Ethics Review System Research Articles

Ethics Review of Biomedical Research in Uzbekistan: Policy and Program Gaps.

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

Ethics and integrity challenges during COVID-19 in China

This paper describes a scoping review of China’s academic resource databases, relevant official websites, news reports and public accounts spanning a period from the end of 2019 to the end of 2022, to investigate the challenges in scientific integrity and ethical soundness of research conducted during and immediately after the COVID-19 pandemic in China. By conducting the scoping review with keywords related to the research questions in Chinese, relevant data were extracted and classified into four categories: challenges in research, challenges in ethics review, challenges in publishing academic work, and research ethics guidelines during and after the pandemic. The paper points out that problematic studies and findings increased with the escalation in medical research projects during the pandemic in China. The situation faced by researchers was more difficult than before the pandemic. The mode of informed consent, and ethics review and oversight systems also underwent changes. In addition, Traditional Chinese Medicine as an alternative medical treatment for COVID-19, attracted attention from the research community and became a topic of discussion. We conclude that the various challenges and concerns identified indicate a need for a proper and timely response system be formulated in preparation for possible future occurrences of new pandemics or other critical situations.

A study on the normative path of ethics review in China: based on the perspective of Panopticism.

Modern biomedical technology is in an era of dramatic development, which brings unprecedented challenges to the work of ethics review and provides a turning point for the construction of ethics review system. The current ethics review committee (ERC) in China is executed with low efficiency and quality, which can hardly meet the current needs of biomedical research involving human beings. This paper summarizes the main connotations and roles of the sign system technique and the discipline mechanism through the idea of Foucault's Panopticism, and proposes to incorporate the Panopticism into the construction of the ethics review system and establish the sign system and discipline mechanism of ethics review, in order to build an ethics review system and the operation system of the ethics review committee suitable for China's national conditions.

Stakeholder Involvement in the Governance of Human Genome Editing in Japan

Genome editing is a technology that can accurately and efficiently modify the genome of organisms, including the human genome. Although human genome editing (HGE) has many benefits, it also involves technical risks and ethical, legal, and social issues. Thus, the pros and cons of using this technology have been actively debated since 2015. Notably, the research community has taken an interest in the issue and has discussed it internationally. However, for the governance of HGE, the roles of government agencies and the general public are also important for an effective regulatory system. Here, we examine the roles of the research community, government, and public in the governance of HGE through an analysis of discussions in the Japanese Expert Panel on Bioethics. During the discussion of the research ethics review system, the professionalism of the research community and the pros and cons of state oversight have become issues for debate. Furthermore, through an examination of the overall policy-making process, three stakeholders are clearly involved in the governance of emerging medical technologies in the Expert Panel on Bioethics, a discussion forum established by government agencies. The contrast among these roles provides insight into the positive roles of government agencies and the research community and the conditions under which these roles are played. We also note that there are diverse actors in the public, which may have an impact on their participation. Our results may serve as a guide for countries and organizations to establish governance on emerging medical technologies.

Strengthening Health Research and Ethics Systems in Timor-Leste.

Meaningful health research should lead to evidence-based decision-making that can be translated into policy and practice. Every country needs to have a well-functioning and resourced ethics review and clearance system to ensure health and medical research is conducted in line with ethical standards, preventing harm to research participants, and contributing to better health outcomes and national priorities. The purpose of this study is to describe the origins of the system for managing health research and ethics in Timor-Leste and how it has evolved over time; to identify the strengths and limitations of the current system; and to recommend areas for improvement. A narrative review of the literature (published papers, gray literature, and unpublished data) was conducted alongside key informant interviews with 15 Ministry of Health (MOH) policymakers and National Institute of Health staff between October 2020 and March 2021. The system for managing health research and ethics in Timor-Leste has remained largely the same since it was first established in 2009, with some adaptations to cope with a progressively increasing workload. Main findings include: the Department of Research and Studies (DRS) oversees complex ethics approval process in addition to other responsibilities; the DRS lacks the legal authority, policies, and procedures to help implement its full range of functions and responsibilities; national research priorities should be identified; MOH experiences difficulties in securing funding to support health research; training in health research, ethics and governance is an important priority for DRS. It is timely and important to invest in strengthening key components of health research and ethics systems in Timor-Leste. Despite limited resources, improvements can be achieved in key areas with focused assistance and collaboration with local, national, and international partners.

Responsible governance of human germline genome editing in China†.

Considerable improvements have been made to gene editing technology, which has been increasingly applied to research involving humans. Nevertheless, human heritable germline genome editing is associated with a series of potential ethical, legal, and social risks, which have generated major controversies and discussions worldwide, especially after the “gene-edited babies” incident. Influenced by this incident, China has realized the importance of ethical governance in the field of life science and technology, has accelerated legislative and policy efforts in this field, and has gradually moved toward the direction of “precautionary” ethical governance. Black letter analysis, big data public opinion analysis, and other research methods are used in this paper. This paper explores the scientific background, ethical debates, and latest developments regarding China’s regulatory framework for human germline gene editing after the “gene-edited babies” controversy and provides several recommendations on the future governance system of human germline gene editing in China. This paper argues that in recent years, the ethics governance of germline genome editing in China has been accelerated and great changes have been made. However, the regulatory system for germline genome editing requires further improvement in three aspects: coordination of legislation and agencies, establishment of an ethics review system at high levels, and public participation and education.

Genetics Adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for genetics service delivery

IntroductionThe high demand for genetic tests and limited supply of genetics professionals has created a need for alternative service delivery models. Digital tools are increasingly being used to support multiple...

Clinical quality registries: urgent reform is required to enable best practice and best care.

Clinical quality registries (CQRs) systematically collect data on pre-agreed markers of quality of care for a given procedure, that can be reliably and reproducibly defined and collected across multiple sites. Data is then risk adjusted, and comparisons may be used to benchmark performance. These data then inform quality improvement initiatives. CQRs require an overarching independent governance structure and surety of funding. CQRs rely upon whole of population enrolment to minimize the risk of selection bias, and often rely on the secondary use of sensitive health information, meaning that the processes for ethical review and consent to participation are different to clinical trials. Despite several local examples of CQR improving practice in Australia and Aotearoa New Zealand, providing substantial cost-benefit to the community, there remain significant barriers to CQR implementation and functions. These include the difficulty of accurate data capture, lack of a fit for purpose ethical review system, the constraints of existing Qualified Privilege legislations and the need for protected funding. Whilst the Australian Government has released a 10-year strategy for CQR reform, and the Aotearoa New Zealand Government has included registries in the planned Health New Zealand reforms for the public sector, we believe more urgent implementation of strategies to overcome these barriers is needed if CQRs are to have the impact on quality of care our Communities deserve.

Current Status and Issues of Ethical Review for Surgical Research in Japanese University Hospitals.

Introduction: In clinical research, ethical review is required prior to conducting the research. A surgical procedure is a complex intervention with properties that make it more difficult to evaluate rigorously and monitor than drug treatments. This study aimed to clarify the current status and issues in the ethical review and monitoring of surgical research. Methods: We developed a self-administered questionnaire on surgical ethical review. The questionnaire was distributed to university hospitals in Japan and collected from November 2018 to February 2019. The distributed questionnaire consisted of the reviewed items, items with difficulties, and important items on ethical review. Fisher’s exact test or the chi-square test was used for analysis. Results: The questionnaires from 39 medical university hospitals were completed with appropriate answers to all items. “Technical review” was conducted at a significantly lower proportion (n = 30/39, 76.9%, p = 0.002). “Evaluation of the progress and results” was also (n = 22/39, 56.4%, p < 0.001). University hospitals in which “technical aspects and ethical review” was regarded the most important and difficult were higher (n = 24/39, 61.5%; n = 26/39, 66.7%, respectively). Respondents considered not only items written in the study protocol but also those on monitoring or oversight of surgical research as difficult. Conclusions: Our findings suggest that it is necessary to improve the ethical review system and provide supports to conduct an appropriate review for surgical research, e.g., technical aspect review or study progress/result evaluation.

Ethical issues of the research and practice in forensic genetics.

Forensic genetics mainly uses human biological samples as the objects, solves the identification of biological materials related to law by detecting genetic information, provides clues for investigation and evidences for trial, thus facing many ethical issues. This paper put forward the ethical principles in forensic genetics research and practice, and discussed the ethical issues in sample collection, forensic DNA phenotyping, forensic genetic genealogy analysis, forensic DNA database development, paternity and kinship testing, and research data sharing. We suggest that specific ethical requirements should be formulated, the ethical review system should be established for forensic genetics and ethical training for practitioners should be strengthened.

Challenges in the Ethical Review of Clinical and Biomedical Research in Malaysia: A Mixed Methods Study.

Empirical evidence of the ethical review of clinical and biomedical research in Malaysia is limited. We have conducted a convergent mixed methods research, which comprises an online survey and semistructured interviews to examine the challenges in the ethical review of clinical and biomedical research. Data collected reveal that the ethics review process is inconsistent, duplicate, and inadequate. The results indicate a strong need for a centralized ethical review mechanism and a national system for mutual recognition of ethics reviews to improve the effectiveness and efficiency of the ethics review system in Malaysia. A joint research ethics committee review between Malaysia and sponsoring countries for multinational research should also be encouraged as it could address the concerns of the lack of expertise and training.

Development of clinical trial of new drugs of traditional Chinese medicines

The relevant laws and regulations of drug clinical trials were introduced in this paper. It is pointed out that with drug re-gulatory laws and technological advances, clinical trials have become an important link in the development of new drugs of traditional Chinese medicines(TCM). Clinical trials of new drugs of TCM must comply with the requirement of &quot;Good Clinical Practice for Trial on Medicinal Products&quot;. In view of the particularities of clinical trials of new drugs of TCM, China has established an ethical review system for clinical research in TCM and carried out ethical review and certification of TCM research. In order to guide the development of clinical trials of new drugs of TCM, relevant departments have promulgated a series of guidelines for clinical trials of it, and established a new review system and technical requirements for clinical trials. Since 1983, the &quot;national clinical pharmacology base&quot; has been established. At present, there are 96 drug clinical trial institutions and 32 phase I clinical research wards in TCM hospitals, which can meet the development of clinical trials of new drugs of TCM. In the long-term practice, the technical team has continued to grow and develop, the research experience and technical strength have been significantly improved, and a large number of experts have become the backbone of clinical research in Chinese medicine. It is pointed out that we should attach importance to risk and benefit assessment, human experience, select scientific, objective and appropriate effectiveness indexes, evaluate the efficacy of TCM syndromes, and encourage the use of electronic methods in clinical research of new drugs of TCM. Based on the analysis of clinical trials of TCM in recent five years, it is pointed out that the active degree of clinical trials of new drugs of TCM is not high, the innovation ability of it is insufficient and the ability and enthusiasm of all aspects need to be improved. It is of great significance to carry out clinical trials of new traditional Chinese medicines to upgrade the TCM industry and produce high-level evidence-based medicine evidences. The high quality development of TCM can be promoted by strengthening clinical trials of new drugs of TCM.

Challenges and strategies to research ethics in conducting COVID-19 research.

The number of research involving human subjects on coronavirus disease 2019 (COVID‐19) is surging, bringing challenges to the ethical review committee (ERC) in terms of reviewing speed and special ethical considerations under the pandemic. However, the existing ethical review system and regulations have their limitations to meet the demand for a prompt and efficient epidemic control. Since the research under the public health emergency is different from that carried out in familiar situations to design and implementation, the strategy for a satisfactory ERC response should balance the duty of protecting individual participants as well as the special public needs derived from the disease control. It is suggested that the ethical review‐related regulations need to be updated, and a unified supervision system to the overall ERC is required. ERC collaboration, capacity‐improving and efficiency‐improving measures need to be taken. With respect to the reviewing guidelines, it is suggested that the international norms should be explained with more consideration of the local condition and the exceptional circumstances in this public health emergency. A joint effort needs to be taken for better research conduction.

Ethical review of clinical study on intervention with traditional Chinese medicine in new public health emergencies

High-quality clinical study on traditional Chinese medicine is of great significance to effectively control new public health emergencies represented by outbreaks of infectious diseases and ensure people's health and safety, but it still faces a series of ethical issues. Based on the seven core values of equity, good deeds, effectiveness, respect for individuals, freedom, reciprocity, and solida-rity proposed in the Guidelines for Management of Ethical Issues in Outbreaks of Infectious Diseases, this article emphasizes the characteristics and laws of clinical studies on traditional Chinese medicine. Main points of ethical review of traditional Chinese medicine were summarized in the aspects of overall concept, syndrome differentiation and treatment, prevention before disease onset, cultural value, and clinical basis. Based on the outbreak of coronavirus disease 2019(COVID-19), we collected relevant registered Chinese medicine clinical studies, summarized the core issues of the ethics review for COVID-19, and further improved the traditional Chinese medicine ethics review system and resources, so as to better serve ethical review and scientific studies in public health emergencies.

Health outcomes, utility and costs of returning incidental results from genomic sequencing in a Canadian cancer population: protocol for a mixed-methods randomised controlled trial

IntroductionGenomic sequencing has rapidly transitioned into clinical practice, improving diagnosis and treatment options for patients with hereditary disorders. However, large-scale implementation of genomic sequencing faces challenges, especially with regard to...

European ethics committees in transition: challenges of new requirements

Guided by the example of ethics committees in medicine, the ethical review system of research projects in Europe is increasingly expanding to other disciplines such as psychology, the social sciences, and engineering, especially when human subjects are directly involved or personal data are collected. However, ethical reviews are not uniformly regulated in most European countries.With the new EU Regulation No. 536/2014, which is expected to come into force in 2020, it is intended to standardize the work of medical research ethics committees for clinical trials. Clear deadlines and the use of acentral electronic EU portal are also given in order to accelerate the approval process for economic reasons. Member states are left free in terms of the scope of the ethical review, but this would run counter to unification and could lead some to choose atest model that excludes the evaluation of the methodology and risks of astudy and thus contributes less to the protection of the participants.The European Research Ethics Committees have been working together since 2005 within the European Network of Research Ethics Committees (EUREC). For adiscussion on the impact and implementation of the new EU Regulation and on the development of the EU portal, EUREC has provided aforum for aqualified debate.In this period of change, it is not clear yet which direction the ethics committees will develop. Professional management can have apositive impact on the quality of the ethics review. However, the marginalization inherent in the EU Regulation is counteracting the increasing evaluation of nonmedical research projects and adequate protection of subjects.

OC 8716 ENHANCING RESEARCH ETHICS REVIEW CAPACITY IN SUDAN

BackgroundIn Sudan, there is an increase in health research in a situation of scarce resources and limited counteractive quality assurance in research ethics. The aim of this project was to enhance the ethical review system in Sudan.MethodsOur framework for enhancing the ethical review capacity was based on the context of Sudan with emphasis on governance, coordination, feasibility, efficiency and sustainability. Activities conducted to achieve our goals included reviewing the guidelines that govern human subjects research, enhancing the governance of national authorities (National Health Research Ethics Committee and National Medicine and Poisons Board), improving coordination between the national authorities by developing a consensus clarifying their roles and functions, capacity building for the oversight bodies and institutional ethical review committees (RECs) as well as establishing a network of research ethics committees.ResultsThe guidelines that govern human subjects research in Sudan were reviewed and updated. In addition, a consensus document was endorsed to clarify the roles of the national regulatory authorities creating channels of coordination and cooperation between them and institutional RECs. Thirty-nine RECs from different parts of Sudan have been trained and the results of the pre/post test have shown an increase in the knowledge score among trainees (p&lt;0.05). The project has also provided a platform for sharing experiences and maintaining partnerships with regional and international institutes in addition to provision of technical support for newly established RECs.ConclusionWe believe that the array of activities conducted through this project had enhanced the governance, coordination, feasibility and, efficiency of the ethical review system in Sudan.

PO 8720 IMPACT OF EXPANDED USE OF AN ONLINE ETHICS REVIEW SYSTEM IN AFRICA: A PARTNERSHIP BETWEEN IAVI, COHRED, AND EDCTP WITH NATIONAL REGULATORY AGENCIES

BackgroundRHInnO Ethics is a cloud-based online ethics review system that enables Reseach Ethics Committees (RECs) to receive, review and approve applications online. Over the last five years, RHInnO Ethics has been installed in 40 RECs that operate in 12 African countries.MethodsPharma Ethics (South Africa), Strathmore University (Kenya) and Uganda Virus Research Institute-UVRI (Uganda) started using RHInnO Ethics in 2014, 2015 and 2017 respectively. Although the platform is currently installed in 40 RECs in Africa, only 1 systematic evaluation has been done to objectively assess its impact on the quality and efficiency of ethics review. Here, we present the experiences of using RHInnO Ethics from three RECs situated in East Africa (2 RECs) and South Africa (1 REC).ResultsStrathmore University started using the online ethics review system since the beginning of its operation, while Pharma Ethics and UVRI transitioned from a manual to an electronic system. Benefits associated with the use of the platform include improved efficiency in communication among key players of the ethics review processes, improved quality of review through standardisation and harmonisation of ethics review procedures, easy management of information, increased submissions and improved turnaround time. The progress of review can also be tracked any time by all users. Challenges include change management from the manual to the online system, difficulties in learning new versions of the system and training new reviewers not conversant with the system, interruption of internet access and limited ability to personalise the platform.ConclusionThere is a need to get buy-in from regulatory authorities to enforce the adaption of the system to all RECs in order to make research coordination in Africa easier. RHInnO Ethics has been shown to improve efficiency and quality of reviews. However, the transition to and full adoption of the online system continues to be slow. To accelerate and scale up the adoption of RHInnO Ethics, there is a need for developers, RECs and sponsors of RECs to engage with REC regulatory authorities, and identify responsive models of financing and funding RECs in order to increase efficiency and quality of ethics review in sub-Saharan Africa.

Ethiopia: Obtaining Ethics Approval and the Role of Social Capital

Ethiopia has a research ethics review system, yet few international researchers obtain approval outside of health studies that involve biological samples or medical testing. This case study outlines three types of ethics approvals in Ethiopia, and which research projects are suitable to them. In outlining these processes, I also reflect upon my own experience of obtaining ethics approval. The questions raised in this case study include concerns about accountability for international researchers as well as areas where universities and ethics bodies could improve their facilitation and support to ensure that the research conducted is approved by national authorities. I critically reflect on the role of social capital and relationships, which in my own case enabled access to information about where ethics approval could be obtained and provided significant support throughout the process. For this case study, I dawn upon my experience of applying for ethics approval in 2014, having that approval granted in 2015 and conducting research until 2016.

Health-related Research Ethics and Social Value: Antibiotic Resistance Intervention Research and Pragmatic Risks.

We consider the implications for the ethical evaluation of research programs of two fundamental changes in the revised research ethical guideline of the Council for International Organizations of Medical Sciences. The first is the extension of scope that follows from exchanging "biomedical" for "health-related" research, and the second is the new evaluative basis of "social value," which implies new ethical requirements of research. We use the example of antibiotic resistance interventions to explore the need to consider the instances of what we term the pragmatic risks of such interventions to evaluate the social value of certain kinds of health-related research. These (pragmatic) risks severely threaten the social value of interventions in every area where human and social responses significantly impact on their effectiveness. Thus, the social value of health-related research needed to demonstrate its effectiveness depends on the extent and successful management of such risks. Research designed to take into account the management of pragmatic risks also gives rise to similar types of risks, and the potential for social value in light of those risks needs to be considered in ethical reviews based on the new guidelines. We argue that, to handle this new expanded task, the international system of research ethical review addressed by the guidelines needs institutional development.