【国外标准】 Standard Guide for Protection of Respondents and Informed Consent for Sensory Evaluation Studies

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; and4.4.3 Does not govern workplace manufacturing exposure to product and ingredients. Occupational safety and health policies govern these workplace manufacturing exposures.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.