Scientific and Ethical Issues with an Institutional Review Board (IRB)’s Clinical Research Protocols in the IRB Review in a Teaching Hospital in South Korea

Jieun Park (박지은); 홍정화; Hahn， Seokyung (한서경); Kim, Ock Joo (김옥주)

doi:10.35301/ksme.2016.19.4.518

Scientific and Ethical Issues with an Institutional Review Board (IRB)’s Clinical Research Protocols in the IRB Review in a Teaching Hospital in South Korea

Korean Journal of Medical Ethics
Abbr : 의료윤리
2016, 19(4), pp.518-530
DOI : 10.35301/ksme.2016.19.4.518
Publisher : The Korean Society For Medical Ethics
Research Area : Medicine and Pharmacy > General Medicine
Published : December 31, 2016

Jieun Park ¹, 홍정화 ², Hahn， Seokyung ³, Kim, Ock Joo ¹

¹서울대학교
²서울대학교병원 임상연구윤리센터, 서울대학교 의과대학 인문의학교실
³서울대학교 의과대학 의학과

Accredited

ABSTRACT

With the increased number of clinical trials being conducted in South Korea, Institutional Review Boards (IRBs) have acquired greater significance. In human clinical trials, unscientific studies may be unethical in light of their potential for causing harm to participants. Therefore, IRBs should review both the scientific and the ethical issues of any research protocol. However, research into the IRB review process is lacking in Korea. This study examined the protocols for clinical trials under the review of the IRB at Seoul National University Hospital. In total 1,244 protocols (752 between 2004 and 2006; 492 in 2013) were analyzed. Of these 22.7% were approved, 64.2% underwent minor revision, and 12.6% underwent major revision. In total, 62.2% of these protocols raised scientific issues, and 47.0% raised ethical issues. Among the scientific issues, “unclear sample size calculation” occurred most frequently. “Subjects’ recruitment/inclusion criteria” was the most frequently cited ethical issue. A total of 67.0% had consent issues and 41.3% raised questions about the case report form. Compared to the period from 2004 to 2006, the prevalence of protocols with “unclear study design” and those that raised questions about “privacy/personal data” increased in 2013. While scientific issues were the most frequent among investigator-initiated trials, consent issues were the most frequent in sponsor-initiated trials. Although all issues were significantly associated with the approval decision, the approval rate of studies with ethical issues was lowest. These results provide a basis for the development of guidelines for researchers by identifying common issues in clinical protocols

KEYWORDS

Institutional Review Board, IRB, clinical protocol, clinical trials, bioethical issues

Citation status

* References for papers published after 2023 are currently being built.

[journal] Im H / 2011 / IRB review process / Korean J Clin Oncol 5 : 72~81

[confproc] 안영미 / 2014 / 인간대상 연구윤리와 IRB / 한국아동간호학회 학술대회 자료집 6 : 73~91

[confproc] 홍정화 / 2012 / IRB 심사 통과를 위한 효율적인 연구계획서 작성법 / 대한외과학회 학술대회 초록집 11 : 45~154

[journal] Abbott L / 2011 / A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn / J Empir Res Hum Res Ethics 6(1) : 3~19

[journal] Dyrbye LN / 2007 / Medical education research and IRB review:an analysis and comparison of the IRB review process at six institutions / Acad Med 82(7) : 654~660

[journal] Khan MA / 2014 / Variability of the institutional review board process within a national research network / Clin Pediatr 53(6) : 556~560

[journal] Kano M / 2015 / Costs and inconsistencies in US IRB review of low-risk medical education research / Med Educ 49(6) : 634~637

[journal] Polito CC / 2014 / Navigating the institutional review board approval process in a multicenter observational critical care study / Crit Care Med 42(5) : 1105~1109

[journal] Grodin MA / 1986 / A 12-year audit of IRB decisions / QRB Qual Rev Bull 12(3) : 82~86

[journal] Jones JS / 1996 / Structure and practice of institutional review boards in the United States / Acad Emerg Med 3(8) : 804~809

[journal] Rodriguez SP / 2009 / Factors related to the approval, development and publication of research protocols in a paediatric hospital / Arch Argent Pediatr 107(6) : 504~509

[journal] Wao H / 2014 / Uncertainty about effects is a key factor influencing institutional review boards' approval of clinical studies / Ann Epidemiol 24(10) : 734~740

[web] Ministry of Food and Drug Safety / 1995 / Korean Good Clinical Practice / http://www.mfds.go.kr/index.do?mid=695

[journal] Pritchard I. / 2011 / How do IRB members make decision? A review and research agenda / J Empir Res Hum Res Ethics 6(2) : 31~46

[web] Ministry of Food and Drug Safety / 2015 / The Trend of Clinical Trial Approval in 2014 / http://www.mfds.go.kr/index.do?mid=675&seq=26770&cmd=v

[journal] Dominguez RA / 2005 / Searching for an efficient institutional review board review model: interrelationship of trainee-investigators, funding, and initial approval / J Lab Clin Med 145(2) : 65~71

[journal] Kim B. / 2008 / The study to find the operation statuses and improvement points of IRB in Korea / Bioeth Policy Res 2(3) : 291~302

[journal] De Vries RG / 2002 / What do IRBs look like? What kind of support do they receive? / Account Res 9(3) : 199~216

[journal] Sengupta S / 2003 / The roles and experiences of nonaffiliated and non-scientist members of institutional review boards / Acad Med 78(2) : 212~218

KJCKorea
Journal Central

Korean Journal of Medical Ethics 2023 KCI Impact Factor : 1.21

Scientific and Ethical Issues with an Institutional Review Board (IRB)’s Clinical Research Protocols in the IRB Review in a Teaching Hospital in South Korea

ABSTRACT

KEYWORDS

Citation status

* References for papers published after 2023 are currently being built.

Korean Journal of Medical Ethics 2023 KCI Impact Factor : 1.21

Scientific and Ethical Issues with an Institutional Review Board (IRB)’s Clinical Research Protocols in the IRB Review in a Teaching Hospital in South Korea

ABSTRACT

KEYWORDS

Statistics

Tools

Issue List

Citation status

KCI Citation Counts (1)

REFERENCES (19) * References for papers published after 2023 are currently being built.

Search PDF

Citation

* References for papers published after 2023 are currently being built.