Improving Compliance With Institutional Review Board Continuing Review Requirements

Abstract

Continuing review of ongoing research is one way by which institutional review boards (IRBs) ensure protection of human subjects. Among the 25 Department of Veterans Affairs (VA) human research protection program performance metrics collected annually since 2010, lapse in IRB continuing reviews had the highest noncompliance rate. In 2013, 10 facilities with lapse rates higher than the VA national average for 3 consecutive years from 2011 to 2013 implemented remedial action plans. Using data from 2011 through 2018, we demonstrated that 70% of these facilities’ lapse rates remain significantly improved. In contrast, none of the 10 facilities with their lapse rates that were higher than the national averages in 2 out of 3 years from 2011 to 2013 and that did not implement remedial action plans showed any improvement. Thus, implementation of effective remedial measures in facilities with high lapse rates can result in long-lasting improvement in the majority of these facilities.

Keywords

human subjects protection institutional review board continuing review lapse in IRB continuing review remedial action plan

Get full access to this article

View all access options for this article.

References

Agresti

(1984). Chapters 9 and 10: Analysis of ordinal categorical data. New York, NY: John Wiley.

Bramstedt

K. A.

Kassimatis

(2004). A study of warning letters issued to institutional review boards by the United States Food and Drug Administration. Clinical and Investigative Medicine, 27, 316-323.

Government Accountability Office. (1996). Scientific research: Continued vigilance critical to protecting human subjects. [GAO/HEHS-96].

Matthews

D. E.

Farewell

V. T.

(1988). Chapter 4: Using and understanding medical statistics (2nd ed.). Basel, Switzerland: Karger.

Menikoff

Kaneshiro

Pritchard

(2017). The common rule, updated. The New England Journal of Medicine, 376, 613-615.

Nguyen

Grabenbauer

Tsan

M. F.

(2016). Improving rates of lapse in IRB continuing reviews: The Department of Veterans Affairs’ experience. IRB: Ethics & Human Research, 38(4), 17-20.

Nightingale

S. L.

(1995, October 20). An update from FDA. Plenary address at PRIM&R IRB Conference, Boston, MA.

Norton

Wilson

D. M.

(2008). Continuing ethics review practices by Canadian research ethics boards. IRB: Ethics & Human Research, 30(3), 10-14.

Tsan

M. F.

(2017). Chapters 1 and 10: Assessing the quality of human research protection programs. Beau Bassin, Mauritius: Scholars’ Press.

10.

Tsan

M. F.

Nguyen

(2015). Lapse in institutional review board continuing review approval. IRB: Ethics & Human Research, 37(2), 14-19.

11.

Tsan

M. F.

Nguyen

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

12.

Tsan

M. F.

Nguyen

Brooks

(2013). Using quality indicators to assess human research protection programs at the Department of Veterans Affairs. IRB: Ethics & Human Research, 35(1), 10-14.

13.

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(1), 9-11.

14.

Tsan

M. F.

Tsan

(2016). Improving and preventing lapse in institutional review board continuing review approval. Jacobs Journal of Clinical Trials, 1(1), 006.

15.

U.S. Department of Health and Human Services. (2010). Office for human research protections guidance on IRB continuing review of research. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-continuing-review-2010/index.html

16.

U.S. Department of Health and Human Services. (2018). 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.html

17.

U.S. Department of Veteran Affairs. (2014). Requirements for the protection of human subjects in research (VHA Handbook 1200.05). Retrieved from http://www.va.gov/vhapublications/

18.

U.S. Department of Veterans Affairs. (2015). Research compliance reporting requirements (VHA Handbook 1058.01). Retrieved from https://www.va.gov/vhapublications/