Authoring and Management of Transparent Research Integrity Assessments of Randomised Clinical Trial Publications Using LLM-assisted Tools and Provenance Knowledge Graphs
Authors: Milan Markovic, Goutham Indukuri, Somayajulu Sripada, Colby J. Vorland, Jack Wilkinson, Clare Robertson, Mark Bolland, Andrew Grey, +2 more
Organizations: Interdisciplinary Institute, University of Aberdeen, UK · Department of Computing Science, University of Aberdeen, UK · Department of Epidemiology and Biostatistics, Indiana University, USA · Centre for Biostatistics, University of Manchester, UK · Aberdeen Centre for Evaluation, University of Aberdeen, UK · Department of Medicine, University of Auckland, NZ
Abstract
Systematic reviews of Randomised Controlled Trials (RCTs) are routinely used as evidence for clinical care guidelines. Such evidence has to meet high research integrity standards to prevent low quality or false research outputs influencing the clinical care. However, assessing research integrity of published RCTs is a complex process requiring manual effort, and potentially resulting in diverse opinions of the human assessors. This paper describes INSPECT-AI, an LLM-based interactive tool that assists human reviewers with research integrity assessments of published RCTs based on the community approved INSPECT-SR framework, and the Research Integrity Provenance and Evidence ontology (RIPE-O) for documenting the provenance of the assessment process. In addition, we present the Research Integrity Provenance and Evidence knowledge graph (RIPE-KG), an initial set of 140 expert research integrity assessments of 95 RCT publications generated by INSPECT-AI and described using RIPE-O.
This work establishes a foundational framework for standardizing AI evaluation RCTs (sometimes called human uplift studies). Drawing on established experimental practices from disciplines with established RCT traditions, including software engineering, economics, clinical and health sciences, and psychology, we adopt the (Shadish et al., 2002) four-validity framework and extend it with a fifth principle on transparency, repeatability, and verification adapted from the Transparency and Openness Promotion (TOP) Guidelines (Center for Open Science, 2025). We operationalize all five principles into 33 guidelines adapted for AI evaluation RCT contexts, expressed as requirements with rationales, implementation instructions, and evidence bases. We position the principles and guidelines as serving three key roles for AI evaluation RCTs: a design tool for planning studies, an evaluation rubric for assessing existing work, and a blueprint for standard setting as the field converges on norms. Our framework extends prior work by centering evaluation on human performance rather than model output alone, formalizing causal inference through RCT methodology for AI contexts, integrating heterogeneity analysis and practical significance assessment, implementing a graded transparency and repeatability framework, and addressing AI-specific challenges including model versioning, human-AI interaction dynamics, contamination and spillover effects, and equitable impact assessment.
Christopher Kelly, Angelica Chowdhury, Alexandra Campili +5
Across the social and medical sciences, researchers recognize that specifying planned research activities (i.e., 'registration') prior to the commencement of research has benefits for both the transparency and rigour of science. Despite this, evidence suggests that study registrations frequently go unexamined, minimizing their effectiveness. In a way this is no surprise: manually checking registrations against papers is labour- and time-intensive, requiring careful reading across formats and expertise across domains. The advent of AI unlocks new possibilities in facilitating this activity. We present RegCheck, a modular LLM-assisted tool designed to help researchers, reviewers, and editors from across scientific disciplines compare study registrations with their corresponding papers. Importantly, RegCheck keeps human expertise and judgement in the loop by (i) ensuring that users are the ones who determine which features should be compared, and (ii) presenting the most relevant text associated with each feature to the user, facilitating (rather than replacing) human discrepancy judgements. RegCheck also generates shareable reports with unique RegCheck IDs, enabling them to be easily shared and verified by other users. RegCheck is designed to be adaptable across scientific domains, as well as registration and publication formats. In this paper we provide an overview of the motivation, workflow, and design principles of RegCheck, and we discuss its potential as an extensible infrastructure for reproducible science with an example use case.
Large language models (LLMs) are increasingly used to support scientific work, but it is unclear whether they uphold responsible conduct of research (RCR) norms or help undermine them. We introduce SciIntBench, an adversarial benchmark of 810 prompts across ten RCR categories and three scientific domains. Each scenario appears as an Overt Adversarial, Covert Adversarial, and Benign version, allowing us to jointly measure framing-sensitive refusal of misconduct and helpfulness on legitimate requests. We evaluate 16 commercial and open-weight LLMs from six providers (2024--2026), producing 12,960 responses. We find that scientific integrity alignment is strongly framing-sensitive: models refuse explicit misconduct far more reliably than covert violations, especially failing when misconduct is presented as a pressure-driven shortcut. Refusals vary by RCR category, with weaker boundaries around transparency, plagiarism, and fabrication.
Almene De Meran Meguimtsop, Maria Leonor Pacheco, Daniel E. Acuna