BackgroundHIV cure research involving cell and gene therapy has intensified in recent years. There is a growing need to identify ethical standards and safeguards to ensure cell and gene therapy (CGT) HIV cure research remains valued and acceptable to as many stakeholders as possible as it advances on a global scale.MethodsTo elicit preliminary ethical and practical considerations to guide CGT HIV cure research, we implemented a qualitative, in-depth interview study with three key stakeholder groups in the United States: (1) biomedical (...) HIV cure researchers, (2) bioethicists, and (3) community stakeholders. Interviews permitted evaluation of informants’ perspectives on how CGT HIV cure research should ethically occur, and were transcribed verbatim. We applied conventional content analysis focused on inductive reasoning to analyze the rich qualitative data and derive key ethical and practical considerations related to CGT towards an HIV cure.ResultsWe interviewed 13 biomedical researchers, 5 community members, and 1 bioethicist. Informants generated considerations related to: perceived benefits of CGT towards an HIV cure, perceived risks, considerations necessary to ensure an acceptable benefit/risk balance, CGT strategies considered unacceptable, additional ethical considerations, and considerations for first-in-human CGT HIV cure trials. Informants also proposed important safeguards to developing CGT approaches towards an HIV cure, such as the importance of mitigating off-target effects, mitigating risks associated with long-term duration of CGT interventions, and mitigating risks of immune overreactions.ConclusionOur study identified preliminary considerations for CGT-based HIV cure across three key stakeholder groups. Respondents identified an ideal cure strategy as one which would durably control HIV infection, protect the individual from re-acquisition, and eliminate transmission to others. Known and unknown risks should be anticipated and perceived as learning opportunities to preserve and honor the altruism of participants. Preclinical studies should support these considerations and be transparently reviewed by regulatory experts and peers prior to first-in-human studies. To protect the public trust in CGT HIV cure research, ethical and practical considerations should be periodically revisited and updated as the science continues to evolve. Additional ethics studies are required to expand stakeholder participation to include traditionally marginalized groups and clinical care providers. (shrink)

The study focused on university students' understanding and conceptions of ethical issues in research. Domain-specific and domain-transcending measures were developed to gauge the students' awareness of ethical issues. Responses were obtained from 269 undergraduate and graduate students at a U.S. regional university. Participant withdrawal, the debriefing of research participants, the dissemination of findings, and giving credit to co-contributors were the most challenging ethical issues for the students. Ethical awareness was predicted by professional and organizational socialization, and perspective taking. Contextualization greatly (...) improved the students' ability to recognize ethical issues. Simulations and role-taking are suggested as the means with which to teach students about the ethical issues perceived as challenging. (shrink)

The present study used quantitative and qualitative measures to examine Iranian applied linguists’ (mis-) conceptions of ethical issues in research. For this purpose, one hundred and twelve applied linguists completed a research ethics questionnaire constructed and validated by the researchers. In the follow-up qualitative phase, 15 applied linguists who were faculty members participated in semi-instructed interviews. Data were analyzed using exploratory factors analyses for the first phase and theme analyses for the second phase. Quantitative results showed that the most important (...) misconceptions among Iranian applied linguists lingered on working with data (data collection and data analyses). For example, removing an outlier was a prevalent act conducted by applied linguists in the present study. Teachers using their students as participants of their own research as well as how they treated those students after a study were other controversial issues. The qualitative results revealed several themes including _lack of knowledge, conflict with real-world practices, a product-oriented approach to education and a publish or perish mentality_ as the reasons for misconceptions of ethics in applied linguistics among Iranian researchers. On general terms, there was an implicit agreement regarding the lack of training on research ethics among Iranian applied linguists. (shrink)

BackgroundOne of the next frontiers in HIV research is focused on finding a cure. A new priority includes people with HIV (PWH) with non-AIDS terminal illnesses who are willing to donate their bodies at the end-of-life (EOL) to advance the search towards an HIV cure. We endeavored to understand perceptions of this research and to identify ethical and practical considerations relevant to implementing it.MethodsWe conducted 20 in-depth interviews and 3 virtual focus groups among four types of key stakeholders in the (...) United States (PWH, biomedical HIV cure researchers, HIV clinicians, and bioethicists) to obtain triangulated viewpoints because little was known about the ethics of this topic. Each group was queried as to ethical considerations, safeguards, and protections for conducting HIV cure-related research at the EOL to ensure this research remains acceptable.ResultsAll four key stakeholder groups generally supported HIV cure-related research conducted at the EOL because of the history of altruism within the PWH community and the potential for substantial scientific knowledge to be gained. Our informants expressed that: (1) Strong stakeholder and community involvement are integral to the ethical and effective implementation, as well as the social acceptability of this research; (2) PWH approaching the EOL should not inherently be considered a vulnerable class and their autonomy must be respected when choosing to participate in HIV cure-related research at the EOL; (3) Greater diversity among study participants, as well as multi-disciplinary research teams, is necessitated by HIV cure-related research at the EOL; (4) The sensitive nature of this research warrants robust oversight to ensure a favorable risk/benefit balance and to minimize the possibility of therapeutic misconception or undue influence; and (5) Research protocols should remain flexible to accommodate participants’ comfort and needs at the EOL.ConclusionBecause of the ethical issues presented by HIV cure-related research at the EOL, robust ethical safeguards are of utmost importance. The proposed ethical and practical considerations presented herein is a first step in determining the best way to maximize this research’s impact and social value. More much inquiry will need to be directed towards understanding context-specific and cultural considerations for implementing EOL HIV cure research in diverse settings. (shrink)

In the context of academic research, a diversity of ethical issues, conditioned by the different roles of members within these institutions, arise. Previous studies on this topic addressed mainly the perceptions of researchers. However, to our knowledge, no studies have explored the transversal ethical issues from a wider spectrum, including other members of academic institutions as the research ethics board (REB) members, and the research ethics experts. The present study used a descriptive phenomenological approach to document the ethical issues experienced (...) by a heterogeneous group of Canadian researchers, REB members, and research ethics experts. Data collection involved socio-demographic questionnaires and individual semi-structured interviews. Following the triangulation of different perspectives (researchers, REB members and ethics experts), emerging ethical issues were synthesized in ten units of meaning: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. This study highlighted several problematic elements that can support the identification of future solutions to resolve transversal ethical issues in research that affect the heterogeneous members of the academic community. (shrink)

Research Ethics is a key element of Responsible Research and Innovation (RRI). In spite of an increased interest in this topic there is little empirical evidence about scientists’ practice and perception of Research Ethics. Drawing on a large-scale survey among 4,180 European researchers we present unique insights into Research Ethics activities, researchers’ motivation for ethical behavior, the perceived barriers and benefits as well as the role of institutional support. According to the survey results, most researchers consider ethical issues in their (...) research projects and see it as part of good research practice or are convinced that research must be ethical. Perceived benefits of Research Ethics are higher quality of scientific outputs, higher social relevance of research, increased societal impact and a changed approach to risk. Barriers to ethics activities are particularly seen in the absence of institutional support and incentives. With regard to institutional support, we show that offers and infrastructures of Research Performing Organisations for Research Ethics are not well known among the employed researchers in general. Through a regression analysis about the influence of institutional support on Research Ethics we see at the same time that the provision of an Ethics team that researchers can address and the existence of a policy for designing ethical values and principles into research practice have a positive influence on researchers to engage in Research Ethics activities. The results underlines the importance of low-threshold services and personal contacts for researchers with ethical questions. (shrink)

This article concerns the ways in which authors from various fields conceptualise the ethical issues arising in the conduct of research. We reviewed critically and systematically the literature concerning the ethics of conducting research in order to engage in a reflection about the vocabulary and conceptual categories used in the publications reviewed. To understand better how the ethical issues involved in conducting research are conceptualised in the publications reviewed, we 1) established an inventory of the conceptualisations reviewed, and 2) we (...) critically assessed them. We found that the publications reviewed mostly showed examples of descriptive ethics, in that most authors describe ethical issues without reflecting much on them, which could be explained both by 1) a lack of ethical education in research contexts, and 2) by the fact that we do not know what researchers know (or do not) about ethical issues. Additionally, the definitions identified in the publications are scarce and at times imprecise, but this seems more to point out the ethical vocabulary’s difficulties in certain contexts. Further, very few authors offer proper conceptualisations of the ethical issues arising in conducting research. When dealing with vast arrays of ethical issues to conceptualise, perhaps one ought to remember that some typologies already exist that could guide further reflection and help understand other realities for which the current ethical vocabulary may be lacking. We believe that combining the reviewed typologies, both with other well-developed typologies and critical reflection, could help support better ethical practice in conducting research. (shrink)