One of the important determinants of development during the transition to adulthood is the undertaking of social roles characteristic of adults, also in the area of finishing formal education, which usually coincides with beginning fulltime employment. In the study discussed in this paper, it has been hypothesized that continuing full-time education above the age of 26, a phenomenon rarely observed in Poland, can be considered as an unpunctual event that may be connected with difficulties in the process of identity formation. (...) Relationships between identity dimensions and identity statuses, and age and educational context were analyzed. 693 individuals aged 19-35 took part in the study. The participants attended three types of educational institutions: full-time university studies, part-time university studies, and full-time post-secondary school. Among the students of full-time university studies predictable dependencies, also in respect of highlevels of indicators of identity crisis and a high frequency of diffused identity occurrence, were observed. Such dependencies were not found in the group of full-time post-secondary school students. (shrink)

The quality of doctoral-level chemistry (N=145), computer science (N=58), geoscience (N=91), mathematics (N=115), physics (N=123), and statistics/biostatistics (N=64) programs at United States universities was assessed, using 16 measures. These measures focused on variables related to: program size; characteristics of graduates; reputational factors (scholarly quality of faculty, effectiveness of programs in educating research scholars/scientists, improvement in program quality during the last 5 years); university library size; research support; and publication records. Chapter I discusses prior attempts to assess quality in (...) graduate education, development of the study plans, and the selection of disciplines and programs to be evaluated. Chapter II discusses the methodology used, focusing on each of the assessment measures. Chapters III to VIII present, respectively, findings from the analyses of the chemistry, computer science, geoscience, mathematics, physics, and statistics/biostatistics programs. Chapter IX includes a summary of results, correlations among measures, several additional analyses, and suggestions for future studies. Among the findings reported are those indicating that mathematics programs had, on the average, the largest number of faculty (N=33) in December 1980 followed closely by physics (N=28) and chemistry (N=23), and that 80 percent of computer science students had job commitments by graduation. (Survey instruments and supporting documentation are included in appendices.) (JN). (shrink)

The quality of doctoral-level biochemistry (N=139), botany (N=83), cellular/molecular biology (N=89), microbiology (N=134), physiology (N=101), and zoology (N=70) programs at United States universities was assessed, using 16 measures. These measures focused on variables related to: (1) program size; (2) characteristics of graduates; (3) reputational factors (scholarly quality of faculty, effectiveness of programs in educating research scholars/scientists, improvement in program quality during the last 5 years); (4) university library size; (5) research support; and (6) publication records. Chapter I discusses (...) prior attempts to assess quality in graduate education, development of the study plans, and the selection of disciplines and programs to be evaluated. Chapter II discusses the methodology used, focusing on each of the assessment measures. Chapters III to VIII present, respectively, findings from the analyses of the biochemistry, botany, cellular/molecular biology, microbiology, physiology, and zoology programs. Chapter IX includes a summary of results, correlations among measures, several additional analyses, and suggestions for future studies. Among the findings reported are those indicating that cellular/molecular biology programs had, on the average, the largest number of faculty and that students in cellular/molecular biology, biology, biochemistry, microbiology, and physiology received a relatively high fraction of financial support. (Survey instruments and supporting documentation are included in appendices.) (JN). (shrink)

Background Standard interpretations of the ethical principle of respect for persons have not incorporated the views and values of patients, especially patients from groups underrepresented in research. This limits the ability of research ethics scholarship, guidance, and oversight to support inclusive, patient-centered research. This study aimed to identify the practical approaches that patients in community-based settings value most for conveying respect in genomics research. Methods We conducted a 3-round, web-based survey using the modified Delphi (...) technique to identify areas of agreement among English-speaking patients at primary care clinics in Washington State and Idaho who had a personal or family history of cancer. In Round 1, respondents rated the importance of 17 items, identified in prior qualitative work, for feeling respected. In Round 2, respondents re-rated each item after reviewing overall group ratings. In Round 3, respondents ranked a subset of the 8 most highly rated items. We calculated each item’s mean and median rankings in Round 3 to identify which approaches were most important for feeling respected in research. Results Forty-one patients consented to the survey, 21 (51%) completed Round 1, and 18 (86% of Round 1) completed each of Rounds 2 and 3. Two sets of rankings were excluded from analysis as speed of response suggested they had not completed the Round 3 ranking task. Respondents prioritized provision of study information to support decision-making (mean ranking 2.6 out of 8; median ranking 1.5) and interactions with research staff characterized by kindness, patience, and a lack of judgment (mean ranking 2.8; median ranking 2) as the most important approaches for conveying respect. Conclusions Informed consent and interpersonal interactions are key ways that research participants experience respect. These can be supported by other approaches to respecting participants, especially when consent and/or direct interactions are infeasible. Future work should continue to engage with patients in community-based settings to identify best practices for research without consent and examine unique perspectives across clinical and demographic groups in different types of research. (shrink)

Drawing on Moreno's cognitive-affective theory of learning with media, this research aims to investigate the effectiveness of different multimedia glosses on learners' vocabulary acquisition and reading comprehension in a CALL environment. A total of 160 university students who learnt English as a foreign language in four classes participated in the study and were exposed to one of the four conditions: L2 definition only, L2 definition coupled with audio, L2 definition plus video, and L2 definition with picture. Participants were asked (...) to read eight hypermediated reading texts. Reading comprehension as well as vocabulary acquisition were measured using a pretest–posttest design. The results show first that all these four conditions led to students' vocabulary gains. More specifically, participants who had access to L2 definition plus picture and plus videos achieved significantly higher scores than the other two groups, L2 definition coupled with audio and L2 definition only. Concerning reading comprehension, all multimedia glossing presentation led to better reading comprehension, but no differences were found among all the glossing groups. The questionnaire and interview data indicate that students preferred L2 definition coupled with video and picture glosses, followed by audio and L2 definition only. The results reflect that multimedia glossing presentation creates a different effect on students' vocabulary acquisition and reading comprehension, respectively. They also provide pedagogical implications for learning in times of COVID-19. (shrink)

This chapter examines the explicit and implicit roles that the concept of beneficence plays in the guidelines that govern biomedical research involving humans. We suggest that the role beneficence is actually playing in the guidelines is more comprehensive than is commonly assumed. The broader conceptualisation of beneficence proposed here clarifies the relationship of beneficence to respect for autonomy. It does this by showing how respect for autonomy is at the service of beneficence rather than in tension with (...) it. (shrink)

Research partnerships between institutions in the Global North and institutions in the Global South have many potential benefits, including sharing of knowledge and resources. However, such partnerships are traditionally exploitative to varying degrees. In order to promote equity in South‐North research partnerships, it is necessary to learn from the experiences of researchers collaborating internationally. This study analyzed transcripts from eleven semi‐structured qualitative interviews with researchers working at Clínica de Familia La Romana, an institution in the Dominican Republic with (...) decades of experience with research and research partnerships with institutions from the Global North. The findings of this study suggest that respect for resources invested in research, as well as for the researchers and institutions themselves, are vital components to a successful global health research partnership. These findings have implications for individual research partnerships, as well as the policies of journals and institutions providing funding that affect these partnerships. (shrink)

Background Respect is essential to providing high quality healthcare, particularly for groups that are historically marginalized and stigmatized. While ethical principles taught to health professionals focus on patient autonomy as the object of respect for persons, limited studies explore patients’ views of respect. The purpose of this study was to explore the perspectives of a multiculturally diverse group of low-income women living with HIV (WLH) regarding their experience of respect from their medical physicians. Methods We analyzed (...) 57 semi-structured interviews conducted at HIV case management sites in South Florida as part of a larger qualitative study that explored practices facilitating retention and adherence in care. Women were eligible to participate if they identified as African American (n = 28), Hispanic/Latina (n = 22), or Haitian (n = 7). They were asked to describe instances when they were treated with respect by their medical physicians. Interviews were conducted by a fluent research interviewer in either English, Spanish, or Haitian Creole, depending on participant’s language preference. Transcripts were translated, back-translated and reviewed in entirety for any statements or comments about “respect.” After independent coding by 3 investigators, we used a consensual thematic analysis approach to determine themes. Results Results from this study grouped into two overarching classifications: respect manifested in physicians’ orientation towards the patient (i.e., interpersonal behaviors in interactions) and respect in medical professionalism (i.e., clinic procedures and practices). Four main themes emerged regarding respect in provider’s orientation towards the patient: being treated as a person, treated as an equal, treated without blame or prejudice, and treated with concern/emotional support. Two main themes emerged regarding respect as evidenced in medical professionalism: physician availability and considerations of privacy. Conclusions Findings suggest a more robust conception of what ‘respect for persons’ entails in medical ethics for a diverse group of low-income women living with HIV. Findings have implications for broadening areas of focus of future bioethics education, training, and research to include components of interpersonal relationship development, communication, and clinic procedures. We suggest these areas of training may increase respectful medical care experiences and potentially serve to influence persistent and known social and structural determinants of health through provider interactions and health care delivery. (shrink)

Ethical issues in biomedical research are traditionally examined as distinct from those of clinical care. However, this traditional framing may obscure questions of equity and fairness in both rese...

Since the end of World War II, most guidelines governing human research seem to have relied on the principle of respect for autonomy as a key, though not sole, criterion in assessing the moral validity of research involving human participants.1 One explanation for this apparent reliance on respect for autonomy may be that respect for autonomy, made effective through the practice of obtaining informed consent, functions as a useful proxy when dealing with competent adults for (...) the more complex principle of respect for human dignity that underpins much of the moral discourse in this area. If this explanation holds, then assessment of the moral licitness of research involving human individuals whose autonomy is limited in some way requires a deeper analysis of the ‘thicker’ concepts of human dignity, since we cannot rely on respect for autonomy to do the work of respect for human dignity where autonomy (understood as a capacity to consent based on adequate information) is not present, is limited or is compromised. (shrink)

I begin the chapter with research, reported recently in The Atlantic, on the surprising phenomenon that many successful women, all accomplished and highly competent, exhibit high degrees of self-doubt. Unlike the original research, the chapter aims to bring into view the role self-respect plays in higher education as another crucial explanatory factor. First, I clarify the main concepts that are relevant for getting a clear view of the notion of self-respect: different kinds of self-respect and (...) the connection to the notion of self-esteem are discussed. After this, in section III, I move on to the main theoretical positions that historically have put self-respect in the centre of their theorizing. The story starts with Immanuel Kant, continues with John Rawls, and ends with the influential accounts of Axel Honneth, Avishai Margalit and several feminist thinkers. Having covered the theoretical and conceptual landscape, I finally connect self-respect to higher education both on the systematic as well as on the more applied level of thinking. I then wrap up the chapter by connecting back to The Atlantic story we have started out with as well as make suggestions of further reading for those with deeper interest in the topic. I also provide a a brief list of the main takeaways as well propose some questions for discussion. (shrink)

Journal Name: Apeiron Issue: Ahead of print.

Respect for autonomy has become a fundamental principle in human research ethics. Nonetheless, this principle and the associated process of obtaining informed consent do have limitations. This can lead to some groups, many of them vulnerable, being left understudied. This book considers these limitations and contributes through legal and philosophical analyses to the search for viable approaches to human research ethics. It explores the limitations of respect for autonomy and informed consent both in law and through (...) the examination of cases where autonomy is lacking (infants), diminished (addicts), and compromised (low socio-economic status). It examines alternative and complementary concepts to overcome the limits of respect for autonomy, including beneficence, dignity, virtue, solidarity, non-exploitation, vulnerability and self-ownership. It takes seriously the importance of human relationality and community in qualifying, tempering and complementing autonomy to achieve the ultimate end of human research - the good of humankind. (shrink)

The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants (...) in English or Spanish about their experiences with respect in the study and perceptions of how researchers in a hypothetical observational study could convey respect or a lack thereof. Most interviewees were female, identified as Hispanic/Latino or non-Hispanic white, reported annual household income under US$60 000 and did not have a Bachelor’s degree ; 30% had limited health literacy. We identified four key domains for demonstrating respect: personal study team interactions, with an emphasis on empathy, appreciation and non-judgment; study communication processes, including following up and sharing results with participants; inclusion, particularly ensuring materials are understandable and procedures are accessible; and consent and authorisation, including providing a neutral informed consent and keeping promises regarding privacy protections. While the experience of respect is inherently subjective, these findings highlight four key domains that may meaningfully demonstrate respect to potential and current research participants. Further empirical and normative work is needed to substantiate these domains and evaluate how best to incorporate them into the practice of research. (shrink)

Re-consent in research, the asking for a new consent if there is a change in protocol or to confirm the expectations of participants in case of change, is an under-explored issue. There is little clarity as to what changes should trigger re-consent and what impact a re-consent exercise has on participants and the research project. This article examines applicable policy statements and literature for the prevailing arguments for and against re-consent in relation to longitudinal cohort studies, tissue banks (...) and biobanks. Examples of re-consent exercises are presented, triggers and non-triggers for re-consent discussed and the conflicting attitudes of commentators, participants and researchers highlighted. We acknowledge current practice and argue for a greater emphasis on ‘responsive autonomy,’ that goes beyond a one-time consent and encourages greater communication between the parties involved. A balance is needed between respecting participants' wishes on how they want their data and samples used and enabling effective research to proceed. (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)

In this article I defend a rule utilitarian approach to paternalistic policies in research with human participants. Some rules that restrict individual autonomy can be justified on the grounds that they help to maximize the overall balance of benefits over risks in research. The consequences that should be considered when formulating policy include not only likely impacts on research participants, but also impacts on investigators, institutions, sponsors, and the scientific community. The public reaction to adverse events in (...) research (such as significant injury to participants or death) is a crucial concern that must be taken into account when assessing the consequences of different policy options, because public backlash can lead to outcomes that have a negative impact on science, such as cuts in funding, overly restrictive regulation and oversight, and reduced willingness of individuals to participate in research. I argue that concern about the public reaction to adverse events justifies some restrictions on the risks that competent, adult volunteers can face in research that offers them no significant benefits. The paternalism defended here is not pure, because it involves restrictions on the rights of investigators in order to protect participants. It also has a mixed rationale, because individual autonomy may be restricted not only to protect participants from harm but also to protect other stakeholders. Utility is not the sole justification for paternalistic research policies, since other considerations, such as justice and respect for individual rights/autonomy, must also be taken into account. (shrink)

Respectfulness is demanded of doctors and predicts more positive patient health-related outcomes, but research is scarce on ways to promote it. This study explores two ways to conceptualize unconditional respect from medical students, defined as respect paid to people on the basis of their humanity, in order to inform strategies to increase it. Unconditional respect conceptualized as an attitude suggests that unconditional respect and conditional respect are additive, whereas unconditional respect conceptualized as a (...) personality trait suggests that people who are high on unconditional respect afford equal respect to all humans regardless of their merits. One hundred and eighty-one medical students completed an unconditional respect measure then read a description of a respect-worthy or a non-respect-worthy man and indicated their respect towards him. The study found a main effect for unconditional respect and a main effect for target respect-worthiness but no interaction between the two when respect paid to the target was assessed, supporting the attitude-based conceptualization. This suggests that unconditional respect can be increased through relevant interventions aimed at increasing the relative salience to doctors of the human worth of individuals. Interventions to increase unconditional respect are discussed. (shrink)

Doctoral programs at U.S. universities play a critical role in the development of human resources both in the United States and abroad. This volume reports the results of an extensive study of U.S. research-doctorate programs in five broad fields: physical sciences and mathematics, engineering, social and behavioral sciences, biological sciences, and the humanities. Research-Doctorate Programs in the United States documents changes that have taken place in the size, structure, and quality of doctoral education since the widely used 1982 (...) editions. This update provides selected information on nearly 4,000 doctoral programs in 41 subdisciplines at 274 doctorate-granting institutions. This volume also reports the results of the National Survey of Graduate Faculty, which polled a sample of faculty for their views on the scholarly quality of program faculty and the effectiveness of doctoral programs in preparing research scholars/scientists. This much-anticipated update of such an essential reference will be useful to education administrators, university faculty, and students seeking authoritative information on doctoral programs. (shrink)

With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account, has been introduced by the European Union . How four different member states—Hungary, Portugal, Sweden and the UK—have chosen to implement the directive is shown. Although this has resulted in four very different ways of structuring RECs, similar themes are present in all four (...) cases, such as centralisation of control over RECs within member states, harmonisation of REC procedures across the EU and increased role of political decision making with regard to such committees. (shrink)

The establishment of a Research Ethics Committee (REC) is a significant step to ensure the standard procedures in ethics review process that protect human participants. However, in instances when RECs are not yet established, surrogate activities are practiced by some institutions. The objective of this study was to identify prevailing research ethical practices of research directors and faculty researchers in the absence of a research ethics committee in their respective academic institutions. Specifically, it aimed to explore (...) the participants’ 1) experiences in research subject protection and 2) challenges when there is no existing REC in the institution. Participants were selected from universities in Manila City whose institutions did not have RECs at the time of the conduct of this study. Key informant interviews and focus group discussions were used as approaches for data collection. The authors used NVivo to organize data from the transcribed audio-recorded interviews and were analyzed utilizing a basic interpretive qualitative approach. Based on the results, surrogate practices of participants involved (1) providing “informed consent forms” to target participants and the (2) roles of different personalities in the evaluation/conduct of the research paper. Implications of this study and recommendations were likewise discussed in this paper. (shrink)

Despite advances in theory, often driven by feminist ethicists, research ethics struggles in practice to adequately account for and respond to the agency and autonomy of people considered vulnerable in the research context. We argue that shifts within feminist research ethics scholarship to better characterise and respond to autonomy and agency can be bolstered by further grounding in discourses from the social sciences, in work that confirms the complex nature of human agency in contexts of structural and (...) other sources of vulnerability. We discuss some of the core concepts and critiques emerging from the literature on women and children's agency in under‐resourced settings, highlighting calls to move from individualistic to relational models of agency, and to recognise the ambiguous, value‐laden, and heterogeneous nature of the concept. We then draw out what these conceptual shifts might mean for research ethics obligations and guidance, illustrating our analysis using a case vignette based on research ethics work conducted in South Africa. We conclude that if research practices are to be supportive of agency, it will be crucial to scrutinise the moral judgements which underpin accounts of agency, derive more situated definitions of and responses to agency, and enable people and participants to influence these based on their own experiences and self‐perceptions. (shrink)

The Russian philosopher and cultural theorist Mikhail Bakhtin has traditionally been seen as the leading figure in the group of intellectuals known as the Bakhtin Circle. The writings of other members of the Circle are considered much less important than his work, while Bakhtin's achievement has been exaggerated in proportion to the downgrading of the thinkers with whom he associated in the 1920s. This volume, which includes new translations and studies of the work of the most important members of the (...) Circle, sets out to correct the distortions in the established representations of its activity. The original contributions to literary and linguistic theory made by Valentin Voloshinov and Pavel Medvedev (but frequently credited to Bakhtin) are assessed, and the distinctiveness of their approaches is highlighted. (shrink)

As part of a (bio)colonial project, the biological information of Indigenous Peoples has historically been under scientific scrutiny, with very limited benefits for communities and donors. Negative past experiences have contributed to further exclude Indigenous communities from novel developments in the field of omics research. Over the past decade, new guidelines, reflections, and projects of genetic research with Indigenous Peoples have flourished in Australia, providing opportunities to move the field into a place of respect and ethical relationships. (...) This review explores the ethical and cultural implications of the use of biological samples from Indigenous communities in biomedical research. A structured framework outlining emerging topics of interest for the development of respectful omics research partnerships with Indigenous Australians is presented. This paper highlights aspects related to Indigenous governance, community and individual consent, respectful handling of biological samples, data management, and communication in order to protect Indigenous interests and rights and to promote communities’ autonomy. (shrink)

Conducting research on adolescents raises a number of ethical issues not often confronted in research on younger children. In part, these differences are due to the fact that although assent is usually not an issue, given cognitive and social competencies, the life situations and behavior of youth make it more difficult to balance rights and privacy of the adolescents. In this article, the three ethical principles of beneficence, justice, and respect for persons are discussed in terms of (...) their application to the study of adolescents. Then, seven vignettes are presented to illustrate how these principles apply to real-life situations. How to balance the rights of adolescents and their parents is discussed, using adolescent girls and their parents for illustrative purposes. (shrink)

Includes bibliographical references and index.

The ethical issues in conducting research on preventing HIV infection are among the most complex of any area of human subjects research. This article is an update of a 1987 article that addressed potential conflicts between research design and ethics with respect to AIDS prevention among injecting drug users. The present article reviews current ethical issues that arise in the design and conduct of HIV/AIDS prevention research focused on injecting drug users.

In the Netherlands, the legalization of assisted suicide for persons with a death wish without severe illness, often referred to as persons with “completed life” or “tiredness of life,” is intensel...

Two large online surveys were conducted among employees in Germany to explore the importance employees and organizations place on aspects of interpersonal respect in relation to other work values. The first study (n = 589) extracted a general ranking of work values, showing that employees rate issues of respect involving supervisors particularly high. The second study (n = 318) replicated the previous value ranking. Additionally, it is shown that the value priorities indicated by employees do not always match (...) their perceptions of actual organizational practices. Particularly, interpersonal respect issues that involve employees’ supervisors diverge strongly negative. Consequences and potentials for change in organizations are discussed. (shrink)

The purpose of this article is to show that animal rights are not necessarily at odds with the use of animals for research. If animals hold basic moral rights similar to those of humans, then we should consequently extend the ethical requirements guiding research with humans to research with animals. The article spells out how this can be done in practice by applying the seven requirements for ethical research with humans proposed by Ezekiel Emanuel, David Wendler (...) and Christine Grady to animal research. These requirements are i) social value, ii) scientific validity, iii) independent review, iv) fair subject selection, v) favorable risk-benefit ratio, vi) informed consent, and vii) respect for research subjects. In practice, this means that we must reform the practice of animal research to make it more similar to research with humans, rather than completely abolish the former. Indeed, if we banned animal research altogether, then we would also deprive animals of its potential benefits – which would be ethically problematic. (shrink)

The articles by Brooks-Gum, Fisher, Hoagwood, Liss, and Scott-Jones (all this issue) present a panoply of real-world ethical issues in conducting scientific research on risky behaviors of children, adolescents, and their parents, particularly those from vulnerable populations. The universal, ethical principles of beneficence, justice, and respect for others are always applicable, but they do not resolve issues of child assent, parental consent, legal reporting requirements for illegal behaviors, and the special problems of studying risky behaviors in risky populations. (...) Taken as a group, the articles raise some of the most interesting ethical problems that arise in developmental research. My discussion elaborates some issues and fails to resolve others. I hold the view that both science and ethics can be served by thoughtfully designed and implemented research on important social issues, but that the studies themselves cannot simultaneously solve the many societal problems of participants and be scientifically credible. (shrink)

Background The ethical use both of human and non-human animals in research is predicated on the assumption that it is of a high quality and its projected benefits are more significant than the risks and harms imposed on subjects. Yet questions remain about whether and how IRBs and IACUCs should consider the scientific value of proposed research studies.Methods We draw upon 45 interviews with IRB and IACUC members and researchers with oversight experience about their perceptions of their own (...) roles in reviewing the quality and value of scientific protocols. Interview transcripts were memoed to highlight specific findings, which were then used to identify key themes through an iterative process.Results IRB and IACUC members expressed broad trust in the need for and value of research, and they often assumed that protocols had social value or that prior review, especially when associated with funding, affirmed both the rigor and merit of those protocols. Some oversight members also took an explicit stance against scientific review by stating that such review is not within the regulatory mandates governing their parts in the oversight system. Yet other interviewees expressed uneasiness about the current paradigm for evaluating the quality and overall value of science, suggesting that IRB and IACUC members perceive gaps in the oversight systems.Conclusions These findings reveal many similarities in how IRB and IACUC members understand the roles and limitations of their respective oversight committees. We conclude with a discussion of how the lack of a clear mandate regarding scientific review within US federal regulations may undermine ethical engagement of whether human and animal research is scientifically justified, resulting in a “mission lapse” wherein no organizational body is clearly responsible for ensuring that the research being conducted has the potential to advance science and benefit society. (shrink)

Socioscientific issues receive considerable public attention and there are concerns that people in general are not able or willing to deal with information at odds with what they believe to be true. In this study, we focused on students’ beliefs about two controversial issues: whether consumption of the artificial sweetener aspartame and use of cell phones, respectively, represent any serious health risks. Our aim was to investigate whether students’ trust in the information was related to prior beliefs, the nature of (...) the message, and students’ critical reading strategies. Results showed interactions between prior beliefs about the issues and text condition (risk vs. no risk) on trust in conclusions that indicated a confirmation bias assumption. Additionally, students trusted conclusions ascertaining that there were risks more than conclusions ascertaining that there were no risks. Finally, students’ self-reported use of critical reading strategies implied less trust in both types of conclusions. (shrink)

To give valid informed consent to participate in clinical research, potential participants should understand the risks, potential benefits, procedures, and alternatives. Potential participants also should understand that they are being invited to participate in research. Yet it is unclear what potential participants need to understand to satisfy this particular requirement. As a result, it is unclear what additional information investigators should disclose about the research; and it is also unclear when failures of understanding in this respect (...) undermine the validity of potential participants' informed consent. An analysis of individuals' interests suggests that potential participants need to understand three additional facts to understand that they are being invited to participate in research: 1) research contribution: those who enroll in the study will be contributing to a project designed to gather generalizable knowledge to benefit others in the future; 2) research relationship: the investigators will rely on participants' efforts to gather the generalizable knowledge to benefit others; and 3) research impact: the extent to which participating in the study will alter what participants do and what happens to them. (shrink)

Given its non-invasive nature, there is increasing interest in the use of transcutaneous vagus nerve stimulation across basic, translational and clinical research. Contemporaneously, tVNS can be achieved by stimulating either the auricular branch or the cervical bundle of the vagus nerve, referred to as transcutaneous auricular vagus nerve stimulation and transcutaneous cervical VNS, respectively. In order to advance the field in a systematic manner, studies using these technologies need to adequately report sufficient methodological detail to enable comparison of results (...) between studies, replication of studies, as well as enhancing study participant safety. We systematically reviewed the existing tVNS literature to evaluate current reporting practices. Based on this review, and consensus among participating authors, we propose a set of minimal reporting items to guide future tVNS studies. The suggested items address specific technical aspects of the device and stimulation parameters. We also cover general recommendations including inclusion and exclusion criteria for participants, outcome parameters and the detailed reporting of side effects. Furthermore, we review strategies used to identify the optimal stimulation parameters for a given research setting and summarize ongoing developments in animal research with potential implications for the application of tVNS in humans. Finally, we discuss the potential of tVNS in future research as well as the associated challenges across several disciplines in research and clinical practice. (shrink)

Biobanking policy needs to take into account the concept of human dignity, because this concept is enshrined in both international and South African law. The accepted understanding of informed consent, which is also required by law, is inadequate for biobanking because it is often not possible to inform people of possible uses of their stored tissue. If human dignity is understood as a multidimensional concept that corresponds to the multidimensionality of the human person, then human dignity can be said to (...) be both (i) something that all people already have, as an inviolable worth that inheres in their potential to live meaningful lives; and (ii) something that people seek to realize through morally good behavior in historically-situated relationships. This understanding of human dignity can be used as both an interpretive lens and a normative vision. It is interpretive because it reveals how various attitudes to biobanking and the various proposed consent regimes--presumed, broad, and specific--might all be underpinned by appeals to human dignity. It is a normative vision because, given that all of these positions can be underpinned as morally meaningful with respect to human dignity, provision should be made for all of the possible consent regimes in law and in biobanking practice. Nonetheless, where compromise cannot be avoided, then, at the very least, human dignity understood as the human potential to live a meaningful moral life must be protected. (shrink)

Given its non-invasive nature, there is increasing interest in the use of transcutaneous vagus nerve stimulation across basic, translational and clinical research. Contemporaneously, tVNS can be achieved by stimulating either the auricular branch or the cervical bundle of the vagus nerve, referred to as transcutaneous auricular vagus nerve stimulation and transcutaneous cervical VNS, respectively. In order to advance the field in a systematic manner, studies using these technologies need to adequately report sufficient methodological detail to enable comparison of results (...) between studies, replication of studies, as well as enhancing study participant safety. We systematically reviewed the existing tVNS literature to evaluate current reporting practices. Based on this review, and consensus among participating authors, we propose a set of minimal reporting items to guide future tVNS studies. The suggested items address specific technical aspects of the device and stimulation parameters. We also cover general recommendations including inclusion and exclusion criteria for participants, outcome parameters and the detailed reporting of side effects. Furthermore, we review strategies used to identify the optimal stimulation parameters for a given research setting and summarize ongoing developments in animal research with potential implications for the application of tVNS in humans. Finally, we discuss the potential of tVNS in future research as well as the associated challenges across several disciplines in research and clinical practice. (shrink)

In research ethics there is a canon regarding what ethical rules ought to be followed by investigators vis-à-vis their treatment of subjects and a canon regarding what fundamental ethical principles apply to the endeavor. What I aim to demonstrate here is that several of the rules find no support in the principles. This leaves anyone who would insist that we not abandon those rules in the difficult position of needing to establish that we are nevertheless justified in believing in (...) the validity of the rules. I conclude by arguing that this is not likely to be accomplished.The rules I call into question are the rules requiring:– that studies be designed in a scientifically valid way– that risks to subjects be minimized– that subjects be afforded post-trial access to experimental interventions– that inducements paid to subjects not be counted as a benefit to them– that inducements paid to subjects not be ‘undue’– that subjects must remain free to withdraw from the study at any time for any reason without penaltyBoth canons, the canon on principles and the canon on rules, are found in the overlap among ethical pronouncements that are themselves canonical: the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, CIOMS's International Ethical Guidelines for Biomedical Research Involving Human Subjects, and NBAC's 2001 report, Ethical Issues in International Research: Clinical Trials in Developing Countries. (shrink)

This paper looks at the issue of consent from children and whether the test of Gillick competency, applied in medical and healthcare practice, ought to extend to participation in research. It is argued that the relatively broad usage of the test of Gillick competency in the medical context should not be considered applicable for use in research. The question of who would and could determine Gillick competency in research raises further concerns relating to the training of the (...) researcher to make such a decision as well as to the obvious issue of the researcher’s personal interest in the project and possibility of benefiting from the outcome. These could affect the judgment of Gillick competency if the researcher is charged with making this decision. The above notwithstanding, there are two exceptional research situations in which Gillick competency might be legitimately applied: when the research is likely to generate significant advantages for the participants while exposing them to relatively minor risks, and when it is likely to generate great societal benefit, pose minimal risks for the participants and yet raise parental objection. In both cases, to ensure that autonomy is genuinely respected and to protect against personal interest, Gillick competency should be assessed by an individual who has no interest or involvement in the research. (shrink)

Research is a global enterprise requiring participation of both genders for generalizable knowledge; advancement of science and evidence based medical treatment. Participation of women in research is necessary to reduce the current bias that most empirical evidence is obtained from studies with men to inform health care and related policy interventions. Various factors are assumed to limit autonomy amongst the Yoruba women of western Nigeria. This paper seeks to explore the experience and understanding of autonomy by the Yoruba (...) women in relation to research participation. Focus is on factors that affect women's autonomous decision making in research participation. An exploratory qualitative approach comprising four focus group discussions, 42 in-depth interviews and 14 key informant interviews was used. The study permits a significant amount of triangulation, as opinions of husbands and religious leaders are also explored. Interviews and discussions were audiotaped and transcribed verbatim. Content analysis was employed for data analysis. Findings show that concepts of autonomy varied amongst the Yoruba women. Patriarchy, religion and culture are conceived to have negative impact on the autonomy of women in respect to research participation. Among the important findings are: 1) male dominance is strongly emphasized by religious leaders who should teach equality, 2) while men feel that by making decisions for women, they are protecting them, the women on the other hand see this protection as a way of limiting their autonomy. We recommend further studies to develop culturally appropriate and workable recruitment methods to increase women's participation in research. (shrink)

Volume 20, Issue 10, October 2020, Page 87-89.