국가임상시험지원재단

● Opportunities and Challenges of Single IRB vs Central IRB

Yong-Jin Kim(Kyungpook National University Hospital)

Clinical research is moving away from the single-site model and increasingly considering how to design studies that will produce generalizable findings. A way to achieve this goal is to include multiple centers in the conduct of these studies. In multi-site studies, each site has its own IRB which conducts an independent review of studies involving human research participants. The use of a “single or central IRB” for multi-site studies will help streamline the IRB review process by eliminating the unnecessary repetition of those reviews across sites.
Now, the using a single or central IRB for multi-site clinical trials should be more popular and convenient  in Korea.
Both are designed to help streamline IRB review and overseeing all clinical trial sites participating in a multi-site study. In 2016, the NIH policy on IRB review for multi-site research brought a newish term into the clinical research lexicon: “single IRB review,” or “sIRB review.” This term seems to be on its way to replacing “central IRB” or “cIRB” in discussions about one IRB review conducted on behalf of all (or most) participating sites in a multi-center study. In general, a “central IRB”  provides the ethical review for all sites participating in more than one multi-site study. The sites are usually in a network, consortium or particular program. A “single IRB” selected on a study-by-study basis, which provides the ethical review for all sites participating in a multi-site study. The “central IRB” has developed connotations of “independence” from a specific institution?for example, independent commercial IRBs and NCI’s CIRB, an independent federal IRB in US. In the NIH policy, a designated “single IRB” may be either completely independent OR associated with an institution.
 In Korea, four single IRBs have been running. “The central IRB of Ministry of Health and Welfare” provides review for only social and behavior science protocols of single or mult-site. The cental IRB of Catholic hospitals reviews multi-site clinical trials in Catholic university networking hospitals,  The “Joint IRB of Daegu city” reviews multi-site clinical trials of six major hospitals located in Daegu connected by mutual recognition policy of Korean GCP. The “Joint IRB of Southeast region” in Busan reviews multi-site studies in hospitals located in southeast area of Korean peninsula.
Now, the using a single or central IRB for multi-site clinical trials should be more popular and convenient  in Korea. ?

● Conflict of Interest Management Plan

Dae Ho Lee(Asan Medical Center)

A conflict of interest (COI) has been defined as a set of circumstances that creates a risk that a professional judgement or action regarding a primary interest will be unduly influenced by secondary interests. The primary interest includes the goal of our profession such as producing generalized knowledge, disseminating research results and ensuring the safety of research subjects. Secondary interests are those beyond our professional goals including publishing, volunteerism, research fund, good income, promotion, reputation and so on. Actually, COIs do not realize that our judgement is biased or that a conflict is occurring. However, what makes COIs problematic is that it can unduly influence our decisions, which might threaten not only integrity of research but also safety of research subjects or participants and finally deprive the public of their trust to the research or science. There are many types of COIs including financial interest, non-financial interest such as professional benefits, and indirect interest related to closely associated persons such as family members. Above of all, financial COIs are usually emphasized on because money is multi-purposed, a key motivating factor and relatively easy to regulate. However, there is a big discrepancy between public’s expectation and investigator’s attitude to financial interest in terms of its nature and amount. To overcome this, some institutions, especially funding agencies, already suggested guidelines regarding disclosure of the financial COIs. Nonetheless, the guidelines include sort of minimal requirement and even more the requirements are different, which embarrasses both investigators, reviewers and institutions. Therefore, each institution should establish its own well written document describing guidelines and methods by which COIs will be mitigated or eliminated. That document is called “Conflict of interest management plan” or COIMP. Of course, managing COI includes not only disclosure of COIs but also mitigation or elimination of investigator’s and institution’s COIs, including modification of research, disqualification of researchers, divestiture or severance of COIs, and close monitoring of research, Therefore, the COIMP should also include these kind of activities or methods. To date, COIMP is not prevalent as much as expected partly due to unresolved or controversial issues in COIs and lack of its standardization. But, lack of knowledge and enthusiasm might be important. It should be realized that establishment of COIMP is not a first step but also a key process to appropriately manage COIs and should be encouraged.

1. Yong-Jin Kim(Kyungpook National University Hospital)

2. Dae Ho Lee(Asan Medical Center) 

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[별표 1]

임상시험등 종사자별 교육과정 및 이수시간

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