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Standard Guide for Protection of Respondents and Informed Consent for Sensory Evaluation Studies 感官评价研究中应答者保护和知情同意的标准指南
发布日期: 2021-10-15
1.1 本指南将涵盖与受访者一起测试产品、材料或配料时应考虑的事项,以了解他们对产品和刺激的感官反应。感官研究是指测量和记录受访者对刺激的感知和反应的研究。公司使用这些数据来帮助设计更好地满足消费者需求的产品,管理开发产品的风险,和/或建立产品感官和性能属性以及消费者产品需求的知识。 1.2 在本指南中,总结了推动安全感官测试的关键原则,然后更详细地描述了维护道德标准、确保人类应答者的安全性和保密性以满足全球政府和监管要求所需考虑的步骤和过程。受试者、测试产品/材料、协议和方法、研究管理和监督以及测试环境都受到监督,以维护道德标准、受试者保密,并确保受试者的安全。 政府和监管机构以及当地组织和专业人士也提供了要求和指导。研究人员有义务了解并遵守其负责的任何研究的这些指南和要求。 1.3 在本指南中,未确定可能适用于感官测试的所有地方法规。定义了感官测试期间受试者道德治疗和安全的最低标准和最佳实践。 1.4 本标准并非旨在解决与其使用相关的所有安全问题(如有)。本标准的用户有责任在使用前制定适当的安全、健康和环境实践,并确定监管限制的适用性。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 本全球指南适用于所有涉及受访者(员工和非员工)的非药物感官测试。与受访者的测试范围可以从早期探索性研究到大规模感官研究和市场索赔测试,无论指定的名称或用于描述研究的术语如何。 4.2 暴露类型或人体(受试者)测试或两者在范围内的规定见 3.1.4 . 产品或材料或两者作为药物或非药物的定义可能因国家而异。了解当地法律法规至关重要。 4.3 受访者、产品、协议和方法、研究管理和监督以及测试环境都在本指南的范围内。 4.4 本全球指南: 4.4.1 不包括药物或专业处方的医疗保健产品; 4.4.2 不包括受访者未接触产品(营销或开发)或材料的研究;和 4.4.3 不适用于产品和成分的工作场所制造暴露。职业安全和健康政策管理这些工作场所的制造风险。
1.1 This guide will cover the considerations that shall be made when testing products, materials, or ingredients with respondents for their sensory response to products and stimuli. A sensory study is defined as a study in which respondents’ perceptions and responses to stimuli are measured and recorded. These data are used by companies to help design products that better meet consumers’ needs, manage risk in developing products, and/or build knowledge of products sensory and performance attributes and consumers’ product needs. 1.2 In this guide, the key principles driving safe sensory testing are summarized, and then in greater detail, the steps and processes to be considered to maintain ethical standards and ensure safety and confidentiality of human respondents to meet government and regulatory requirements globally are described. Respondents, test product/material, protocols and methods, study administration and oversight, and testing environment are all subject to oversight to maintain ethical standards, respondent confidentiality, and ensure a respondent’s safety. Governmental and regulatory bodies, along with local organizations and professions, also provide requirements and guidance. It is incumbent upon the researcher to be aware of, and follow, these guidelines and requirements for any study for which they are responsible. 1.3 In this guide, all local regulations that may apply to sensory testing are not identified. The minimum standards and best practices for ethical treatment and safety of respondents during sensory testing are defined. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 This global guide applies to all nonpharmaceutical sensory testing involving respondents (employees and non-employees). Testing with respondents can range from early exploratory studies to large-scale sensory studies and market claims tests regardless of the name assigned or the nomenclature used to describe the study. 4.2 The type of exposure or human (respondent) testing or both in scope is specified in 3.1.4 . Definition of a product or material or both as pharmaceutical or non-pharmaceutical may vary by country. Knowledge of local laws and regulations is essential. 4.3 Respondents, products, protocols and methods, study administration and oversight, and the testing environment are all within the scope of this guide. 4.4 This global guide: 4.4.1 Does not cover pharmaceutical or professionally prescribed healthcare products; 4.4.2 Does not cover studies in which respondents are not exposed to a product (marketed or developmental) or material; and 4.4.3 Does not govern workplace manufacturing exposure to product and ingredients. Occupational safety and health policies govern these workplace manufacturing exposures.
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归口单位: E18.05
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