Standard Guide for Protection of Respondents and Informed Consent for Sensory Evaluation Studies

Importancia y uso:

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.

Subcomité:

E18.05

Volúmen:

14.03

Número ICS:

03.020 (Sociology. Demography), 03.100.20 (Trade. Commercial function. Marketing)

Palabras clave:

adverse event; Declaration of Helsinki; ethics committee; exposure/human (respondent) testing; medical monitor; quality assurance; study manager; study owner; study plan;