ABSTRACT The ethical review process is an important component of contemporary health research worldwide. Sudan started an ethical review process rather late in comparison with other countries. In this study, we evaluate the structure and functions of existing ethics review committees. We also explore the knowledge and attitudes of Sudanese researchers toward the ethical review process and their experience with existing ethics review committees. There are four ethics review committees in the (...) country; these committees have no institutional regulations to govern their functions. Furthermore, Sudan also lacks national guidelines. Ethical reviews are carried out primarily for studies seeking international funding and are almost always governed by the funding agencies’ requirements. Nearly half of respondents (46.3%) knew about the existence of research ethics committees in Sudan. Researchers reported a variety of experiences with the ethical review process; most of them were unable to define ‘ethics committee’. (shrink)

ABSTRACT The ethical review process is an important component of contemporary health research worldwide. Sudan started an ethical review process rather late in comparison with other countries. In this study, we evaluate the structure and functions of existing ethics review committees. We also explore the knowledge and attitudes of Sudanese researchers toward the ethical review process and their experience with existing ethics review committees. There are four ethics review committees in the (...) country; these committees have no institutional regulations to govern their functions. Furthermore, Sudan also lacks national guidelines. Ethical reviews are carried out primarily for studies seeking international funding and are almost always governed by the funding agencies’ requirements. Nearly half of respondents (46.3%) knew about the existence of research ethics committees in Sudan. Researchers reported a variety of experiences with the ethical review process; most of them were unable to define ‘ethics committee’. (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)

Objective: To examine the current ethical review process of ethics committees in a non-pharmacological trial from the perspective of a clinical investigator.Design: Prospective collection of data at the Study Centre of the German Surgical Society on the duration, costs and administrative effort of the ERP of a randomised controlled multicentre surgical INSECT Trial between November 2003 and May 2005.Setting: Germany.Participants: 18 ethics committees, including the ethics committee handling the primary approval, responsible overall for 32 clinical sites (...) throughout Germany. 8 ethics committees were located at university medical schools and 10 at medical chambers. Duration was measured as days between submission and receipt of final approval, costs in euros and administrative effort by calculation of the product of the total number of different types of documents and the mean number of copies required .Results: The duration of the ERP ranged from 1 to 176 days. The median duration was 26 days at MSUs compared with 34 days at medical chambers. The total cost was €2947. 1 of 8 ethics committees at universities and 8 of 10 at medical chambers charged a median fee of €162 . The administrative effort for primary approval was 30. Four ethics committees required a higher administrative effort for secondary approval .Conclusion: The ERP for non-pharmacological multicentre trials in Germany needs improvement. The administrative process has to be standardised: the application forms and the number and content of the documents required should be identical or at least similar. The fees charged vary considerably and are obviously too high for committees located at medical chambers. However, the duration of the ERP was, with some exceptions, excellent. A centralised ethics committee in Germany for multicentre trials such as the INSECT Trial can simplify the ERP for clinical investigators in and outside the country. (shrink)

Summary: Edward Lanphier and colleagues contend that human germline editing is an unethical technology because it could have unpredictable effects on future generations. In our view, such misgivings do not justify their proposed moratorium.

Background The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). Methods We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics (...) review processes during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. Results Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. Conclusions There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics. (shrink)

Ethics review processes are frequently perceived as extending from codes and protocols rooted in biomedical disciplines. As a result, many researchers in the humanities and social sciences (HASS) find these processes to be misaligned, if not outrightly obstructive to their research. This leads some scholars to advocate against HASS participation in institutional review processes as they currently stand, or in their entirety. While ethics review processes can present a challenge to HASS (...) researchers, these are not insurmountable and, in fact, present opportunities for ethics review boards (ERBs) to mediate their practices to better attend to the concerns of the HASS disciplines. By highlighting the potential value of the ethics review process in recognising the nuances and specificity across different forms of research, this article explores the generative possibilities of greater collaboration between HASS researchers and ERBs. Remaining cognisant of the epistemic and methodological differences that mark different disciplinary formations in turn will benefit the ethical conduct of all researchers. (shrink)

In this response, the Australian Health Ethics Committee (AHEC) indicates that it shares, and has strategies in place to address, the majority of the concerns identified by Susan Dodds. AHEC believes it is too early to assess the full impact of the National Statement on Ethical Conduct in Research Involving Humans (1999) or to call for a major review of the ethics committee process. While some Human Research Ethics Committees (HRECs) are over-stretched, the system is not (...) on the verge of collapse. (shrink)

A review of the literature and ethnographic data from Australia, Canada, New Zealand, the United States, and the United Kingdom on the research ethics review process suggest that moral panics can become triggers for punctuated equilibrium in the review process at both the macro and microlevel, albeit with significantly different levels of magnitude and impact. These data suggest that neither the development of the ethics review process nor the process itself proceeds gradually, but both (...) are characterized by periodic major shifts evoked by particular events or situations that result in varying levels of moral panic. One way to deal with this moral panic is to increase the regulation of research and the depth or intensity of the scrutiny of applications under ethics review. Moral panics at the macrolevel influence those at the microlevel and, if the moral panic evoked at the local or microlevel is not satisfactorily resolved, it will evoke action at a higher level. Understanding the evolution of research ethics review processes from this perspective might help make actions by ethics committees and policy makers more understandable and help explain why attention to research ethics are heightened at particular points in time. It may also provide a basis for developing recommendations for adaptations to the ethics review process and policy at both the local and macrolevel. (shrink)

A growing body of literature critical of ethics review boards has drawn attention to the processes used to determine the ethical merit of research. Citing criticism on the bureaucratic nature of ethics review processes, this literature provides a useful provocation for (re)considering how the ethics review might be enacted. Much of this criticism focuses on how ethics review boards _deliberate,_ with particular attention given to the lack of transparency and opportunities (...) for researcher recourse that characterise ethics review processes. Centered specifically on the conduct of ethics review boards convened within university settings, this paper draws on these inherent criticisms to consider the ways that ethics review boards might enact more communicative and deliberative practices. Outlining a set of principles against which ethics review boards might establish strategies for engaging with researchers and research communities, this paper draws attention to how _Deliberative communication_, _Engagement with researchers_ and the _Distribution of responsibility_ for the ethics review might be enacted in the day-to-day practice of the university human ethics review board. This paper develops these themes via a conceptual lens derived from Habermas’ (The theory of communicative action. Volume 1: Reason and the rationalization of society, 1984 ) articulation of ‘communicative action’ and Fraser’s (Social Text, 25(26), 56–80, 1990 ) consideration of ‘strong publics’ to cast consideration of the role that human ethics review boards might play in supporting university research cultures. _Deliberative communication_, _Engagement with researchers_ and the _Distribution of responsibility_ provide useful conceptual prompts for considering how ethics review boards might undertake their work. (shrink)

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; (...) investigators not following checklists; limited expertise in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general. (shrink)

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; (...) investigators not following checklists; limited expertise in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general. (shrink)

Most countries, including Botswana, have established Institutional Review Boards to provide oversight of research involving human beings. Although much has been published on the structure and function of IRBs around the world, there is less literature that empirically describes the perspectives of stakeholders in low- and middle-income country settings regarding IRB processes. In this study, we employed primarily quantitative methods to examine the perceptions of researchers at the University of Botswana about the review of research protocols by (...) local IRBs. Data were collected using a web-based survey. This was a preliminary effort to document some of the emerging experiences of researchers with ethics review in a context where both research and research oversight are relatively new. Findings from 85 researchers indicate that researchers recognized the need for an IRB to review all human research protocols, expressed the need for research ethics training, experienced hig... (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 27-29, June 2011.

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)

Objectives: To review the performance of research ethics committees in Spain in assessing multicentre clinical trial drug protocols, and to evaluate if they would comply with the requirements of the new EU Directive to be implemented by May 2004.Design and setting: Prospective study of applications of MCT submitted to RECs.Main measurements: Protocol related features and evaluation process dynamics.Results: 187 applications to be performed in 114 centres, were reviewed by 62 RECs. RECs had a median number of 14 members, (...) of which three were lay members. All applications were approved except four which were however approved by the other RECs involved. The median times from submission to approval and from submission to reception at the sponsor’s offices were 48 and 62 days, respectively. In 55% of all applications approved, 41 RECs raised 307 queries, 40% of these were protocol related issues, and 38% related to the patients’ information sheets. RECs charging an evaluation fee in advance and applications with no queries raised were statistically significantly associated with shorter evaluation times. However, there is a gap of at least 1.5 weeks between the date of the meeting and the reception of the approval letter in the sponsor’s office.Conclusions: Evaluating MCT protocols by RECs is a time consuming process. Needing 1.5 weeks for communicating the decision taken by RECs to the sponsor suggests serious administrative shortcomings within most RECs. By significantly reducing the time for communication of their decisions, the majority of RECs would comply with the Directive requirement of a maximum 60 day period for the assessment of MCT. (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)

Most public and non-profit organisations that fund health research provide the majority of their funding in the form of grants. The calls for grant applications are often untargeted, such that a wide variety of applications may compete for the same funding. The grant review process therefore plays a critical role in determining how limited research resources are allocated. Despite this, little attention has been paid to whether grant review criteria align with widely endorsed ethical criteria for allocating health (...) research resources. Here, we analyse the criteria and processes that ten of the largest public and non-profit research funders use to choose between competing grant applications. Our data suggest that research funders rarely instruct reviewers to consider disease burden or to prioritise research for sicker or more disadvantaged populations, and typically only include scientists in the review processes. This is liable to undermine efforts to link research funding to health needs. (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)

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)

Given that health systems research involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical areas we discuss include (...) the nature of intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, inclusion of vulnerable groups, and benefits of research. HSR involving human participants is necessary to ensure health systems strengthening and quality of care and to guide public policy intelligently. Health systems researchers must carefully define their intent and goals and openly clarify the values that may influence the premises and design of protocols. As new types of population-level research activities become more commonplace, it is critical that institutional review board and research ethics committee review processes evolve to evaluate these research protocols in ways that address the nuanced features of these studies. (shrink)

Ethical review systems need to build on their experiences of COVID-19 research to enhance their preparedness for future pandemics. Recommendations from representatives from over twenty countries include: improving relationships across the research ecosystem; demonstrating willingness to reform and adapt systems and processes; and making the case robustly for better resourcing.

The ethics review system of research is now well-established, at least in the developed world, although there are many differences in how countries view it and go about managing it. The UK specifically is now seeking to revise its system by speeding up the process of ethics approval but only for some studies. It is proposed that only those studies which pose “no material ethical issues” should be “fast-tracked”. However, it is unclear what this means, who should (...) decide and what should be included in this category. In this paper, we go some way towards answering these questions. While we are certain that the debate is only just beginning, we are equally certain that it will continue to run long after the system has been reformed. To stimulate this conversation and to inform a pilot project of the new system directly, we review two candidates to help give some substance to the notion of “material” ethical issues. Firstly, material could mean a certain type or degree of risk. Second, material could mean how physically invasive the research is. We conclude that there is still much work to be done on making the system of governing health and social care consistent and practicable. (shrink)

ABSTRACTGiven the ethical controversies concerning HIV vaccine trials , we aimed to understand through an exploratory study how members of institutional review boards in the United States and research ethics committees in South Africa view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires . In both countries, members tended to (...) be white males with advanced academic degrees. Compared to the US, SA members called for ‘major changes’ in HVT protocols more frequently , and were less likely to think that HVT participants understood risks and benefits or informed consent forms . In both countries, members were divided on several critical issues , but agreed that they needed more training. Of the SA respondents, 40% reported that they were ‘self‐taught’ in ethics. This study, the first we know of to offer quantitative data comparing US vs. non‐US IRBs/RECs, thus suggests key similarities and differences , along with needs for education. These initial exploratory data in this area have important implications for IRBs, RECs, policy‐makers and scholars concerning future practice, training, policy, and investigations in research ethics, and prevention and treatment of HIV and other diseases in the developing world and elsewhere. (shrink)

Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of proportional review depends (...) on the possibility of effectively identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted. (shrink)

This article examines forms of subjectivation propagated through the processes and practices of ethics review in UK Higher Education Institutions. Codified notions of research ethics are particularly prevalent in the university context along with stringent institutional regulation of the procedures surrounding ethics review of research proposals. Michel Foucault’s concept of neoliberal governmentality is argued in this article to help illuminate the combination of power processes reflected in ethics review practices. These operate (...) insidiously in accordance with a neoliberal rationality that champions self-sustaining individuals and the inauguration of human capital. Moreover, ethics review processes and attendant regulatory modes of control compound the construction of the student as a ‘permanent performer’ and the associated requirement for her to self-govern through risk management. A combination of overtly controlling and self-relational mechanisms of neoliberal governmentality are in operation, both of which have the potential to generate particular forms of subjectivation in the university context. Foucault’s conceptualisation of the ethical relation to the self helps indicate alternative, resistant styles of self-confrontation to those correlating with neoliberal governmentality. These are based on autonomous choice-making and self-censoring rather than unquestioning conformity to the regimens of ethics review. (shrink)

The current ethical structure for collaborative international health research stems largely from developed countries' standards of proper ethical practices. The result is that ethical committees in developing countries are required to adhere to standards that might impose practices that conflict with local culture and unintended interpretations of ethics, treatments, and research. This paper presents a case example of a joint international research project that successfully established inclusive ethical review processes as well as other groundwork and components necessary (...) for the conduct of human behavior research and research capacity building in the host country. (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)

The U.S. review system for human subjects research has been widely criticized in recent years for requirements that delay research without improving human subjects protections. Any major reformulation of regulations may take some time to implement. In the meantime, current regulations often allow for streamlined ethics review without jeopardizing—and possibly improving—protections for research participants. We discuss underutilized options, including research that need not be classified as “human subjects research,” categories of studies that can be exempt from ethical (...) review, and studies that need only undergo expedited review by one IRB member. In addition, we consider ways to simplify review of multi-center research using one institution’s IRB. We speculate on multiple reasons for the underuse of these mechanisms, and exhort IRBs and researchers to take advantage of these important opportunities to improve the review process. (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)

Life sciences research is increasingly international and data-intensive. Researchers work in multi-jurisdictional teams or formally established research consortia to exchange data and conduct research using computation of multiple sources and volumes of data at multiple sites and through multiple pathways. Despite the internationalization and data intensification of research, the same ethics review process as applies to single-site studies in one country tends to apply to multi-site studies in multiple countries. Because of the standard requirement for multi-jurisdictional or multi-site (...) ethics review, international research projects are subjected to multiple ethics reviews of the same research protocol. Consequently, the reviews may be redundant and resource-consuming, whilst the opinions delivered by ethics committees may be inconsistent both within and across jurisdictions. In this article, we present findings based on interviews conducted with international experts in research ethics on the topic of et... (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)

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)

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)

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.

A Decent Proposal: Ethical Review of Clinical Research Donald Evans and Martyn Evans Centre for Philosophy and Health Care University of Wales Swansea, UK The investigation and development of modern medicines and medical technology can create numerous ethical dilemmas both for clinical researchers and research ethics committees. A Decent Proposal: Ethical Review of Clinical Research seeks to facilitate and encourage good clinical research by exploring the concerns, responsibilities, general issues and particular pitfalls associated with ethical aspects of (...) research. It provides practical guidelines for researchers on how to improve the quality of research design, while for those appointed to scrutinise research proposals it offers advice on how to apply consistent, careful and critical reasoning to the process of assessing ethical standards. As such, it will provide invaluable assistance to clinical researchers and ethics committees alike in understanding the moral challenges posed by modern health care. (shrink)

Ensuring that countries have adequate research capacities is essential for an effective and efficient response to infectious disease outbreaks. The need for ethical principles and values embodied in international research ethics guidelines to be upheld during public health emergencies is widely recognized. Public health officials, researchers and other concerned stakeholders also have to carefully balance time and resources allocated to immediate treatment and control activities, with an approach that integrates research as part of the outbreak response. Under such circumstances, (...) research “ethics preparedness” constitutes an important foundation for an effective response to infectious disease outbreaks and other health emergencies. A two-day workshop was convened in March 2018 by the World Health Organisation Global Health Ethics Team and the African coaLition for Epidemic Research, Response and Training, with representatives of National Ethics Committees, to identify practical processes and procedures related to ethics review preparedness. The workshop considered five areas where work might be undertaken to facilitate rapid and sound ethics review: preparing national ethics committees for outbreak response; pre-review of protocols; multi-country review; coordination between national ethics committees and other key stakeholders; data and benefit sharing; and export of samples to third countries. In this paper, we present the recommendations that resulted from the workshop. In particular, the participants recommended that Ethics Committees would develop a formal national standard operating procedure for emergency response ethical review; that there is a need to clarify the terminology and expectations of pre-review of generic protocols and agree upon specific terminology; that there is a need to explore mechanisms for multi-country emergency ethical consultation, and to establish procedures for communication between national ethics committees and other oversight bodies and public health authorities. In addition, it was suggested that ethics committees should request from researchers, at a minimum, a preliminary data sharing and sample sharing plan that outlines the benefit to the population from which data and samples are to be drawn. This should be followed in due time by a full plan. It is hoped that the national ethics committees, supported by the WHO, relevant collaborative research consortia and external funding agencies, will work towards bringing these recommendations into practice, for supporting the conduct of effective research during outbreaks. (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)

A needs assessment survey of ethics review committees (ERCs) across Africa was conducted in order to establish their major needs and areas of weaknesses in terms of ethical review capacity. The response rate was 84% (31 of 37 targeted committees), and committees surveyed were located in 18 African countries. The majority of the responding committees (61%) have been in existence between 5 and 10 years; approximately 74% of the respondents were institutional committees, with the remainder being either (...) national (6/31) or regional (2/31). In terms of the ethical review process, nine of the 31 committees that responded did not have standard operating procedures (SOPs), and seven of the 22 that did have SOPs had never revised them after their initial development (an average period of three years). Of the 31 committees, 10 operated without any ethical guidelines. Many of the committees (13/30) met once per month, and the number of proposals reviewed annually varied, ranging from five to over 100. All respondents relied on paper-based data management and archiving systems. Overall, the survey identified the major constraints on ERCs as lack of office equipment, outdated or lack of SOPs, lack of electronic data management systems, inadequate resources, lack of or insufficient expertise on the committees, and poor recognition of the importance of the role of the committees. Consequently, the authors are addressing the identified needs and weaknesses through the Bill and Melinda Gates Foundation-funded capacity building project. The impact of the intervention project will be assessed during and at the end of the four-year longitudinal project. (shrink)

In the context of a public health emergency it is imperative to conduct research studies that will produce evidence rapidly while upholding ethical standards. The Ebola and Zika outbreaks highlighted the importance of devising agile processes for ethics review in emergencies, and international research ethics guidelines stress the duty to depart from standard processes for ethics review in emergency circumstances. However, before the COVID-19 pandemic it was not entirely clear what emergency procedures should (...) look like. An additional challenge is that while the same substantive ethical standards apply in emergency and non-emergency settings, deciding what these standards entail in the specific circumstances of a pandemic may be difficult. During the COVID-19 pandemic, challenges included identifying thresholds of social and scientific value, along with duties towards research participants, given the absence of therapeutic options; assessing continually changing risk–benefit profiles of studies, given rapidly emerging new evidence; developing appropriate informed consent processes, given lockdown scenarios; and even addressing the ethics of offering unproven interventions outside research settings. Additional issues raised during epidemics include devising feasible and meaningful community engagement strategies, mechanisms to ensure fairness in the distribution of the benefits that may result from research, and equitable and effective data-sharing plans that will inform pandemic response. Learning from these procedural and substantive challenges encountered in the ethics review of COVID-19 research is important for enhancing ethics preparedness for future emergencies. It can also potentially contribute to improving the ethics review of research in non-emergency circumstances. The seven cases in this chapter highlight ethical issues associated with ethics approval of multi-centre studies in pandemics, the need for careful consideration of the social and scientific value of research and challenges encountered when interventions are being transitioned from research to rollout, and issues that can arise when existing regulations and policies may limit capacities to appropriately adapt research to pandemic contexts. (shrink)

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)

The National Women's Hospital research scandal saw women being involved in medical research without their knowledge and without the opportunity to make a choice about their participation. The 1988 Cartwright Inquiry into this decades-long study established a template for ethics review in New Zealand. Ethics committees were subsequently established to independently assess the potential benefits as well as risks of research. This book describes the gradual undermining of the independence of New Zealand ethics review and (...) the politicisation of ethics committees between 1988 and 2014. The authors, involved continuously in ethics review matters over the period, have seen substantial change brought about by government in response to another medical research crisis - in Gisborne in the late 1990s - and then between 2008 and 2010 an economic crisis involving foreign pharmaceutical companies. Some New Zealand medical researchers claimed that the ethics review process for clinical trials was too slow and was losing the country its economic advantage. This book traces the changes and the implications for a robust ethics review process in all research environments in New Zealand, especially those affecting Maori. The book includes a set of suggestions and recommendations aimed at enhancing independent ethics review, best practice, and the provision of adequate protection for all citizens. (shrink)

The expansion of ethics review, beyond its origins in medical research, is the subject of growing critical analysis internationally, especially from social science researchers. Our study builds on this analysis by considering ethics review specifically within tertiary-based educational research. As a foundation for a larger study, we explore the reporting of ethics review within articles from a snapshot of education journals. A cross-sectional review considered 125 articles from 24 journals spanning medical and nurse (...) education, the Scholarship of Teaching and Learning, and educational technology. Among similar types of research our findings highlight variation in institutional ethical review processes and outcomes. Despite most journals providing guidelines for reporting ethics review, adherence to these guidelines by authors or editors was not always evident, but more likely in health-related education journals. We argue that identified areas of variation may reflect the differing influence and proximity of biomedical values. This influence has been under examined in tertiary-based educational research but may contribute to inequitable learning, researching and publishing experiences, potentially adding to negative sentiment about ethics review. (shrink)

The current paper discusses the peer review process in journals that publish research papers purveying new science and understandings. Different aspects of peer review including the selection of reviewers, the review process and the decision policy of editor are discussed in details. Here, the pros and cons of different conventional methods of review processes are mentioned. Finally, a suggestion is presented for the review process of scientific papers.

In the United States, the Presidential Commission for the Study of Bioethical Issues has proposed deliberative democracy as an approach for dealing with ethical issues surrounding synthetic biology. Deliberative democracy might similarly help us as we update the regulation of human subjects research. This paper considers how the values that deliberative democratic engagement aims to realize can be realized in a human subjects research context. Deliberative democracy is characterized by an ongoing exchange of ideas between participants, and an effort to (...) justify decisions that bind participants by appeal to reasons that the participants can understand and share. Even when unanimous agreement is not reached, the active participation of everyone along with the requirement that reasons be made accessible enhances the legitimacy of the ultimate outcome. Importantly, deliberative democratic structures avoid strict hierarchies and place participants, as much as possible, in the position of equals. Human subjects research has some features that may make deliberative democratic principles seem initially unappealing. For one, there are asymmetries in knowledge between expert researchers conducting the research and participants in the research process. For another, statistical validity is made easiest by research paradigms that produce standardized, quantitative data, which can be difficult to achieve if research participants are given the power to deliberatively reshape the research design as it progresses. These and other problems have tended to produce a human subjects research process where subjects do not actively participate in shaping research, but rather consent to a predefined set of interventions designed by expert researchers and vetted by Institutional Review Boards (IRBs). In this paper, I suggest some ways in which human subjects research could do more to realize deliberative democratic values, and, in particular, how a revised Common Rule might help to realize these values. First, research participants could be treated not as passive subjects but instead involved in research design, ethical review, and the ongoing conduct and dissemination of research. Such participation might involve, for instance, including people who have served as research subjects on IRBs, or replacing IRB oversight for certain forms of research exempted from IRB oversight under a revised Common Rule with oversight by a body of community members or research subjects. It might also involve having the oversight of research that uses more participatory models be more participatory and less hierarchical in nature. I also raise questions about the exemption of research on public benefit programs from any research-level oversight and from consent requirements. While IRBs are likely not the correct overseers, there may be good reason to view such research with a critical eye, because of its potential for long-range impacts on the lives of participants. By giving research subjects a greater voice in research that aims at fine-tuning public benefit programs on which subjects rely, a deliberative oversight process has the potential to recast research participation as a form of active democratic participation and to address a “democratic deficit” in public health. Numerous proposals regarding health care have called for greater participation by laypeople and a more nonhierarchical approach to setting health priorities. Involving lay research subjects in the conduct of public benefits research and other forms of public health research may help to further these goals. (shrink)