Research Ethics by Disciplines is focusing on main disciplines of research and related specific ethical concerns.

Recent Submissions

  • Experimentações em Seres Humanos e Populações Vulneráveis

    Pereira, André Gonçalo Dias; Prata, Beatriz Isabel da Silva (2024-04-11)
    Dissertação de Mestrado em Ciências Jurídico-Forenses apresentada à Faculdade de Direito
  • ROSiE Training Materials for Responsible Open Science: Natural Sciences

    Mežinska, Signe; Neiders, Ivars (Zenodo, 2024-03-09)
    <p>The aim of the ROSiE Training Materials for Responsible Open Science is to learn how to practice open science (OS) responsibly and how to prevent research misconduct in the context of OS by providing necessary knowledge and developing specific skills and attitudes.</p> <p>The training material consists of a trainers' file including 8 units and respective activities, as well as materials for trainees – <a href="https://rosie-project.eu/knowledge-hub/#!training/social-sciences">handouts and printouts</a>. The activities can be implemented separately (e.g., for organising a single workshop to discuss cases) or for organising a complete two-day training course. </p> <p>Additionally, trainers can use the <a href="https://classroom.eneri.eu/node/82">ROSiE online training course</a> as a complementary resource to this training material. Students and researchers can use ROSiE online learning modules to implement <strong>self-directed learning.</strong> In this case, the trainee as a user of online ROSiE training materials takes the initiative, with or without the help of the trainer, determines his/her learning needs, formulates learning goals and evaluates learning outcomes. In this process, trainees are in charge of their learning, and they are autonomous in choosing what, how and where they are learning. Online training materials can also be used for the implementation of <strong>blended learning</strong>, which combines traditional on-site training led by a trainer with using online content to allow trainees to build their own learning experience. By blending face-to-face and online training methods, trainees can benefit from guidance and interaction with a trainer while having access to interactive and flexible training opportunities outside the classroom. Blended learning allows development of <strong>multimodal learning</strong> through visual, auditory, reading, discussion and writing methods. Multimodal learning expands inclusive learning opportunities.</p>
  • ROSiE Training Materials for Responsible Open Science: Social Sciences

    Mežinska, Signe; Neiders, Ivars (Zenodo, 2024-03-09)
    <p><span>The aim of the ROSiE Training Materials for Responsible Open Science is to learn how to practice open science (OS) responsibly and how to prevent research misconduct in the context of OS by providing necessary knowledge and developing specific skills and attitudes.</span></p> <p><span><span>The training material consists of a trainers' file including 8 units and respective activities, as well as materials for trainees – <a href="https://rosie-project.eu/knowledge-hub/#!training/social-sciences">handouts and printouts</a>. The activities can be implemented separately (e.g., for organising a single workshop to discuss cases) or for organising a complete two-day training course. </span></span></p> <p><span>Additionally, trainers can use the </span><span><a href="https://classroom.eneri.eu/node/82"><span>ROSiE online training course</span></a></span><span> as a complementary resource to this training material. Students and researchers can use ROSiE online learning modules to implement <strong>self-directed learning.</strong> In this case, the trainee as a user of online ROSiE training materials takes the initiative, with or without the help of the trainer, determines his/her learning needs, formulates learning goals and evaluates learning outcomes. In this process, trainees are in charge of their learning, and they are autonomous in choosing what, how and where they are learning. Online training materials can also be used for the implementation of <strong>blended learning</strong>, which combines traditional on-site training led by a trainer with using online content to allow trainees to build their own learning experience. By blending face-to-face and online training methods, trainees can benefit from guidance and interaction with a trainer while having access to interactive and flexible training opportunities outside the classroom. Blended learning allows development of <strong>multimodal learning</strong> through visual, auditory, reading, discussion and writing methods. Multimodal learning expands inclusive learning opportunities.</span><span><br></span></p>
  • ROSiE Training Materials for Responsible Open Science: Humanities

    Mežinska, Signe; Neiders, Ivars (Zenodo, 2024-03-09)
    <p>The aim of the ROSiE Training Materials for Responsible Open Science is to learn how to practice open science (OS) responsibly and how to prevent research misconduct in the context of OS by providing necessary knowledge and developing specific skills and attitudes.</p> <p>The training material consists of a trainers' file including 8 units and respective activities, as well as materials for trainees – <a href="https://rosie-project.eu/knowledge-hub/#!training/social-sciences">handouts and printouts</a>. The activities can be implemented separately (e.g., for organising a single workshop to discuss cases) or for organising a complete two-day training course. </p> <p>Additionally, trainers can use the <a href="https://classroom.eneri.eu/node/82">ROSiE online training course</a> as a complementary resource to this training material. Students and researchers can use ROSiE online learning modules to implement <strong>self-directed learning.</strong> In this case, the trainee as a user of online ROSiE training materials takes the initiative, with or without the help of the trainer, determines his/her learning needs, formulates learning goals and evaluates learning outcomes. In this process, trainees are in charge of their learning, and they are autonomous in choosing what, how and where they are learning. Online training materials can also be used for the implementation of <strong>blended learning</strong>, which combines traditional on-site training led by a trainer with using online content to allow trainees to build their own learning experience. By blending face-to-face and online training methods, trainees can benefit from guidance and interaction with a trainer while having access to interactive and flexible training opportunities outside the classroom. Blended learning allows development of <strong>multimodal learning</strong> through visual, auditory, reading, discussion and writing methods. Multimodal learning expands inclusive learning opportunities.</p>
  • Human subjects research guidelines for undergraduate researchers : an analysis of Institutional Review Board (IRB) websites at top Liberal Arts Colleges in the United States

    Marcos Miguel, Nausica; Noy, Shiri (2023)
    Teaching students about the ethics of Human Subject Research (HSR) should be a fundamental component of students' education about research. In this article, we analyze the Institutional Review Board (IRB) websites of top-ranked Liberal Arts Colleges (LACs) to examine their framing of HSR carried out by undergraduate students. Our descriptive quantitative analysis from 50 top-ranked LACs in the United States indicates that a majority of IRB websites provide information about undergraduate research, and most include information about students' classroom-based research. Our qualitative content analysis of a subsample of ten colleges' IRB websites provides information on how they inform and educate about issues including informed consent and highlight different resources for students including their research advisor, and disciplinary standards. We conclude by discussing recommendations for IRBs in their accessibility to undergraduates.
  • Human subjects research guidelines for undergraduate researchers : an analysis of Institutional Review Board (IRB) websites at top Liberal Arts Colleges in the United States

    Marcos Miguel, NausicaLW220002216409568020042586390000-0003-0351-81743d24dc98-8a28-11ed-af7a-91df7bd0848f; Noy, Shiri (2023)
    Teaching students about the ethics of Human Subject Research (HSR) should be a fundamental component of students' education about research. In this article, we analyze the Institutional Review Board (IRB) websites of top-ranked Liberal Arts Colleges (LACs) to examine their framing of HSR carried out by undergraduate students. Our descriptive quantitative analysis from 50 top-ranked LACs in the United States indicates that a majority of IRB websites provide information about undergraduate research, and most include information about students' classroom-based research. Our qualitative content analysis of a subsample of ten colleges' IRB websites provides information on how they inform and educate about issues including informed consent and highlight different resources for students including their research advisor, and disciplinary standards. We conclude by discussing recommendations for IRBs in their accessibility to undergraduates.
  • A flimsy case for the use of non-human primates in research: a reply to Arnason

    Faria, Catia (BMJ Publishing Group, 2018)
    This work has been supported by the Portuguese Foundation for Science and Technology (Grant number: SFRH/BPD/116818/2016).
  • A response to Dr. Gudjonsson's commentary

    Alison Beck (15594652); James McGuire (1523626); Martin Grann (191293); Mats Dernevik (17156695); Todd Hogue (17160013) (2023-10-20)
    " We thank Dr Gudjonsson for his thoughtful response to our article on acomplex and controversial issue. He places our paper in the context of theHome O?ce commissioning independent ‘experts’ to conduct riskassessments. It was indeed such an assessment that inspired us to writethe paper and to draw attention to some of the concerns for professional andethical practice. In our view, the central arguments of our paper still hold,and therefore we are grateful for the opportunity to address the points hemakes.First, our central argument is that there is no proper empirical basis forapplying existing risk assessment scales used in mental health settings to thepopulation under discussion. Dr Gudjonsson’s response does nothing toaddress that criticism. His contention that an ‘informed and valid riskassessment of convicted terrorists provides important information forauthorities seeking to protect their citizens from future harm’ is bothunfounded (there are no informed or valid assessments available) anduntested (there are no outcome data that indicate it would be helpful even ifthere were). The standard type of evidence we would expect to see to supportthe use of a risk assessment measure would consist, for example, of a followup correlational study or an experimental trial. A recent review of the mostwidely used instruments for violence risk assessment, including the HCR-20,has been reported by Farrington, Jolli?ee, and Johnstone (2008). Thatreview relies, as scienti?cally we would expect it to, on evidence from followup studies of prisoner cohorts and similar sets of data. As far as we canestablish there is no parallel to this in relation to persons who have engagedin terrorism. If there is, it seems odd that Dr Gudjonsson does not cite it. "
  • Küçük ve kısıtlılara yönelik klinik araştırmalarda velayet ve vesayet: Geleneksel derleme

    Özkaş Açıkgöz, Perihan (Türkiye Klinikleri Yayınevi, 2023-08-15)
    Kişilerin kendileri hakkında karar verebilmeleri, tıp etiği ilke lerinden özerklik ilkesi ile açıklanmakta, özerkliğini kullanabilmesi için de kişilerin, fiil ehliyetine sahip olması gerekmektedir. Fiil ehliyeti, ergin olmak, ayırt etme gücüne haiz olmak ve kısıtlı olmamak unsur larının birlikte varlığı ile tam olabilmektedir. Bu unsurlardan bir kıs mının eksikliği, fiil ehliyetinin de sınırlandırılması sonucunu doğurmaktadır. Fiil ehliyeti kısıtlı kişilerin tasarruf iradesi ancak veli veya vasinin kişi adına verdiği kararlar ile anlam kazanabilmektedir. Velayet ve vesayet kurum ve makamlarının küçük veya kısıtlı adına karar verebilme sürecine katılımını gerektiren durumlar uluslararası sözleşmeler ve yasal düzenlemelerle belirlenmiş olmakla birlikte, uy gulamada, küçük ve kısıtlıların tıbbi müdahaleler için aydınlatılması, onamlarının alınması, onam kapasitelerinin ve iradelerinin anlaşılabil mesi konularında yetkili mercilerin sürece katılımı ile ilgili birtakım aksaklıklar görülebilmektedir. Tıbbi müdahaleleri koruyucu, tedavi edici, rehabilite edici, palyatif veya araştırmalar gibi sınıflamalara tabi tutmak mümkündür. Tıbbi müdahalenin hukuka uygun olması için ki şinin bilgilendirilmiş onamı, müdahalenin gerekliliği ve tıbbi standart lara uygunluğu, tıbbi müdahalenin yetkili kişi ve kurumlarca yapılabilmesi gibi birtakım şartların sağlanmış olması gerekmektedir. Pandemi sürecinde küçük ve kısıtlıların klinik araştırmalara alınması ile ilgili olarak gündeme sıklıkla gelmiş olan çekinceleri gidermek adına, vesayet ve denetim makamlarının klinik araştırmalara katılıma dair karar verebilme yetkisinin tartışılması, makalenin amacını oluş turmaktadır.
  • La vertu des sciences sociales à l’épreuve des comités d’éthique de la recherche en santé

    Derbez, Benjamin (Presses universitaires d'Aix-Marseille - PUAMCahiers Droit, Sciences & Technologies, 2023-08-08)
    Afin d’alimenter la réflexion sur l’encadrement éthique de la recherche en sciences sociales, cet article propose d’analyser le fonctionnement d’un comité d’éthique de la recherche (CER) en santé. Après avoir présenté l’histoire, la composition et les procédures du comité, le cas de l’évaluation d’un « protocole ethnographique » est examiné. L’analyse des discussions entre les membres du comité montrent toute la difficulté que peut présenter l’évaluation a priori de projets de recherche en sciences sociales au moyen d’outils éthiques formalisés. La valeur de la confiance qui peut être accordée aux chercheurs, comme condition ultime de validation, rappelle le rôle fondamental et irréductible de l’ethos du chercheur dans la conduite de son enquête et pointe, par-delà les questions de déontologie, vers une éthique de la vertu qu’il s’agit de cultiver en sciences sociales.
  • A global assessment of Indigenous community engagement in climate research

    Dominique M David-Chavez; Michael C Gavin (IOP Publishing, 2018-01-01)
    For millennia Indigenous communities worldwide have maintained diverse knowledge systems informed through careful observation of dynamics of environmental changes. Although Indigenous communities and their knowledge systems are recognized as critical resources for understanding and adapting to climate change, no comprehensive, evidence-based analysis has been conducted into how environmental studies engage Indigenous communities. Here we provide the first global systematic review of levels of Indigenous community participation and decision-making in all stages of the research process (initiation, design, implementation, analysis, dissemination) in climate field studies that access Indigenous knowledge. We develop indicators for assessing responsible community engagement in research practice and identify patterns in levels of Indigenous community engagement. We find that the vast majority of climate studies (87%) practice an extractive model in which outside researchers use Indigenous knowledge systems with minimal participation or decision-making authority from communities who hold them. Few studies report on outputs that directly serve Indigenous communities, ethical guidelines for research practice, or providing Indigenous community access to findings. Further, studies initiated with (in mutual agreement between outside researchers and Indigenous communities) and by Indigenous community members report significantly more indicators for responsible community engagement when accessing Indigenous knowledges than studies initiated by outside researchers alone. This global assessment provides an evidence base to inform our understanding of broader social impacts related to research design and concludes with a series of guiding questions and methods to support responsible research practice with Indigenous and local communities.
  • Moving out of the Human Vivarium: Live-in Laboratories and the Right to Withdraw

    Mollen, J.K. (author) (2023)
    Homes are increasingly being built as sensor-laden living environments to test the performance of novel technologies in interaction with real people. When people’s homes are turned into the site of experiments, the inhabitants become research subjects. This paper employs findings from biomedical research ethics to evaluate live-in laboratories and argues that when live-in laboratories function as a participant’s main residence, they constrain an individual’s so-called ‘right to withdraw’. Withdrawing from the live-in laboratory as a participant’s main residence means losing one’s home, which creates negative financial and psychological consequences for participants. I will argue that such costs conflict with a participants’ right to withdraw on two counts. First, that the exit costs from the live-in laboratory constitute a penalty, and second, that the costs of withdrawing from the live-in laboratory function as a constraint on a participant’s liberty. The paper concludes that (i) the right to withdraw is a necessary condition for the ethical permissibility of modern live in lab experiments and conclude (ii) the practice of making an experimental home as a participant’s main residence is ethically problematic.
  • Publication of Case Reports: Is Consent Required?

    Gibson, Elaine (Schulich Law Scholars, 2008-01-01)
    Case reports in medicine are fundamentally individual patient stories generally describing unique or unexpected findings in terms of disease or treatment. Anecdotally based, they are considered to be less rigorous an evidentiary base than other types of research. As described by Jenicek (1), although case reports rank low on the scale of types of evidence to be relied on, they are highly important in their frequent role as the “first line of evidence”. Historically, case reports were published without consent of the patient. However, standards have been evolving in law and ethics such that consent should now be viewed as mandatory. The remainder of the present commentary provides justification for this assertion.
  • Global Pandemic and Higher Education Institutions: Building Back Better in BRICS and Beyond

    Niemczyk, Ewelina (Alliance for Community Capacity Building, 2023-06-28)
    The COVID-19 pandemic manifested in health and socioeconomic crises globally on many levels. At its outset, the pandemic interrupted higher education institutions (HEIs) in 185 countries, dramatically affecting the lives of millions of students and staff. The unexpected disruption also exacerbated inequalities and placed the most vulnerable members of society at even greater risk, especially in lower-income countries. Simultaneously, the pandemic underscored the importance of HEIs as intellectual leaders and experts in overcoming societal challenges. This study reviewed international scholarly literature and global surveys corresponding to the pandemic’s impact on higher education, particularly its influence on academic research activities, teaching practice, and HEIs’ response to such challenges. Findings indicate a need for HEIs to adapt to new realities, harness lessons learned, and convert challenges into opportunities. Moreover, institutional responses provide lessons of commitment and creativity that can be informative for building a better future for research and teaching among HEIs in BRICS states and beyond.
  • Clinically-driven safety benchmarks

    Barazzetti, Gaia; Hurst, Samia; Mauron, Alex (2012)
    Enhancing the capacity of preclinical studies to predict efficacy in humans would be a welcome move and its usefulness would reach beyond stem cell-based trials. Such an adaptation, however, would be incomplete as regards the more specific field pf cellular transplantation studies. In addition to concerns regarding predictions of efficacy, preclinical benchmarks aimed at assessing safety also require adaptation –and rethinking- in order to successfully do their work in the area of stem cell-based interventions. For example, hESC-based intervention involve risks that are potentially more durable and cannot be easily tamed through point-in-time validation of preclinical benchmarks. A further example is the concept of purity, which is crucial in the assessment of safety in preclinical drug assessment but cannot simply be transposed to stem cell-based interventions. Rather than true preclinical criteria, such benchmarks should be viewed as proxies intended to assess different components of safety and efficacy in preparing for research with human subjects.
  • Data-driven sudden cardiac arrest research in Europe: Experts’ perspectives on ethical challenges and governance strategies

    Marieke A.R. Bak; Jelle C.H. Vroonland; Marieke T. Blom; Domagoj Damjanovic; Dick L. Willems; Hanno L. Tan; M. Corrette Ploem (Elsevier, 2023-09-01)
    Background: Observational studies using large-scale databases and biobanks help improve prevention and treatment of sudden cardiac arrest (SCA) but the lack of guidance on data protection issues in this setting may harm patients’ rights and the research enterprise itself. This qualitative study explored the ethical aspects of observational SCA research, as well as solutions. Methods: European experts in SCA research, medical ethics and health law reflected on this topic through semi-structured interviews (N = 29) and a virtual roundtable conference (N = 18). The ESCAPE-NET project served as a discussion case. Findings were coded and thematically analysed. Results: The first theme concerned the potential benefits and harms (at individual and group level) of observational data-based SCA studies and included the following sub-themes: societal value, scientific validity, data privacy, disclosure of genetic findings, stigma and discrimination, and medicalisation of sudden death. The second theme involved governance through ‘privacy by design’, ‘privacy by policy’ and associated regulation and oversight. Sub-themes were: de-identification of data, informed consent (broad and deferred), ethics review, and harmonisation. Conclusions: Researchers and scientific societies should be aware that ethico-legal issues may arise during data-driven studies in SCA and other emergencies. These can be mitigated by combining technical data protection safeguards with appropriate informed consent policies and proportional ethics oversight. To ensure responsible conduct of data research in emergency medicine, we recommend the establishment of ‘codes of conduct’ which should be developed in interdisciplinary groups and together with patient representatives.
  • Concordance of International Regulation of Pediatric Health Research

    Mattsson, Titti; Rothstein, Mark A.; Patrinos, Dimitri; Brothers, Kyle; Wright Clayton, Ellen; Joly, Yann; Zawati, Man H; Andanda, Pamela; Arawi, Thalia; Castaneda, Mireya (ElsevierAcademic Press, 2023)
    Conclusion: Similar regulation of pediatric research in 21 countries suggests that international reciprocity is a viable strategy.
  • Volunteers for clinical trials: from the history of abuses and exploitation to the inclusion movement, and to an income resource

    Christiane Druml (Oswaldo Cruz Foundation, Health Law Program, 2021-09-01)
    Medical research is essential to develop new and better therapies, increase social standards and a better life for all of us. Scientific curiosity has helped to achieve many successful innovations, but history also demonstrates that research can lead to abuses of individuals neglecting autonomy and integrity of the human being. Since the 1960ies we have witnessed a continuous development of international regulations and ethics guidelines (soft law) in medical research, leading to a higher quality of scientific results. An important focus lies on recognizing human vulnerability and a therefore adapted informed consent procedure. Our modern clinical trials structure requires the inclusion of healthy volunteers in the first phases of the development of a new medicinal product, leading to new ethical questions and challenges. The Corona-Pandemic has accelerated vaccine development in a successful way also leading to a new importance of healthy volunteers in the medical research landscape.
  • Dr. Cézanne and the Art of Re(Peat)Search: Competing Interests and Obligations in Clinical Research

    Bluhm, Robyn; Downie, Jocelyn; Nisker, Jeff (Schulich Law Scholars, 2010-01-01)
    Clinician researchers have a number of roles, each of which carries specific obligations. There are times when these obligations may be in competition (up to and including conflict) with each other. Using a narrative case study that describes a group of colleagues discussing their clinical department's participation in an industry-sponsored research protocol, we illustrate a number of the obligations faced by clinician researchers, and discuss how competing interests and obligations can lead to ethical problems. The case study is followed by a discussion of the effect of university–industry relations on competing interests and obligations in both clinical research and the role of the university, and a suggested framework that could be used to determine when university involvement in commercial research is ethically acceptable.

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