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Protecting human subjects participating in research.

Min-Fu Tsan1, J Thomas Puglisi1

  • 1Research Service, McGuire Research Institute Richmond, VA, USA.

American Journal of Translational Research
|October 19, 2023
PubMed
Summary

Performance metrics show Department of Veterans Affairs human research protection programs effectively safeguard subjects. Data from 2010-2021 indicate significant improvements in protecting human research participants.

Keywords:
Human research subject protectionshuman research protection programinstitutional review boardperformance metricunanticipated adverse event

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Area of Science:

  • Clinical Research Oversight
  • Human Subject Protection
  • Health Services Research

Background:

  • Institutions conducting human subjects research utilize Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) to safeguard participants.
  • Assessing the effectiveness of these protection measures is crucial for maintaining ethical research standards.

Purpose of the Study:

  • To develop and implement performance metrics for evaluating the efficacy of HRPPs in protecting human research subjects.
  • To assess the performance of IRBs and HRPPs at Department of Veterans Affairs (VA) research facilities.

Main Methods:

  • Developed a set of five key performance metrics to measure human research subject protections.
  • Collected data through annual audits of informed consent documents and research protocols across 107 VA facilities.
  • Analyzed data spanning from 2010 to 2021.

Main Results:

  • Incident rates for all five performance metrics were consistently low.
  • Three metrics demonstrated statistically significant improvement trends, with reductions of 70% to 100%.
  • No performance metrics showed a decline in effectiveness over the study period.

Conclusions:

  • VA HRPPs demonstrated effectiveness in protecting human research subjects between 2010 and 2021.
  • The developed performance metrics proved valuable for monitoring and improving HRPP effectiveness.
  • Continuous monitoring using these metrics can enhance the protection of human research participants.