COVID-19 Test Us: A Case for Embedding Ethics and Regulatory Expertise

Area of Science:

• Biomedical Engineering
• Public Health
• Regulatory Science

Background:

• The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program aimed to expedite novel diagnostic device development for COVID-19.
• A Clinical Studies Core, including specialized committees, was integral to the program's success in study implementation.
• Ethical and regulatory considerations are paramount in the rapid development and deployment of medical diagnostics.

Purpose of the Study:

• To describe the role and impact of the Ethics and Human Subjects Oversight Team (EHSO) within the RADx Tech program.
• To highlight the development and application of ethical principles for guiding diagnostic technology development.
• To detail the consultation services provided by the EHSO to address ethical and regulatory challenges.

Main Methods:

• Establishment of an Ethics and Human Subjects Oversight Team (EHSO) with dedicated expertise.
• Development of a comprehensive set of Ethical Principles to govern the RADx Tech initiative.
• Regular (weekly) meetings of EHSO experts to consult with investigators on ethical and regulatory issues.

Main Results:

• The EHSO provided essential ethics and regulatory guidance to RADx Tech stakeholders.
• A defined set of Ethical Principles was created and implemented to steer the program.
• Consultation addressed diverse ethical and regulatory concerns, facilitating study development and implementation.

Conclusions:

• The EHSO's expert consultation and ethical framework were critical to the RADx Tech program's success.
• Proactive ethical and regulatory oversight is vital for the efficient development of diagnostic technologies.
• Collaboration between ethics experts and investigators accelerates the translation of novel diagnostics into practice.