Should research ethics committees police reporting bias?

BackgroundGood governance and regulatory supervision are required to conduct research in an international public health emergency context and to ensure compliance with ethical standards. The “Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic” study is a regional effort in which research ethics stakeholders participated in addressing research ethics governance and preparedness response challenges to the COVID-19 pandemic in Central America and the Dominican Republic.MethodsA qualitative action research study was conducted following a participatory approach. Research ethics stakeholders in Central America and the Dominican Republic were mapped; a regional webinar and three virtual workshops were conducted discussing research ethics governance, ethics review and collaborative research practice during the pandemic. A roundtable session presented results and obtained feedback on a draft of a policy to strengthen regional research ethics governance.ResultsCountries across Central America and the Dominican Republic are at different stages in their development of research ethics systems. Countries with more established systems before COVID-19 were better organized and prepared to respond. This finding argues against improvisation and supports further work on strengthening governance of research ethics systems. Community engagement in research ethics public policy-making is practically absent in the region. Research and research ethics collaboration schemes are lacking amongst the countries; however, there are incipient initiatives in the region, such as the Central America and Caribbean Network of Research Ethics Committees. A policy brief with recommendations on how to advance towards strengthening the governance of research ethics systems was prepared and submitted to the Central American Integration System for analysis and possible approval.ConclusionNational research ethics systems in Central America and the Dominican Republic were unprepared to respond to the COVID-19 pandemic with respect to research oversight and effective collaboration. In most cases, national research ethics systems were found to be weak, and regional research collaboration was practically absent. To promote collaboration, a joint strategy needs to be developed with a regional vision towards sharing knowledge and best practices.

Cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines for several reasons. For one, the units of allocation, intervention, and observation often may differ within a single trial. In the absence of tailored and internationally accepted ethics guidelines for CRTs, researchers and research ethics committees have no common standard by which to judge ethically appropriate practices in CRTs. Moreover, lack of familiarity with and consideration of the unique features of the CRT design by research ethics committees may cause difficulties in the research ethics review process, and amplify problems such as variability in the requirements and decisions reached by different research ethics committees. We aimed to characterize research ethics review of CRTs, examine investigator experiences with the ethics review process, and assess the need for ethics guidelines for CRTs. An electronic search strategy implemented in MEDLINE was used to identify and randomly sample 300 CRTs published in English language journals from 2000 to 2008. A web-based survey with closed- and open-ended questions was administered to corresponding authors in a series of six contacts. The survey response rate was 64%. Among 182 of 285 eligible respondents, 91% indicated that they had sought research ethics approval for the identified CRT, although only 70% respondents reported research ethics approval in the published article. Nearly one-third (31%) indicated that they have had to meet with ethics committees to explain aspects of their trials, nearly half (46%) experienced variability in the ethics review process in multijurisdictional trials, and 38% experienced negative impacts of the ethics review process on their trials, including delays in trial initiation (28%), increased costs (10%), compromised ability to recruit participants (16%), and compromised methodological quality (9%). Most respondents (74%; 95% confidence interval (CI): 67%-80%) agreed or strongly agreed that there is a need to develop ethics guidelines for CRTs, and (70%; 95% CI: 63%-77%) that ethics committees could be better informed about distinct ethical issues surrounding CRTs. Thirty-six percent of authors did not respond to the survey. Due to the absence of comparable results from a representative sample of authors of individually randomized trials, it is unclear to what extent the reported challenges result from the CRT design. CRT investigators are experiencing challenges in the research ethics review of their trials, including excessive delays, variability in process and outcome, and imposed requirements that can have negative consequences for study conduct. Investigators identified a clear need for ethics guidelines for CRTs and education of research ethics committees about distinct ethical issues in CRTs.

Ethics of healthcare research in developing countries

Ethical conduct of research involving humans has gained relevance and importance over the years with the expansion of research beyond boundaries of traditional medical and clinical research into a multiplicity of disciplines with human participation. Human research is regarded as research conducted on or with or about people, or their tissues or cells or data obtained from them. Historically, it is stated that the Greek Philosopher Aristotle (384-322 BCE) was probably the first to discuss principles of ethics ‘by studying and offering criteria to assess human behaviour’. It is believed that he taught a course of ethics at the Lyceum during his mature years which was based on the many treatises he wrote on the subject. Increased attention to ethics in human research started after the Second World War following the judgment of the International Military Tribunal which also included 10 principles of permissible medical experiments which have since then been referred to as the Nuremburg Code (1949). Later discussions by the World Medical Assembly of the Code led to the adoption of the Helsinki Declaration (1964) which has been revised many times since then. The Council for International Organizations of Medical Sciences (CIOMS) which in association with the World Health Organizations (WHO) undertook its work on ethics in biomedical research in late 1970s. It has published an updated version with a wider scope of coverage titled ‘International Ethical Guidelines for Health-Related Research Involving Humans’ (2016). Close cooperation with World Medical Assembly has ensured that the guidelines are closely aligned to the Helsinki Declaration. Traditionally, ethics has received much attention both in clinical practice and in health research. Faculties of Medicine were the first to establish ethics review boards and ethics review committees in Sri Lanka to undertake review of research proposals with human participation for ethical aspects and issues and granting approval. The primary aim is to safeguard the interests and right of participants of research and prevent their exploitation. There is no doubt about the value of health research and the benefits it has brought and will continue to bring to ensure health, wellbeing, safety and quality of life of people. Most research on human participants is simple, observational, descriptive and non-invasive and the ethical issues though may be minimal, still needs explicit attention and review by an ethics review board before approval. The more complex research where human participants are subject to ‘experimentation’ or ‘interventions’ has many ethical issues that need to assessed by recognized ethics review committees with experience and capability to do so. If a new drug, a new vaccine, medicinal product, device, or equipment not already in use by people is to be tested on humans before being granted approval for use in day-to-day life by the appropriate authority, the researcher should adopt recommended procedures, regulations and registration mechanism prescribed. In Sri Lanka any interventional research requires applying and obtaining approval of ethics review committees that have been gazetted under the National Medicines Regulatory Authority (NMRA) as being approved by name to undertake ethics review. The interventional research should also be registered with the Sri Lanka Clinical Trials Registry. Both these need to be submitted to the Clinical Trials Evaluation Committee of the NMRA in order to be evaluated prior to being granted approval and registration. These approvals and registrations are also requested by peer reviewed high impact journals to consider such research manuscripts for publication. There are certain values which provides the framework for principles guiding formulation of research proposals and ethics of research. These include and are not limited to respect, integrity, justice, beneficence and research merit. It is implicit in research that badly designed, conduced, analysed and reported research is unethical. Clinical Centre researchers at National Institute of Health of USA have enunciated seven principles to guide the conduct of ethical research. These are social and clinical value, scientific validity, fair subject selection, favourable risk benefit ratio, independent review, informed consent, respect for potential and enrolled subjects. Given the importance of scientific merit and integrity of research, good research practice needs much attention both by researchers and research institutions. In order to meet these needs the National Health Research Council and the Education, Training and Research Unit of the Ministry of Health have taken steps to publish, ‘The Code of Conduct on Health Research in Sri Lanka’ (2018) (available at http://www.health.gov.lk/moh_final/english/public/elfinder/files/publications/2018/TheCodeofConduct.pdf). The Code covers aspects of: formulation of research proposals; management of research data and primary materials; collaborative research; conflict of interest; supervision of research; peer review, and dissemination of research findings, publication and responsible authorship. With the expansion of research on human participation into may other sciences such as branches of engineering, computing, bio technology, genetics, artificial intelligence, machine learning, nano technology and others, the ethical issues of human research have reached a new dimension. It has to be emphasized that whatever the branch of science or discipline, if the research requires human participants, then approval of an ethics review committee is a must. Thus, it behoves on research institutes, universities, and faculties to establish ethics review committees beyond the traditional practice of having ethics review committees in medical faculties. It is necessary that members of such a committee, functions within the set terms of references, standard operating procedures, ensure confidentiality and also have appropriate training in ethics of research, approval processes and documentation. In Sri Lanka too universities have gone one step ahead to establish ethics review committees at university level to facilitate research on humans in disciplines other than health and medical practice. Time has come when universities and research institutions take steps to develop codes of conduct on research, conduct courses on such practices and ethics of research for all researchers in order to safeguard the interests and safety of both researchers and participants of research.

BackgroundResearch has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is to explore if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance.MethodsWe conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research.Results10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplate strategies with recommendations for concrete actions for a timely and rigorous review.ConclusionLA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies.

Strengthening clinical and research ethics in Nigeria—an agenda for change

Background: Know the conception of ethics in research of the researches and members of the ethics in research committees – CEP (secretaries, presidents/coordinators and advisors); identify the significance attributed to the CEP by researchers and members of the CEP; identify the reasons that bring the researchers to submit their projects to the CEP. Methods: Quantitative and descriptive survey approved by the CEP/UESB and performed with 95 people. Data were analyzed by Sphinx Software. Results: 52,5% of the participants of the survey said that ethics in research is an “interdisciplinary science that deals with the protection of all those involved in research with livings beings”. Among the members of the CEP who participated of the survey, 50% stated that the importance of the CEP resides in the fact of having increased the awareness about the relevance of ethics in research; while for 38,1% of the participant researchers of the survey, submitting research projects to ethical review is significant to protect themselves and the research participant, being this, in their opinion, the main reason to submission of the project to the CEP. Also were brought forward as motives the necessity to fulfill the requirements of the university, the research financiering institution, the data recollection institution, the CONEP and for publication. Conclusions: The CEP has assumed every time more significance and prominence as social mechanism of science control, which has direct relation with the improvement of the ethic consciousness of the researchers, the increase of scientific development of the institutions and the ethical-scientific quality of the researches. Key words: Ethics, Research, Ethics Committees, Ethical Review, Bioethics.

BackgroundThe University of Botswana (UB) received a grant from the European and Developing Countries Clinical Trials Partnership (EDCTP) from 2011 to 2013. The overall aim of the grant was to...

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 ethics review mutual recognition. We explore the issues associated with ethics committee review of multi-jurisdictional data-intensive research projects, identifying current problems, real-life experiences, and potential solutions that are both bottom-up (via researchers, participants and publics) and top-down (via statutory regulation), as well as challenges in achieving both. On the whole, participants recommended multiple changes to the current ethics review regime for data-intensive international research with the aim of reducing inefficiency and inconsistency. But, the changes recommended differ in terms of degree and scope. In general, participants stressed that key drivers of success in a reformed system should be strong leadership (on the ground and in government) and demonstration of value.

BackgroundFor ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs). In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN), to gain insight into the Canadian system.MethodsThe applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved.ResultsEach REB had a different application form. Most (n = 9) had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days) to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days). Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval.ConclusionsFor CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review.

The purpose of the review is to assess frequencies of reporting adherence to professional practice standards and research ethics in studies of technology-based home health care programs. Key databases were searched to yield 2,866 abstracts that were independently rated by two reviewers using inclusion-exclusion criteria, resulting in 107 articles that were then reviewed for reports of practice standards and research ethics. Issues related to professional practice standards and research ethics were not well reported. When reported, adherence to practice standards included preintervention training, use of intervention protocols, supervision, and mechanisms for risk management. Research ethics most commonly reported were informed consent, REB/IRB approval, and protection of privacy. The results raise questions as to whether practice standards and research ethics are addressed sufficiently when health service delivery occurs in technology-based environments. Guidelines for professional accountability in e-health service delivery are needed.

PURPOSEBuilding equitable research collaborations between high-income countries (HICs) and low- and middle-income countries (LMICs) requires effective coordination among international ethical review committees, which is often logistically challenging. This case report presents the insights gained when acquiring ethical approval for a cervical cancer research program conducted jointly by the University of Pennsylvania and the University of Botswana.METHODSWe conducted a descriptive case study of the Ipabalele project, a 6-year HIC-LMIC partnership involving three complex research protocols that required approvals by multiple distinct ethical bodies. We analyzed various challenges affecting review procedures, timelines, and staffing. We then documented strategies employed in Ipabalele and other global initiatives to strengthen ethical review processes and build research capacity in LMICs.RESULTSIn Ipabalele, ethical approvals were initially delayed by 2 years because of fragmented review processes with variable timelines and conflicting recommendations. Innovations to the process included centralizing institutional review board oversight within Botswana, implementing joint virtual meetings among review bodies, enhancing digital infrastructure, and streamlining research staffing and communication.CONCLUSIONBy providing practical strategies, this study highlights how empowered local leadership, centralized review processes, joint review mechanisms, and intentional capacity building can overcome logistical barriers in multinational ethical review.

This study aims to provide an overview of RECs (research ethics committees) in Chinese universities, encompassing both medical and non-medical studies. The primary objective is to identify major challenges faced by RECs in Chinese universities and draw meaningful implications from the findings. The investigation focuses on 42 comprehensive Chinese universities, and the results reveal that while all universities have implemented RECs in various forms, only 28.6% explicitly stipulate ethical review requirements for non-medical disciplines. Furthermore, RECs in Chinese universities encounter various challenges, including insufficient attention to research ethics review, inadequate ethics review systems and regulations, a lack of education and training, and lacking ethics review for non-medical research. This paper proposes recommendations for establishing robust RECs in Chinese universities, seeking to enhance ethical governance in research. By addressing the challenges identified, these recommendations aim to strengthen ethical oversight, foster a culture of responsible research, and uphold the highest ethical standards across diverse academic disciplines.

University based academic Research Ethics Boards (REB) face the particularly difficult challenge of trying to achieve representation from a variety of disciplines, methodologies and research interests. Additionally, many are currently facing another decision – whether to have students as REB members or not. At Ryerson University, we are uniquely situated. Without a medical school in which an awareness of the research ethics review process might be grounded, our mainly social science and humanities REB must also educate and foster awareness of the ethics review process throughout the academic community. Our Board has had and continues to have students as active members. While there are challenges to having students as Board members, these are clearly outweighed by the advantages, for both the academic community and the future of ethically sound research in the social sciences and humanities. Moreover, the challenges are often based on misconceptions and can be easily overcome through increased education and understanding of the research ethics review process by the academic community at large. The purpose of this paper is to describe and discuss the experiences, advantages and challenges of having students as REB members. The advantages of having students as REB members include the following: (1) Students are the proposed participants in many of our reviewed protocols and student members may illuminate unique issues of participation. (2) Students are active and highly engaged members of the REB. (3) Having students on the REB enhances awareness of research ethics within the University. (4) Student REB members have an opportunity to mentor other students and provide leadership for both undergraduate and graduate students. (5) Students are more vigorously recruited than faculty members and often apply for student positions with enthusiasm and preparation. (6) In creating an atmosphere of excellence in research, engaging students at the beginning of their research career will help in creating tomorrow’s leaders in research and research ethics. The challenges of having students as REB members include the following: (1) Faculty members may be uneasy regarding the prospect of students reviewing protocols. (2) Faculty members may be concerned about confidentiality and respect with students reviewing faculty research protocols. (3) There may be an increased burden for students who serve as members on an REB. (4) There is concern that students will offer less continuous service to the REB. (5) There is a common misconception that students do not have the experience to carry out ethical reviews. While there are challenges from faculty members and others regarding having students as REB members, these challenges are often based on misconceptions about the nature of the REB work and the ethics review process in general. These challenges are also often based on the misconception of the ethics review process as one of peer review and evaluation, instead of a community-based and inclusive process. Having student members is a long-term strategy for both overcoming the misconceptions of the REB as a “necessary evil” and for fostering an awareness of the imperative for ethically sound research in the social sciences and humanities.

BackgroundResearch is an essential component of the response to health challenges such as weak health care systems and high disease burden that Africa faces. In addition to these challenges, the...