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Open research questions in Ethics in Clinical Research

74 unresolved questions extracted from the limitations and future-work sections of 1,175 Ethics in Clinical Research papers in our library. Each links back to the study that raised it.

What the literature leaves open

  • This study takes the first step towards gathering information on access practices at various research repositories in the United States. The results offer some preliminary insight into trends and identifies areas of future study. Ideally, future work could eventually lead to guidance on standardizing access policies and creating more uniformity among reference practices for collections that contain historic IIHI. This work could provide evidence for librarians and archivists to advocate for revising access restrictions and reference services at their institutions which would reduce confusion for students and researchers trying to access collections. The preliminary data and analysis produced by this study set the groundwork for more in-depth research in the future. A more extensive research approach should include a larger sample size targeting a larger number of eligible repositories and focus on recruiting more diverse participants. This study was predominantly completed by archivists and curators and lacks the perspectives of librarians who may also handle these types of requests or staff a special collections department. A targeted and broadly publicized distribution of future surveys or other research methods, such as focus groups, interviews, and policy reviews, may help recruit these participants. Future surveys can be tailored to either address policies or procedures to capture more nuances than were captured during this study, especially relating to rationale behind restrictions beyond the legal limitations. A diversification of research methods, including discussion groups, presentations, or an environmental scan, would also aid in collecting more data – particularly for those questions that failed to receive a follow up during this study. jmla.mlanet.org 114 (3) July 2026 Journal of the Medical Library Association 2 4 4 G a r f u n k e l DOI: dx.doi.org/10.5195/jmla.2026.2259 Access to research collections that contain historic IIHI can be a long and confusing process that is complicated by inconsistent restrictions beyond legal guidelines. Research institutions have to balance ethical practices and patient privacy with the availability of materials to advance research. Librarians, archivists, and curators who facilitate access also have to balance the needs of their parent institutions with the expectations of the communities they serve. These expectations can be confusing and time consuming and difficult to convey to users. Surveying the access practices at various research institutions offers an opportunity to find consistencies that can be used to advocate for more standardized access policies within the professions. ACKNOWLEDGEMENTS The author would like to thank Nicole J. Milano for her encouragement and support during the launch of this project.

    Access to historic individually identifiable health information: a multi-institutional survey of research institutions · 2026 · DOI

  • While substantial research exists on how prescriptions are written and clinical outcomes measured, there remains a significant gap in understanding the patient journey- the real-world challenges, decision-making processes, and behavioural factors that lead to medication mishaps, non-adherence, or unintended consequences.

    Opportunities and challenges in patient-led research in India · 2026 · DOI

  • Urgent actions include reinforcing international standards for trial registries, harmonizing data fields, improving registry interoperability, leveraging unique identifiers, enhancing multilingual accessibility, auditing data quality, pooling analytical resources, promoting open data policies, and investing in registry infrastructure and trained personnel.

    Enhancing global clinical trial transparency for better health outcomes for all · 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 (5, 6, 8). Customisation and adaptability are highlighted as key in successful implementation, with a recognition that a single standardised system may not suit all institutional environments (5). factors Rani et al.

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

  • the is No doubt, there is a dearth of literature on informed consent preferences among biobanking research stakeholders in Africa, especially with the growing impact of the H3Africa project on the continent. 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

  • This study possesses several notable strengths. First, the use of an online questionnaire enabled data collec- tion from a large and diverse population across multiple MENA countries, thereby enhancing the generalizability of the findings. The approach was also cost-effective and provided participants with the convenience of complet- ing the questionnaire at their own pace. Furthermore, the inclusion of participants from different countries and backgrounds offers valuable insight into regional varia- tions in knowledge and attitudes toward cancer clinical trials. Nevertheless, several limitations must be acknowl- edged. The use of convenience sampling may have introduced selection bias, as individuals who chose to participate could differ systematically from those who declined, potentially leading to over- or underestimation of awareness levels. In addition, the reliance on online recruitment may have excluded individuals without internet access or those less comfortable with technol- ogy, thereby limiting the representativeness of the sam- ple. While the study encompassed a diverse group from multiple MENA nations, cultural and socioeconomic differences may not be fully captured, which could com- promise the broader generalizability of the results. The reliance on self-reported data further raises the possibil- ity of social desirability bias, with participants provid- ing responses they perceived as more acceptable rather than reflecting their true views. Moreover, by targeting only literate individuals able to read and write, the study excluded the illiterate population, which may hold dis- tinct perspectives or levels of awareness regarding clini- cal trials. Finally, although the questionnaire was adapted from validated tools, the use of a modified version may not have fully captured all dimensions of knowledge and attitudes toward clinical trials, potentially leaving gaps in understanding.

    Knowledge and attitudes toward cancer clinical trials: a multi-national cross-sectional study in the Middle East and North Africa · 2026 · DOI

  • These include: extensive workloads, limited information technology systems, and few universally accepted or consistently measured metrics for HRPP/IRB quality and effectiveness.

    Engaging key stakeholders to overcome barriers to studying the quality of research ethics oversight · 2022 · DOI

  • CLINICAL IMPLICATIONS: Given the ethical primacy of informed consent and issues of justice for impaired populations who might be harmed by an absence of research-based treatment advances, continued search for ways to more meaningfully engage people with AD in the consent or assent process is warranted.

    Multimedia Aided Consent for Alzheimer’s Disease Research · 2017 · DOI

  • However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place--and a need--for informed consent in personal genome testing, also when it is offered commercially.

    Informed Consent in Direct‐to‐Consumer Personal Genome Testing: The Outline of A Model between Specific and Generic Consent · 2012 · DOI

  • BACKGROUND: In randomized controlled trials (RCTs), the intention-to-treat (ITT) principle, which involves maintaining study participants in the treatment groups to which they were randomized regardless of postrandomization withdrawal, is the recommended analytic approach for preserving the integrity of randomization, yet little is known about the use of ITT in nursing RCTs.

    The Use of the Intention-to-Treat Principle in Nursing Clinical Trials · 2009 · DOI

  • RESULTS: On the original TGN1412 participant information sheet, participants could not find answers and some of the found information was not understood.

    Performance-based readability testing of participant materials for a phase I trial: TGN1412: Table 1 · 2009 · DOI

  • More streamlined interaction between public funders and policy makers could help drive public R&D (Research & Development) investment towards under-researched areas such as prevention, equity and access, and strengthen the evidence base that underpins NICE guidance and broader clinical and public health practice in the UK.

    Imbalances in funding for clinical and public health research in the UK: can NICE research recommendations make a difference? · 2008 · DOI

  • Applying the Common Rule to CQIR undermines First Amendment principles because it is insufficiently tailored to meet the minimal risk presented by CQIR.

    Promoting Free Speech in Clinical Quality Improvement Research · 2007

  • Abstract Select research areas affecting individuals with intellectual disabilities (ID) are understudied, resulting in their often being routinely excluded from drug trials and other medically based research.

    Attitudes of Research Ethics Committee Members Toward Individuals with Intellectual Disabilities: The Need for More Research · 2006 · DOI

  • For instance, in the Salk polio vaccine studies of the 1950s, randomized trials that were mounted in some states produced estimates of the vaccine's effect on polio that were appreciably greater than estimates from a parallel series of nonrandomized trials, The factors that might have led to this difference are still not well understood.

    The Virtues of Randomness: For Years, Researchers Have Used Randomized Field Trials to Evaluate the Effectiveness of Medical Procedures. (Feature) · 2002

  • While adult oncology literature has identified predictors of withdrawal, little is known about caregiver decision‐making for child participation in trials.

    Determining Parental Factors for Clinical Trial Attrition in Pediatric Acute Lymphoblastic Leukemia · 2026 · DOI

  • BackgroundIn Canada, there is a lack of data relating sociodemographic characteristics to the likelihood of consent and clinical trial participation.

    Sociodemographic Predictors of Consent: A Protocol and Statistical Analysis Plan for a Nested Observational Study of Canadian Sites in the REVISE Trial · 2026 · DOI

  • We therefore conducted a scoping review aiming to map the extent and type of available research examining monetary incentives for recruiting and retaining trial participants to identify critical areas where evidence remains sparse.

    Research exploring monetary incentives for recruiting and retaining participants in randomised controlled trials: a scoping review · 2026 · DOI

  • Thus biobank may be very large with public or private funding, for commercial or non commercial use and on other hand may be small limited to a researcher who stores samples in the laboratory or at institutional level where common facility is available for storing samples.

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

  • Despite significant investment by government and providers, the resources to be dedicated to this goal are scarce, leading to a growing interest in learning `what works´ for widening participation.

    Useful parameters for the statistical design of trials in widening participation · 2024 · DOI

  • The establishment of biobanks in Portugal is still an understudied phenomenon, although there are signs of a growing trend in setting up these repositories to support biomedical research.

    Portuguese and the biobanks: Profiles and attitudes of the Portuguese population towards biobanks for health research · 2022 · DOI

  • Yet how researchers can best fulfill the ethical obligations of respect for persons in pragmatic clinical trials (PCTs)-particularly those that may alter or waive informed consent-remains unknown.

    Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials · 2022 · DOI

  • Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs.

    Regulators, Pivotal Clinical Trials, and Drug Regulation in the Age of COVID-19 · 2020 · DOI

  • Initiatives including adoption of person-first language, addressing stereotyping of people who use drugs, and emphasizing the benefits of including these populations in clinical research should be explored to reduce bias while retaining needed protections.

    Researcher perspectives on including people who use drugs in clinical research · 2020 · DOI

  • Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive.

    In Defense of a Social Value Requirement for Clinical Research · 2017 · DOI

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74 open questions have been extracted from the limitations and future-work passages of 1,175 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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