• Title/Summary/Keyword: Ethical guideline

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Survey of Institutional Review Board Risk Level Classification of Clinical Trials Among Korean University Hospitals (임상시험심사위원회(Institutional Review Board)의 임상시험에 대한 위험평가 분류조사연구)

  • Lee, Sun Ju;Kang, Su Jin;Maeng, Chi Hoon;Shin, Yoo Jin;Yoo, Soyoung
    • The Journal of KAIRB
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    • v.4 no.2
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    • pp.36-41
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    • 2022
  • Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

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Sustainable Development and Sustainability Marketing - Integration of customer and socio-ecological aspect in Marketing concept - (글로벌 기업 환경 변화의 새로운 패러다임으로서 지속가능한 발전과 마케팅 - 지속가능마케팅의 의사결정 지향적 컨셉 -)

  • Nam, Sang-Min;Kim, Jong-Ho;Noh, Jung-Koo
    • Journal of Global Scholars of Marketing Science
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    • v.17 no.3
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    • pp.83-108
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    • 2007
  • Since the 1992 UN Conference for Environment and Development held in Rio de Jaineiro, Sustainable Development has become the global thesis. More than 170 countries signed the Agenda 21 for the sustainable action plan, and adopted the sustainability concept as the key concept of dealing with the environmental, social, ethical, and economic problem. Sustainability is one of the main marketing challenges in the 21st century. By integrating social and ecological criteria, marketing may can make valuable contributions to sustainable development. Regarding the sustainability marketing, it is difficult to find the domestic marketing research on the thesis of sustainable development, and this is the definite evidence that the Korean marketing researchers do not realize the importance of the thesis of sustainable development which is internationally suggested as the new paradigm of change. The purpose of this study is to build the conceptual background and explore the research direction in order to introduce and adopt the concept of sustainable development in the domestic marketing research field. The present paper proposes a comprehensive conception of sustainability marketing, defined by six step: analysis of social-ecological problems; analysis of consumer behavior; normative sustainability marketing; strategic sustainability marketing; instrumental sustainability marketing; and transformative sustainability marketing. The aim of the paper are to clarify the concept of sustainability marketing. To accomplish this research purpose we discuss the sustainable development which is the conceptual background of sustainability marketing, analyze the characteristics of the sustainability marketing, and finally summarize the research results and present the suggestions for further research. Sustainability marketing embraces the idea of sustainable development, a development that meets the needs of the present without compromising the ability of future generation to meet their own needs. Sustainability Marketing goes beyond conventional marketing thinking. If marketing is about satisfying customer needs and building profitable relationships with customers, sustainability marketing may be defined as building and maintaining sustainable relationships with customers, the social environment and natural environment. By creating social and environmental value, sustainability marketing tries to deliver and increase customer value. Sustainability Marketing aims at creating customer value, social value and environmental value. Sustainability marketing integrates social and ecological criteria into the whole process of marketing, and can be differentiated in six steps: (1) Analysis of the social and ecological problems, generally and specifically with respect to products which satisfy customer needs and wants; (2) Analysis of customer behavior with special aspect to social and ecological concerns; (3) Corporate commitments to sustainable development in the mission statement, development of sustainability visions, formulation of sustainable principles and guideline, setting of socio-ecological marketing objectives and goals (normative aspects of sustainability marketing); (4) Sustainability segmentation, targeting and positioning, and timing of market entry(strategic aspects of sustainability marketing); (5)Integration of social and ecological criteria into the marketing-mix, i.e. products, services and brands, pricing, distribution and communication(instrumental aspects of sustainability marketing); (6) Participation in public and political change processes, which transform existing institutions towards sustainability(transformative aspects of sustainability marketing). The first two steps begin with an analysis of the company situation. In sustainability marketing it is crucial not just to know consumer needs and wants, but also to find out about the ecological and social problems of products along their whole life cycle. The intersection of socio-ecological problems and consumer wants sets the ground for sustainability marketing. Step three to five describe the implementation of sustainability marketing. Social and ecological criteria are fully integrated into the mission statement, strategies and marketing-mix. Step six is one of the specifics of sustainability marketing. It is about the commitment of company to sustainable development and their active participation in public and political processes in order to change the existing framework in favor of sustainability.

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