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"Research ethics"
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Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands
Background
Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands.
Methods
We examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together.
Results
Nine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories – evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation – were exempted by one country each. The remaining categories were exempted by two or three countries.
Conclusions
Examples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales.
Journal Article
A framework for enhancing ethical genomic research with Indigenous communities
Integration of genomic technology into healthcare settings establishes new capabilities to predict disease susceptibility and optimize treatment regimes. Yet, Indigenous peoples remain starkly underrepresented in genetic and clinical health research and are unlikely to benefit from such efforts. To foster collaboration with Indigenous communities, we propose six principles for ethical engagement in genomic research: understand existing regulations, foster collaboration, build cultural competency, improve research transparency, support capacity building, and disseminate research findings. Inclusion of underrepresented communities in genomic research has the potential to expand our understanding of genomic influences on health and improve clinical approaches for all populations.
Indigenous peoples are still underrepresented in genetic research. Here, the authors propose an ethical framework consisting of six major principles that encourages researchers and Indigenous communities to build strong and equal partnerships to increase trust, engagement and diversity in genomic studies.
Journal Article
Ethics review or compliance check? an empirical analysis of 6740 requests for information in Belgian clinical trial evaluations (2017–2024)
The EU Clinical Trials Regulation (CTR) was introduced to harmonize clinical trial evaluations across Member States while upholding participant protection and ethical integrity. This study analyzes 6740 Requests for Information (RFIs) issued by Belgian Medical Research Ethics Committees (MRECs) across 266 trial dossiers evaluated between 2017 and 2024, spanning both the CTR pilot phase and the initial CTIS implementation. Using framework content analysis, we examined the number and content of RFIs in relation to trial outcomes, sponsor type (commercial vs. non-commercial), and the MREC’s role as Reporting Member State (RMS) or Member State Concerned (MSC).
Results show a decline in total RFIs over time, mainly due to a reduction in typographical and linguistic remarks, yet significant variability persists in the formulation and scope of ethical feedback. While statistical and methodological concerns remained central in Part I evaluations, RFIs increasingly addressed newer challenges such as decentralized trials, e-consent, and data collection on ethnicity. Part II RFIs continued to focus heavily on informed consent documents. We further observed that MSCs raised fewer RFIs than RMSs for Part I, prompting reflection on the necessity and efficiency of full multi-state review in this section.
The study also highlights a growing emphasis on regulatory compliance—sometimes at the expense of ethical deliberation—and the limited authority of policy advisors to correct inconsistencies, despite their expertise. We recommend clearer guidance, formalized roles for policy advisors in quality control, improved pre-submission processes, and limited direct communication between MRECs and sponsors. These findings support ongoing efforts to improve ethics review efficiency and quality under the CTR, with broader relevance for harmonization across Europe.
Journal Article
Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation
Background
Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature.
Methods
We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis.
Results
Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low.
Conclusion
The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs.
Journal Article
Judging passions : moral emotions in persons and groups
\"Psychological research shows that our emotions and feelings often guide the moral decisions we make about our own lives and the social groups to which we belong. But should we be concerned that our important moral judgments can be swayed by \"hot\" passions, such as anger, disgust, guilt, shame and sympathy? Aren't these feelings irrational and counterproductive? Using a functional conflict theory of emotions (FCT), Giner-Sorolla proposes that each emotion serves a number of different functions, sometimes inappropriately, and that moral emotions in particular are intimately tied to problems faced by the individuals in a group, and by groups interacting with each other. Specifically, the author suggests that these emotions help us, as individuals and group members, to: appraise developments in the environment; learn through association; regulate our own behavior; and communicate convincingly with others. Drawing on extensive research, including many studies from the author's own lab, this book shows why emotions work to encourage reasonable moral behaviour, and why they sometimes fail. This is the first single-authored volume in the field of psychology dedicated to a separate examination of the major moral and positive emotions. As such, the book is ideal reading for researchers, postgraduates and undergraduates of social psychology, sociology, philosophy and politics.\"-- Provided by publisher.
Book
From Subject to Participant: Ethics and the Evolving Role of Community in Health Research
Belmont Report principles focus on the well-being of the research subject, yet community-engaged investigators often eschew the role of subject for that of participant. We conducted semistructured interviews with 29 community and academic investigators working on 10 community-engaged studies. Interviews elicited perspectives on ethical priorities and ethical challenges. Interviewees drew on the Belmont Report to describe 4 key principles of ethical community-engaged research (embodying ethical action, respecting participants, generalizing beneficence, and negotiating justice). However, novel aspects of the participant role were the source of most ethical challenges. We theorize that the shift in ethical focus from subject to participant will pose new ethical dilemmas for community-engaged investigators and for other constituents interested in increasing community involvement in health research.
Journal Article