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Related Experiment Videos

Single-Patient Expanded Access Requests: IRB Professionals' Experiences and Perspectives.

Carolyn Riley Chapman1, Jenni A Shearston2, Kelly McBride Folkers1

  • 1a Division of Medical Ethics, Department of Population Health , NYU School of Medicine, NYU Langone Health , New York , New York , USA.

AJOB Empirical Bioethics
|April 10, 2019
PubMed
Summary

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Most Institutional Review Board (IRB) professionals believe reviewing single-patient expanded access (EA) requests for investigational drugs is important and feel prepared for this task. Their input guides future regulatory practices for expanded access drug use.

Area of Science:

  • Medical Ethics
  • Regulatory Science
  • Clinical Research Administration

Background:

  • U.S. physicians can use expanded access (EA) or Right to Try (RTT) pathways for investigational drugs outside clinical trials.
  • EA requires U.S. Food and Drug Administration (FDA) and often Institutional Review Board (IRB) approval.
  • IRB professionals' views on reviewing single-patient EA requests remain understudied.

Purpose of the Study:

  • To survey IRB professionals about their experiences and preparedness for reviewing single-patient EA requests.
  • To assess IRB professionals' attitudes regarding the importance of IRB review for EA requests.

Main Methods:

  • A cross-sectional online survey was distributed to 234 IRB professionals via the SMART IRB platform.
  • The survey included Likert scale questions to gauge agreement on specific statements regarding EA request reviews.
Keywords:
Expanded accessIRBcompassionate useinvestigational drugpolicyregulationright to try

Related Experiment Videos

  • Eighty-three professionals completed the survey, yielding a 36.4% response rate.

    • Main Results:

    • 78.3% of respondents deemed IRB review of single-patient EA requests important.
    • 86.6% of IRB professionals felt their boards were prepared to review these requests.
    • A majority favored local review by a designated member over full board review.

    Conclusions:

    • A significant majority of surveyed IRB professionals find IRB review of single-patient EA requests crucial.
    • Most respondents expressed confidence in their IRBs' preparedness to manage these reviews.
    • Findings highlight the perceived importance and readiness for IRB oversight in expanded access.