Legislative and regulatory changes are allowing drugs, medical devices, and digital health technologies to gain approval based on low-quality evidence. The resulting uncertainty about risks and benefits for medical products may compromise bioethical principles including autonomy and non-maleficence. The team will assess if and how physicians convey this uncertainty to patients. A modified Delphi panel will identify consensus solutions to enhance patient protection and inform a regulatory framework that reconciles ethical principles with the need to generate new knowledge to inform care for patients.
Our Grants
A Bioethical Framework to Inform Use of Novel Drugs, Devices, and Digital Health Technologies Approved with Incomplete Evidence
Rita F. Redberg, MD
University of California San Francisco
University of California San Francisco
Grant Type
Making a Difference
Grant Cycle
spring 2019
Duration
2 years
Amount
$280,000
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Sanket S. Dhruva et al., Physicians’ Perspectives On FDA Regulation Of Drugs And Medical Devices: A National Survey, Health Affairs, Jan 2024.
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Sanket S. Dhruva et al., Strategies to Manage Drugs and Devices Approved Based on Limited Evidence: Results of a Modified Delphi Panel, ASCPT, Mar 2022.
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Sanket S. Dhruva et al., Ensuring Patient Safety and Benefit in Use of Medical Devices Granted Expedited Approval, The Future of Medical Device Regulation: Innovation and Protection, Mar 2022.
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Sanket S. Dhruva et al., Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care, Journal of General Internal Medicine, Feb 2022.
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Jonathan J. Darrow et al., Changing FDA Approval Standards: Ethical Implications for Patient Consent, Journal of General Internal Medicine, Apr 2021.
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Grant Focus Areas
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