BackgroundThe increasing emphasis on research, development and innovation for health in providing solutions to the high burden of diseases in the African Region has warranted a proliferation of studies including clinical trials. This changing public health landscape requires that countries develop adequate ethics review capacities to protect and minimize risks to study participants. Therefore, this study assessed the readiness of national ethics committees to respond to challenges posed by a globalized biomedical research system which is constantly challenged by new public (...) health threats, rapid scientific and technological advancements affecting biomedical research and development, delivery and manufacture of vaccines and therapies, and health technology transfer.MethodsThis is a descriptive study, which used a questionnaire structured to elicit information on the existence of relevant national legal frameworks, mechanisms for ethical review; as well as capacity requirements for national ethics committees. The questionnaire was available in English and French and was sent to 41 of the then 46 Member States of the WHO African Region, excluding the five Lusophone Member States. Information was gathered from senior officials in ministries of health, who by virtue of their offices were considered to have expert knowledge of research ethics review systems in their respective countries.ResultsThirty three of the 41 countries responded. Thirty of respondent countries had a national ethics review committee ; 79 % of which were established by law. Twenty-five NECs had secretarial and administrative support. Over 50 % of countries with NECs indicated a need for capacity strengthening through periodic training on international guidelines for health research ethics; and allocation of funds for administrative and secretariat support.ConclusionsDespite the existing training initiatives, the Region still experiences a shortage of professionals trained in health research ethics/ethicists. Committees continue to face various capacity needs especially for evaluating clinical trials, for monitoring ongoing research, database management and for accrediting institutional ethics committees. Given the growing number of clinical trials involving human participants in the African Region, there is urgent need for supporting countries without NECs to establish them; capacity strengthening where they exist; and creation of a regional network and joint ethical review mechanisms, whose membership would be open to all NECs of the Region. (shrink)

BackgroundImplementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials.DiscussionImplementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of completed or piloted research. A co-creation approach involves collaboration between researchers and end users from the onset, in question framing, research design and delivery, (...) and influencing strategy, with implementation and broader dissemination strategies part of its design from gestation. A defining feature of co-creation is its emergent and adaptive nature, making detailed pre-specification of interventions and outcome measures impossible. This methodology sits oddly with ethics committee protocols that require precise pre-definition of interventions, mode of delivery, outcome measurements, and the role of study participants. But the strict requirements of ethics committees were developed for a purpose – to protect participants from harm and help ensure the rigour and transparency of studies. We propose some guiding principles to help square this circle. First, ethics committees should acknowledge and celebrate the diversity of research approaches, both formally and informally ; without active support, their members may not understand or value participatory designs. Second, ground rules should be established for co-design applications and communicated to committee members and stakeholders. Third, the benefits of power-sharing should be recognised and credit given to measures likely to support this important goal, especially in research with vulnerable communities. Co-design is considered best practice, for example, in research involving indigenous peoples in New Zealand, Australia and Canada. (shrink)

Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards and research ethics committees’ about the need for researchers to translate consent forms and other study materials. Sixty US IRBs were contacted, and leaders from 34 and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals—what, when and (...) how to translate , why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy and justice against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions. (shrink)

Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear.METHODS: I conducted in-depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%).RESULTS: US IRBs face (...) ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long-standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and ‘negotiate’ for maximum benefits for participants and fearing ‘worst-case scenarios’.CONCLUSIONS: US and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice. (shrink)

Background: The Directive 2001/20/EC was an important first step towards consistency in the requirements and processes for clinical trials across Europe. However, by applying the same rules to all types of drug trials and transposing the Directive’s principles into pre-existing national legislations, the Directive somewhat failed to meet its facilitation and harmonisation targets. In the field of ethics, the Directive 2001/20/EC conditioned the way of understanding and transposing the “single opinion” process in each country. This led to a situation in (...) which two models of research ethics committees organisation systems exist, being the model in which the “single opinion” is considered to be the decision made by a single ethics committee more effective and simpler in terms of administrative and logistic workload. Method: A survey was conducted in 10 European countries. Members of the European Clinical Research Infrastructures Network working party number 1, with expertise in the field of ethics, responded. Results: There is a major heterogeneity in the composition of ethics committees among the surveyed countries based on the number of members, proportion of experts versus lay members and expertise of the scientific members. A harmonised education of the ethics committees’ membership based in common curricula is recommended by the majority of countries. Conclusions: Despite the efforts for harmonisation of the European Clinical Trial Directive, from an ethical point of view, there remains a plurality of ethics committees' systems in Europe. It is important to comprehend the individual national systems to understand the problems they are facing. (shrink)

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

Institutional review board delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in (...) the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improv... (shrink)

OBJECTIVES: To compare the practices of local research ethics committees and the time they take to obtain ethical approval for a multi-centre study. DESIGN: A retrospective analysis of outcome of applications for a multi-centre study to local research ethics committees. SETTING: Thirty-six local research ethics committees covering 38 district health authorities in England. MAIN MEASURES: Response of chairmen and women, the time required to obtain approval, and questions asked in application forms. RESULTS: We received replies from all 36 chairmen contacted: (...) four (11%) granted their approval, and 32 (89%) required our proposal to be considered by their local research ethics committee. Three committees asked us to attend their meetings. The application was approved by all 36 local research ethics committees but the time to obtain ethical approval varied between six to 208 days. One third of the committees did not approve the project within three months, and three took longer than six months. There was considerable variation in the issues raised by local research ethics committees and none conformed exactly to the Royal College of Physicians' guidelines. CONCLUSION: Obtaining ethical approval for a multi-centre study is time-consuming. There is much diversity in the practice of local research ethics committees. Our data support the recommendation for a central or regional review body of multi-centre studies which will be acceptable to all local research ethics committees. (shrink)

The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service procedures and the electronic Integrated Research Application System. We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive (...) research, and suggest directions for radical system change. We have recorded 491 exchanges with 89 individuals involved in research ethics and governance approvals, generating 193 pages of email text excluding attachments. These are conservative estimates. The exchanges were conducted outside IRAS, expected to be the platform where all necessary documents are provided and questions addressed. Importantly, the figures exclude the actual work of preparing the ethics documentation. We propose six areas of work to enable system change: 1. Support the development of a broad range of customised research ethics and governance templates to complement generic, typically clinical trials orientated, ones; 2. Develop more sophisticated and flexible frameworks for study classification; 3. Link with associated processes for assessment, feedback, monitoring and reporting, such as ones involving funders and patient and public involvement groups; 4. Invest in a new generation IT infrastructure; 5. Enhance system capacity through increasing online reviewer participation and training; and 6. Encourage researchers to quantify the approvals processes for their studies. Ethics and governance approvals are burdensome for historical reasons and not because of the nature of the task. There are many opportunities to improve their efficiency and analytic depth in an age of innovation, increased connectivity and distributed working. If we continue to work under current systems, we are perpetuating, paradoxically, an unethical system of research approvals by virtue of its wastefulness and impoverished ethical debate. (shrink)

Obtaining ‘informed consent’ from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require ‘informed consent form’ as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low-and middle-income countries in recent years, only limited (...) work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent. (shrink)

Research ethics review is a critical aspect of the research governance framework for human subjects research. This usually requires that research protocols be submitted to a research ethics committee for review and approval. This has led to very rapid developments in the domain of research ethics, as RECs proliferate all over the globe in rhyme with the explosion in human subjects research. The work of RECs has increasingly become elaborate, complex, and in many cases urgent, necessitating supporting rules and procedures (...) of operation. Guidelines for elaborating standard operating procedures for the functioning of RECs have also been proposed. The SOPs of well-placed and well-resourced RECs have tended to pay much attention to details, resulting, as a consequence, in generally long, elaborate, intricate and complex SOPs; a model that can hardly be replicated by other committees, equally under ethics review pressures, but working under much more constraining conditions in resource-destitute environments. In this paper, we looked at the content and length of SOPs from African RECs and compared them to the World Health Organization ’s guidelines as the gold standard. We also looked at the SOPs from the Ethics Review and Consultancy Committee of the Cameroon Bioethics Initiative that we elaborated in a simplified way in 2013, and compared them to the WHO’s guidelines and to the other SOPs. Sixteen SOPs from 14 African countries were collected from various sources. Their average length was of 30 pages. By comparison to the guidance of the WHO, only six of them were found acceptable with more than 70 % of the criteria from the gold standard that were fully described. Among those six, two of them were very long and detailed, while the four remaining SOPs ranged from 16 to 24 pages. The ERCC SOPs are seven pages long but maintain all that is of essence for the rigorous, efficient and timely review of protocols. We are convinced that, because of their brevity, simplicity, clarity and user-friendliness, the ERCC SOPs recommend themselves as a model template to, at least, committees similarly situated and/or circumstanced as the ERCC of the Cameroon Bioethics Initiative is. In fact, brevity, clarity, simplicity and user-friendliness are recognized values. Whatever is brief and clear is better than what is not and saves time. What is simple and user-friendly is better than what is not even though the two have the same aims because it saves both time and mental energy. And if this be true in general, it is even truer of the context and its peculiar constraints that we are addressing. (shrink)

Conducting research during or in the aftermath of disasters poses many specific practical and ethical challenges. This is particularly the case with research involving human subjects. The extraordinary circumstances of research conducted in disaster settings require appropriate regulations to ensure the protection of human participants. The goal of this study is to systematically and qualitatively review the existing ethical guidelines for disaster research by using the constant comparative method. We performed a systematic qualitative review of disaster research ethics guidelines to (...) collect and compare existing regulations. Guidelines were identified by a three-tiered search strategy: 1) searching databases, 2) an Internet search, and 3) a search of the references in the included documents from the first two searches. We used the constant comparative method for analysis of included guidelines. Fourteen full text guidelines were included for analysis. The included guidelines covered the period 2000-2014. Qualitative analysis of the included guidelines revealed two core themes: vulnerability and research ethics committee review. Within each of the two core themes, various categories and subcategories were identified. Some concepts and terms identified in analyzed guidelines are used in an inconsistent manner and applied in different contexts. Conceptual clarity is needed in this area as well as empirical evidence to support the statements and requirements included in analyzed guidelines. (shrink)

Background In their paper “Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better” Petrova and Barclay highlight concerns with the health research regulatory environment in the UK. Discussion As long-standing chairs of NHS research ethics committees, researchers, and also academics in research ethics, we are also often frustrated with the regulatory process in the UK. However, we think that Petrova and Barclay’s analysis is misleading because it conflates research (...) ethics with governance and funding processes, thus failing to adequately distinguish between the national coordinating function of the Health Research Authority, local research governance processes, and interactions with research sponsors and/or the Clinical Research Network. (shrink)

BackgroundThis paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi.DiscussionThe current research ethics regulations and guidelines in Malawi do not (...) allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes.SummaryIn conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi. (shrink)

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

Background Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Aim Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Method Postal survey of all RECs in Ireland. Results Response rate was 62.5% (n=50). 80% of RECs (...) reported not to have any established policy on the payment of research subjects while 20% had refused ethics approval to studies because the investigators proposed to pay research participants. The most commonly cited concerns were the potential for inducement and undermining of voluntary consent. Conclusions There is considerable variability among RECs on the payment of research participants and a lack of clear consensus guidelines on the subject. The development of standardised guidelines on the payment of research subjects may enhance recruitment of research participants. (shrink)