This paper considers concerns that social care research may be stifled by health-focused ethical scrutiny under the Mental Capacity Act 2005 and the requirement for an ?appropriate body? to determine ethical approval for research involving people who are deemed to lack capacity under the Act to make decisions concerning their participation and consent in research. The current study comprised an online survey of current practice in university research ethics committees (URECs), and explored through semi-structured interviews (...) the views of social researchers engaged in or exploring work concerning people who may, under the Act, lack the capacity to make decisions to consent to participate in a research programme. The paper concludes that there was a lack of overt knowledge of and reference to the implications of the Act for research and some concerns that a restrictive focus on health-related scrutiny might prevent social care research from taking place. There was also a degree of creativity shown by social care researchers in responding to changing demands and a wish to assist people in making decisions to participate where possible. (shrink)

There is a growing body of literature on the research ethics review process, a process that can have important effects on the nature of research in contemporary times. Yet, many people know little about what the actual process entails once an application has been submitted for review. This lack of knowledge can affect researchers and committee members' responses to the review process. Based on ethnographic research on the ethics review process in (...) 5 countries (Australia, Canada, New Zealand, the United States, and the United Kingdom) this article takes the reader through common aspects of the research ethics review process, including some of the kinds of narratives that influence decision making. Greater understanding of the nature of the review process and the narratives that often form the core of the process can help contextualize responses that researchers get from committees so they can better address them. It may also help committee members reflect on how these narratives influence their decision making and the responses they make to researchers. (shrink)

This paper suggests that the increasing bureaucracy of ethics review by committee is more about fulfilling institutional requirements than it is about ethics. It is suggested that ethics committees should not be instruments of bureaucratic regulation and control. They should be freed to play a critical role within the institution, to support and develop ethical research and researchers, and given time to discuss and explore difficult ethical issues where they arise. To burden research (...) class='Hi'>ethics committees with trivial bureaucratic tasks is to miss an opportunity for healthy exchanges of views about ethics and to distort the nature and meaning of ethics. (shrink)

BackgroundResearch Ethics Boards, or Institutional Review Boards, protect the safety and welfare of human research participants. These bodies are responsible for providing an independent evaluation of proposed research studies, ultimately ensuring that the research does not proceed unless standards and regulations are met.Main bodyConcurrent with the growing volume of human participant research, the workload and responsibilities of Research Ethics Boards (REBs) have continued to increase. Dissatisfaction with the review process, particularly the (...) time interval from submission to decision, is common within the research community, but there has been little systematic effort to examine REB processes that may contribute to inefficiencies. We offer a model illustrating REB workflow, stakeholders, and accountabilities.ConclusionBetter understanding of the components of the research ethics review will allow performance targets to be set, problems identified, and solutions developed, ultimately improving the process. (shrink)

Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine of University Eduardo Mondlane and the Maputo Central Hospital established a joint Institutional Committee on Bioethics for Health. This study examines the experience of the first 4 years of (...) the CIBS FM & MCH. This study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee’s respective reviews and actions. A total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master’s degree research. Descriptive cross-sectional studies were the most frequently reviewed research. The majority were prospective and used quantitative methodologies. The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS’s average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS. Our results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training and ethical capacity building for CIBS across the country continue to be needed, as Mozambique develops greater capacity for research and makes progress toward improving the health of all its citizens. (shrink)

Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed ‘too great an emphasis on guidelines and research ethics review’, which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment (...) to ethical practices that are reinforced by upstream enabling conditions, which are in turn influenced by developmental conditions. Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities. (shrink)

Ethical conduct is a maxim in scholarly research as well as scholarly endeavour generally. In the case of research involving humans, few if any question the necessity for ethics approval of procedures by ethics boards or committees. However, concerns have been raised about the appropriateness of ethics approval processes for social science research arguing that the orientation of ethics boards and committees to biomedical and experimental scientific research, institutional risk aversion, and other (...) factors lead to over-protection of research participants and overly restrictive processes that delay and sometimes prevent important social science research. This is particularly significant when social science research is required to respond to social, environmental, or health emergencies and in contract research projects for the reasons explained. This analysis of an ethics approval case study adds to increasing concerns that ethics approval processes can have perverse effects in the social sciences. While a single case study does not provide generalizable findings, in-depth analysis of a significant case can identify issues that need to be further explored. Recommendations offer pathways for facilitating social science research including in emergency situations in which timeliness is important and in collaborative approaches such as participatory action research, while maintaining high ethical standards. (shrink)

Review boards responsible for vetting the ethical conduct of research have been criticised for their costliness, unreliability and inappropriate standards when evaluating some non-medical research, but the basic value of mandatory ethical review has not been questioned. When the standards that review boards use to evaluate research proposals are applied to review board practices, it is clear that review boards do not respect researchers or each other, lack merit and integrity, are not (...) just and are not beneficent. The few benefits of mandatory ethical review come at a much greater, but mainly hidden, social cost. It is time that responsibility for the ethical conduct of research is clearly transferred to researchers, except possibly in that small proportion of cases where prospective research participants may be so intrinsically vulnerable that their well-being may need to be overseen. (shrink)

Conducting large multi-site research within universities highlights inconsistencies between universities in approaches, requirements and responses of research ethics committees. Within the context of a social science research study, we attempted to obtain ethical approval from 101 universities across England to recruit students for a short online survey. We received varied responses from research ethics committees of different universities with the steps to obtaining ethics approval ranging from those that only required proof of approval (...) from our home institution, to universities that facilitated fast-track applications to those that required a full ethics review. Some universities also completely refused. After contacting all 101 universities in England, 60 universities gave clearance to our study. In this article, we present the different approaches universities adopted in response to our application to sample from students in their institution. We consider a number of conceptual and ethical issues pertinent to considering ethics approval for researchers from other universities in England and critically discuss three possible models of ethics governance that would cover all universities in England. (shrink)

Research on research ethics—regarding both the governance and practice of the ethical review of human subjects research—has a tumultuous history in North America and Europe. Much of the academic literature focuses on issues to do with regulating the conduct and quality of ethics review of research protocols by ethics committees (research ethics boards (REBs) in Canada and institutional review boards (IRBs) in the United States). In addition, some of (...) the literature attends to issues particular to the review of qualitative research, and still other literature addresses the challenges posed by and the need for research on REBs/IRBs. It is this third group of literature within which our article is situated. (shrink)

The research ethics committee is a key element of university administration and has gained increasing importance as a review mechanism for those institutions that wish to conduct responsible...

The Mental Capacity Act 2005 placed for the first time research concerning adults lacking mental capacity upon a statutory footing. However, while the legislation which regulates the inclusion of such adults in ‘intrusive research’ safeguards researchers and research participants alike some controversy remains as to its implementation. This paper focuses upon two specific issues raised by the legislation. First, what constitutes ‘intrusive’ research and whether all issues concerning research involving adults lacking mental capacity should be (...) referred to NHS research ethics committees. Secondly, the role of one of the statutory safeguards–the ‘consultee’. These are individuals who are to be consulted regarding the inclusion of adults lacking mental capacity in research. It contrasts the ‘personal’ and ‘nominated’ consultees and considers whether there is a risk that the legislation may result in a new ‘quasi profession’ of consultees in the future. (shrink)

Dyck and Allen claim that the current model for mandatory ethical review of research involving human participants is unethical once the harms that accrue from the review process are identified. However, the assumptions upon which the authors assert that this model of research ethics governance is justified are false. In this commentary, I aim to correct these assumptions, and provide the right justificatory account of the requirement for research ethics review. This account (...) clarifies why the subsequent arguments that Dyck and Allen make in the paper lack force, and why the ‘governance problem’ in research ethics that they allude to ought to be explained differently. (shrink)

BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths (...) and weaknesses of ERCs in ensuring ethical oversight. Second, we map these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science.ConclusionsWe believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large. (shrink)

Ethics review committees have become a common institution in English-speaking research communities, and are now increasingly being adopted in a variety of research environments. In light of existing debates on the aptness of ethics review boards for assessing research work in the social sciences, this article investigates the ways in which researchers navigate issues of research ethics in the absence of a formal review procedure or of an ethics (...) class='Hi'>review board. Through the analysis of qualitative and quantitative data, the article questions the overall utility of ethics review boards. Highlighting the importance of space for sharing, the authors argue for the development of a new type of structure that takes into account researchers’ ‘ethos of responsibility’ as an adequate ethical compass for research in the social sciences. (shrink)

For decades now, researchers in the social sciences and humanities have been expressing a deep dissatisfaction with the process of research-ethics review in academia. Continuing the ongoing critique of ethics review begun in Will C. van den Hoonard's Walking the Tightrope and The Seduction of Ethics, The Ethics Rupture offers both an account of the system's failings and a series of proposals on how to ensure that social research is ethical, rather than (...) merely compliant with institutional requirements. Containing twenty-five essays written by leading experts from around the world in various disciplines, The Ethics Rupture is a landmark study of the problems caused by our current research-ethics system and the ways in which scholars are seeking solutions. (shrink)

We describe the national health research ethics review system of Uzbekistan and identify policy and program gaps that impede the protection of human research subjects. We find that the National Ethic Committee (NEC), functioning at the national level, is solely responsible for conducting research ethics review. There is little evidence that regional ethics committees work as intended, and there is no research ethics review at medical institutes and research (...) centers even though they conduct CDTs (clinical drug trials). There is no national policy for the ethical review of non-clinical trials. We recommend the establishment of institutional review boards (IRBs) at medical institutes and research centers while at the same time building capacity at the national level to oversee and support the research ethics review system of the entire country. (shrink)

There is an international consensus that medical research involving humans should only be undertaken in accordance with ethical principles. Paradoxically though, there is no consensus over the kinds of activities that constitute research and should be subject to review. In the UK and elsewhere, research requiring review is distinguished from clinical audit. Unfortunately the two activities are not always easy to differentiate from one another. Moreover, as the volume of audit increases and becomes more formal (...) in response to the demand for evidence-based practice in medicine, the overlap between research and audit grows more acute. Arguably, similar ethical standards and systems for ensuring that those standards are met should be applied regardless of whether or not a project is classified as research or audit. At a time when the research ethics review system in the UK is undergoing significant reform it is important that the opportunity is not missed to address the longstanding research-audit problem. We discuss suggestions for further reform that addresses this issue. (shrink)

In 2019, a new national Ethics Review Authority (Etikprövningsmyndigheten, EPM) was created in Sweden. In 2020, Sweden’s Ethical Review of Research Involving Humans Act was revised, tightening this legislation, and increasing penalties for its infraction. This article draws on empirical material generated by artistic research conducted with a norm-critical contemporary music ensemble. Two of the musicians who collaborated with this research identify as disabled. Consequently, in accordance with EPM, my artistic research was subject (...) to mandatory ethics review. Reflecting critically on my own experience of seeking ethical approval for this artistic research project, I show how EPM’s process of ethics review enacts scientific boundary work in Sweden that privileges the interests of academic disciplines that are already well-established. As a corrective to EPM’s scientific boundary work I propose the application of an ethics of care that recognises the complex relationalities that exist between research institutions, researchers and research participants. (shrink)

The history of the National Health Service research ethics system in the UK and some of the key drivers for its change into the present system are described. It is suggested that the key drivers were the unnecessary delay of research, the complexity of the array of processes and contradictions between research ethics committee (REC) decisions. It is then argued that the primary drivers for this change are and will be replicated by the systems of (...) research ethics review being put in place at UK universities in response to the Economic and Social Research Council research ethics framework. It is argued that this is particularly problematic for multi-centre review and for researchers who switch institutions. Finally, some potential solutions to this problem and their feasibility are discussed. (shrink)

It is not unusual for researchers to complain about institutional review board (IRB) oversight, but social scientists have a unique set of objections to the work of ethics committees. In an effort to better understand the problems associated with ethics review of social, behavioral, and economic sciences (SBES) research, this article examines 3 different aspects of research ethics committees: (a) the composition of review boards; (b) the guidelines used by these boards to (...) review SBES - and in particular, behavioral health - research; and (c) the actual deliberations of IRBs. The article concludes with recommendations for changes in the review process and with suggestions for filling the gaps in knowledge about the way IRBs work. (shrink)

Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers (...) in developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research. (shrink)

This article considers the process of ethical review of research on human subjects at a very large multinational consumer products company. The commercial context of this research throws up unique challenges and opportunities that make the ethics of the process of oversight distinct from mainstream medical research. Reflection on the justification of governance processes sheds important, contrasting light on the ethics of governance of other forms and context of research.

In their article, “The job of ‘ethics committees’”, Andrew Moore and Andrew Donnelly argue that current guidance documents provide that institutional research review committees ) perform two different and distinct functions, namely, a regulative review and an ethical review. They argue for separating those functions and for eliminating the ethics review role from IRBs. Instead, they want IRBs to focus exclusively on determining whether research proposals conform to governing regulations. In their argument, (...) Moore and Donnelly correctly note that regulatory requirements and ethical requirements can conflict. That point is correct, but hardly surprising. After all, regulations are general and the research proposals are specific, so an individual proposal may not conform to the general formulation of the rule and yet be consistent with ethics. Thus, a rule may generally be regarded as expressing a relevant moral consideration while providing a conclusion that does not appropriately reflect an ethical determination in the specific case. This inconsistency need not amount to what Moore and Donelly characterise as a ‘repellent’ or an ‘unconscionable’ review decision. Moore and Donnelly are also concerned that IRB decisions may differ from each other in their review of the same proposal. Again, they are correct in recognising that such inconsistent outcomes would be less likely if IRBs were to focus exclusively on whether proposals conformed to the regulations. That said, I reach the opposite conclusion. As I see it, IRBs present us with a good example of when the possibility of inconsistency is a relatively small consideration in comparison to the important values that are served by IRBs considering their protocol reviews in light of ethics and conforming to regulations. Allow me to explain. The authors and endorsers of research ethics …. (shrink)

The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to understanding for members of research ethics committees (RECs), professionals involved with medical research and those with an academic interest in the subject.

BackgroundWe conducted a survey to identify what types of health/medical research could be exempt from research ethics reviews in Australia.MethodsWe surveyed Australian health/medical researchers and Human Research Ethics Committee members. The survey asked whether respondents had previously changed or abandoned a project anticipating difficulties obtaining ethics approval, and presented eight research scenarios, asking whether these scenarios should or should not be exempt from ethics review, and to provide comments. Qualitative data were (...) analysed thematically; quantitative data in R.ResultsWe received 514 responses. Forty-three per cent of respondents to whom the question applied, reported changing projects in anticipation of obstacles from the ethics review process; 25% reported abandoning projects for this reason. Research scenarios asking professional staff to provide views in their area of expertise were most commonly exempted from ethics review ; scenarios involving surplus samples and N-of-1 studies were most commonly required to undergo ethics review. HREC members were 26% more likely than researchers to require ethics review. Need for independent oversight, and low risk, were most frequently cited in support of decisions to require or exempt from ethics review, respectively.ConclusionsConsiderable differences exist between researchers and HREC members, about when to exempt from review the research that ultimately serves the interests of patients and the public. It is widely accepted that evaluative research should be used to reduce clinical uncertainties—the same principle should apply to ethics reviews. (shrink)

One of the pressures placed upon researchers is the process of ethics review. This frequently provides considerable conflict. The process of review of student projects of little inherent risk is identical to that of their more senior colleagues. In this article I propose that we should be more tolerant of design problems within student research if the overall risk is minimal in order that the student can learn about the process of carrying out research.The frequency (...) and content of papers discussing research ethics review in specialist,1 professional2 3 and lay4 press suggests that many senior researchers find the process challenging. The opinion most frequently expressed is that research ethics committees work to an imprecise set of rules and represent a barrier to significant pieces of clinical research. In particular, specific criticism has been aimed at the review of student research5–8 and the difficulties that students and their supervisors face.In ethics committees we usually police research very carefully, monitoring the detail of projects, including how participants will be selected, what data will be collected, how it will be handled and how the research is funded in addition to the adequacy of the consent process and information that underlies it. My experience as a member of NHS REC and governance committees and, more particularly, coordinator of student research, is that National Research Ethics Service REC usually apply the same standards to student research with little inherent risk as to complex phase 1 studies with significant risk. Guidance in the standard operating procedures for NHS REC is at best unhelpful and at worst supportive of this view. …. (shrink)

Action research has repeatedly demonstrated how it can facilitate problem solving and change in many settings through a process of collaboration which is driven by the community at the heart of the research. The ethical review of action research can be challenging for action researchers and research ethics committees. This paper explores how seven ethical principles can be used by action researchers and research ethics committees as the basis for ethical review. (...) This paper concludes by offering some suggestions for a way forward for both action researchers and research ethics committees. (shrink)

The ethical review of research using methods of artificial intelligence and machine learning in health care contexts has become an important challenge for Research Ethics Boards (also refer...

Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a few well-established ethical issues that researchers need to address to obtain ethical approval to begin their research. While such prospective review of research is important, we argue that it is not sufficient to address all aspects of research (...) class='Hi'>ethics. We propose retrospective review as an important complement to prospective review. We offer two arguments to support our claim that prospective review is insufficient. First, as currently practiced, research ethics has become for some a ‘tick box’ exercise to get over the ‘hurdle’ of ethics approval. This fails to capture much of what is important in ethics and does not promote careful reflection on the ethical issues involved. Second, the current approach tends to be rules-based and we argue that research ethics should go beyond this to develop people’s capacity to be sensitive to the relevant moral features of their research, their ethical decision-making skills and their integrity. Retrospective review of a project’s ethical issues, and how they were addressed, could help to achieve those aims better. We believe that a broad range of stakeholders should be involved in such retrospective review, including representatives of ethics committees, participating communities and those involved in the research. All stakeholders could then learn from others’ perspectives and experiences. An open and transparent assessment of research could help to promote trust and understanding between stakeholders, as well as identifying areas of agreement and disagreement and how these can be built upon or addressed. Retrospective review also has the potential to promote critical reflection on ethics and help to develop ethical sensitivity and integrity within the research team. Demonstrating this would take empirical evidence and we suggest that any such initiatives should be accompanied by research into their effectiveness. Our article concludes with a discussion of some possible objections to our proposal, and an invitation to further debate and discussion. (shrink)

The role of Human Research Ethics Committees (HRECs) in health research is well established. Ethics committees have the good of research participants in mind but they must also assess scientific merit including the design and conduct of studies. In this article the authors’ focus is on qualitative research method and the challenge that the National Statement on Ethical Conduct in Human Research (2007) poses for ethics committees when they assess proposals using the (...) methods outlined in the National Statement.We set out a process for judging the standard of qualitative research proposals and propose that qualitative health research can be assessed using a hierarchy designed for evaluating interview studies. We contrast well-designed studies with those that have design flaws in order to focus on the hallmarks of research merit in studies that use qualitative research methods. Finally, we show that our proposal is compatible with the National Statement.Ethics review provides an early opportunity to identify and redesign inadequate studies that will not contribute to our knowledge base. The challenge for members of ethics committees with little experience in qualitative studies is to be able to assess research excellence by assessing research merit in proposals, recognising the special design features of qualitative research methods. (shrink)

Within international development [1], public health [2], and clinical medicine [3]–[5], there is increasing interest in determining whether cash payments or other economic incentives can be used to influence the choices and behavior of individuals and groups in order to promote desired health goals. However, a number of complex issues affect the review and approval by research ethics committees of research studying the effectiveness of using financial incentives to promote desired health goals. Current ethical and regulatory (...) frameworks regard the provision of gifts or cash payments to participants in human research as potentially problematic. Specifically, these frameworks imply that such incentives may undermine the autonomy of participant choice, hinder the disclosure of medical information, exacerbate social inequalities, or result in the exploitation or degradation of vulnerable populations [6]–[9]. Typically, these frameworks provide guidance about payment to research participants to reimburse expenses, to compensate for time and effort, to provide insurance coverage, or as an incentive to participate in the research itself. However, the issue of payment as a component of the research intervention is relatively new. RECs thus lack explicit guidance about ethical issues surrounding research that evaluates the use of financial incentives as an intervention to promote health. (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 outlines the potential for Research Higher Degree supervisors at universities and similar institutions to use ethical review as a constructive, dynamic tool in guiding RHD students in the timely completion of effective, innovative research projects. Ethical review involves a bureaucratized process for checking that researchers apply risk management strategies when dealing with human participants. Ethical review can also be a powerful instrument for RHD supervisors in the creative arts if they use it to (...) lead students through processes of imagining, articulating, and improving their methodologies and relationships with research participants. Proposed strategies involve adaptation of theories of visualization and imagination from several disciplines—imagined interaction from the social sciences and psychology, dramatic rehearsal from political science, and creative visualization from the health professions, sports coaching and many other personal–professional development contexts. By using creativity and imagination, supervisors can use ethical review to help students to ‘walk through’ the potential, progressive phases of proposed research in order to refine or redesign both ‘big picture’ strategies and specific steps taken to reach research goals. This can stimulate students to unearth possibilities that improve the quality and quantity of knowledge that their research generates and to avoid or manage problems that might disrupt their research. (shrink)

This paper shares my reflections on the research ethics review process, from the point of view of both a qualitative researcher and a member of an institutional research ethics review board. By considering research ethics review, first as practice, then as policy, as a relationship and, finally, as a performance, I attempt to outline a new vision of research ethics, one that engages seriously with the relationship between receiving (...) class='Hi'>ethics approval, and conducting ethical research. (shrink)

The fast growing interest in the work of university ethics review boards is evident in the proliferation of research and literature in the area. This article focuses on a Research Ethics Board (REB) in the Canadian context. In-depth, open-ended interviews with REB members and findings from a qualitative study designed to examine the ethics review of school-based research are used to illustrate points raised in the paper. The author’s experiences as academic researcher, (...) advisor to student researchers and a 3-year term as an REB member inform the discussion. Macro issues related to the general workings of the board (e.g., maintaining appropriate membership) and micro issues connected to individual REB members’ experiences of reviewing research applications are examined. The author’s goal is to contribute to a fastgrowing conversation related to the issues that influence university ethics review while drawing attention to the contribution that faculty members’ understandings of their work as REB members can make to that conversation. (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)

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees. The urgent need for continued capacity development in Africa has necessitated research initiatives to identify existing capacity. This discussion paper describes the mapping of RECs (...) in Africa through MARC project, second phase and discusses the findings. MARC provides a platform and tool on COHRED's Health Research HRWeb, which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. (shrink)

Zachary Schrag would like to put the burden of proof for continuation of research ethics review in the Social Sciences on those who advocate for research ethics committees (RECs), and asks that we take the concerns that he raises seriously. I separate his concerns into a principled issue and a number of pragmatic issues. The principled issue concerns the justification for having research ethics committees; the pragmatic issues concern questions such as the effectiveness (...) of review and the expertise of the committee members. I argue that RECs can be justified by their role in improving ethical practice and in reducing wrongs done to research participants. I propose a model of review for doing this, which I think would also address the pragmatic issues raised. I then offer an account of where the UK ethics review system is now and suggest three steps which could improve social science ethics review in the UK and move it in a perhaps more desirable direction. (shrink)

Consistent and well-designed frameworks for ethical oversight enable socially valuable research while forestalling harmful or poorly designed studies. I suggest some alterations that might strengthen the valuable checklist Rattani & Hyder propose for the ethical review of health policy and systems research (HPSR), or prompt future work in the area.

BackgroundCountries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.DiscussionResearch ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and (...) conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.ConclusionOutcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed? (shrink)

BackgroundThe research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent may be used to assess the research subject’s comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the (...) beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.MethodsThe search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews : Checklist and Explanation guideline was used to report this work.ResultsOf 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs followed by accessibility, comprehension engagement, autonomy, confidentiality, language, and parental consent. Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.ConclusionThe current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/rec members during a review process on electronic informed consent and useful to the future preparation of a checklist. (shrink)

This study examined Canadian Research Ethics Board practices concerning continuing ethics review of approved studies. A mail-out questionnaire was used to elicit information from Canadian REB representatives about whether their board engaged in continuing ethics review, and, if so, what their methods were. The study found that a majority of REBs conduct continuing ethics review. REBs conduct continuing ethics review of clinical trial research significantly more often than of academic (...) research. The study also found little difference in the frequency of continuing ethics review between academic and other types of REBs. The most commonly reported method for conducting continuing ethics review was a review of ongoing research reports. (shrink)

This project is based on the unique ‘Shared ethical debate’ between NHS RECs in the UK in which one research application is reviewed by several research ethics committees. This programme is now in its 6th cycle. In the fifth cycle a prison- based research project was reviewed by each of three NHS RECs that are ‘ flagged’ for such research and their debate and discussions were observed directly by one researcher who recorded the committee processes (...) and the issues raised in committee. Subsequently a focus group of REC members from all three committees was constituted to consider the ethical importance of these issues. The three RECs were consistent in both process and identifying ethical issues. The focus group formulated a basic framework that will further contribute to ensuring a consistent and balanced approach to ethical review within this area of research. (shrink)