Journal Articles
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US FDA Approval of Pediatric Artificial Intelligence and Machine Learning–Enabled Medical Devices
This article from JAMA Pediatrics discusses the ethical challenges associated with implementing AI and machine learning in pediatric healthcare. It emphasizes the importance of ensuring data privacy, obtaining informed consent, and addressing potential biases in AI algorithms that could affect children differently than adults. The authors advocate for the development of ethical frameworks tailored to pediatric populations to guide the responsible integration of AI technologies in children’s healthcare. It highlights the critical need for ethical considerations when involving human participants, especially vulnerable populations like children, in AI research. It also underscores the importance of safeguarding personal data, ensuring informed consent, and mitigating biases in AI systems.
Authors: Ryan C. L. Brewster, MD; Matthew Nagy, MD, MPH; Susmitha Wunnava, PhD
Past Journal Articles
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Equipping AI for Unbiased and Inclusive Neurology
This paper in JAMA discusses AI’s role in neurology research, including the analysis of brain imaging and other data. The author demonstrates how AI can advance understanding and treatment of neurological conditions, while emphasizing the ethical responsibility to ensure participant safety, informed consent, and unbiased data interpretation.
Author: Nina F. Schor, MD, PhD
AI ethics in medical research: the 2024 Declaration of Helsinki
This article in the Lancet explores AI’s transformative role in healthcare. It also showcases AI’s potential to enhance clinical trials and improve patient outcomes while addressing challenges like bias, data privacy, and participant trust in AI tools.
Author: Howard Lopes Ribeiro Jr.
FDA Commissioner Robert Califf on Setting Guardrails for AI in Health Care
This JAMA article details the application of AI in research. It demonstrates the growing role of AI in advancing scientific discovery while addressing ethical considerations like participant privacy, data integrity, and equitable access to research benefits.
Authors: Roy Perlis and Jennifer Abbasi
The Prospect of Artificial Intelligence-Supported Ethics Review
This article from Ethics & Human Research discusses the ethical considerations and frameworks for conducting research involving human participants. This is important to human participant research because it highlights the need for ethical guidelines to protect participants’ rights, ensure informed consent, and promote transparency and accountability in studies.
Author: Philip J. Nickel
Joint Editorial: Informed Consent and AI Transcription of Qualitative Data
This SAGE Journal editorial focuses on ethics in research involving human participants, exploring a specific aspect of ethical review, consent, as it relates to the integration of technology or AI for transcribing qualitative data from interviews, focus groups, etc. Establishing and maintaining ethical standards ensures the protection of participants’ rights and well-being. The authors discuss how ethical practices evolve in response to new research challenges, and offer guidance to researchers, institutions, and review boards on maintaining integrity and public trust in research that incorporates AI technologies.
Authors: Gabriel Samuel and Doug Wassenaar
Human Participants in AI Research: Ethics and Transparency in Practice
This Institute of Electrical and Electronics Engineers (IEEE) article emphasizes the ethical considerations when incorporating human participants into AI studies. The author discusses the importance of transparency in data collection and analysis, ensuring informed consent, and addressing biases in data that could impact AI system outcomes. These principles are crucial to maintaining the integrity of research involving human participants, especially as AI technologies become more embedded in decision-making processes across fields like healthcare and social services.
Author: Kevin McKee
FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine
The article from the Journal of the American Medical Association (JAMA) discusses the FDA’s perspective on regulating AI in healthcare, focusing on its application in clinical settings and biomedical research. This is crucial for human participant research, because it addresses the safety, efficacy, and ethical concerns around AI tools used in trials, diagnostics, and treatment. Ensuring AI compliance with FDA standards helps safeguard participants and ensures that AI technologies are deployed responsibly in clinical research environments.
Authors: Haider J. Warraich, Troy Tazbaz, and Robert M. Califf
Medicine’s Lessons for AI Regulation
This article from The New England Journal of Medicine discusses the need for contemporary strategies in informed consent to ensure that participants are genuinely informed and able to make autonomous decisions, addressing both ethical and practical aspects of modern research practices. This article emphasizes the need for accurate data interpretation and responsible communication, especially in research involving AI. It underscores the importance of rigorous data analysis and transparency in research involving human participants.
Author: Laura Stark
This article from Scientific Reports explores how biases among researchers can influence study outcomes, emphasizing the need for strategies to minimize these biases to enhance the validity and reliability of clinical trials. This article demonstrates how the use of AI and other research tools can lead to a more comprehensive understanding of an issue.
Authors: Kent F. Hubert, Kim N. Awa, and Darya L. Zabelina
Research Handbook on Health, AI and the Law
This article from Elgar Online provides a comprehensive examination of ethical standards and regulatory frameworks across different jurisdictions, offering insights into best practices and fostering improved protection for research participants globally. This article is significant because it explores the intersection of technology and ethics in the context of research. It delves into the ethical and legal considerations of using AI technologies in studies involving human participants, including issues of consent, privacy, and data security.
Authors: Barry Solaiman and Glenn Cohen
AI and the Falling Sky: Interrogating X- Risk [PDF]
This article from the Journal of Medical Ethics addresses contemporary ethical challenges and considerations in human participant research, offering valuable insights into evolving norms and practices that enhance the protection and respect for participants in the research process. The article contributes to a deeper understanding of the potential long-term impacts of AI, guiding both research practices and the responsible development of AI technologies.
Authors: Nancy S. Jecker, Jean- Christophe Bélisle- Pipon, Caesar Alimsinya Atuire, Vardit Ravitsky, and Anita Ho
Disparities in Clinical Studies of AI Enabled Applications from a Global Perspective
This article from Nature focuses on the application of artificial intelligence (AI) to predict cardiovascular disease risk using electronic health records (EHRs). It highlights the transformative potential of AI in improving cardiovascular risk prediction and patient care, while also emphasizing the need for careful management of ethical and privacy concerns in research involving human participants.
Authors: Rui Yang, Sabarinath Vinod Nair, Yuhe Ke, Danny D’Agostino, Mingxuan Liu, Yilin Ning, and Nan Liu