Protecting human subjects participating in research

Objectives: Institutions conducting research involving human subjects establish institutional review boards (IRBs) and/or human research protection programs to protect human research subjects. Our objectives were to develop performance metrics to measure human research subject protections and to assess how well IRBs and human research protection programs are protecting human research subjects. Methods: A set of five performance metrics for measuring human research subject protections was developed and data were collected through annual audits of informed consent documents and human research protocols at 107 Department of Veterans Affairs re-search facilities from 2010 through 2021. Results: The proposed performance metrics were: local adverse events that were serious, unanticipated, and related or probably related to research, including those that resulted in hos-pitalization or death; where required informed consent was not obtained; required Heath Insurance Portability and Accountability Act authorization was not obtained; non-exempt research was conducted without IRB approval; and research activities were continued during a lapse in IRB continuing reviews. Analysis of these performance metric data from 2010 through 2021 revealed that incident rates of all five performance metrics were very low; three showed a statistically significant trend of improvement ranging from 70% to 100%; and none of these five perfor-mance metrics deteriorated. Conclusions: Department of Veterans Affairs human research protection programs ap-peared to be effective in protecting human research subjects and showed improvement from 2010 through 2021. These proposed performance metrics will be useful in monitoring the effectiveness of human research protection programs in protecting human research subjects.