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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

<I>Conducting Hermeneutic Research: From Philosophy to Practice is the only textbook that teaches the reader ways to conduct research from a philosophical hermeneutic perspective. It is an invaluable resource for graduate students about to embark in hermeneutic research and for academics or other researchers who are novice to this research method or who wish to extend their knowledge. In 2009, the lead author of this proposed text was one of three co-founders of the Canadian Hermeneutic (...) Institute. The institute was created as a means of bringing together scholars of hermeneutics and hermeneutic research across disciplines in creative dialogue and conversations of philosophy, research, and practice. An outcome of this was the launch of the <I>Journal of Applied Hermeneutics, with Nancy J. Moules serving as Editor. The work of the institute and the journal make clear that people (both students and professors) seek practical guidance on how to conduct hermeneutic research. This book is a must read for this audience. (shrink)

The draft Code of Conduct for Research is an important initiative towards assisting the scientific community in complying with the provisions of the Protection of Personal Information Act 4 of 2013 (POPIA). However, its approach towards cross-border data sharing should be reconsidered to clarify the ambiguities inherent in the legal requirements for the cross-border sharing of health data in the POPIA. These ambiguities include the concept of ‘transfer of information’, the application of adequacy as a legal mechanism for (...) transfer, the nature of consent for cross-border sharing and the scope of the recipient third party. We suggest that the draft Code of Conduct for Research can be improved by: Explaining or defining the concept of ‘transfer of information’ and when it applies to cross-border sharing in research Clarifying the application of adequacy as a legal mechanism for transfer vis-à-vis the other alternatives Expanding on the interpretation and application of consent as a legal mechanism for cross-border transfers Expanding the category of persons who may be recipients of personal information in a third country. (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)

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

Nanomedicine research raises ethical concerns beyond those covered by the Common Rule. Investigators and research institutions should comply with environmental and occupational health laws protect research staff and the environment. Though the IRB should concentrate on risks to human research participants, it should also consider risks to identifiable third parties. Investigators should also address risks to identifiable third parties. Professional and governmental organizations should deal with the long-term social, ethical, and environmental consequences of nanomedicine.

Ethics in scientific research has never been more important. Recent controversies over the integrity of data in federally funded science, the manipulation and distortion of privately sponsored research, cloning, stem cell research, and the patenting of DNA and cell lines, illustrate the need for a more thorough education in ethics for researchers at all levels. Now in its second edition, Responsible Conduct of Research provides an introduction to many of the social, ethical, and legal issues (...) facing scientists today. The fully updated volume includes three brand new chapters and additional cases for discussion, as well as analysis of the latest issues and problems in research ethics. Featuring chapters that treat such topics as ethical decision-making, research misconduct, and intellectual property, this new edition will be an indispensable resource for students and teachers, academics and industry professionals alike. (shrink)

The purpose of this paper is to provide a simple yet comprehensive organizing scheme for the responsible conduct of research (RCR). The heuristic offered here should prove helpful in research ethics education, where the many and heterogeneous elements of RCR can be bewildering, as well as research into research integrity and efforts to form RCR policy and regulations. The six domains are scientific integrity, collegiality, protection of human subjects, animal welfare, institutional integrity, and social responsibility.

The Common Rule is a set of regulations for protecting human participants in research funded by the Department of Health and Human Services, which has been adopted in part by 17 federal agencies. It includes four different subparts: Subpart A, Subpart B, Subpart C, and Subpart D. The Common Rule has not been significantly revised since 1981 although some significant changes may be forthcoming. The Food and Drug Administration has adopted its own regulations for the protection of human participants, (...) which are similar to the Common Rule in many key areas, such as the structure and function of the Institutional Review Board, and the criteria for approving research. (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)

In order to increase understanding of the ethical implications of biomedical, behavioral and clinical research, the Fogarty International Center, part of the United States National Institutes of Health, established an International Research Ethics Education and Curriculum Development Award to support programs in low- and middle-income countries. To develop research ethics expertise in Jordan, the University of California San Diego fellowship program in collaboration with Jordan University of Science and Technology provides courses that enable participants to develop skills (...) in varied research ethics topics, including research with human subjects. The program provides a master’s level curriculum, including practicum experiences. In this article we describe a practicum project to modify an existing introduction to human subjects research for a US audience to be linguistically and culturally appropriate to Arabic-speaking-Islamic communities. We also highlight key differences that guided the conversion of an English version to one that is in Arabic. And finally, as Institutional Review Boards follow the ethical principles of the Belmont Report in evaluating and approving biomedical and behavioral human subjects research proposals, we provide observations on the conformity of the three ethical principles of the Belmont Report with Islam. (shrink)

This article presents research on the scale of the phenomenon of sexual violence against students at selected 33 universities across Poland, the mechanisms used to combat the problem and the awareness of students on the subject. The study focuses on the practical dimension of combating sexual violence against students in the Polish academic environment. It looks at the existence and functioning of both specialised bodies and the procedures used to help the victims and punish the perpetrators. Additionally, the paper (...) describes how the diversity of available legal measures to address the problem by both helping the victims and holding perpetrators accountable creates the issue of the coexistence of two systems—criminal and intra-university. Presenting preliminary results of gathered opinions of universities’ officials regarding functioning of the bodies specialised in combating sexual violence shows not only the most dominant observations and conclusions the professionals have regarding the functions they hold at their home universities, but also main challenges that have to be considered in both creating sufficient policies in order to deal with sexual violence and conducting comprehensive research on said phenomenon. (shrink)

BackgroundResearch codes of conduct offer guidance to researchers with respect to which values should be realized in research practices, how these values are to be realized, and what the respective responsibilities of the individual and the institution are in this. However, the question ofhowthe responsibilities are to be divided between the individual and the institution has hitherto received little attention. We therefore performed an analysis of research codes of conduct to investigate how responsibilities are positioned as (...) individual or institutional, and how the boundary between the two is drawn.MethodWe selected 12 institutional, national and international codes of conduct that apply to medical research in the Netherlands and subjected them to a close-reading content analysis. We first identified the dominant themes and then investigated how responsibility is attributed to individuals and institutions.ResultsWe observed that the attribution of responsibility to either the individual or the institution is often not entirely clear, and that the notion ofcultureemerges as a residual category for such attributions. We see this notion of responsible research cultures as important; it is something that mediates between the individual level and the institutional level. However, at the same time it largely lacks substantiation.ConclusionsWhile many attributions of individual and institutional responsibility are clear, the exact boundary between the two is often problematic. We suggest two possible avenues for improving codes of conduct: either to clearly attribute responsibilities to individuals or institutions and depend less on the notion of culture, or to make culture a more explicit concern and articulate what it is and how a good culture might be fostered. (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)

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)

Arab researchers encounter formidable obstacles when conducting and publishing their scientific work. We conducted semi-structured interviews with 17 Arab researchers from various Arab Middle East countries to gain a comprehensive understanding of the difficulties they face in research and publication. We analyzed the transcripts using reflexive thematic analysis. Our findings revealed several key challenges. First, Arab researchers struggle to conduct high-quality research due to limited resources, inadequate funding, and a lack of a supportive research infrastructure. Furthermore, (...) a shortage of teamwork and mentoring diminishes research productivity. Perverse promotion policies, heavy teaching loads, and low salaries force many researchers to seek external income sources, leaving them with insufficient time for research. Regarding publishing in high-impact journals, Arab researchers confront challenges existing of insufficient scientific writing skills, underrepresentation on editorial boards, and unconscious biases against researchers from economically challenged areas. Finally, achieving research integrity is closely tied to lack of access to essential resources. To address these issues, our participants proposed targeted interventions at the institutional and external levels. For example, universities can implement mentoring programs, offer workshops on scientific writing and publishing, and foster a supportive institutional culture for research. Addressing the underrepresentation of Arabic researchers on editorial boards is crucial for equity in global scientific publishing. In conclusion, acknowledging and addressing these challenges will empower Arab researchers, elevate research quality, and promote equitable global scientific collaboration. Our findings provide guidance for universities, governments, and international donors seeking to enhance research and publication practices in the Arab Middle East. (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)

: 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)