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Changing Ethics in Clinical Trials_공통보수

구분 온라인교육
카테고리온라인 > KoNECT International Conference_공통 > 2018 KoNECT International Conference
과정명Changing Ethics in Clinical Trials
신청기간 상시 교육기간 -
학습일수/시간 30 일 / 42 분 교육장소 미정
수강료 무료 교육정원인원제한없음
  • 소개
  • 목차
  • 교육일정
학습개요

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.

 

강사명

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

2. Dae Ho Lee(Asan Medical Center) 

교육대상

상기 과정은 보수과정으로 직능별, 단계별 인정가능시간이 상이함으로 관련규정 '[별표1] 임상시험등 종사자별 교육과정 및 이수시간'을 꼭 확인하시기 바랍니다.

[별표 1]

임상시험등 종사자별 교육과정 및 이수시간

(5조 관련)

교육과정

해당 분야 실시경험이

없는 종사자

해당 분야 실시경험이 있는 종사자2)

신규자 교육과정

(우선교육시간)1)

심화 교육과정

보수 교육과정

 . 임상시험등 시험책임자3), 시험담당자4)

8시간 이상

(4시간 이상)

6시간 이상

4시간 이상

 . 심사위원회 위원

의사등3)

8시간 이상

(4시간 이상)

6시간 이상

4시간 이상

그 밖의 위원

12시간 이상

(6시간 이상)

6시간 이상

4시간 이상

 . 관리약사

8시간 이상

(4시간 이상)

6시간 이상

4시간 이상

 . 임상시험등 모니터요원

40시간 이상

(20시간 이상)

24시간 이상

8시간 이상

 . 임상시험등 코디네이터

 . 임상시험등 실시기관 품질보증 담당자

 . 임상시험등 업무 담당자5)

4시간 이상

(2시간 이상)

3시간 이상

2시간 이상

1) 규칙 제38조의23항 후단 및 제5조제2항에 따라 임상시험등 업무 경력이 없는 사람이 그 업무를 시작하기 전에 받아야 하는 교육시간을 말한다.

2) 보수교육과정은 평가를 생략할 수 있고, 해당 교육과정의 교육대상이면서 교육을 실시한 경우에는 교육시간을 이수시간으로 인정하며, 심포지엄, 워크숍, 온라인 교육 등으로 이수할 수 있으며, 이수시간의 최대 50/100까지 인정된다.

3) 의사 등이 시험책임자?시험담당자 교육과정에서 이수 받은 교육시간은 심사위원회 교육과정에서 이수 받은 교육시간으로 보며, 반대의 경우도 동일하게 적용한다.

4) 의약품 등의 안전에 관한 규칙[별표 4] 의약품 임상시험 관리기준 제2호코목에 따른 시험당당자(Subinvestigator)를 말한다.

5) 시험담당자(Subinvestigator), 관리약사, 임상시험등 코디네이터를 제외한 시험책임자의 위임 및 감독에 따라 임상시험등 업무를 담당하는 사람(임상병리사, 방사선사 등)을 말한다.

 

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