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
- Status
- Published
- Publication Date
- 14-Oct-2021
- Technical Committee
- E18 - Sensory Evaluation
- Drafting Committee
- E18.07 - Personal Care and Household Evaluation
Overview
ASTM E3314-21: Standard Guide for Protection of Respondents and Informed Consent for Sensory Evaluation Studies provides essential guidelines for conducting nonpharmaceutical sensory testing involving human respondents. Developed by ASTM International, this global standard focuses on ensuring ethical practices, respondent safety, confidentiality, and compliance with applicable regulations. Sensory evaluation studies covered by this guide range from exploratory research to large-scale consumer tests, all designed to measure and record human perceptions and responses to products, materials, or ingredients.
Key Topics
Ethical Standards and Regulatory Compliance
- The guide emphasizes adherence to global ethical principles, including the Declaration of Helsinki.
- Researchers are responsible for understanding and following relevant local, regional, and national laws and regulations.
- Independent ethics committees or institutional review boards (IRBs) may be required, depending on the study.
Informed Consent
- All participants must provide voluntary, documented informed consent before participating in sensory studies.
- Consent documents should describe the study, highlight risks and benefits, explain confidentiality protocols, and provide emergency contacts.
Respondent Protection and Safety
- Safety plans and procedures should be implemented before any testing begins.
- The study environment, test products, and methods must be evaluated for safety and documented.
- Procedures for handling adverse events and medical concerns must be clear and accessible.
Confidentiality and Data Protection
- Personally identifiable respondent information is strictly protected in compliance with privacy regulations.
- Study managers must ensure confidentiality is maintained according to current industry best practices and regional laws.
Quality Assurance and Training
- All personnel involved in testing must be appropriately trained and qualified.
- Quality assurance (QA) procedures should monitor ongoing compliance and drive corrective actions as needed.
Applications
ASTM E3314-21 is applicable in a wide range of industries where sensory testing is used for nonpharmaceutical products, including:
- Food and Beverage, Cosmetics, and Personal Care: Evaluation of flavor, aroma, texture, or other sensory attributes to align products with consumer preferences.
- Consumer Goods: Market claims testing for new or existing nonpharmaceutical products.
- Household Products: Assessing user experience with cleaning agents, air fresheners, and related items.
In each application, the standard serves to:
- Demonstrate a commitment to respondent welfare and safety.
- Protect participant data and privacy.
- Satisfy business, scientific, and regulatory expectations around testing protocols.
- Provide documented justification for study designs and oversight processes.
Related Standards
Organizations following ASTM E3314-21 often find it beneficial to consider these related guidelines and resources to strengthen their sensory evaluation programs:
- ICH E6 (R1) Good Clinical Practice: Guidance on ethical and scientific quality standards in human research.
- ISO/IEC 27002:2013: Code of practice for information security management, supporting data privacy initiatives.
- Declaration of Helsinki: International principles for ethical medical research involving human subjects.
- SOC 2 / SOC 3 (AICPA): Standards for trust, privacy, and confidentiality in service organizations.
Adhering to ASTM E3314-21 helps organizations manage risk, foster consumer trust, and drive successful innovation through robust, ethical sensory testing practices.
Keywords: ASTM E3314-21, sensory evaluation, informed consent, respondent protection, ethics committee, nonpharmaceutical sensory testing, confidentiality, quality assurance, data privacy, adverse event, regulatory compliance.
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
Bureau Veritas
Bureau Veritas is a world leader in laboratory testing, inspection and certification services.
DNV
DNV is an independent assurance and risk management provider.
Sponsored listings
Frequently Asked Questions
ASTM E3314-21 is a guide published by ASTM International. Its full title is "Standard Guide for Protection of Respondents and Informed Consent for Sensory Evaluation Studies". This standard covers: 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.
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.
ASTM E3314-21 is classified under the following ICS (International Classification for Standards) categories: 03.020 - Sociology. Demography; 03.100.20 - Trade. Commercial function. Marketing. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM E3314-21 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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
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
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.
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
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-
Available from International Council for Harmonisation of Technical Require-
ments for Pharmaceuticals for Human Use (ICH), ICH Secretariat, Route de
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.
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.
Current edition approved Oct. 15, 2021. Published November 2021. DOI: “Declaration of Helsinki,” Bulletin of the World Health Organization, Vol 79,
10.1520/E3314-21. No. 4, 2001, p. 373.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E3314 − 21
3.1.3.1 Discussion—Thelegalstatus,composition,function, claims tests regardless of the name assigned or the nomencla-
operations, and regulatory requirements pertaining to indepen- ture used to describe the study.
dent ethics committees may differ among countries but should
4.2 The type of exposure or human (respondent) testing or
allow the independent ethics committees to (minimally) act in
both in scope is specified in 3.1.4. Definition of a product or
agreement with good clinical practices (GCP) as described in
material or both as pharmaceutical or non-pharmaceutical may
ICH-GCP E6. An ethics committee may also be known as an
vary by country. Knowledge of local laws and regulations is
independent ethics committee (IEC), an institutional review
essential.
board (IRB), or a research ethics board (REB).
4.3 Respondents, products, protocols and methods, study
3.1.4 exposure/human (respondent) testing, n—any research
administration and oversight, and the testing environment are
that involves respondents and one or more of: exposure (by
all within the scope of this guide.
means of taste, touch, smell, or any other physical contact) to
4.4 This global guide:
a product, material, or ingredient; obtaining, handling, or
4.4.1 Does not cover pharmaceutical or professionally pre-
sensory testing of human biological samples (for example,
scribed healthcare products;
blood or any other type of tissue or body fluid); measures of
4.4.2 Does not cover studies in which respondents are not
human physiological responses (for example, biomedical,
exposed to a product (marketed or developmental) or material;
biometrics, neurometrics, and so forth); or use of biological
and
sensors.
4.4.3 Does not govern workplace manufacturing exposure
3.1.4.1 Discussion—When the research includes physically
to product and ingredients. Occupational safety and health
invasive tests or physiological procedures, these tests or
policies govern these workplace manufacturing exposures.
procedures or both are to be conducted by personnel with the
appropriate expertise.
5. Key Guidance Principles
3.1.5 medical monitor, n—fulfills the sponsor requirement
5.1 The key guidance points in 5.1.1 – 5.1.9 summarize the
of “medical expertise.”
basic principles and general guidance to be followed for
3.1.5.1 Discussion—Per ICH-GCPE6, “The sponsor should
ensuring the rights, safety, and well-being of human testing
designate appropriately qualified medical personnel who will
subjects (that is, respondents) are in compliance with global
be readily available to advise on (human testing) related
regulatory requirements and business, scientific, and ethical
medical questions or problems. If necessary, outside consul-
standards derived from the Declaration of Helsinki.
tant(s) may be appointed for this purpose.”
5.1.1 All individuals involved in conducting tests with
3.1.6 quality assurance, QA, n—QAauditors assess compli-
respondents shall be trained and qualified to perform their role,
ancewiththestudyplanandappropriateregulationsandcanbe
including training to understand the rights, safety, and well-
internal or external auditors.
being of the respondents.
3.1.7 study manager, n—person responsible for execution of
5.1.2 Testing involving respondents shall be scientifically
the study plan, that is, how the respondent (sensory) test is
sound, documented in a clear and detailed study plan before
conducted.
conduct, and the results recorded and maintained as per any
3.1.7.1 Discussion—The study owner and study manager
regulatory requirements.
can be the same person.
5.1.3 The study owner is accountable for all aspects of the
study and, therefore, all planned respondent testing shall be
3.1.8 study owner, n—person (study sponsor) accountable
reviewed and approved by the study owner without exception
for initiating the respondent (sensory) test and taking or
for compliance with regulatory and safety expectations.
recommending action based on the study results.
5.1.4 Respondent testing will be evaluated by the study
3.1.8.1 Discussion—The accountable person is responsible
owner to determine if an ethics committee submission is
for making or approving all decisions related to the study
required and this decision documented.
design or plan or both, items to be tested, and issues that may
5.1.5 Freely given, documented informed consent shall be
arise during the study.
obtained from every respondent (or legal caregiver) before
3.1.9 study plan, n—includes the study plan (protocol and
study participation. Documented informed consent shall be
methods) components described within this guide, as well as
maintained with the study plan and results.
any amendments to the plan.
5.1.6 Confidentiality of records that could identify respon-
3.1.9.1 Discussion—A study plan should assure the test is
dents (personally identifiable information) will be protected in
scientifically sound and includes enough information to ensure
accordance with applicable regulatory requirements (for
reproducibility, as well as aid in compliance to relevant
example, local, regional, national, and so forth).
regulations.
5.1.7 Safety plan and procedures are in place before the
study is designed and implemented. The safety plan and
4. Significance and Use
procedures shall b
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...