Research Ethics Governance Research Articles

Troubling understandings of childhood competence in research ethics governance processes: Implications for research with children and their families

Troubling understandings of childhood competence in research ethics governance processes: Implications for research with children and their families

Towards meaningful institutional change: Responsive bureaucracy and the governance of anthropological ethics

This article advocates for a deeper engagement with the organizational structures that shape the governance of research ethics in anthropology. The authors argue that anthropological critiques of bureaucracy often sidestep the kinds of knowledge needed to pursue meaningful institutional change. They show how different regulatory dynamics and organizational arrangements across jurisdictions produce more or less responsive bureaucracies, comparing Institutional Review Boards in the United States with a case study of a European university's Ethics Review Committee. The authors suggest that such organizational understandings of bureaucratic processes can more meaningfully inform their redesign and contribute to developing more appropriately scaled ethics governance. In so doing, ethics review promises greater responsiveness to the particular demands of ethnographic research while remaining legible to regulatory stakeholders.

Developing a Framework for Self-regulatory Governance in Healthcare AI Research: Insights from South Korea

This paper elucidates and rationalizes the ethical governance system for healthcare AI research, as outlined in the ‘Research Ethics Guidelines for AI Researchers in Healthcare’ published by the South Korean government in August 2023. In developing the guidelines, a four-phase clinical trial process was expanded to six stages for healthcare AI research: preliminary ethics review (stage 1); creating datasets (stage 2); model development (stage 3); training, validation, and evaluation (stage 4); application (stage 5); and post-deployment monitoring (stage 6). Researchers identified similarities between clinical trials and healthcare AI research, particularly in research subjects, management and regulations, and application of research results. In the step-by-step articulation of ethical requirements, this similarity benefits from a reliable and flexible use of existing research ethics governance resources, research management, and regulatory functions. In contrast to clinical trials, this procedural approach to healthcare AI research governance effectively highlights the distinct characteristics of healthcare AI research in research and development process, evaluation of results, and modifiability of findings. The model exhibits limitations, primarily in its reliance on self-regulation and lack of clear delineation of responsibilities. While formulated through multidisciplinary deliberations, its application in the research field remains untested. To overcome the limitations, the researchers’ ongoing efforts for educating AI researchers and public and the revision of the guidelines are expected to contribute to establish an ethical research governance framework for healthcare AI research in the South Korean context in the future.

Situation analysis of research ethics governance in Pakistan.

Mapping of ethical governance structures is very useful in identifying strengths and weaknesses in order to uphold integrity and ensure standardization. However, reliable countrywide data about ethical review committees (ERCs) is unavailable in Pakistan. To evaluate the research ethics governance mechanisms at national level and at key healthcare institutions in Pakistan. This pilot mapping exercise used a mixed-methods approach, involving a cross-sectional survey of 19 key healthcare research institutions, and structured in-depth interviews with the chairs of the National Bioethics Committee and the Drug Regulatory Authority of Pakistan. Eighteen institutions responded to the ethics mapping survey. Twelve public sector ERCs had a permanent structure and 17 had formal terms of reference. Seven ERCs claimed accreditation, although no central accreditation agency exists in Pakistan. Eight ERCs were chaired by the heads of the institutions. There was no fixed tenure for the heads in 13 committees, and 14 committees allowed multiple terms. Six ERCs had follow-up mechanisms for ethical approvals, and 6 took punitive actions in response to any deviation from an approved protocol, or to a scientific misconduct. Two respondents recalled situations where applicants pressured committee members for favourable approvals. Survey respondents mentioned the lack of central research ethics guidelines as a weakness of the national governance system. Structured interviews revealed the need for formal training of committee members and capacity strengthening, particularly for administrative staff. There is a need to develop guidelines for local ethics governance in Pakistan, and ensure accreditation of ERCs through the National Bioethics Committee to uphold the integrity of the ethics governance structure.

Accreditation of research ethics committees in Paraguay: An ethical imperative.

In the last decade, Paraguay has made progress in the development of health-related research involving human subjects. This entails the obligation of the State to ensure that research is conducted ethically: protecting the dignity, rights and welfare of the participants, scientific integrity and adherence to international ethical guidelines. Research Ethics Committees are the main instance or resource to guarantee the aforementioned obligation. In view of the above and the context lacking adequate regulation in which research is currently carried out in the country, this article will defend the ethical imperative of establishing an accreditation system for research ethics committees. To this end, its necessity will be presented and justified and some objections related to the ethical imperative defended will be answered, such as the per se value of the accreditation of research ethics committees in the protection of participants, the investment of time and bureaucracy involved in the accreditation processes and the incipient regulatory framework for research on human beings in Paraguay. Finally, it will be proposed to strengthen the governance of research ethics in the country, as the main means to establish, implement and supervise an accreditation system for research ethics committees.

Governance of research involving people with psychosocial disabilities.

Health-related research with human participants is governed by research ethics regulations in most jurisdictions. Globally, the 2016 International Ethical Guidelines for Health-related Research Involving Humans, published by the Council for International Organizations of Medical Sciences (CIOMS), are especially influential and widely held as an international standard. The CIOMS guidelines support the inclusion of people with psychosocial disabilities in research and offer clear guidance to promote their recruitment, including by outlining provisions for substitute decision-making. The CIOMS guidelines sit alongside the United Nations' Convention on the Rights of Persons with Disabilities (CRPD). Adopted in 2006 and ratified in 2008, the CRPD offers a robust framework for recognizing the rights of persons with disabilities, including individuals with psychosocial disabilities. Though the CRPD does not explicitly reference research inclusion, its core principles-especially pertaining to the right to universal legal capacity-have clear implications for research ethics governance, specifically with respect to the use of substitute decision-making for research participation. In this paper, we review the extent to which existing research ethics regulations across selected jurisdictions concord with each of these two frameworks, offering first a broad analysis of regulations across 26 African countries, and then exploring two country-specific case studies from Malaysia and Peru. We find that, while many countries' research ethics regulations align with key aspects of the CIOMS guidelines, core principles of the CRPD are absent. Given the shortcomings of existing regulations, we analyse a key point of tension between CIOMS and the CRPD-the right to participate in research-and offer a proposal for revised regulations that aims to bridge this tension and meet the standards of both frameworks.

Ethics requirements for environmental research

ABSTRACT Research into the best forms of conservation management or climate intervention is critically important, but carries its own risks of impacts. Unless research requires a legal permit, evaluation of whether the benefits of such research outweigh risks is left to research ethics processes. We ask whether the ethics processes governing outdoor research in Australia ensure that potential environmental impacts are addressed adequately. We examine how environmental considerations are incorporated into Australia’s research ethics governance framework 25 years after the Australian Science, Technology and Engineering Council issued national guidelines for the ethical conduct of environmental research. These guidelines have not been incorporated into national research ethics frameworks or institutional processes. Current ethics codes apply only partially to environmental research and no research institution has developed its own processes or body for considering the environmental impacts of research. The national guidelines are partially reflected in protected area permitting requirements, but these lack explicit mechanisms for ethical deliberation. We conclude that the national guidelines remain relevant today. We stop short of recommending new formal ethics requirements, but encourage researchers and research institutions to consider how the deliberative procedures and substantive principles reflected in the ASTEC Guidelines might be relevant to their work.

Ethics governance in Scottish universities: how can we do better? A qualitative study

While ethical norms for conducting academic research in the United Kingdom are relatively clear, there is little empirical understanding of how university research ethics committees (RECs) themselves operate and whether they are seen to operate well. In this article, we offer insights from a project focused on the Scottish university context. We deployed a three-sided qualitative approach: (i) document analysis; (ii) interviews with REC members, administrators, and managers; and (iii) direct observation of REC meetings. We found that RECs have diverse operation and vary in terms of what members understand to be the remit of their REC and what should constitute the content of ethics review. Overall, though, most participants perceive university RECs as operating well. When asked what they consider to be areas for further improvement, most commented on: implementation of an online system; more experience with how to evaluate various kinds of research projects; best practice exchange and training opportunities; more accurate reflection of the REC role as part of the university’s workload allocation model; and greater recognition of the importance of research ethics governance in the university’s research environment, and, for the members themselves, their career advancement. Based on our findings and subsequent discussions during an end-of-project roundtable with stakeholders, we propose a model of collaboration that can address some of the identified areas that could benefit from further improvement. This model would facilitate a heightened awareness of the importance of supporting REC members in their own effort in assisting students and staff alike in undertaking as ethically robust research as possible.

Population-Based Clinical Studies Using Routinely Collected Data in Hong Kong, China: A Systematic Review of Trends and Established Local Practices

Background: Routinely collected health data are increasingly used in clinical research. No study has systematically reviewed the temporal trends in the number of publications and analyzed different aspects of local research practices and their variations in Hong Kong, China, with a specific focus on research ethics governance and approval. Methods: PubMed was systematically searched from its inception to March 28, 2023, for studies using routinely collected healthcare data from Hong Kong. Results: A total of 454 studies were included. Between 2000 and 2009, 32 studies were identified. The number of publications increased from 5 to 120 between 2010 and 2022. Of the investigator-led studies using the Hospital Authority (HA)’s cross-cluster data (n = 393), 327 (83.2%) reported receiving ethics approval from a single cluster/university-based REC, whereas 50 studies (12.7%) did not report approval from a REC. For use of the HA Data Collaboration Lab, approval by a single hospital-based or University-based REC is accepted. Repeated submission of identical ethics applications to different RECs is estimated to cost HK$4.2 million yearly. Conclusions: Most studies reported gaining approval from a single cluster REC before retrieval of cross-cluster HA data. Substantial cost savings would result if repeated review of identical ethics applications were not required.

Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic: a qualitative study

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.

Clinical practice guideline adherence in oncology: A qualitative study of insights from clinicians in Australia.

The burden of cancer is large in Australia, and rates of cancer Clinical Practice Guideline (CPG) adherence is suboptimal across various cancers. The objective of this study is to characterise clinician-perceived barriers and facilitators to cancer CPG adherence in Australia. Semi-structured interviews were conducted to collect data from 33 oncology-focused clinicians (surgeons, radiation oncologists, medical oncologists and haematologists). Clinicians were recruited in 2019 and 2020 through purposive and snowball sampling from 7 hospitals across Sydney, Australia, and interviewed either face-to-face in hospitals or by phone. Audio recordings were transcribed verbatim, and qualitative thematic analysis of the interview data was undertaken. Human research ethics committee approval and governance approval was granted (2019/ETH11722, #52019568810127). Five broad themes and subthemes of key barriers and facilitators to cancer treatment CPG adherence were identified: Theme 1: CPG content; Theme 2: Individual clinician and patient factors; Theme 3: Access to, awareness of and availability of CPGs; Theme 4: Organisational and cultural factors; and Theme 5: Development and implementation factors. The most frequently reported barriers to adherence were CPGs not catering for patient complexities, being slow to be updated, patient treatment preferences, geographical challenges for patients who travel large distances to access cancer services and limited funding of CPG recommended drugs. The most frequently reported facilitators to adherence were easy accessibility, peer review, multidisciplinary engagement or MDT attendance, and transparent CPG development by trusted, multidisciplinary experts. CPGs provide a reassuring framework for clinicians to check their treatment plans against. Clinicians want cancer CPGs to be frequently updated utilising a wiki-like process, and easily accessible online via a comprehensive database, coordinated by a well-trusted development body. Future implementation strategies of cancer CPGs in Australia should be tailored to consider these context-specific barriers and facilitators, taking into account both the content of CPGs and the communication of that content. The establishment of a centralised, comprehensive, online database, with living wiki-style cancer CPGs, coordinated by a well-funded development body, along with incorporation of recommendations into point-of-care decision support would potentially address many of the issues identified.

Ethics challenges in sharing data from pragmatic clinical trials.

Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trials data, and trial sponsors and journals are increasingly requiring it. However, data sharing in pragmatic clinical trials presents ethical challenges related to the use of waivers or alterations of informed consent for some pragmatic clinical trials and corresponding limitations of informed consent to guide sharing decisions; the potential for data sharing in pragmatic clinical trials to present risks not only for individual patient-subjects, but also for health systems and the clinicians within them; sharing of data from electronic health records instead of data newly collected for research purposes; and researchers' limited capacity to control sensitive data within an electronic health record and potential implications of such limits for meeting obligations inherent to Certificates of Confidentiality. These challenges raise questions about the extent to which traditional research ethics governance structures are capable of guiding decisions about pragmatic clinical trial data sharing. This article identifies and examines these ethical challenges for pragmatic clinical trial data sharing. We suggest several areas for future empirical scholarship, including the need to identify patient and public attitudes regarding pragmatic clinical trial data sharing as well as to assess the demand for pragmatic clinical trial data and the correspondingly likely benefit of such sharing. Further conceptual work is also needed to explore how requirements to respect patient-subjects about whom data are shared in the context of pragmatic clinical trials should be understood, particularly in the absence of informed consent for initial research activities, and the appropriate balance between promoting the generation of socially valuable knowledge and respecting autonomy.

Improving research ethics review and governance can improve human health.

Improving research ethics review and governance can improve human health.

The Privatization of Human Research Ethics: An American Story

Abstract In recent decades, there has been a remarkable shift in the governance of human research ethics in the United States. A model once based on review by panels of local volunteers has given way to a system dominated by large, for-profit research ethics committees. America’s reliance on for-profit ethics review is unique among wealthy industrialized countries. How can we account for this anomaly? In this article, I show that for-profit irb s represent only the most visible aspect of the privatization of human research protections in the United States. I suggest that private institutions have emerged as “workaround” solutions to systemic problems, in the absence of comprehensive policy reforms.

Variation in Human Research Ethics Committee and governance processes throughout Australia: a need for a uniform approach.

In Australia, ethics committees across different states vary in application, requirement and process for the ethical review and approval for clinical research. This may lead to confusion and delays in the enablement of multicentre research projects. This study explores the effect of differing processes for Ethics and Governance in the establishment of the CovidSurg-Cancer study during the global COVID-19 pandemic. An anonymous, structured web-based questionnaire was designed using the Research Electronic Data Capture application (REDCap) platform to capture consultant surgeons, fellows, and trainees experience in the ethics application process. 'CovidSurg-Cancer' was an international multicentre collaborative study to assess the impact of COVID-19 on the outcomes of patients undergoing cancer surgery. The ethics process to set up this observational study was used as to explore the differing processes applied across Australia. The CovidSurg-Cancer study was successfully set up in 14 hospitals. Four hospitals approved the study directly as an audit. Of the remaining sites, 10 ethics applications underwent Human Research Ethics Committee review following which two (14%) were subsequently approved as an audit activity and eight hospitals (57%) were given formal ethical approval with waiver of consent. Ethics application acceptance from another Australian Human Research Ethics Committee was provided with six applications; however, only three were reciprocated without the requirement for further agreements. A third of (30%) respondents suggested that the details of the application pathway, process and documentation were unclear. Ethics processes are varied across Australia with considerable repetition. A centralized, harmonized application process would enhance collaborative research.

코로나19와 연구윤리*

This article examines disaster-related research ethics in terms of its values, principles, systems of review, and methodologies. The article also reviews some of the major ethical issues in, and current status of, research ethics related to COVID-19 in Korea. Principles to be considered in disaster-related research include scientific validity, social value, risk-to-benefit ratio, time-sensitive reviews, and informed consent. It is necessary to develop guidelines for disaster-related research ethics that facilitate complete, yet time-sensitive ethical reviews. The potential benefits, scientific validity, and social value of research plans should be harmonized, and the participation of research subjects should be based on scientific evidence. A comprehensive review and plan for national-level research and research ethics governance appropriate to disasters is needed in Korea.

Prospective Active National Surveillance of Preschools and Primary Schools for SARS-CoV-2 Infection and Transmission in England, June 2020: (sKIDs: COVID-19 Surveillance in School KIDs)

Background: Many countries re-opened schools after national lockdown but little is known about the risk of SARS-CoV-2 infection and transmission in educational settings. Public Health England conducted six-month prospective surveillance in primary schools across England. Methods: The COVID-19 Surveillance in School KIDs (sKIDs) study included two arms: weekly nasal swabs for ≥4 weeks following partial reopening during the summer half-term (June to mid-July 2020) and blood sampling with nasal and throat swabs at the beginning and end of the summer half-term, and, following full reopening in September 2020, at the end of the autumn term (end-November 2020). Results: In round 1, 12,026 participants (59.1% students, 40.9% staff) in 131 schools had 43,091 swabs taken. Weekly SARS-CoV-2 infection rates were 3.9 (1/25,537; 95% CI, 0.10-21.8) and 11.3 (2/17,554; 95% CI, 1.4-41.2) per 100,000 students and staff. At recruitment, N-antibody positivity in 45 schools was 11.1% (91/817; 95%CI, 9.2-13.5%) in students and 15.1% (209/1381; 95%CI, 13.3-17.1%) in staff, similar to local community seroprevalence. Seropositivity was not associated with school attendance during lockdown or staff contact with students. Round 2 participation was 73.7% (1,619/2,198) and only five (4 students, 1 staff) seroconverted. In round 3, when 61.9% (1,361/2,198) of round 1 participants were re-tested, seroconversion rates were 3.4% (19/562; 95%CI, 2.0-5.2) in students and 3.9% (36/930; 95%CI, 2.7-5.3) in staff. Conclusions: SARS-CoV-2 infection rates, assessed using nasal swabs for acute infection and serum antibodies for prior infection, were low following partial and full reopening of primary schools in England.Funding Statement: This surveillance was funded by the Department of Health and Social Care (DHSC).Declaration of Interests: None to declare.Ethics Approval Statement: The surveillance protocol was approved by the Public Health England Research Ethics Governance Group (R&D REGG Ref: NR0209, 16 May 2020).

Moral bureaucracies and social network research

In the wake of Europe’s General Data Protection Regulation (GDPR), research ethics governance does not just affect the ethical dimensions of social research but also the range of scientific decisions available to researchers. Because of the sensitive status of personal data and the aversion to even minimal risk by what we call “moral bureaucracies”, we are concerned that social network researchers will increasingly limit their research decisions to “safe” options, like reusing anonymized datasets, choosing target populations based on convenience rather than theoretical relevance, and routinely subcontracting fieldwork to professional data collection companies, among others. We also suggest that scientific associations and social scientists in general need to adopt a proactive role in preserving both scientific freedom and genuine ethics advice within this new regulatory framework.

Enriching the concept of vulnerability in research ethics: An integrative and functional account.

The concept of vulnerability is widely used in research ethics to signal attention to participants who require special protections in research. However, this concept is vague and under-theorized. There is also growing concern that the dominant categorical approach to vulnerability (as exemplified by research ethics regulations and guidelines delineating vulnerable groups) is ethically problematic because of its assumptions about groups of people and is, in fact, not very guiding. An agreed-upon strategy is to move from categorical towards analytical approaches (focused on analyzing types and sources of vulnerability) to vulnerability. Beyond this agreement, however, scholars have been advancing competing accounts of vulnerability without consensus about its appropriate operationalization in research ethics. Based on previous debates, we propose that a comprehensive account of vulnerability for research ethics must include four components: definition, normative justifications, application, and implications. Concluding that no existing accounts integrate these components in a functional (i.e., practically applicable) manner, we propose an integrative and functional account of vulnerability inspired by pragmatist theory and enriched by bioethics literature. Using an example of research on deep brain stimulation for treatment-resistant depression, we illustrate how the integrative-functional account can guide the analysis of vulnerability in research within a pragmatist, evidence-based approach to research ethics. While ultimately there are concerns to be addressed in existing research ethics guidelines on vulnerability, the integrative-functional account can serve as an analytic tool to help researchers, research ethics boards, and other relevant actors fill in the gaps in the current landscape of research ethics governance.

Ethical issues experienced during palliative care provision in nursing homes.

Palliative care is acknowledged as an appropriate approach to support older people in nursing homes. Ethical issues arise from many aspects of palliative care provision in nursing homes; however, they have not been investigated in this context. To explore the ethical issues associated with palliative care in nursing homes in the United Kingdom. Exploratory, sequential, mixed-methods design. Semi-structured interviews with 13 registered nurses and 10 healthcare assistants (HCAs) working in 13 nursing homes in the United Kingdom were used to explore ethical issues in palliative care. The 'Ethical Issues in Palliative Care for Nursing Homes' instrument was used to measure the frequency and level of distress arising from ethical issues through a cross-sectional survey with 69 registered nurses and 129 healthcare assistants. Data collection occurred between December 2014 and November 2015. Ethical approval was granted by Queen's University's School of Nursing and Midwifery Research Ethics Committee and governance sought from each nursing home's manager. The interviews revealed three themes: ethical issues in practice; relational issues; and organisational issues. No significant differences between registered nurses and healthcare assistants were evident, confirming the patterns emerging from the interviews. Relational issues, primarily issues with residents and families, occurred most frequently and caused greater distress. The shared environment is key in the experience of ethical issues; therefore, multidisciplinary education is needed for ethical decision making in palliative care. Addressing staff knowledge and service organisation may reduce ethical issues locally and provide a benchmark for global change.