Federal Guidance
Artificial Intelligence in Research: Policy Considerations and Guidance
This resource from the National Institutes of Health (NIH) outlines the policies and guidelines related to the use of AI in research funded by the National Institutes of Health (NIH). It provides a framework for how AI should be integrated into research projects, with a focus on maintaining ethical standards and ensuring responsible use. The NIH’s AI policies provide essential guidance for integrating AI into research involving human participants, ensuring that ethical considerations, data security, and regulatory compliance are prioritized in the research process.
Author: National Institutes of Health (NIH)
FDA Guidelines on AI/ML in Medical Devices
This guidance from the FDA outlines the development of the FDA’s regulatory framework for AI and machine learning in medical devices, ensuring that any AI-driven medical devices undergo rigorous testing, including clinical trials with human participants to affirm their safety and efficacy before these technologies are widely adopted.
Author: U.S. Food and Drug Administration (FDA)
IRB Considerations for AI in Human Subjects Research
This resource from Office for Human Research Protections (OHRP) outlines IRBs’ role in overseeing AI-driven research, ensuring that human subjects are protected, and ethical principles are followed, particularly with respect to informed consent, data privacy, and the potential risks associated with AI systems in research.
Author: Office for Human Research Protections (OHRP)