IRB: Ethics & Human Research

Assessing the Quality of Human Research Protection Programs: The Experience at the Department of Veterans Affairs

Considerable efforts have been made in recent years to improve the safety of human subjects who participate in research. However, there are no data to demonstrate that we have made human research safer. There is a critical need to determine whether we have achieved our goal of better protecting research subjects. We have developed 16 quality indicators for assessing the quality of human research protection programs at the Department of Veterans Affairs. Our experience implementing these quality indicators at the VA may help other institutions to develop appropriate quality indicators for assessing their own human research protection programs.

Key words/concepts: human subjects research, human research protection program, quality indicators, institutional review boards (IRBs)

Min-Fu Tsan, Karen Smith, and Baochong Gao, “Assessing the Quality of Human Research Protection Programs: The Experience at the Department of Veterans Affairs,” IRB: Ethics & Human Research 32, no. 4: 16-19.