Society of Automotive Engineers of Japan: Ethical Guidelines
for Research Involving Human Subjects
Introduction
Studies based on a variety of research (experiments, investigations, and observations)involving human subjects are a prerequisite for achieving a safer and more secure vehicle-basedsociety.

Accordingly, such research must be carried out with a firm ethical foundation toguarantee the safety of the research subjects, human rights, and social consensus with respect tothe research.

The Society of Automotive Engineers of Japan (JSAE) has formulated these

ethical guidelines for research involving human subjects as a recommended code for achieving
this purpose.
Scope
These guidelines shall be applied to research in the field of automotive engineering thatinvolves a person or persons as research subjects.

All persons presenting research(presentations, manuscripts, contributions, and the like) through the JSAE shall follow theseguidelines.
Section 1

Basic Principles for Researchers Performing Research Involving Human Subjects

Note that the terminology in these guidelines is defined in Section 2.
1.1. Ensuring validity from scientific, ethical, and other standpoints
Researchers performing research involving human subjects (abbreviated to “research” below)
shall follow the items listed below when planning and performing the research.
(1) The contents of the research shall have sufficient scientific and ethical validity, and shallrespect the dignity and human rights, and ensure the safety of the research subjects.
(2) Detailed checks shall be made of the required information before planning and performing
the research.

A clear and specific research plan shall be prepared that reflects these checks.

(3) Before starting the research, the research plan shall be examined by an Ethics Review
Board or similar organization, and approval obtained from the Chief or equivalent person of theresearch institution to which the researcher belongs.

The same procedure shall be followed if

the research plan is changed.
1.2. Protection of personal information
Data, information, or the like relating to research subjects shall be handled appropriately.

1All personal information shall be protected.

Personal information obtained in the course of theresearch shall not be disclosed to a third party without due reason.

This shall apply even after

the person responsible for the research or the person or persons conducting the research haveleft their posts.
1.3. Acquisition of informed consent
Before carrying out any research, informed consent shall be obtained in advance from theresearch subjects.

The details of explanations given to the research subjects and the method ofconfirming consent shall be clearly stated in the research plan.
1.4. Measures when announcing results
The necessary measures shall be carried out to protect the personal information and privacyof research subjects when the research results are announced.
1.5. Guidance obligation of person or persons responsible for the research
The person or persons responsible for research involving human subjects shall guide andmonitor the person or persons conducting the research to ensure that the research satisfies allnecessary items, including points 1.1 to 1.4 above.
Section 2

Definitions of Terminology in the Basic Principles

2.1. Research
The research covered by these guidelines is likely to result in the collection of a variety ofdata and samples relating to people or groups of people under various conditions.

Thecollection methods can be broadly categorized in accordance with the means of collecting thedata or samples into experiments, investigations, and observations.
(1) Experiments
Experiments are methods of actively collecting data or samples by artificially establishingconditions or environments for an individual or specified group.

For example, experiment

methods include the comparison of results before and after applying certain conditional controls
or between groups that are subjected or not subjected to certain controls, or the extrapolation of
the effects of establishing factors within a certain environment.
(2) Investigations
Investigations are methods of actively collecting data or samples when the artificial
establishment of conditions or environments is carried out on only a minor level.

For example,investigation methods include the use of language, numbers, or the like to identify the response2

of individuals, specified groups, or unspecified general groups based on questions (paper-based,interviews, and the like) or the contents of recorded natural action states in vehicle usage
scenarios.
(3) Observations
Observations are methods of collecting data or samples without active intervention and withthe artificial establishment of conditions or environments kept to a minimum, and then using
these results to identify the natural behavior, action states, or the like of individuals, specified
groups, or unspecified general groups.
2.2. Research subjects
In research involving human subjects, the scope of the term “research subjects” covers theperson or persons that are being researched, the person or persons who requested the research,and the person or persons who provided human-derived samples (for example, saliva, urine,blood, and the like) or human-derived information (for example, related to lifestyles, behavior,preferences, impressions, and the like) used in the research.

Research subjects include

individuals, specified groups, or unspecified general groups.
2.3. Person or persons responsible for the research
These people are defined as the person or persons that take responsibility for planning andperforming research involving human subjects, and who administer, manage, and monitor work
related to that research.
2.4. Person or persons conducting the research
These people are defined as the person or persons involved in the collection, analysis,management, and the like of data, samples, and so on in the planning, experiments,
investigations, and observations of research involving human subjects.

These people also

include persons engaged in auxiliary roles such as measurement, analysis, and the like.
2.5. Third party
A third party is anyone related to the research not covered by the definitions of the person orpersons responsible for the research, the person or persons conducting the research, or theresearch subjects.
2.6. Ethics Review Board, etc.
This is an organization with the multifaceted role of investigating, deliberating, and advising
the planning of research involving human subjects from various ethical standpoints, including3

the personal dignity, human rights, and safety of the research subjects, while considering thesocial and scientific aspects of the research.
2.7. Personal information
Of the information obtained from the research subjects and the like or the information used in
the research and the like, this covers information related to individual research subjects.

Thisis information that can be used to identify specific individuals from descriptions, images, or thelike, including names, dates of birth, and so on, which results in violations of an individual’s
privacy, dignity, safety, and so on.

It also includes information that may be easily verified

against other information to identify specific individuals.
2.8. Necessary measures to protect personal information, privacy, and the like
These are measures that should be carried out so that individual research subjects cannot beidentified when the results of the research are announced.
2.9. Informed consent
This refers to the process that shall be carried out by the person or persons conducting theresearch when requesting someone to become a research subject.

This process involves anexplanation from the person or persons conducting the research so that the potential researchsubjects can determine whether to agree to participate in the research.

This explanation shallenable the potential research subjects to fully understand the contents of the research, to makean intentional judgment and agreement for themselves about whether to become a researchsubject, and to consent with respect to the handling of data, samples, personal information, andthe like obtained in the research.
Section 3

Supplemental Explanation of Basic Principles

3.1. Deliberations of research plans by Ethics Review Board or the like(1) Key points to be noted when formulating research plans- Hazards or risks in excess of the minimum levels faced by research subjects in their daily
lives shall be predicted.

If the Ethics Review Board or the like judges that the plan does notcontain measures capable of avoiding these hazards or risks, such research shall not be plannedon principle.
- The research plan shall contain all the specific information required by the Ethics Review
Board or the like to judge the ethical validity of the research.
examples of items that shall be included in the plan.

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The following points are

The action plan for the research itself (*)
The disadvantages, hardships, and risks involved in the research, and the methods to prevent
them or ensure safety
The details of explanations about the research to research subjects and methods to confirm
consent (i.e., the informed consent procedure)
Whether or not participating in the research involves any form of compensation, and if so, thedetails of the compensation
Methods of announcing the results (including the necessary measures to protect personalinformation) and the like(*) Details of action plan
The research duration, person or persons responsible for the research, person or persons
conducting the research, locations where the research is to be conducted, purpose of the research,
research methods (devices to be used, measurement items, as well as the likely burden to be
imposed on the research subjects, issues related to the work, time required to spend participatingin the research, and the like), information related to the research subjects (including payment
information), and so on(2) Deliberations by Ethics Review Board or the like- The aim of the deliberations by the Ethics Review Board or the like is to examine theindividual research plans from ethical and scientific standpoints and to provide advice toimprove the research plan by expressing opinions about its details and the like so that theresearch can be carried out appropriately and smoothly.
- If the research organization does not have an Ethics Review Board or the like, it shallestablish such a function as soon as possible.

While this function is being established, theorganization shall obtain confirmation from a suitable third-party that the research plan inquestion complies with the Ethical Guidelines for Research Involving Human Subjects preparedby the JSAE.

Note that a “suitable third-party” refers to a person or persons with the necessary

experience to take responsibility for ethical and legal compliance.

This experience shall havebeen obtained, for example on the Ethics Review Board of another organization or in theorganization in question.
- The Ethics Review Board or the like shall consist of people with various backgrounds toensure that the deliberations can be carried out fairly and impartially from a number of different
standpoints.
- The members of the Ethics Review Board or the like shall not disclose information obtainedin the course of their work without due reason.

This shall apply even after the member has leftthe Ethics Review Board or the like.
- Persons related to the research plan to be deliberated (i.e., the person or persons responsible

5for the research, the person or persons conducting the research, and the like) may not participate
in deliberations about the research.
(3) Management in the research implementation stage- The research shall be suspended or stopped in the following events: if the risks are judged tooutweigh the expected merits of the research, if a serious accident occurs, if the research meets
its targets by obtaining sufficient results prior to the initially planned completion of the research,or if it is no longer meaningful to perform the research.
- Systems and procedures in the event of an accident or the like shall be established inadvance.

The person or persons conducting the research and the like shall have thoroughknowledge of these procedures and shall follow the procedures without fail.
- The necessary systems to protect personal information related to the research shall beestablished.

Safety procedures shall be followed when the person or persons conducting theresearch or the like handle personal information.
3.2. Protection of personal information- In principle, data and samples that include personal information in research shall beanonymized.

Anonymizing personal information refers to the removal of all or part of

information capable of identifying individuals from that personal information to prevent
disclosure of personal information outside the research.

The removed information shall bereplaced by symbols or codes.
- There are two methods of anonymizing personal information, traceable and untraceable
anonymization.

Traceable anonymization involves applying a new symbol or code for a

research subject to ensure that person can be identified as necessary, and maintaining a table that
explains the meanings of the symbols or codes.

In untraceable anonymization, such a table is

not created.
- When research results are announced, it shall not be possible to identify individual researchsubjects from the results.

However, if there is value in announcing the results in a format thatis capable of identifying individual research subjects (for example, research using facialexpressions), then the consent of the research subjects shall be obtained in advance.
Supplement: Paragraph 1 of Article 50 of the Japanese Act on the Protection of Personal
Information makes exclusions to the application of this Act in reference to the basic human rightof academic freedom guaranteed under the Japanese Constitution.

Therefore, legal obligations

and other regulations may not be applicable when a university or other institute that aims toperform academic research handles personal information.

However, even in these cases,

Paragraph 3 of Article 50 of the same Act requires such institutes to voluntarily establish
measures to secure personal information when it is handled.

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It is preferable that academic

research should be carried out in accordance with the details of related governmental codes in
the medical research field and the like.
3.3. Informed consent- In principle, informed consent shall be obtained using a written explanation of the researchdetails.

Consent to participate in the research shall also be obtained in writing using a consent

form.
Supplement: There shall be no need to obtain written consent in the case of anonymousquestionnaires and the like.

In these cases, filling out the questionnaire itself may be regarded

as consent.
- Explanations for potential research subjects shall be written in such a way that the researchsubjects can thoroughly understand the details of the research and make a free judgment forthemselves about whether to participate.

The research subjects may refuse to participate in theresearch after reading and thoroughly understanding the explanation.

The written explanation

shall contain specific descriptions with all the information necessary to make a judgment aboutparticipation.

In addition, the explanation shall not cause misunderstanding or be at variancewith the facts.

Specialist terminology shall be avoided whenever possible and the explanation

shall be written in plain language.

The following points are examples of items that shall beincluded in the explanation.
The action plan for the research itself (*)
The disadvantages, hardships, and risks involved in the research, and the methods to prevent
them or ensure safety
Whether or not participating in the research involves any form of compensation, and if so, thedetails of the compensation
Methods of handling the research data and announcing the results (including the necessary
measures to protect personal information)
The right to refuse to participate and the right to stop participating at any time
Contact details for queries or complaints about the research(*) Details of action plan
The research duration, person or persons responsible for the research, locations where theresearch is to be conducted, purpose of the research, research methods (measurement items,details of any personal information or human-derived samples, as well as the likely burden to be
imposed on the research subjects, issues related to the work, time required to spend participatingin the research, and the like), information related to the research subjects, and so on- Informed consent shall be obtained directly from the actual potential research subject,providing that person is capable of expressing the intention to participate.

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If the potential

research subject is living but cannot effectively express the intention to participate, theninformed consent shall be obtained from a proxy (a legal representative capable of representing
the intentions and interests of the research subject, or a close family member).

If the potential

research subject is deceased, then informed consent shall be obtained from the family of thedeceased (spouse, adult child or grandchild, sibling, parent, grandparent, a family member that
cohabited with the deceased, or an equivalent person).
- If informed consent is not obtained in this way, or informed consent is obtained through a
proxy, then the appropriateness of the consent shall be deliberated by the Ethics Review Boardor the like.
EndPermission was obtained from the Japan Ergonomics Society to reference its Code ofConduct for Ergonomic Research in formulating these guidelines.
Related materials- World Medical Association: Declaration of Helsinki- Ministry of Health, Labour and Welfare: Ethical Guidelines for Epidemiological Research- Ministry of Health, Labour and Welfare: Ethical Guidelines for Clinical Research- Nuremberg Code- Belmont Report: National Commission for the Protection of Human Subjects of Biomedicaland Behavioral Research.

Research Ethics Committee
Society of Automotive Engineers of JapanMarch, 20128