Background: Error communication includes both reporting errors to superiors and disclosing their consequences to patients and their families. It significantly contributes to error prevention and safety improvement. Yet, some errors in intensive care units are not communicated. Objectives: The aim of the present study was to explore factors affecting error communication in intensive care units. Design and participants: This qualitative study was conducted in 2019. Participants were 17 critical care nurses purposively recruited from the intensive care units of (...) 2 public hospitals affiliated to Iran University of Medical Sciences, Tehran, Iran. Data were collected through in-depth semi-structured interviews and were analyzed through the conventional content analysis method proposed by Graneheim and Lundman. Ethical considerations: The Ethics Committee of Iran University of Medical Sciences, Tehran, Iran approved the study (code: IR.IUMS. REC.1397.792). Participants were informed about the study aim and methods and were ensured of data confidentiality. They were free to withdraw from the study at will. Written informed consent was obtained from all of them. Findings: Factors affecting error communication in intensive care units fell into four main categories, namely the culture of error communication (subcategories were error communication organizational atmosphere, clarity of processes and guidelines, managerial support for nurses, and learning organization), the consequences of errors for nurses and nursing (subcategories were fear over being stigmatized as incompetent, fear over punishment, and fear over negative judgments about nursing), the consequences of errors for patients (subcategories were monitoring the effects of errors on patients and predicting the effects of errors on patients), and ethical and professional characteristics (subcategories were ethical characteristics and inter-professional relationships). Discussion: The results of this study show many factors affect error communication, some facilitate and some prohibit it. Organizational factors such as the culture of error communication and the consequences of error communication for the nurse and the patient, as well as individual and professional characteristics, including ethical characteristics and interprofessional relationship, influence this process. Conclusion: Errors confront nurses with ethical challenges and make them assess error consequences and then, communicate or hide them based on the results of their assessments. Health authorities can promote nurses’ error communication through creating a supportive environment for them, developing clear error communication processes and guidelines, and providing them with education about the principles of ethical practice. (shrink)

The paper is an analysis of Dworkin's attempt to develop, within liberal theory, a conception of community and associative obligations, where community is taken as a particular intrinsic value. Certainly, this attempt encounters various difficulties, like the insufficiently robust distinction between political community and other types of communities, as well as Dworkin's too narrow delimitation of the scope of activities and competences of political community. It is argued nevertheless that this endeavor is highly significant, complementing substantially the theoretical concerns of (...) standard liberal theories. U ovom radu autor analizira Dworkinov pokusaj da u okviru liberalisticke teorije razvije koncepciju zajednice i duznosti iz udruzivanja, pri cemu zajednistvo shvata kao posebnu intrinsicnu vrednost. Mada u ovom pokusaju iskrsavaju problemi, kao sto je nedovoljno jasno distingviranje politicke od drugih zajednica, kao i Dworkinovo preusko odredjenje domena aktivnosti i kompetencija politicke zajednice, autor smatra da je rec o izuzetno znacajnom poduhvatu, koji bitno upotpunjuje teorijska interesovanja standardnih liberalistickih teorija. (shrink)

BackgroundA fundamental ethical challenge in conducting genomics research is the question of what and how individual level genetic findings and aggregate genomic results should be conveyed to research participants and communities. This is within the context of minimal guidance, policies, and experiences, particularly in Africa. The aim of this study was to explore the perspectives of key stakeholders' on returning genomics research results to participants in Kenya.MethodsThis qualitative study involved focus group discussions (FGDs) and in-depth interviews (IDIs) with 69 stakeholders. (...) The purposively selected participants, included research ethics committee (REC) members (8), community members (44), community resource persons (8), and researchers (9). A semi-structured interview guide was used to facilitate discussions. Six FGDs and twenty-five (IDIs) were conducted among the different stakeholders. The issues explored in the interviews included: (1) views on returning results, (2) kind of results to be returned, (3) value of returning results to participants, and (4) challenges anticipated in returning results to participants and communities. The interviews were audio-recorded, transcribed verbatim, and coded in Nvivo 12 pro. Thematic and content analysis was conducted.ResultsParticipants agreed on the importance of returning genomic results either as individual or aggregate results. The most cited reasons for returning of genomic results included recognizing participants' contribution to research, encouraging participation in future research, and increasing the awareness of scientific progress. Other aspects on how genomic research results should be shared included sharing easy to understand results in the shortest time possible and maintaining confidentiality when sharing sensitive results.ConclusionsThis study identified key stakeholders’ perspectives on returning genomic results at the individual and community levels in two urban informal settlements of Nairobi. The majority of the participants expect to receive feedback about their genomic results, and it is an obligation for researchers to see how to best fulfil it. (shrink)

Disquiet about the research ethics review process has, historically, been anecdotal and often takes the form of ‘atrocity stories’ from researchers about the bureaucratic nature of the application process or inconsistency and capriciousness in decision-making. However, systematic evidence has often been lacking. We analysed 100 decision letters written by NHS research ethics committees (RECs). We found evidence of poor communication in the way in which REC decisions were conveyed to applicants. Typos and grammatical mistakes were found in almost 30% (...) of letters; sometimes wording was impolite and demonstrated a lack of respect towards applicants; and there was often lack of clarity about the nature of a revision and whether the revision was compulsory or optional. The analysis provides messages for RECs about how they can improve their practices to establish a more cooperative relationship between researcher and committee through the careful use of language and attention to detail in decision letters. (shrink)

Background There is no definition of what constitutes a lie when working with people with moderate to severe dementia. Lies are often defined as therapeutic with no evidence of how therapeutic value is gauged. There is no previous research that observes lies being told or the impact the lies have on people with dementia. Aim The aim was to develop a taxonomy of lies for use when supporting people with moderate to severe dementia and then use this to develop a (...) model, which could be used to explore the impact of lie telling. Research design Ethnography was used, with the researcher observing and recording lies told to people with moderate to severe dementia, by professional caregivers. Data analysis was based on Burnard’s thematic analysis. Ethical consideration Ethical approval for the study was obtained from Northumbria University, the Research Ethics Committee (REC) and the Health Research Authority (HRA) in the United Kingdom. Study number 227508. Findings Six categories of lie were identified; blatant, avoidance, familiarity, props, banter and going along with. Spontaneous and planned lies were observed. Motivation, validation and genuineness were key in terms of how the person with dementia responded. These affective domains were used to develop the Lie ARM (affective reflective model). Discussion Planned and spontaneous lies are an effective intervention for people with moderate to severe dementia. Healthcare professionals need to be aware of their motivation for using lies, as well as the impact they have on patients. Conclusion The taxonomy is an objective way to categorise lies. It supports increased reflection, particularly if used in conjunction with the Lie ARM. The Lie ARM is a useful tool to help staff reflect on practice or to predict whether a proposed lie is likely to be therapeutic. (shrink)

Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. Results Health RECs (...) in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity. (shrink)

This joint response from the National Research Ethics Advisors' Panel (NREAP) and the Association of Research Ethics Committees (AREC) has been formulated on the basis of detailed in depth discussion between the two organizations, in consultation with their membership. NREAP is a body that was constituted by the United Kingdom Ethics Committee Authority (UKECA) in order to provide guidance to, and strategic oversight of the NHS Research Ethics Service. AREC represents all sectors of the Research Ethics Committee (REC) community and (...) serves to engage in discussion and debate concerning best practice and to serve the best interests of REC membership. (shrink)

Research Ethics Committees (RECs) are frequently a focus of complaints from researchers, but evidence about the operation and decisions of RECs tends to be anecdotal. We conducted a systematic study to identify and compare the ethical issues raised in 54 letters to researchers about the same 18 applications submitted to three RECs over one year. The most common type of ethical trouble identified in REC letters related to informed consent, followed by scientific design and conduct, care and protection of research (...) participants, confidentiality, recruitment and documentation. Community considerations were least frequently raised. There was evidence of variability in the ethical troubles identified and the remedies recommended. This analysis suggests that some principles may be more institutionalized than others, and offers some evidence of inconsistency between RECs. Inconsistency is often treated as evidence of incompetence and caprice, but a more sophisticated understanding of the role of RECs and their functioning is required. (shrink)

Members of research ethics committees (RECs) face a number of ethical challenges when reviewing genomic research. These include issues regarding the content and type of consent, the return of individual research results, mechanisms of sharing specimens and health data, and appropriate community engagement efforts. This article presents the findings from a survey that sought to investigate the opinions and attitudes of REC members from four Arab countries in the Middle East and North Africa (Egypt, Morocco, Sudan, and Jordan) toward these (...) ethical issues. Our findings suggest that efforts are required to better familiarize REC members with the requirements for ethical biobank research. Additionally, we recommend that further research is undertaken with REC members regarding the main items that should be present in the Material Transfer Agreements /Data Transfer Agreements in their corresponding countries and the type of consent that should be used in genomic research. (shrink)

The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards, to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to (...) highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research. (shrink)

BackgroundSharing de-identified individual-level health research data is widely promoted and has many potential benefits. However there are also some potential harms, such as misuse of data and breach of participant confidentiality. One way to promote the benefits of sharing while ameliorating its potential harms is through the adoption of a managed access approach where data requests are channeled through a Data Access Committee (DAC), rather than making data openly available without restrictions. A DAC, whether a formal or informal group of (...) individuals, has the responsibility of reviewing and assessing data access requests. Many individual groups, consortiums, institutional and independent DACs have been established but there is currently no widely accepted framework for their organization and function.Main textWe propose that DACs, should have the role of both promotion of data sharing and protection of data subjects, their communities, data producers, their institutions and the scientific enterprise. We suggest that data access should be granted by DACs as long as the data reuse has potential social value and provided there is low risk of foreseeable harms. To promote data sharing and to motivate data producers, DACs should encourage secondary uses that are consistent with the interests of data producers and their own institutions. Given the suggested roles of DACs, there should be transparent, simple and clear application procedures for data access. The approach to review of applications should be proportionate to the potential risks involved. DACs should be established within institutional and legal frameworks with clear lines of accountability, terms of reference and membership. We suggest that DACs should not be modelled after research ethics committees (RECs) because their functions and goals of review are different from those of RECs. DAC reviews should be guided by the principles of public health ethics instead of research ethics.ConclusionsIn this paper we have suggested a framework under which DACs should operate, how they should be organised, and how to constitute them. (shrink)

Questions have been raised over the acceptability of conducting human challenge studies in low and middle income countries. Most of these concerns are based on theoretical considerations and there exists little data on the attitudes of stakeholders in these countries. This study examines the view of researchers and REC members in Thailand regarding the design and conduct of challenge studies in the country. A questionnaire was developed based on ethical frameworks for human challenge studies. The target respondents included those who (...) had experience with health-related research at universities, non-university hospitals, and research institutes. A total of 240 respondents completed the on-line survey. In general, the respondents felt that the ethical issues raised by human challenge studies in LMICS do not differ significantly from those in high income countries, including: scientific rationale, safety, appropriate risks, and robust informed consent process. In contrast, issues that have been described as important for human challenge studies in LMICs were rated as having lower importance, including: a publicly available rationale, national priority, and community engagement. Responses did not vary significantly between researchers in different fields, nor between researchers and REC members. These findings provide an important perspective for assessing existing frameworks for human challenges studies in LMICs. (shrink)

Health research has increased during the last decade, which has enhanced the importance of research ethics. However, little is known regarding the knowledge, awareness, attitudes, and practices of investigators in Myanmar. To assess awareness, knowledge, and attitudes of post-graduates regarding research ethics and research ethics committees (RECs) and their informed consent practices and to determine the association between their responses and certain independent factors. We conducted a cross-sectional study using a questionnaire that was distributed to a convenience sample of post-graduates (...) at the Defence Services Medical Academy in Myanmar. We used descriptive, t test, and chi-square statistics to analyze the data. Significance was set at p < 0.05. We obtained surveys from 204 participants, which included 177 MSc and 27 PhDs of whom 63.6% had performed research and 86.5% had prior ethics training. Regarding awareness, 92.2% were aware of an REC at their academy, but only 47.1% were “fully aware” of the functions of an REC and only 52.9% stated they were familiar with ethical principles that govern human subject research. More than 90% thought that research involving human subjects should be submitted to an REC and that post-graduates should have training on research ethics. However, several of their attitudes were sub-optimal; for example, 20.2% said that informed consent is only necessary from the community leader of a village rather than from the individual, 32.8% agreed it is acceptable to fabricate research data, and 33.0% believed that ethical review of research should be restricted to international collaborative research. Calculated mean total attitude scores were statistically significantly higher in post-graduates with PhDs compared with those with MSc and higher in those with knowledge of research ethics principles compared with those lacking such knowledge. Significant gaps exist among post-graduates regarding their knowledge, awareness, and attitudes regarding research ethics and RECs. We recommend that post-graduates receive further training in research ethics to ensure the ethical conduct of research. Further studies should be performed to determine the generalizability of our findings to other institutions in Myanmar. (shrink)

The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, since post-disaster research is essential to the improvement of the humanitarian response, it is important that adequate research ethics oversight be available. We aim to answer the following questions: 1) what do research ethics committee members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries perceive as the (...) key ethical concerns associated with disaster research?, and 2) in what ways do REC members understand these concerns to be distinct from those arising in research conducted in non-crisis situations? This qualitative study was developed using interpretative description methodology; 15 interviews were conducted with REC members. Four key ethical issues were identified as presenting distinctive considerations for disaster research to be implemented in LMICs, and were described by participants as familiar research ethics issues that were amplified in these contexts. First, REC members viewed disaster research as having strong social value due to its potential for improving disaster response, but also as requiring a higher level of justification compared to other research settings. Second, they identified vulnerability as an overarching concern for disaster research ethics, and a feature that required careful and critical appraisal when assessing protocols. They noted that research participants’ vulnerabilities frequently change in the aftermath of a disaster and often in unpredictable ways. Third, they identified concerns related to promoting and maintaining safety, confidentiality and data security in insecure or austere environments. Lastly, though REC members endorsed the need and usefulness of community engagement, they noted that there are significant challenges in a disaster setting over and above those typically encountered in global health research to achieve meaningful community engagement. Disaster research presents distinctive ethical considerations that require attention to ensure that participants are protected. As RECs review disaster research protocols, they should address these concerns and consider how justification, vulnerability, security and confidentially, and community engagement are shaped by the realities of conducting research in a disaster. (shrink)

Background: Certain factors may facilitate or inhibit the formation of moral sensitivity in nurses performing cardiopulmonary resuscitation (CPR). The identification of these factors in the context can help develop strategies to promote nurses’ moral sensitivity and offer new insights into the consequences of their moral decisions. Objective: Taking into account the possibly multi-factorial nature of moral sensitivity, this study aimed to identify the factors affecting the formation of nurses’ moral sensitivity in CPR settings. Research design and methods: This study performed (...) a conventional qualitative content analysis. Twenty-one participants were selected via purposive and theoretical sampling. The data were collected through in-depth semi-structured interviews and simultaneously analyzed via content analysis. Participants and research context: In total, twenty-one participants (fourteen clinical care nurses, three head nurses, two educational supervisors, and two faculty members) from different cities of Iran were interviewed. Ethical considerations: The research was approved by the Ethics Committee of Urmia University of Medical Sciences in Iran (IR.UMSU.REC.1399.337). Findings: Four categories (underlying factors, professional factors, organizational inhibitors of ethics, and professional limitations) and 13 sub-categories were extracted. Discussion: The formation of moral sensitivity requires a range of ethical standards and their maintenance, not only at the individual level but also at the profession, organization, and community levels. So eliminating inhibitors of ethics in these contexts can improve nurse’s ethical performance in CPR settings. Conclusion: Any measures taken or decisions made by nurses in CPR are driven by numerous ethical issues to which nurses must be morally sensitive. Some factors facilitate and some inhibit the formation of moral sensitivity in nurses. (shrink)

BackgroundBrazil is among the sixteen countries that conducts the most clinical trials in the world. It has a system to review research ethics with human beings made up by the National Commission on Research Ethics and 779 Research Ethics Committees, in 2017. The RECs are supposed to follow the same rules regarding their membership, although the RECs that review Social Science and Humanities researches must respect Resolution 510/16. There are Brazilian RECs that review SSH and clinical trials. This study aimed (...) to analyze the academic professional profile of the members of the CONEP and Brazilian RECs, their adequacy to the norms, and the challenges faced by the REC’s Chairs to compose their membership. MethodsAll 779 Brazilian RECs’ chairs are invited to fill in a questionnaire informing academic and professional background of the RECs members, and 92 answered. However, eight were excluded for having sent an incomplete questionnaire, leaving a total of 84 participants. The variables were described by absolute and relative frequency. The Chi-square test and ANOVA was used to analyze regional differences related difficulties to compose the committee. The significance level was 95%. ResultsThe results showed a predominance of members from the biomedical area, while 33% were members of the Social Sciences and Humanities and 5.5% were community representatives. As for the academic degree, there were PhD and masters. The divergences in relation to the guidelines result from the difficulties of having participants in some areas and the little interest in the work carried out by the committees.ConclusionThe RECs are partially adequate to the norms and their performance may be compromised by the low participation of community representatives. The organization of REC’s specifics to review biomedical research could improve the ethical review process, ensuring a membership more qualified for these protocols. (shrink)

In this paper the author is attempting to establish the relationship - or the lack of it - of the Critical Theory to the "Jewish question" and justification of perceiving signs of Jewish religious heritage in the thought of the representatives of this movement. The holocaust marked out by the name of "Auschwitz", is here tested as a point where the nature of this relationship has been decided. In this encounter with the cardinal challenge for the contemporary social theory, the (...) particularity of the Frankfurt School reaction is here revealed through Adorno installing Auschwitz as unexpected but lawful emblem of the ending of the course that modern history has assumed. The critique of this "fascination" with Auschwitz, as well as certain theoretical pacification and measured positioning of the holocaust into discontinued plane of "unfinished" and continuation and closure of the valued project, are given through communicative-theoretical pre-orientation of J?rgen Habermas?s Critical Theory and of his followers. Finally, through the work of Detlev Claussen, it is suggested that in the youngest generation of Adorno?s students there are signs of revision to once already revised Critical Theory and a kind of defractured and differentiated return to the initial understanding of the decisiveness of the holocaust experience. This shift in the attitude of the Critical Theory thinkers to the provocation of holocaust is not, however, particularly reflected towards the status of Jews and their tradition, but more to the age old questioning and explanatory patterns for which they served as a "model". The question of validity of the enlightenment project, the nature of occidental rationalism, existence of historical theology and understanding of the identity and emancipation - describe the circle of problems around which the disagreement is concentrated in the social critical theory. U ovoj studiji autor nastoji da ustanovi odnos - ili manjak odnosa - Kriticke teorije drustva prema "jevrejskom pitanju", te opravdanost uvidjanja eventualnih tragova jevrejskog religijskog nasledja u misljenju njenih predstavnika. Pritom se holokaust, amblematicki naznacen u imenu "Ausvic" iskusava kao tacka na kojoj se odlucivalo o karakteru tog odnosa. U tom susretu sa kardinalnim izazovom za savremenu drustvenu teoriju, posebnost reakcije Frankfurtske skole izlaze se preko Adornovog instaliranja Ausvica u neoCekivano ali zakonito znamenje kraja onog toka koji je moderna istorija poprimila. Kritike ove "opcinjenosti" Ausvicom, kao i izvesna teorijska pacifikacija i odmereno smestanje holokausta u diskontinuiranu ravan jednog "nedovrsenog" i nastavljanja i dovrsenja vrednog projekta, date su kroz komunikativno teorijsku preorijentaciju Kriticke teorije Jirgena Habermasa i nastavljaca. Najzad se preko dela Detlefa Klausena sugerise da u najmladjoj generaciji Adornovih ucenika postoje signali revizije jednom vec revidirane Kriticke teorije i jednog prelomljenog i diferenciranog povratka izvornim uvidima u odlucnost iskustva holokausta. Ova mena u stavovima Kritickih teoreticara drustva prema provokaciji holokausta se, medjutim, ne ogledu u nekakvoj partikularnoj usmerenosti na status Jevreja i njihove tradicije, vec radije u onim vec dugovekim nedoumenjima i eksplanatornim matricama za koja su posluzili kao "model". Pitanja validnosti projekta prosvetiteljstva prirode okcidentalne racionalnosti, postojanja istorijske teleologije i razumevanja koncepcija identiteta i emancipacije - opisuju onaj problemski krug oko kojega se, i kada je o holokaustu rec, koncentrisu nesaglasja Kriticke teorije drustva. (shrink)

The article deals with a study of a distinct criminal punishment established in the Criminal Code and the Code of Punishment Enforcement of the Republic of Lithuania—restriction of liberty, as an alternative to imprisonment. Without investigating extensively the course of development of this penalty, in the article it is sought to overview the development trends of restriction of liberty; analyse the problems of enforcing this penalty and suggest measures to eliminate them; investigate whether the legal regulation of Lithuania is in (...) line with the provisions of the main international instruments relating to non-custodial sanctions (1990 United Nations Standard Minimum Rules for Non-custodial Measures (the so-called Tokyo Rules), Recommendation R (92) 16 of the Committee of Ministers of the Council of Europe to Member States on the European rules on community sanctions and measures, Recommendation Rec (2000) 22 of the Committee of Ministers of the Council of Europe to Member States on improving the implementation of the European rules on community sanctions and measures); review the progressive legal regulation of restriction of liberty in place in individual states and provide a comparison between the national and foreign experience in relation to the penalty of restriction of liberty. In addition, the article offers guidelines for the improvement of the legal regulation and implementation of the legal institute of restriction of liberty. (shrink)

La France est une nation légère - ce lieu commun antique est abondamment repris tout au long du XVIIIe siècle, témoignant de profonds bouleversements axiologiques, scientifiques et éthiques, dont ce volume collectif cherche à mesurer l'importance et les enjeux, en racontant l'histoire d'un autre siècle des Lumières: celle d'un siècle de la Légèreté. Ce volume collectif offre une perspective interdisciplinaire, croisant les champs d'études concernés par la question de la légèreté. Les 15 articles réunis analysent tant la peinture que la (...) morale, tant les sciences que l'histoire politique, tant la littérature que les technologies ou l'économie. Ensemble, ces articles révèlent la complexité de la légèreté au dix-huitième siècle, en proposant non seulement des analyses nouvelles originales de sources bien connues (Hogarth, Fontenelle ou Voltaire) mais aussi des découvertes de textes et des objets moins souvent étudiés (La Morlière, le Père Castel, Octave Uzanne, les cabriolets ou les parfums). L'un des atouts principaux de cette recherche est son approche critique et historiographique de la légèreté qui remet en question la façon dont s'écrit l'Histoire. Derrière les idées reçues, ce livre découvre les enjeux nationaux, diplomatiques, voire parfois aussi existentiels qui ont participé à la construction des représentations du dix-huitième siècle français. (shrink)

Qu'est-ce qu'un enseignement? Une pensée? Qu'autorisent-ils? À la suite de Claire Brunet, Sandra Laugier et Frédérique Ildefonse qui dirigent ce volume, d'anciens étudiants, aujourd'hui chercheurs renommés ou plus discrets, creusent à travers le sillon de leur discipline ce que leur a permis l'enseignement de leur maître commune à l'École normale supérieure. Les amitiés intellectuelles s'y joignent. Ce que l'on appelle communément communication dans le monde académique devient texte. Tous, en creux, décrivent l'influence d'un enseignement, la liberté qu'il permet à (...) des esprits pour s'épanouir et nous laissent découvrir un portrait intellectuel d'une grande originalité. La pensée de Claude Imbert, philosophe, logicienne, longtemps directrice du département de philosophie de la rue d'Ulm, n'a pas les honneurs médiatiques français en sus des "académiques" d'usage. S'y prêterait-elle? Pourtant, la philosophe française est depuis plus de vingt ans lue, reçue et écoutée dans les universités du monde entier, des Etats-Unis à la Chine en passant par l'Amérique du Sud. Tous les textes rassemblés ici, comme autant de variations, sans jamais le dire, souhaitent contribuer à la reconnaissance de l'oeuvre. Un inédit "Ne rien oublier et tout apprendre" de la philosophe et un texte de Pascalle Monnier, écrivain, accompagnent le volume."--Page 4 of cover. (shrink)

Background The South African legal framework requires mandatory parental/legal guardian consent for all research with children. Ethics guidelines provide some reprieve by allowing RECs to grant waivers of parental or guardianship consent in certain defined circumstances. In the first instance, consent may be provided by a proxy when parents or guardians are unavailable, for example with orphaned children. In the second instance, guidelines permit adolescent self-consent when the nature of the study justifies this approach, for example, research on sensitive issues (...) like sexual behaviour or substance use. Discussion South African guidelines set several conditions that must be met for waivers to be granted. These norms overlap with those in international guidelines. However, the ethical norms, especially related to self-consent are sometimes vague. This article critically evaluates the consent norms in the national ethics guidelines and makes recommendations for reform to ethics guidelines in a way that recognises the value of child participation in research, their evolving decision-making capacity and their best interests. Conclusion Recommendations are made to harmonise ethics guidelines and law in a way that promotes child participation in research, to ensure additional protections for adolescents when self-consent is allowed, and to withdraw procedural requirements for the community endorsement of self-consent strategies. (shrink)

BackgroundThe areas of Research Ethics (RE) and Research Integrity (RI) 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 (44.9%). The non-adherence to pertinent laws and regulations, such as lack of informed consent and REC approval, was the second most frequently tagged violation (15.7%), followed by patient safety issues (11.1%) and plagiarism (6.9%). 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 (45.4%), followed by exclusion from funding applications (35.5%).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)

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)

Background In the course of the COVID-19 pandemic, the biomedical research community’s attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees. Methods We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and (...) synthesis of challenges and potential solutions that we grouped under established principles for clinical research ethics. Results We received an overall response rate of 42%. The 22 responding RECs reported that they had assessed a total of 441 study proposals on COVID-19 until 21 April 2020. For the review of these proposals the RECs indicated a broad spectrum of challenges regarding social value, scientific validity, favourable risk–benefit ratio, informed consent, independent review, fair selection of trial participants, and respect for study participants. Mentioned solutions ranged from improved local/national coordination, over guidance on modified consent procedures, to priority setting across clinical studies. Conclusions RECs are facing a broad spectrum of pressing challenges in reviewing COVID-19 studies. Some challenges for consent procedures are well known from research in intensive care settings but are further aggravated by infection measures. Other challenges such as reviewing several clinical studies at the same time that potentially compete for the recruitment of in-house COVID-19 patients are unique to the current situation. For some of the challenges the proposed solutions in our survey could relatively easy be translated into practice. Others need further conceptual and empirical research. Our findings together with the increasing body of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development of hands-on guidance for researchers, funders, RECs, and further oversight bodies. (shrink)

Background: Concerns have been expressed regarding the adequacy of ethics review systems in developing countries. Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs) in the Middle East. The purpose of this study was to survey the existing RECs in Egypt to better understand their functioning status, perceived resource needs, and challenges. Methods: We distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of the REC, membership (...) composition, ethics training, workload, process of ethics review, perceived challenges to effective functioning, and financial and material resources. We used basic descriptive statistics to evaluate the quantitative data. Results: We obtained responses from 67% (12/18) of the identified RECs. Most RECs (10/12) have standard operating procedures and many (7/12) have established policies to manage conflicts of interests. The average membership was 10.3 with a range from 7-19. The predominant member type was physicians (69.5% of all of the REC members) with little lay representation (13.7%). Most RECs met at least once/month and the average number of protocols reviewed per meeting was 3.8 with a range from 1-10. Almost three-quarters of the members from all of the 12 RECs indicated they received some formal training in ethics. Regarding resources, roughly half of the RECs have dedicated capital equipment (e.g., meeting room, computers, office furniture, etc); none of the RECs have a formal operating budget. Perceived challenges included the absence of national research ethics guidelines and national standards for RECs and lack of ongoing training of its members in research ethics. Conclusion: Our study documents several areas of strengths and areas for improvements in the operations of Egyptian RECs. Regarding strengths, many of the existing RECs meet frequently, have a majority of members with prior training in research ethics, and have written policies. Regarding areas for improvements, many RECs should strive for a more diverse membership and should receive more financial resources and administrative support personnel. We recommend that RECs include more individuals from the community and develop a continuing educational program for its members. Institutional officials should be aware of the resource capacity needs of their RECs. (shrink)

Biobanks are precariously situated at the intersection of science, genetics, genomics, society, ethics, the law and politics. This multi-disciplinarity has given rise to a new discourse in health research involving diverse stakeholders. Each stakeholder is embedded in a unique context and articulates his/her biobanking activities differently. To researchers, biobanks carry enormous transformative potential in terms of advancing scientific discovery and knowledge. However, in the context of power asymmetries in Africa and a distrust in science born out of historical exploitation, researchers (...) must balance the scientific imperative of collecting, storing and sharing high quality biological samples with obligations to donors/participants, communities, international collaborators, regulatory and ethics authorities. To date, researcher perspectives on biobanking in South Africa have not been explored and documented. In-depth qualitative interviews were conducted with a purposive sample of 21 researchers – 8 in the Western Cape, 3 in Gauteng and 10 in Kwa-Zulu Natal. Interviews lasted approximately 40–60 min and were audiotaped with consent. Thematic analysis of the transcribed interviews was conducted by the co-authors. Researchers articulated serious concerns over standardised regulatory approaches that failed to consider the heterogeneity of biobanks. Given that biobanks differ considerably, guidelines and RECs need to stratify risk accordingly and governance processes and structures must be flexible. While RECs were regarded as an important component of the governance structure researchers expressed concern about their expertise in biobanking. Operational management of biobanks was regarded as an ethical imperative and a pre-requisite to building trust during consent processes. While broad general consent was preferred, tiered consent was thought to be more consistent with respect for autonomy and building trust. Material Transfer Agreements were often lacking when biosamples were exported and this was perceived to impact negatively on trust. On the other hand, researchers believed that authentic community engagement would help to build trust. Building trust will best be achieved via a system of governance structures and processes that precede the establishment of a biobank and monitor progress from the point of sample collection through to future use, including export. Such governance structures must be robust and must include comprehensive national legislation, policy and contextualised guidelines. Currently such governance infrastructure appears to be lacking in many African countries including South Africa. Capacity development of all stakeholders including REC members will enhance expeditious and efficient review of biobanking protocols which in turn will reinforce trust in the researcher-donor relationship. Science translation and community engagement in biobanking is integral to the success of biobanking in South Africa. (shrink)

The article argues in favour of a pragmatist enactive interpretation of the emergence of the symbolic and contentful mind from a basic form of social communicative interaction in which basic cognitive capacities are involved. Through a critical overview of Radical Enactivists (RECers)’ view about language, the article focuses on Mead’s pragmatist behavioural theory of meaning that refers to the gestural conversation as the origin of the evolution of linguistic conversation. The article develops as follows. After exposing the main elements of (...) REC’s theory of cognition and language that involve the construction of a theory of natural signs (teleosemiotics) and basic directionality (Ur-intentionality), some critical points of Hutto and Myin’s proposal will be highlighted. To foster a continuist perspective of language, the behavioural theory of meaning and language that Mead develops from the notion of gesture will be analysed. His theory is akin to REC and could augment the bare bones of REC’s sketched perspective, helping to include Ur-intentionality in a broader non-dualistic phylogenetic and ontogenetic theory of symbolic language from gestural communication, thus helping to overcome the distinction between a content-less intentionality and a content-involving intentionality, i.e., a semantic propositional intentionality. Furthermore, a recent revival of Mead’s theory testifies to its up-to-date relevance to explain the innate social dimension of human and non-human animals, and the human communicative capacity through the conditioning of bio-social canons and structures. (shrink)

Human subjects research has increased in Myanmar since 2010 and, accordingly, the establishment of research ethics committees has increased review of these research studies. However, characteristics that reflect the operations of RECs in Myanmar have not been assessed. To assess the structures and processes of RECs at medical institutions in Myanmar, we used a self-assessment tool for RECs operating in low- and middle-income countries. This tool consists of the following ten domains: organizational aspects, membership and ethics training, submission arrangements and (...) materials, meeting minutes, policies referring to review procedures, review of specific protocol and informed consent items, communication a decision, continuing review, REC resources and institutional commitment. We distributed this self-administered questionnaire to RECs from 15 medical institutions in Myanmar and one representative from each REC completed this questionnaire and returned it anonymously. We used descriptive, bivariate and multivariate statistics to analyse the data. Out of a maximum 200 points, the total mean score for Myanmar medical institutions was 112.6 ± 12.77, which is lower compared with the aggregate mean score of 137.4 ± 35.8 obtained from RECs in other countries. Domains in which the average percentage score was less than 60% included organizational commitment, membership and ethics training, continuing review and REC resources. Many RECs have a diverse membership and appropriate gender balance but lacked essential policies. The results show that for Myanmar RECs, there is significant room for improvement in their “structures and processes” as well as the extent of institutional commitment. The self-assessment tool proved to be a valuable method to assess the quality of RECs. (shrink)

BackgroundThe COVID-19 pandemic presents significant challenges to research ethics committees (RECs) in balancing urgency of review of COVID-19 research with careful consideration of risks and benefits. In the African context, RECs are further challenged by historical mistrust of research and potential impacts on COVID-19 related research participation, as well as the need to facilitate equitable access to effective treatments or vaccines for COVID-19. In South Africa, an absent National Health Research Ethics Council (NHREC) also left RECs without national guidance for (...) a significant duration of the COVID-19 pandemic. We conducted a qualitative descriptive study that explored the perspectives and experiences of RECs regarding the ethical challenges of COVID-19 research in South Africa.MethodsWe conducted in-depth interviews with 21 REC chairpersons or members from seven RECs at large academic health institutions across South Africa that were actively involved in the review of COVID-19 related research from January to April 2021. In-depth interviews were conducted remotely via Zoom. Interviews (60–125 min) were conducted in English using an in-depth interview guide, until data saturation was achieved. Audio-recordings were transcribed verbatim and field notes were converted into data documents. Line-by-line coding of transcripts was performed, and data were organised into themes and sub-themes. An inductive approach to thematic analysis was used to analyse data.ResultsFive main themes were identified, namely: rapidly evolving research ethics landscape, extreme vulnerability of research participants, unique challenges to informed consent, challenges to community engagement during COVID-19, and overlapping research ethics and public health equity issues. Sub-themes were identified for each main theme.ConclusionsNumerous, significant ethical complexities and challenges were identified by South African REC members in the review of COVID-19 related research. While RECs are resilient and adaptable, reviewer and REC member fatigue were major concerns. The numerous ethical issues identified also highlight the need for research ethics teaching and training, especially in informed consent, as well as the urgent requirement for the development of national guidelines for research ethics during public health emergencies. Further, comparative analysis between different countries is needed to develop the discourse around African RECs and COVID-19 research ethics issues. (shrink)

Dual Use Research of Concern constitutes a major challenge for research practice and oversight on the local, national and international level. The situation in Germany is shaped by two partly competing suggestions of how to regulate security-related research: The German Ethics Council, as an independent political advisory body, recommended a series of measures, including national legislation on DURC. Competing with that, the German National Academy of Sciences and the German Research Foundation, as two major professional bodies, presented a strategy which (...) draws on the self-control of science and, inter alia, suggests expanding the scope of research ethics committees to an evaluation of DURC. This situation is taken as an occasion to further discuss the scope and limits of professional self-control with respect to security-related research. The role of RECs as professional bodies of science is particularly analyzed, referring to the theoretical backgrounds of professionalism. Two key sociological features of professionalism – ethical orientation and professional self-control – are discussed with respect to the practice of biomedical science. Both attributes are then analyzed with respect to the assessment of DURC by RECs. In conclusion, it is stated that issues of biosecurity transcend the boundaries of the scientific community and that a more comprehensive strategy should be implemented encompassing both professional self-control and legal oversight. (shrink)

Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear.METHODS: I conducted in-depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%).RESULTS: US IRBs face (...) ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long-standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and ‘negotiate’ for maximum benefits for participants and fearing ‘worst-case scenarios’.CONCLUSIONS: US and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice. (shrink)

This paper describes a three-year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross-section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research. Following the (...) training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants’ knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically. (shrink)

BackgroundThe ethical concerns associated with HIV prevention and treatment research have been widely explored in South Africa over the past 3 decades. However, HIV cure research is relatively new to the region and significant ethical and social challenges are anticipated. There has been no published empirical enquiry in Africa into key informant perspectives on HIV cure research. Consequently, this study was conducted to gain preliminary data from South African HIV clinicians, researchers and activists.MethodsIn-depth interviews were conducted on a purposive sample (...) of fourteen key informants in South Africa. Audiotaped interviews were transcribed verbatim with concurrent thematic analysis. The perspectives of HIV clinicians, researchers and activists were captured. Analyst triangulation occurred as the data were analysed by three authors independently.ResultsThe rapid evolution of HIV cure research agendas was prominent with participants expressing some concern that the global North was driving the cure agenda. Participants described a symbiotic relationship between cure, treatment and prevention research necessitating collaboration. Assessing and managing knowledge and expectations around HIV cure research emerged as a central theme related to challenges to constructing ‘cure’ - how patients understand the idea of cure is important in explaining the complexity of cure research especially in the South African context where understanding of science is often challenging. Managing expectations and avoiding curative misconception will have implications for consent processes. Unique strategies in cure research could include treatment interruption, which has the potential to create therapeutic and ethical conflict and will be perceived as a significant risk. Ethical challenges in cure research will impact on informed consent and community engagement.ConclusionsIt was encouraging to note the desire for synergy amongst researchers and clinicians working in the fields of prevention, treatment and cure. Translation of complex HIV cure science into lay language is critical. Moving forward, RECs must be adequately constituted with scientific expertise and community representation when reviewing cure protocols. It is hoped that knowledge and resource sharing in the context of collaboration between research scientists working in cure and those working in treatment and prevention will accelerate progress towards cure. (shrink)

The role of the Research Ethics Committee (REC) in the design, conduct and dissemination of scientific research is still evolving and many important questions remain unanswered. Hence, the aim of this paper is to address some of the uncertainty that exists around the role and responsibilities of RECs and to discuss some of the controversy that exists over the criteria that RECs should follow when evaluating a research proposal. The discussion is organised around five of the major roles currently performed (...) by RECs when assessing proposals in the biomedical sciences. It will be shown that these five roles need to be critically evaluated and reassessed. The five roles addressed are: assessing the legitimacy and validity of the informed consent process, second, conducting a comprehensive risk/benefit analysis, third, assessing the validity of a research proposal, fourth, ensuring that researchers observe the social norms, values, customs, traditions and laws that prevail in the community or jurisdiction in which the research will be conducted and finally, monitoring the research project as it unfolds and providing an ongoing advisory and consultancy service to both new and experienced researchers. In reassessing the role of the REC, this paper concludes with a set of general recommendations for RECs. These provide some guidance on the minimum criteria that should be followed when RECs evaluate proposals. These guidelines will be beneficial for new and experienced members of REC, and will help to make the process a more objective, efficient and standardised process. The guidelines will also be beneficial for researchers in the biomedical sciences who are preparing proposals for ethical review. (shrink)

BackgroundInstitutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia.MethodThis was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to (...) 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions.ResultsTwenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review.ConclusionSaudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies. (shrink)

The current rise in malpractice litigation has led to concern in the research community as to the prospect of litigation against researchers. Clearly as the responsibility for the day-to-day conduct of the research falls upon the researchers they will be potentially liable should there be negligence in the conduct of the research project itself. But to what extent can the research ethics committee and its members be held liable should harm result to the research subject? How far does the prospect (...) of the threat of litigation equate with the reality of the prospect of liability? Although the NHS research governance framework suggests that primary responsibility for the conduct of the trial is with the researcher this does not mean that REC members will be immune from actions in tort where research subjects suffer harm in the conduct of a research project approved by their NHS REC. This paper focuses upon the prospect for liability in the law of tort of NHS RECs and their members. While in practice the vast majority of such claims are unlikely to be successful members of RECs may incur resultant legal costs as a consequence of involvement in proposed litigation. It is submitted that the scope of indemnity provision provided to RECs and their members should be precisely determined, otherwise there is a real prospect that the risk of malpractice litigation may deter individuals from serving on such committees. (shrink)

Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises – particularly in resource-poor settings – is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees. Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster research and argue that ethical disaster research (...) requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like – how it might be conceptualized and utilized – using the concept of real-time responsiveness. The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained. (shrink)

Resumen Ésta es la primera traducción al español de las guías “Atención después de la investigación: un marco para los comités de ética de investigación del National Health Service (NHS) (borrador versión 8.0)”. El documento afirma que existe una fuerte obligación moral de garantizar que los participantes enfermos de un estudio clínico hagan una transición después del estudio hacia una atención de la salud apropiada. Con “atención de la salud apropiada” se hace referencia al acceso para los participantes a la (...) atención de la salud, proporcionada principalmente por el National Health Service (en adelante NHS), el sistema de salud del Reino Unido, y/o a la intervención en estudio, también llamada producto o tratamiento en investigación. Las guías “Atención después de la investigación” están dirigidas principalmente a los miembros de los 79 comités de ética de investigación del NHS y a quienes presentan sus estudios de investigación ante estos comités. Se trata de un documento borrador muy avanzado, trabajado en numerosas reuniones, durante más de 3 años, que ha sido discutido por participantes de estudios y miembros de la comunidad, miembros y presidentes de comités de ética de investigación del Reino Unido, especialistas internacionales en ética de la investigación, representantes de la industria y otras partes interesadas. La redacción de las guías es producto de la colaboración de Neema Sofaer y Penney Lewis, ambas investigadoras del King’s College London, en el Centre of Medical Law and Ethics del Dickson Poon School of Law, y Hugh Davies, Asesor en Ética de la Investigación de la Health Research Authority (HRA) del NHS. El traductor del presente documento, Ignacio Mastroleo, participó del workshop en la Fundación Brocher (Ginebra, Suiza, diciembre de 2011) donde se revisó el borrador versión 7.0 y contribuyó en la revisión del borrador de la versión 8.0 durante el 2012. -/- Abstract This is the first Spanish translation of the guidelines “Care after research: a framework for NHS RECs (8th draft)”. The document states that there is a strong moral obligation to ensure that participants in a clinical study who are ill transition after the study to appropriate healthcare. The terms "appropriate healthcare" refer to participants’ access to health care, mainly provided by the National Health Service (NHS), the health system in the UK, and/or to the intervention study also named investigational treatment or product. The guides "Care after research" are mainly directed to members of the 79 NHS committees of research ethics (RECs) and to those who submit their research to these committees. This is a very advanced draft document, worked in several meetings, for more than three years, that has been discussed with study participants and community members, members and chairs of RECs in the UK, international specialists in research ethics, industry representatives and other stakeholders. The drafting of the guidelines is the result of the collaboration of Neema Sofaer and Penney Lewis, both researchers at King's College London, at the Centre of Medical Law and Ethics of Dickson Poon School of Law, and Hugh Davies, Research Ethics Advisor of the Health Research Authority (HRA) of the NHS. The translator of this document, Ignacio Mastroleo, attended the workshop at the Brocher Foundation (Geneva, Switzerland, December 2011) where draft version 7.0 was revised and contributed in the revision of draft version 8.0 during 2012. (shrink)

Africa has a colonial past that renders it a linguistic melting pot, where language is not only important for communication but is inextricably related to cultural identity. In Africa, there are over 2000 languages that are still being used and spoken. Language diversity coupled with cultural diversity may affect the process of obtaining informed consent in data-intensive research. We explore some of the challenges and opportunities of multilingualism in handling informed consent in the context of data-intensive research. In multilingual (...) contexts, as in most African countries, language is exceptionally central, and translation has potential cultural, social, historical, functional and scientific importance. However, it is recognised that terminological and translation activities may not always be cost-effective or feasible. We consider alternative mechanisms of harmonisation of data-related terminology and concepts in multilingual contexts, such as iconography, graphic elicitation and other multimedia formats of information sharing. The inclusion of visual or multimedia explanations in informed consent forms can improve comprehension, enhance information transfer and learning, reduce potential vulnerabilities associated with low literacy levels or the inability to interpret technical language associated with data-intensive research, build trust with participants and their communities, and promote autonomy of potential participants. We recognise that the inclusion of visual or multimedia content to facilitate information transfer is only one component of the informed consent process for data-intensive research. Research ethics committees (RECs) should be mindful of other key considerations and challenges of informed consent for data-intensive research in sub-Saharan Africa (SSA), and to explore whether these alternative forms of consent are ethical and effective in multilingual contexts. (shrink)

This paper explores the perceptions and experiences of four doctoral researchers to examine how research ethics committee (REC) processes have shaped and influenced specific health-based ethnographic studies. This paper considers how a universal tightening of ethical REC scrutiny at university level, as well as those governing the health and social care sector in the United Kingdom, impacts upon social research involving the inclusion of participants from certain groups. Increased restrictions in ethics scrutiny is justified as protecting vulnerable people from intrusive (...) research and is embedded in legislation, specifically the UK Mental Capacity Act 2005. The general international trend towards greater ethical scrutiny is heralded as an uncontested social good, yet this unquestioned assumption is tested in relation to qualitative social research methodologies that seek to explore the experiences of ?vulnerable? individuals. It is consequently argued that ethics review restrictions are in danger of disenfranchising sectors of the community, excluding them from engaging in social research activities that would serve to highlight their experiential and lived conditions. The enhanced bureaucratic control of the doctoral process in conjunction with the REC is also discussed as inhibiting proposed studies. (shrink)

Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees personnel, and a government agency member involved in multinational HIV Prevention Trials Network research in emerging economies. Ministries of Health or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can (...) lack resources, be poorly organized, have inconsistent review processes and limited expertise, and use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country's population. The MOH/governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply-rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration. (shrink)

Background In April 2019, our hospital transitioned to an electronic patient record system and patient portal. MyGOSH enables young people aged 12 years or older and their parents to access results, documentation, appointments, and to communicate with their care team. Aims A focus group was conducted to explore the ethical and legal considerations of young people and their parents using a patient portal from the perspective of hospital Ethics Committee members. Participants and research context Members of the hospital Paediatric Bioethics (...) Centre were recruited. Written informed consent was provided by all participants. Research design The focus group discussion was recorded, transcribed verbatim and analysed using thematic analysis. Ethical considerations Health Research Authority Research Ethics Committee Approval was granted by London Southeast REC. Results Four themes, and sub-themes, were identified: granting access – complexities of assessing competence/capacity, exclusion from MyGOSH due to non-disclosure of diagnosis, and truth-telling; inequalities resulting in inequities – complexities of inequity in access; responding to change – providing support and managing expectations; engagement, empowerment and understanding – data safety, empowering young people to take ownership of their health data, a one-size fits all system may not meet the needs of all families, and early engagement with young people/parents. Discussion Giving families portal access can increase engagement, empowering them to be more involved in care, yet poses challenges for all. Complexities exist in the assessment for portal access, and supporting and managing user expectations whilst providing an equitable service. Conclusions Ongoing support is required for all stakeholders following patient portal implementation to navigate the ethical and legal complexities, and to promote equity and portal utility for patient benefit. (shrink)

Background In April 2019, our hospital transitioned to an electronic patient record system and patient portal (MyGOSH). MyGOSH enables young people aged 12 years or older and their parents to access results, documentation, appointments, and to communicate with their care team. Aims A focus group was conducted to explore the ethical and legal considerations of young people and their parents using a patient portal from the perspective of hospital Ethics Committee members. Participants and research context Members of the hospital Paediatric (...) Bioethics Centre were recruited ( n = 7). Written informed consent was provided by all participants. Research design The focus group discussion was recorded, transcribed verbatim and analysed using thematic analysis. Ethical considerations Health Research Authority Research Ethics Committee (REC) Approval was granted by London Southeast REC (IRAS Project ID: 248793; REC Reference: 18/LO/1945). Results Four themes, and sub-themes, were identified: (1) granting access – complexities of assessing competence/capacity, exclusion from MyGOSH due to non-disclosure of diagnosis, and truth-telling; (2) inequalities resulting in inequities – complexities of inequity in access; (3) responding to change – providing support and managing expectations; (4) engagement, empowerment and understanding – data safety, empowering young people to take ownership of their health data, a one-size fits all system may not meet the needs of all families, and early engagement with young people/parents. Discussion Giving families portal access can increase engagement, empowering them to be more involved in care, yet poses challenges for all. Complexities exist in the assessment for portal access, and supporting and managing user expectations whilst providing an equitable service. Conclusions Ongoing support is required for all stakeholders following patient portal implementation to navigate the ethical and legal complexities, and to promote equity and portal utility for patient benefit. (shrink)

BackgroundEvery year, research specimens are shipped from one institution to another as well as across national boundaries. A significant proportion of specimens move from poor to rich countries. Concerns are always raised on the future usage of the stored specimens shipped to research insitutions from developing countries. Creating awareness of the processes is required in all sectors involved in biomedical research. To maintain fairness and respect in sharing biomedical specimens and reserch products requires safeguarding by Ethics Review Committees in both (...) provider and recepient institutions. Training in basic ethical principles in research is required to all sectors involved in biomedical research so as to level up the research playing field.DiscussionBy agreeing to provide specimens, individuals and communities from whom samples are collected would have placed their trust and all ensuing up-keep of the specimens to the researchers. In most collaborative set-up, laid down material transfer agreements are negotiated and signed before the shipment of specimens. Researchers, research ethics committees and institutions in the countries of origin are supposed to serve as overseers of the specimens. There is need to advocate for honesty in sample handling and sharing, and also need to oversee any written commitments by researchers, RECs and institutions at source as well as in recipient institution. Commitments from source RECs and Institutional Review Boards and in the receiving institution on overseeing the future usage of stored specimens are required; including the ultimate confirmation abiding by the agreement. Training in ethical issues pertaining to sample handling and biomedical research in general is essential at all levels of academic pursuit. While sharing of biological specimens and research data demands honesty and oversight by ethical regulatory agents from both institutions in developing country and recepient institutions in developed countries.Concluding summaryArchiving of biological specimens requires reconsideration for the future of biomedical findings and scientific break-throughs. Biomedical ethical regulations still need to established clear viable regulations that have vision for the future of science through shared and archived samples. This discussion covers and proposes essential points that need to be considered in view of future generations and scientific break-throughs. The discussion is based on the experience of working in resource-limited settings, the local regulatory laws and the need to refine research regulations governing sharing and storage of specimens for the future of science. (shrink)

Objectives: To review the performance of research ethics committees in Spain in assessing multicentre clinical trial drug protocols, and to evaluate if they would comply with the requirements of the new EU Directive to be implemented by May 2004.Design and setting: Prospective study of applications of MCT submitted to RECs.Main measurements: Protocol related features and evaluation process dynamics.Results: 187 applications to be performed in 114 centres, were reviewed by 62 RECs. RECs had a median number of 14 members, of which (...) three were lay members. All applications were approved except four which were however approved by the other RECs involved. The median times from submission to approval and from submission to reception at the sponsor’s offices were 48 and 62 days, respectively. In 55% of all applications approved, 41 RECs raised 307 queries, 40% of these were protocol related issues, and 38% related to the patients’ information sheets. RECs charging an evaluation fee in advance and applications with no queries raised were statistically significantly associated with shorter evaluation times. However, there is a gap of at least 1.5 weeks between the date of the meeting and the reception of the approval letter in the sponsor’s office.Conclusions: Evaluating MCT protocols by RECs is a time consuming process. Needing 1.5 weeks for communicating the decision taken by RECs to the sponsor suggests serious administrative shortcomings within most RECs. By significantly reducing the time for communication of their decisions, the majority of RECs would comply with the Directive requirement of a maximum 60 day period for the assessment of MCT. (shrink)

Background Compassion fatigue and professional quality of life are important in health and professional ethics. Aim This study aimed to determine the relationship between compassion satisfaction, compassion fatigue, secondary traumatic stress, and moral injury in nurses. Research design This research is a cross-sectional descriptive-analytical study. The research community of this research was all the nurses of the teaching hospitals of Ardabil city. Three questionnaires on demographic characteristics, the Professional Quality of Life Scale (ProQOL), and the Moral Injury Events Scale were (...) used to collect data. SPSS (version 22) software was used for data analysis. Participants and research context The study recruited 297 nurses randomly selected from five teaching hospitals in Ardabil city. Ethical considerations Ethical approval was obtained from the Ardabil University of Medical Sciences ethics committee (with the code of ethics IR.ARUMS.REC.1401.198). Informed consent was obtained from the participants. Results The results showed that the mean compassion satisfaction score of this study’s participants was 37.61 ± 8.86, the mean compassion fatigue score of this study’s participants was 28.73 ± 7.04, and the mean secondary traumatic stress score of this study’s participants was 29.95 ± 7.84. The mean score of moral injury among nurses was 31.19 ± 8.54. The results showed a negative significant relationship between compassion satisfaction and moral injury ( p < 0.001). Also, there is a positive significant relationship between compassion fatigue and secondary traumatic stress with moral injury ( p < 0.001). Conclusion The results of this study show a negative relationship between compassion satisfaction and moral injury. According to the results of the present study, nurse managers should implement educational interventions, create ethical processes, and clear ethical guidelines to reduce moral injury and increase compassion satisfaction. (shrink)

Background Maintaining patients’ dignity is a key ethical requirement in healthcare and is emphasized in nursing standards. This issue is particularly significant for patients with schizophrenia because they face unique challenges such as physical and psychological difficulties, dependence on others, and social isolation, making them more vulnerable. Organizational factors can either threaten or preserve their dignity. However, there is little knowledge in this domain within the sociocultural context of Iran. Research Objective This study aimed to explore the role of the (...) healthcare organization in the dignity of patients with schizophrenia, based on the opinions of patients, healthcare personnel, and family caregivers. Research Design This qualitative study was conducted with 26 participants (16 patients, 4 family caregivers, 2 nurses, 3 psychologists, and 1 service worker) who were selected using a purposeful sampling method. The data were collected through semi-structured, in-depth face-to-face interviews until data saturation was reached. The data were analyzed via Graneheim and Lundman’s method. Ethical Considerations The study protocol was approved by the Research Ethics Committee of Urmia University of Medical Sciences (IR.UMSU.REC.1401.099). Findings Based on data analysis, participants reported the three following challenges as organizational hidden threats to patients’ dignity: “Lack of facilities,” “premature management,” and “ineffective communication.” Conclusion The study findings indicated that the healthcare organization does not support the dignity of patients. Management inefficiency and lack of facilities are evident in psychiatric hospitals, and healthcare centers are not monitored based on standard criteria. Limited interactions between healthcare personnel and patients were identified as the main reasons for the neglect of patients with schizophrenia and the violation of their dignity. The results of this study can help healthcare policymakers in designing and implementing effective programs to preserve the dignity of patients with schizophrenia. (shrink)

This paper describes the establishment of and the issues experienced by the Research Ethics Committee (REC) of a Business School within a University in Ireland. It identifies the issue of voluntarily given informed consent as a key challenge for RECs operating in a Business School context. The paper argues that whilst the typology of ethical issues in business research are similar to the wider social sciences, the fact that much research is carried out in the workplace adds to the complexity (...) of the REC deliberations. The use of deception in the design of research studies, pestering the local community and the potential for harm to the researcher are also discussed briefly in the context of business research. The experiences of the authors’, two of whom have served as respective chairpersons of the business school REC since its inception in addition to being members of the university level REC, inform the discussion. (shrink)

Research ethics approval procedures and research ethics committees (RECs) are now well-established in most Western Universities. RECs base their judgements on an ethics code that has been developed by the health and biomedical sciences research community and that is widely considered to be universally valid regardless of discipline. On the other hand, a sizeable body of literature has emerged criticising the work of RECs, as, among other things, overly bureaucratic and unresponsive to the needs of disciplines outside the biomedical sciences. (...) This article adopts the format of a debate between a Chair of a university REC and a social science researcher as a vehicle for contrasting different perspectives on research ethics. The fictional debate allows for a productive discussion between the two sides, incorporating key insights from the recent literature and concludes with a synthesis that sketches out some ideas about how university RECs can be made more responsive and accountable. (shrink)

This paper argues that qualitative research is both useful and necessary, as it provides an essential means of gaining a richer understanding of patients' perceptions, social processes and meanings. In their paper in this edition of Clinical Ethics, Hallowell and Lawton raise many issues relating to the way that qualitative research is treated by RECs in the UK. In this paper I discuss just three key topics stimulated by their paper: the way that methodology relates to ethics, the experience and (...) character of the researcher, and the normative/descriptive distinction. I strongly support Hallowell and Lawton's appeal for greater communication between qualitative researchers and RECs. In other respects, I would argue that they do not go far enough. The recent review of research ethics structures and the review process provides an opportunity to move away from the present 'one size fits all' approach to ethical review. I would argue that this change could only benefit qualitative research and researchers. (shrink)