Ethics & human research最新文献

Institutional review boards (IRBs) are charged with conducting risk-benefit analysis for early phase clinical trials that often involve high levels of uncertainty regarding a trial's potential risks and benefits. Our study used a survey of IRB chairs to explore how IRBs conduct risk-benefit analysis, the unique facets of risk-benefit analysis for early phase clinical trials and specifically for early phase neurology trials, and what facilitates high-quality risk-benefit analysis. The survey measured IRB chairs’ perceived difficulty, preparedness, processes, and satisfaction with risk-benefit analysis for early phase trials. The survey was completed by 148 of the 259 eligible IRB chairs for a response rate of 64.6%. Two-thirds of respondents found risk-benefit analysis for early phase clinical trials more challenging than for later phase trials. Ninety-one percent of respondents felt that their IRB did an “excellent” or “very good” job conducting risk-benefit analysis, but more than one-third of respondents did not feel “very prepared” to conduct key aspects of risk-benefit analysis. Over two-thirds of respondents reported that additional resources, like a standardized process for conducting risk-benefit analysis, would be mostly or very valuable. Our results suggest that conducting risk-benefit analysis for early phase clinical trials generally and early phase neurology trials specifically is challenging for IRBs. One-third of respondents reported that they lack preparation for assessing the scientific value of these types of trials and the risks and benefits to research participants, and a majority desire additional support.

Enhanced protection for research participants is often stated as a goal and potential benefit of engaging community partners in research. However, many community-engaged research teams report challenges in completing human research protection (HRP) training. Some human research protection programs (HRPPs) require community researchers to complete the same training that university faculty and staff members are required to do, while others allow alternatives that are more accessible and appropriately suited to community researchers’ background and roles. To learn more about general HRPP requirements for training and alternatives for community researchers, we surveyed 163 research institutions funded by the National Institutes of Health's Clinical and Translational Science Award program. Out of 55 respondents, 34 HRPPs (61.8%) allow community researchers to complete different HRP training from that required for faculty/staff. Reasons for allowing or denying alternative training vary, and some institutions that currently do not allow alternatives report that they are reconsidering their policy. The fact that some institutions do not allow alternatives and are not considering changing their policies, even when requested by the principal investigators of studies, may pose significant barriers to community-engaged research. Effort is needed to increase awareness about alternatives as well as their acceptability in meeting training requirements of federal funding agencies.

Physicians engaged in clinical research have dual roles as members of the research team and as physicians. Although various medical ethics codes and associated ethics opinions state that physicians have substantially similar obligations to research participants as they have to patients, the reality is different. Research physicians follow study protocols that often require practices that depart from the standard of care. The proposed Bill of Rights for Clinical Research Participants incorporates key ethics principles from the physician-patient relationship, some of which already are reflected in provisions of the ethics codes and opinions addressing nontraditional physician relationships. The Bill of Rights is intended to promote greater transparency and accountability in a frequently misunderstood relationship.

Drawing from a 2023 symposium panel that focused on conducting health equity research with Black communities, we propose to expand our interpretation of core research ethics principles. In light of a surge of research conducted in Black diasporic communities since the 2020 killing of George Floyd, the symposium sought to enhance the quality and impact of research involving Black Canadians. We contend that by broadening the interpretation and application of respect for persons, beneficence, and justice, researchers will conduct impactful and transformative research projects that foster health equity. We emphasize the importance of not limiting the core principle of respect for persons to individual participants but to extend it to communities throughout the research process. Furthermore, we suggest that researchers can deepen their commitment to the core principle of beneficence or concern for welfare and design relevant and empowering research projects through meaningful community involvement. We highlight that to further the implementation of the core principle of justice, scholars should adopt a human development approach and mobilize innovative outreach recruitment strategies to ensure that Black communities have the opportunity to participate in biomedical and public health research while also benefiting from the knowledge produced.

We conducted a scoping review to characterize natural language processing (NLP) applications in clinical trials recruitment and conducted semistructured interviews to obtain stakeholders’ perspectives on these technologies, with a focus on ethical considerations. The scoping review focused on English-language original articles published from January 2021 to June 2024, sourced from Ovid Medline. Data extracted included the characteristics of NLP systems, their evaluations, and ethical considerations regarding patient autonomy and equity. Additionally, semistructured interviews with experts from various specialties were conducted, and the data were analyzed using thematic analysis. Most of the 47 eligible articles focused on NLP models for electronic health records screening. The literature predominantly emphasized the models’ accuracy and efficiency, while ethical considerations received little attention. Interview findings underscored the need for more ethical reflection and real-world implementation analysis, revealing differing opinions on anonymization, consent, and the impact of NLP tools on fair opportunities. NLP applications for participant recruitment in clinical research are in early stages, with a gap between ethical discourse and reporting in current literature. Practical guidelines are needed for implementing and reporting ethical aspects throughout the lifecycle of NLP applications, along with empirical research to assess their ethical impact.

The need for community involvement in human translational research has gained international recognition, with a growing consensus on its critical role in ensuring ethical and impactful health outcomes. In Australia, several bodies are beginning to mandate community involvement in research, reflecting this global trend. However, there remains a notable gap in practical guidance on effectively engaging communities, particularly in the emerging field of genomic research. To address this, Australian Genomics, a national collaboration supporting the translation of genomic research into clinical practice, coordinated an initiative called Involve Australia (IA). IA has developed comprehensive guidelines, together with and informed by the needs and perspectives of those directly impacted by genomic research, through surveys, interviews, and public consultations. The IA Guidelines provide practical information for genomic researchers on involving community members effectively and meaningfully in projects to ensure effective research translation, emphasizing the importance of building relationships, setting clear expectations, valuing community contributions, evaluating and reporting on the community involvement process, and translation of research outcomes. The IA Guidelines have been endorsed by various research and patient organizations, demonstrating the growing support for resources in this area. The development and implementation of these guidelines represent a crucial step forward in promoting community involvement in genomic research, setting a precedent for other areas of health and medical research to follow.