Hofmann and Holm’s (2019) recent survey on issues of research misconduct with PhD graduates culminated with a notable conclusion by the authors: ‘ Scientific misconduct seems to be an environmental issue as much as a matter of personal integrity’. Here, we re-emphasise the usefulness of an education-based countermeasure against toxic research environments or cultures that promote unethical practices amongst the younger researchers. We posit that an adequately conducted course in research ethics and integrity, with a good (...) dose of case studies and analyses, can function in a manner that is metaphorically akin to vaccination. The training would cultivate the ability to analyse and build confidence in young researchers in making decisions with sound moral reasoning as well as in speaking up or arguing against pressure and coercions into unacceptable behaviour. A sufficiently large number of young researchers exposed to research ethics trainings would essentially provide a research community some degree of lasting herd immunity at its broadest base. Beyond passive immunity, a crop of research ethics-savvy young researchers could also play active and influential roles as role models for others at their level and perhaps even help correct the wayward attitudes of some senior researchers and initiate prompt action from institutional policy makers in a bottom-up manner. (shrink)

Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a (...) chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s. (shrink)

This study examined how research conducted at several federally funded institutions designated as Clinical Research Centers or Specialized Programs of Research Excellence addressed the issues of consent, control over biological materials, confidentiality, and disclosure of results in protocols and consent forms for genetic research with stored biological materials. Although a majority of the documents reviewed addressed most of the issues raised in the research ethics literature, topics identified in the literature that were missing include (...) the return of research results, the right to withdraw from research involving biological materials, and the consent of children when they become legal adults. If typical, these findings suggest greater educational efforts may be needed to prompt investigators and IRBs to consider these and other issues that were either not addressed in the protocols or consent forms or were addressed inadequately. (shrink)

This is the first in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. The first considers the rationale for having ethics review by committee at all; seeking to explain why ethics committees, as we currently have them, are so important to the wider system of governing (...) class='Hi'>research. (shrink)

In their contribution, Wiggins and Wilbanks (2019) discuss the rise of citizen science and elaborate on several ethical issues that go beyond standard approaches in research ethics. They rightly sa...

Research Ethics, Volume 18, Issue 1, Page 51-63, January 2022. Aboriginal and Torres Strait Islander peoples in Australia, have historically experienced research as another means of colonialization and oppression. Although there are existing frameworks, guidelines and policies in place that respond to this history, the risk of exploitation and oppression arising from research still raises challenging ethical questions. Since the 1990s the National Health and Medical Research Council in Australia has developed specific sets of guidelines (...) that govern research with these populations in an attempt to redress injustices of the past. The current guidelines: Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders, 2018, emphasis six core values which are bound together by “spirit and integrity.” The values are reflected through respect for cultural inheritance, and genuine negotiation of partnerships between researchers, other stakeholders, and communities. We examine whether these guidelines can lead to research and research practices that redress some of the ongoing traumas of colonialization and racism. We draw upon Margaret Urban Walker’s formulation of restorative justice, based upon her “pragmatics of repair” which relies upon “voice, validation and vindication” and at its core, the restoration of relationships. (shrink)

This is the third in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper examines the role of ethics committees in balancing the social value of the research it reviews against the risks it imposes on those who take part. The ethics committee's role in (...) assessing the social value of research goes well beyond checking its scientific validity and this assessment may affect the risks ethics committees are prepared to ask of subjects not only for their own potential personal interests but importantly and inevitably in the name of science. However, their function is importantly restricted by the wider regulatory and governance environment in which they work. (shrink)

The current rise in malpractice litigation has led to concern in the research community as to the prospect of litigation against researchers. Clearly as the responsibility for the day-to-day conduct of the research falls upon the researchers they will be potentially liable should there be negligence in the conduct of the research project itself. But to what extent can the research ethics committee and its members be held liable should harm result to the research (...) subject? How far does the prospect of the threat of litigation equate with the reality of the prospect of liability? Although the NHS research governance framework suggests that primary responsibility for the conduct of the trial is with the researcher this does not mean that REC members will be immune from actions in tort where research subjects suffer harm in the conduct of a research project approved by their NHS REC. This paper focuses upon the prospect for liability in the law of tort of NHS RECs and their members. While in practice the vast majority of such claims are unlikely to be successful members of RECs may incur resultant legal costs as a consequence of involvement in proposed litigation. It is submitted that the scope of indemnity provision provided to RECs and their members should be precisely determined, otherwise there is a real prospect that the risk of malpractice litigation may deter individuals from serving on such committees. (shrink)

Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and (...) participation. REC members supported a contextual and holistic approach to vulnerability and risk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatric research requires continuous ethical competence development within RECs. (shrink)

In this paper, we report the findings from the data we collected from a survey in order to measure how common research ethics education in economics is. We have found out that (1) research ethics is taught in only a very few economics departments around the globe; (2) topics related to research ethics are not taught in courses on economics and ethics; and (3) the number of papers published in specialised peer-reviewed journals on (...) economics education is only a tiny fraction of the number of papers published in these journals. There has been no evidence in economics showing that economics departments have taken strong initiative on teaching research ethics to undergraduate and graduate students. (shrink)

In this article, we interpret sex education from the perspective of feminist care ethics, emphasizing the concept of caring democracy, advanced by Joan Tronto one of the most influential feminist political theorists. According to Tronto, these theories show that a deficit of care and a lack of democracy are mutually conducive. We argue that, as in other areas of life, a lack of care in sexuality and sex education leads to social inequalities that eventually translate into an unequal approach (...) to freedom, equality, and justice, and to a deficit of democracy in the lives of some people. At the same time, we believe that, as a moral theory, care ethics, with its emphasis on the needs of men and women, can be adequately applied to the design of research projects, as well as to sexuality policies and practices. This may contribute to overcoming the stalemate in the debate on sex education and other topics in Slovakia. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the (...) wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

This is the fourth in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper explores the role of ethics committees in reviewing proposed conditions for recruiting human subjects and in checking the intended procedures for gaining consent. In so doing the paper will reiterate the conditions which (...) are traditionally thought to make consent valid, identify a number of limitations to meeting these conditions, and show when consent, however broadly construed or indeterminately focused, may be unnecessary. (shrink)

Research ethics guidelines grew out of several infamous episodes where research subjects were exploited. There is significant international synchronization of guidelines. However, indigenous groups in New Zealand, Canada and Australia have criticized these guidelines as being inadequate for research involving indigenous people and have developed guidelines from their own cultural perspectives. Whilst traditional research ethics guidelines place a lot of emphasis on informed consent, these indigenous guidelines put much greater emphasis on interdependence and trust. (...) This article argues that traditional guidelines are premised on relationships of equal power, and that often the researcher has more power that is not fully equalized by providing information. Where there is a relationship of unequal power, then focusing on interdependence and trust is more likely to achieve ethical safety. We illustrate this thesis by describing the detail of a research project looking at the use of interpreters, where we video-recorded live consultations and then interviewed the patient, interpreter and doctor. We conclude by suggesting that mainstream research ethics guidelines should pay more attention to the development of a trustworthy relationship between subject and researcher, and that, following the lead from clinical medicine, we should develop a culturally competent ethical framework for research on human subjects. (shrink)

The study reported in this paper explored the ethical requirements of social research participants, an area where there is still little empirical research, by interviewing people who had participated in one of five recent social research studies. The findings endorse the conceptualization of informed consent as a process rather than a one-off event. Four different dynamics of decision-making were followed by participants in terms of the timing of decisions to participate and the information on which they were (...) based. Multiple information events were important, as was verbal as well as written information. Study participants reacted unfavourably to the idea of written consent. Although prior information was relevant to participant experience of the interview, what emerged more strongly as relevant was the behaviour of interviewers and the interviewing strategy used. The authors suggest that naturalistic, authentic approaches to information-giving are necessary, and that in scrutinizing them research ethics committees need to look not only at written information but also at verbal information giving, and how interviewer information-giving is supported by training and supervision. They suggest that committees also need to concern themselves more broadly with who will carry out interviews and the training, mentoring and monitoring in place to shape their conduct of interviews. In considering research instruments, research ethics committees need to consider not only whether interviewers will capture accurate and appropriate data but also whether they are likely to lead to a satisfactory interaction for participants. Given the impossibility of anticipating each individual participants information needs and their reaction to the interviewing strategy, the authors suggest that interviewers and participants need to be encouraged to negotiate the conduct of interviews jointly, and discuss how such negotiating roles might be supported. (shrink)

Research on behavioral ethics is thriving and intends to offer advice that can be used by practitioners to improve the practice of ethics management. However, three barriers prevent this research from generating genuinely useful advice. It does not sufficiently focus on interventions that can be directly designed by management. The typical research designs used in behavioral ethics research require such a reduction of complexity that the resulting findings are not very useful for practitioners. (...) Worse still, attempts to make behavioral ethics research more useful by formulating simple recommendations are potentially very damaging. In response to these limitations, this article proposes to complement the current behavioral ethics research agenda that takes an ‘explanatory science’ approach with a research agenda that uses a ‘design science’ approach. Proposed by Joan van Aken and building on earlier work by Herbert Simon, this approach aims to develop field-tested ‘design propositions’ that present often complex but useful recommendations for practitioners. Using a ‘CIMO-logic’, these propositions specify how an ‘intervention’ can generate very different ‘outcomes’ through various ‘mechanisms’, depending on the ‘context’. An illustration and a discussion of the contours of this new research agenda for ethics management demonstrate its advantages as well as its feasibility. The article concludes with a reflection on the feasibility of embracing complexity without drowning in a sea of complicated contingencies and without being paralyzed by the awareness that all interventions can have both desirable and undesirable effects. (shrink)

Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey (...) of the top 50 technical universities in the world shows that, where not specifically mandated by law, most technical universities do not employ ethics committees to review human studies. As the domains of basic and applied sciences expand, ethics committees are increasingly needed to guide and oversee all such research regardless of legal requirements. We offer as examples, from our experience as an ethics committee in a major European technical university, ways in which such a committee provides needed services and can help ensure more ethical studies involving humans outside the standard medical context. We provide some arguments for creating such committees, and in our supplemental article, we provide specific examples of cases and concerns that may confront technical, engineering, and design research, as well as outline the general framework we have used in creating our committee. (shrink)

Informed by interviews conducted with members of a local research ethics committee (REC), this article reflects upon how RECs can act to improve the quality of patient consent to clinical trials. Two emergent narratives which trial participants have drawn upon to account for their experiences are explored: the narrative of the clinical trial itself and a narrative of individualized treatment. Informed consent requires participants to recognize that only the first of these narratives is relevant to the design, and (...) their experience, of randomized controlled trials. Improving the clarity of patient information is argued to be a relevant, but insufficient, strategy for increasing patient familiarity with the methodology of clinical trials. In the concluding sections of the article, other approaches, and the role of RECs, are considered. (shrink)

In December 2006 there was an amendment to the Medicines for Human Use (Clinical Trials) Regulations 2004, the statutory instrument that translated the European directive into UK law. I will demonstrate how the European directive stifled much needed clinical research in urgent critical states whilst there is an international consensus that research in these situations be allowed. The amendments to the UK Medicines for Human Use (Clinical Trials) Regulations 2004 in allowing such exception have failed to preserve the (...) high degree of respect and protection of the participants' interest as reflected in the spirit of the numerous guidelines, conventions and laws appertaining to the ethics of research in clinical emergencies. (shrink)

The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 ± 31.7 (range: 0–131) projects of clinical trials and 71.1 ± 139.8 (range: 0–638) projects of other types of medical research. During one BC meeting an average of 10.3 ± 14.7 (range: (...) 0–71) projects of medical research were assessed (2006). The amendment of Polish laws according with Directive 2001/20/EC caused a percentage increase in BCs which assessed less than 20 projects per year (16% vs. 33% or 42% in 2003 vs. 2005 or 2006 respectively, p < 0,05). The results confirm the usefulness of the current practice of creating BCs by medical universities, medical institutes and regional chambers of physicians and dentists but rationalization of the workload for individual BCs is necessary. (shrink)

This paper is an attempt to discuss how ethics associated with social research in connection with the collection of authentic and reliable data, use of appropriate data process and impartial data analysis for preparing an acceptable research report. Ethics is closely related to moral integrity, and values associated with appropriate methods and techniques applied for collection of reliable and authentic information that ensure the trust worthy research findings. This paper is based on secondary data collected (...) through reviewing the relevant literatures. This paper examine to what extent the research findings contribute to the knowledge of planners and policy makers in formulating the appropriate policy and at the same time preparing effective as well as pragmatic planning based on the quality of research findings and finally thus may affect on development. (shrink)

Many economists, it is said, “are inclined to deny that moral philosophy has anything to do with economics” . In this paper I challenge such inclinations bydrawing an analogy between economic interventions and humansubjects research. It is undeniable that investigators engaged in thelatter should adhere to specific ethical principles. I argue that analogousfeatures of economic interventions should lead us to recognise thatsimilar ethical concerns actually arise in both activities, and thusthat economic interventions should also be conducted in accordancewith ethical (...) principles. By exploring the analogy further I formulatesome ethical guidelines for economic practice, which in turn imply thatethical responsibilities will extend to all members of the economicsprofession. (shrink)

Research ethics training during post-graduate education is necessary to improve ethical standards in the design and conduct of biomedical research. We studied quality and quantity of research ethics training in the curricula of post-graduate programs in the medical science in I.R. Iran. We evaluated curricula of 125 post-graduate programs in medical sciences in I.R. Iran. We qualitatively studied the curricula by education level, including the Master and PhD degrees and analyzed the contents and the amount (...) of teaching allocated for ethics training in each curriculum. We found no research ethics training in 72 of the programs. Among the 53 programs that considered research ethics training, only 17 programs had specific courses for research ethics and eight of them had detailed topics on their courses. The research ethics training was optional in 25% and mandatory in 76% of the programs. Post-graduate studies that were approved in the more recent years had more attention to the research ethics training. Research ethics training was neglected in most of the medical post-graduate programs. We suggest including sufficient amount of mandatory research ethics training in Master and PhD programs in I.R. Iran. Further research about quality of research ethics training and implementation of curricula in the biomedical institutions is warranted. (shrink)

This is a comprehensive and practical guide to the ethical issues raised by different kinds of medical research, and is the first such book to be written with the needs of the researcher in mind. Clearly structured and written in a plain and accessible style, the book covers every significant ethical issue likely to be faced by researchers and research ethics committees. The author outlines and clarifies official guidelines, gives practical advice on how to adhere to these, (...) and suggests procedures in areas where official recommendations are vague or absent. This invaluable handbook will help researchers identify and address the ethical issues at an early stage in the design of their studies, to avoid unnecessary delay and to safeguard the wellbeing of patients and healthy volunteers. It will also be extremely useful to members of research ethics committees. (shrink)

The Kingdom of Saudi Arabia passed a Law and Implementing Regulations of Ethics of Research on Living Creatures in 14/09/1431 Hijri. We have performed an ethical analysis of this law and, accordingly, this paper discusses the major components, key strengths, and weaknesses of this law. The Saudi system considers Islamic Shariah in addition to international research ethics guidelines. The Law and its Implementing Regulations contain all ethical requirements for research. We conclude that this law can (...) serve as an example, not only for other Arab countries in the region that have similar values and social structure to the Kingdom of Saudi Arabia, but also for other Islamic countries. (shrink)

The Internet has been used as a place for and site of an array of research activities. From online ethnographies to public data sets and online surveys, researchers and research regulators have struggled with an array of ethical issues around the conduct of online research. This paper presents a discussion and findings from Buchanan and Ess's study on US-based institutional review boards and the state of internet research ethics.

This article aim to show the aesthetics and ethics values whose relation traces could be found in theological text studies. We use bibliographic review as methodology to this research. Considering these elements and how it was found we ask: how can we validate such elements to understand the theological text? When we are analyzing ethics behaviors can we consider the found results as intrinsic values in such discoveries and can it be compared in different times, in other (...) words, it is available if we bring it out to our time without prejudice considering criteria. We know values and beliefs can change according different times, but the main question that translates our doubt is: how can we consider the ethical and aesthetical values described in different times avoiding damage then to be impartial in the research? In spite of lots of doubts rose, what can support on our research reading are historic and current images we can validate as support line to comparative analysis considering ethics and aesthetics values found. This text will be presented as communication in this event.Key Words: Methodology. Ethics and research. Aesthetics and research. Theological methodology. (shrink)

Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises – particularly in resource-poor settings – is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees. Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster (...) class='Hi'>research and argue that ethical disaster research requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like – how it might be conceptualized and utilized – using the concept of real-time responsiveness. The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained. (shrink)

In the management academic research, academic advancement, job security, and the securing of research funds at one’s university are judged mainly by one’s output of publications in high impact journals. With bogus resumes filled with published journal articles, universities and other allied institutions are keen to recruit or sustain the appointment of such academics. This often places undue pressure on aspiring academics and on those already recruited to engage in research misconduct which often leads to research (...) integrity. This structured review focuses on the ethics and integrity of management research through an analysis of retracted articles published from 2005 to 2016. The study employs a structured literature review methodology whereby retracted articles published between 2005 and 2016 in the field of management science were found using Crossref and Google Scholar. The searched articles were then streamlined by selecting articles based on their relevance and content in accordance with the inclusion criteria. Based on the analysed retracted articles, the study shows evidence of ethical misconduct among researchers of management science. Such misconduct includes data falsification, the duplication of submitted articles, plagiarism, data irregularity and incomplete citation practices. Interestingly, the analysed results indicate that the field of knowledge management includes the highest number of retracted articles, with plagiarism constituting the most significant ethical issue. Furthermore, the findings of this study show that ethical misconduct is not restricted to a particular geographic location; it occurs in numerous countries. In turn, avenues of further study on research misconduct in management research are proposed. (shrink)

This article provides a critical overview of the most important issues pertaining to the ongoing debate on international research ethics. It critically describes three problems of continuing concern: 1) the question of whether the distinction between therapeutic and non‐therapeutic research should be upheld; 2) the questions of whether the currently demanded best proven diagnostic and therapeutic method of treatment for all research subjects is feasible both in developed and in developing countries, and whether it should be (...) upheld; 3) the questions of who owns international research ethics guidelines and regulatory frameworks and, how decisions about changes to such international guidelines can possibly be achieved, given that it seems to be the case that genuine disagreement about issues of content is possible and likely. (shrink)

Freedom of information requests are increasingly used in sociology, criminology and other social science disciplines to examine government practices and processes. University ethical review boards in Canada have not typically subjected researchers’ FOI requests to independent review, although this may be changing in the United Kingdom and Australia, reflective of what Haggerty calls ‘ethics creep’. Here we present four arguments for why FOI requests in the social sciences should not be subject to formal ethical review by ERBs. These four (...) arguments are: existing, rigorous bureaucratic vetting; double jeopardy; infringement of citizenship rights; and unsuitable ethics paradigm. In the discussion, we reflect on the implications of our analysis for literature on ethical review and qualitative research, and for literature on FOI and government transparency. (shrink)

Few could disagree with the starting premise in, “Strangers at the Benchside: Research Ethics Consultation” (Cho et al. 2008). Over the past 40 years, the efforts for addressing the breadth and dep...

All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may (...) come into conflict with the principles of ethical research. (shrink)

Privacy by Design, a globally accepted framework for personal data management and privacy protection, advances the view that privacy cannot be assured solely by compliance with regulatory frameworks but must become an organisation’s default mode of operation. We are proposing a similar template for the research ethics review process. The Research Ethics by Design framework involves research ethics committees engaging researchers during the design phase of the proposal so that ethical considerations may be directly (...) embedded in the science as opposed to being viewed as addendums after the fact. This collaborative research design proposal results in the establishment of a culture of ethical research rather than research with ethical oversight. Both researchers and research ethics committees come to view the review process as one in which individual protection and collective benefit co-exist in a doubly-enabling positive-sum manner. (shrink)

We identify three distinct ethical problems that can arise with risk displacement. Risk displacement is the shifting of extant risk from one or more individuals to other individual(s) such that the reduction of risk to the first group is causally implicated in increasing risk to the second group. These problems are: concentration of risk in inequitable ways; transfer of risk to already vulnerable or disadvantaged populations; and exercise of undue influence over potential research participants. The first two arise in (...) both public policy and research initiatives, whereas the third is a special concern that only applies to research initiatives. We argue that when one or more of these is of high magnitude, then the study or policy intervention may be ethically wrong. Finally, we conclude that although some risk displacement is ethically permissible, researchers and policymakers still have ethical reasons to reduce the magnitude of these problems. (shrink)

Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. (...) Results Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity. (shrink)

Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs (...) attain different levels of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures. (shrink)

In Canada, all research conducted by individuals associated with universities must be subjected to review by research ethics boards (REB). Unfortunately, decisions reached by REBs may seriously compromise the integrity of university-based research. In this paper attention will focus on how requirements of REBs and a legal department in four Canadian universities affected response rates to a survey of domestic and international students. It will be shown that in universities in which students were sent a legalistic (...) cover letter to a mail survey, or were required to sign a consent form, lower response rates were achieved than in universities in which students were sent a relatively friendly letter. In turn, lower response rates resulted in: sample characteristics that deviated from population characteristics; a reduction in the possibility of testing research hypotheses; and increased survey costs. As a consequence, it is argued that the unreasonable demands of REBs are seriously compromising the quality of research that can be carried out on Canadian university students. (shrink)

Abstract:This paper explores how Finnish research ethics deals with matters of justice on the levels of practical regulation, political morality, and theoretical studies. The bioethical sets of principles introduced by Tom Beauchamp and James Childress in the United States and Jacob Dahl Rendtorff and Peter Kemp in Europe provide the conceptual background, together with a recently introduced conceptual map of theories of justice and their dimensions. The most striking finding is that the internationally recognized requirement of informed consent (...) for research on humans can be ideologically tricky in a Scandinavian welfare state setting. (shrink)

Professions have a social obligation to ensure that their members’ professional behavior is morally appropriate. The psychology profession in most jurisdictions delegates the responsibility of ensuring that psychologists entering the profession are ethically competent to pre-practicum training programs. Educators responsible for teaching the ethics courses in these programs often base them on Rest’s (1984, 1994) theory that does not take into account a vast amount of contemporary psychological and neuroscientific research data on moral decision making. My aim with (...) this article is therefore to summarize the psychological and neuroscience research findings relevant to moral decision making and consider how educators who teach ethics courses can apply them in developing ethics courses grounded in research. (shrink)

The behavior analytic research community emphasizes within-subject research methodologies to study relations between individual behavior and the environment. This is unique as behavior analytic practitioners can then replicate directly the research they read when determining whether a research finding applies to the clients with whom they work. Research Ethics in Behavior Analysis: From Laboratory to Clinic and Classroom is a reference guide for behavior analysts who conduct, supervise, or consume research specific to behavior (...) analysis. This book is sequenced to follow the natural research process, beginning with an introduction to the history of research ethics that led to modern principles and values of scientific research ethics. The reader is taken through sequential steps from obtaining resources to support a research project through participant recruitment, conducting the study, communicating results, and supporting replication. Each chapter incorporates critical and under-discussed topics unique to research ethics in behavior analysis such as diversity, equity, and inclusion in the research process; balancing methodological rigor with clinical outcomes; aligning research and clinical goals; assessing generalization of research findings; the gray lines of assent and consent for intervention versus research; identifying and obtaining resources to support research; conflicts of interest; using technology and social media; and ethically handling data. Incorporates critical and under-discussed topics unique to research ethics in behavior analysis Reviews how to use technology and social media within your research Explains various approaches to communicating both negative and positive results Explores the gray lines of assent and consent for intervention versus research Written specifically for behavior analysts who conduct, supervise, or consume research specific to behavior analysis. (shrink)