Comparison of the Initial Review Efficiency of Joint Institutional Review Board and Local Institutional Review Board for Multicenter Clinical Research

다기관 임상연구에 대한 공동 Institutional Review Board (IRB)와 개별 기관 IRB 초기 심사 효율성 비교

  • Sun Choi (The Catholic University of Korea, Catholic Medical Center) ;
  • Sunhye Shin (The Catholic University of Korea, Catholic Medical Center) ;
  • Hee Young Ham (The Catholic University of Korea, Catholic Medical Center) ;
  • Jua Kwon (The Catholic University of Korea, Catholic Medical Center) ;
  • Joohee Park (The Catholic University of Korea, Catholic Medical Center) ;
  • Dong Won Yang (The Catholic University of Korea, Catholic Medical Center) ;
  • Hyeon Woo Yim (Department of Preventive Medicine, College of Medicine, The Catholic University of Korea)
  • 최선 (가톨릭대학교 가톨릭중앙의료원) ;
  • 신선혜 (가톨릭대학교 가톨릭중앙의료원) ;
  • 함희영 (가톨릭대학교 가톨릭중앙의료원) ;
  • 권주아 (가톨릭대학교 가톨릭중앙의료원) ;
  • 박주희 (가톨릭대학교 가톨릭중앙의료원) ;
  • 양동원 (가톨릭대학교 가톨릭중앙의료원) ;
  • 임현우 (가톨릭대학교 의과대학 예방의학교실)
  • Received : 2024.02.02
  • Accepted : 2024.03.11
  • Published : 2024.09.30

Abstract

Purpose: The purpose of this study is to compare the efficiency of 2 types of Institutional Review Boards (IRBs) for multicenter research. Methods: The 2 types are joint IRB and local IRB. For this study, we selected multicenter research reviewed and approved by joint or local IRBs between October 2019 and December 2022. We assessed the time it took for each IRB to approve the research based on the number of working days per IRB review case. We then stratified the data according to the number of participating institutions, the type of research, and the type of IRB review. Results: The results of our study show that joint IRB is more efficient than local IRB. The median IRB approval time for joint IRB was 27 days, 73.5% shorter than local IRB (27 days vs. 102 days, respectively, p<0.001). As the number of participating institutions in multicenter research increased, joint IRB reviews became more efficient regarding the required approval time than local IRB reviews. We also found that joint IRB was faster in every administrative step until new research was approved (p<0.005) when compared to local IRB. Conclusion: Our study highlights that a single review through a joint IRB can significantly reduce the time required for IRB approval of multicenter research. This approach can ensure that all participating institutions follow the same review results. Therefore, a single IRB review effectively reduces the burden of IRB for multicenter research.

Keywords

Acknowledgement

이 연구는 대한기관윤리심의기구협의회 재원으로 2022 KAIRB 학술연구과제지원사업의 지원을 받아 수행된 결과임(과제명: 다기관 임상연구 IRB 심사자료 분석을 통한 공동 IRB와 개별 기관 IRB 심사 특성 비교. 과제번호: KAIRB-과2022-03).

References

  1. Silverman H, Hull SC, Sugarman J. Variability among institutional review boards' decisions within the context of a multicenter trial. Crit Care Med 2001;29:235-41.
  2. Ervin AM, Taylor HA, Ehrhardt S. NIH Policy on Single-IRB Review - A New Era in Multicenter Studies. N Engl J Med 2016;375:2315-7.
  3. National Institutes of Health. Final NIH policy on the use of a single institutional review board for multi-site research [Internet]. Bethesda (MD): National Institutes of Health; 2016 [cIted 2024 Feb 1]. Available from: https://grants.nih.gov/grants/guide/notice-files/not-od-16-094.html.
  4. Chung EJ, Kim MH, Baik SJ. Policy Suggestions for Institutional Bioethics Committees: based on the U.S. single IRB mandate in the revised common rule. Korean J Med Ethics 2021;24:221-44.
  5. Korean Law Information Center. Pharmaceutical Affairs Act. Sejong (Korea): Korean Law Information Center; 2016 [cited 2024 Feb 1]. Available from: https://elaw.klri.re.kr/eng_service/lawView.do?hseq=40196& lang=ENG.
  6. Korean Law Information Center. Bioethics And Safety Act [Internet]. Sejong (Korea): Korean Law Information Center; 2014 [cited 2024 Feb 1]. Available from: https://elaw.klri.re.kr/eng_mobile/viewer.do?hseq=33442&type=part&key=36.
  7. Murray A, Pivovarova E, Klitzman R, Stiles DF, Appelbaum P, Lidz CW. Reducing the single IRB burden: streamlining electronic IRB systems. AJOB Empir Bioeth 2021;12:33-40.
  8. Lee MH, Kim YJ, Seo SW. The need for joint IRB in multi-clinical trials and searching for a systemization strategy for IRB review. Korean J Health Common 2022;17:25-30.
  9. Kim DG. Analysis and suggestion for operating the joint Institutional Review Boards in Korea [desertion]. Busan (Korea): Graduate School, Dong-A University, 2015. p. 23.
  10. Park SY, Noh YH, Cho SJ, Shim KY, Park EY, Kim JS. A survey on current status and introduction of single Institutional Review Board (IRB) in Korea. J KAIRB 2020;2:6-22
  11. Shin HY, Improving the efficiency of IRB through Joint IRB in multicenter clinical trials in Korea. Korea J Clin Pharmacol Ther 2009;17:44-50.
  12. Kim HM. Establishment of Joint Institutional Review Board (Joint IRB) and cooperative governance in early stage operation - case of Joint IRB in Daegu [thesis]. Daegu (Korea): Graduate School, Kyungpook National University; 2015. p. 109.
  13. Korean Academy of Medical Sciences. Central Institutional Review Board Guide (Ver3) [Internet]. Seoul (Korea): Korean Academy of Medical Sciences; 2023 [cited 2024 Feb 1]. Available from: https://cirb.kams.or.kr/cirb/user/aboutCIRB/ctrIntrd/ctrIntrdPage.do?menuId=MENU0438.
  14. Korean Academy of Medical Sciences. Notice of the expansion of Central IRB Review subject [Internet]. Seoul (Korea): Korean Academy of Medical Sciences; 2023 [cited 2024 Feb 1]. Available from: https://cirb.kams.or.kr/cirb/user/aboutCIRB/notice/noticeDetail.do?pageIndex=1¬iceSn=3&searchNoticeSe=&searchCondition=sjcn&searchKeyword=.
  15. Menikoff J. The paradoxical problem with multiple-IRB review. N Engl J Med 2010;363:1591-3.
  16. Neuman MD, Gaskins LJ, Ziolek T; REGAIN Investigators. Time to institutional review board approval with local versus central review in a multicenter pragmatic trial. Clin Trials 2018;15:107-11.
  17. Hall DE, Hanusa BH, Stone RA, Ling BS, Arnold RM. Time required for institutional review board review at one Veterans Affairs medical center. JAMA Surg 2015;150:103-9.
  18. Abramovici A, Salazar A, Edvalson T, Gallagher N, Dorman K, Tita A, et al. Review of multicenter studies by multiple institutional review boards: characteristics and outcomes for perinatal studies implemented by a multicenter network. Am J Obstet Gynecol 2015;212:110.e1-6.
  19. U.S. Food and Drug Administration. Guidance for industry: using a centralized IRB review process in multicenter clinical trials [Internet]. Bethesda (MD): U.S. Food and Drug Administration; 2006 [cited 2024 Feb 1]. https://www.fda.gov/media/75329/download.
  20. Green JM, Goodman P, Kirby A, Cobb N, Bierer BE. Implementation of single IRB review for multisite human subjects research: persistent challenges and possible solutions. J Clin Transl Sci 2023;7:e99.
  21. Taylor HA, Ervin AM. A measure of effectiveness is key to the success of sIRB policy. Am J Bioeth 2017;17:41-3.
  22. Dove ES. Requiring a single IRB for cooperative research in the revised common rule: what lessons can be learned from the UK and elsewhere? J Law Med Ethics 2019;47:264-82.
  23. Hahn C, Kaufmann P, Bang S, Calvert S. Resources to assist in the transition to a single IRB model for multisite clinical trials. Contemp Clin Trials Commun 2019;15:100423.
  24. Johnson AR, Kasimatis Singleton M, Ozier J, Serdoz E, Beadles JG, Maddox-Regis J, et al. Key lessons and strategies for implementing single IRB review in the Trial Innovation Network. J Clin Transl Sci 2022;6:e53.