Portfolio

This article discusses how advancements in emerging technologies like artificial intelligence/machine learning (AI/ML), wearable devices with mobile health applications, augmented reality (AR), and virtual reality (VR) are revolutionizing data collection, intervention delivery, and participant engagement in clinical and behavioral studies within human subjects research. This initiative reflects our commitment to educating researchers on integrating these innovations responsibly and ethically in their work. This was written for PHRP Online Training.

This article highlights how informed consent forms (ICFs) often grow lengthy not from intent to overwhelm, but due to years of incremental revisions driven by evolving regulations, emerging safety data, legal complexities, and institutional preferences. This educational resource offers practical strategies to streamline consent documents, ensuring clarity and participant understanding while adhering to necessary compliance standards. This was written for the Clinical Leader.

This article explores diverse frameworks developed by various organizations with distinct purposes and audiences ranging from broad AI governance to specialized health and medicine contexts. Despite their differences, this educational initiative highlights the shared ethical themes that underpin AI governance, supporting researchers and practitioners in navigating responsible AI use in clinical research. This was written for CITI Program's blog.

This article explores the vital role animal models play in biomedical research and regulatory systems worldwide while highlighting emerging scientific advancements and policy shifts that promote reducing reliance on animal testing. This initiative supports our commitment to educating researchers on innovative alternatives that enhance ethical standards and safety in medical product evaluations. This was written for CITI Program's blog.

This article delves into the FDA’s issuance of 61 warning letters over the past five years due to regulatory failures that risk participant safety and research credibility. This educational initiative highlights common compliance pitfalls and offers practical strategies for clinical investigators to strengthen oversight and maintain adherence with regulatory standards. This was written for CITI Program's blog.

In January 2025, the International Council for Harmonisation (ICH) finalized the Good Clinical Practice (GCP) E6(R3) framework, introducing key concepts such as risk proportionality, quality by design (QbD), and participant-centered research by replacing "subject" with "participant." This article offers in-depth education to equip professionals with essential insights on these transformative guidelines and describes the FDA's current thinking on the framework. This was written for the Public Responsibility in Medicine & Research (PRIM&R) blog, Ampersand.

This article discusses the important revisions released by the Office of Research Integrity (ORI) on September 17, 2024, updating the Public Health Service (PHS) Policies on Research Misconduct (42 CFR 93). This resource equips educational institutions and researchers with essential insights to navigate compliance and foster ethical research practices in today’s evolving regulatory landscape. The blog was written for the Association of Clinical Research Professionals (ACRP).