The practice of paying research subjects for participating inclinical trials has yet to receive an adequate moral analysis.Dickert and Grady argue for a wage payment model in whichresearch subjects are paid an hourly wage based on that ofunskilled laborers. If we accept this approach, what follows?Norms for just working conditions emerge from workplacelegislation and political theory. All workers, includingpaid research subjects under Dickert and Grady''s analysis,have a right to at least minimum wage, a standard work week,extra pay for overtime hours, (...) a safe workplace, no faultcompensation for work-related injury, and union organization.If we accept that paid research subjects are wage earners likeany other, then the implications for changes to current practiceare substantial. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Protecting Human Research SubjectsThe Office for Protection from Research RisksJoan Paine Porter (bio)The office for Protection from Research Risks (OPRR), located within the National Institutes of Health, has two divisions: Human Subject Protections and Animal Welfare. This article will address the overall responsibilities and current projects relating to human subject protections.OPRR implements the Department of Health and Human Services' (HHS) regulations for the protection of human subjects (...) (45 CFR 46 (1991)). These regulations fulfill the responsibilities set forth in the Public Health Service (PHS) Act with regard to institutional review boards (IRB) and other protections for human subjects involved in biomedical and behavioral research conducted or supported by HHS. The PHS Act also mandates a program to clarify ethical issues in biomedical research involving human subjects and to address violations of the rights of human subjects of research (P.L. 99-158 (1985)).OPRR staff negotiate assurances of compliance with institutions conducting Federally-supported research involving human subjects. The assurances describe the policies and procedures each institution will follow to fulfill the requirements of the regulations, including specific IRB composition and functions.In addition, OPRR cosponsors with the Food and Drug Administration and awardee institutions a series of regional workshops that address human subject protections issues. These are attended by IRB members, institutional officials, research investigators, and others involved with human subject protections.Current ActivitiesNumerous activities are underway in OPRR. The following describes only a few of the initiatives and studies aimed at helping develop policies and procedures to protect human subjects of research."Points to Consider" DocumentsOPRR is currently working with the National Center for Human Genome Research (NCHGR) to develop a "points to consider" document for IRBs and others involved in large genetic pedigree studies. Many questions have emerged [End Page 279] on topics such as how subjects should be recruited, with whom information should be shared about others in the family, social risks of disclosure in employment and insurance, the circumstances and timing of informing subjects about study results, and involvement of children. OPRR and NCHGR hope to assemble a group this fall to review and refine the points that are now being developed jointly. A conference in South Carolina organized by the American Association for Advancement in the Sciences entitled "Project on the Ethical and Legal Implications of Genetic Testing," helped generate advice, and identified some of the more controversial issues in design and conduct of genetic research that involves large groups of family members.Another "points to consider" effort concerns enrollment of women and minorities in research. The PHS has established a policy that members of these groups must be included in research projects unless there are valid scientific justifications for their exclusion which can be made on a project by project basis (ADAMHA/NIH Policy 1990; NIH/ADAMHA Policy 1990). OPRR has commissioned several scholarly papers to help in developing "points to consider" for IRBs as they balance issues of equitable selection of subjects and protection of these selected individuals. Concerns about enrolling women of childbearing age in research that may be harmful to a fetus, and liability issues frequently dominate discussion in this area. The papers will address ethical, legal, and statistical aspects of enrollment of minorities and women as well as provide a description of various practices and roles of IRBs in addressing goals of fair selection of participants and appropriate protections.OPRR is also working with the PHS Panel on Women, Adolescents and Children to produce a document, also in the form of "points to consider" guidance, concerning enrollment of children who are wards of the state in HIV-related research. Subpart D of the regulations for the protection of human subjects (45 CFR 46) specifically addresses research involving children who are wards of the state, including the special protections that must be provided. State and local officials who have authority to enroll foster care children in research have indicated a desire to obtain advice in this area.The IRB GuidebookA major project that is now being completed under contract to the Poynter Center at Indiana University is the IRB Guidebook. It will revise and expand the current IRB Guidebook produced in the 1980s... (shrink)

Responding to the Special Issue's call for “new thinking” on gender and governance in developing societies, we introduce our research on the social organization of development knowledge and its ethical implications. Our feminist‐based approach, institutional ethnography, analyses the ruling relations of development and the standpoints represented in knowledge about development and its governance. Our paper offers an alternative to what we see as “the institutional standpoint” prevailing, but taken for granted, in business and society scholarship addressing development. Instead of (...) theorizing development relationships between institutions and their “stakeholders,” we illustrate what can be learned about the social relations of development beginning from the experiences of local subjects. Our analysis of an environmental research and development project in Uzbekistan shows that being missed is knowledge about development subjects that could have revealed what is locally relevant and needed. Instead, we discover gender inequality being constituted, unknowingly, within this project's institutionally generated knowledge and the activities it authorizes. (shrink)

This article discusses some ethical issues that can arise when researchers decide to increase the amount of payment offered to research subjects to boost enrollment. Would increasing the amount of payment be unfair to subjects who have already consented to participate in the study? This article considers how five different models of payment—the free market model, the wage payment model, the reimbursement model, the appreciation model, and the fair benefits model—would approach this issue. The article also considers several practical problems (...) related to changing the amount of payment, including determining whether there is enough money in the budget to offer additional payments to subjects who have already enrolled, ascertaining how difficult it will be to re-contact subjects, and developing a plan of action for responding to subjects who find out they are receiving less money and demand an explanation. (shrink)

The capacity-building strategy used by a US-based research organisation, the Pacific Institute for Research and Evaluation , to strengthen the system for the protection of human research subjects and the infrastructure of its international collaborating partner, the University of Liberia, are discussed. To conduct the much-needed biomedical and social science-based research-related activities in the future, this partnership is expected by PIRE to gradually evolve over time to strengthen the capacity of the local investigators and administrators of the University of Liberia. (...) Accordingly, a unique opportunity to share technology and resources with a post-conflict, resource-constrained country is created by this partnership. This capacity-building model to strengthen the protection of human subjects in research can also be replicated in similar resource-constrained international settings and, accordingly, our experiences and limitations are shared in this paper. (shrink)

How might a design approach be applied to Research? Following Glanville’sGlanville, Ranulph observation that design and researchResearch are fundamentally related and that design methodsDesignmethods may be applied across domains, we framed a case study of the perceptual effects of alternate contemporary lighting technologies at an architectural scale to show how a designer/researcher could approach this kind of investigation. Design proceeds in complex domains with incomplete data and open questions. It is often concerned with the singular or unique solution rather (...) than with generalizability. Its products are applied under hybrid and dynamic, rather than controlled, conditions. Rather than work with subjects approximating a general population, informants were recruited with more extensive or diverse experiences than our own. Color perception was investigated in large-scaled installations allowing for locomotion and full visual immersion in a color-field. The effort was not to frame hypotheses for confirmation or refutation but probe the phenomena for insights. Design researchDesignresearch methods might be preferred when the nature of the investigation is exploratory or when ecological validity dominates reliability. They might also be useful in situations where significant progress is no longer being made within a particular paradigm by recasting the nature of the inquiryEnquiry outside the frameworks that presently dominate. (shrink)

In this paper, I explore the ethics of subject selection in the context of biomedical research. I reject a key principle of what I shall refer to as the standard view. According to this principle, investigators should select participants so as to minimise aggregate risk to participants and maximise aggregate benefits to participants and society. On this view, investigators should exclude prospective participants who are more susceptible to risk than other prospective participants. I argue instead that investigators should select (...) subjects in accordance with an alternative principle: formal equality of opportunity. According to this principle, investigators must treat all prospective participants the same unless differential treatment is warranted by the scientific goals of the study or the need to promote participants' medically related interests. All prospective participants (1) who meet the scientifically defined eligibility criteria and (2) for whom participation is consistent with their medically related interests should have an equal, formal opportunity to participate in the study. Prospective participants should not be excluded simply because they are more susceptible to risk than others. (shrink)

From some years now, the social sciences have been highlighting the existence of a type of goods that are neither material things, nor ideas, nor functional performances but consist, instead, of social relations and, for this reason, are called relational goods. This contribution proposes to clarify this concept from the viewpoint of relational sociology, which avoids both methodological individualism and holism. Subsequently, it argues that such goods can be produced only by specific social subjects, which the Author calls ‘relational (...) subjects’. Relying upon many theoretical and empirical researches, the paper explains in which sense and in which way relational subjects, and the goods they generate, can contribute to making civil society more robust: that is, no longer the typically capitalist society of the market, but an ‘associational’ society able to sustain a mature democracy. (shrink)

Recent research in the educational context has focused not only on academic achievement but also on subjective well-being (SWB) as both play a major role in students’ lives. Whereas the determinants of academic achievement have been extensively investigated, little research has been conducted on school-related determinants of SWB in comparison with other students’ characteristics. In the present cross-sectional study, we set out to investigate whether perceived school climate predicts school grades and SWB above and beyond other variables that are important (...) for SWB and academic achievement. A sample of 767 8th and 9th grade students (n = 361 female adolescents; age: M = 14.07 years, SD = 0.92) completed measures of SWB, perceived school climate, test anxiety, self-efficacy, and interest. Grade point average (GPA) indicated students’ academic achievement. Data were analyzed with latent structural equation models in which GPA and SWB were regressed on the school climate variables and students’ characteristics. Results indicated that a positive school climate as well as self-efficacy and the worry component of test anxiety predicted SWB and/or GPA after all other variables were controlled for. Directions for future research and the importance of school climate variables on adolescents’ SWB and academic achievement are discussed. (shrink)

There have been serious controversies in the latter part of the 20th century about the roles and functions of scientific and medical research. In whose interests are medical and biomedical experiments conducted and what are the ethical implications of experimentation on subjects unable to give competent consent? From the decades following the Second World War and calls for the global banning of medical research to the cautious return to the notion that in controlled circumstances, medical research on human subjects is (...) in the best interest of the given individual and the broader population, this book addresses the key implications of experimentation on humans. This volume covers major ethical themes within biomedical research providing historical, philosophical, legal and policy reflections on the literature and specific issues in the field of research on human subjects. Focusing on special populations (the elderly, children, prisoners and the cognitively impaired) it represents the most up-to-date review of the special ethical and legal conflicts that arise with relation to experimentation on subjects from these groups. In the light of current initiatives for law reform pertaining to research ethics the world over, this volume provides a timely, comprehensive and provocative exploration of the field. The volume has been carefully organized to present important philosophical perspectives on organizing principles that should underlie any practical application. A forward-looking historical review of the regulatory regimes of principal jurisdictions, including of the legal controls already in place, provides the backdrop for future policy initiatives. Additionally, in the light of global restructuring of health care systems, several chapters have been devoted to epidemiological research and related issues. (shrink)

This paper outlines a theoretical context for research into ‘the subject of ethics’ in terms of how students come to see themselves as self-reflective actors. I maintain that the ‘subject of ethics’, or ethical subjectivity, has been overlooked as a necessary aspect of creating politically transformative spaces in education. At the heart of egalitarian politics lies a fundamental tension between the equality of voices and the notion that one way of being or one voice may be deemed more (...) legitimate than another; which in turn puts the equality of beings into question. Building from Michel Foucault’s work regarding ethics and subjectivity, I suggest that a ‘subject of ethics’ can be viewed, in part, as a series of relations of self that form the horizon upon which a subject comes to work on themselves relative to moral codes and power relations. Ethical relations of self can be a useful concept for those interested in educational research that furthers social and ecological justice. In the conclusion of this paper I also discuss the limitations of locating ethics entirely within a constituted human subject. (shrink)

The question of how to become and remain an effective leader has been discussed for decades, and the answers that have been proposed have led to numerous theories and taxonomies of leadership behavior. By taking a critical approach to a contemporary integrative model of leadership behavior, this theoretical research proposes an alternative approach that can supplement both the integrative model and current leader–member exchange theory. Our approach is sensitive to both objective and subjective aspects of leadership behavior. We argue that (...) perceptions of leadership behavior are influenced by interpersonal relations and contextual variables in an organization. We further argue that multilevel aspects must be investigated to understand leadership behavior and that the perceptions thereof shape and are shaped by relations and contextual variables. A distinct methodological approach based on mixed methods is then proposed to better understand what influences perceptions of leadership behavior. The article discusses the conceptual, epistemological, and methodological consequences of studying leadership behavior and perceptions of such behavior. (shrink)

Human beings with diminished decision-making capacities are usually thought to require greater protections from the potential harms of research than fully autonomous persons. Animal subjects of research receive lesser protections than any human beings regardless of decision-making capacity. Paradoxically, however, it is precisely animals’ lack of some characteristic human capacities that is commonly invoked to justify using them for human purposes. In other words, for humans lesser capacities correspond to greater protections but for animals the opposite is true. Without explicit (...) justification, it is not clear why or whether this should be the case. Ethics regulations guiding human subject research include principles such as respect for persons—and related duties—that are required as a matter of justice while regulations guiding animal subject research attend only to highly circumscribed considerations of welfare. Further, the regulations guiding research on animals discount any consideration of animal welfare relative to comparable human welfare. This paper explores two of the most promising justifications for these differences␣between the two sets of regulations. The first potential justification points to lesser moral status for animals on the basis of their lesser capacities. The second potential justification relies on a claim about the permissibility of moral partiality as␣found in common morality. While neither potential justification is sufficient to justify the regulatory difference as it stands, there is possible common ground between supporters of some regulatory difference and those rejecting the current difference. (shrink)

Of late, probability subjectivism was resuscitated by the development of statistical decision theory. In the decision model, which is briefly described in the paper, the knowledge of a probability distribution over the states of nature plays a decisive role. What sources of probability knowledge are legitimate, or at all possible, is the main point at issue. Different definitions, evaluations, and foundations of probability are narrated, discussed, and weighed against each other. The typical research strategy of the statistician is set against (...) axiomatics of subjective or mathematical probability. Finally, the epistemological roots of the probability concept are located by the author in what he calls the “etiality principle”. (shrink)

The highly publicized deaths of research participants Ellen Roche and Jesse Gelsinger are stark reminders that risk is inherent in medical research and while untoward outcomes are infrequent when compared to individual and societal benefits, injury and even death will happen. Who is responsible for the welfare of research subjects and what are they owed? Why were they put at risk to begin with? Are obligations, if any, to research subjects dependent on the type of study in which they participate, (...) in recognition that there may be personal benefit from participation in some studies?The issue of injury resulting from participation in research and answers to questions such as those just posed were last considered in depth nearly 20 years ago by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. (shrink)

Over the past three decades, two separate federal regulatory structures have emerged, each seeking to assure separate aspects of the integrity and ethics of research conducted using federal funding. One set of regulations is described in the Public Health Service Policies on Research Misconduct and relates to research misconduct, defined as consisting of fabrication of data or results, falsification of data and results, or plagiarism, in accordance with the federal‐wide definition adopted by the Office of Science and Technology Policy. The (...) second set of regulations, set forth in the Department of Health and Human Services regulations on the protection of human subjects (known as the “Common Rule”), prescribes a set of ethical and procedural protections for research involving human subjects.These two sets of research regulations are distinguished from each other by having different foci of enforcement, priorities of protection, oversight officials, oversight procedures, seizure of evidence, standards of proof, expectations of privacy, and appeal procedures for researchers who are subject to adverse findings and penalties. These differences are significant and fundamental. They complicate the process of compliance for institutions and researchers, who are expected to adhere to both sets of standards for the same federally funded research activities in research with human subjects. Compliance is especially complicated when suspected violations of both sets of standards must be investigated and resolved concurrently. This document represents an effort to provide institutions and individuals with practical suggestions as they try to comply with both sets of regulations. (shrink)

Brownfield has become one of the critical issues in modern cities. Over the past few decades, a considerable number of papers on brownfield research have been published. This study reviewed 773 documents themed with “brownfield” in the Web of Science core database between 1980 and 2020 and used the CiteSpace software to sort out the spatial and temporal distribution, knowledge groups, subject structures and hotspot fields, and evolutionary trends of global brownfield research. The analysis focuses on distribution of lead (...) authors and their institutions, high-frequency categories and keywords, high influential journals, author contribution, and evolutionary trends based on coword analysis, coauthor analysis, cocitation analysis, and cluster analysis of documents. On the basis of the aforementioned keywords, clusters, and citation bursts analysis, this paper establishes a multidisciplinary framework for brownfield research, suggesting the main research directions for the future development, which provides theoretical support and practical guidance for the research direction of future brownfield research. (shrink)

Compensation for research related injuries is a subject that is increasingly gaining traction in developing countries which are burgeoning destinations of multi center research. However, the existence of disparate compensation rules violates the ethical principle of fairness. The current paper presents a comparison of the policies of Brazil, Russia, India, China and South Africa. A systematic search of good clinical practice guidelines was conducted employing search strategies modeled in line with the recommendations of ADPTE Collaboration. The search focused on (...) three main areas namely bibliographic data bases, clinical practice guidelines data bases and a restricted internet search. A manual search of references cited in relevant guideline documents was also conducted. The search terms, Medical Subject Headings and key words were developed for a PubMed platform and then adapted for all other data bases. The search terms were kept constant for each country with the only difference being the country name. The documents so obtained were subjected to systematic content analysis. The study revealed that there is vast panoply of regulations which exist on a continuum. On one extreme is India with comprehensive regulations that are codified into law, and on the other end there is China which does not have specific laws regulating research related injuries. There are a number of differences and similarities such as mandatory insurance requirements, existence of no fault compensation, compensable injuries and the role of research ethics committees. It is imperative to enact legislations that protect participants without stifling the research enterprise. There is need for consistency and ideally harmonization of such regulations at a global level. A model policy on compensation for research related injuries should borrow from the best aspects of the different country policies and should be informed by the cardinal ethics principles of autonomy, justice and beneficence. (shrink)

In the U.S., there is no requirement for research sponsors to compensate human research subjects who experience injuries as a result of their participation. In this article, we review the moral justifications that compel the establishment of a better research-related injury compensation system. We explore how other countries and certain institutions within the U.S. have adopted various systems of compensation. The existence of these systems demonstrates both that the U.S. lags behind other nations in its protection of human research subjects (...) and that the establishment of a compensation system is both practical and feasible. We then examine factors which have prevented the U.S. from establishing its own compensation system. We consider possible alternatives for the U.S. by examining the advantages and disadvantages of both established and proposed systems. We offer a new proposal that addresses the justice concerns which compel the establishment of a national compensation system, distributes the burdens of such a system on multiple stakeholders that benefit from research, and has the additional advantage of minimizing the administrative and logistical challenges associated with initiating such a system. (shrink)

Procedures for the selection of subjects for participation in randomized clinical trials--usually formalized as eligibility criteria in the study protocol--have both scientific and ethical implications. In this thesis, I undertake an examination of eligibility criteria at three stages in the genesis and dissemination of medical knowledge: clinical trial protocol, interpretation by investigators, and reporting of study results.In the first chapter, ethical issues in subject selection are reviewed and the main study questions are presented. In the second chapter, the results (...) of an examination of eligibility criteria in two sets of clinical trials, one sponsored by the NSABP, the other sponsored by POG, covering a twenty-year time span are presented. The POG trials had far fewer eligibility criteria than the NSABP studies, suggesting that large numbers of criteria may not be necessary for high quality research. In the third chapter, the impact of subjective eligibility criteria on enrollment and investigator uncertainty is explored. Subjective criteria were associated with more variable enrollment decisions and greater uncertainty. Such criteria represent a threat to the validity, conduct and interpretation of trials and, therefore, should only be included when carefully justified. The fourth chapter examines the accuracy of the reporting of eligibility criteria in sets of corresponding study protocol, methods paper, journal article, and Clinical Alert. Important information is lost at each step in the dissemination of study results. Unnecessary criteria ought to be dropped at a trial's inception; all other criteria must be reported faithfully. The fifth chapter attempts to provide a comprehensive philosophical account of just selection procedures for clinical research using the political philosophy of Michael Walzer. The sixth, and last, chapter, discusses explanatory and pragmatic approaches to clinical trial design, overlapping scientific and ethical concerns related to eligibility criteria, and questions for further study. (shrink)

FADYL JK and NICHOLLS DA. Nursing Inquiry 2013; 20: 23–29 Foucault, the subject and the research interview: a critique of methodsResearch interviews are a widely used method in qualitative health research and have been adapted to suit a range of methodologies. Just as it is valuable that new approaches are explored, it is also important to continue to examine their appropriate use. In this article, we question the suitability of research interviews for ‘history of the present’ studies informed by (...) the work of Michel Foucault – a form of qualitative research that is being increasingly employed in the analysis of healthcare systems and processes. We argue that several aspects of research interviewing produce philosophical and methodological complications that can interfere with achieving the aims of the analysis in this type of study. The article comprises an introduction to these tensions and examination of them in relation to key aspects of a Foucauldian philosophical position, and discussion of where this might position researchers when it comes to designing a study. (shrink)

This article argues that lingering uncertainty about the normative foundations of research ethics is perpetuated by two unfounded dogmas of research ethics. The first dogma is that clinical research, as a social activity, is an inherently utilitarian endeavor. The second dogma is that an acceptable framework for research ethics must impose constraints on this endeavor whose moral force is grounded in role-related obligations of either physicians or researchers. This article argues that these dogmas are common to traditional articulations of the (...) equipoise requirement and to recently articulated alternatives, such as the non-exploitation approach. Moreover, important shortcomings of these approaches can be traced to their acceptance of these dogmas. After highlighting these shortcomings, this article illustrates the benefits of rejecting these dogmas by sketching the broad outlines of an alternative called the "integrative approach" to clinical research. (shrink)

Although it is well accepted that working memory is intimately related to consciousness, little research has illuminated the liaison between the two phenomena. To investigate this under-explored nexus, we used an imagery monitoring task to investigate the subjective aspects of WM performance. Specifically, in two experiments, we examined the effects on consciousness of holding in mind information having a low versus high memory load, and holding memoranda in mind during the presentation of distractors . Higher rates of rehearsal occurred in (...) the high load and distractor conditions than in comparable control conditions. Examination of the temporal properties of the rehearsal-based imagery revealed that, across subjects, imagery events occurred evenly throughout the delay. We hope that future variants of this new imagery monitoring task will reveal additional insights about WM, consciousness, and action control. (shrink)

Background: In order to protect the autonomy of human subjects, we need to take their culture into account when we are obtaining informed consent. Objective and research design: This study describes the cultural aspects related to informed consent in health research and is based on electronic searches that were conducted using the Scopus, PubMed, CINAHL, and Cochrane databases published between 2000 and 2013. A total of 25 articles were selected. Findings: Our findings indicate that cultural perspectives relating to the informed (...) consent process are essential during the whole research process and particularly crucial in the planning phase of a study. Our study indicates that appropriate communication between different stakeholders plays a vital role in cultural understanding. Discussion and conclusion: The researchers’ awareness of cultural differences and their ability to work in a culturally sensitive way are key factors in improving study participation and retention in a multicultural context. Taking cultural aspects into account during the whole research process improves the quality of research. (shrink)

Special moral, regulatory, and scientific questions surround the inclusion of children in health-related research. These questions arise from a fundamental moral tension between the obligation to expose children to research participation to ensure that they share in the benefits that arise from it and the obligation to protect them from the harms associated with their inappropriate involvement in research. This tension is felt in the development of moral and regulatory frameworks for the protection of child research subjects and in the (...) implementation and interpretation of these frameworks by institutional review boards. (shrink)

This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, (...) such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust. (shrink)

International health-related research on human subjects entails unique ethical responsibilities and difficulties. Often, these difficulties are augmented by the lack of a local ethical review infrastructure. In a recent cross-national study conducted by us, three critical components of ethical regulation were identified—external oversight, local oversight and subject involvement—and integrated into the study design. These three concepts are outlined and established as an important aspect of ensuring ethical coherence in the local context, particularly when reviews by the local institutional review (...) boards cannot practically be obtained. The three levels of ethical oversight identified are suggested to be the framework within which future field studies on human subjects are developed and a standard for maintaining ethical rigorousness in research on humans. (shrink)

This book, written by leading authors in the field, takes a completely new approach to objectivity and subjectivity, no longer treating them as opposed - as many existing texts do - but as logically and methodologically related in social research. The authors explain complex arguments with great clarity for social science students, while also providing the detail and comprehensiveness required to meet the needs of practicing researchers and scholars.

Background Compensating participants of biomedical research is a common practice. However, its proximity with ethical concerns of coercion, undue influence, and exploitation, demand that participant compensation be regulated. The objective of this paper is to discuss the current regulations for compensation of research participants in Malawi and how they can be improved in relation to ethical concerns of coercion, undue influence, and exploitation. Main text In Malawi, national regulations recommend that research subjects be compensated with a stipend of US$10 per (...) study visit. However, no guidance is provided on how this figure was determined and how it should be implemented. While necessary to prevent exploitation, the stipend may expose the very poor to undue influence. The stipend may also raise the cost of doing research disadvantaging local researchers and may have implications on studies where income stipend is the intervention under investigation. We recommend that development and implementation of guidelines of this importance involve interested parties such as the research community and patient groups. Conclusion Compensating human research subjects is important but can also act as a barrier to voluntary participation and good research efforts. Deliberate measures need to be put in place to ensure fair compensation of research participants, avoid their exploitation and level the field for locally funded research. (shrink)

ABSTRACT Genetics research, like research in sociology and anthropology, creates risks for groups from which research subjects are drawn. This paper considers what sort of protection for groups from the risks of genetics research should be provided and by whom. The paper categorizes harms by distinguishing process‐related from outcome‐related harms and by distinguishing two kinds of group harms. It argues that calls for community engagement are justified with respect to some kinds of harms, but not with respect to others; and (...) it cautions that community engagement may itself be harmful. (shrink)

Critical social theory has long been marked by a deep, creative, and productive relationship with psychoanalysis. Whereas Freud and Fromm were important cornerstones for the early Frankfurt School, recent thinkers have drawn on the object-relations school of psychoanalysis. Transitional Subjects is the first book-length collection devoted to the engagement of critical theory with the work of Melanie Klein, Donald Winnicott, and other members of this school. Featuring contributions from some of the leading figures working in both of these fields, (...) including Axel Honneth, Joel Whitebook, Noëlle McAfee, Sara Beardsworth, and C. Fred Alford, it provides a synoptic overview of current research at the intersection of these two theoretical traditions while also opening up space for further innovations. Transitional Subjects offers a range of perspectives on the critical potential of object-relations psychoanalysis, including feminist and Marxist views, to offer valuable insight into such fraught social issues as aggression, narcissism, “progress,” and torture. The productive dialogue that emerges augments our understanding of the self as intersubjectively and socially constituted and of contemporary “social pathologies.” Transitional Subjects shows how critical theory and object-relations psychoanalysis, considered together, have not only enriched critical theory but also invigorated psychoanalysis. (shrink)

The aim of this paper is to investigate how children use their participation in research as a potential transformative social practice in everyday life. The concept of transformative social practice will be discussed in relation to the notion of transformation. Through empirical examples provided by Holly (12) and Oliver (11), the article argues that research processes open up possibilities for understanding ourselves (researchers and participants) in new ways. ‘Life Mapping’ - as dialogical method in research with children - will be (...) presented and reflected upon as a way for children to develop different understandings of themselves, their families, and everyday life. This emphasizes the connection between the use of child-relevant methodologies and how specific children can bring dialogues from the research process in to play in their everyday lives. Data is drawn from a qualitative study and is a part of a PhD project studying children’s everyday lives with two households as a result of parental divorce. The project involves ten children aged 8- 12 and their parents. (shrink)

The convergence of increasingly efficient high throughput sequencing technology and ubiquitous Internet use by the public has fueled the proliferation of companies that provide personal genetic information (PGI) direct-to-consumers. Companies such as 23andme (Mountain View, CA) and Navigenics (Foster City, CA) are emblematic of a growing market for PGI that some argue represents a paradigm shift in how the public values this information and incorporates it into how they behave and plan for their futures. This new class of social networking (...) business ventures that market the science of the personal genome illustrates the new trend in collaborative science. In addition to fostering a consumer empowerment movement, it promotes the trend of democratizing information—openly sharing of data with all interested parties, not just the biomedical researcher—for the purposes of pooling data (increasing statistical power) and escalating the innovation process. This target article discusses the need for new approaches to studying DTC genomics using social network analysis to identify the impact of obtaining, sharing, and using PGI. As a locus of biosociality, DTC personal genomics forges social relationships based on beliefs of common genetic susceptibility that links risk, disease, and group identity. Ethical issues related to the reframing of DTC personal genomic consumers as advocates and research subjects and the creation of new social formations around health research may be identified through social network analysis. (shrink)

Principles of research ethics, derived largely from Western philosophical thought, are spreading across the world of higher education. Since 2006 the Japanese Ministry of Education has required universities in Japan to establish codes of ethical conduct and ensure that procedures are in place to punish research misconduct. Drawing on semi-structured interviews with 13 academics in a research-intensive university in Japan, this paper considers how research ethics is interpreted in relation to their own practice. Interviewees articulated a range of ethical issues (...) connected with data gathering and interpretation, applying for and using research funds, relationships with peers and research subjects, and the dissemination of results. The paper also explores the effect of personal values and cultural norms on the Japanese interpretation of research ethics identifying the impact in terms of the treatment of graduate research students and decision-making processes. (shrink)

The present study explores the underlying mechanism of the relationship between college students’ social anxiety and mobile phone addiction. Adopting college students’ social anxiety scale, regulatory emotional self-efficacy scale, subjective well-being scale and mobile phone addiction scale, this research tested valid samples of 680 Chinese college students. The results indicated that social anxiety exerted a significant and positive impact on mobile phone addiction. Regulatory emotional self-efficacy played a partial mediating role between social anxiety and mobile phone addiction. Subjective well-being also (...) played a partial mediating role between social anxiety and mobile phone addiction. Moreover, both regulatory emotional self-efficacy and subjective well-being were found to play a chain mediating role between social anxiety and mobile phone addiction. The study provides valuable insights into the impact of college students’ social anxiety on mobile phone addiction. (shrink)

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give (...) informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only.. Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject’s life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject’s participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject’s consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject’s autonomy and rights it is necessary to add to them two other conditions: the emergency research could not be conducted using other research participants capable of giving informed consent; and informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible. A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible. (shrink)

In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable more extensive (...) data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research. Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges. (shrink)

Se realizó un estudio con el objetivo de ejemplificar los modos de actuación en el trabajo metodológico interdisciplinario que respondan a la formación académica, laboral e investigativa de los estudiantes de la carrera de Medicina de la Facultad de Ciencias Médicas de Camagüey, desde una concepción intra e interdisciplinaria, rectorada por la disciplina Informática Médica. Se elaboraron propuestas de tareas docentes problematizadoras desde una estrategia metodológica a partir de la planificación que cada asignatura del año debe diseñar, las que permitieron (...) la realización de trabajos investigativos por los estudiantes en cada semestre del curso escolar, en las que se combinaron de manera creciente los contenidos y los diversos métodos teóricos y prácticos de las unidades curriculares del plan de estudio de las asignaturas Informática Médica, Metodología de la Investigación, Educación Física, Psicología General y Medicina General Integral como disciplina rectora en la carrera, influyendo en la formación de un profesional más competente. Determining a mode of on-the-job acting interdisciplinary methodologic that the intra answer to Camagüey's academic, labor and investigating formation of the students of the carrier of Medicine of Ciencias Médicas's Faculty, from a conception and interdisciplinary, manager for Information-Technology Medical discipline, he identified the objective of this work. The problem from a strategy elaborated bidding of teaching tasks themselves methodologic as from the planning that he must design each subject of study of the year, the ones that permitted the realization of investigating works for students in each semester of the school year, in the ones that combined of increasing manner the contentses and various theoretic methods themselves and pilots of units curriculares of the curriculum of Information-Technology Medical subjects of study, Methodology of Investigation, Physical Education, Psicología General and Medicine General Integral like ruling discipline in the carrier influencing a more competent professional's formation. (shrink)

This article explores tacit knowledge of lived experience and how this form of knowledge relates to design research. It investigates how interior designers interpret user lived experiences when creating designed environments. The article argues that user experience is the basis of a form of knowledge that is useful for designers. The theoretical framework proposed in the article examines the nature of user experience and how it can be utilized in the design process. The study of lived experiences is contextualized within (...) aesthetic, subjective, and functional aspects of the interior design process, which requires users to express their meanings and needs. A case study is described to illustrate the various stages of this process. (shrink)

In the biomedical and behavioral sciences, it is widely recognized that researchers conducting studies involving human participants must respect the autonomy of research subjects. There is significant debate in the clinical research ethics and bioethics literatures about what it means for an individual to be autonomous. According to proponents of the Liberal Conception of Autonomy, an autonomous person is an agent who has interests and opinions and the capacity to deliberate about them. In contrast, proponents of the Relational Conception of (...) Autonomy argue that because humans are social creatures, autonomy is a relational concept and ought to be recognized as such by medical professionals. In this article, I argue that the LCA/RCA debate is flawed, and that the notion of freedom as non-domination, rather than autonomy, ought to be adopted for biomedical research ethics policies regarding informed consent and research agenda-setting. I then argue that this view of freedom should also be adopted... (shrink)

Introducción: La asignatura Metodología de la Investigación Cualitativa en Salud se imparte a los estudiantes de tercer año de la Licenciatura en Enfermería en la modalidad de clase teórico-práctica como forma organizativa de la docencia. Ello recalca la importancia del trabajo independiente. Las insuficiencias con relación a éste inciden directamente en la asimilación y apropiación de los conocimientos de la asignatura. Objetivo: Elaborar una estrategia didáctica que contribuya al desarrollo del trabajo independiente correspondiente a la asignatura Metodología de la Investigación (...) Cualitativa en Salud.Material y métodos: Se realizó una investigación de desarrollo, encaminada a perfeccionar el proceso docente educativo en la Facultad de Enfermería, de la Universidad de Ciencias Médicas de Camagüey, durante el curso escolar 2011-2012. Para el diagnóstico inicial se procedió al análisis de documentos: los planes de estudio y el programa de la asignatura. También se aplicaron encuestas a un grupo de estudiantes y al colectivo de profesores que imparten la asignatura. Una vez elaborada la estrategia se evaluó por criterio de expertos. Resultados y discusión: La estrategia pone a disposición de la comunidad académica un software educativo que relaciona los contenidos de la asignatura, lo que permitirá al estudiantado realizar las tareas docentes que se orientan en clases así como asimilar, consolidar y sistematizar los conocimientos con mayor facilidad. Introduction: The subject Methodology of Qualitative Research in Health is taught to the students of the third year of the Bachelor in nursing in the form of theoretical and practical lesson as organizational way of teaching. This underscores the importance of self-employment. The shortcomings in relation to this affect directly the assimilation and appropriation of knowledge in the subject. Objective: To develop a teaching strategy that contributes to the development of self-employ ment for the subject Methodology of Qualitative Research in Health. Material aids and methods: A development research was made which aims at improving the educational teaching process in the Faculty of nursing from the University of Medical Sciences in Camagüey, during the 2011-2012 course. For an initial diagnosis the analyses of documents was made: the curriculum and the program of the course. Surveys were also applied to a group of students and the staff of teachers of the subject. Once the strategy was made it was evaluated through criteria of experts. Results and discussion: Strategy makes available to the academic community educational software that relates to the contents of the course, allowing students to perform teaching tasks which are assigned in lessons as well as assimilate, consolidate and systematize the knowledge easiest. (shrink)

Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases to each other and engage in (...) substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics. This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations. Key Features- Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise. Supplemented by short introductions to each section. Focus on ethical rather than regulatory issues. Essential Reading for graduate students in bioethics and post-doctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF Presenting challenging cases to stimulate reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Examining the Ethics of Human Subjects ResearchPaul S. Appelbaum (bio)The work of the Advisory Committee on Human Radiation Experiments confirms once again the value of combining empirical and normative approaches to problems in clinical and research ethics. The Committee, like its predecessor, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, spent relatively modest sums of money gathering targeted data to inform (...) its deliberations. The results of the Committee’s research, which are discussed by Nancy Kass and Jeremy Sugarman in this issue of the Kennedy Institute of Ethics Journal, enhance our understanding of the current ethical status of human subjects research, helping to focus attention on areas of particular concern, and lay the basis for future research and policy development.My comments here focus on the two major empirical studies conducted by the Committee—the Research Proposal Review Project and the Subject Interview Study. I will underscore just a few of the primary findings from these studies, consider their limitations, and explore their implications. Readers interested in the details of the studies should consult the Committee’s Final Report (ACHRE 1995), on which I rely in part and which provides additional information on the methodology and findings of the studies.Research Proposal Review ProjectWhat can be learned from the Committee’s review of 125 federally-funded human research studies? In answering that question, one cannot ignore the irony inherent in the Committee’s decision to review documents related to institutional review board (IRB) consideration of the selected protocols. The single most frequent complaint about the current system for protecting human subjects is that IRBs focus almost exclusively on review of consent forms and other research documents, as if they bore some close relationship to what actually transpires between investigators and potential research subjects. Only a small number of studies examine the research consent process. Nevertheless, existing data strongly [End Page 283] suggest that subject recruitment often involves an extended process of courtship, during which the information contained in consent forms is only a small part of the information passed between investigators and subjects (Benson, Roth, and Winslade 1985; Lidz et al. 1984).Indeed, the second of the Committee’s studies—the Subject Interview Study, which is discussed below—appears to confirm these findings. In-depth interviews with 99 individuals who reported that they were former or current research subjects suggest that “[f]or many, the decision to participate seemed to have been made before the consent form was given to them, and they signed it almost as a formality” (ACHRE 1995 [GPO, p. 742; Oxford, p. 471]). 1 Why, then, did the Committee focus its attention on documents that in many cases seem to play only a tangential role in the consent process? As is the case with IRBs around the country, the answer appears to be that consent forms and related documents are the only easily available window on consent transactions. In addition, under the current system, consent forms constitute the part of the process that IRBs can influence most easily. Consequently, it suits almost everyone’s needs—except perhaps those of the research subjects—to pretend that they reflect what actually transpires in the recruitment process. To the Committee’s credit, it was well aware of this dilemma. Nonetheless, it struggled to wring valid lessons from these limited data in its Final Report.Perhaps the most interesting finding from the Research Proposal Review Project is just how poor so many consent forms are. Given the disproportionate emphasis that many IRBs place on the content of the forms, one would expect that investigators by now would have learned to design documents that meet objective standards of adequacy, such as those applied by the Committee. Indeed, except in the most unusual circumstances, doing so would virtually guarantee that the IRB will ask no further questions about subject recruitment procedures. Although the data justify the inference that many investigators do not yet understand which information is essential to communicate to potential subjects, nor have learned how to do so effectively, they also force us to a still more radical conclusion. If the IRBs were doing their jobs, the Committee... (shrink)

In this article the authors reflect on regulations which have been developed to protect research subjects and data in research which uses human subjects. They suggest that regulations related to informed consent and privacy protection are burdensome in research which uses human subjects. They argue that a new category of research risk must be established which informs research subjects of the level of risk that they will be exposed to by participating in the research.

In their target article, “The Rise of Citizen Science in Health and Biomedical Research,” Andrea Wiggins and John Wilbanks (2019) summarize some of the emerging ethical issues related to citizen sc...

In this paper, I discuss the ethical issues related to deception in human subject research in terms of honesty. First, I introduce the background and suggest the conception of honesty that understands it as involving respect for the right not to be deceived (RND). Next, I examine several ways to address the ethical issues of deceptive elements in the human subject research and show why they fail to adequately meet the demand of honesty. I focus on how to (...) make an honest research plan and examine after participation and before participation phases in turn. Then I conclude by suggesting possible strategies to minimizes dishonesty in human subject research. (shrink)