Article 米国AAHRPP(研究対象者保護プログラム認証協会) Dr. Elyse I. Summers(会長・CEO), Dr. Sarah H. Kiskaddon (Director・Public Affairs)インタビュー: 米国と世界の被験者保護システムの最近の動向

栗原, 千絵子  ,  I. Summers, Elyse  ,  H. Kiskaddon, Sarah

45 ( 1 )  , pp.67 - 79 , 2017-04 , 臨床評価刊行会
This is a record of interview with Dr. Elyse I. Summers, President & CEO, and Dr. Sarah H. Kiskaddon, Vice President, Global Development & Public Affairs, Association for the Accreditation of Human Research Protection Program (AAHRPP) in June 2015, and following discussion through the process of construction of this interview article.  Recently, an increasing number of institutions that conduct research involving human subjects are getting accreditation by AAHRPP. AAHRPP accreditation system is for the whole institutional program for human research subject protection, not limited to IRB (institutional review board) or EC (ethicscommittee). Recently the trend of research communities in the United States (U.S.) and some of Asian countries such as Korea and Taiwan is shifting from “IRB-oriented” to “HRPP-oriented” human subject protection.  AAHRPP is a non-governmental, not-for-profit organization, keeping partnership with government. Although their accreditation is not legally-obligated process, it is well- acknowledged assurance of compliance with governmental regulations, and as a result, it works as a proof of trust-worthy institutional practices. Also, recent trends in the U.S. and in some Asian countries shows that pharmaceutical companies prefer to work with AAHRPP-accredited institutions; and the “single IRB approach” for multicenterresearch seems to promote reviews at AAHRPP-accredited institutions.  In Japan, a new law for clinical research is going to be enacted and some institutions are interested in AAHRPP accreditation. In this context, it is a good opportunity for the Japanese research community to discuss more about HRPP-oriented human subject protection and the possibility of getting international accreditation of HRPPs, such as AAHRPP.

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