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Open research questions in Ethics in Clinical Research

390 gap statements mined from Ethics in Clinical Research papers in our 7.9M-paper local library, which holds 3,260 papers on the topic — drawn mostly from each paper's own stated research gap, future-work, challenge and limitation notes, and its abstract. The ones listed below are a selection still marked open; each names the study that raised it, with a DOI link where the paper has one.

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What the literature leaves open

  • Future studies are needed to evaluate these approaches in other clinical settings.

    Implementation of a novel strategy to increase participation of Black and Hispanic people in parkinsonism research · 2026 · DOI

  • Human immunodeficiency virus (HIV) cure-related trials remain insufficiently representative of populations most affected by HIV.

    Participation thresholds and recruitment milestones for HIV cure-related trials: a modified Delphi study · 2026 · DOI

  • Latino individuals are poorly represented in dialysis research, and little is known about strategies to enhance Latino representation in dialysis research.

    The Perspectives of Patients and Community Health Workers on the Recruitment and Retention of Latino Individuals in Research in Dialysis: A Qualitative Study · 2026 · DOI

  • Most toolkits were not rigorously evaluated for effectiveness, were often context-specific (eg, limited to transplantation), and rarely addressed structural drivers of inequity.

    A Scoping Review of Toolkits Addressing Ethical Issues in Health Registry and Clinical Research Enrollment Among African Americans With CKD · 2026 · DOI

  • Further studies to expand our understanding of the barriers patients face in feeling comfortable enrolling in research and initiatives to improve their care are warranted.

    Barriers to Enrolling Mental Health Emergency Patients in a Quality Improvement Study · 2026 · DOI

  • Survey responses were analysed descriptively (for category questions) and using a combination of deductive and inductive analysis (for open questions).

    Standardising management of consent withdrawal and other clinical trial participation changes: The UKCRC Registered Clinical Trials Unit Network’s PeRSEVERE project · 2025 · DOI

  • Data monitoring committee charters set out the role and processes for data monitoring committees in monitoring clinical trials; however, little is known about the information charters contain.

    Charting the content of data monitoring committee charters for clinical trials · 2025 · DOI

  • Further research to develop more efficient and scalable systems to return results to participants, and to understand the preferences of participants in larger, more representative samples, is warranted.

    Returning Individualized Wearable Sensor Results to Older Adult Research Participants: A Pilot Study · 2025 · DOI

  • Particular focus must be placed on the often underexplored aspect of trial termination for INDs.

    Where is the exit? The ethical importance of exit plans in clinical trials with neural implants · 2024 · DOI

  • In the context of SIRS personalised therapy research, there is a sensitivity to the issue of social justice, but no consensus how to ensure it.

    Issues of social justice in the development of personalised therapy for paediatric SIRS patients · 2024 · DOI

  • The rapid expansion of GxE research in biomedical studies for complex diseases raises many unique ethical, legal, and social implications (ELSIs) that have not been extensively explored and addressed.

    Ethical, Legal, and Social Implications of Gene‐Environment Interaction Research · 2024 · DOI

  • This review of UK clinical trial protocol highlights that information surrounding premature termination is lacking, with only 42% providing guidance on the care of trial participants.

    UK paediatric clinical trial protocols: A review of guidance for participant management and care in the event of premature termination · 2024 · DOI

  • Although numerous methods have been used to increase trial recruitment, no studies have been conducted to explore factors associated with incentive redemption, regardless of clinical area.

    Factors associated with incentive redemption among participants in a multicenter prospective syncope clinical study · 2024 · DOI

  • Future studies are needed to describe and explore reasons to address this issue, and alternative financial incentives may be warranted for older adults.

    Factors associated with incentive redemption among participants in a multicenter prospective syncope clinical study · 2024 · DOI

  • In terms of research methods, there was insufficient application of Evidence-Based Medicine (EBM) and a weak scientific research design.

    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

  • There is a need for further guidance on when to forgo prospective informed consent for clinical trials. The implications of waiving informed consent are not well understood.

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

  • Identifying eligible patients for glioma clinical trials is challenging due to molecular subclassification. There is a need for multicentric collaboration in trial design and recruitment.

    Not all cancers are equal: uneven access to glioma clinical trials in Europe · 2026 · DOI

  • These should not be attempted, as we possess insufficient information at present to understand the effects of attempts to alter/enhance the genetic machinery of humans. Sometimes re-contact may lead to withdrawal, resulting in limited data analysis. This must also include review of the informed consent obtained originally to see if re-consent is warranted.

    Regulatory and Ethical Frameworks for First-in-Human Clinical Trials in India: Proceedings of a Codesigned Capacity-Building Workshop · 2026 · DOI

  • Future research can focus on addressing the missing demographic data and improving the representativeness of the survey sample. Future research can also explore the topics of importance to CAFM members and current issues in family medicine education.

    Protocol for the 2025 CERA General Membership Survey · 2026 · DOI

  • Before such systems can be studied in real-world consent interactions, it is essential to establish that they can reliably deliver document-grounded information without inference or hallucination. Future research should compare performance across LLMs or against humans as the reference standard.

    Performance of a large language model in the informed consent process for participation in a clinical trial · 2026 · DOI

  • The question of how to handle clinically actionable outcomes from retrospective research studies is poorly explored.

    Decision making for health‐related research outcomes that alter diagnosis: A model from paediatric brain tumours · 2024 · DOI

  • Globally, the literature on consent preferences in biobanking and genomic research is predominantly studies from Europe and America. Most of the research surveyed public perspectives on consent for biobanking, while very few studies explored the views and opinions of scientists (Master et al., 2014).

    Biobank consent preferences and implications for a mixed consent model: biomedical researchers vs. community stakeholders in a semi-urban Yoruba community, Nigeria · 2026 · DOI

  • The literature emphasises the importance of aligning DPER with institutional context and stakeholder needs. Studies (n = 3) suggest that system design should involve research stakeholders, including committee members and administrative staff, to ensure usability and acceptance.

    Digital platforms for ethics review: a mini review · 2026 · DOI

  • The analysis revealed that of the 48 trials, a significant portion underreported race and ethnicity, with 43.

    Pediatric Acute Otitis Media Clinical Trials: An Analysis of Diversity · 2024 · DOI

Most-cited papers in Ethics in Clinical Research

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Open questions raised by papers listed on this page include: (1) Future studies are needed to evaluate these approaches in other clinical settings (“Implementation of a novel strategy to increase participation of Black and…”, 2026); (2) Latino individuals are poorly represented in dialysis research, and little is known about strategies to enhance Latino representation in dialysis research (“The Perspectives of Patients and Community Health Workers on the Recruitment…”, 2026); (3) There is a need for further guidance on when to forgo prospective informed consent for clinical trials (“Systematic Review of Approaches to Informed Consent in Recent High-Impact…”, 2026); (4) There is a need for multicentric collaboration in trial design and recruitment (“Not all cancers are equal: uneven access to glioma clinical trials in Europe”, 2026); (5) This must also include review of the informed consent obtained originally to see if re-consent is warranted (“Regulatory and Ethical Frameworks for First-in-Human Clinical Trials in India:…”, 2026). 390 gap statements have been mined from Ethics in Clinical Research papers in our 7.9M-paper local library, which holds 3,260 papers on the topic; the gaps come from whichever of those papers state one. They are mostly the research gaps the authors state and the papers' abstracts, plus future-work, limitations and challenges passages. The ones listed below are a selection still marked open; each names the study that raised it, with a DOI link where the paper has one, so you can read the original claim in context.

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