Many countries consider long-term implications for society.

A leading concern about single IRB (sIRB) review for multisite studies, as is now required by federal policies, is whether and how sIRBs consider local context in their review. While several types of local context considerations have been proposed, there is no shared agreement among those charged with the ethics oversight of human subjects research as to the goals and content of local context review, nor the types of research studies for which sIRB review might be inappropriate. Through a scoping review of published scholarship, public comments, and federal guidance documents, we identified five assumed goals for local context review: protecting the rights and welfare of local participants; ensuring compliance with applicable laws and policies; assessing feasibility; promoting the quality of research; and promoting procedural justice. While a variety of content was proposed to be relevant, it was largely grouped into four domains: population/participant-level characteristics; investigator and research team characteristics; institution-level characteristics; and state and local laws. Proposed characteristics for exclusion from sIRB requirements reflected both protection- and efficiency-based concerns. These findings can inform ongoing efforts to assess the implications of policies mandating sIRB review, and when exceptions to those policies might be appropriate.

The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey-based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice.

Background: Institutional review boards (IRBs) face delays in reviewing research proposals, underscoring the need for optimized standard operating procedures (SOPs). This study assesses the abilities of three artificial intelligence (AI) platforms to address IRB challenges and draft essential SOPs. Methods: An observational study was conducted using three AI platforms in 10 case studies reflecting IRB functions, focusing on creating SOPs. The accuracy of the AI outputs was assessed against good clinical practice (GCP) guidelines. Results: The AI tools identified GCP issues, offered guidance on GCP violations, detected conflicts of interest and SOP deficiencies, recognized vulnerable populations, and suggested expedited review criteria. They also drafted SOPs with some differences. Conclusion: AI platforms could aid IRB decision-making and improve review efficiency. However, human oversight remains critical for ensuring the accuracy of AI-generated solutions.

All life science and medical research involving human subjects must be conducted in compliance with the Declaration of Helsinki and the relevant laws and guidelines. Additionally, its scientific and ethical suitability must be reviewed by a committee well versed in the nature and content of the research. Failure to comply with these requirements when conducting research involving human subjects is a serious violation of Japanese laws, guidelines, and local regulations, so several ethics committees and institutional review boards have been established within the Nippon Medical School (NMS) Foundation and its affiliated institutions. It is essential for investigators to keep up to date with the latest developments in the ethical review process and to ensure that any projects they propose to embark on are subjected to an appropriate ethical review before the research is initiated. To help researchers and other staff affiliated with the NMS Foundation keep abreast of these developments, this report outlines NMS\'s current ethical review processes for research involving human subjects.

BACKGROUND: Educators are challenged to find better ways to prepare doctoral nursing students to conduct scholarly work involving human subjects.
OBJECTIVE: To better understand doctoral nursing students\' attitudes toward programmatic scholarly work and Institutional Review Board (IRB)/Quality Improvement Committee (QIC) education and submission processes.
METHODS: Recent Doctor of Nursing Practice (DNP) and Philosophy of Nursing (PhD) graduates were recruited using convenience sampling techniques to participate in this cross-sectional, descriptive, mixed-methods pilot study. Data were collected using two researcher-developed instruments.
CONCLUSIONS: Nineteen doctoral nursing students participated in this study. Students most often used a quantitative approach with health care providers to complete their scholarly work requirements. Both PhD and DNP participants were overall satisfied with the IRB/QIC content in the curricula and the submission process. Four themes were identified: (a) Efficiency, (b) Collaboration, (c) Faculty Mentorship, and (d) Areas for Improvement.
CONCLUSIONS: Findings from this pilot study may be used to enhance IRB/QIC processes through revision of administrative processes and student education.

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In recognition of the importance of evaluation for funding, research, and quality improvement, a longstanding Community Advisory Board in Flint Michigan embarked on a process to evaluate their impact. The Community-Based Organization Partners (CBOP)-Community Ethics Review Board (CERB) engaged a research team composed of an academic researcher (Solomon Cargill) and a community partner (Spencer) to obtain funding, design and implement an evaluation of the CBOP-CERB. This evaluation study yielded two evaluations of the CBOP-CERB, one with researchers who had engaged with the CBOP-CERB and the other with Flint area community residents. The results of these two evaluations can serve to show other Community Advisory Boards how to establish and expand their impact, establish their worth for future funding, and how to articulate, evaluate, and achieve their goals.

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