Ethical Review Process Research Articles

Toward an integrated ethical review process: an animal-centered research framework for the refinement of research procedures.

The involvement of animals in research procedures that can harm them and to which they are deemed unable to consent raises fundamental ethical dilemmas. While current ethical review processes emphasize the application of the 3Rs (Replacement, Reduction, and Refinement), grounded in a human-centered utilitarian ethical approach, a comprehensive ethical review also involves a harm-benefit analysis and the consideration of wider ethical issues. Nevertheless, to our knowledge, approaches are still needed to facilitate the integrative assessment and iterative revision of research designs to improve their ethical value or to identify cases in which using animals is irremediably unethical. Additionally, frameworks are lacking that explicitly include an animal-centered perspective into the ethical review process beyond welfare concerns, failing to cover broader ethical considerations (such as consent). In previous work we proposed an Animal-Centered Research framework (ACRf) comprising four animal-centered research principles (relevance, impartiality, welfare and consent) which could help researchers and ethical review bodies apprise research designs from an animal-centered perspective. This paper builds on and further develops our previous work by contextualizing the ACRf within the bigger picture of animal research ethical review and by illustrating how the ACRf could be operationalized within current ethical review processes. We contribute an extended framework that integrates the application of the ACRf principles within the ethical review process. To this end, we present findings from a theoretical case study focusing on the ethical review of a research protocol on the study of stress response in pigs. We discuss how our extended framework could be easily applied to facilitate a holistic approach to the ethical review process, and inform an iterative process of refinement, to support the development of research designs that are both more ethical and scientifically valid.

Ethical clearance paper as a bottleneck.

The significance of the ethical review process in human-based research undertakings cannot be overemphasized as it is necessary to uphold ethical standards and protect participants. However, the review process per se can act as a bottleneck, potentially hindering research progress and leading to academic dishonesty. The present work explores the benefits and challenges of ethical review, emphasizing issues like intellectual theft, forced authorship, and the stifling of independent researchers. Proposed solutions include leveraging previously approved designs, empowering experienced professors for clearance, establishing panels of researchers, creating voluntary ethical approval offices, utilizing private consultancy offices, and establishing a transnational ethical clearance authority. In conclusion, this work stresses the importance of finding mechanisms to streamline the ethical review process while maintaining ethical standards to foster integrity in research and combat academic dishonesty.

Ethics Review Committees of Public Health Institutes in Japan

Recent legislative changes in the wake of the novel coronavirus pandemic have placed an increased emphasis on the research activities of Local Public Health Institutes (PHIs) in Japanese municipalities. However, few studies have examined the ethical review processes of these institutes. We analyzed information on (a) the status and year of establishment of "Ethics Review Committees" (and equivalent committees), (b) the number of review cases for each year, (c) the status of public disclosure of committee activities, and (d) the composition of committee members for 85 PHIs across Japan. Publicly available information from each PHI and the Ministry of Health, Labour and Welfare was used for the analysis. Out of 85 PHIs nationwide, about half of them publicly disclosed the establishment of their committees (41 committees, 48.2%). The number of review cases handled by the committees varied, with some committees having no cases or only one case. Among the committees, approximately 20% still maintained adherence to outdated national research ethics guidelines, and approximately 15% did not specify any guidelines they followed. Furthermore, we identified committees without external members (at least two committees) and those lacking public representation (four committees). There are differences in the operational performance of ethics review committees at PHIs, possibly owing to varying levels of understanding of the guidelines, the degree of proactive engagement in academic research, and the emphasis on human subject research. There is a crucial need to accumulate and share experiences that support the review functions of the committees.

AI research ethics is in its infancy: the EU’s AI Act can make it a grown-up

As the artificial intelligence (AI) ethics field is currently working towards its operationalisation, ethics review as carried out by research ethics committees (RECs) constitutes a powerful, but so far underdeveloped, framework to make AI ethics effective in practice at the research level. This article contributes to the elaboration of research ethics frameworks for research projects developing and/or using AI. It highlights that these frameworks are still in their infancy and in need of a structure and criteria to ensure AI research projects advance in a way that respects norms and principles. This article proposes to draw from the European Union’s AI Act currently in development to shape these frameworks. Although, in the current form of the draft (as of August 2023), the obligations of the AI Act do not apply to scientific research, it is most likely that they will still have a strong impact on AI research considering the need to anticipate market placement or to test new tools in real world conditions. This article investigates what the risk-based approach in the AI Act implies for research ethics and highlights some AI Act obligations of particular value to implement for ethics review processes.

Three to one – an ethicolegal outline of mitochondrial donation in the South African context

Mitochondrial donation or mitochondrial transfer enables a woman with mitochondrial disease to have a genetically related child without transmitting the disease to the child. The techniques used for mitochondrial donation or transfer which are maternal spindle transfer or pro-nuclei transfer, require three gametes to ultimately produce a healthy embryo. Both these techniques result in the child inheriting nuclear DNA from the intending parents and mitochondrial DNA from the female donor. Following the legalisation of mitochondrial donation in the UK, after a rigorous process of scientific and ethical review, and the birth of another baby using the technique, coupled with the fact that there is no cure for mitochondrial disease, suggests that it is prudent for us to consider this reproductive intervention and its application in the South African setting. In addition, the 2019 UNESCO Report of the International Bioethics Committee (IBC) on assisted reproductive technologies (ART) and parenthood, encourages debate on changes in models of parenthood influenced by ART including the emergence of new models of families and forms of parenthood that extend beyond the classical rule of mater semper certa est (the mother is always known). ART, in particular mitochondrial donation, challenges this rule. The aim of this paper is to provide an outline of the legal and ethical positions of mitochondrial donation and resume the discussion with specific focus on the South African context.

Methodological and ethical challenges in designing and conducting research at the end of life: A systematic review of qualitative and textual evidence.

This systematic review aims to identify methodological and ethical challenges in designing and conducting research at the end of life from the perspective of researchers and provide a set of recommendations. Conducting research with patients and family carers facing end-of-life issues is ethically and methodologically complex. A systematic review was conducted. Four databases (MEDLINE, EMBASE, CINAHL, PsycInfo) were searched from inception until the end of 2021 in February 2022. The Preferred Reporting Items for Systematic Reviews was followed, and the JBI Approach to qualitative synthesis was used for analysis. Seventeen of 1983 studies met inclusion criteria. Data were distilled to six main themes. These included (1) the need for flexibility at all stages of the research process; (2) careful attention to timing; (3) sensitivity in approach; (4) the importance of stakeholder collaboration; (5) the need for unique researcher skills; and (6) the need to deal with the issue of missing data. The findings illuminate several considerations that can inform training programmes, ethical review processes and research designs when embarking on research in this field.

Protecting and empowering adults with capacity-affecting conditions to take part in health and health-related research

Health research is essential if people are to enjoy the highest attainable standard of health and healthcare. Yet, persons with capacity-affecting conditions are routinely excluded from research, as they are often judged to lack the capacity to give consent. Focusing on the Mental Capacity Act England and Wales 2005 (MCA), which regulates research involving adults judged to lack capacity, we outline the provision of the MCA and then describe the process of ethical review designed to ensure compliance with these provisions; 2) present findings from interviews with members of the committees responsible for ethical review and with researchers, who have experience of working with the MCA; 3) discuss the implications of these findings for the inclusion of adults lacking capacity in research as well as drawing conclusions about the effectiveness of the MCA.

When Ethics and the Law Collide: A Multicenter Demonstration Cohort Study of Pre-Exposure Prophylaxis Provision to Adolescent Men Who Have Sex With Men and Transgender Women in Brazil

PurposeTo explore legal and ethical challenges related to adolescents’ participation in human immunodeficiency virus (HIV) research that may affect their best interests. MethodsWe analyzed the ethical principles and legal aspects of the participation of 15–17-year-old men who have sex with men and transgender women in the pre-exposure prophylaxis (PrEP) 1519 study, a PrEP demonstration cohort study in three Brazilian cities. The analyses of ethics review committees’ (ERCs) evaluations and court decisions followed ethical and human rights principles. An HIV vulnerability score was created, and descriptive statistics and multivariate logistic regression were performed using data from 347 participants. ResultsThe ERCs evaluated the benefits and risks of research participation, all finding that the benefits outweighed the risks. ERCs deferred responsibility for decisions about waiving parental consent to the judiciary. State courts reached different decisions about waiving parental consent, reflecting variation in recognition of adolescents’ evolving capacities and the adolescent as a subject of sexual rights and the primary agent capable of deciding on their health and best interests. The most vulnerable adolescent participants were found in sites where the blanket waiver was in place. DiscussionJudicializing the ethical review process is detrimental to fulfilling the ethical principle of justice and vulnerable adolescents’ access to health research. ERCs must be sufficiently independent and autonomous and have the capacity to respect, protect, and help fulfill the rights of participants while ensuring the generation of adequate evidence to inform public health practice.

Teaching in Paediatrics for UK Foundation Doctors: A Cross-Sectional Study.

Background Most doctors will care for children regularly during their careersin settings such as the emergency department, general practice, surgery,or, for a minority, during paediatric specialist training. As such, exposure to topics related to child health ought to be part of the broad curriculum of learning offered to UK Foundation Programme doctors. Objective This study aimed to quantify teaching in paediatrics that is accessed by Foundation doctors. Methods A cross-sectional electronic survey of foundation year one or two (F1/F2) doctors at the end of the 2020-2021 academic year. Ethical approval was granted by the Imperial College London (ICL) Education Ethics Review Process (EERP 2021-082). Results Two-hundred and five Foundation doctors completed the survey, from 16 of the 18 Foundation schools. Respondents attended a median of two hours (interquartile range (IQR) 0-10) of paediatric teaching during the past 12 months, including a median of one hour (IQR 0-2) of core teachingand a median of one hour (IQR 0-9) of non-core teaching. Those who had worked in a paediatric post in the past 12 months, or who were interested in Paediatrics as a career, attended more median hours of teaching. Conclusions Although many doctors will care for children routinely during their later careers, the number of teaching hours in paediatrics experienced by Foundation doctors is low. The UK Foundation Programme should incorporate more teaching in paediatrics to increase exposure to child health amongst newly graduated and as-yet unspecialised doctors.

Ethics review of artistic research: challenging the boundaries and appealing for care

In 2019, a new national Ethics Review Authority (Etikprövningsmyndigheten, EPM) was created in Sweden. In 2020, Sweden’s Ethical Review of Research Involving Humans Act was revised, tightening this legislation, and increasing penalties for its infraction. This article draws on empirical material generated by artistic research conducted with a norm-critical contemporary music ensemble. Two of the musicians who collaborated with this research identify as disabled. Consequently, in accordance with EPM, my artistic research was subject to mandatory ethics review. Reflecting critically on my own experience of seeking ethical approval for this artistic research project, I show how EPM’s process of ethics review enacts scientific boundary work in Sweden that privileges the interests of academic disciplines that are already well-established. As a corrective to EPM’s scientific boundary work I propose the application of an ethics of care that recognises the complex relationalities that exist between research institutions, researchers and research participants.

Research ethics during infectious disease outbreaks: A survey of African research stakeholders using the Ebola virus disease outbreak as a case.

Conducting research during disease outbreaks can be ethically challenging as evidenced in the 2014-2016 Ebola outbreak in West Africa and COVID-19 pandemic. Yet, there has been little empirical research conducted for understanding the views and perspectives of different stakeholders regarding ethical issues in conducting research during disease outbreaks. This preliminary study was conducted to empirically explore African public health research stakeholders' views about research ethics issues during infectious disease outbreaks in Africa. We conducted an online survey of 330 participants attending the International Conference on Re-emerging and Emerging Infectious Disease (ICREID) meeting that took place from 13-15 March 2019 in Addis Ababa, Ethiopia to elicit their views on various research ethics complexities experienced in the 2014 Ebola outbreak. Study results revealed some divergent views on several ethical themes including: ethics of using unregistered interventions in outbreaks; acceptable study design; ethics review processes; risks-benefit assessment; exclusion of pregnant women and children; and biological sample and data sharing. Majority (76.3%) of respondents felt that in the absence of available standard treatments or prevention modalities, the use of investigational interventions can be ethically justifiable if there is a strong scientific rationale and favorable risk-benefit ratio. Regarding conventional placebo-controlled trials during outbreaks with high case fatality rates, respondents that considered this unethical were more than three times those that felt such design were ethically justifiable. We were somewhat surprised that a majority (almost 60%) of respondents were satisfied with the exclusion of pregnant women and children in clinical trials during outbreaks. All respondents concurred with the prioritization of informed consent for research during an outbreak. Based on our findings, research ethics guidance is needed to equip research stakeholders in dealing with ethical complexities arising in the conduct of research during emerging disease outbreaks-especially regarding using experimental interventions; placebo trial design; inclusion or justified exclusion of pregnant women and children; and biological sample/data sharing. The findings will be used in ongoing efforts of developing a consultative and coherent African-centric framework to support ethical conduct of research for future emerging infectious disease outbreaks in Africa.

Guidelines for the establishment and functioning of Animal Ethics Commitees (Institutional Animal Care and Use Committees) in Africa.

Animals are used for scientific purposes across Africa to benefit humans, animals or the environment. Nonetheless, ethical and regulatory oversight remains limited in many parts of the continent. To strengthen this governance framework, the Pan-African Network for Laboratory Animal Science and Ethics brought together experts from 12 African countries to create an Africa-centric practical guide to facilitate the establishment and appropriate functioning of Institutional Animal Ethics Committees across Africa. The Guidelines are based on universal principles for the care and use of sentient animals for scientific purposes, with consideration of the cultural, religious, political and socio-economic diversity in Africa. They focus on 11 key elements, including responsibilities of institutions and of the Institutional Official; composition of the Committee; its responsibilities, functioning and authority; ethical application and review processes; oversight and monitoring of animal care and use and of training and competence; quality assurance; and the roles of other responsible parties. The intent is for African institutions to adopt and adapt the guidelines, aligning with existing national legislation and standards where relevant, thus ensuring incorporation into practice. More broadly, the Guidelines form an essential component of the growing discourse in Africa regarding moral considerations of, and appropriate standards for, the care and use of animals for scientific purposes. The increased establishment of appropriately functioning animal ethics committees and robust ethical review procedures across Africa will enhance research quality and culture, strengthen societal awareness of animals as sentient beings, improve animal well-being, bolster standards of animal care and use, and contribute to sustainable socio-economic development.

Structured Ethical Review for Wastewater-Based Testing in Support of Public Health.

Wastewater-based testing (WBT) for SARS-CoV-2 has rapidly expanded over the past three years due to its ability to provide a comprehensive measurement of disease prevalence independent of clinical testing. The development and simultaneous application of WBT measured biomarkers for research activities and for the pursuit of public health goals, both areas with well-established ethical frameworks. Currently, WBT practitioners do not employ a standardized ethical review process, introducing the potential for adverse outcomes for WBT professionals and community members. To address this deficiency, an interdisciplinary workshop developed a framework for a structured ethical review of WBT. The workshop employed a consensus approach to create this framework as a set of 11 questions derived from primarily public health guidance. This study retrospectively applied these questions to SARS-CoV-2 monitoring programs covering the emergent phase of the pandemic (3/2020-2/2022 (n = 53)). Of note, 43% of answers highlight a lack of reported information to assess. Therefore, a systematic framework would at a minimum structure the communication of ethical considerations for applications of WBT. Consistent application of an ethical review will also assist in developing a practice of updating approaches and techniques to reflect the concerns held by both those practicing and those being monitored by WBT supported programs.

Development of Two Korean IACUC Guidance Documents to Foster Implementation of the Three Rs.

In Korea, Institutional Animal Care and Use Committees (IACUCs) have been legally required to apply the Three Rs principles (i.e. replacement, reduction and refinement) and undertake the ethical review of animal study protocols, since 2008. According to Korean law, each IACUC is required to appoint at least one lay member recommended by a non-governmental animal protection organisation, who participates in the ethical review process as part of this role. Despite the importance of the Three Rs and the ethical review process, limited information and practical resources are available for IACUC members in the Korean language, particularly for lay members who are inexperienced in animal experimentation. In January 2020, the Animal and Plant Quarantine Agency announced the funding for a six-month research project to develop guidance to assist IACUC members in carrying out effective and efficient protocol reviews in line with Korean legislative requirements. This funding was awarded for the production of two IACUC guidance documents - 'Guide for Animal Study Protocols' and 'Guide for the IACUC Lay Member' - which were published in December 2020. These guidance documents aim to foster the implementation of the Three Rs and provide practical resources for IACUC members, researchers and other relevant personnel. This paper describes the framework for animal use in Korea and the overall production of these two IACUC Guidance Documents.

Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study

Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study

Observing resuscitative practice. A novice researcher's experience of obtaining ethics approval.

Undertaking research involving vulnerable groups, such as those requiring resuscitation involves careful analysis during the ethical review process. When a person lacks the capacity to make an informed choice about their participation in a research study, a waiver of consent offers an alternative. This paper is based on a doctoral research study using ethnography to explore the resuscitative practices and experiences of rural nurses through observation and interviews. This paper aims to explore the ethical issues raised by the Human Research Ethics Committee relating to consent of vulnerable patients requiring resuscitation within a rural context. In particular, the challenges of addressing risk (privacy) vs benefit (public) associated with a waiver of consent. This paper will consider why the rural context should be championed during the ethical review process, when decisions about public benefit are being deliberated. Utilising a communitarianism approach that advocates for greater rural representation during the ethical review processes will ensure that rural research involving vulnerable groups can be addressed safely and benefit not only the experiences and practices of rural nurses but also the wider rural communities they serve.

University ethics boards are not ready for Indigenous scholars.

Ethics review processes routinely impede Indigenous academics’ research with Indigenous communities. Ethics review processes routinely impede Indigenous academics’ research with Indigenous communities.

The ethics review and the humanities and social sciences: disciplinary distinctions in ethics review processes

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

258: CHALLENGES IN INSTITUTIONAL APPROVAL PROCESS FOR A MULTINATIONAL STUDY: THE GLOBAL PARITY

Introduction: Multicenter, multinational collaborative research has increased across differing resource capacities by country. Inconsistencies in ethical review processes is an under recognized resource limitation and in resource-limited settings across regions may lead to barriers to rapid deployment of important clinical studies. Methods: An ancillary prospective study of the global PARITY (pediatric acute critical illness study) point prevalence study of pediatric critical illness in resource-limited settings. We surveyed participating sites to explore ethical and board review processes. The aim of the study was to describe the time, costs, and barriers in obtaining institutional review board and ethics approval for a multinational, multicenter, non-interventional study in critically ill children involving low and middle-income countries. Results: Fifty-six centers completed the survey. Of those hospitals, 72% (n= 40) required a full board review of the global PARITY study prior to approval, and 17% (n=9) accepted an ethics approval from a separate institution. The frequency of institutional review board (irb) committee is variable between centers, 16% (n=9) weekly, 56% (n=31) meet every 1 – 2 month, 11% (n=6) every 3 – 6 month and in 16% (n=9) > six months. The IRB approval process took a median of 62 days (n=40; range 1-294 days). Sixteen centers (30%) reported costs associated with ethical review. The waived consent was approved by 71% (n=38) of the centers, and 23% (n=12) required a data sharing agreement. The protocol required translation to local language in 47% (n=26) centers, from which 25% (n=6) required a professional certificated translation. Of the centers surveyed, 32% (n=17) required a legal review of protocol or data sharing agreement. Conclusions: There is great variability in ethical review requirements and time of approval for a non-interventional multinational study of critically ill children in low and middle-income countries in both private and public hospitals. We show that this time resource must be considered when planning multinational studies. Enhancing the capacity for ethics and board review process across regions will allow for better matching of disease burden with clinical research and likely increase participation in this multicenter research.

Methods and operational aspects of human-centred design into research processes for individuals with multiple chronic conditions: A survey study.

To examine ways in which human-centred design was integrated into a nursing school's research processes involving individuals with multiple chronic conditions. Cross-sectional survey study. Three surveys were sent out, with surveys 1 and 2 involving faculty who had worked closely with design strategists and survey 3 as a school-wide survey eliciting experience with human-centred design, respectively. Survey respondents (n=7 for surveys 1 and 2 and n=36 for survey 3) had no or minimal experience with human-centred design. Faculty respondents indicated it helped engaging various stakeholders, particularly in intervention development. Key lessons learned included: (1) the importance of designer involvement from study conception, (2) distinguishing a design strategist's skillset from strictly visual design, (3) challenges during the ethical review processes, and (4) sustainability of resources. The dynamic approach of human-centred design has benefited our efforts to advance the science of caring for individuals with multiple chronic conditions.