International direct-to-participant (DTP) genomics research involves the use of mobile technology to recruit, consent, and study participants remotely. This model can facilitate research across broad geographies and many countries, but must also comply with the norms of multiple recruitment jurisdictions, with each jurisdiction typically requiring at least one local research ethics review. Each additional research ethics review increases bureaucratic hurdles without necessarily strengthening the protection of participants’ rights and interests. For DTP genomic research, obtaining a review may in fact be (...) impossible in the absence of a local research partner. This paper proposes an “adequacy” approach, inspired by data protection law, to coordinate the regulation and oversight of international DTP genomics research. This involves one country voluntarily assessing whether another country’s research ethics reviews are equivalent to its own, in terms of objectives and effectiveness. Ethics-approved projects led by researchers from countries recognized as adequate are deemed to comply with local norms, eliminating the need for a duplicative local review. Adequacy preserves the sovereignty of countries to determine their own regulatory aims and which other countries to trust. It therefore provides a voluntary, incremental path towards greater global coordination of health research oversight. (shrink)

The significance of animals in research cannot be over-emphasized. The use of animals for research and training in research centres, hospitals and schools is progressively increasing. Advances in biotechnology to improve animal productivity require animal research. Drugs being developed and new interventions or therapies being invented for cure and palliation of all sorts of animal diseases and conditions need to be tested in animals for their safety and efficacy at some stages of their development. Drugs and interventions for human use (...) pass through a similar development process and must be tested pre-clinically in laboratory animals before clinical trials in humans can be conducted. Therefore, animals are important players in research processes which directly and indirectly benefit animals and humans. However, questions remain as to whether these uses of animals consider the best interests of animals themselves. Various research and training institutions in Tanzania have established some guidelines on animal use, including establishing animal ethics committees. However, most institutions have not established oversight committees. In institutions where there may be guidelines and policies, there are no responsible committees or units to directly oversee if and how these guidelines and policies are enforced; thus, implementation becomes difficult or impossible. This paper endeavours to raise some issues associated with the responsible use of animals in research and training in Tanzania and highlights suggestions for improvement of deficiencies that exist in order to bridge the gap between what ought to be practised and what is practised. (shrink)

Human subjects research has increased in Myanmar since 2010 and, accordingly, the establishment of research ethics committees has increased review of these research studies. However, characteristics that reflect the operations of RECs in Myanmar have not been assessed. To assess the structures and processes of RECs at medical institutions in Myanmar, we used a self-assessment tool for RECs operating in low- and middle-income countries. This tool consists of the following ten domains: organizational aspects, membership and ethics training, submission arrangements and (...) materials, meeting minutes, policies referring to review procedures, review of specific protocol and informed consent items, communication a decision, continuing review, REC resources and institutional commitment. We distributed this self-administered questionnaire to RECs from 15 medical institutions in Myanmar and one representative from each REC completed this questionnaire and returned it anonymously. We used descriptive, bivariate and multivariate statistics to analyse the data. Out of a maximum 200 points, the total mean score for Myanmar medical institutions was 112.6 ± 12.77, which is lower compared with the aggregate mean score of 137.4 ± 35.8 obtained from RECs in other countries. Domains in which the average percentage score was less than 60% included organizational commitment, membership and ethics training, continuing review and REC resources. Many RECs have a diverse membership and appropriate gender balance but lacked essential policies. The results show that for Myanmar RECs, there is significant room for improvement in their “structures and processes” as well as the extent of institutional commitment. The self-assessment tool proved to be a valuable method to assess the quality of RECs. (shrink)

Caracterización de un grupo de comités de ética en investigación en Colombia Caracterização de um grupo de comitês de ética em pesquisa na Colômbia In the last decades, controlled clinical trials sponsored by the pharmaceutical industry have increased considerably. This has led to the need for greater control and assistance by regulators and ethics committees to ensure appropriate compliance with established ethical standards and good clinical practices in general. In Colombia, the National Food and Drug Surveillance Institute, the regulator in (...) the country, controls and monitors the operation of clinical research with drugs. In 2008, this entity issued Resolution 2378, which provides and regulates research actors in Colombia, including ethics committees. After being in force for several years, it is necessary to know whether research ethics committees in Colombia operate in accordance with this regulation and to determine the status of implementation of the requirements therein. For this purpose, a survey was designed to be voluntarily answered and a response was obtained from 25 of the 69 certified committees in Colombia. Twenty-two of them could be analyzed because their information was complete. Compared with previous studies, favorable changes in development and organization were observed in accordance with the current proposed regulation. Para citar este artículo / To reference this article / Para citar este artigo Suárez-Obando F, Reynales H, Urina M, Camacho J, Viteri M. Caracterización de un grupo de comités de ética en investigación en Colombia. pers. bioét. 2018; 22: 303-318. DOI: 10.5294/pebi.2018.22.2.8. (shrink)

In his article ‘The case against ethics review in the social sciences’, Schrag asserts that the social sciences should not be subject to ethical review. He recounts a number of examples where ethical review has seemingly failed. He further suggests some alternative models for dealing with ethical review in the social sciences. Finally, he concludes, and we concur, that there is a lack of empirical evidence as to the benefit of research ethics review.

Proposed changes to the Common Rule are proffered to save almost 7,000 reviews annually and consequently vast amounts of investigator and IRB-member time. However, the proposed changes have been subject to criticism. While some have lauded the changes as being imperfect, but nevertheless as improvements, others have contended that ‘neither the scientific community nor the public can be confident that improved practices will emerge from the regulatory changes mandated by the NPRM.’ In the present article, I discuss an important aspect (...) that has been overlooked: the question of whether benefits will emerge is demonstrably empirical, yet data upon which to draw conclusions are conspicuous by their absence. This is thrown into sharp relief when we consider the current environment in which health research is increasingly focused on providing evidence of need or benefit, where there is greater emphasis on evidence-based practice, and when we have the nascent field of implementation science. (shrink)

The significance of animals in research cannot be over‐emphasized. The use of animals for research and training in research centres, hospitals and schools is progressively increasing. Advances in biotechnology to improve animal productivity require animal research. Drugs being developed and new interventions or therapies being invented for cure and palliation of all sorts of animal diseases and conditions need to be tested in animals for their safety and efficacy at some stages of their development. Drugs and interventions for human use (...) pass through a similar development process and must be tested pre‐clinically in laboratory animals before clinical trials in humans can be conducted. Therefore, animals are important players in research processes which directly and indirectly benefit animals and humans. However, questions remain as to whether these uses of animals consider the best interests of animals themselves. Various research and training institutions in Tanzania have established some guidelines on animal use, including establishing animal ethics committees. However, most institutions have not established oversight committees. In institutions where there may be guidelines and policies, there are no responsible committees or units to directly oversee if and how these guidelines and policies are enforced; thus, implementation becomes difficult or impossible. This paper endeavours to raise some issues associated with the responsible use of animals in research and training in Tanzania and highlights suggestions for improvement of deficiencies that exist in order to bridge the gap between what ought to be practised and what is practised. (shrink)

The authors report the first Italian experience of a research ethics committee (REC) audit focused on the evaluation of the REC’s compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009–February 2011) divided into quarters to better value the influence of the new insurance coverage regulation (...) that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC’s opinions and research studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of the research ethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place. (shrink)

Background. The increased number of clinical trials taking place in developing countries and the complexity of trial protocols mandate that local ethics review committees reviewing them have the capacity to ensure that they are conducted to the highest ethical standards.Methods. The Kenya AIDS Vaccine Initiative Institute of Clinical Research and the Kenyan National Council for Science and Technology embarked on an exercise to enhance the capacity of ERCs in Kenya to review such protocols. This process involved conducting an audit of (...) all ERCs in the country, and performing training needs assessments to identify knowledge and capacity gaps. Information obtained was used to develop training materials for ERC members at workshops conducted in different parts of the country.Results. Five accredited and 13 non-accredited ERCs were identified. Four of the accredited ERCs were located in the capital city of Kenya, Nairobi. The most common challenges cited by participants during the needs assessments were excess workload, and a lack of co-ordination and/or communication between the ERCs. Subsequently, 140 ERC members from 17 institutions across the country were trained as follows: 36 from institutions in the western part of Kenya, 38 from institutions in the south-eastern coastal region, 38 from the eastern region and 44 from Nairobi.Conclusion. The KAVI-ICR and the NCST have developed training modules for training ERC members in Kenya and are in the process of developing a manual to train members. The Kenyan experience may be used to enhance the capacity of ERCs in the East African region. (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 role of ethics committees is to protect and safeguard the rights and welfare of participants, and promote good research by providing ethical guidance to researchers. In order for ethics committees to fulfil their role and obligations, they need to have adequate understanding of the science and scientific methods used in research. Genomics is a novel and rapidly evolving research field, and identifying the ethical issues raised by it is not straightforward. Limited understanding of, and expertise in, reviewing genomic research (...) may lead ethics committees to either hamper novel research, or overlook important ethical problems. Researchers are in the best position to assist ethics committees in their efforts to remain informed about scientific advancements. (shrink)

Biomedical research is an increasingly multidisciplinary activity bringing together a range of different academic fields and forms of expertise to investigate diseases that are increasingly understood to be complex and multifactorial. Recently the discipline of ethics has been starting to find a place in large-scale biomedical collaborations. In this article we draw from our experience of working with the Malaria Genomic Epidemiology Network and other research projects to reflect upon the integration of ethics into biomedical research. We examine the way (...) in which ethics input may be valuable to research, the forms it tends to take, and also the problems and limitations of such collaborations. (shrink)

As evidenced by high-throughput sequencers, genomic technologies have recently undergone radical advances. These technologies enable comprehensive sequencing of personal genomes considerably more efficiently and less expensively than heretofore. These developments present a challenge to the conventional framework of biomedical ethics; under these changing circumstances, each research project has to develop a pragmatic research policy. Based on the experience with a new large-scale project—the Genome Science Project—this article presents a novel approach to conducting a specific policy for personal genome research in (...) the Japanese context. In creating an original informed-consent form template for the project, we present a two-tiered process: making the draft of the template following an analysis of national and international policies; refining the draft template in conjunction with genome project researchers for practical application. Through practical use of the template, we have gained valuable experience in addressing challenges in the ethical review process, such as the importance of sharing details of the latest developments in genomics with members of research ethics committees. We discuss certain limitations of the conventional concept of informed consent and its governance system and suggest the potential of an alternative process using information technology. (shrink)

Research ethics, once a platform for declaring intent, discussing moral issues and providing advice and guidance to researchers, has developed over time into an extra-legal regulatory system, complete with steering documents (ethics guidelines), overseeing bodies (research ethics committees) and formal procedures (informed consent). The process of institutionalizing distrust is usually motivated by reference to past atrocities committed in the name of research and the need to secure the trustworthiness of the research system. This article examines some limitations of this approach. (...) First, past atrocities cannot provide the necessary justification unless institutionalized distrust is a necessary or efficient means to prevent future ones – and there are several reasons to doubt this. Second, the efficacy of ethics review in safeguarding morally acceptable research depends on the moral competence and integrity of individual researchers – the very qualities that institutionalized distrust calls into question. Third, ethics guidelines cannot, as is sometimes assumed, educate or guide researchers in moral behaviour unless they already possess considerable capacity for moral judgment. Fourth, institutionalized distrust is a potential threat to the moral competence and integrity of researchers by encouraging a blinkered view of ethical issues, inducing moral heteronomy through incentives, and alienating them to research ethics. We conclude that the moral problem posed by inappropriate short-term behaviour on behalf of researchers is dwarfed by the potential long-term consequences if their moral competence is allowed to deteriorate. Measures must therefore be taken to ensure that researchers are equipped to take their individual responsibility and are not obstructed from so doing. (shrink)

The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials on ethical, safety, and protection topics. A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT as well as non-participants with (...) one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial. A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies, and that medical care of industry-sponsored research trials is better than their usual medical care. The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study. The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation. Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants. (shrink)

Protection of human participants is a fundamental facet of biomedical research. We report the activities of a health service research study in which there were three institutional review boards (IRBs), three legal departments and one research administration department providing recommendations and mandating changes in the study methods. Complying with IRB requirements can be challenging, but can also adversely affect study outcomes. Multiple protocol changes mandated from multiple IRBs created a research method that was not reflective of how substance use screening (...) would be performed in a clinical setting. There was direct conflict between the IRBs' perceptions of participants' protection with the researchers' need to use research methodology that assures the clinical relevancy of results. (shrink)

We analyse the system of ethical review of human research in the Baltic States by introducing the principle of equivalent stringency of ethical review, that is, research projects imposing equal risks and inconveniences on research participants should be subjected to equally stringent review procedures. We examine several examples of non-equivalence or asymmetry in the system of ethical review of human research: (1) the asymmetry between rather strict regulations of clinical drug trials and relatively weaker regulations of other types of clinical (...) biomedical research and (2) gaps in ethical review in the area of non-biomedical human research where some sensitive research projects are not reviewed by research ethics committees at all. We conclude that non-equivalent stringency of ethical review is at least partly linked to the differences in scope and binding character of various international legal instruments that have been shaping the system of ethical review in the Baltic States. Therefore, the Baltic example could also serve as an object lesson to other European countries which might be experiencing similar problems. (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)

Background Meaningfully evaluating the quality of institutional review boards (IRBs) and human research protection programs (HRPPs) is a long-recognized challenge. To be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), organizations must demonstrate that they measure and improve HRPP “quality, effectiveness, and efficiency” (QEE). We sought to learn how AAHRPP-accredited organizations interpret and satisfy this standard, in order to assess strengths, weaknesses, and gaps in current approaches and to inform recommendations for improvement.Methods We conducted 3 (...) small-group interviews with a total of 19 participant representatives of accredited organizations at the 2019 AAHRPP annual meeting. Participants were eligible if they had familiarity with their organization’s approach to satisfying the relevant QEE standard.Results Participants reported lacking clear definitions for HRPP quality or effectiveness but described various approaches to assessing QEE, typically focused on turnaround time, compliance, and researcher satisfaction. Evaluation of IRB members was described as relatively superficial and information regarding research subject experience was not reported as central to QEE assessment, although participants described several efforts to improve consideration of patient, subject, and community perspectives in IRB review. Participants also described efforts to educate and build relationships with key stakeholders as important features of a high-quality HRPP. While generally satisfied with their approaches, participants expressed concern about resource and time constraints that pushed them to be reactive and automatic about QEE, rather than proactive and critical.Conclusions The relevant AAHRPP accreditation standard may obscure critical gaps in defining and measuring QEE elements. We recommend that AAHRPP: (1) offer a definition of QEE or require accredited organizations to provide their own, to help clarify the rationale and goals behind assessment and improvement efforts, and (2) require accredited organizations to establish QEE objectives and measures focused on participant outcomes and deliberative quality during protocol review. (shrink)

The primary purpose of Institutional Review Boards (IRBs) is to protect the rights and welfare of human research participants. Evaluation and measurement of how IRBs satisfy this purpose and other important goals are open questions that demand empirical research. Research on IRBs, and the Human Research Protection Programs (HRPPs) of which they are often a part, is necessary to inform evidence-based practices, policies, and approaches to quality improvement in human research protections. However, to date, HRPP and IRB engagement in empirical (...) research about their own activities and performance has been limited. To promote engagement of HRPPs and IRBs in self-reflective research on HRPP and IRB quality and effectiveness, barriers to their participation need to be addressed. These include: extensive workloads, limited information technology systems, and few universally accepted or consistently measured metrics for HRPP/irb quality and effectiveness. Additionally, institutional leaders may have concerns about confidentiality. Professional norms around the value of participating in this type of research are lacking. Lastly, obtaining external funding for research on IRBs and HRPPs is challenging. As a group of HRPP professionals and researchers actively involved in a research consortium focused on IRB quality and effectiveness, we identify potential levers for supporting and encouraging HRPP and IRB engagement in research on quality and effectiveness. We maintain that this research should be informed by the core principles of patient- and community-engaged research, in which members and key stakeholders of the community to be studied are included as key informants and members of the research team. This ensures that relevant questions are asked and that data are interpreted to produce meaningful recommendations. As such, we offer several ways to increase the participation of HRPP professionals in research as participants, as data sharers, and as investigators. (shrink)

This paper examines the ability of countries in Central and Eastern Europe to ensure appropriate protection of research participants in the field of increasingly globalizing biomedical research. By applying an analytical framework for identifying gaps in policies and programs for human subjects protection to four countries of CEE—Belarus, Latvia, Lithuania, and Poland, substantial gaps in the scope and content of relevant policies and major impediments to program performance have been revealed. In these countries, public policies on the protection of research (...) participants lack consistency and reliable mechanisms for their implementation. Impediments to program performance most often relate to inadequacies in the national research ethics systems with regard to organizational structure, budgetary support, supervision, and training. The level of research ethics capacity varies from country to country and depends on socio-economic and political factors of post-communist transition. The breadth and depth of the problems identified suggest that the current level of protection for research participants in CEE might be inadequate to the challenges posed by the globalization of biomedical research. In CEE countries, there is a need for strengthening research ethics capacity through modification of relevant policies and improvement of program management. The differences among the countries call for further research on identifying the best approaches for filling the gaps in the policies and programs aimed at ensuring effective protection of research participants. (shrink)

BackgroundAlthough animal research ethics committees are well established in Western countries, this field is weakly developed and its concept is poorly understood in the Middle East and North Africa region.ObjectiveOur main objective was to introduce the concept and requirements of ethical approaches in dealing with experimental animal in research and teaching in Egypt.MethodsDue to its very recent inception, Cairo University, Faculty of Science IACUC decided to operate in accordance with Guide for the Care and Use of Laboratory Animals 8th Edition (...) 2011 since Egypt has not yet compiled its own guide.ResultsFifty protocols were reviewed in 2013–2014. Only ten protocols were reviewed in 2013, but in 2014, forty protocols were reviewed. In 2013 all protocols were approved and in 2014, number of approvals were 35, the number of deferrals were 4, and one refused protocol. Master’s theses research protocols constituted the majority of the total reviewed protocols. This is attributed to the decision of the Board of the Faculty of Science, Cairo University in September, 2013 that the approval of the IACUC is mandatory before conducting any research involving animals or theses registration.ConclusionThe first IACUC was established in the Cairo University, Faculty of Science, since 2012. The challenges encountered by the committee were diverse, such as the absence of laws that control the use of animal models in scientific research, lack of guidelines and, mandatory ethical approval for any experimental animal research. (shrink)

This paper reports an initiative from the National Research Ethics Service and research ethics committees in the UK to develop a shared ethical debate between committees and to promote standards of ethical review, exploring the problems and practicalities of such an approach.

The role of research ethics committees, and research ethics issues more broadly are often not viewed in the context of the development of scientific methods and the academic community. This topic piece seeks to redress this gap. I begin with a brief outline of the changes we experience within the social sciences before exploring in more detail their impact on research ethics and the practices of research ethics committees. I conclude with recommendations for how the existing research ethics processes may (...) be made more future-proof. (shrink)

One of the key criticisms of the ethical review process is the time taken to decision, and associated resource use. A key source of delay is that most submissions are required to respond to at leas...

Ethics issues in the areas of science, technology and medicine have emerged during the last few decades. Many countries have responded by establishing ethics committees at the national level. Identification of National Ethics Committees (NECs) in the Eastern Mediterranean (EM) region and the extent of their functions and capacity would be helpful in developing capacity building programs that address the needs of these committees. Accordingly, we conducted a survey to determine the characteristics of existing NECs in the EM region.

In response to the increasing need for research ethics expertise in low and middle income countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research (...) ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of research ethics as applied to LMIC research, the underpinning and evolution of the Fogarty bioethics program, and summarize key conclusions from the other papers in the collection. (shrink)