Return to homepagePandemic Pact

Ethics in the Interim: Learning from the COVID-19 pandemic to develop ethical guidance for data and safety monitoring committees overseeing clinical trials

Grant number: unknown

Grant search

Key facts

  • Disease

    COVID-19

  • Principal Investigator

    Unspecified Seema Shah

  • Research Location

    United States of America

  • Lead Research Institution

    Ann & Robert H. Lurie Children?s Hospital of Chicago

  • Research Priority Alignment

    N/A

  • Research Category

    Research to inform ethical issues

  • Research Subcategory

    Research to inform ethical issues in Research

  • Special Interest Tags

    N/A

  • Study Type

    Unspecified

  • Clinical Trial Details

    N/A

  • Broad Policy Alignment

    Pending

  • Age Group

    Adults (18 and older)

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

The COVID-19 pandemic has revealed major gaps in research oversight, particularly regarding data and safety monitoring boards (DSMBs). DSMBs dynamically integrate uncertain information to determine whether to prematurely stop or otherwise modify trials. This makes DSMB ethics conceptually interesting as well as operationally challenging. Taking a mixed-methods approach, this project proposes to develop a pragmatic ethical framework and model charter to explicitly address the ethical considerations embedded in DSMB determinations, including in contexts of rapidly evolving evidence and policy.