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"Ethics, Research"
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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
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
A New Era of Indigenous Research
Indigenous communities across Canada have established principles to guide ethical research within their respective communities. Thorough cataloging and description of these would inform university research ethics boards, researchers, and scholars and facilitate meaningful research that respects Indigenous-defined ethical values. A scoping study was conducted of all relevant peer-reviewed literature and public-facing Indigenous research ethical guidelines from First Nations, Metis, and Inuit communities and organizations in Canada. A total of 20 different Indigenous research ethics boards, frameworks, and protocols were identified. Analysis resulted in three key themes: (1) balancing individual and collective rights; (2) upholding culturally-grounded ethical principles; and (3) ensuring community-driven/self-determined research. Findings demonstrate how employment of Indigenous ethical principles in research positively contributes to research outcomes.
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
Prevalence of questionable research practices, research misconduct and their potential explanatory factors: A survey among academic researchers in The Netherlands
Prevalence of research misconduct, questionable research practices (QRPs) and their associations with a range of explanatory factors has not been studied sufficiently among academic researchers. The National Survey on Research Integrity targeted all disciplinary fields and academic ranks in the Netherlands. It included questions about engagement in fabrication, falsification and 11 QRPs over the previous three years, and 12 explanatory factor scales. We ensured strict identity protection and used the randomized response method for questions on research misconduct. 6,813 respondents completed the survey. Prevalence of fabrication was 4.3% (95% CI: 2.9, 5.7) and of falsification 4.2% (95% CI: 2.8, 5.6). Prevalence of QRPs ranged from 0.6% (95% CI: 0.5, 0.9) to 17.5% (95% CI: 16.4, 18.7) with 51.3% (95% CI: 50.1, 52.5) of respondents engaging frequently in at least one QRP. Being a PhD candidate or junior researcher increased the odds of frequently engaging in at least one QRP, as did being male. Scientific norm subscription (odds ratio (OR) 0.79; 95% CI: 0.63, 1.00) and perceived likelihood of detection by reviewers (OR 0.62, 95% CI: 0.44, 0.88) were associated with engaging in less research misconduct. Publication pressure was associated with more often engaging in one or more QRPs frequently (OR 1.22, 95% CI: 1.14, 1.30). We found higher prevalence of misconduct than earlier surveys. Our results suggest that greater emphasis on scientific norm subscription, strengthening reviewers in their role as gatekeepers of research quality and curbing the “publish or perish” incentive system promotes research integrity.
Journal Article