上智大学「人を対象とする研究」に関するガイドライン
Sophia University Guidelines for Research on Human Subjects
Enacted 1 April 2010
Revised 1 May 2023
Article1: Purpose
The objectives of the Guidelines (referred to herein as “the Guidelines”) shall outline considerations
on Research on Human Subjects conducted within or outside of Sophia University (referred to herein as “theUniversity”) to protect the human dignity and human rights of Research Subjects, emphasize thesignificance of social responsibilities, and promote research activities smoothly at the University.
Article 2: Subject“Researchers” to whom the Guidelines apply shall mean faculty members of the University, as well as allundergraduate students, postgraduate students, and researchers engaged in research activities at theUniversity. Research activities conducted by students must be properly supervised by a supervising faculty
who understands the Guidelines. In particular, the supervising faculty member shall be responsible for
examining the research plans of their students.
Article 3: Definitions of Terms
The meaning of the following terminology in the Guidelines shall be defined as follows:(1) “Research on Human Subjects” shall mean research activities conducted by means of the accumulation orcollection of “information and data related to emotions, thoughts, behaviors, environment, or physical andmental condition, etc. of individuals or groups,” specified in Item (3).
(2) “Personal Information, etc.” shall mean “Personal Information” defined in Article 2 Clause 1,“Personal Information Requiring Special Care” defined in Article 2 Clause 2, “Pseudonymized PersonalInformation” defined in Article 2 Clause 6, “Anonymized Personal Information” and “Personal RelatedInformation”defined in Article 2 Clause 6 (information relating to a living individual which doesn't fallunder Personal Information, Pseudonymized Personal Information and Anonymized Personal Information), which
are all specified in the Regulations for the Protection of Personal Information of the University (referredto herein as “the Personal Information Protection Regulations”).
(3) “Information and data related to emotions, thoughts, behaviors, environment or physical and mentalcondition, etc. of individuals or groups” (referred to herein as “Personal Information and Data, etc.”)
shall mean information and data related to characteristics, emotions, cognitions, thoughts, beliefs,behaviors, experiences, habits, environment, economic situation, or physical health of individuals orgroups (results of examinations and measurements related to movement, exercise, physical conditions, etc.),
as well as material or data of human and human origin (blood, body fluids, tissue, cells, genes, etc.).
(4) “Research Subject(s)” shall refer to the collective term for individuals who are the subjects ofresearch (including those who are requested to participate in experiments as the subjects) and individuals
who provided existing specimens and information to Researchers. It also includes individuals who
participate in experiments or cooperate in field studies as Research Subjects.
Article 4: General Rules
Those who conduct Research on Human Subjects must respect the dignity of life and the individual, based on
the founding spirit of the University, and carry out their research using scientific and sociallyappropriate means and methods, while adhering to the following general rules.
(1) Those who conduct Research on Human Subjects must adhere to the Guidelines, the regulations of theUniversity, such as Sophia University Guidelines for "Academic Research Ethics" and the Personal
Information Protection Regulations, as well as Japanese laws and regulations, the ordinances and guidelinesof the relevant government offices, and the guidelines of academic societies.
(2) When implementing research, the human rights of Research Subjects must be given the highest regard andefforts must be made to conduct research that is scientifically and socially significant.
(3) Researchers must use the safest methods to collect Personal Information and Data, etc., in order tominimize the risks of physical or emotional stress or pain for Research Subjects as little as possible.
Article 5: Informed Consent(1) Prior explanation to Research Subjectsa) When conducting Research on Human Subjects, Researchers must provide an easy-to-understand mannerexplanation to the Research Subject beforehand, regarding the purpose of the research, the method ofpresenting the research results, and the research plan.

1b) When any kind of physical or emotional stress, pain or danger to the Research Subject is expected during
the collection process of Personal Information and Data, etc., Researchers must explain the expected
effects of the research participation as easy as possible to the Research Subject beforehand.
(2) Obtaining Research Subjects’ consent
When Researchers conduct Research on Human Subjects, Researchers must obtain the freely exercised consentof the Research Subjects beforehand, either in writing or by another method.
a) "Research Subjects’ consent" shall include the matters concerning research purpose, handling of
Personal Information and Data, etc. and the method of presentation or publication.
b) Researchers must respond to requests from the Research Subjects for disclosure, correction, deletion,suspension of use, etc. (referred to herein as "disclosure, etc.") of Personal Information and Data, etc..
If Personal Information and Personal Information Requiring Special Care are included in the request, theprovisions of Articles 17 to Article 19 of the Personal Information Protection Regulations shall apply tothe procedures. When there is a probability that the life, physical health, property, or other rights andinterests of Research Subject or a third party could be harmed, Researchers could stop disclosing genetic
information by following the Ministry of Education, Culture, Sports, Science and Technology, the Ministryof Health, Labour and Welfare, and the Ministry of Economy, Trade and Industry.
c) If a Research Subject is under the age of 18, Researchers must obtain the consent from the Research
Subject as well as a guardian or a person with parental authority of the Research Subject(referred toherein as "Parental Authority, etc."). However, an exception is made in instances where any of the items ofArticle 6 apply.
d) If a Research Subject is an infant or disabled and it is difficult to verify the consent of the Research
Subject, Researchers must obtain the consent of the Parental Authority, etc.
e) If a Research Subject could provide her/his intension to participate in research, Researchers must gain
their understandings and give an easy-to-understand and sufficient explanation to Research Subject, even if
Researchers obtain consent from the Parental Authority etc..
f) Unless there are special circumstances, Researchers must obtain the consent from the Research Subject inadvance. In particular, if any kind of physical or emotional stress, pain, or danger to the Research
Subject is expected, the Research Subject must provide written consent in advance.
g) Researchers must maintain provided consent records securely for an appropriate period of time. However,Researchers must discard information and data promptly if a Research Subject withdrawn his/her consent.
Article 6: Simplification or Waiver of Informed ConsentThe procedures for informed consent specified in the previous Article may be simplified or waived only inthe circumstances detailed below. Except for cases to which Item (3) of this Article applies, the Research
Subject must be given an explanation beforehand.
(1) For surveys in which answers and cooperation are left to the will of the Research Subject, if eitherof the following applies, the responding act of the Research Subject to the questions may be substituted
for the consent of the Research Subject.
a) Anonymous surveys that do not collect Personal Information, etc.
b) Surveys in which the questions are assumed to pose no physical or emotional stress, pain, or danger tothe Research Subject (except the cases to obtain special care-required personal information).
(2) When all of the following apply, the procedures of informed consent may be simplified or waived(except the cases to obtain Personal Information Requiring Special Care).
a) If the research cannot actually be implemented without simplifying or waiving the procedures of informed
consent, or if such procedures would considerably undermine the merit of the research in questionb) If there is expected to be no physical or emotional stress, pain, or danger to the Research Subject fromsimplifying or waiving the procedures of informed consentc) If the research in question is deemed to be of high social urgency(3) Regardless of Items (1) and (2) of this Article, if revealing the true purpose of the research would
make it impossible to implement the research in question, or if it would considerably undermine the meritof the research in question, the following provisions shall apply (except the cases to obtain Personal
Information Requiring Special Care).
a) If an explanation cannot be given beforehand because prior awareness of the true purpose of the researchwould alter the response of the participant in the experiment, or if giving a false explanation isnecessary, then the true purpose of the research must be explained promptly after the completion of theexperiment, and consent should be obtained.
b) In field research, if it is difficult to obtain prior consent because prior explanation of the purposeof the study to the Research Subject and obtaining of consent would hinder the formation of a naturalrelationship with the Research Subject, then the purpose of the survey must be promptly explained to theResearch Subject afterwards (before the results of the survey are publicized at the latest) and consent
should be obtained.

2Article 7: Contracting to Third Parties(1) If Researchers contract a third party to collect and analyze Personal Information and Data,etc.,
Researchers must contract with the third party in accordance with the Guidelines and Personal Information
Protection Regulations.
(2) When a Research Subject requests Researchers for an explanation, Researchers must explain it to theResearch Subject regarding the purpose of the intention of contract with a third party.
Article 8: Requests to participate in research in classes and other educational settings(1) Researchers must obtain the consent from students in advance, when Researchers unavoidably request
students to submit their Personal Information and Data, etc. for research in the educational
implementations or courses such as classes, seminars, practical skills, experiments, practical training,and other educational practices.
(2) Due to the presence or absence of the provision of Personal Information and Data etc., Researchers must
not disadvantage students in grade or other related evaluations.
Article 9: Examination of Research Plans(1) Examination of research plans published or implemented by Researchers conducting Research on HumanSubjects (referred to herein as “Research Plans”) shall be conducted by the Sophia University Ethics
Committee for Research on Human Subjects (referred to herein as “the Committee”) based on the Application
for Examination of Research Plan (Form 1), Research Proposal, and other appended documentation from theResearcher (the applicant).
(2) Provisions related to the Committee shall be specified separately.
Article 10: OtherIn addition to stipulated definitions in the Guidelines, Researchers will be responsible for following andcomplying with the Personal Information Protection Regulations.
Supplementary ProvisionsThe Guidelines are effective from April 1, 2010.
The Guidelines are effective from May 1, 2023.
Note: The English translation is provided for information. The original Japanese version remains the sole
official version. If there is any discrepancy between the two versions, the Japanese original should takeprecedence.

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