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What Should Be Clinicians' Roles in Regulatory Assessment of Prospective Interventions' Risks of Exacerbating

Anushka Bhaskar1, Daniel Carpenter2

  • 1MPhil student in population health sciences at the University of Cambridge in the United Kingdom.

AMA Journal of Ethics
|March 3, 2023
PubMed

Insights

Regulatory decisions on new health interventions require balancing speed with public trust, especially during crises. Over or underestimating an intervention

Area of Science:

  • Public Health Policy
  • Regulatory Science
  • Health Equity

Background:

  • Expedited review, emergency use authorization, and approval of interventions require assessing downstream impact on public trust during health crises.
  • Overconfidence in interventions can worsen health inequity due to cost or misinformation; underestimation risks neglecting populations needing care.

Purpose of the Study:

  • To examine the critical role of clinicians in regulatory processes.
  • To analyze the balance between promoting public safety and public health.
  • To consider the risks of over/underestimation of intervention value in regulatory decision-making.

Main Methods:

  • Conceptual analysis of regulatory decision-making frameworks.
  • Review of ethical considerations in public health emergencies.
  • Discussion of clinician involvement in balancing competing risks.

Main Results:

  • Regulatory decisions must account for potential impacts on public trust and confidence.
  • The risk of exacerbating health inequity exists with both overconfident and underestimated intervention assessments.
  • Clinicians play a vital role in navigating these complex regulatory considerations.

Conclusions:

  • Balancing speed, efficacy, and equity in regulatory processes is crucial for public health.
  • Understanding and mitigating risks associated with regulatory decisions is essential for maintaining public trust.
  • Defining the scope of clinicians' roles in regulatory processes can enhance public safety and health equity.

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