This study explores the experiences of researchers in Chile when submitting disability-related projects to Research Ethics Committees. Through a qualitative approach involving 18 semi-structured interviews with researchers, the study identifies the barriers that arise from applying existing ethical frameworks to social research on disability. The results reveal a "presumption of incapacity" toward people with disabilities-an infantilizing and overprotective view that leads to excessive and detrimental requirements. Key findings highlight the questioning of the capacity to consent, the medicalization of disability, and the imposition of third parties in decision-making processes. These practices impact research by altering methodologies, excluding people with disabilities from studies, causing burnout within research teams, and limiting the production of evidence relevant to public policy. The study underscores the need to move toward more flexibility, integrating a rights-based perspective and the necessary supports to ensure the full and effective participation of people with disabilities in research.
Low-risk pragmatic trials improve clinical services. Informed consent is gold standard to ensure ethical research. However, its implementation can impact participation of underserved groups who face disproportionate barriers around communication, health and research literacy, and limited availability for burdensome processes. Carefully considered application of waived consent may overcome barriers to inclusive participation. However, an understanding of when waived consent has been used, whether it supported inclusion research, and lessons that can be learnt, is lacking. We reviewed the UK Health Research Authority Confidentiality Advisory Group (HRA CAG) database for non-emergency individually randomised trials that were granted a waiver of consent. Nine trials were identified; these aimed to boost cancer screening uptake in deprived or underserved populations. Waived consent enabled inclusive research approaches for evaluating interventions such as culturally tailored screening kits and barrier-reducing tools. Further research is needed on patient perspectives and ethical safety in these consent models.
This study explores systemic factors that can influence unethical practices in academic publishing, particularly institutional pressures, editorial practices, and the impact of artificial intelligence (AI) tools. The study shifts responsibility away from individual actors. It takes a qualitative approach to examine how the interactions between researchers, editors, and institutional structures contribute to conditions in which unethical practices may occur. A qualitative research design was used to gather data through semi-structured interviews and observations with 30 participants, comprising university lecturers, postgraduate students, journal editors, and research support professionals from various regions. The results suggest that competition for publication and career advancement, as well as a lack of mentorship, create environments that participants see as encouraging unethical practices - such as author manipulation, use of third-party writers, and inappropriate use of AI - to occur. AI tools were specifically characterized as facilitating interventions that may support these practices in the context of systemic pressures. Furthermore, some participants expressed concerns about the editorial and financial arrangements, which could negatively affect the peer-review process. This study indicates that unethical publishing practices should be understood as resulting from complex systemic and cultural factors, rather than individual actions. The study identifies the need for institutional changes, guidance on AI use, and policies to promote research integrity. The qualitative nature and limited sample size of the study mean the results are explorative and suggestive of perceived patterns, rather than generalizable. We suggest that future research use mixed methods to investigate the extent and effects of these dynamics.
Human biological samples are a valuable source of information that may aid in the generation of new knowledge. However, the use of human biological samples for research poses various ethical, legal and social issues (ELSI). We performed a scoping review to identify the ethical issues surrounding the use of human biological samples for research. We developed a search string strategy to identify literature in PubMed, Scopus, Web of Science, and Google Scholar. Out of 4067 identified articles, 61 articles were included for final analysis. The findings of this study revealed multiple ethical issues stemming from the knowledge and awareness of different stakeholders involved in research, the factors affecting donors' study participation, the consent process, and the governance and structures of these human biological samples. This study will provide guidance for researchers, IRB members, and other stakeholders involved in the ethical consideration of using human biological samples for secondary research.
Self-experimentation is a research practice that might advance scientific progress and benefit populations worldwide. However, it also carries risks, both in terms of potential harm to researchers and the possibility of undermining research. This study seeks to explore expert perspectives on self-experimentation, examining its potential benefits and risks, identifying areas of consensus and divergence, and highlighting key themes to inform debates on its role in medical research.We conducted a three-round online Delphi study with a multi-regional panel of 16 experts with varying views on self-experimentation. The panel assessed, commented on, and proposed revisions to statements drafted by both the authors and panellists.Consensus was reached on several key points. Experts agreed that self-experimentation can serve as a means of gathering preliminary evidence, accelerating research, and assessing the technical feasibility of an intervention. However, there was also agreement that self-experimentation can harm scientists, has limited scientific value, and may produce unreliable data.
Research ethics committees occupy a central position in scientific governance, yet the literature reveals a persistent gap in structured, theoretically grounded guidelines for drafting ethical opinions. Opinions are frequently characterised by insufficient substantiation and communicative opacity, eroding researcher trust and institutional legitimacy. This study provides an integrated framework for the production of quality ethical opinions. A narrative review was conducted through searches in PubMed, SCOPUS, and Web of Science, supplemented by normative documents from the WHO, Council for International Organizations of Medical Sciences, and World Medical Association. Opinion quality depends on three interdependent dimensions: normative grounding in foundational principles, deliberative integrity in collective processes, and communicative responsibility in documented reasoning. The most frequent deficiencies concern informed consent and risk-benefit analysis. Structured discretionary judgement proves superior to algorithmic standardisation. This work is original in integrating Habermasian communicative rationality with the Aristotelian concept of phronesis to propose a tripartite framework that transcends compliance-based approaches.
Most research funders and journals now require researchers to make their data available for sharing. There is a growing body of literature on research participants' attitudes towards health data sharing, but less evidence regarding views of participants taking part in longitudinal studies, clinical trials or public health research.1,664 respondents from the UK (participants in longitudinal studies ALSPAC and ACONF and members of Patient and Public Involvement (PPI) groups completed a questionnaire survey exploring attitudes towards data sharing, including consent and data storage. Respondents were most concerned about privacy and data security and highlighted concerns about open access and sharing with commercial organisations.
Trauma-related research is essential for advancing knowledge, yet ethical concerns persist regarding participant distress. Using a mixed-methods approach, this study examined reactions to trauma-related research and motivations for future participation among Korean college students. Participants (N = 138) completed measures of trauma exposure, PTSD symptoms, perceived understanding of informed consent, and reactions to research participation. Quantitative analyses indicated that greater perceived understanding was associated with higher willingness to participate, fewer perceived drawbacks, and more favorable global evaluations. Elevated PTSD symptoms were associated with stronger emotional reactions and greater perceived drawbacks. Participants without elevated PTSD symptoms also reported more favorable benefit-to-emotional-reaction evaluations. Qualitative content analysis of open-ended responses revealed that motivations for future participation differed by PTSD symptom status, with non-elevated participants emphasizing the value of trauma research and elevated participants highlighting self-understanding and trauma reappraisal. Overall, findings highlight importance of incorporating participant perspectives to support ethical and inclusive trauma research.
Purpose This Commentary examines whether current ethics approval systems for medical research, grounded in the Belmont Report's principles of respect for persons, beneficence, and justice, paradoxically result in preventable deaths by delaying patient access to experimental therapies and proposes a framework for democratizing ethics oversight while maintaining safety. Findings Peer-reviewed evidence demonstrates that ethics delays impose mortality costs that vastly exceed the harms they prevent, particularly for terminal illnesses. Bayesian decision analysis confirms current statistical thresholds are substantially more conservative than optimal for fatal diseases. COVID-19 pandemic responses proved that regulatory timelines can be dramatically compressed through organizational innovation, including accelerated vaccine development and distributed open-source manufacturing, without sacrificing safety. Conclusions A five-part framework can enable patient autonomy in research ethics while preserving robust safeguards against exploitation: tiered consent based on disease severity, adaptive trial designs with patient governance, mandatory open-source transparency, post-market surveillance, and independent safety monitoring with patient representation.
BackgroundClinical trials are vital for advancing medical knowledge, yet engaging diverse populations-those under-represented due to race, age, income, education, geography, sexual orientation, or gender identity-remains a challenge, limiting research generalizability.MethodsThis study used a literature review and semi-structured interviews with participants from diverse backgrounds recruited on LinkedIn. A demographic survey was conducted via Qualtrics, yielding 21 responses and 15 study participants. The research identified barriers to participation: inadequate community engagement, trial awareness, mistrust, and unaddressed social determinants of health, with data analyzed for key themes.ResultsFour themes emerged: (1) Community engagement builds trust; (2) Addressing social determinants alleviates barriers; (3) Peer education empowers participants; (4) A representative workforce enhances recruitment.DiscussionFindings emphasize the necessity of inclusive practices in clinical research, highlighting that targeted strategies can improve diversity in clinical trials, leading to more equitable healthcare outcomes. Future research should refine these strategies in specific therapeutic areas.
The rapid integration of generative artificial intelligence (AI) into academic and professional workflows is reshaping human participants research. While prior discourse has focused largely on AI-assisted writing and analysis, less attention has been given to its influence on data generation and integrity. This invited commentary examines emerging risks associated with generative AI use by researchers and participants, including data fabrication and AI-mediated participant responses. These developments challenge foundational assumptions regarding data authenticity, measurement validity, and the evidentiary basis of research. Implications for research ethics oversight, particularly for institutional review boards and research ethics committees, are also explored, including the need to consider transparency, data provenance, and methodological accountability in AI-enabled research environments. Practical strategies are proposed to mitigate risks. Ultimately, human participants research will require a shift toward systems that balance trust-based models with structured verification mechanisms, alongside the development of clear institutional and international guidelines for responsible AI integration.
Mozambique has a robust HIV control program and currently conducts HIV vaccine trials. One measure of a vaccine's success is development of antibodies, the vaccine-induced seropositivity(VISP). This study assesses the understanding and practices regarding VISP from trial participants and healthcare providers, as well as ethical challenges encountered during the informed consent. We conducted in-depth, semi-structured interviews using open and closed-ended questions with three categories of participants: healthcare professionals [n = 26], researchers [n = 5] and trial participants [n = 20]. For qualitative data, content analysis was performed and thematic axes were assigned. For quantitative analysis, descriptive analysis was performed. Trial participants had a better understanding of VISP's implications than front-line healthcare professionals. 53.8% healthcare professionals interviewed, stated that they would test the trial participants using an HIV rapid test, and initiate antiretroviral therapy immediately if positive. VISP may result in HIV misdiagnoses for trial participants when its broader pratical implications are not well understood.
There is a growing demand for postdoctoral bioethics training in Africa, driven by the significant rise in graduate programs offered by universities. This study sought to evaluate the Fogarty African Bioethics Consortium Post-Doctoral Fellowship program and to explore the experiences and perspectives of its trainees as well as the program's impact on their careers in their home countries. This study adopted an exploratory qualitative design involving in-depth interviews with fellows of the postdoctoral training program. Six fellows participated in the interviews. They expressed satisfaction with the training program and indicated that it effectively fulfilled their expectations. The fellows found mentorship the most valuable component of the training program. The study also found that all fellows are now actively engaged in bioethics-related activities following their training. Bioethics is increasingly becoming a prominent area of study, and African universities need to identify innovative ways of sustaining bioethics training programs on the continent, particularly at the postdoctoral level.
Training in responsible and ethical conduct of research (RECR) is essential for fostering a strong research culture. We surveyed faculty, students, and research staff at R1/R2 and primarily undergraduate institutions (PUIs) to assess practices in mentoring, administrative support, grant writing, and project management. While many institutions provide formal education in research ethics and grant writing, major gaps persist in mentoring, grant implementation, and project management. R1/R2 faculty reported the greatest institutional support, yet disparities remain across research integrity areas, including human and animal subject protocols. Students were generally satisfied with training but showed limited awareness of RECR foundations, such as data lifecycle management and export compliance. Findings underscore the need for more consistent, comprehensive research training-especially at PUIs.
This study investigates the impact of the Fogarty/NIH-funded Responsible Conduct of Research (RCR) EducationFellowship Program on scientists'RCR activities and practices by following up on 110 of 117 fellows who graduatedfrom the program. The results suggest that the program played a crucial role in promoting RCR activities among the fel-lows, leading to positive outcomes such as publications in research ethics (64%), attendance of RCR conferences (68.2%),conducting training workshops (74.2%), developing training RCR modules (44%) and institutional ethics guidelines (28%),serving on research ethics committees (48.2%), and providing RCR consultations (52.9%). Most fellows reported significant(high to moderate) improvement in the implementation of ethics/research standards in their work (88%) and in their insti-tutions'commitment to RCR (75%). In conclusion, the study strongly suggests the role that RCR training might play inenhancing RCR education and ethical practices among researchers and their institutions in the low and middle-incomeMiddle Eastern and North African countries.
While guidelines exist for returning genetic, biomarker, and radiologic research results, there is little guidance regarding the return of patient-reported outcome (PRO) research results. As a supplement to an ongoing trial of palliative care for Parkinson's disease, we conducted thirty qualitative, semi-structured interviews of persons with Parkinson's disease, their carepartners, community neurologists, primary care physicians, and researchers to elicit their perceptions of returning PRO research data to persons with Parkinson's disease and carepartners. Interviews were audio-taped, transcribed, double-coded, and analyzed for themes. Participants supported returning tailored PRO research results when feasible. Clinicians wanted clinically-actionable results. Researchers thought that returning aggregate results should be standard practice. However, our persons with Parkinson's disease and carepartners reported privacy concerns. Clinicians had mixed reactions about receiving non-actionable research results. Researchers worried whether returning individual results during a study could impact research integrity. Additional research is needed to develop optimal guidelines for future research studies.
