerged as a promising means of expanding access to mental healthcare. Prospective participants reporting severe symptoms or suicidal ideation are often excluded from DMHI trials and may struggle to access alternative treatments. However, evidence suggests that DMHIs are efficacious for people reporting these characteristics. We suggest that there are risks to both including and excluding people from DMHI trials, and we urge researchers to ensure that their eligibility criteria are designed in an evidence-based and (...) ethically conscious manner. We also make specific recommendations for those working in various other capacities within the academic community. (shrink)

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, (...) Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)

Consistent and well-designed frameworks for ethical oversight enable socially valuable research while forestalling harmful or poorly designed studies. I suggest some alterations that might strengthen the valuable checklist Rattani & Hyder propose for the ethical review of health policy and systems research (HPSR), or prompt future work in the area.

It is a common practice for authors of an academic work to thank the anonymous reviewers at the journal that is publishing it. Allegedly, scholars thank the reviewers because their comments improved the paper and thanking them is a proper way to show gratitude to them. Yet often, a paper that is eventually accepted by one journal is first rejected by other journals, and even though those journals’ reviewers also supply comments that improve the quality of the work, those reviewers (...) are not customarily thanked. We contacted prominent scholars in bioethics and philosophy of medicine and asked whether thanking such reviewers would be a welcome trend. Having received responses from 107 scholars, we discuss the suggested proposal in light of both philosophical argument and the results of this survey. We argue that when an author’s work is published, the author should thank the reviewers whose comments improved the paper regardless of whether those reviewers’ journals rejected or accepted the work. That is because scholars should show gratitude to those who deserve it, and those whose comments improved the paper deserve gratitude. We also consider objections against this practice raised by scholars and show why they are not entirely persuasive. (shrink)

Psychiatric research often poses special ethical concerns. This chapter first provides historical context, including scandals that stoked public concern about psychiatric research and led to the promulgation of canonical documents and bioethics scholarship, and then explores issues related to the decision-making capacity and safety of participants—including the use of placebos and washout periods, the design of suicide prevention studies, and research in emergency psychiatry. The chapter then describes how shifting models of psychiatric nosology have precipitated conflicts in the determination of (...) research priorities. Finally, the chapter attends to emerging issues related to research in psychedelic psychiatry and the use of artificial intelligence and social media by investigators. (shrink)

An increase in global violence has forced the displacement of more than 70 million people, including 26 million refugees and 3.5 asylum seekers. Refugees and asylum seekers face serious socioeconomic and healthcare barriers and are therefore particularly vulnerable to physical and mental health risks, which are sometimes exacerbated by immigration policies and local social discriminations. Calls for a strong evidence base for humanitarian action have encouraged conducting research to address the barriers and needs of refugees and asylum seekers. Given the (...) role of epigenetics factors to mediate the effect of psychological and environmental exposures, epigenetic modifications have been used as biomarkers for life adversity and disease states. Therefore, epigenetic research can be potentially beneficial to address some of the issues associated with refugees and asylum seekers. Here, we review the value of previous and ongoing epigenetic studies with traumatized populations, explore some of the ethical challenges associated with epigenetic research with refugees and asylees and offer suggestions to address or mitigate some of these challenges. Researchers have an ethical responsibility to implement strategies to minimize the harms and maximize the short and long-term benefits to refugee and asylee participants. (shrink)

My paper builds on the conceptual tools from three interrelated philosophical debates that—as I believe—may help structure important if chaotic discussions about surrogates for living human brains and resolve some practical issues related to regulatory matters. In particular, I refer to the discussions about the “moral precautionary principle” in research ethics (Koplin and Wilkinson 2019); about normative uncertainty in ethics (MacAskill, Bykvist, and Ord 2020), and about the inductive risk problem for animal welfare scientists (Birch 2018). I elucidate upon the (...) possible meanings of the phrase “a too good human brain surrogate” used by Henry T. Greely (2021), and I demonstrate that the evaluation of the practical and regulatory implications of the “goodness” of such surrogates created for research purposes should be sensitive to the possible consequences of two types of errors: the under-attribution and over-attribution of moral status to such beings. Many authors writing about this topic (including Greely 2021, but see also, e.g., Koplin and Savulescu 2019) concentrate only on the first type of error, neglecting the negative consequences of the second type, i.e., over-attribution. (shrink)

The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is judged to be of (...) particular value. However, several different terms are used to refer to this value, indicating a lack of conceptual clarity regarding the appropriate test for access to health data for research without consent. In this paper we do three things. First we describe the current confusion and instability in terminology relating to public interest in the context of consent waivers. Second we argue for harmonisation of terminology on the grounds of clarity, transparency and consistency. Third we argue that the term ‘public interest’ best reflects the normative work required to justify consent waivers because it is the broadest of the competing terms. ‘Public interest’ contains within its scope positive and negative implications of a study, as well as welfare, justice and rights considerations. In making this argument, we explain the normative basis for consent waivers, and provide a starting place for further discussion about the precise conditions in which a given study can be said to advance the public interest. Ipsos MORI study found that: … the public would be broadly happy with administrative data linking for research projects provided Those projects have social value, broadly defined. Data are de-identified. Data are kept secure. Businesses are not able to access the data for profit. (shrink)

Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is “too immature” and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, and/or (...) limit adolescent participation, jeopardizing study findings’ validity. This paper presents recommendations on when researchers and Institutional Review Boards should waive parental permission, and what special protections should be adopted for adolescents who consent for themselves, e.g., assuring adolescent privacy and confidentiality, screening for capacity to consent, and identifying adolescents who are at elevated risk from study participation. We also present a series of specific areas for future research to design tools to help make these assessments, and to inform researcher and IRB decisions. These recommendations can help ensure that research is conducted that can aid adolescents at risk for HIV, while minimizing risks and protecting these individuals' rights as much as possible. (shrink)