Background Community involvement in research has been advocated by researchers, communities, regulatory agencies, and funders with the aim of reinforcing subjects’ protection and improving research efficiency. Community involvement also has the potential to improve dissemination, uptake, and implementation of research findings. The fields of community based participatory research conducted with indigenous populations and of participatory action research offer a large base of experience in community involvement in research. Rules on involving the population affected when (...) conducting research have been established in these fields. But what is the role of community engagement in clinical research and observational studies conducted in biomedical research outside of these specific areas? Main body of the abstract More than 20 years ago, in the field of HIV medicine, regulatory bodies and funding agencies recommended the constitution of a formal organism, the Community Advisory Board, as part of the study requirements for HIV trials. More recently, CABs have been adopted and used in other fields of medical research, such as malaria. CABs are not without limitations, however, and there is little research on the effectiveness of their use in achieving community protection and participation. Nevertheless, CABs could be a model to import into clinical trials and observational research where no alternative model of community representation is currently being used. Conclusions Allocating more resources to training and shifting more power to community representatives could be part of the solution to current CAB limitations. However, for researchers to be able to apply these recommendations on community involvement, certain conditions need to be met. In particular, funding agencies need to recognize the human and financial resources required for serious community involvement, and the academic environment needs to take community involvement into account when appraising, mentoring, and training researchers. (shrink)

CITATION: Horn, L. M. 2015. Promoting responsible research conduct in a developing world academic context. South African Journal of Bioethics and Law, 6:21-24, doi:10.7196/SAJBL.256.

Emergency care research sometimes involves incapacitated adults as research participants. The ethical principle of respect for autonomy may not necessarily apply to an incapacitated person unable to act in an autonomous manner, although it can be argued that researchers still have a duty of respect towards such people because they have moral status despite being incapacitated. Sharing some common ground with theories of moral status based on ‘humanness’ and the ability for rational thought is the notion of human (...) dignity, which features in arguments regarding researcher conduct with incapacitated patients. However, human dignity premised upon the unique ability of humans for rational thought and moral self-regulation is contingent upon these capabilities – a limitation that possibly makes dignity a less useful framework for research conduct in emergency care research. In this article, I will discuss the different conceptions of human dignity – as equality, status and virtue – and then draw on more recent literature that explains human dignity as a social constraint and as a factor influencing the conduct of healthcare professionals and researchers. I will address questions of whether dignity as a principle ought to apply only to those who have the ability to think rationally, or to all humans regardless of their condition or mental status. I will argue that, in relation to offering protection to research participants in emergency conditions, it is immaterial which view is taken. (shrink)

Although the terms mentor and thesis advisor (or research supervisor) are often used interchangeably, the responsibilities associated with these roles are distinct, even when they overlap. Neither are role models necessarily mentors, though mentors are role models: good examples are necessary but not sufficient. Mentorship is both a personal and a professional relationship. It has the potential for raising a number of ethical concerns, including issues of accuracy and reliability of the information conveyed, access, stereotyping and tracking of advisees, (...) and the abuse of power. Nevertheless, mentors can be critically important for professional success and are one of a number of elements that affect the responsible conduct of research. In addition, the community as a whole has a responsibility to mentor junior members. (shrink)

Ethical research conduct is a cornerstone of research practice particularly when research participants include vulnerable populations. This study mapped the extent of reporting ethical research practices in studies conducted among refugees and war-affected populations in the Arab World, and assessed variations by time, country of study, and study characteristics. An electronic search of eight databases resulted in 5668 unique records published between 2000 and 2013. Scoping review yielded 164 eligible articles for analyses. Ethical research (...) practices, including obtaining institutional approval, access to the community/research site, and informed consent/assent from the research participants, were reported in 48.2, 54.9, and 53.7% of the publications, respectively. Institutional approval was significantly more likely to be reported when the research was biomedical in nature compared to public health and social, when the study employed quantitative compared to qualitative or mixed methodologies, and when the journal required a statement on ethical declarations. Institutional approval was least likely to be reported in papers that were sole-authored, when these did not mention a funding source, or when published in national journals. Similar results were obtained for access to the community site and for seeking informed consent/assent from study participants. The responsibility of inadequacies in adherence to ethical research conduct in crisis settings is born by a multitude of stakeholders including funding agencies, institutional research boards, researchers and international relief organizations involved in research, as well as journal editors, all of whom need to play a more proactive role for enhancing the practice of ethical research conduct in conflict settings. (shrink)

A great deal of effort has gone into developing capacity in the sphere of human research protection programmes in South Africa and Africa over the last decade or more, by several international organisations. However the promotion of the broader agenda of research integrity or ‘RCR’ has lagged behind. From a global perspective South Africa and other African countries are actively involved in research endeavours and collaborations across a very broad spectrum of scientific fields. For this research (...) to fulfil its potential social value it must be reliable and trustworthy and hence it is essential that research institutions and universities take the promotion of research integrity seriously. The purpose of this paper is to consider the role of an institutional office of research integrity within the context of academic research particularly in South Africa but also in Africa. I will reflect on my own experience over a period of five years as a research integrity officer at a South African academic institution to highlight concerns in five domains; the promotion of an ethic of responsibility in opposition to compliance and bureaucracy, collaboration ethics and collegiality especially in the context of North-South collaborations, authorship and publication ethics, the problem of plagiarism and the utility of policy and procedure. I will suggest that the establishment of such an office can be of great value in the promotion of a broad culture of research ethics and responsible research conduct. The possible role and scope of function of an institutional office of research integrity will be briefly outlined. (shrink)

There is a growing interest in the ethics of Health Policy and Systems Research, and especially in areas that have particular ethical salience across HPSR. Hyder et al provide an initial framework to consider this, and call for more conceptual and empirical work. In this paper, we respond by examining the ethical issues that arose for researchers over the course of conducting three HPSR studies in Kenya in which health managers and providers were key participants. All three studies involved (...) qualitative work including observations and individual and group interviews. Many of the ethical dilemmas researchers faced only emerged over the course of the fieldwork, or on completion, and were related to interactions and relationships between individuals operating at different levels or positions in health/research systems. The dilemmas reveal significant ethical challenges for these forms of HPSR, and show that potential ‘solutions’ to dilemmas often lead to new issues and complications. Our experiences support the value of research ethics frameworks, and suggest that these can be enriched by incorporating careful consideration of context embedded social relations into research planning and conduct. Many of these essential relational elements of ethical practice, and of producing quality data, are given stronger emphasis in social science research ethics than in epidemiological, clinical or biomedical research ethics, and are particularly relevant where health systems are understood as social and political constructs. We conclude with practical and research implications. (shrink)

Introduction Numerous guidelines and policies for ethical research practice have evolved over time, how this translates to global health practice in resource-constrained settings is unclear. The purpose of this paper is to describe how the concept of ancillary care has evolved over time and how it is included in the ethics guidelines and policy documents that guide the conduct of research in the global south with both an international focus and providing a specific example of Malawi, where (...) the first author lives and works, as a case study. Methods Discourse analysis was conducted on 34 international ethics guidelines and policy documents. Documents were purposively selected if they contained a set of key terms that reflect the concept of ancillary care. Following a process of inductive discourse analysis, five key interrelated text phrases relating to ancillary care were extracted from the documents. The evolution of these phrases over time was explored as they represented the development of the concept of ancillary care as a component of ethical health research guidance and practice. Results We found key interrelated phrases that represent discourses regarding the evolution of ancillary care including participant protection; provide care as appropriate; supererogation; patient needs prevail over science; and ancillary care as an obligation. Arguments for the provision of ancillary care were characterised by safeguarding the safety, health rights and well-being of study participants. However, despite the evolution of discourse around ethical obligations to provide ancillary care, this is rarely made explicit within guidance documents, leaving interpretive space for differential application in practice. Conclusion While there have been major changes to the ethics guidance that reflect significant evolution in the ethical conduct of research, the specific vocabulary or language used to explain the ethics of researchers' ancillary care obligations to the health needs of their research participants, lacks clarity and consistency. As a result, the concept of ancillary care continues to be under-represented in local ethical guidelines and regulations, with no clear directives for country-level research ethics committees to apply in regulating ancillary care responsibilities. (shrink)

Objectives Disclosures of funding sources and conflicts of interests (COI) in published peer-reviewed journal articles have recently begun to receive some attention, but many critical questions remain, for example, how often such reporting occurs concerning research conducted in the developing world and what factors may be involved. Design Of all articles indexed in Medline reporting on human subject HIV research in 2007 conducted in four countries (India, Thailand, Nigeria and Uganda), this study explored how many disclosed a funding (...) source and COI, and what factors are involved. Results Of 221 articles that met the criteria, 67.9% (150) disclosed the presence or absence of a funding source, but only 20% (44) disclosed COI. Studies from Uganda were more likely, and those from Nigeria were less likely to mention a funding source (p<0.001). Of articles in journals that had adopted International Committee of Medical Journal Editors (ICMJE) guidelines, 56% did not disclose COI. Disclosure of funding was more likely when: ≥50% of the authors and the corresponding author were from the sponsoring country, the sponsor country was the USA, and the articles were published in journals in which more of the editors were from the sponsoring countries. Conclusions Of the published studies examined, over a third did not disclose funding source (ie, whether or not there was a funding source) and 80% did not disclose whether COI existed. Most articles in ICMJE-affiliated journals did not disclose COI. These data suggest the need to consider alteration of policies to require that published articles include funding and COI information, to allow readers to assess articles as fully as possible. (shrink)

This is the final paper in a four-part series which addresses the methodology of research studies under ethical review. The focus is on study conduct, governance and peer review. The nature and adequacy of peer review as a mechanism for assessing the study design and analysis are discussed. The paper argues that a properly constituted and functioning research team is crucial to the ethical conduct of a study and that an ethical review of methodology should extend (...) beyond study design and analysis to a concern with data collection, storage and availability, and publication. While ethical review committees cannot monitor study conduct, they can ensure that the protocol pays sufficient attention to appropriate monitoring structures and personnel. (shrink)

To determine factors affecting successful research and publication among medical students, a cross-sectional survey study was carried out at four Thai medical schools during 2018–2022. Medical students who had previously performed research under research advisors’ supervision and their research advisors were included. There were 120 participants, 78 medical students and 42 research advisors. The most common problems reported by the students were student’s lack of knowledge of research design (78%) and research topic (53%), (...) while the most common problems reported by the advisors were student’s lack of knowledge of research topic (55%) and how to prepare documents for ethics committee approval (48%). The promoting factors for research success commonly reported by the students and advisors were “an advisor helps with protocol writing and reviewing the manuscript”, “research teaching in the curriculum”, “provision of an example of a written ethics committee protocol”, and “arranging a special session so that advisors can talk to students about their research of interest”. Among the 78 participating students, 20 (26%) had successfully published their research in journals. These 20 students were more likely than those without publications to be from an institute that had a special research project or conference for medical students (20% vs. 0%,) and to suggest that teaching protocol writing helped in promoting research success (70% vs. 43%). These findings suggest that teaching research, a special research project or conference for medical students, and faculty development of research advising could potentially increase the success rate of students’ research publications. (shrink)

In light of rapid globalization, there has been an increase in U.S. psychologists conducting international cross-cultural research. Such researchers face unique ethical dilemmas. Although the American Psychological Association has its own Code of Ethics with guidelines regarding research, these guidelines do not specifically address international and cross-cultural research. The purposes of this article are to (a) provide a review of current ethical guidelines for research on human subjects, (b) provide a review of major ethical challenges and (...) dilemmas in conducting cross-cultural research, (c) highlight several existing frameworks that maybe useful for increasing cross-cultural understanding of these ethical challenges for U.S. psychologists, and (d) issue a call to the American Psychological Association to begin to assess and evaluate the nature and extent of ethical problems in conducting cross-cultural research among its members. (shrink)

Contestable motives of filing reports comprise a set of factors which were not present in the origin of the reported criminal act, as stated by the reporting individual. The objective of such reports is to create circumstances which would lead to the either an imaginary or implicated perpetrator being brought to criminal justice. These types of reports generate a number of doubts and investigative problems. Recently, in the light of newly introduced legislative changes into the methods of investigative procedures in (...) relation to sexual assault, this issue has become much more significant. The following publication includes a detailed description of the legal and psychological situation of an individual who has been classified as a victim in a case of sexual assault. The article includes an analysis of statistical data encompassing the period after the introduction of the aforementioned legislative changes in the type of investigative procedures as well as a qualitative analysis of the major factors influencing the process of filing contestable reports of such crimes. The research has been conducted on the basis of analysing a total of 50 cases. It is the opinion of the author that an expert court psychologist, whose presence is mandatory in these types of cases and whose opinion formulated in the course of preparatory proceedings ought to play a key role in the disclosure of false pretences accompanying such reports. (shrink)

Background While community engagement is increasingly promoted in global health research to improve ethical research practice, it can sometimes coerce participation and thereby compromise ethical research. This paper seeks to discuss some of the ethical issues arising from community engagement in a low resource setting. Methods A qualitative study design focusing on the engagement activities of three biomedical research projects as ethnographic case studies was used to gain in-depth understanding of community engagement as experienced by multiple (...) stakeholders in Malawi. Data was collected through participant observation, 43 In-depth interviews and 17 focus group discussions with community leaders, research staff, community members and research participants. Thematic analysis was used to analyse and interpret the findings. Results The results showed that structural coercion arose due to an interplay of factors pertaining to social-economic context, study design and power relations among research stakeholders. The involvement of community leaders, government stakeholders, and power inequalities among research stakeholders affected some participants’ ability to make autonomous decisions about research participation. These results have been presented under the themes of perception of research as development, research participants’ motivation to access individual benefits, the power of vernacular translations to influence research participation, and coercive power of leaders. Conclusion The study identified ethical issues in community engagement practices pertaining to structural coercion. We conclude that community engagement alone did not address underlying structural inequalities to ensure adequate protection of communities. These results raise important questions on how to balance between engaging communities to improve research participation and ensure that informed consent is voluntarily given. (shrink)

Scientific research and ethics -- Ethical theory and decision making -- Data acquisition and management -- Mentoring and professional relationship -- Collaboration in research -- Authorship -- Publication and peer review -- Misconduct in research -- Intellectual property -- Conflicts of interest and scientific objectivity -- The use of animals in research -- The use of human subjects in research -- The use of vulnerable subjects in research -- Genetics, cloning, and stem cell (...) class='Hi'>research -- International research. (shrink)

BackgroundAs Canadian global health researchers who conducted a qualitative study with adults with and without disabilities in Uganda, we obtained ethics approval from four institutional research ethics boards (two in Canada and two in Uganda). In Canada, research ethics boards and researchers follow the research ethics norms of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), and the National Guidelines for Research Involving Humans as Research Participants of Uganda (NGRU) in (...) Uganda. The preparation and implementation of this qualitative research raised specific ethical issues related to research participant privacy and the importance of availability and management of financial resources.Main bodyOur field experience highlights three main issues for reflection. First, we demonstrate that, in a global health research context, methodological and logistic adjustments were necessary throughout the research implementation process to ensure the protection of study participants’ privacy, especially that of people with disabilities, despite having followed the prescribed Canadian and Ugandan ethics norms. Data collection and management plans were adapted iteratively based on local realities. Second, securing financial support as a key aspect of financial management was critical to ensure privacy through disability-sensitive data collection strategies. Without adequate funding, the recruitment of research participants based on disability type, sex, and region or the hiring of local sign language interpreters would not have been possible. Third, although the TCPS2 and NGRU underscore the significance of participants’ privacy, none of these normative documents clearly express this issue in the context of global health research and disability, nor broadly discuss the ethical issue related to financial availability and management.ConclusionsConducting research in resource limited settings and with study participants with different needs calls for a nuanced and respectful implementation of research ethics in a global health context. We recommend a greater integration in both the TCPS2 and NGRU of global health research, disability, and responsible conduct of research. This integration should also be accompanied by adequate training which can further guide researchers, be they senior, junior, or students, and funding agencies. (shrink)

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) (...) class='Hi'>research (P = 0.001), more sponsor‐country authors (P = 0.003), sponsor‐country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host‐country involved (P = 0.002), journals having sponsor‐country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor‐country editors and research being biomedical.Conclusions: One‐third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards. (shrink)

Researchers and others involved in the research enterprise from 12 African countries met with those working in ethics and oversight in the United States as part of an effort to develop research ethics capacity. Drawing on a wealth of experience among participants, discussions at the meeting revealed five categories of issues that warrant careful attention by those engaged in similar efforts as well as international policymakers and those charged with oversight of research. (1) Principal investigators should build (...) ‘true research teams’ where members of the team are meaningfully involved in decisions regarding the protocol and its implementation. (2)There should be explicit discussion about the ‘standard of care’ at the outset of project planning that includes clarification of the terminology that is being used. (3) While internationally collaborative research may involve populations that have inherent vulnerabilities, it is important to recognize the limitations of host country solutions (such as elaborated consent processes) and look for means to negotiate appropriate protections for those willing to participate. (4) In conducting research involving biological materials it would be prudent to develop material transfer agreements at the outset of the study to clarify expectations and to minimize the likelihood of harm. (5) Those engaged in internationally collaborative research need to be alert to the potential conflicts of interests of host country ethics committees during the approval process and to take measures to manage them if they indeed exist. (shrink)

This study examines the social impacts of labor-related corporate social responsibility policies or corporate codes of conduct on upholding labor standards through a case study of CSR discourses and codes implementation of Reebok - a leading branded company enjoying a high-profiled image for its human rights achievement - in a large Taiwanese-invested athletic footwear factory located in South China. I find although implementation of Reebok labor-related codes has resulted in a "race to ethical and legal minimum" labor standards when (...) notoriously inhumane and seriously illegal labor rights abuses were curbed, Chinese workers were forced to work harder and faster but, earned less payment and the employee-elected trade union installed through codes implementation operated more like a "company union" rather than an autonomous workers' organization representing worker' interests. In order to explain the paradoxical effects of Reebok labor-related codes on labor standards, I argue the result is determined by both structural forces and agency-related factors embedded in industrial, national and local contexts. To put it shortly, I find the effectiveness of Reebok labor-related codes is constrained not only by unsolved tension between Reebok's impetus for profit maximization and commitment to workers' human rights, but also by hard-nosed competition realities at marketplace, and Chinese government's insufficient protection of labor rights. Despite drawing merely from a single case study, these findings illuminate key determinants inhibiting the effectiveness of labor-related CSR policies or codes in upholding labor standards, and hence two possible way-outs of the deadlock: sharing cost for improving labor standards among key players in global supply chain; and combining regulatory power of voluntary codes and compulsory state legislations. (shrink)

The aim of this article is to present some of the results of empirical research on the communication process at a trial conducted in Polish courts. These results will concern the participation of non-professional participants of a trial and the ways in which they deal with the communication process in the courtroom. The article presents the results of the analysis of the research material conducted in accordance with the detailed research questions and analytical categories. The analysis has (...) especially shown that: (1) the non-professional participants used some legal terminology, but the statements without legal terminology were also communicatively effective; (2) the level of activity of non-professional participants related to participation at the trial varied depending on what the activity concerned; the activity in asking questions to the presiding judges regarding legal issues and the course of the court proceedings appeared to be significant; (3) the non-professional participants’ had a real and significant problem with asking questions during the examination (the proper realization of this element of the trial); (4) the statements of the non-professional participants of a trial were very protective; they used many different “linguistic means of protection” (e.g., acts of supposition or acts of doubt) which are connected with the obligation to tell the truth, the prohibition of concealing the truth and giving false testimony during examination; (5) the non-professional participants of a trial reach for adequate argumentative acts, which are suitable for influencing the perception of specific events or persons, and they strengthen their statements by using appropriate linguistic means of persuasion. (shrink)

In the past decade, policy-makers in science have been concerned with harmonizing research integrity standards across Europe. These standards are encapsulated in the European Code of Conduct for Research Integrity. Yet, almost every European country today has its own national-level code of conduct for research integrity. In this study we document in detail how national-level codes diverge on almost all aspects concerning research integrity – except for what constitutes egregious misconduct. Besides allowing for potentially (...) unfair responses to joint misconduct by international collaborations, we argue that the divergences raise questions about the envisaged self-regulatory function of the codes of conduct. (shrink)

This open access book offers insights into the development of the ground-breaking Global Code of Conduct for Research in Resource-Poor Settings (GCC) and the San Code of Research Ethics. Using a new, intuitive moral framework predicated on fairness, respect, care and honesty, both codes target ethics dumping – the export of unethical research practices from a high-income setting to a lower- or middle-income setting. The book is a rich resource of information and argument for any (...) class='Hi'>research stakeholder who opposes double standards in research. It will be indispensable for applicants to European Union framework programmes, as the GCC is now a mandatory reference document for EU funding. (shrink)

Recognizing the growing interdependence of the European Union and the importance of codes of conduct in companies’ operations, this research examines the effect of a country’s culture on the implementation of a code of conduct in a European context. We examine whether the perceptions of an activity’s ethicality relates to elements found in company codes of conduct vary by country or according to Hofstede’s (1980, Culture’s Consequences (Sage Publications, Beverly Hills, CA)) cultural constructs of: Uncertainty Avoidance, (...) Masculinity/Femininity, Individualism, and Power Distance. The 294 individuals, who participated in our study, were from 8 Western European countries. Their responses to our 13 scenarios indicate that differences in the perceptions of ethicality associate primarily with the participants’ country as opposed to their employer (i.e., accounting firm), employment level, or gender. The evidence also indicates that these country differences associate with Hofstede constructs of Individualism and Masculinity. (shrink)

This study explored the challenges of informed consent and understanding of the research process among Black and Latino men under community supervision. Between February and October 2012, we conducted cognitive face-to-face interviews using open-ended questions on the significant areas of research participation among 259 men aged 35 to 67 under community supervision in Bronx, New York. Content analysis of the open-ended questions revealed limited knowledge concerning the understanding of research participation. The study participants appeared to generally understand (...) concepts such as compensation after research participation and confidentiality. Participants demonstrated a lack of understanding of certain aspects of the research process—informed consent, human subject, Institutional Review Board, and clinical trials. These findings are informative to researchers conducting studies with criminal justice populations and Institutional Review Boards reviewing research studies. (shrink)

An increase in global violence has forced the displacement of more than 70 million people, including 26 million refugees and 3.5 asylum seekers. Refugees and asylum seekers face serious socioeconomic and healthcare barriers and are therefore particularly vulnerable to physical and mental health risks, which are sometimes exacerbated by immigration policies and local social discriminations. Calls for a strong evidence base for humanitarian action have encouraged conducting research to address the barriers and needs of refugees and asylum seekers. Given (...) the role of epigenetics factors to mediate the effect of psychological and environmental exposures, epigenetic modifications have been used as biomarkers for life adversity and disease states. Therefore, epigenetic research can be potentially beneficial to address some of the issues associated with refugees and asylum seekers. Here, we review the value of previous and ongoing epigenetic studies with traumatized populations, explore some of the ethical challenges associated with epigenetic research with refugees and asylees and offer suggestions to address or mitigate some of these challenges. Researchers have an ethical responsibility to implement strategies to minimize the harms and maximize the short and long-term benefits to refugee and asylee participants. (shrink)

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) (...) class='Hi'>research (P = 0.001), more sponsor-country authors (P = 0.003), sponsor-country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host-country involved (P = 0.002), journals having sponsor-country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor-country editors and research being biomedical.Conclusions: One-third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards. (shrink)

Does responsible conduct of research (RCR) training improve levels of trust between researchers? Using data gathered as part of a survey on the attitudes of master's and doctoral-level students toward RCR, we found that RCR training correlated with a weakened beliefs of students toward their supervisors' ethicality but a stronger belief in the ethicality of their peers. We believe that these findings point to new avenues of research on trust in the academic setting and to needs for (...) curriculum changes in RCR training. (shrink)

Why devote an issue of an ethics journal to prison medicine? Why conduct ethics research in prisons in the first place? In this editorial, we explain why prison ethics research is vitally important and illustrate our argument by introducing and briefly discussing the fascinating papers in this special issue of the Journal of Bioethical Inquiry.Ethics is often regarded as a theoretical discipline. This is in large part due to ethics’ origin as a type of moral philosophy, which (...) is frequently associated with armchair theorising about principles and virtues and seems to have little connection with the “real world.” However, medical ethics and bioethics are increasingly becoming empirical disciplines. The “empirical turn” in ethics has led to an explosion in field research in ethics that uses the empirical methods of sociology, anthropology, and the health sciences to investigate a variety of ethical issues. The results of such research are often of much more value than purely theoret. (shrink)

Conducting or overseeing research in correctional settings requires knowledge of specific federal rules and regulations designed to protect the rights of individuals in incarceration. To investigate the extent to which relevant groups possess this knowledge, using a 10-item questionnaire, we surveyed 885 IRB prisoner representatives, IRB members and chairs with and without experience reviewing HIV/AIDS correctional protocols, and researchers with and without correctional HIV/AIDS research experience. Across all groups, respondents answered 4.5 of the items correctly. Individuals who have (...) overseen or conducted correctional research had the highest scores; however, even these groups responded correctly only to slightly more than half of the items. These findings emphasize the need for ongoing training in federal guidelines governing correctional research, particularly for those individuals who are embarking on this type of research. (shrink)

An overview and assessment of the current state of research on individual consumption of Fair Trade (FT) products is given on the basis of 51 journal publications. Arranging this field of ethical consumption research according to key research objectives, theoretical approaches, methods, and study population, the review suggests that most studies apply social psychological approaches focusing mainly on consumer attitudes. Fewer studies draw on economic approaches focusing on consumers’ willingness to pay ethical premia for FT products or (...) sociological approaches relying on the concept of consumer identity. Experimental, qualitative and conventional survey methods are used approximately equally often. Almost all studies draw on convenience or purposive samples and most studies are conducted in the USA or the United Kingdom. Several problems in current research are identified: amongst others, studies’ rather narrow theoretical focus, potential hypothetical and social desirability bias of conventional survey data, and a lack of generalizability of empirical findings. In turn, we suggest that research would benefit from both a multiple-motives and a multiple-methods perspective. Considering competing theories can help to single out key behavioral determinants of individual FT consumption. The combination of different methods such as conventional surveys and field experiments contributes to uncovering respondents’ truthful answers and improves generalizability of results. Scholars in the field of ethical consumption research should use experiments to detect causal relations proposed by theories and conduct cross-country surveys to gather insights as to how differences in market structures, cultural traits, and other path dependencies affect patterns of individual FT consumption. (shrink)

A large body of literature supports the notion that the language used in informed consent forms is not comprehensible to most research participants. Creating comprehensible informed consent forms for international research presents a further challenge because they are generally written first in English and then translated into the local language. The Kenya Medical Research National Ethical Review Committee determines readability of English consent forms before translation; however, it is neither their policy nor practice to determine whether the (...) forms, once translated into Kiswahili, are of comparable readability to the English forms. Thus, the aim of this study is to measure and compare the text difficulty in 10 pairs of English informed consent forms and their translated Kiswahili forms. The results show that a readable English-language consent form does not necessarily result in a readable form once translated into Kiswahili. (shrink)

Research integrity climate is an important factor that influences an individual’s behavior. A strong research integrity culture can lead to better research practices and responsible conduct of research. Therefore, investigations on organizational climate can be a valuable tool to identify the strengths and weaknesses of each group and develop targeted initiatives. This study aims to assess the perceptions on integrity climate in three universities in Hungary. A cross-sectional study was conducted with PhD students, postdocs, and (...) professors from three Hungarian universities. The survey included demographic questions, such as gender, age, scientific field, academic rank, and the Survey of Organizational Research Climate. A total of 432 participants completed the survey. Our results show that postdocs and assistant professors perceived integrity climate more negatively than PhD students and full professors in every survey scale. Contrarily, PhD students perceive more positively than the other groups. Disciplinary differences show that researchers in the Biomedical sciences perceive regulatory bodies to be fairer when evaluating their projects than those in the Natural sciences. Natural sciences also perceive more negatively how the department values integrity when compared to Humanities. Humanities perceive more positively Advisor/Advisee Relations than Biomedical Sciences. Our results suggest that institutions should pay more attention to early career researchers, especially insecure and temporary positions like postdocs and assistant professors. They should provide RCR resources, socialize them in RCR, and set more reasonable expectations. Moreover, department leaders should develop initiatives to foster better integrity climates. (shrink)

For graduate students to succeed as professionals, they must develop a set of general “survival skills”. These include writing research articles, making oral presentations, obtaining employment and funding, supervising, and teaching. Traditionally, graduate programs have offered little training in many of these skills. Our educational model provides individuals with formal instruction in each area, including their ethical dimensions. Infusion of research ethics throughout a professional skills curriculum helps to emphasize that responsible conduct is integral to succeeding as (...) a researcher. It also leads to the consideration of ethical dimensions of professional life not covered in traditional ethics courses. (shrink)

Recognizing that truth is socially constructed or that knowledge and power are related is hardly a novelty in the social sciences. In the twenty-first century, however, there appears to be a renewed concern regarding people’s relationship with the truth and the propensity for certain actors to undermine it. Organizations are highly implicated in this, given their central roles in knowledge management and production and their attempts to learn, although the entanglement of these epistemological issues with business ethics has not been (...) engaged as explicitly as it might be. Drawing on work from a virtue epistemology perspective, this paper outlines the idea of a set of epistemic vices permeating organizations, along with examples of unethical epistemic conduct by organizational actors. While existing organizational research has examined various epistemic virtues that make people and organizations effective and responsible epistemic agents, much less is known about the epistemic vices that make them ineffective and irresponsible ones. Accordingly, this paper introduces vice epistemology, a nascent but growing subfield of virtue epistemology which, to the best of our knowledge, has yet to be explicitly developed in terms of business ethics. The paper concludes by outlining a business ethics research agenda on epistemic vice, with implications for responding to epistemic vices and their illegitimacy in practice. (shrink)

The rapid growth of pharmaceutical markets in the 20th century has increased the demand for human research participants in clinical trials. However, with the globalization of clinical research, most clinical trials are conducted in low-income countries (LICs) with political and economic instability, and lack of basic healthcare, but easy access to human subjects. This paper explores the unique ethical challenges faced during the pre-enrollment phase of cross-cultural research in a country like Pakistan, and how these challenges make (...) the Pakistani population vulnerable to exploitation. It also outlines recommendations regarding conducting research in Pakistan within ethical parameters adopted according to local culture. This discussion is important because researchers must focus on the pre-enrollment phase of the research process for it’s cultural suitability and acceptability so that the research conducted is credible and valid and has social value for the research population. (shrink)

. The ability to enforce the provisions of a code of conduct influences whether the code is effective in shaping behavior. Enforcement relies in part on the willingness of organization members to report violations of the code, but research from the business and educational environment suggests that fewer than half of those who observe code violations follow their organizations procedures for reporting them. Based on a review of the literature in the business and educational environments, and a survey (...) of 3605 students at a mid-sized comprehensive university, this paper attempts to make conceptual sense of the non-reporting phenomenon. We present a conceptual framework based on four distinct factors which we have labeled: (1) factual non-responsibility; (2) moral non-responsibility; (3) consequential exoneration; and, (4) functional exoneration. Each of these factors suggest a different remedial strategy as well as provide a theoretical foundation for future research. Testable propositions for future research are developed, and some implications for organization leaders are discussed. (shrink)

Conducting research in a prison setting is ethically challenging. Because history is full of unethical research conducted in prison settings, researchers are often afraid of doing research in this area. It is argued that too much emphasis has been put on the protection of prison inmates as a vulnerable population. Consequently, too little research is being conducted where the focus is on those factors which serve to make the prison population vulnerable. In this paper ethical questions, (...) emerging when conducting a study on literacy and mental health among Norwegian prison inmates, are presented and discussed. Relevant questions relate to topics which include ethical clearance of the research protocol, the consent procedure, clarification of roles and the publication of the results. The ethical questions are discussed in relation to the four principles of ‘respect for the client's rights and dignity’, ‘competence’, ‘responsibility’ and ‘integrity’ set out in the meta-code of ethics, formulated by the European Federation of Professional Psychologists Associations. The wider relationships between ethics in society, research ethics in general, and ethics when conducting research in a prison setting are also considered. (shrink)

Conducting research in a prison setting is ethically challenging. Because history is full of unethical research conducted in prison settings, researchers are often afraid of doing research in this area. It is argued that too much emphasis has been put on the protection of prison inmates as a vulnerable population. Consequently, too little research is being conducted where the focus is on those factors which serve to make the prison population vulnerable. In this paper ethical questions, (...) emerging when conducting a study on literacy and mental health among Norwegian prison inmates, are presented and discussed. Relevant questions relate to topics which include ethical clearance of the research protocol, the consent procedure, clarification of roles and the publication of the results. The ethical questions are discussed in relation to the four principles of ‘respect for the client's rights and dignity’, ‘competence’, ‘responsibility’ and ‘integrity’ set out in the meta-code of ethics, formulated by the European Federation of Professional Psychologists Associations. The wider relationships between ethics in society, research ethics in general, and ethics when conducting research in a prison setting are also considered. (shrink)

The U.S. military is developing augmented reality (AR) capabilities for use on the battlefield as a means of achieving greater situational awareness. The superimposition of digital data—designed to expand surveillance, enhance geospatial understanding, and facilitate target identification—onto a live view of the battlefield has important implications for virtuous conduct in war: Can the soldier exercise practical wisdom while integrated into a system of militarized legibility? Adopting a virtue ethics perspective, I argue that AR disrupts the soldier’s immersion in the (...) scene such that he is blinded to features beyond those identified in advance by the military’s system of cybernetic judgment. I turn to Michael Walzer’s classic account of the “naked soldier” dilemma to illustrate how AR capabilities radically shrink the bounds within which the soldier can cultivate the capacity for right conduct. By transforming the ambiguous ethical matter of killing an enemy combatant into the straightforward application of a rule, AR hollows out the soldier’s potential for virtuous action. The “smart battlefield” leaves no space for deliberative judgments that transcend the technical and legal determinations already written into the soldier’s view of the scene. (shrink)

This article reports on a method of group mentoring to strengthen responsible research conduct. A key feature of this approach is joint exploration of the issues by trainees and their faculty research supervisors. These interactions not only help participants learn about current ethical norms for research practice, but also draw on the accumulated experience of faculty and staff about practical problems of research conduct, and help to make faculty more articulate about responsible research (...) conduct and so better able to guide their trainees. By working with departments or laboratories as a whole the method facilitates the formulation of specific norms appropriate to particular research situations and to strengthen the group’s ability to support appropriate behavior and deal with new issues as they arise. It also gives students more ways to ask questions about research practice and to benefit from the experience of all members of their department or group as well as their own research supervisors. The method is well tested and has been well received by a wide variety of departments and research groups. It provides the means for a constructive and enjoyable response to the Public Health Service’s (PHS) new Policy on Instruction in the Responsible Conduct of Research (RCR) that requires education in the responsible conduct of research for all those funded by PHS funds, including faculty and staff as well as trainees. (shrink)

Education in the responsible conduct of research typically takes the form of online instructions about rules, regulations, and policies. Research Ethics takes a novel approach and emphasizes the art of philosophical decision-making. Part A introduces egoism and explains that it is in the individual's own interest to avoid misconduct, fabrication of data, plagiarism and bias. Part B explains contractualism and covers issues of authorship, peer review and responsible use of statistics. Part C introduces moral rights as the (...) basis of informed consent, the use of humans in research, mentoring, intellectual property and conflicts of interests. Part D uses two-level utilitarianism to explore the possibilities and limits of the experimental use of animals, duties to the environment and future generations, and the social responsibilities of researchers. This book brings a fresh perspective to research ethics and will engage the moral imaginations of graduate students in all disciplines. (shrink)

The purpose of this study was to identify and describe published research articles that were named in official findings of scientific misconduct and to investigate compliance with the administrative actions contained in these reports for corrections and retractions, as represented in PubMed. Between 1993 and 2001, 102 articles were named in either the NIH Guide for Grants and Contracts ( Findings of Scientific Misconduct ) or the U.S. Office of Research Integrity annual reports as needing retraction or correction. (...) In 2002, 98 of the 102 articles were indexed in PubMed. Eighty-five of these 98 articles had indexed corrections: 47 were retracted; 26 had an erratum; 12 had a correction described in the comment field. Thirteen had no correction, but 10 were linked to the NIH Guide Findings of Scientific Misconduct , leaving only 3 articles with no indication of any sort of problem. As of May 2005, there were 5,393 citations to the 102 articles, with a median of 26 citations per article (range 0–592). Researchers should be alert to Comments linked to the NIH Guide as these are open access, and the Findings of Scientific Misconduct’ reports are often more informative than the statements about the retraction or correction found in the journals. (shrink)

Research-oriented universities are known for prolific research activity that is often supported by students in faculty-guided research. To maintain ethical standards, universities require on-going training of both faculty and students to ensure Responsible Conduct of Research (RCR). However, previous research has indicated RCR-based training is insufficient to address the ethical dilemmas that are prevalent within academic settings: navigating issues of authorship, modeling relationships between faculty and students, minimization of risk, and adequate informed consent. U.S. (...) universities must explore ways to identify and improve RCR concerns for current (faculty) and future researchers (students). This article reports the findings of a self-study (_N_ = 50) of research stakeholders (students and faculty) at a top tier research institution. First, we report on their perceived importance of applying RCR principles. Second, we explore relationships between stakeholder backgrounds (e.g., prior training, field, and position) and how they ranked the degree of ethical concerns in fictitious vignettes that presented different unethical issues university students could encounter when conducting research. Vignette rankings suggested concerns of inappropriate relationships, predatory authorship and IRB violations which were judged as most unethical, which was dissimilar to what sampled researchers reported in practice as the most important RCR elements to understand and adhere to for successful research. Regression models indicated there was no significant relationship between individuals’ vignette ethics scores and backgrounds, affirming previous literature suggesting that training can be ineffectual in shifting researcher judgments of ethical dilemmas. Recommendations for training are discussed. (shrink)

This paper comments on Polish legal guarantees for diseased persons with reference to the hazards that accompany experimental treatment. While acknowledging that participation in a clinical research program provides patients with additional opportunities for advanced treatment, the paper also points out that systems for monitoring patients participating in experimental treatment require improvement.

: In light of information uncovered about human radiation experiments conducted during the Cold War, an important charge for the Advisory Committee on Human Radiation Experiments was to assess the current state of protections for human research subjects. This assessment was designed to enhance the Committee's ability to make informed recommendations for the improvement of future policies and practices for the protection of research subjects. The Committee's examination of current protections revealed great improvement over those from the past, (...) yet some problems remain. Although the data collected by the Committee highlight specific areas in need of attention, the Committee's work should be viewed in part as the beginning of a series of ongoing assessments of the adequacy and effectiveness of the protections afforded to human subjects. (shrink)

Responsible conduct of research courses are widely taught, but little is known about the purposes or effectiveness of such courses. As one way to assess the purposes of these courses, students were surveyed about their perspectives after recent completion of one of eleven different research ethics courses at ten different institutions. Participants enrolled in RCR courses in spring and fall of 2003 received a voluntary, anonymous survey from their instructors at the completion of the course. Responses were (...) received from 268 participants. Seventy-seven percent of open-ended responses listed specific kinds of information learned; only a few respondents talked about changes in skills or attitudes. The perception that courses did more to provide information than to foster skills or attitudes was verified in quantitative responses. Over 75% of the respondents specifically noted that courses were useful in preparing them to recognize, avoid, and respond to research misconduct. The two principal findings of this multi-institutional study are that respondents reported: a wide variety of positive outcomes for research ethics courses, but that the impact on knowledge was greater than that for changes in skills or attitudes. (shrink)

Training in the responsible conduct of research (RCR) is required for many research trainees nationwide, but little is known about its effectiveness. For a preliminary assessment of the effectiveness of a short-term course in RCR, medical students participating in an NIH-funded summer research program at the University of California, San Diego (UCSD) were surveyed using an instrument developed through focus group discussions. In the summer of 2003, surveys were administered before and after a short-term RCR course, (...) as well as to alumni of the courses given in the summers of 2002 and 2001. Survey responses were analyzed in the areas of knowledge, ethical decision-making skills, attitudes about responsible conduct of research, and frequency of discussions about RCR outside of class. The only statistically significant improvement associated with the course was an increase in knowledge, while there was a non-significant tendency toward improvements in ethical decision-making skills and attitudes about the importance of RCR training. The nominal impact of a short-term training course should not be surprising, but it does raise the possibility that other options for delivering information only, such as an Internet-based tutorial, might be considered as comparable alternatives when longer courses are not possible. (shrink)

Despite increased academic and practitioner interest in codes of conduct, there has been little research into the actual compliance of suppliers in developing countries with the codes of conduct of multinational corporations. This paper addresses this lack by analysing Chinese suppliers' level of compliance with Swedish toy retailers' codes of conduct. Based on unannounced and unofficial interviews with employees of Chinese suppliers, the study shows that all of the nine studied suppliers breached some of the standards (...) in the toy retailers' codes, with over two-thirds of the suppliers not complying with the majority of the studied standards. While there are different explanations of this lack of compliance, the main explanation seems to be that Chinese suppliers successfully deceive toy retailers' monitoring organisations by decoupling the formal monitored part of their organisation from the actual operational part of their organisation. The paper concludes with a discussion of how to increase compliance with MNCs' codes of conduct. (shrink)