Assessing the Quality and Performance of Human Research Protection Programs to Guide Compliance Oversight Activities

Abstract

Routine on-site reviews should focus primarily on facilities that are at risk of harming human subjects. Using human research protection program performance metric data from 107 facilities, we defined a facility to be at risk when one of its noncompliance/incident rates was among the top three highest rates of that performance metric. Based on 14 performance metrics with noncompliance and incidents in 2017, 27 facilities were identified to be at risk. These 27 facilities at risk, while constituting only 25% of all facilities, contributed to 70% ± 25% (M ± SD; range = 32%-100%) of all reported noncompliance/incidents. Thus, performance metric data can be used to guide compliance oversight activities.

Keywords

human research protection program performance measurement performance metrics compliance oversight activity

Get full access to this article

View all access options for this article.

References

Matthews

D. E.

Farewell

V. T.

(1988). Approximate significance tests for contingency tables. In D.E.Matthews, & V.T.Farew (Eds.), Using and understanding medical statistics (2nd ed., pp. 39-57). Basel, Switzerland: Karger.

Nguyen

Brooks

Tsan

M. F.

(2014). Human research protection programs at the Department of Veterans Affairs: Quality indicators and program size. IRB: Ethics & Human Research, 36, 16-20.

Tsan

M. F.

Nguyen

(2015). Lapse in institutional review board continuing review approval. IRB: Ethics & Human Research, 37, 14-19.

Tsan

M. F.

Nguyen

(2017). Effectiveness of human research protection program performance measurements. Journal of Empirical Research on Human Research Ethics. 12, 217-228.

Tsan

M. F.

Nguyen

Brooks

(2013a). Assessing the quality of VA human research protection programs: VA vs. affiliate university institutional review board. Journal of Empirical Research on Human Research Ethics 8, 153-160.

Tsan

M. F.

Nguyen

Brooks

(2013b). Using quality indicators to assess Human Research Protection Programs at the Department of Veterans Affairs. IRB: Ethics & Human Research, 35(1), 10-14.

Tsan

M. F.

Nguyen

Brooks

(2015). Using quality indicators to assess and improve human research protection programs: Experience of the Department of Veterans Affairs. Federal Practitioner, 32, 31-36.

Tsan

M. F.

Puglisi

J. T.

(2014). Health care operations activities that may constitute research—The Department of Veterans Affairs’ perspective. IRB: Ethics & Human Research, 36, 9-11.

Tsan

M. F.

Tsan

(2015). Assessing the quality of human research protection programs to improve protection of human subjects participating in clinical trials. Clinical Trials, 12, 224-231.

10.

U.S. Department of Health and Human Services. (1991). Federal Policy for the protection of human subjects (45 Code of Federal Registration [CFR] 46). Retrieved from http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.htm

11.

U.S. Department of Health and Human Services, Office for Human Research Protections. (2009). Compliance oversight procedures for evaluating institutions. Retrieved from http://www.hhs.gov/ohrp/compliance-and-reporting/evaluating-institutions/index.htm/

12.

U.S. Department of Veterans Affairs. (2014). Research compliance reporting requirements (VHA Handbook 1058.01). Retrieved from http://www1.va.gov/vha/publications/

13.

U.S. Department of Veterans Affairs. (2017). Research compliance officer audit tools, office of research oversight. Retrieved from http://www.va.gov/ORO/rcep.asp

14.

U.S. Department of Veterans Affairs. (2018). Office of Research Oversight. Retrieved from http://www.va/gov/ORO/