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KMID : 1142220150100020141
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Regulatory Research on Food, Drug & Cosmetic
2015 Volume.10 No. 2 p.141 ~ p.153
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Development of Education Programs in HRPP System
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Lee Jong-Gu
Kim Seung-Hee
Choi Yea-Eun
Seo Doo-Won
Ryu Sun-Ae
Kim Yong-Kyu
Na Han-Sung
Kim Jeong-Mi
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Abstract
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Clinical studies are highly important in assessing safety and efficacy of drug products under development. However, most subjects do not make their decision of participating in clinical studies with accurate understanding of information on clinical studies. Instead, their participation is mainly based on medical doctors’ recommendations. Accordingly, there are many problems in the course of clinical trials, such as conflict of interests and regret of participation. Owing to uncertainty about effectiveness and side effects, clinical studies have to be scientifically and ethically conducted to protect the safety and human rights of subjects. The Nuremberg Code, the Belmont Report and the Declaration of Helsinki have promoted international discussions and improvements to assure ethical clinical studies and protect subjects. As a result, the institutional review board (IRB) is organized and operated, but it has limitations on control of all aspects to protect subjects. So, the concept of “Human Research Protection Program (HRPP)” has been accepted by many regulatory authorities and clinical study organizations to try to solve many ethical issues in connection with clinical studies. Especially, the WHO’s the Forum for Ethical Review Committees in the Asian and western Pacific region (FERCAP) and Association for the Accreditation of Human Research Protection Program (AAHRPP) are the representative international
organization for accreditation of clinical researches which accredits clinical study organizations in member countries. In addition, many countries have laws and regulations for protection of subjects in clinical studies. In order to respond to international changes in clinical development program, the Korean government has revised the Bioethics and Safety Act to expand the exemption from informed consents for clinical studies, the Pharmaceutical Affairs Act to introduce the system for accreditation of subjects protection program and the Enforcement Decree of the Pharmaceutical Affairs Act to require mandatory training of persons engaged in clinical studies. Moreover, the Korean government has published the guideline on human research protection program. In order to effectively implement the HRPP policy, it is essential to support the fundamental systems, such as cultivation and training of HRPP professionals. Since it is necessary to make people correctly understand the HRPP, a project for development of training program has to be systematically considered. Accordingly, this study was conducted to identify regulations and trends relating to protection of subjects in clinical studies and operational conditions of related organizations. In addition, in-depth interviews were conducted with many professionals. From this study, it was found that some organizations in Korea have independent units for HRPP and conduct training activities and they emphasize the need for introduction of HRPP system. So, the Korean model of HRPP training program is proposed and mid to long-term plan is developed for HRPP. They may contribute to development of policies for protection of subjects in clinical studies.
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KEYWORD
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Clinical Trials, HRPP, Education
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