• 대한기관윤리심의기구협의회지
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• 제2권1호
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• pp.23-31
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• 2020

Purpose: To obtain opinions from Korean Institutional Review Board (IRB) members' self-evaluation on ability to conduct fairness review of clinical trial protocol with presence of conflict of interest and from investigators and IRB members on financial conflict of interest through surveying. Methods: IRB members and researchers in 9 different hospitals were asked to answer survey questions via email. Results: Responders were 115 personnel (IRB Chair/vice 18, medical member 30, non-medical member 28, and researcher 39) from 9 centers. Compared to IRB medical members, IRB chair/vice respondents scored higher with statistically significance on 10 point scale (8.44±1.381 vs. 7.30±1.685, p=0.005) when asked to self-evaluate fairness reviewing a protocol proposed by an investigator from the same department and a protocol from the company that supports the scientific committee of responders. When reviewing a protocol proposed by a hospital director, non-medical members scored statistically significantly higher than medical-members (7.47±1.76 vs. 8.07±2.70, p=0.034). When asked about the limitation of labor fee for principal investigator on phase 3 Human clinical trials of the Investigational new drug, while the responses range was wide, 60% answered that labor cost of principal investigator should be less than 30% of total budget for clinical trials with a budget of 100 million won. 51.3% answered that there is no need to disclose the labor cost of the principal investigator in the consent form. Since every investigator can be influenced unconsciously by conflict of interest, the answer that 'responder agrees that there is need for management' was the most chosen answer (IRB member 61.8%, investigator 64.1%, multiple answers allowed). Conclusion: Considering scores on questions of fairness by IRB members were between 7.23-8.56 on scale of 0 to 10 point when IRB members were asked about reviewing a clinical trial protocol, it cannot be said with absolute certainty that there is no issue regarding fairness in the review process. Therefore, there should be more ways to safeguard fairness for these issues. There is a need that the disclosure amount of honorarium from sponsor should be lower than 100 million Korean won. Considering the results of the survey in which respondents expressed their thoughts, it is likely that more education on the concept of conflict of interest is needed.

• 한국중재학회지:중재연구
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• 제10권1호
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• pp.3-25
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• 2000

At its thirty-second session in 1999, the UNCITRAL had before it the requested note entitled "Possible future work in the area of international commercial arbitration." After concluding the discussion on its future work in the area of international commercial arbitration, it was agreed that the priority items for the working group should be conciliation, requirement of written form for the arbitration and enforceability of interim measures of protection. the Commission entrusted the work to the Working Group on Arbitration which held its thirty-second session at Vienna from 20 to 31 March 2000. The Working Group discussed agenda item 3 on the basis of the report of Secretary General entitled "Possible uniform rules on certain issues concerning settlement of commercial disputes : conciliation, interim measures of protection, written form for arbitration agreement." At its thirty-three session in 2000, the UNCITRAL had before it the report of Secretary General on agenda item 3 discussed by the Working Group. The Working Group discussed the issues relating to certain aspects of conciliation proceedings ; (1) Admissibility of certain evidence in subsequent judicial or arbitral proceedings ; (2) Role of conciliatior in arbitration or court proceedings ; (3) Enforceability of settlement agreements reached in conciliation proceedings ; (4) Other possible items for harmonized treatment : a) Admissibility or desirability of conciliation by arbitrators b) Effect of an agreement to conciliate on judicial or arbitral proceedings c) Effect of conciliation on the running of limitation period d) Communication between the conciliator and parties ; disclosure of information e) Role of conciliator. It was generally considered that decisions as to the form of the text to be prepared should be made at a later stage when the substance of prepared solutions would become clearer. However, it was noted that model legislative provisions seemed to be appropriate form for a number of matters proposed to be discussed in the area conciliation. There was general support in the Working Group for the proposition to perpare a legislative regime governing the enforcement of interim measures of protection ordered by arbitral tribunals. It was generally considered that legislative regime should apply to enforcement of interim measures issued in arbitration taking place in State where enforcement was sought as well as outside that State. It was generally observed that there was a need for provisions which conformed to current practice in international trade with regard to requirements of written form for arbitration agreement. The view was adopted by the Working Group that the objective of ensuring a uniform interpretation of the form requirement that responded to the needs of international trade could be achieved by : preparing a model legislative provision clarifying, for avoidance of doubt, the scope of article 7(2) of the UNCITRAL Model Law on International Commercial Arbitration : and adopting a declaration, resolution or statement addressing the interpretation of the New York Convention that would reflect a broad understanding of the form requirement. There was general agreement in the Working Group that, in order to promote the use of electronic commerce for international trade and leave the parties free to agree to the use of arbitration in the electronic commerce sphere, article II(2) of the New York Convention should be interpreted to cover the use of electronic means of communication as defined un article 2 of the Model Law on Electronic Commerce and that it required no amendment to do that. The UNCITRAL may wish to consider to the desirability of preparing uniform provisions on any of those issues concerning conciliation and arbitration proceedings, possibly indicating whether future work should be towards a legislative text or non-legislative text.