ASTM E3314-21
(Guide)Standard Guide for Protection of Respondents and Informed Consent for Sensory Evaluation Studies
Standard Guide for Protection of Respondents and Informed Consent for Sensory Evaluation Studies
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.
SCOPE
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.
General Information
Standards Content (Sample)
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.
Designation: E3314 − 21
Standard Guide for
Protection of Respondents and Informed Consent for
1
Sensory Evaluation Studies
This standard is issued under the fixed designation E3314; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 This guide will cover the considerations that shall be
mendations issued by the World Trade Organization Technical
made when testing products, materials, or ingredients with
Barriers to Trade (TBT) Committee.
respondents for their sensory response to products and stimuli.
A sensory study is defined as a study in which respondents’
2. Referenced Documents
perceptions and responses to stimuli are measured and re-
2.1 ICH Standard:
corded. These data are used by companies to help design
2
ICH E6 (R1) Good Clinical Practices
products that better meet consumers’ needs, manage risk in
2.2 ISO/IEC Standard:
developing products, and/or build knowledge of products
ISO/IEC 27002:2013 Information technology—Security
sensory and performance attributes and consumers’ product
techniques—Code of practice for information security
needs.
3
controls
1.2 In this guide, the key principles driving safe sensory
testingaresummarized,andtheningreaterdetail,thestepsand
3. Terminology
processes to be considered to maintain ethical standards and
3.1 Definitions:
ensure safety and confidentiality of human respondents to meet
3.1.1 adverse event, n—unexpected/unusual reaction or
government and regulatory requirements globally are de-
health effect by a respondent during the exposure to or use of
scribed. Respondents, test product/material, protocols and
a product or test stimulus.
methods, study administration and oversight, and testing envi-
3.1.1.1 Discussion—Causality of the effect to the product or
ronment are all subject to oversight to maintain ethical
test stimulus is not necessary. (ICH-GCP E6)
standards, respondent confidentiality, and ensure a respon-
3.1.2 Declaration of Helsinki, n—ethical principles for
dent’s safety. Governmental and regulatory bodies, along with
medical research involving human subjects (in this case, the
local organizations and professions, also provide requirements
sensory respondents), most recently updated in October 2013,
and guidance. It is incumbent upon the researcher to be aware
4
as defined by the World Health Organization.
of, and follow, these guidelines and requirements for any study
for which they are responsible.
3.1.3 ethics committee, n—independent body (a review
board or a committee, institutional, regional, national, or
1.3 In this guide, all local regulations that may apply to
supranational), constituted of medical professionals and non-
sensory testing are not identified. The minimum standards and
medical members whose responsibility it is to ensure the
best practices for ethical treatment and safety of respondents
protection of the rights, safety, and well-being of human
during sensory testing are defined.
subjects (respondents) involved in a study and to provide
1.4 This standard does not purport to address all of the
public assurance of that protection by, among other things,
safety concerns, if any, associated with its use. It is the
reviewing and approving/providing favorable opinion on the
responsibility of the user of this standard to establish appro-
(study plan), the suitability of the investigator(s), facilities, and
priate safety, health, and environmental practices and deter-
the methods and material to be used in obtaining and docu-
mine the applicability of regulatory limitations prior to use.
menting informed consent of the trial subjects.
1.5 This international standard was developed in accor-
dance with internationally recognized principles on standard-
2
Available from International Council for Harmonisation of Technical Require-
ments for Pharmaceuticals for Human Use (ICH), ICH Secretariat, Route de
1
This guide is under the jurisdiction of ASTM Committee E18 on Sensory Pré-Bois, 20, P.O Box 1894, 1215 Geneva, Switzerland, https://www.ich.org.
3
Evaluation and is the direct responsibility of Subcommittee E18.07 on Personal Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
Care and Household Evaluation. 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Current edition approved Oct. 15, 2021. Published November 2021. DOI: “Decl
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.