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Open research questions in Ethics in Clinical Research

161 unresolved questions extracted from the limitations and future-work sections of 1,400 Ethics in Clinical Research papers in our library. Each links back to the study that raised it.

What the literature leaves open

  • The gap in current practice is the reliance on power calculations as a ritualized practice, rather than a thoughtful and nuanced approach to trial design. The gap is also in the lack of consideration of uncertainty and heterogeneity in trial design. The paper identifies a need for a more flexible and adaptive approach to trial design.

    Tell me lies, tell me sweet little lies: power calculations in clinical trials · 2026 · DOI

  • Further research is needed to develop and implement the expanded WHO definition of clinical trials in mental health.

    What is a clinical trial? A proposal for expanding the WHO definition of a clinical trial for use in mental health research · 2026 · DOI

  • The current WHO definition of a clinical trial is narrow and restricts the adoption of a learning health system. There is a lack of implementation science and innovative trial methodologies in mental health clinical trials. The current focus on physiological and human health outcomes only is narrow.

    What is a clinical trial? A proposal for expanding the WHO definition of a clinical trial for use in mental health research · 2026 · DOI

  • The implementation of HCS in settings like Vietnam raises special ethical, social, and practical concerns due to limited clinical care facilities and research capacity. Concerns about transmitting infection to others, particularly family members, contributed to hesitation among students. Time commitment, particularly compulsory quarantine duration, was a major barrier to participation in HCS.

    Balancing altruism, risk and ethics: Vietnamese students’ views on human challenge studies · 2026 · DOI

  • limited to students at the University of Medicine and Pharmacy in Ho Chi Minh City, Vietnam, - no specific regulatory framework for HCS exists in Vietnam, - clinical care facilities and research capacity are limited in Vietnam

    Balancing altruism, risk and ethics: Vietnamese students’ views on human challenge studies · 2026 · DOI

  • Privacy concerns are a challenge in using digital tools for recruitment. Digital literacy gaps and differences in usership rates across demographic groups can bias participant samples. Ethical considerations, such as avoiding exclusionary or biased language, must be addressed in recruitment materials.

    Leveraging digital tools to enhance diversity and inclusion in clinical trial recruitment · 2024 · DOI

  • The lack of diversity in clinical research participant samples is a significant gap that needs to be addressed. Current recruitment strategies often fail to reach underrepresented populations. The use of digital tools and inclusive strategies can help bridge this gap and promote diversity in clinical research recruitment.

    Leveraging digital tools to enhance diversity and inclusion in clinical trial recruitment · 2024 · DOI

  • Investigating reasons for non-participation holds promise for the planning of future study designs and recruitment strategies. Further research is needed to develop feasible and effective mental health support for children and adolescents. Research on the effectiveness of different online interventions for the prevention and treatment of mental health problems as well as mental health promotion is ongoing.

    Reasons for non-participation of children and adolescents in a large-scale school-based mental health project · 2024 · DOI

  • The authors seek to fill a gap in research ethics frameworks that arises with the conduct of big team science, at the mesolevel of research networks.

    Preventing Diffusion of Moral Responsibility in Big Team Science: Taking an Ecosystem Approach · 2026 · DOI

  • One such shift, which is the focus of "Filling the Network Gap in Research Ethics: Analyzing Ethical Issues at Scale in Big Team Science," by Susan Wolf and colleagues in this issue of the Hastings Center Report, is the evolution of biomedical research toward very large scientific teams.

    Preventing Diffusion of Moral Responsibility in Big Team Science: Taking an Ecosystem Approach · 2026 · DOI

  • The article moves unevenly among research ethics, responsible conduct of research, bioethics, organizational theory, and responsible innovation while offering a definition of network ethics that is insufficiently differentiated from existing frameworks.

    Whose Responsibility? Research Ethics, Integrity, and Governance in Networked Science · 2026 · DOI

  • In responding to the article "Filling the Network Gap in Research Ethics: Analyzing Ethical Issues at Scale in Big Team Science," by Susan Wolf et al.

    Whose Responsibility? Research Ethics, Integrity, and Governance in Networked Science · 2026 · DOI

  • However, the gap in knowledge of what participants should be told remains unresolved and addressing it would support both trialists and patients.

    Informing patients about the use of their healthcare systems data in RCTs: a cohort analysis of information leaflets · 2026 · DOI

  • Our objective was to describe the barriers and facilitators to clinical trial participation among this understudied and underserved population.

    “I'm tired of seeing my friends die”: Barriers and facilitators to participating in clinical trials among rural people who use drugs in the United States · 2025 · DOI

  • Addressing key barriers, particularly concerns about side effects and limited information, could enhance participation, ultimately advancing cancer research and treatment in the region.

    Clinical Trial Awareness, Perceptions, and Participation Among Cancer Patients in Saudi Arabia · 2025 · DOI

  • Conclusions and Relevance: In this survey study of patients with cancer and their relatives, significant gaps in knowledge and persistent concerns about clinical trial safety were highlighted, impacting participation.

    Understanding of Clinical Trials Among Patients With Cancer and Their Relatives · 2025 · DOI

  • However, little is known about the psychometric properties in low and middle-income countries.

    Evaluation of the psychometric properties of the UBACC questionnaire in a multi-country psychiatric study in Africa · 2024 · DOI

  • Discussions focused on required skillsets, barriers to conducting trials, improvement recommendations, gaps in research education, and strategies for the Saudi National Institute of Health (SNIH) to support clinical trials.

    Exploring the Challenges and Solutions in Conducting Clinical Trials in Saudi Arabia: A Qualitative Study Perspective · 2024 · DOI

  • Previous studies have reported variations in requirements with a lack of standardization in the Institutional Review Board (IRB) processes between centers, imposing barriers for approval, participation, and development of multicenter research.

    Challenges in institutional ethical review process and approval for international multicenter clinical studies in lower and middle-income countries: the case of PARITY study · 2024 · DOI

  • However, there is limited research investigating the decision-making processes, the role of members and their social interactions during funding committee meetings conducted both virtually and face-to-face.

    Exploring virtual funding committee practices in the allocation of National Institute for Health and Care Research funding: A netnographic study · 2024 · DOI

  • Furthermore, fundamental deficiencies in trial support infrastructure limited research activity, including within programs currently conducting research as well as at sites interested in future clinical research opportunities.

    Barriers to Clinical Trial Implementation Among Community Care Centers · 2024 · DOI

  • Importance: While disparities in consent rates for research have been reported in multiple adult and pediatric settings, limited data informing enrollment in pediatric intensive care unit (PICU) research are available.

    Racial and Ethnic Disparity in Approach for Pediatric Intensive Care Unit Research Participation · 2024 · DOI

  • The gap in competency of clinical trial assessors and ethical reviewers in Tanzania. The need for targeted and stratified capacity-building approaches.

    Training Needs Assessment and Capacity Building of Clinical Trial Assessors and Ethical Reviewers to Strengthen Regulatory Review in Tanzania · 2026 · DOI

  • There is a gap between the scale expansion and quality improvement of Master of Chinese Medicine education. Insufficient clinical scientific research ability and poor research quality are key shortcomings.

    Analysis of Problems and Countermeasures in Clinical Research among Master of Chinese Medicine (MCM) Students · 2026 · DOI

  • Balancing the need for informed consent with the need for efficient and effective clinical trials. Ensuring appropriate oversight of clinical trials that do not require prospective written informed consent.

    Systematic Review of Approaches to Informed Consent in Recent High-Impact Clinical Trials · 2026 · DOI

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161 open questions have been extracted from the limitations and future-work passages of 1,400 Ethics in Clinical Research papers in our library. Each one below links back to the study that raised it, so you can read the original claim in context.

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