79C3C34C52B45572883A05D425EB0F82
Ethical Guidelines for Medical and Health Research Involving Human Subjects
https://www.mhlw.go.jp/file/06-Seisakujouhou-10600000-Daijinkanboukouseikagakuka/0000080278.pdf
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This file was generated: 2020-12-01 07:34:00
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / political affiliation
Searching for indicator party:
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p.000041: implementing entity;
p.000041: (ii) Purpose of the utilization of the retained personal information, with respect to information utilized in
p.000041: research, a statement to the effect that it is utilized in research (including that it is provided to other
p.000041: research implementing entity(s), if such is the case) and, with respect to information not utilized in
p.000041: research, intended use of such information;
p.000041: (iii) Procedures to meet requests made pursuant to the provisions of (2) of this section or Section 2 (1),
p.000041: (3), (4) or (6) below (hereinafter referred to as “request for disclosure, etc.”) including the amount of
p.000041:
p.000042: 42
p.000042:
p.000042:
p.000042: charges, if set pursuant to the provisions of Section 2 (2); and
p.000042: (iv) The place where consultation, etc. concerning the handling of the retained personal information is
p.000042: undertaken.
p.000042: (2) When the chief executive of research implementing entity is requested by a person, etc. for notification of the
p.000042: purpose of utilization of such retained personal information as may lead to the identification of the person
p.000042: concerned, the said chief executive shall, without delay, notify to the requesting person, etc. (hereinafter
p.000042: referred to as the “claimant”) of such purpose.
p.000042: (3) The provisions of (1) (ii) and (2) above shall not apply to any of the following cases:
p.000042: (i) Cases in which making the purpose of the utilization easily accessible or notifying it to
p.000042: the claimant are likely to harm the life, body, properties and other rights and interests of research subjects, etc.
p.000042: or any other third-party individual(s); or
p.000042: (ii) Cases in which making the purpose of the utilization easily accessible or notifying it to
p.000042: the claimant are likely to harm the rights or legitimate interests of the research implementing entity.
p.000042: (4) When the chief executive of research implementing entity has decided not to notify pursuant to the provisions
p.000042: of (3) above, with respect to the purpose of utilization pursuant to the provisions of (2) above, the
p.000042: said chief executive shall, without delay, notify the claimant of that effect. In addition, the said chief executive
p.000042: shall endeavor to explain the reasons and to obtain understanding of the claimant.
p.000042:
p.000042: 2. Response to request for disclosure, etc.
p.000042: (1) When the chief executive of research implementing entity is requested by a person, etc. to disclose the retained
p.000042: personal information as may lead to the identification of the person (such disclosure also includes notifying the
p.000042: person that the research implementing entity has no such retained personal information as may lead to the
p.000042: identification of the person concerned; the same shall apply hereinafter), the said chief executive shall, without
p.000042: delay, disclose relevant personal information to the claimant. In falling under any of the following, however, the said
p.000042: chief executive may keep all or part of the retained personal information undisclosed. In addition, when any
p.000042: provision has been established in laws or ordinances concerning the
p.000042:
p.000043: 43
p.000043:
p.000043:
p.000043: disclosure of the retained personal information, such provisions shall be applied.
p.000043: (i) Cases in which disclosure is likely to harm the life, body, property, or other rights and interests of the
p.000043: research subjects, etc. or a third party;
p.000043: (ii) Cases in which disclosure is likely to seriously impede the proper execution of the research work of
p.000043: the research implementing entity; or
p.000043: (iii) Cases in which disclosure violates any laws or ordinances.
p.000043: (2) When the chief executive of research implementing entity is requested to notify the purpose of utilization
p.000043: pursuant to the provisions of Section 1 (2) or to make a disclosure pursuant to the provisions of (1) above, the said
p.000043: chief executive may collect charges for taking the measure. In this case, however, the said chief
p.000043: executive shall determine the amount of such charges within the scope considered reasonable in consideration of
p.000043: actual costs.
p.000043: (3) When the chief executive of research implementing entity is requested by a person, etc. to correct, add,
p.000043: or delete (hereinafter referred to as “correction, etc.”) such retained personal information as may
p.000043: lead to the identification of the person on the grounds that the retained personal information is contrary
p.000043: to the fact, the said chief executive shall, except in cases in which special procedures are prescribed
p.000043: by any laws and ordinances for such correction, etc., make a necessary investigation without
p.000043: delay within the scope necessary for the achievement of the purpose of utilization and, on the basis of
p.000043: the results, execute relevant correction, etc. of the retained personal information.
p.000043: (4) Where the chief executive of research implementing entity is requested by a person to discontinue using or
p.000043: to erase (hereinafter referred to as “discontinuance, etc.”) such retained personal information as may lead to the
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Political / vulnerable
Searching for indicator vulnerable:
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p.000003: human subjects can take a variety of forms. It is required that all individuals concerned, such as investigators,
p.000003: etc., the chief executive of a research implementing entity and members of ethical review committee shall
p.000003: have high-level ethical standards and carry out each responsibility in compliance with these rules in order that
p.000003: their research can contribute to society by obtaining understanding and trust from society.
p.000003:
p.000003: Chapter 1 General Provisions
p.000003: Part 1 Purpose and Basic Principles
p.000003: The purpose of these Guidelines is to ensure that human dignity and rights be protected and that medical and
p.000003: health research involving human subjects be promoted appropriately, by prescribing the rules and procedures with
p.000003: which those who are concerned in such research should comply. Any of those concerned in this type of
p.000003: research shall carry out their research, in accordance with these Guidelines as basic principles for the
p.000003: matters as defined below:
p.000003: (i) Implementation of research with social and academic values;
p.000003:
p.000004: 4
p.000004:
p.000004:
p.000004: (ii) Ensuring of scientific validity suitable to the characteristics in the particular field of research;
p.000004: (iii) Comprehensive assessment of the burdens on research subjects and predicted risks and benefits;
p.000004: (iv) Review by an independent and fair ethical review committee;
p.000004: (v) Adequate prior explanation and voluntary informed consent of research subjects;
p.000004: (vi) Special consideration for vulnerable subjects;
p.000004: (vii) Protection of personal information, etc.; and
p.000004: (viii) Ensuring of integrity and transparency of research.
p.000004:
p.000004: Part 2 Glossary
p.000004: The terms used in these Guidelines shall be defined as follows:
p.000004: (1) Medical and Health Research Involving Human Subjects
p.000004: An activity involving human subjects (including specimens and information acquired from them) to be
p.000004: carried out for the purpose of obtaining knowledge contributing to maintain and promote people’s good
p.000004: health or to recover from injury and disease and improve quality of life for patients, through understanding the
p.000004: cause of diseases (including the frequency and distribution of various health-related incidents and
p.000004: factors affecting them) and their pathology and through improving measures to prevent injury and disease as
p.000004: well as diagnostic and treatment measures in medical care or through verifying those measures’ validity.
p.000004: In these Guidelines, the term “research” refers to the above-defined medical and health research involving
p.000004: human subjects, when it is mentioned without any specific remark.
p.000004:
p.000004: (2) Invasiveness
p.000004: To cause injuries or distress to research subjects’ body and/or mind by conducting a procedure for investigational
p.000004: purpose, such as puncture, incision, administration of drugs, irradiation and questions related to the
p.000004: subject’s mental trauma, etc.
p.000004: Of various types of invasiveness, one causing minor injury and/or distress on the research subjects’ body
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Health / Cognitive Impairment
Searching for indicator impaired:
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p.000011: (3) Investigators, etc. shall respond appropriately and promptly to consultation, inquiries,
p.000011: complaints, etc. (hereinafter referred to as “consultation, etc.”) of research subjects or their
p.000011: legally acceptable representatives, etc. (hereinafter referred to as “research subjects, etc.”) and other
p.000011: individuals concerned.
p.000011: (4) Investigators, etc. shall not disclose information obtained while they are engaged in research without
p.000011: justifiable reason. The same shall apply even after investigators, etc. are no longer engaged in the research.
p.000011: (5) When an investigator, etc. becomes aware of any serious concern with respect to human rights of the
p.000011: research subject, etc. or with respect to implementing of the research, such as leakage of information related
p.000011: to the research, the investigator, etc. shall report promptly to the chief executive of research implementing entity
p.000011: and the principal investigator.
p.000011:
p.000011: 2. Ensuring, etc. of ethical justification and scientific validity of research
p.000011: (1) Investigators, etc. shall carry out research appropriately, complying with laws, ordinances, guidelines,
p.000011: etc. and in accordance with the research protocol reviewed by the ethical review committee and approved
p.000011: by the chief executive of the research implementing entity.
p.000011:
p.000012: 12
p.000012:
p.000012:
p.000012: (2) When an investigator, etc. becomes aware of any fact or obtains any information that ethical
p.000012: justification or scientific validity of the research he/she is engaged in is, or might be, impaired (not including
p.000012: cases which correspond to (3) below), the investigator, etc. shall report promptly to the principal investigator.
p.000012: (3) When an investigator, etc. becomes aware of any fact or obtains any information that appropriateness
p.000012: of implementing the research he/she is engaged in or the reliability of results of the research is, or
p.000012: might be, impaired, the investigator, etc. shall promptly report to the principal investigator or the chief
p.000012: executive of the research implementing entity.
p.000012:
p.000012: 3. Education and training
p.000012: Investigators, etc. shall receive education and training on the ethics of research and on knowledge and
p.000012: skills necessary to carry out the research prior to its implementation. They shall also receive education and
p.000012: training during the research period on a regular basis as necessary.
p.000012:
p.000012: Part 5 Obligations of Principal Investigator
p.000012: 1. Preparation of research protocol and compliance of investigators, etc.
p.000012: (1) The principal investigator shall prepare an appropriate research protocol prior to any implementation of
p.000012: research. In the same manner, the principal investigator shall revise the research protocol prior to any implementation
p.000012: of a changed conduct of research.
p.000012: (2) The principal investigator shall prepare a research protocol to ensure ethical justification and
p.000012: scientific validity of the research. In addition, when preparing the research protocol, the principal
p.000012: investigator shall comprehensively assess the burdens on research subjects and predicted risks and benefits as
p.000012: well as take measures to minimize such burdens and risks.
p.000012: (3) When the principal investigator intends to carry out research which involves invasiveness (not
p.000012: including minor invasiveness) along with medical technique beyond usual medical practice, the
p.000012: principal investigator shall take beforehand necessary measures, such as purchasing insurance, etc., in preparation
p.000012: for compensation to the research subject in the event of research-related injuries, appropriately.
p.000012: (4) Pursuant to the provisions in Part 9 of these Guidelines below, the
p.000012:
p.000013: 13
p.000013:
p.000013:
p.000013: principal investigator shall appropriately register the summary of his/her research and other related
p.000013: information, and make results of the research public.
p.000013: (5) The principal investigator shall instruct and manage other investigators and those concerned in his/her
p.000013: research implementing entity, in order that the research shall be appropriately carried out in compliance with
p.000013: the research protocol and that reliability of results of the research can be secured.
p.000013:
p.000013: 2. Management and supervision of research progress and identification and reporting adverse events, etc.
p.000013: (1) The principal investigator shall endeavor to take action in order that his/her research shall be
p.000013: carried out appropriately and the reliability of results of the research can be secured, for
p.000013: example, by collecting information necessary in carrying out the research.
p.000013: (2) When a principal investigator becomes aware of any fact or obtains any information that ethical
p.000013: justification or scientific validity of the research is, or might be, impaired, and if the continuation of the
p.000013: research will be hindered (not including cases which correspond to (3) below), the principal
p.000013: investigator shall report to the chief executive of the research implementing entity without delay and, as
p.000013: necessary, suspend or terminate the research or revise the research protocol.
p.000013: (3) When a principal investigator becomes aware of any fact or obtains any information that
p.000013: appropriateness of implementing the research he/she is engaged in or reliability of results of the research is,
p.000013: or might be, impaired, the principal investigator shall report to the chief executive of the research implementing
p.000013: entity promptly and, as necessary, suspend or terminate the research or revise the research protocol.
p.000013: (4) In the course of implementing research, when it is considered that predicted risks are larger
p.000013: than expected benefits of the research or it is considered that a satisfactory outcome has been achieved or
p.000013: that such an outcome cannot be achieved, the principal investigator shall terminate the said research.
p.000013: (5) When a principal investigator becomes aware of any serious adverse event which occurs in implementing of research
p.000013: and involves any invasiveness, the principal investigator shall promptly take relevant measures.
p.000013:
p.000014: 14
p.000014:
p.000014:
p.000014: (6) The principal investigator shall report to the chief executive of the research implementing entity, with respect
p.000014: to the progress of the research and status of any adverse event which occurs in implementing of the research,
p.000014: in accordance with specifications prescribed in the research protocol.
p.000014: (7) When research is finished (including the case of discontinuance; the same applies hereinafter), the principal
p.000014: investigator of the research shall report to the chief executive of the research implementing entity with respect to
p.000014: matters required.
p.000014: (8) When conducting research collaboratively with other research implementing entity(s), the
p.000014: principal investigator shall share relevant information to the research with the principal investigator of
p.000014: such other research implementing entity(s).
p.000014:
p.000014: 3. Following-up research subjects after end of research
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p.000015: entity, in accordance with the procedures established at the research implementing entity.
p.000015:
p.000015: 3. Approval, etc. of research
p.000015: (1) When the chief executive of research implementing entity is asked by principal investigator for
p.000015: approval for any implementation of research or revision of the approved research protocol, the said chief executive
p.000015: shall submit the matter to ethical review committee for deliberation and make decision on relevant measures, such as
p.000015: approval, disapproval, etc., to the matter with due respect to opinions presented by the ethical review
p.000015:
p.000016: 16
p.000016:
p.000016:
p.000016: committee.
p.000016: (2) When the chief executive of research implementing entity has received any report from principal investigator
p.000016: or other investigators, etc. concerning facts or information deemed to affect the propriety of continuance
p.000016: of a research, the said chief executive, as necessary, shall submit the matter to the ethical review committee
p.000016: for deliberation and, with due respect to opinions presented by the ethical review committee, take
p.000016: appropriate countermeasures promptly such as suspension of the research and examination of the cause.
p.000016: (3) The chief executive of research implementing entity shall provide cooperation with the
p.000016: investigation carried out by relevant ethical review committee.
p.000016: (4) When the chief executive of research implementing entity has received any report concerning the fact or
p.000016: information that appropriateness of implementing the research or reliability of results of the research
p.000016: is, or might be, impaired, the said chief executive shall take relevant measures promptly.
p.000016: (5) When the chief executive of research implementing entity has received any report from principal investigator that
p.000016: research has finished, the said chief executive shall report necessary matters to the ethical review committee
p.000016: which made reviews on the said research.
p.000016:
p.000016: 4. Report, etc. to the Minister(s)
p.000016: (1) When the chief executive of research implementing entity becomes aware that any research which the entity
p.000016: is implementing or implemented previously is not complying with these Guidelines, the said chief executive shall
p.000016: promptly submit the matter to the ethical review committee for deliberation and take relevant measures as well
p.000016: as, if such noncompliance is serious, shall report to the Minister of Health, Labour and Welfare (if the research
p.000016: implementing entity is a college/university and the like, to the Minister of Health, Labour and Welfare and the
p.000016: Minister of Education, Culture, Sports, Science and Technology; hereinafter referred to the “Minister(s)”)
p.000016: concerning the status and results of such countermeasures and make the said status and results public.
p.000016: (2) The chief executive of research implementing entity shall provide cooperation with the inspection
p.000016: carried out by the Minister(s) or entity(s)
p.000016:
p.000017: 17
p.000017:
p.000017:
p.000017: entrusted with the duties by the Minister(s) (hereinafter referred to as the “Minister(s), etc.”) to confirm that the
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Health / Mentally Disabled
Searching for indicator mentally:
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p.000001:
p.000002: 2
p.000002:
p.000002:
p.000002: 1. Public announcement, etc. concerning retained personal information
p.000002: 2. Response to request for disclosure, etc. Chapter 7 Response to Serious Adverse Event
p.000002: Part 17 Response to Serious Adverse Event
p.000002: 1. Response to be made by investigators, etc.
p.000002: 2. Response to be made by principal investigator
p.000002: 3. Response to be made by the chief executive of research implementing entity
p.000002: Chapter 8 Ensuring of Reliability of Research Part 18 Managing Conflicts of Interest
p.000002: Part 19 Storage of Specimens and Information, etc. for Research Part 20 Monitoring and Audit
p.000002: Chapter 9 Supplementary Provisions Part 21 Effective Date
p.000002: Part 22 Transitional Measures Part 23 Amendment
p.000002:
p.000002: Preamble
p.000002: Medical and health research involving human subjects contributes significantly to society in terms of
p.000002: maintaining and promoting people’s good health and advancing patients’ recuperation from injury and disease
p.000002: as well as quality of life, through the development of medical and health science and medical technology.
p.000002: Furthermore, such research also acts an important foundation which leads to progress in good health and welfare for
p.000002: society. In this sense, on the one hand, it is required that an institutional framework be developed and maintained
p.000002: in which investigators can carry out research appropriately and smoothly under academic freedom. On the other hand,
p.000002: medical and health research involving human subjects can have a major impact on such research subjects both
p.000002: physically and mentally or, indeed, on society itself, as well as cause a variety of ethical, legal and social
p.000002: problems. The welfare of those research subjects shall be given priority over scientific and social results of
p.000002: research, and human dignity and rights shall be protected.
p.000002: From this point of view, the Ministry of Education, Culture, Sports, Science and Technology and the
p.000002: Ministry of Health, Labour and Welfare established the Ethical Guidelines for Epidemiological Research (Public
p.000002: Notice of the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health,
p.000002: Labour and Welfare No. 1 of 2007), originally in 2002 and later amended entirely in 2007, and the
p.000002:
p.000003: 3
p.000003:
p.000003:
p.000003: Ethical Guidelines for Clinical Research (Public Notice of the Ministry of Health, Labour and Welfare No.
p.000003: 415 of 2008), originally in 2003 and later amended entirely in 2008, in order that investigators can respect and
p.000003: protect human dignity and rights as well as carry out research appropriately and smoothly. Both guidelines were
p.000003: based on the Constitution of Japan, the Act on the Protection of Personal Information and other related acts, and the
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Searching for indicator disability:
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p.000008: The above-defined anonymization also includes the process of removing all or part of information, even if such
p.000008: information by itself does not enable identification of any specific individuals, which will enable identification of
p.000008: a specific individual if referred to other information available in order to ensure that the said
p.000008: information cannot enable such identification.
p.000008:
p.000008: (23) Linkable Anonymization
p.000008: Anonymization to enable identification of each specific individual when required, by retaining a decoding index
p.000008: which is a list of the specific individuals’ identification and the corresponding symbols or numbers given to
p.000008: each individual.
p.000008:
p.000008: (24) Unlinkable Anonymization
p.000008: Anonymization to disable identification of each specific individual, by
p.000008:
p.000009: 9
p.000009:
p.000009:
p.000009: not retaining a decoding index listing the specific individuals’ identification and the corresponding symbols or
p.000009: numbers given to each individual.
p.000009:
p.000009: (25) Adverse Event
p.000009: Any unfavorable and unintended injury and illness or any sign of such (including an abnormal laboratory finding)
p.000009: caused to research subjects, regardless of whether there is or is not any causal relation with the research
p.000009: implemented.
p.000009:
p.000009: (26) Serious Adverse Event
p.000009: Of the above-defined adverse events, an event that:
p.000009: (i) Results in death;
p.000009: (ii) Is life-threatening;
p.000009: (iii) Requires inpatient hospitalization or prolongation of existing hospitalization;
p.000009: (iv) Results in persistent or significant disability or incapacity; or
p.000009: (v) Is a congenital anomaly or birth defect to offspring.
p.000009:
p.000009: (27) Unexpected Serious Adverse Event
p.000009: Of the above-defined serious adverse events, an event not consistent with the information in the research
p.000009: protocol, the document used for obtaining informed consent and so on, or not consistent with the severity
p.000009: described in such, even if there is any description about the event.
p.000009:
p.000009: (28) Monitoring
p.000009: An act of overseeing the progress of research, and of determining whether the research is being
p.000009: conducted in compliance with these Guidelines and the research protocol, in order to ensure that the research
p.000009: is properly conducted. Such act is performed by an individual appointed by the principal investigator.
p.000009:
p.000009: (29) Audit
p.000009: An examination of research-related activities to determine whether the research has been conducted in
p.000009: compliance with these Guidelines and the research protocol, in order to assure the reliability of results of the
p.000009: research. Such examination is performed by an individual appointed by the principal
p.000009:
p.000010: 10
p.000010:
p.000010:
p.000010: investigator.
p.000010:
p.000010: Part 3 Scope of Application
p.000010: 1. Research applicable to these Guidelines
p.000010: These Guidelines shall apply to any medical and health research involving human subjects which is carried out
p.000010: by a Japanese research implementing entity or carried out in Japan. Of research which falls under the scope to which
p.000010: other guidelines are applicable, however, matters not set forth in such other guidelines shall be carried out in
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Health / Motherhood/Family
Searching for indicator family:
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p.000039: (3) When a research subject expresses his/her will of refusal all or part of the research to be commenced or
p.000039: continued, in the course of the procedures for obtaining informed assent pursuant to the provisions of (1) above,
p.000039: the investigator, etc. or the individual providing existing specimens or information shall endeavor to
p.000039: respect such will. This, however, shall not apply when direct benefits to the research subjects’ health are expected
p.000039: if the research is commenced or continued and when the legally acceptable representative gives consent to it.
p.000039:
p.000039: Chapter 6 Personal Information, etc.
p.000039: Part 14 Basic Obligations about Personal Information, etc.
p.000039: 1. Protection of personal information, etc.
p.000039: (1) With respect to the handling of personal information, investigators, etc. and the chief executive of
p.000039: research implementing entity shall comply with the Act on the Protection of Personal Information (Act No. 57 of 2003),
p.000039: the Act on the Protection of Personal Information Held by Administrative Organs (Act No. 58 of 2003), the Act
p.000039: on the Protection of Personal Information Held by Incorporated Administrative Agencies, etc. (Act No. 59 of 2003)
p.000039: and other ordinances established by local governments in addition to the relevant provisions of these
p.000039: Guidelines.
p.000039: (2) Respecting the dignity of the deceased and the sentiment of the bereaved family, investigators, etc. and the chief
p.000039: executive of research implementing
p.000039:
p.000040: 40
p.000040:
p.000040:
p.000040: entity shall handle information about a deceased individual which can identify the specific individual in
p.000040: the same appropriate manner as they handle information about a living individual and take necessary and
p.000040: appropriate measures pursuant to the provisions in Section 2 of this part and in Part 15 below. In addition,
p.000040: they shall endeavor to handle such information appropriately and take relevant measures pursuant to the
p.000040: provisions in Part 16 below.
p.000040:
p.000040: 2. Proper acquisition, etc.
p.000040: (1) Investigators, etc. shall not acquire personal information by deception or other dishonest means when carrying
p.000040: out research.
p.000040: (2) In principle, investigators, etc. shall not handle personal information, etc. acquired in relation with
p.000040: implementation of their research, beyond the scope for which the research subjects have given consent in advance.
p.000040:
p.000040: Part 15 Security Control Measures
p.000040: 1. Proper handling
p.000040: (1) Investigators, etc. shall appropriately handle the personal information, etc. which has been acquired in relation
p.000040: with implementation of their research and retained by the research implementing entity to which they belong
p.000040: (including information retained by contractor(s) under entrustment agreement; hereinafter referred to
p.000040: the “retained personal information, etc.”) for security control of such information, etc., for the prevention of
p.000040: leakage or loss of or damage and for other security control of the said information.
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Health / Physically Disabled
Searching for indicator illness:
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p.000008:
p.000008: (21) Personal Information, etc.
p.000008: Information including the above-defined personal information as well as information about a deceased individual,
p.000008: which can identify the specific deceased individual.
p.000008:
p.000008: (22) Anonymization
p.000008: Removal from the above-defined personal information, etc. of all or part of descriptions, etc. which enable
p.000008: identification of a specific individual (including a specific deceased individual; the same applies hereinafter)
p.000008: and assignment of symbols or numbers irrelevant to the said specific individual in place of such removed descriptions.
p.000008: The above-defined anonymization also includes the process of removing all or part of information, even if such
p.000008: information by itself does not enable identification of any specific individuals, which will enable identification of
p.000008: a specific individual if referred to other information available in order to ensure that the said
p.000008: information cannot enable such identification.
p.000008:
p.000008: (23) Linkable Anonymization
p.000008: Anonymization to enable identification of each specific individual when required, by retaining a decoding index
p.000008: which is a list of the specific individuals’ identification and the corresponding symbols or numbers given to
p.000008: each individual.
p.000008:
p.000008: (24) Unlinkable Anonymization
p.000008: Anonymization to disable identification of each specific individual, by
p.000008:
p.000009: 9
p.000009:
p.000009:
p.000009: not retaining a decoding index listing the specific individuals’ identification and the corresponding symbols or
p.000009: numbers given to each individual.
p.000009:
p.000009: (25) Adverse Event
p.000009: Any unfavorable and unintended injury and illness or any sign of such (including an abnormal laboratory finding)
p.000009: caused to research subjects, regardless of whether there is or is not any causal relation with the research
p.000009: implemented.
p.000009:
p.000009: (26) Serious Adverse Event
p.000009: Of the above-defined adverse events, an event that:
p.000009: (i) Results in death;
p.000009: (ii) Is life-threatening;
p.000009: (iii) Requires inpatient hospitalization or prolongation of existing hospitalization;
p.000009: (iv) Results in persistent or significant disability or incapacity; or
p.000009: (v) Is a congenital anomaly or birth defect to offspring.
p.000009:
p.000009: (27) Unexpected Serious Adverse Event
p.000009: Of the above-defined serious adverse events, an event not consistent with the information in the research
p.000009: protocol, the document used for obtaining informed consent and so on, or not consistent with the severity
p.000009: described in such, even if there is any description about the event.
p.000009:
p.000009: (28) Monitoring
p.000009: An act of overseeing the progress of research, and of determining whether the research is being
p.000009: conducted in compliance with these Guidelines and the research protocol, in order to ensure that the research
p.000009: is properly conducted. Such act is performed by an individual appointed by the principal investigator.
p.000009:
p.000009: (29) Audit
p.000009: An examination of research-related activities to determine whether the research has been conducted in
p.000009: compliance with these Guidelines and the research protocol, in order to assure the reliability of results of the
...
Searching for indicator physically:
(return to top)
p.000001: Personal Information
p.000001:
p.000002: 2
p.000002:
p.000002:
p.000002: 1. Public announcement, etc. concerning retained personal information
p.000002: 2. Response to request for disclosure, etc. Chapter 7 Response to Serious Adverse Event
p.000002: Part 17 Response to Serious Adverse Event
p.000002: 1. Response to be made by investigators, etc.
p.000002: 2. Response to be made by principal investigator
p.000002: 3. Response to be made by the chief executive of research implementing entity
p.000002: Chapter 8 Ensuring of Reliability of Research Part 18 Managing Conflicts of Interest
p.000002: Part 19 Storage of Specimens and Information, etc. for Research Part 20 Monitoring and Audit
p.000002: Chapter 9 Supplementary Provisions Part 21 Effective Date
p.000002: Part 22 Transitional Measures Part 23 Amendment
p.000002:
p.000002: Preamble
p.000002: Medical and health research involving human subjects contributes significantly to society in terms of
p.000002: maintaining and promoting people’s good health and advancing patients’ recuperation from injury and disease
p.000002: as well as quality of life, through the development of medical and health science and medical technology.
p.000002: Furthermore, such research also acts an important foundation which leads to progress in good health and welfare for
p.000002: society. In this sense, on the one hand, it is required that an institutional framework be developed and maintained
p.000002: in which investigators can carry out research appropriately and smoothly under academic freedom. On the other hand,
p.000002: medical and health research involving human subjects can have a major impact on such research subjects both
p.000002: physically and mentally or, indeed, on society itself, as well as cause a variety of ethical, legal and social
p.000002: problems. The welfare of those research subjects shall be given priority over scientific and social results of
p.000002: research, and human dignity and rights shall be protected.
p.000002: From this point of view, the Ministry of Education, Culture, Sports, Science and Technology and the
p.000002: Ministry of Health, Labour and Welfare established the Ethical Guidelines for Epidemiological Research (Public
p.000002: Notice of the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health,
p.000002: Labour and Welfare No. 1 of 2007), originally in 2002 and later amended entirely in 2007, and the
p.000002:
p.000003: 3
p.000003:
p.000003:
p.000003: Ethical Guidelines for Clinical Research (Public Notice of the Ministry of Health, Labour and Welfare No.
p.000003: 415 of 2008), originally in 2003 and later amended entirely in 2008, in order that investigators can respect and
p.000003: protect human dignity and rights as well as carry out research appropriately and smoothly. Both guidelines were
p.000003: based on the Constitution of Japan, the Act on the Protection of Personal Information and other related acts, and the
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000013: than expected benefits of the research or it is considered that a satisfactory outcome has been achieved or
p.000013: that such an outcome cannot be achieved, the principal investigator shall terminate the said research.
p.000013: (5) When a principal investigator becomes aware of any serious adverse event which occurs in implementing of research
p.000013: and involves any invasiveness, the principal investigator shall promptly take relevant measures.
p.000013:
p.000014: 14
p.000014:
p.000014:
p.000014: (6) The principal investigator shall report to the chief executive of the research implementing entity, with respect
p.000014: to the progress of the research and status of any adverse event which occurs in implementing of the research,
p.000014: in accordance with specifications prescribed in the research protocol.
p.000014: (7) When research is finished (including the case of discontinuance; the same applies hereinafter), the principal
p.000014: investigator of the research shall report to the chief executive of the research implementing entity with respect to
p.000014: matters required.
p.000014: (8) When conducting research collaboratively with other research implementing entity(s), the
p.000014: principal investigator shall share relevant information to the research with the principal investigator of
p.000014: such other research implementing entity(s).
p.000014:
p.000014: 3. Following-up research subjects after end of research
p.000014: When a principal investigator has carried out the research which involves any medical technique beyond usual
p.000014: medical practice, the principal investigator, even after the end of the research, shall endeavor to
p.000014: ensure that the research subjects can access the best possible preventive measures, diagnosis and
p.000014: treatment identified by the outcome of the research.
p.000014:
p.000014: Part 6 Obligations of the Chief Executive of Research Implementing Entity
p.000014: 1. Overall supervision of research
p.000014: (1) The chief executive of research implementing entity shall exercise necessary supervision over the
p.000014: research he/she approved for implementing, in order that it shall be carried out appropriately, and shall take ultimate
p.000014: responsibility for it.
p.000014: (2) The chief executive of research implementing entity shall ensure that those involved in the research work carry
p.000014: out the research with due respect to the life, health and human rights of the research subjects.
p.000014: (3) The chief executive of research implementing entity shall not disclose, without any justifiable
p.000014: reason, information obtained during the duties related to the research. The same shall apply, even after he/she
p.000014: has ceased to be engaged in the duties.
p.000014: (4) When entrusting a part of research work, the chief executive of research implementing entity shall enter into
p.000014: a written agreement for matters the contractor(s) shall comply with and shall exercise necessary
p.000014: and
p.000014:
p.000015: 15
p.000015:
p.000015:
p.000015: appropriate supervision of the contractor(s).
p.000015:
p.000015: 2. Arrangement, etc. of systems and procedures for implementation of research
p.000015: (1) The chief executive of research implementing entity shall arrange systems and procedures necessary for the
p.000015: appropriate implementation of research.
p.000015: (2) When a research subject has incurred any injury related to the research carried out by the research
...
p.000034: statement to that effect and details of such;
p.000034: (xvi) When the research involves any medical technique beyond usual medical practice, description of alternative
p.000034: procedure(s) or course(s) of treatment;
p.000034: (xvii) When the research involves any medical technique beyond usual medical practice, response related to the
p.000034: healthcare delivery to the research subjects after the research;
p.000034: (xviii) When any significant finding concerning the subject’s health or generic characteristics which may be inherited
p.000034: by his/her offspring, etc. may be obtained through implementing the research, handling of the research results
p.000034: related to the research subject (including incidental findings);
p.000034: (xix) When the research involves any invasiveness, whether or not compensation will be
p.000034: offered for research-related injury and details of such compensation;
p.000034: (xx) With respect to specimens and information acquired from the research subject, when any of those may
p.000034: be utilized or provided to other research implementing entity(s) for the research in future that is not identified at
p.000034: the time of obtaining consent from the research subject, etc., a statement to that effect and the contents of
p.000034: utilization assumed at the time of obtaining consent; or
p.000034: (xxi) When the research involves any invasiveness (not including minor invasiveness) and intervention,
p.000034: the fact that the monitor(s), the auditor(s) and the ethical review committee will be granted direct access
p.000034: to the specimens and information acquired from the research subject, without violating confidentiality of the
p.000034: research subjects, to the extent necessary.
p.000034:
p.000034: 4. Procedures to utilize specimens and information in research unidentified at the time consent was given
p.000034: When the investigator, etc. has provided the information including purpose of
p.000034:
p.000035: 35
p.000035:
p.000035:
p.000035: the utilization of specimens and information which is presumed at the time of obtaining consent of the research
p.000035: subject, etc. as fully as possible, and when, later, such purposes of the utilization, etc. are newly
p.000035: identified, the investigator, etc. shall notify the research subjects, etc. of, or make public, information
p.000035: including the newly identified purposes of the utilization, etc. in accordance with the specifications prescribed in
p.000035: the prepared or revised research protocol, and with regards that the research is implemented,
p.000035: opportunities to withdraw such consent shall be ensured for the research subject, etc.
p.000035:
p.000035: 5. Procedures in the research in emergency situations involving obvious life-threatening risk to the
p.000035: research subject
p.000035: When the investigator, etc. considers that the research subject fulfills all the following conditions, in
p.000035: accordance with specifications prescribed in the research protocol, the investigator, etc. may enroll such
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000007: shall be commenced or continued (including how specimens or information shall be handled), having enough
p.000007: understanding after receiving adequate prior information with regard to the purpose and significance of
p.000007: the research, burdens on the research subjects and predicted results of the research (including both risks
p.000007: and benefits), etc.
p.000007:
p.000007: (17) Legally Acceptable Representative
p.000007: An individual expected to speak for the will and benefit of a living research subject, and if the research
p.000007: subject is considered objectively unable to give informed consent, competent to give informed consent
p.000007: to investigators, etc. or individuals providing existing specimens or information on behalf of the
p.000007: said research subject.
p.000007:
p.000007: (18) Legally Acceptable Representative, etc.
p.000007: An individual including the above-defined legally acceptable representative as well as individual
p.000007: who is competent to give informed consent on behalf of the deceased research subject.
p.000007:
p.000007: (19) Informed Assent
p.000007: Expression of agreement, with respect to whether the research shall be commenced or continued, of research
p.000007: subjects who are considered
p.000007:
p.000008: 8
p.000008:
p.000008:
p.000008: objectively unable to give informed consent after having been given information concerning the
p.000008: research to be commenced or continued in an intelligible language depending on the subjects’ level of
p.000008: comprehension.
p.000008:
p.000008: (20) Personal Information
p.000008: Information about a living individual which can identify the specific individual by name, date of birth,
p.000008: or other description contained in such information, including such information as will allow easy
p.000008: reference to other information and will thereby enable the identification of the specific individual.
p.000008:
p.000008: (21) Personal Information, etc.
p.000008: Information including the above-defined personal information as well as information about a deceased individual,
p.000008: which can identify the specific deceased individual.
p.000008:
p.000008: (22) Anonymization
p.000008: Removal from the above-defined personal information, etc. of all or part of descriptions, etc. which enable
p.000008: identification of a specific individual (including a specific deceased individual; the same applies hereinafter)
p.000008: and assignment of symbols or numbers irrelevant to the said specific individual in place of such removed descriptions.
p.000008: The above-defined anonymization also includes the process of removing all or part of information, even if such
p.000008: information by itself does not enable identification of any specific individuals, which will enable identification of
p.000008: a specific individual if referred to other information available in order to ensure that the said
p.000008: information cannot enable such identification.
p.000008:
p.000008: (23) Linkable Anonymization
p.000008: Anonymization to enable identification of each specific individual when required, by retaining a decoding index
p.000008: which is a list of the specific individuals’ identification and the corresponding symbols or numbers given to
p.000008: each individual.
p.000008:
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000017: said chief executive may decide to give
p.000017:
p.000018: 18
p.000018:
p.000018:
p.000018: approval prior to deliberation by relevant ethical review committee, however, when it is considered
p.000018: necessary to implement the research urgently in order to prevent public health-related harm from occurring or
p.000018: spreading. In this case, the said chief executive shall submit the matter to the ethical review committee for
p.000018: deliberation without delay after giving approval, and if the ethical review committee forms an opinion
p.000018: that the research shall be suspended or terminated or that revision shall be made in the research protocol, the said
p.000018: chief executive shall respect such opinions and take appropriate measures, such as ordering the principal investigator
p.000018: to suspend or terminate the research or getting the research protocol revised.
p.000018: (2) When the chief executive of research implementing entity submits a matter to ethical review committee for
p.000018: deliberation concerning research to be conducted collaboratively with other research implementing entity(s), the
p.000018: said chief executive shall provide the committee with information necessary for making reviews,
p.000018: including information on approval for the implementation of research at other collaborative research
p.000018: implementing entity(s), results of the review by other ethical review committee(s) and the progress status of the
p.000018: research.
p.000018: (3) The chief executive of research implementing entity may submit a matter to a single ethical review
p.000018: committee for deliberation to make a comprehensive review on the research protocol for the research
p.000018: to be conducted collaboratively with other research implementing entity(s).
p.000018:
p.000018: 3. Approval by chief executive of research implementing entity
p.000018: The chief executive of research implementing entity shall respect opinions of ethical review committee and make
p.000018: decision on whether the implementation of the research should be approved or not and on other measures
p.000018: necessary in relation with the research. In the course of such decision, the chief executive of the research
p.000018: implementing entity shall not approve the implementation of the research if the ethical review committee has
p.000018: considered it inappropriate.
p.000018:
p.000018: 4. Procedures after end of research
p.000018: (1) When principal investigator has finished any research, the principal investigator shall submit
p.000018: to the chief executive of the research implementing entity without delay, in writing, a statement
p.000018: to that effect
p.000018:
p.000019: 19
p.000019:
p.000019:
p.000019: and a summary of the results of the research.
p.000019: (2) When the chief executive of research implementing entity has received a report from principal investigator
p.000019: pursuant to the provisions of (1) above, the said chief executive shall report, in writing, a statement to the
p.000019: effect that the research has been finished and summarized results of the research, to the ethical review committee
p.000019: which made reviews on the research.
p.000019:
p.000019: Part 8 Contents of Research Protocol
p.000019: (1) Contents of research protocol (not including cases as defined in (2) below) shall, in principle, include the
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.000042: the claimant are likely to harm the rights or legitimate interests of the research implementing entity.
p.000042: (4) When the chief executive of research implementing entity has decided not to notify pursuant to the provisions
p.000042: of (3) above, with respect to the purpose of utilization pursuant to the provisions of (2) above, the
p.000042: said chief executive shall, without delay, notify the claimant of that effect. In addition, the said chief executive
p.000042: shall endeavor to explain the reasons and to obtain understanding of the claimant.
p.000042:
p.000042: 2. Response to request for disclosure, etc.
p.000042: (1) When the chief executive of research implementing entity is requested by a person, etc. to disclose the retained
p.000042: personal information as may lead to the identification of the person (such disclosure also includes notifying the
p.000042: person that the research implementing entity has no such retained personal information as may lead to the
p.000042: identification of the person concerned; the same shall apply hereinafter), the said chief executive shall, without
p.000042: delay, disclose relevant personal information to the claimant. In falling under any of the following, however, the said
p.000042: chief executive may keep all or part of the retained personal information undisclosed. In addition, when any
p.000042: provision has been established in laws or ordinances concerning the
p.000042:
p.000043: 43
p.000043:
p.000043:
p.000043: disclosure of the retained personal information, such provisions shall be applied.
p.000043: (i) Cases in which disclosure is likely to harm the life, body, property, or other rights and interests of the
p.000043: research subjects, etc. or a third party;
p.000043: (ii) Cases in which disclosure is likely to seriously impede the proper execution of the research work of
p.000043: the research implementing entity; or
p.000043: (iii) Cases in which disclosure violates any laws or ordinances.
p.000043: (2) When the chief executive of research implementing entity is requested to notify the purpose of utilization
p.000043: pursuant to the provisions of Section 1 (2) or to make a disclosure pursuant to the provisions of (1) above, the said
p.000043: chief executive may collect charges for taking the measure. In this case, however, the said chief
p.000043: executive shall determine the amount of such charges within the scope considered reasonable in consideration of
p.000043: actual costs.
p.000043: (3) When the chief executive of research implementing entity is requested by a person, etc. to correct, add,
p.000043: or delete (hereinafter referred to as “correction, etc.”) such retained personal information as may
p.000043: lead to the identification of the person on the grounds that the retained personal information is contrary
p.000043: to the fact, the said chief executive shall, except in cases in which special procedures are prescribed
p.000043: by any laws and ordinances for such correction, etc., make a necessary investigation without
p.000043: delay within the scope necessary for the achievement of the purpose of utilization and, on the basis of
p.000043: the results, execute relevant correction, etc. of the retained personal information.
p.000043: (4) Where the chief executive of research implementing entity is requested by a person to discontinue using or
...
Social / Victim of Abuse
Searching for indicator trauma:
(return to top)
p.000004: (vi) Special consideration for vulnerable subjects;
p.000004: (vii) Protection of personal information, etc.; and
p.000004: (viii) Ensuring of integrity and transparency of research.
p.000004:
p.000004: Part 2 Glossary
p.000004: The terms used in these Guidelines shall be defined as follows:
p.000004: (1) Medical and Health Research Involving Human Subjects
p.000004: An activity involving human subjects (including specimens and information acquired from them) to be
p.000004: carried out for the purpose of obtaining knowledge contributing to maintain and promote people’s good
p.000004: health or to recover from injury and disease and improve quality of life for patients, through understanding the
p.000004: cause of diseases (including the frequency and distribution of various health-related incidents and
p.000004: factors affecting them) and their pathology and through improving measures to prevent injury and disease as
p.000004: well as diagnostic and treatment measures in medical care or through verifying those measures’ validity.
p.000004: In these Guidelines, the term “research” refers to the above-defined medical and health research involving
p.000004: human subjects, when it is mentioned without any specific remark.
p.000004:
p.000004: (2) Invasiveness
p.000004: To cause injuries or distress to research subjects’ body and/or mind by conducting a procedure for investigational
p.000004: purpose, such as puncture, incision, administration of drugs, irradiation and questions related to the
p.000004: subject’s mental trauma, etc.
p.000004: Of various types of invasiveness, one causing minor injury and/or distress on the research subjects’ body
p.000004: and/or mind is called “minor invasiveness.”
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005:
p.000005: (3) Intervention
p.000005: A practice for investigational purpose to control the presence or absence of factors, which can affect a variety
p.000005: of events occurring in relation with human health (including activities to maintain and promote good health and
p.000005: medical practices such as medication and examinations for prevention, diagnosis and treatment of the patients),
p.000005: or the degree of such factors. The above-defined intervention also includes medical technique beyond usual
p.000005: medical practice that is conducted for investigational purpose.
p.000005:
p.000005: (4) Human Biological Specimen
p.000005: A part of human body (including that of deceased individuals) to be utilized (or which has been utilized) in
p.000005: research, such as blood, body fluids, tissues, cells, excrement and DNA extracted from these, etc.
p.000005:
p.000005: (5) Information Utilized in Research
p.000005: Information on human health, such as the name of disease, details of medication and results of
p.000005: examination and measurement obtained through diagnosis and treatment of research subjects, and other
p.000005: information (including that concerning deceased individuals) to be utilized (or which have been utilized) in
p.000005: research.
p.000005:
p.000005: (6) Specimen and/or Information
p.000005: The above-defined human biological specimen and/or the above-defined information utilized in research.
p.000005:
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000004: (vii) Protection of personal information, etc.; and
p.000004: (viii) Ensuring of integrity and transparency of research.
p.000004:
p.000004: Part 2 Glossary
p.000004: The terms used in these Guidelines shall be defined as follows:
p.000004: (1) Medical and Health Research Involving Human Subjects
p.000004: An activity involving human subjects (including specimens and information acquired from them) to be
p.000004: carried out for the purpose of obtaining knowledge contributing to maintain and promote people’s good
p.000004: health or to recover from injury and disease and improve quality of life for patients, through understanding the
p.000004: cause of diseases (including the frequency and distribution of various health-related incidents and
p.000004: factors affecting them) and their pathology and through improving measures to prevent injury and disease as
p.000004: well as diagnostic and treatment measures in medical care or through verifying those measures’ validity.
p.000004: In these Guidelines, the term “research” refers to the above-defined medical and health research involving
p.000004: human subjects, when it is mentioned without any specific remark.
p.000004:
p.000004: (2) Invasiveness
p.000004: To cause injuries or distress to research subjects’ body and/or mind by conducting a procedure for investigational
p.000004: purpose, such as puncture, incision, administration of drugs, irradiation and questions related to the
p.000004: subject’s mental trauma, etc.
p.000004: Of various types of invasiveness, one causing minor injury and/or distress on the research subjects’ body
p.000004: and/or mind is called “minor invasiveness.”
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005:
p.000005: (3) Intervention
p.000005: A practice for investigational purpose to control the presence or absence of factors, which can affect a variety
p.000005: of events occurring in relation with human health (including activities to maintain and promote good health and
p.000005: medical practices such as medication and examinations for prevention, diagnosis and treatment of the patients),
p.000005: or the degree of such factors. The above-defined intervention also includes medical technique beyond usual
p.000005: medical practice that is conducted for investigational purpose.
p.000005:
p.000005: (4) Human Biological Specimen
p.000005: A part of human body (including that of deceased individuals) to be utilized (or which has been utilized) in
p.000005: research, such as blood, body fluids, tissues, cells, excrement and DNA extracted from these, etc.
p.000005:
p.000005: (5) Information Utilized in Research
p.000005: Information on human health, such as the name of disease, details of medication and results of
p.000005: examination and measurement obtained through diagnosis and treatment of research subjects, and other
p.000005: information (including that concerning deceased individuals) to be utilized (or which have been utilized) in
p.000005: research.
p.000005:
p.000005: (6) Specimen and/or Information
p.000005: The above-defined human biological specimen and/or the above-defined information utilized in research.
p.000005:
p.000005: (7) Existing Specimen and/or Information
p.000005: Of the above-defined specimen and/or information, specimen and/or information which corresponds to any of the
p.000005: following:
...
p.000012: executive of the research implementing entity.
p.000012:
p.000012: 3. Education and training
p.000012: Investigators, etc. shall receive education and training on the ethics of research and on knowledge and
p.000012: skills necessary to carry out the research prior to its implementation. They shall also receive education and
p.000012: training during the research period on a regular basis as necessary.
p.000012:
p.000012: Part 5 Obligations of Principal Investigator
p.000012: 1. Preparation of research protocol and compliance of investigators, etc.
p.000012: (1) The principal investigator shall prepare an appropriate research protocol prior to any implementation of
p.000012: research. In the same manner, the principal investigator shall revise the research protocol prior to any implementation
p.000012: of a changed conduct of research.
p.000012: (2) The principal investigator shall prepare a research protocol to ensure ethical justification and
p.000012: scientific validity of the research. In addition, when preparing the research protocol, the principal
p.000012: investigator shall comprehensively assess the burdens on research subjects and predicted risks and benefits as
p.000012: well as take measures to minimize such burdens and risks.
p.000012: (3) When the principal investigator intends to carry out research which involves invasiveness (not
p.000012: including minor invasiveness) along with medical technique beyond usual medical practice, the
p.000012: principal investigator shall take beforehand necessary measures, such as purchasing insurance, etc., in preparation
p.000012: for compensation to the research subject in the event of research-related injuries, appropriately.
p.000012: (4) Pursuant to the provisions in Part 9 of these Guidelines below, the
p.000012:
p.000013: 13
p.000013:
p.000013:
p.000013: principal investigator shall appropriately register the summary of his/her research and other related
p.000013: information, and make results of the research public.
p.000013: (5) The principal investigator shall instruct and manage other investigators and those concerned in his/her
p.000013: research implementing entity, in order that the research shall be appropriately carried out in compliance with
p.000013: the research protocol and that reliability of results of the research can be secured.
p.000013:
p.000013: 2. Management and supervision of research progress and identification and reporting adverse events, etc.
p.000013: (1) The principal investigator shall endeavor to take action in order that his/her research shall be
p.000013: carried out appropriately and the reliability of results of the research can be secured, for
p.000013: example, by collecting information necessary in carrying out the research.
p.000013: (2) When a principal investigator becomes aware of any fact or obtains any information that ethical
p.000013: justification or scientific validity of the research is, or might be, impaired, and if the continuation of the
p.000013: research will be hindered (not including cases which correspond to (3) below), the principal
...
p.000016: which made reviews on the said research.
p.000016:
p.000016: 4. Report, etc. to the Minister(s)
p.000016: (1) When the chief executive of research implementing entity becomes aware that any research which the entity
p.000016: is implementing or implemented previously is not complying with these Guidelines, the said chief executive shall
p.000016: promptly submit the matter to the ethical review committee for deliberation and take relevant measures as well
p.000016: as, if such noncompliance is serious, shall report to the Minister of Health, Labour and Welfare (if the research
p.000016: implementing entity is a college/university and the like, to the Minister of Health, Labour and Welfare and the
p.000016: Minister of Education, Culture, Sports, Science and Technology; hereinafter referred to the “Minister(s)”)
p.000016: concerning the status and results of such countermeasures and make the said status and results public.
p.000016: (2) The chief executive of research implementing entity shall provide cooperation with the inspection
p.000016: carried out by the Minister(s) or entity(s)
p.000016:
p.000017: 17
p.000017:
p.000017:
p.000017: entrusted with the duties by the Minister(s) (hereinafter referred to as the “Minister(s), etc.”) to confirm that the
p.000017: research carried out by the research implementing entity is complying with these Guidelines.
p.000017: (3) When any unexpected serious adverse event occurs in implementing of the research which involves invasiveness
p.000017: (not including minor invasiveness) and intervention and if the said unexpected serious adverse event may be in
p.000017: direct consequence of the research, the chief executive of the research implementing entity shall report to the
p.000017: Minister of Health, Labour and Welfare concerning the status and results of countermeasures pursuant to the
p.000017: provisions of Section 3 (2) above and make the said status and results of such countermeasures public.
p.000017:
p.000017: Chapter 3 Research Protocol
p.000017: Part 7 Procedures Related to Research Protocol
p.000017: 1. Preparation and revision of research protocols
p.000017: (1) When principal investigator intends to carry out any research (including the case in which research is
p.000017: implemented after revision(s) in the research protocol; the same applies hereinafter), the principal
p.000017: investigator shall prepare the research protocol beforehand and receive approval of the chief executive of the
p.000017: research implementing entity.
p.000017: (2) When principal investigator intends to conduct any research collaboratively with other
p.000017: research implementing entity(s), the principal investigator shall clarify the role and responsibility of
p.000017: the principal investigators of each of other collaborative research implementing entity(s), in the
p.000017: course of the preparation of a research protocol.
p.000017: (3) When principal investigator intends to entrust a part of work related to research to be carried out
p.000017: by the research implementing entity he/she belongs to, the principal investigator shall prescribe which work
p.000017: shall be entrusted in the course of preparation of the research protocol.
p.000017:
...
p.000019: utilized in research);
p.000019: (xi) Matters to be reported to the chief executive of the research implementing entity and procedures
p.000019: for such reports;
p.000019: (xii) Status of research-related conflicts of interest of the research implementing entity, such as
p.000019: research fund resources, as well as
p.000019:
p.000020: 20
p.000020:
p.000020:
p.000020: research-related conflicts of interest of each investigator, etc., such as his/her individual income;
p.000020: (xiii) Means to disclose information on research;
p.000020: (xiv) Means to respond to the consultation, etc. made by the research subjects, etc. and other individuals
p.000020: concerned;
p.000020: (xv) When obtaining informed consent from legally acceptable representative, etc., procedures
p.000020: pursuant to the provisions in Part 13 below (including matters related to the criteria to select legally
p.000020: acceptable representatives, etc. and to be informed and consented to pursuant to the provisions in Parts 12 and 13
p.000020: below);
p.000020: (xvi) When obtaining informed assent, procedures pursuant to the provisions in Part 13 below
p.000020: (including information to be provided);
p.000020: (xvii) When the research is to be implemented pursuant to the provisions in Part 12.5 below, means to determine
p.000020: on conformity of all requirements set forth in the Section;
p.000020: (xviii) When the research involves any financial expenditure on or remuneration for the research
p.000020: subject, etc., a statement to the effect that and details of such;
p.000020: (xix) When the research involves invasiveness (not including minor invasiveness), means to respond in cases
p.000020: of serious adverse event;
p.000020: (xx) When the research involves any invasiveness, whether or not compensation will be offered for
p.000020: research-related injury and detail of such compensation;
p.000020: (xxi) When the research involves any medical technique beyond usual medical practice, response related to
p.000020: the healthcare delivery to the research subjects after the research;
p.000020: (xxii) When any significant finding concerning the research subject’s health or genetic characteristics which
p.000020: may be inherited by his/her offspring, etc. may be obtained through implementing the research, handling of the
p.000020: research results related to the research subject (including incidental findings);
p.000020: (xxiii) When a part of work related to the research is entrusted, the content of work to be entrusted and
p.000020: means of supervision over the contractor(s);
p.000020: (xxiv) With respect to specimens and information acquired from the research subject, when any of those may be
p.000020: utilized or provided to
p.000020:
p.000021: 21
p.000021:
p.000021:
p.000021: other research implementing entity(s) for the research in future that is not identified at the time of obtaining
p.000021: consent from the research subject, etc., a statement to that effect and the contents of utilization
p.000021: assumed at the time of obtaining consent; and
p.000021: (xxv) When monitoring or audit is performed pursuant to the provisions in Part 20 below, organizational
p.000021: framework and procedures for such.
p.000021: (2) Contents of the research protocol for operating research work acquiring specimens or information from
...
p.000022: When the principal investigator intends to carry out any research which involves intervention, the
p.000022: principal investigator shall, prior to the implementation of the research, register a summary of the
p.000022: research in a public database operated by the National University Hospital Council of Japan, the Japan
p.000022: Pharmaceutical Information Center, or the Japan Medical Association, shall update the registered contents
p.000022: appropriately according to revisions of the research protocol or the progress of the research, and shall
p.000022: register, without delay, the results of the research when the research is finished. Any of contents may be omitted
p.000022: from the registration, however, when the chief executive of the research implementing entity gives approval for that,
p.000022: by reason that it shall be confidential in order to protect human rights of the research subject, etc. and
p.000022:
p.000023: 23
p.000023:
p.000023:
p.000023: other individuals concerned or rights and interests of the investigator, etc. and other entity concerned, after
p.000023: relevant ethical review committee deliberation.
p.000023:
p.000023: 2. Publication of research results
p.000023: When the principal investigator has finished research, the principal investigator shall, without delay,
p.000023: make public the results of the research, having taken necessary measures to protect human rights of the
p.000023: research subject, etc. and other individuals concerned and rights and interests of the investigator, etc. and other
p.000023: entity concerned. In addition, if the research involves invasiveness (not including minor invasiveness) and
p.000023: intervention, the principal investigator shall, without delay, report to the chief executive of the research
p.000023: implementing entity, when the final publication of results of the research has made.
p.000023:
p.000023: Chapter 4 Ethical Review Committee
p.000023: Part 10 Organizing, etc. of Ethical Review Committee
p.000023: 1. Qualifications for organizing ethical review committee
p.000023: The organizer of ethical review committee shall meet the following qualifications:
p.000023: (i) Being capable of performing administrative work related to review appropriately;
p.000023: (ii) Having the capacity for sustainable operation of the ethical review committee; and
p.000023: (iii) Having the competence to operate the ethical review committee in a neutral and fair manner.
p.000023:
p.000023: 2. Obligations of organizer of ethical review committee
p.000023: (1) The organizer of ethical review committee shall prescribe the organizational structure
p.000023: of the committee and rules to operate the committee as well as ensure members of the ethical review
p.000023: committee and other individuals engaged in administrative work perform their duties in accordance with the
p.000023: said rules.
p.000023: (2) The organizer of ethical review committee shall appropriately retain review materials concerning the
p.000023: research which the ethical review committee has examined until the end of the said research is
p.000023: reported (when the research involves invasiveness (not including minor invasiveness) and
p.000023: intervention, the review materials shall be retained for
p.000023:
p.000024: 24
p.000024:
p.000024:
p.000024: five (5) years from the date the end of the said research is reported).
p.000024: (3) When beginning operation of ethical review committee, the organizer of the committee shall make
p.000024: public, in the Ethical Review Committee Reporting System, the organization of, provisions for operating and list
p.000024: of members of the committee.
p.000024: In addition, the said organizer shall similarly make public, in the Ethical Review Committee Reporting System, the
p.000024: status of the committee’s meetings held and a summary of the committee’s reviews at least once a year. With respect
p.000024: to the summary of the committee’s reviews, however, any of the contents may be omitted from such publication,
p.000024: when the committee considers it shall be confidential in order to protect human rights of the research
p.000024: subject, etc. and other individuals concerned or rights and interests of the investigator, etc. and other entity
p.000024: concerned.
p.000024: (4) The organizer of ethical review committee shall take necessary measures to ensure that members of the
p.000024: ethical review committee and other individuals engaged in administrative work receive education and training
p.000024: concerning relevant reviews and other related duties.
p.000024: (5) The organizer of ethical review committee shall provide cooperation with the inspection carried out by the
p.000024: Minister(s), etc. on the compliance of the ethical review committee’s organization and operation with
p.000024: these Guidelines.
p.000024:
p.000024: Part 11 Roles, Responsibilities, etc. of Ethical Review Committee
p.000024: 1. Roles and responsibilities
p.000024: (1) When the chief executive of research implementing entity asks for any opinion with regard to the
p.000024: appropriateness of implementing research or other matters, the ethical review committee shall make reviews
p.000024: on the matter, in accordance with these Guidelines, neutrally and fairly including information on any conflicts of
p.000024: interest of the research implementing entity and the investigator etc. as well as from ethical and scientific
p.000024: viewpoints, and shall present its opinions in writing.
p.000024: (2) The ethical review committee may make a necessary investigation from ethical and scientific viewpoints
p.000024: on the research it makes reviews of pursuant to the provisions of (1) above, and may present relevant opinions
p.000024: to the chief executive of the research implementing entity, with respect to revisions of the research protocol,
p.000024: termination of the research and other
p.000024:
p.000025: 25
p.000025:
p.000025:
p.000025: matters related to the research.
p.000025: (3) Of the research it has made reviews of pursuant to the provisions of (1) above, for the research
p.000025: which involves invasiveness (not including minor invasiveness) and intervention, the ethical review committee may make
p.000025: a necessary investigation to secure the appropriateness of implementing the research and the reliability of
p.000025: results of the research, and may present relevant opinions to the chief executive of the research
p.000025: implementing entity, with respect to revisions of the research protocol, termination of the research and other matters
p.000025: related to the research.
p.000025: (4) Members of ethical review committee and individuals engaged in the administrative work shall not
p.000025: disclose, without justifiable reason, any information obtained during the duties related to the committee. The same
p.000025: shall apply, even after they cease to be engaged in the duties.
p.000025: (5) When a member of ethical review committee or an individual engaged in the administrative work becomes aware
p.000025: of any serious concern with respect to human rights of the research subject, etc. or with respect to the
p.000025: appropriateness for implementing the research which the committee made reviews of pursuant to the provisions of
p.000025: (1) above, such as leakage of information related to such research, as well as with respect to the
p.000025: neutrality or fairness of its reviews, the said member or individual shall report promptly to the organizer
p.000025: of the committee.
p.000025: (6) Members of ethical review committee and individuals engaged in the administrative work shall
p.000025: receive education and training to acquire knowledge necessary for reviews from ethical and scientific
p.000025: viewpoint, etc. prior to being engaged in reviews or other related duties. They shall also receive education and
...
p.000026: committee’s consent.
p.000026: (4) The ethical review committee may invite nonmembers with expertise in special areas for assistance
p.000026: depending on matters subject to review and content of such.
p.000026: (5) When reviewing the research protocol of which research subjects are those who need special considerations and
p.000026: presenting its opinions on such research, the ethical review committee shall, as necessary, seek opinions of
p.000026: experts who have discernment on such research subjects.
p.000026: (6) The ethical review committee shall endeavor to make adoption of its opinions unanimously.
p.000026:
p.000026: 3. Expedited review
p.000026: Under any of the following circumstances the ethical review committee may delegate reviews to member(s) designated by
p.000026: the committee (hereinafter referred to as “expedited review”) and adopt their opinion. The result of such
p.000026: an expedited review shall be considered as the conclusion of the entire ethical
p.000026:
p.000027: 27
p.000027:
p.000027:
p.000027: review committee and shall be reported to other members of the committee.
p.000027: (i) Review of research to be conducted collaboratively with other research implementing entity(s),
p.000027: the entire scope of which has already been reviewed by the ethical review committee to which the
p.000027: collaborative research entity(s) submitted it for deliberation and opinions to indicate the appropriateness of such
p.000027: research have already been presented;
p.000027: (ii) Review of minor revisions of research protocol;
p.000027: (iii) Review of the research which does not involve any invasiveness and intervention; or
p.000027: (iv) Review of the research which involves minor invasiveness but does not involve any intervention.
p.000027:
p.000027: 4. Review of research to be carried out by other research implementing entity(s)
p.000027: (1) When the chief executive of research implementing entity submits the matters for deliberation by
p.000027: the ethical review committee which is organized by the institution he/she belongs to, the said
p.000027: ethical review committee shall have enough information concerning the site-specific information for the
p.000027: research at the research implementing entity, in order to make reviews and present its opinions.
p.000027: (2) With respect to research carried out by other research implementing entity(s) than the institution to
p.000027: which the organizer of the ethical review committee belongs, when the chief executive of the said
p.000027: research implementing entity requests the ethical review committee to continue to make reviews after the committee
p.000027: has made reviews on the same research, the said ethical review committee shall make reviews and present its
p.000027: opinions.
p.000027:
p.000027: Chapter 5 Informed Consent, etc.
p.000027: Part 12 Procedures for Obtaining Informed Consent, etc.
p.000027: 1. Procedures, etc. for obtaining informed consent
p.000027: The investigator, etc. who intends to carry out any research and the individual providing existing
p.000027: specimens or information who intends to provide any of those shall, in principle, obtain informed
...
p.000034: (xiv) Response to consultation, etc. made by research subjects, etc. and other individuals concerned;
p.000034: (xv) When the research involves any financial expenditure on or remuneration for the research subject, etc., a
p.000034: statement to that effect and details of such;
p.000034: (xvi) When the research involves any medical technique beyond usual medical practice, description of alternative
p.000034: procedure(s) or course(s) of treatment;
p.000034: (xvii) When the research involves any medical technique beyond usual medical practice, response related to the
p.000034: healthcare delivery to the research subjects after the research;
p.000034: (xviii) When any significant finding concerning the subject’s health or generic characteristics which may be inherited
p.000034: by his/her offspring, etc. may be obtained through implementing the research, handling of the research results
p.000034: related to the research subject (including incidental findings);
p.000034: (xix) When the research involves any invasiveness, whether or not compensation will be
p.000034: offered for research-related injury and details of such compensation;
p.000034: (xx) With respect to specimens and information acquired from the research subject, when any of those may
p.000034: be utilized or provided to other research implementing entity(s) for the research in future that is not identified at
p.000034: the time of obtaining consent from the research subject, etc., a statement to that effect and the contents of
p.000034: utilization assumed at the time of obtaining consent; or
p.000034: (xxi) When the research involves any invasiveness (not including minor invasiveness) and intervention,
p.000034: the fact that the monitor(s), the auditor(s) and the ethical review committee will be granted direct access
p.000034: to the specimens and information acquired from the research subject, without violating confidentiality of the
p.000034: research subjects, to the extent necessary.
p.000034:
p.000034: 4. Procedures to utilize specimens and information in research unidentified at the time consent was given
p.000034: When the investigator, etc. has provided the information including purpose of
p.000034:
p.000035: 35
p.000035:
p.000035:
p.000035: the utilization of specimens and information which is presumed at the time of obtaining consent of the research
p.000035: subject, etc. as fully as possible, and when, later, such purposes of the utilization, etc. are newly
p.000035: identified, the investigator, etc. shall notify the research subjects, etc. of, or make public, information
p.000035: including the newly identified purposes of the utilization, etc. in accordance with the specifications prescribed in
p.000035: the prepared or revised research protocol, and with regards that the research is implemented,
p.000035: opportunities to withdraw such consent shall be ensured for the research subject, etc.
p.000035:
p.000035: 5. Procedures in the research in emergency situations involving obvious life-threatening risk to the
p.000035: research subject
...
p.000035: including the information to be provided pursuant to the provisions in Section 3 above.
p.000035: (i) The research subject is facing an emergency involving obvious life-threatening risk;
p.000035: (ii) When the research involves intervention, currently available treatments are unlikely to achieve sufficient
p.000035: therapeutic effects in the research subject and there is sufficient possibility of saving the life of the research
p.000035: subject in a life-threatening condition by implementing the said research;
p.000035: (iii) The burdens and risks to be caused on the research subjects are minimized; and
p.000035: (iv) The legally acceptable representative or the prospective legally acceptable representative cannot immediately
p.000035: be contacted for consent.
p.000035:
p.000035: 6. Omission of procedures concerning informed consent, etc.
p.000035: (1) When carrying out the research which corresponds to all of the requirements as defined
p.000035: below, the investigator, etc. or the individual providing existing specimens or information may omit all
p.000035: or part of the procedures pursuant to the provisions in Section 1 and 2 above, in accordance with
p.000035: specifications prescribed in the research protocol approved by the chief executive of the research
p.000035: implementing entity.
p.000035:
p.000036: 36
p.000036:
p.000036:
p.000036: (i) The research to be implemented does not involve invasiveness (not including minor invasiveness);
p.000036: (ii) The omission of procedures pursuant to the provisions in Section 1 and 2 above is not against research
p.000036: subjects’ interests;
p.000036: (iii) If procedures pursuant to the provisions in Section 1 and 2 above are not omitted, it will be difficult to
p.000036: implement the research or the value of the said research will be significantly undermined; and
p.000036: (iv) The research to be implemented is recognized as being of socially high significance.
p.000036: (2) When any procedure(s) pursuant to the provisions in Section 1 and 2 above is to be omitted pursuant to the
p.000036: provisions of (1) above, the investigator, etc. shall take appropriate measures among those defined below.
p.000036: (i) To make announcement for the population to which the research subjects, etc. belong, with respect
p.000036: to the purpose of collection and utilization of the specimens or information as well as details
p.000036: (including the method) of such collection and utilization;
p.000036: (ii) To offer an ex-post explanation to the research subject, etc. promptly (including such explanation made to the
p.000036: group to which the subjects, etc. belong); and
p.000036: (iii) In the case that the specimens or information are collected or utilized continuously for a long period, the
p.000036: investigator, etc. shall endeavor to make public announcement, with respect to such situation of collection
p.000036: or utilization, including the purposes and methods of collection or utilization of the said specimens or
p.000036: information, in order to make it widely known to society.
p.000036:
p.000036: 7. Withdrawal of consent, etc.
...
p.000037: representative has given consent, of all or part of with regard that the research is commenced or continued, in
p.000037: the course of procedures for obtaining informed consent from the said research subjects.
p.000037:
p.000037: Part 13 Procedures, etc. for Obtaining Informed Consent from Legally Acceptable Representatives, etc.
p.000037: 1. Requirements for obtaining informed consent from legally acceptable representatives, etc.
p.000037: (1) When the investigator, etc. or the individual providing existing specimens or information obtains informed
p.000037: consent from a legally acceptable representative, etc. pursuant to the provisions in Part 12 above,
p.000037: all requirements as defined below shall be met.
p.000037: A. The research protocol has description on the following matters:
p.000037: (i) Criteria for selection of legally acceptable representatives, etc.;
p.000037: (ii) Information to be provided to the legally acceptable representative, etc. (including
p.000037: information on (iii) below, when research subjects are those who correspond to either (a) or (b) in
p.000037: B. below); and
p.000037: (iii) When the research subject is an individual who corresponds to either (a) or (b) in B. below, the
p.000037: reason why such an individual shall be the research subject.
p.000037: B. The research subject shall correspond to any of the following:
p.000037: (a) The research subject is a minor. When the research subject has completed junior high school or other
p.000037: relevant schooling, or is 16
p.000037:
p.000038: 38
p.000038:
p.000038:
p.000038: years or older, and is considered to have enough judgment concerning the research to be implemented on
p.000038: him/herself, as well as the following matters are prescribed in the research protocol and the chief
p.000038: executive of the research implementing entity approves to carry out the research after relevant ethical
p.000038: review committee deliberation, informed consent shall be obtained not from representative but from the said
p.000038: research subject.
p.000038: (i) The research to be implemented does not involve any invasiveness; and
p.000038: (ii) Information concerning implementation of the research, including purpose of the research and how
p.000038: specimens or information will be handled, is made public, and opportunities to refuse that
p.000038: the research is commenced or continued on the research subject are ensured for persons who exercise
p.000038: parental authority over the said research subject and guardians of the minor.
p.000038: (b) The research subject is an adult but objectively considered unable to give informed consent.
p.000038: (c) The research subject is a decedent, however, excluding cases in which the implementation of
p.000038: research is against the subject’s explicit will expressed during lifetime.
p.000038: (2) When obtaining informed consent from legally acceptable representative pursuant to the provisions in
p.000038: Part 12 above, the investigator, etc. or the individual providing existing specimens or information shall select
p.000038: legally acceptable representative, etc. in accordance with the criteria pursuant to the provisions of (1) A. (i)
p.000038: above and provide information to the said legally acceptable representative, etc. pursuant to the
p.000038: provisions in Part
p.000038: 12.3 and of (1) A. (ii) above.
p.000038: (3) When having obtained informed consent from legally acceptable representative, etc., and the
p.000038: research subject has completed junior high school or other relevant schooling, or is 16 years or older,
p.000038: and is considered to have enough judgment concerning the research to be implemented on
p.000038: him/herself, the investigator, etc., or the individual providing existing specimens or information shall
p.000038: obtain informed consent also from the said research subject.
p.000038:
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039:
p.000039: 2. Procedures, etc. for obtaining informed assent
...
p.000046: occurrence of such adverse event with other investigators, etc. engaged in implementing the research.
p.000046: (2) When a principal investigator becomes aware of the occurrence of a serious adverse event while carrying
p.000046: out the research which involves any invasiveness and is being conducted collaboratively with other research
p.000046: implementing entity(s), the principal investigator shall share information on the occurrence of such an event
p.000046: with the principal investigator(s) at the collaborative research implementing entity(s).
p.000046:
p.000046: 3. Response to be made by the chief executive of research implementing entity
p.000046: (1) When carrying out the research which involves any invasiveness, the chief executive of the research
p.000046: implementing entity shall prepare written operating procedures detailing what should be done by the
p.000046: investigators, etc. in response to a serious adverse event and take relevant measures in order that response will
p.000046: be made properly and smoothly in accordance with the said operating procedures.
p.000046: (2) When the chief executive of research implementing entity has received a report from a principal investigator
p.000046: concerning the occurrence of a serious adverse event pursuant to the provisions of Section 2 (1) above, the said chief
p.000046: executive shall make relevant response promptly in accordance with its operating procedures as well as take
p.000046: relevant measures after relevant ethical review committee deliberation to obtain its opinions on the said
p.000046: adverse event.
p.000046: (3) When any unexpected serious adverse event occurs while carrying out the research which involves invasiveness
p.000046: (not including minor invasiveness) and intervention and if the said unexpected serious adverse event may be
p.000046:
p.000047: 47
p.000047:
p.000047:
p.000047: in direct consequence of the said research, the chief executive of the research implementing entity where
p.000047: such an adverse event has occurred shall promptly report to the Minister of Health, Labour and Welfare and make
p.000047: public the status and results of response pursuant to the provisions of
p.000047: (2) above.
p.000047:
p.000047: Chapter 8 Ensuring of Reliability of Research Part 18 Managing Conflicts of Interest
p.000047: (1) When carrying out research, investigators, etc. shall report to the principal investigator concerning the
p.000047: status of conflicts of interest related to the research such as individual income, etc. and make appropriate
p.000047: response to ensure transparency of such.
p.000047: (2) When carrying out the research which may be related to any commercial activity, such as that to confirm the
p.000047: effectiveness or safety of medicine or medical device, the principal investigator shall understand the status
p.000047: of such research-related conflicts of interest and describe it in the research protocol.
p.000047: (3) Investigators, etc. shall provide information concerning the status of conflicts of interest described
p.000047: in the research protocol pursuant to the provisions of (2) above, to the research subject, etc. in the
p.000047: course of procedures for obtaining informed consent pursuant to the provisions in Part 12 above.
p.000047:
p.000047: Part 19 Storage of Specimens and Information, etc. for Research
p.000047: (1) Investigators, etc. shall ensure that information utilized in research and records related to such
p.000047: information (hereinafter referred to as “information, etc.”) are accurate.
p.000047: (2) When retaining human biological specimens and information, etc., the principal investigator shall
p.000047: prescribe means for storage in the research protocol in accordance with the operating procedures pursuant
p.000047: to the provisions of (3) below, instruct and manage the investigators, etc. to ensure that they retain
p.000047: accurate information, etc. and perform necessary management in order to prevent leakage, mix-up, robbery,
p.000047: loss, etc. of such specimens and information, etc.
p.000047: (3) The chief executive of research implementing entity shall prepare written operating procedures for retention
p.000047: of human biological specimens and
p.000047:
p.000048: 48
p.000048:
p.000048:
p.000048: information, etc. and exercise necessary supervision in order that such human biological specimens and
p.000048: information, etc. concerning the research carried out by the research implementing entity are retained appropriately.
p.000048: (4) The principal investigator shall report to the chief executive of the research implementing entity concerning
p.000048: the management status pursuant to the provisions of (2) above, in accordance with the operating
p.000048: procedures pursuant to the provisions of (3) above.
p.000048: (5) The chief executive of research implementing entity shall endeavor to ensure that information, etc.
p.000048: of the research implementing entity will be retained for as long as possible and for research
p.000048: which involves invasiveness (not including minor invasiveness) and intervention, the said chief executive shall
p.000048: exercise necessary supervision to ensure that such information, etc. be retained appropriately at least until
p.000048: five (5) years have passed from the date the end of the research is reported or three (3) years have passed from the
p.000048: date the final publication on the research results is reported, whichever is the later. In addition, the same shall
p.000048: apply to cases in which the research implementing entity retains a decoding index of linkably anonymized
p.000048: information.
p.000048: (6) When disposing of human biological specimens and information, etc., the chief executive of the research
p.000048: implementing entity shall exercise necessary supervision to ensure that such human biological specimens and
p.000048: information, etc. have been anonymized.
p.000048:
p.000048: Part 20 Monitoring and Audit
p.000048: (1) The principal investigator shall endeavor to secure the reliability of research and when carrying out
p.000048: research which involves invasiveness (not including minor invasiveness) and intervention, shall perform monitoring and,
p.000048: as necessary, audit, in accordance with the specifications prescribed in the research protocol approved by the
p.000048: chief executive of the research implementing entity.
p.000048: (2) The principal investigator shall offer necessary instruction and management to those engaged
p.000048: in monitoring or audit to ensure that such monitoring and audit will be appropriately carried out in accordance with
p.000048: the specifications prescribed in the research protocol approved by the chief executive of the research implementing
p.000048: entity.
p.000048: (3) The principal investigator shall not appoint those engaged in implementing
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049: and monitoring of the research, which is subject to the audit, to execute such audit.
p.000049: (4) Those engaged in monitoring shall report to the principal investigator concerning results of the said
p.000049: monitoring. In addition, those engaged in audit shall report to the principal investigator and the chief
p.000049: executive of the research implementing entity concerning results of the said audit.
p.000049: (5) Those engaged in monitoring and those engaged in audit shall not disclose, without justifiable reason, any
p.000049: information obtained while performing their duties. The same shall apply even after they cease to be engaged
p.000049: in the duties.
p.000049: (6) The chief executive of research implementing entity shall support the execution of monitoring and audit
p.000049: pursuant to the provisions of (1) above and take relevant measures for the execution of such monitoring and audit.
p.000049:
p.000049: Chapter 9 Supplementary Provisions Part 21 Effective Date
...
Social / education
Searching for indicator education:
(return to top)
p.000001:
p.000001: Provisional Translation (as of March 2015)
p.000001: Ethical Guidelines for Medical and Health Research Involving Human Subjects Table of Contents
p.000001: Preamble
p.000001: Chapter 1 General Provisions
p.000001: Part 1 Purpose and Basic Principles Part 2 Glossary
p.000001: Part 3 Scope of Application
p.000001: 1. Research applicable to these Guidelines
p.000001: 2. Research carried out outside Japan Chapter 2 Obligations of Investigators, etc.
p.000001: Part 4 Basic Obligations of Investigators, etc.
p.000001: 1. Consideration for research subjects, etc.
p.000001: 2. Ensuring, etc. of ethical justification and scientific validity of research
p.000001: 3. Education and training
p.000001: Part 5 Obligations of Principal Investigator
p.000001: 1. Preparation of research protocol and compliance of investigators, etc.
p.000001: 2. Management and supervision of research progress and identification and reporting adverse events, etc.
p.000001: 3. Following-up research subjects after end of research
p.000001: Part 6 Obligations of the Chief Executive of Research Implementing Entity
p.000001: 1. Overall supervision of research
p.000001: 2. Arrangement, etc. of systems and procedures for implementation of research
p.000001: 3. Approval, etc. of research
p.000001: 4. Report, etc. to the Minister(s) Chapter 3 Research Protocol
p.000001: Part 7 Procedures Related to Research Protocol
p.000001: 1. Preparation and revision of research protocols
p.000001: 2. Submission of matters to ethical review committee for deliberation
p.000001: 3. Approval by chief executive of research implementing entity
p.000001: 4. Procedures after end of research Part 8 Contents of Research Protocol
p.000001: Part 9 Registration and Publication of Research
p.000001:
p.000001: 1
p.000001:
p.000001:
p.000001: 1. Registration of summary of research protocol and results
p.000001: 2. Publication of research results Chapter 4 Ethical Review Committee
p.000001: Part 10 Organizing, etc. of Ethical Review Committee
p.000001: 1. Qualifications for organizing ethical review committee
p.000001: 2. Obligations of organizer of ethical review committee
p.000001: Part 11 Roles, Responsibilities, etc. of Ethical Review Committee
p.000001: 1. Roles and responsibilities
p.000001: 2. Composition and quorum, etc.
p.000001: 3. Expedited review
p.000001: 4. Review of research to be carried out by other research implementing entity(s)
p.000001: Chapter 5 Informed Consent, etc.
...
p.000002: Chapter 8 Ensuring of Reliability of Research Part 18 Managing Conflicts of Interest
p.000002: Part 19 Storage of Specimens and Information, etc. for Research Part 20 Monitoring and Audit
p.000002: Chapter 9 Supplementary Provisions Part 21 Effective Date
p.000002: Part 22 Transitional Measures Part 23 Amendment
p.000002:
p.000002: Preamble
p.000002: Medical and health research involving human subjects contributes significantly to society in terms of
p.000002: maintaining and promoting people’s good health and advancing patients’ recuperation from injury and disease
p.000002: as well as quality of life, through the development of medical and health science and medical technology.
p.000002: Furthermore, such research also acts an important foundation which leads to progress in good health and welfare for
p.000002: society. In this sense, on the one hand, it is required that an institutional framework be developed and maintained
p.000002: in which investigators can carry out research appropriately and smoothly under academic freedom. On the other hand,
p.000002: medical and health research involving human subjects can have a major impact on such research subjects both
p.000002: physically and mentally or, indeed, on society itself, as well as cause a variety of ethical, legal and social
p.000002: problems. The welfare of those research subjects shall be given priority over scientific and social results of
p.000002: research, and human dignity and rights shall be protected.
p.000002: From this point of view, the Ministry of Education, Culture, Sports, Science and Technology and the
p.000002: Ministry of Health, Labour and Welfare established the Ethical Guidelines for Epidemiological Research (Public
p.000002: Notice of the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health,
p.000002: Labour and Welfare No. 1 of 2007), originally in 2002 and later amended entirely in 2007, and the
p.000002:
p.000003: 3
p.000003:
p.000003:
p.000003: Ethical Guidelines for Clinical Research (Public Notice of the Ministry of Health, Labour and Welfare No.
p.000003: 415 of 2008), originally in 2003 and later amended entirely in 2008, in order that investigators can respect and
p.000003: protect human dignity and rights as well as carry out research appropriately and smoothly. Both guidelines were
p.000003: based on the Constitution of Japan, the Act on the Protection of Personal Information and other related acts, and the
p.000003: ethical principles as defined in the Declaration of Helsinki adopted by the World Medical Association, etc. In recent
p.000003: years, however, research falling under the above-mentioned guidelines has become more and more diversified
p.000003: and the objectives and methods of such research are increasingly becoming common in both of the above-mentioned
p.000003: guidelines and hence, it has been pointed out that the scope of those guidelines are not clear enough. Now,
p.000003: therefore, it has been decided to establish new ethical guidelines to merge the previously in place guidelines above.
p.000003: The new Guidelines provide fundamental requirements to be observed by any of those concerned in medical
p.000003: and health research involving human subjects. The chief executive of a research implementing entity is
...
p.000011: (5) When an investigator, etc. becomes aware of any serious concern with respect to human rights of the
p.000011: research subject, etc. or with respect to implementing of the research, such as leakage of information related
p.000011: to the research, the investigator, etc. shall report promptly to the chief executive of research implementing entity
p.000011: and the principal investigator.
p.000011:
p.000011: 2. Ensuring, etc. of ethical justification and scientific validity of research
p.000011: (1) Investigators, etc. shall carry out research appropriately, complying with laws, ordinances, guidelines,
p.000011: etc. and in accordance with the research protocol reviewed by the ethical review committee and approved
p.000011: by the chief executive of the research implementing entity.
p.000011:
p.000012: 12
p.000012:
p.000012:
p.000012: (2) When an investigator, etc. becomes aware of any fact or obtains any information that ethical
p.000012: justification or scientific validity of the research he/she is engaged in is, or might be, impaired (not including
p.000012: cases which correspond to (3) below), the investigator, etc. shall report promptly to the principal investigator.
p.000012: (3) When an investigator, etc. becomes aware of any fact or obtains any information that appropriateness
p.000012: of implementing the research he/she is engaged in or the reliability of results of the research is, or
p.000012: might be, impaired, the investigator, etc. shall promptly report to the principal investigator or the chief
p.000012: executive of the research implementing entity.
p.000012:
p.000012: 3. Education and training
p.000012: Investigators, etc. shall receive education and training on the ethics of research and on knowledge and
p.000012: skills necessary to carry out the research prior to its implementation. They shall also receive education and
p.000012: training during the research period on a regular basis as necessary.
p.000012:
p.000012: Part 5 Obligations of Principal Investigator
p.000012: 1. Preparation of research protocol and compliance of investigators, etc.
p.000012: (1) The principal investigator shall prepare an appropriate research protocol prior to any implementation of
p.000012: research. In the same manner, the principal investigator shall revise the research protocol prior to any implementation
p.000012: of a changed conduct of research.
p.000012: (2) The principal investigator shall prepare a research protocol to ensure ethical justification and
p.000012: scientific validity of the research. In addition, when preparing the research protocol, the principal
p.000012: investigator shall comprehensively assess the burdens on research subjects and predicted risks and benefits as
p.000012: well as take measures to minimize such burdens and risks.
p.000012: (3) When the principal investigator intends to carry out research which involves invasiveness (not
p.000012: including minor invasiveness) along with medical technique beyond usual medical practice, the
p.000012: principal investigator shall take beforehand necessary measures, such as purchasing insurance, etc., in preparation
p.000012: for compensation to the research subject in the event of research-related injuries, appropriately.
p.000012: (4) Pursuant to the provisions in Part 9 of these Guidelines below, the
p.000012:
p.000013: 13
p.000013:
p.000013:
p.000013: principal investigator shall appropriately register the summary of his/her research and other related
p.000013: information, and make results of the research public.
...
p.000014: has ceased to be engaged in the duties.
p.000014: (4) When entrusting a part of research work, the chief executive of research implementing entity shall enter into
p.000014: a written agreement for matters the contractor(s) shall comply with and shall exercise necessary
p.000014: and
p.000014:
p.000015: 15
p.000015:
p.000015:
p.000015: appropriate supervision of the contractor(s).
p.000015:
p.000015: 2. Arrangement, etc. of systems and procedures for implementation of research
p.000015: (1) The chief executive of research implementing entity shall arrange systems and procedures necessary for the
p.000015: appropriate implementation of research.
p.000015: (2) When a research subject has incurred any injury related to the research carried out by the research
p.000015: implementing entity, the chief executive of the research implementing entity shall ensure that necessary
p.000015: measures are taken appropriately, such as compensation for the research-related injury.
p.000015: (3) The chief executive of research implementing entity shall ensure that information concerning its
p.000015: research, including results of the research, shall be made public appropriately.
p.000015: (4) The chief executive of research implementing entity himself/herself shall, as necessary, verify and review
p.000015: whether the research carried out by the research implementing entity is complying with these Guidelines and shall
p.000015: take appropriate measures based on the results of such verification and reviews.
p.000015: (5) The chief executive of research implementing entity shall take measures to ensure that investigators, etc. of
p.000015: the research implementing entity shall receive education and training related to the ethics of research as well as
p.000015: knowledge and skills necessary to carry out the research. The chief executive of research implementing
p.000015: entity himself/herself shall also receive such education and training.
p.000015: (6) The chief executive of research implementing entity may delegate the authority and duties set
p.000015: forth in these Guidelines to appropriate individual(s) who belong to the research implementing
p.000015: entity, in accordance with the procedures established at the research implementing entity.
p.000015:
p.000015: 3. Approval, etc. of research
p.000015: (1) When the chief executive of research implementing entity is asked by principal investigator for
p.000015: approval for any implementation of research or revision of the approved research protocol, the said chief executive
p.000015: shall submit the matter to ethical review committee for deliberation and make decision on relevant measures, such as
p.000015: approval, disapproval, etc., to the matter with due respect to opinions presented by the ethical review
p.000015:
p.000016: 16
p.000016:
p.000016:
p.000016: committee.
p.000016: (2) When the chief executive of research implementing entity has received any report from principal investigator
p.000016: or other investigators, etc. concerning facts or information deemed to affect the propriety of continuance
p.000016: of a research, the said chief executive, as necessary, shall submit the matter to the ethical review committee
p.000016: for deliberation and, with due respect to opinions presented by the ethical review committee, take
p.000016: appropriate countermeasures promptly such as suspension of the research and examination of the cause.
p.000016: (3) The chief executive of research implementing entity shall provide cooperation with the
p.000016: investigation carried out by relevant ethical review committee.
p.000016: (4) When the chief executive of research implementing entity has received any report concerning the fact or
p.000016: information that appropriateness of implementing the research or reliability of results of the research
p.000016: is, or might be, impaired, the said chief executive shall take relevant measures promptly.
p.000016: (5) When the chief executive of research implementing entity has received any report from principal investigator that
p.000016: research has finished, the said chief executive shall report necessary matters to the ethical review committee
p.000016: which made reviews on the said research.
p.000016:
p.000016: 4. Report, etc. to the Minister(s)
p.000016: (1) When the chief executive of research implementing entity becomes aware that any research which the entity
p.000016: is implementing or implemented previously is not complying with these Guidelines, the said chief executive shall
p.000016: promptly submit the matter to the ethical review committee for deliberation and take relevant measures as well
p.000016: as, if such noncompliance is serious, shall report to the Minister of Health, Labour and Welfare (if the research
p.000016: implementing entity is a college/university and the like, to the Minister of Health, Labour and Welfare and the
p.000016: Minister of Education, Culture, Sports, Science and Technology; hereinafter referred to the “Minister(s)”)
p.000016: concerning the status and results of such countermeasures and make the said status and results public.
p.000016: (2) The chief executive of research implementing entity shall provide cooperation with the inspection
p.000016: carried out by the Minister(s) or entity(s)
p.000016:
p.000017: 17
p.000017:
p.000017:
p.000017: entrusted with the duties by the Minister(s) (hereinafter referred to as the “Minister(s), etc.”) to confirm that the
p.000017: research carried out by the research implementing entity is complying with these Guidelines.
p.000017: (3) When any unexpected serious adverse event occurs in implementing of the research which involves invasiveness
p.000017: (not including minor invasiveness) and intervention and if the said unexpected serious adverse event may be in
p.000017: direct consequence of the research, the chief executive of the research implementing entity shall report to the
p.000017: Minister of Health, Labour and Welfare concerning the status and results of countermeasures pursuant to the
p.000017: provisions of Section 3 (2) above and make the said status and results of such countermeasures public.
p.000017:
p.000017: Chapter 3 Research Protocol
p.000017: Part 7 Procedures Related to Research Protocol
p.000017: 1. Preparation and revision of research protocols
p.000017: (1) When principal investigator intends to carry out any research (including the case in which research is
p.000017: implemented after revision(s) in the research protocol; the same applies hereinafter), the principal
p.000017: investigator shall prepare the research protocol beforehand and receive approval of the chief executive of the
...
p.000023: said rules.
p.000023: (2) The organizer of ethical review committee shall appropriately retain review materials concerning the
p.000023: research which the ethical review committee has examined until the end of the said research is
p.000023: reported (when the research involves invasiveness (not including minor invasiveness) and
p.000023: intervention, the review materials shall be retained for
p.000023:
p.000024: 24
p.000024:
p.000024:
p.000024: five (5) years from the date the end of the said research is reported).
p.000024: (3) When beginning operation of ethical review committee, the organizer of the committee shall make
p.000024: public, in the Ethical Review Committee Reporting System, the organization of, provisions for operating and list
p.000024: of members of the committee.
p.000024: In addition, the said organizer shall similarly make public, in the Ethical Review Committee Reporting System, the
p.000024: status of the committee’s meetings held and a summary of the committee’s reviews at least once a year. With respect
p.000024: to the summary of the committee’s reviews, however, any of the contents may be omitted from such publication,
p.000024: when the committee considers it shall be confidential in order to protect human rights of the research
p.000024: subject, etc. and other individuals concerned or rights and interests of the investigator, etc. and other entity
p.000024: concerned.
p.000024: (4) The organizer of ethical review committee shall take necessary measures to ensure that members of the
p.000024: ethical review committee and other individuals engaged in administrative work receive education and training
p.000024: concerning relevant reviews and other related duties.
p.000024: (5) The organizer of ethical review committee shall provide cooperation with the inspection carried out by the
p.000024: Minister(s), etc. on the compliance of the ethical review committee’s organization and operation with
p.000024: these Guidelines.
p.000024:
p.000024: Part 11 Roles, Responsibilities, etc. of Ethical Review Committee
p.000024: 1. Roles and responsibilities
p.000024: (1) When the chief executive of research implementing entity asks for any opinion with regard to the
p.000024: appropriateness of implementing research or other matters, the ethical review committee shall make reviews
p.000024: on the matter, in accordance with these Guidelines, neutrally and fairly including information on any conflicts of
p.000024: interest of the research implementing entity and the investigator etc. as well as from ethical and scientific
p.000024: viewpoints, and shall present its opinions in writing.
p.000024: (2) The ethical review committee may make a necessary investigation from ethical and scientific viewpoints
p.000024: on the research it makes reviews of pursuant to the provisions of (1) above, and may present relevant opinions
p.000024: to the chief executive of the research implementing entity, with respect to revisions of the research protocol,
p.000024: termination of the research and other
p.000024:
p.000025: 25
p.000025:
p.000025:
p.000025: matters related to the research.
p.000025: (3) Of the research it has made reviews of pursuant to the provisions of (1) above, for the research
p.000025: which involves invasiveness (not including minor invasiveness) and intervention, the ethical review committee may make
p.000025: a necessary investigation to secure the appropriateness of implementing the research and the reliability of
p.000025: results of the research, and may present relevant opinions to the chief executive of the research
p.000025: implementing entity, with respect to revisions of the research protocol, termination of the research and other matters
p.000025: related to the research.
p.000025: (4) Members of ethical review committee and individuals engaged in the administrative work shall not
p.000025: disclose, without justifiable reason, any information obtained during the duties related to the committee. The same
p.000025: shall apply, even after they cease to be engaged in the duties.
p.000025: (5) When a member of ethical review committee or an individual engaged in the administrative work becomes aware
p.000025: of any serious concern with respect to human rights of the research subject, etc. or with respect to the
p.000025: appropriateness for implementing the research which the committee made reviews of pursuant to the provisions of
p.000025: (1) above, such as leakage of information related to such research, as well as with respect to the
p.000025: neutrality or fairness of its reviews, the said member or individual shall report promptly to the organizer
p.000025: of the committee.
p.000025: (6) Members of ethical review committee and individuals engaged in the administrative work shall
p.000025: receive education and training to acquire knowledge necessary for reviews from ethical and scientific
p.000025: viewpoint, etc. prior to being engaged in reviews or other related duties. They shall also receive education and
p.000025: training later than that, on a regular basis as necessary.
p.000025:
p.000025: 2. Composition and quorum, etc.
p.000025: (1) The composition of ethical review committee shall meet each of the following requirements in order that
p.000025: the duties of the committee, such as reviews of research protocols, be executed appropriately. Those members as defined
p.000025: in each of the groups of (i) to (iii) below cannot concurrently hold status for other groups. The same
p.000025: requirements shall apply to the quorum of the committee’s meetings.
p.000025: (i) The committee shall have a member who is expert in natural science,
p.000025:
p.000026: 26
p.000026:
p.000026:
p.000026: such as a medicine and medical care professional, etc.;
p.000026: (ii) The committee shall have a member who is expert in humanities and social sciences, such as a professional in
p.000026: ethics and law, etc.;
p.000026: (iii) The committee shall have a member who can provide opinions of the general public, including viewpoints of
p.000026: research subjects;
p.000026: (iv) The committee shall have at least two members who do not belong to the organization to which the organizer of
p.000026: the committee belongs;
p.000026: (v) The committee shall have both male and female members; and
p.000026: (vi) The committee shall have five or more members.
p.000026: (2) Investigators, etc. engaged in the research which is subject to deliberation shall not be present when the
p.000026: deliberation and adoption of opinions are made at the committee’s meeting. When so requested by the ethical review
p.000026: committee, however, such investigators, etc. may attend the meeting to provide information on the said
p.000026: research.
...
Searching for indicator schooling:
(return to top)
p.000037: the course of procedures for obtaining informed consent from the said research subjects.
p.000037:
p.000037: Part 13 Procedures, etc. for Obtaining Informed Consent from Legally Acceptable Representatives, etc.
p.000037: 1. Requirements for obtaining informed consent from legally acceptable representatives, etc.
p.000037: (1) When the investigator, etc. or the individual providing existing specimens or information obtains informed
p.000037: consent from a legally acceptable representative, etc. pursuant to the provisions in Part 12 above,
p.000037: all requirements as defined below shall be met.
p.000037: A. The research protocol has description on the following matters:
p.000037: (i) Criteria for selection of legally acceptable representatives, etc.;
p.000037: (ii) Information to be provided to the legally acceptable representative, etc. (including
p.000037: information on (iii) below, when research subjects are those who correspond to either (a) or (b) in
p.000037: B. below); and
p.000037: (iii) When the research subject is an individual who corresponds to either (a) or (b) in B. below, the
p.000037: reason why such an individual shall be the research subject.
p.000037: B. The research subject shall correspond to any of the following:
p.000037: (a) The research subject is a minor. When the research subject has completed junior high school or other
p.000037: relevant schooling, or is 16
p.000037:
p.000038: 38
p.000038:
p.000038:
p.000038: years or older, and is considered to have enough judgment concerning the research to be implemented on
p.000038: him/herself, as well as the following matters are prescribed in the research protocol and the chief
p.000038: executive of the research implementing entity approves to carry out the research after relevant ethical
p.000038: review committee deliberation, informed consent shall be obtained not from representative but from the said
p.000038: research subject.
p.000038: (i) The research to be implemented does not involve any invasiveness; and
p.000038: (ii) Information concerning implementation of the research, including purpose of the research and how
p.000038: specimens or information will be handled, is made public, and opportunities to refuse that
p.000038: the research is commenced or continued on the research subject are ensured for persons who exercise
p.000038: parental authority over the said research subject and guardians of the minor.
p.000038: (b) The research subject is an adult but objectively considered unable to give informed consent.
p.000038: (c) The research subject is a decedent, however, excluding cases in which the implementation of
p.000038: research is against the subject’s explicit will expressed during lifetime.
p.000038: (2) When obtaining informed consent from legally acceptable representative pursuant to the provisions in
p.000038: Part 12 above, the investigator, etc. or the individual providing existing specimens or information shall select
p.000038: legally acceptable representative, etc. in accordance with the criteria pursuant to the provisions of (1) A. (i)
p.000038: above and provide information to the said legally acceptable representative, etc. pursuant to the
p.000038: provisions in Part
p.000038: 12.3 and of (1) A. (ii) above.
p.000038: (3) When having obtained informed consent from legally acceptable representative, etc., and the
p.000038: research subject has completed junior high school or other relevant schooling, or is 16 years or older,
p.000038: and is considered to have enough judgment concerning the research to be implemented on
p.000038: him/herself, the investigator, etc., or the individual providing existing specimens or information shall
p.000038: obtain informed consent also from the said research subject.
p.000038:
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039:
p.000039: 2. Procedures, etc. for obtaining informed assent
p.000039: (1) Even when having obtained informed consent from legally acceptable representative but when the
p.000039: research subject is considered to be able to express his/her will concerning the research is to be
p.000039: implemented on him/herself, the investigator, etc. or the individual providing existing specimens or
p.000039: information shall endeavor to obtain informed assent from the said research subject. The same shall not
p.000039: apply to cases in which informed consent is obtained from the research subject pursuant to the provisions
p.000039: of Section 1 (3) above.
p.000039: (2) When carrying out the research for which procedures for obtaining informed assent will be
p.000039: predicted pursuant to the provisions of (1) above, the principal investigator shall, in advance, prescribe
p.000039: information to be provided and the means to provide to research subjects, in the research protocol.
p.000039: (3) When a research subject expresses his/her will of refusal all or part of the research to be commenced or
p.000039: continued, in the course of the procedures for obtaining informed assent pursuant to the provisions of (1) above,
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000017: research implementing entity(s), the principal investigator shall clarify the role and responsibility of
p.000017: the principal investigators of each of other collaborative research implementing entity(s), in the
p.000017: course of the preparation of a research protocol.
p.000017: (3) When principal investigator intends to entrust a part of work related to research to be carried out
p.000017: by the research implementing entity he/she belongs to, the principal investigator shall prescribe which work
p.000017: shall be entrusted in the course of preparation of the research protocol.
p.000017:
p.000017: 2. Submission of matters to ethical review committee for deliberation
p.000017: (1) When principal investigator asks for approval for any implementation of research at the research implementing
p.000017: entity, the chief executive of the research implementing entity shall submit the matter to ethical review
p.000017: committee for deliberation with respect to appropriateness of implementing the research. The
p.000017: said chief executive may decide to give
p.000017:
p.000018: 18
p.000018:
p.000018:
p.000018: approval prior to deliberation by relevant ethical review committee, however, when it is considered
p.000018: necessary to implement the research urgently in order to prevent public health-related harm from occurring or
p.000018: spreading. In this case, the said chief executive shall submit the matter to the ethical review committee for
p.000018: deliberation without delay after giving approval, and if the ethical review committee forms an opinion
p.000018: that the research shall be suspended or terminated or that revision shall be made in the research protocol, the said
p.000018: chief executive shall respect such opinions and take appropriate measures, such as ordering the principal investigator
p.000018: to suspend or terminate the research or getting the research protocol revised.
p.000018: (2) When the chief executive of research implementing entity submits a matter to ethical review committee for
p.000018: deliberation concerning research to be conducted collaboratively with other research implementing entity(s), the
p.000018: said chief executive shall provide the committee with information necessary for making reviews,
p.000018: including information on approval for the implementation of research at other collaborative research
p.000018: implementing entity(s), results of the review by other ethical review committee(s) and the progress status of the
p.000018: research.
p.000018: (3) The chief executive of research implementing entity may submit a matter to a single ethical review
p.000018: committee for deliberation to make a comprehensive review on the research protocol for the research
p.000018: to be conducted collaboratively with other research implementing entity(s).
p.000018:
p.000018: 3. Approval by chief executive of research implementing entity
p.000018: The chief executive of research implementing entity shall respect opinions of ethical review committee and make
p.000018: decision on whether the implementation of the research should be approved or not and on other measures
p.000018: necessary in relation with the research. In the course of such decision, the chief executive of the research
...
p.000024: (3) When beginning operation of ethical review committee, the organizer of the committee shall make
p.000024: public, in the Ethical Review Committee Reporting System, the organization of, provisions for operating and list
p.000024: of members of the committee.
p.000024: In addition, the said organizer shall similarly make public, in the Ethical Review Committee Reporting System, the
p.000024: status of the committee’s meetings held and a summary of the committee’s reviews at least once a year. With respect
p.000024: to the summary of the committee’s reviews, however, any of the contents may be omitted from such publication,
p.000024: when the committee considers it shall be confidential in order to protect human rights of the research
p.000024: subject, etc. and other individuals concerned or rights and interests of the investigator, etc. and other entity
p.000024: concerned.
p.000024: (4) The organizer of ethical review committee shall take necessary measures to ensure that members of the
p.000024: ethical review committee and other individuals engaged in administrative work receive education and training
p.000024: concerning relevant reviews and other related duties.
p.000024: (5) The organizer of ethical review committee shall provide cooperation with the inspection carried out by the
p.000024: Minister(s), etc. on the compliance of the ethical review committee’s organization and operation with
p.000024: these Guidelines.
p.000024:
p.000024: Part 11 Roles, Responsibilities, etc. of Ethical Review Committee
p.000024: 1. Roles and responsibilities
p.000024: (1) When the chief executive of research implementing entity asks for any opinion with regard to the
p.000024: appropriateness of implementing research or other matters, the ethical review committee shall make reviews
p.000024: on the matter, in accordance with these Guidelines, neutrally and fairly including information on any conflicts of
p.000024: interest of the research implementing entity and the investigator etc. as well as from ethical and scientific
p.000024: viewpoints, and shall present its opinions in writing.
p.000024: (2) The ethical review committee may make a necessary investigation from ethical and scientific viewpoints
p.000024: on the research it makes reviews of pursuant to the provisions of (1) above, and may present relevant opinions
p.000024: to the chief executive of the research implementing entity, with respect to revisions of the research protocol,
p.000024: termination of the research and other
p.000024:
p.000025: 25
p.000025:
p.000025:
p.000025: matters related to the research.
p.000025: (3) Of the research it has made reviews of pursuant to the provisions of (1) above, for the research
p.000025: which involves invasiveness (not including minor invasiveness) and intervention, the ethical review committee may make
p.000025: a necessary investigation to secure the appropriateness of implementing the research and the reliability of
p.000025: results of the research, and may present relevant opinions to the chief executive of the research
p.000025: implementing entity, with respect to revisions of the research protocol, termination of the research and other matters
p.000025: related to the research.
p.000025: (4) Members of ethical review committee and individuals engaged in the administrative work shall not
...
p.000026: deliberation and adoption of opinions are made at the committee’s meeting. When so requested by the ethical review
p.000026: committee, however, such investigators, etc. may attend the meeting to provide information on the said
p.000026: research.
p.000026: (3) The chief executive of the research implementing entity who submitted the matter for which the ethical review
p.000026: committee makes deliberation shall not be present when deliberation and adoption of opinions are made at the
p.000026: committee’s meeting. When it is necessary to do so in order to understand the details of deliberation made by the
p.000026: ethical review committee, however, the said chief executive may attend the meeting by obtaining the
p.000026: committee’s consent.
p.000026: (4) The ethical review committee may invite nonmembers with expertise in special areas for assistance
p.000026: depending on matters subject to review and content of such.
p.000026: (5) When reviewing the research protocol of which research subjects are those who need special considerations and
p.000026: presenting its opinions on such research, the ethical review committee shall, as necessary, seek opinions of
p.000026: experts who have discernment on such research subjects.
p.000026: (6) The ethical review committee shall endeavor to make adoption of its opinions unanimously.
p.000026:
p.000026: 3. Expedited review
p.000026: Under any of the following circumstances the ethical review committee may delegate reviews to member(s) designated by
p.000026: the committee (hereinafter referred to as “expedited review”) and adopt their opinion. The result of such
p.000026: an expedited review shall be considered as the conclusion of the entire ethical
p.000026:
p.000027: 27
p.000027:
p.000027:
p.000027: review committee and shall be reported to other members of the committee.
p.000027: (i) Review of research to be conducted collaboratively with other research implementing entity(s),
p.000027: the entire scope of which has already been reviewed by the ethical review committee to which the
p.000027: collaborative research entity(s) submitted it for deliberation and opinions to indicate the appropriateness of such
p.000027: research have already been presented;
p.000027: (ii) Review of minor revisions of research protocol;
p.000027: (iii) Review of the research which does not involve any invasiveness and intervention; or
p.000027: (iv) Review of the research which involves minor invasiveness but does not involve any intervention.
p.000027:
p.000027: 4. Review of research to be carried out by other research implementing entity(s)
p.000027: (1) When the chief executive of research implementing entity submits the matters for deliberation by
p.000027: the ethical review committee which is organized by the institution he/she belongs to, the said
p.000027: ethical review committee shall have enough information concerning the site-specific information for the
p.000027: research at the research implementing entity, in order to make reviews and present its opinions.
p.000027: (2) With respect to research carried out by other research implementing entity(s) than the institution to
p.000027: which the organizer of the ethical review committee belongs, when the chief executive of the said
...
General/Other / Incapacitated
Searching for indicator incapacity:
(return to top)
p.000008: information by itself does not enable identification of any specific individuals, which will enable identification of
p.000008: a specific individual if referred to other information available in order to ensure that the said
p.000008: information cannot enable such identification.
p.000008:
p.000008: (23) Linkable Anonymization
p.000008: Anonymization to enable identification of each specific individual when required, by retaining a decoding index
p.000008: which is a list of the specific individuals’ identification and the corresponding symbols or numbers given to
p.000008: each individual.
p.000008:
p.000008: (24) Unlinkable Anonymization
p.000008: Anonymization to disable identification of each specific individual, by
p.000008:
p.000009: 9
p.000009:
p.000009:
p.000009: not retaining a decoding index listing the specific individuals’ identification and the corresponding symbols or
p.000009: numbers given to each individual.
p.000009:
p.000009: (25) Adverse Event
p.000009: Any unfavorable and unintended injury and illness or any sign of such (including an abnormal laboratory finding)
p.000009: caused to research subjects, regardless of whether there is or is not any causal relation with the research
p.000009: implemented.
p.000009:
p.000009: (26) Serious Adverse Event
p.000009: Of the above-defined adverse events, an event that:
p.000009: (i) Results in death;
p.000009: (ii) Is life-threatening;
p.000009: (iii) Requires inpatient hospitalization or prolongation of existing hospitalization;
p.000009: (iv) Results in persistent or significant disability or incapacity; or
p.000009: (v) Is a congenital anomaly or birth defect to offspring.
p.000009:
p.000009: (27) Unexpected Serious Adverse Event
p.000009: Of the above-defined serious adverse events, an event not consistent with the information in the research
p.000009: protocol, the document used for obtaining informed consent and so on, or not consistent with the severity
p.000009: described in such, even if there is any description about the event.
p.000009:
p.000009: (28) Monitoring
p.000009: An act of overseeing the progress of research, and of determining whether the research is being
p.000009: conducted in compliance with these Guidelines and the research protocol, in order to ensure that the research
p.000009: is properly conducted. Such act is performed by an individual appointed by the principal investigator.
p.000009:
p.000009: (29) Audit
p.000009: An examination of research-related activities to determine whether the research has been conducted in
p.000009: compliance with these Guidelines and the research protocol, in order to assure the reliability of results of the
p.000009: research. Such examination is performed by an individual appointed by the principal
p.000009:
p.000010: 10
p.000010:
p.000010:
p.000010: investigator.
p.000010:
p.000010: Part 3 Scope of Application
p.000010: 1. Research applicable to these Guidelines
p.000010: These Guidelines shall apply to any medical and health research involving human subjects which is carried out
p.000010: by a Japanese research implementing entity or carried out in Japan. Of research which falls under the scope to which
p.000010: other guidelines are applicable, however, matters not set forth in such other guidelines shall be carried out in
p.000010: accordance with these Guidelines.
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000001: 4. Report, etc. to the Minister(s) Chapter 3 Research Protocol
p.000001: Part 7 Procedures Related to Research Protocol
p.000001: 1. Preparation and revision of research protocols
p.000001: 2. Submission of matters to ethical review committee for deliberation
p.000001: 3. Approval by chief executive of research implementing entity
p.000001: 4. Procedures after end of research Part 8 Contents of Research Protocol
p.000001: Part 9 Registration and Publication of Research
p.000001:
p.000001: 1
p.000001:
p.000001:
p.000001: 1. Registration of summary of research protocol and results
p.000001: 2. Publication of research results Chapter 4 Ethical Review Committee
p.000001: Part 10 Organizing, etc. of Ethical Review Committee
p.000001: 1. Qualifications for organizing ethical review committee
p.000001: 2. Obligations of organizer of ethical review committee
p.000001: Part 11 Roles, Responsibilities, etc. of Ethical Review Committee
p.000001: 1. Roles and responsibilities
p.000001: 2. Composition and quorum, etc.
p.000001: 3. Expedited review
p.000001: 4. Review of research to be carried out by other research implementing entity(s)
p.000001: Chapter 5 Informed Consent, etc.
p.000001: Part 12 Procedures for Obtaining Informed Consent, etc.
p.000001: 1. Procedures for obtaining informed consent, etc.
p.000001: 2. Revising research protocol
p.000001: 3. Information to be provided to research subjects, etc.
p.000001: 4. Procedures to utilize specimens and information in research unidentified at the time consent was given
p.000001: 5. Procedures in the research in emergency situations involving obvious life-threatening risk to the research
p.000001: subject
p.000001: 6. Omission of procedures concerning informed consent, etc.
p.000001: 7. Withdrawal of consent, etc.
p.000001: Part 13 Procedures, etc. for Obtaining Informed Consent from Legally Acceptable Representatives, etc.
p.000001: 1. Requirements for obtaining informed consent from legally acceptable representatives, etc.
p.000001: 2. Procedures, etc. for obtaining informed assent Chapter 6 Personal Information, etc.
p.000001: Part 14 Basic Obligations about Personal Information, etc.
p.000001: 1. Protection of personal information, etc.
p.000001: 2. Proper acquisition, etc.
p.000001: Part 15 Security Control Measures
p.000001: 1. Proper handling
p.000001: 2. Arrangement of systems and supervision, etc. for security control measures Part 16 Disclosure, etc. of Retained
p.000001: Personal Information
p.000001:
p.000002: 2
p.000002:
p.000002:
p.000002: 1. Public announcement, etc. concerning retained personal information
p.000002: 2. Response to request for disclosure, etc. Chapter 7 Response to Serious Adverse Event
p.000002: Part 17 Response to Serious Adverse Event
p.000002: 1. Response to be made by investigators, etc.
p.000002: 2. Response to be made by principal investigator
p.000002: 3. Response to be made by the chief executive of research implementing entity
p.000002: Chapter 8 Ensuring of Reliability of Research Part 18 Managing Conflicts of Interest
...
p.000034: (xxi) When the research involves any invasiveness (not including minor invasiveness) and intervention,
p.000034: the fact that the monitor(s), the auditor(s) and the ethical review committee will be granted direct access
p.000034: to the specimens and information acquired from the research subject, without violating confidentiality of the
p.000034: research subjects, to the extent necessary.
p.000034:
p.000034: 4. Procedures to utilize specimens and information in research unidentified at the time consent was given
p.000034: When the investigator, etc. has provided the information including purpose of
p.000034:
p.000035: 35
p.000035:
p.000035:
p.000035: the utilization of specimens and information which is presumed at the time of obtaining consent of the research
p.000035: subject, etc. as fully as possible, and when, later, such purposes of the utilization, etc. are newly
p.000035: identified, the investigator, etc. shall notify the research subjects, etc. of, or make public, information
p.000035: including the newly identified purposes of the utilization, etc. in accordance with the specifications prescribed in
p.000035: the prepared or revised research protocol, and with regards that the research is implemented,
p.000035: opportunities to withdraw such consent shall be ensured for the research subject, etc.
p.000035:
p.000035: 5. Procedures in the research in emergency situations involving obvious life-threatening risk to the
p.000035: research subject
p.000035: When the investigator, etc. considers that the research subject fulfills all the following conditions, in
p.000035: accordance with specifications prescribed in the research protocol, the investigator, etc. may enroll such
p.000035: research subject without obtaining consent of the research subjects, etc. When such research is
p.000035: implemented, however, the investigator, etc. shall promptly follow procedures to obtain written informed consent
p.000035: including the information to be provided pursuant to the provisions in Section 3 above.
p.000035: (i) The research subject is facing an emergency involving obvious life-threatening risk;
p.000035: (ii) When the research involves intervention, currently available treatments are unlikely to achieve sufficient
p.000035: therapeutic effects in the research subject and there is sufficient possibility of saving the life of the research
p.000035: subject in a life-threatening condition by implementing the said research;
p.000035: (iii) The burdens and risks to be caused on the research subjects are minimized; and
p.000035: (iv) The legally acceptable representative or the prospective legally acceptable representative cannot immediately
p.000035: be contacted for consent.
p.000035:
p.000035: 6. Omission of procedures concerning informed consent, etc.
p.000035: (1) When carrying out the research which corresponds to all of the requirements as defined
p.000035: below, the investigator, etc. or the individual providing existing specimens or information may omit all
p.000035: or part of the procedures pursuant to the provisions in Section 1 and 2 above, in accordance with
p.000035: specifications prescribed in the research protocol approved by the chief executive of the research
p.000035: implementing entity.
p.000035:
p.000036: 36
p.000036:
p.000036:
p.000036: (i) The research to be implemented does not involve invasiveness (not including minor invasiveness);
p.000036: (ii) The omission of procedures pursuant to the provisions in Section 1 and 2 above is not against research
p.000036: subjects’ interests;
p.000036: (iii) If procedures pursuant to the provisions in Section 1 and 2 above are not omitted, it will be difficult to
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000015: (1) The chief executive of research implementing entity shall arrange systems and procedures necessary for the
p.000015: appropriate implementation of research.
p.000015: (2) When a research subject has incurred any injury related to the research carried out by the research
p.000015: implementing entity, the chief executive of the research implementing entity shall ensure that necessary
p.000015: measures are taken appropriately, such as compensation for the research-related injury.
p.000015: (3) The chief executive of research implementing entity shall ensure that information concerning its
p.000015: research, including results of the research, shall be made public appropriately.
p.000015: (4) The chief executive of research implementing entity himself/herself shall, as necessary, verify and review
p.000015: whether the research carried out by the research implementing entity is complying with these Guidelines and shall
p.000015: take appropriate measures based on the results of such verification and reviews.
p.000015: (5) The chief executive of research implementing entity shall take measures to ensure that investigators, etc. of
p.000015: the research implementing entity shall receive education and training related to the ethics of research as well as
p.000015: knowledge and skills necessary to carry out the research. The chief executive of research implementing
p.000015: entity himself/herself shall also receive such education and training.
p.000015: (6) The chief executive of research implementing entity may delegate the authority and duties set
p.000015: forth in these Guidelines to appropriate individual(s) who belong to the research implementing
p.000015: entity, in accordance with the procedures established at the research implementing entity.
p.000015:
p.000015: 3. Approval, etc. of research
p.000015: (1) When the chief executive of research implementing entity is asked by principal investigator for
p.000015: approval for any implementation of research or revision of the approved research protocol, the said chief executive
p.000015: shall submit the matter to ethical review committee for deliberation and make decision on relevant measures, such as
p.000015: approval, disapproval, etc., to the matter with due respect to opinions presented by the ethical review
p.000015:
p.000016: 16
p.000016:
p.000016:
p.000016: committee.
p.000016: (2) When the chief executive of research implementing entity has received any report from principal investigator
p.000016: or other investigators, etc. concerning facts or information deemed to affect the propriety of continuance
p.000016: of a research, the said chief executive, as necessary, shall submit the matter to the ethical review committee
p.000016: for deliberation and, with due respect to opinions presented by the ethical review committee, take
p.000016: appropriate countermeasures promptly such as suspension of the research and examination of the cause.
p.000016: (3) The chief executive of research implementing entity shall provide cooperation with the
p.000016: investigation carried out by relevant ethical review committee.
p.000016: (4) When the chief executive of research implementing entity has received any report concerning the fact or
...
p.000037: information on (iii) below, when research subjects are those who correspond to either (a) or (b) in
p.000037: B. below); and
p.000037: (iii) When the research subject is an individual who corresponds to either (a) or (b) in B. below, the
p.000037: reason why such an individual shall be the research subject.
p.000037: B. The research subject shall correspond to any of the following:
p.000037: (a) The research subject is a minor. When the research subject has completed junior high school or other
p.000037: relevant schooling, or is 16
p.000037:
p.000038: 38
p.000038:
p.000038:
p.000038: years or older, and is considered to have enough judgment concerning the research to be implemented on
p.000038: him/herself, as well as the following matters are prescribed in the research protocol and the chief
p.000038: executive of the research implementing entity approves to carry out the research after relevant ethical
p.000038: review committee deliberation, informed consent shall be obtained not from representative but from the said
p.000038: research subject.
p.000038: (i) The research to be implemented does not involve any invasiveness; and
p.000038: (ii) Information concerning implementation of the research, including purpose of the research and how
p.000038: specimens or information will be handled, is made public, and opportunities to refuse that
p.000038: the research is commenced or continued on the research subject are ensured for persons who exercise
p.000038: parental authority over the said research subject and guardians of the minor.
p.000038: (b) The research subject is an adult but objectively considered unable to give informed consent.
p.000038: (c) The research subject is a decedent, however, excluding cases in which the implementation of
p.000038: research is against the subject’s explicit will expressed during lifetime.
p.000038: (2) When obtaining informed consent from legally acceptable representative pursuant to the provisions in
p.000038: Part 12 above, the investigator, etc. or the individual providing existing specimens or information shall select
p.000038: legally acceptable representative, etc. in accordance with the criteria pursuant to the provisions of (1) A. (i)
p.000038: above and provide information to the said legally acceptable representative, etc. pursuant to the
p.000038: provisions in Part
p.000038: 12.3 and of (1) A. (ii) above.
p.000038: (3) When having obtained informed consent from legally acceptable representative, etc., and the
p.000038: research subject has completed junior high school or other relevant schooling, or is 16 years or older,
p.000038: and is considered to have enough judgment concerning the research to be implemented on
p.000038: him/herself, the investigator, etc., or the individual providing existing specimens or information shall
p.000038: obtain informed consent also from the said research subject.
p.000038:
p.000038:
p.000038:
p.000039: 39
p.000039:
p.000039:
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000002: problems. The welfare of those research subjects shall be given priority over scientific and social results of
p.000002: research, and human dignity and rights shall be protected.
p.000002: From this point of view, the Ministry of Education, Culture, Sports, Science and Technology and the
p.000002: Ministry of Health, Labour and Welfare established the Ethical Guidelines for Epidemiological Research (Public
p.000002: Notice of the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health,
p.000002: Labour and Welfare No. 1 of 2007), originally in 2002 and later amended entirely in 2007, and the
p.000002:
p.000003: 3
p.000003:
p.000003:
p.000003: Ethical Guidelines for Clinical Research (Public Notice of the Ministry of Health, Labour and Welfare No.
p.000003: 415 of 2008), originally in 2003 and later amended entirely in 2008, in order that investigators can respect and
p.000003: protect human dignity and rights as well as carry out research appropriately and smoothly. Both guidelines were
p.000003: based on the Constitution of Japan, the Act on the Protection of Personal Information and other related acts, and the
p.000003: ethical principles as defined in the Declaration of Helsinki adopted by the World Medical Association, etc. In recent
p.000003: years, however, research falling under the above-mentioned guidelines has become more and more diversified
p.000003: and the objectives and methods of such research are increasingly becoming common in both of the above-mentioned
p.000003: guidelines and hence, it has been pointed out that the scope of those guidelines are not clear enough. Now,
p.000003: therefore, it has been decided to establish new ethical guidelines to merge the previously in place guidelines above.
p.000003: The new Guidelines provide fundamental requirements to be observed by any of those concerned in medical
p.000003: and health research involving human subjects. The chief executive of a research implementing entity is
p.000003: required to make decision on the appropriateness of the research protocol prepared by principal investigator,
p.000003: prior to the implementation of the research, having deliberation by relevant ethical review
p.000003: committee, while investigators, etc. are required to implement their research appropriately in
p.000003: accordance with the research protocol approved by chief executive of research implementing entity. These new
p.000003: Guidelines only set basic rules, taking into consideration that medical and health research involving
p.000003: human subjects can take a variety of forms. It is required that all individuals concerned, such as investigators,
p.000003: etc., the chief executive of a research implementing entity and members of ethical review committee shall
p.000003: have high-level ethical standards and carry out each responsibility in compliance with these rules in order that
p.000003: their research can contribute to society by obtaining understanding and trust from society.
p.000003:
...
Orphaned Trigger Words
p.000006:
p.000006: (11) Organization Collecting and Providing Specimens or Information
p.000006: Of the above-defined research implementing entities, an organization which conducts research work to
p.000006: acquire specimens or information from research subjects or from other entity(s), to retain and to provide
p.000006: the said specimens or information to other research implementing entity(s) repeatedly and on an ongoing
p.000006: basis.
p.000006:
p.000006: (12) Investigator, etc.
p.000006: Principal investigator(s) and others who are engaged in implementing of research (including the execution of
p.000006: operations at the above-defined “organization collecting and providing specimens or information”), not
p.000006: including individuals who do not belong to research implementing entities and are engaged only in the provision of
p.000006: existing specimens or information or in part in entrusted research work.
p.000006:
p.000006: (13) Principal Investigator
p.000006: An individual who is engaged in implementing of research and directing overall research work at the research
p.000006: implementing entity he/she belongs to.
p.000006:
p.000007: 7
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: (14) Chief Executive of Research Implementing Entity
p.000007: The representative of a legal entity, the head of an administrative organ or an individual business owner who carries
p.000007: out research.
p.000007:
p.000007: (15) Ethical Review Committee
p.000007: An organization utilizing a consensual decision making system, which is organized to make examination and
p.000007: reviews concerning the ethical justification and scientific validity to commence or continue research
p.000007: and other relevant matters.
p.000007:
p.000007: (16) Informed Consent
p.000007: Consent to be given voluntarily by research subjects or their legally acceptable representative, etc. to
p.000007: investigators, etc. or individuals providing existing specimens or information, with respect to whether the research
p.000007: shall be commenced or continued (including how specimens or information shall be handled), having enough
p.000007: understanding after receiving adequate prior information with regard to the purpose and significance of
p.000007: the research, burdens on the research subjects and predicted results of the research (including both risks
p.000007: and benefits), etc.
p.000007:
p.000007: (17) Legally Acceptable Representative
p.000007: An individual expected to speak for the will and benefit of a living research subject, and if the research
p.000007: subject is considered objectively unable to give informed consent, competent to give informed consent
p.000007: to investigators, etc. or individuals providing existing specimens or information on behalf of the
p.000007: said research subject.
p.000007:
p.000007: (18) Legally Acceptable Representative, etc.
p.000007: An individual including the above-defined legally acceptable representative as well as individual
p.000007: who is competent to give informed consent on behalf of the deceased research subject.
p.000007:
p.000007: (19) Informed Assent
p.000007: Expression of agreement, with respect to whether the research shall be commenced or continued, of research
p.000007: subjects who are considered
p.000007:
p.000008: 8
p.000008:
p.000008:
...
p.000010: (i) Specimens and information, the value of which has already been established academically, widely
p.000010: utilized in research and generally available; and
p.000010: (ii) Information which has already been anonymized unlinkably.
p.000010:
p.000010: 2. Research carried out outside Japan
p.000010: (1) When carrying out research outside Japan (including when conducting research collaboratively with
p.000010: foreign research implementing entities), a Japanese research implementing entity shall follow these
p.000010: Guidelines and also adhere to the provisions set forth in local laws, ordinances, guidelines, etc. When the
p.000010: provision(s) set forth in such local laws, ordinances, guidelines, etc. are stricter than the provision(s)
p.000010: of these Guidelines, however, research shall be carried out in accordance with the provision(s) of the said local
p.000010: laws, ordinances, guidelines, etc. in place of the relevant provision(s) of these Guidelines.
p.000010: (2) When the provision(s) of these Guidelines are stricter than the provision(s) of local laws, ordinances,
p.000010: guidelines, etc. and it is difficult to carry out research in accordance with the provision(s) of these
p.000010: Guidelines, if the following is prescribed in the research protocol and the chief executive of Japanese research
p.000010: implementing entity gives approval after relevant ethical
p.000010:
p.000011: 11
p.000011:
p.000011:
p.000011: review committee deliberation with respect to the implementation of the research, the said research may
p.000011: be carried out in accordance with the provision(s) of local laws, ordinances, guidelines, etc. in place
p.000011: of the relevant provision(s) of these Guidelines.
p.000011: (i) Appropriate measures to be taken with respect to informed consent at the overseas research implementing sites;
p.000011: and
p.000011: (ii) Appropriate measures to be taken to protect and safeguard personal information, etc. acquired in relation
p.000011: with implementation of the research at the overseas research implementing sites.
p.000011:
p.000011: Chapter 2 Obligations of Investigators, etc.
p.000011: Part 4 Basic Obligations of Investigators, etc.
p.000011: 1. Consideration for research subjects, etc.
p.000011: (1) Investigators, etc. shall carry out research with the utmost respect for the life, health and human rights of
p.000011: research subjects.
p.000011: (2) In principle, investigators, etc. shall obtain informed consent prior to implementing research.
p.000011: (3) Investigators, etc. shall respond appropriately and promptly to consultation, inquiries,
p.000011: complaints, etc. (hereinafter referred to as “consultation, etc.”) of research subjects or their
p.000011: legally acceptable representatives, etc. (hereinafter referred to as “research subjects, etc.”) and other
p.000011: individuals concerned.
p.000011: (4) Investigators, etc. shall not disclose information obtained while they are engaged in research without
p.000011: justifiable reason. The same shall apply even after investigators, etc. are no longer engaged in the research.
p.000011: (5) When an investigator, etc. becomes aware of any serious concern with respect to human rights of the
p.000011: research subject, etc. or with respect to implementing of the research, such as leakage of information related
p.000011: to the research, the investigator, etc. shall report promptly to the chief executive of research implementing entity
p.000011: and the principal investigator.
p.000011:
p.000011: 2. Ensuring, etc. of ethical justification and scientific validity of research
...
p.000018: considered it inappropriate.
p.000018:
p.000018: 4. Procedures after end of research
p.000018: (1) When principal investigator has finished any research, the principal investigator shall submit
p.000018: to the chief executive of the research implementing entity without delay, in writing, a statement
p.000018: to that effect
p.000018:
p.000019: 19
p.000019:
p.000019:
p.000019: and a summary of the results of the research.
p.000019: (2) When the chief executive of research implementing entity has received a report from principal investigator
p.000019: pursuant to the provisions of (1) above, the said chief executive shall report, in writing, a statement to the
p.000019: effect that the research has been finished and summarized results of the research, to the ethical review committee
p.000019: which made reviews on the research.
p.000019:
p.000019: Part 8 Contents of Research Protocol
p.000019: (1) Contents of research protocol (not including cases as defined in (2) below) shall, in principle, include the
p.000019: items below. Any of those items may be omitted, however, when the chief executive of the research implementing
p.000019: entity gives approval for that after relevant ethical review committee deliberation.
p.000019: (i) Title of the research;
p.000019: (ii) Site-specific information for the research (including names of the research implementing entity(s) and the
p.000019: investigator(s), etc.);
p.000019: (iii) Objectives and significance of the research;
p.000019: (iv) Method and time period of the research;
p.000019: (v) Enrolling Criteria of research subjects;
p.000019: (vi) Basis of scientific validity for implementing the research;
p.000019: (vii) Procedures pursuant to the provisions in Part 12 below for obtaining informed consent,
p.000019: etc. (including information to be provided and consented to pursuant to the relevant provisions in Part
p.000019: 12, when obtaining informed consent);
p.000019: (viii) Handling of personal information, etc. (including process of anonymization, when anonymization
p.000019: is conducted);
p.000019: (ix) Burdens to be caused on the research subjects and predicted risks and benefits, including comprehensive
p.000019: assessment of such burdens, risks and benefits as well as measures to minimize those burdens and risks;
p.000019: (x) Means for storage and disposal of specimens and information (including records related to information
p.000019: utilized in research);
p.000019: (xi) Matters to be reported to the chief executive of the research implementing entity and procedures
p.000019: for such reports;
p.000019: (xii) Status of research-related conflicts of interest of the research implementing entity, such as
p.000019: research fund resources, as well as
p.000019:
p.000020: 20
p.000020:
p.000020:
p.000020: research-related conflicts of interest of each investigator, etc., such as his/her individual income;
p.000020: (xiii) Means to disclose information on research;
p.000020: (xiv) Means to respond to the consultation, etc. made by the research subjects, etc. and other individuals
p.000020: concerned;
p.000020: (xv) When obtaining informed consent from legally acceptable representative, etc., procedures
p.000020: pursuant to the provisions in Part 13 below (including matters related to the criteria to select legally
p.000020: acceptable representatives, etc. and to be informed and consented to pursuant to the provisions in Parts 12 and 13
p.000020: below);
p.000020: (xvi) When obtaining informed assent, procedures pursuant to the provisions in Part 13 below
p.000020: (including information to be provided);
...
p.000021: consent from the research subject, etc., a statement to that effect and the contents of utilization
p.000021: assumed at the time of obtaining consent; and
p.000021: (xxv) When monitoring or audit is performed pursuant to the provisions in Part 20 below, organizational
p.000021: framework and procedures for such.
p.000021: (2) Contents of the research protocol for operating research work acquiring specimens or information from
p.000021: research subjects or being provided from other entities, and retaining and providing such specimens or information to
p.000021: other research implementing entities repeatedly and continuously (hereinafter referred to as
p.000021: “collection and provision”) shall, in principle, include the items below. Any of those items may be
p.000021: omitted, however, when the chief executive of research implementing entity gives approval for that after relevant
p.000021: ethical review committee deliberation.
p.000021: (i) Organizational framework for the collection and provision of specimens or information
p.000021: (including name(s) of the organization collecting and providing specimens or information and the
p.000021: investigator(s), etc.);
p.000021: (ii) Objectives and significance of the collection and provision of specimens or information;
p.000021: (iii) Method and time period for the collection and provision of specimens or information;
p.000021: (iv) Types of specimens or information to be collected and provided;
p.000021: (v) Procedures pursuant to the provisions in Part 12 below for obtaining informed consent,
p.000021: etc. (including information to be provided and consented to pursuant to the relevant provisions in Part
p.000021: 12, when obtaining informed consent);
p.000021: (vi) Handling of personal information, etc. (including process of anonymization, when anonymization
p.000021: is conducted);
p.000021: (vii) Burdens to be caused on the research subjects and predictable risks and benefits, including comprehensive
p.000021: assessment of such burdens, risks and benefits as well as measures to minimize those burdens and risks;
p.000021: (viii) Means for storage of specimens or information and for quality control of them;
p.000021:
p.000022: 22
p.000022:
p.000022:
p.000022: (ix) Handling of specimens or information after the end of collection and provision;
p.000022: (x) Status of research-related conflicts of interest of the organization collecting and providing
p.000022: specimens or information, such as fund resources for the collection and provision, as well
p.000022: as research-related conflicts of interest of each investigator, etc., such as his/her individual income;
p.000022: (xi) Response to consultation, etc. made by the research subjects, etc. and other individuals concerned;
p.000022: (xii) When the research involves any medical technique beyond usual medical practice, a statement to that
p.000022: effect and details of such;
p.000022: (xiii) When any significant finding concerning the research subject’s health or genetic characteristics which
p.000022: may be inherited by his/her offspring, etc. may be obtained through implementing the research, handling of the
p.000022: research results related to the research subject (including incidental findings); and
p.000022: (xiv) With respect to specimens or information acquired from the research subject, when any of those
p.000022: may be utilized or provided to other research implementing entity(s) for the research in future that is not identified
p.000022: at the time of obtaining consent from the research subject, etc., a statement to that effect and the
p.000022: contents of utilization assumed at the time of obtaining consent.
p.000022:
p.000022: Part 9 Registration and Publication of Research
p.000022: 1. Registration of summary of research protocol and results
p.000022: When the principal investigator intends to carry out any research which involves intervention, the
p.000022: principal investigator shall, prior to the implementation of the research, register a summary of the
p.000022: research in a public database operated by the National University Hospital Council of Japan, the Japan
p.000022: Pharmaceutical Information Center, or the Japan Medical Association, shall update the registered contents
p.000022: appropriately according to revisions of the research protocol or the progress of the research, and shall
p.000022: register, without delay, the results of the research when the research is finished. Any of contents may be omitted
p.000022: from the registration, however, when the chief executive of the research implementing entity gives approval for that,
p.000022: by reason that it shall be confidential in order to protect human rights of the research subject, etc. and
p.000022:
p.000023: 23
p.000023:
p.000023:
p.000023: other individuals concerned or rights and interests of the investigator, etc. and other entity concerned, after
p.000023: relevant ethical review committee deliberation.
p.000023:
p.000023: 2. Publication of research results
p.000023: When the principal investigator has finished research, the principal investigator shall, without delay,
p.000023: make public the results of the research, having taken necessary measures to protect human rights of the
p.000023: research subject, etc. and other individuals concerned and rights and interests of the investigator, etc. and other
...
p.000027: ethical review committee shall have enough information concerning the site-specific information for the
p.000027: research at the research implementing entity, in order to make reviews and present its opinions.
p.000027: (2) With respect to research carried out by other research implementing entity(s) than the institution to
p.000027: which the organizer of the ethical review committee belongs, when the chief executive of the said
p.000027: research implementing entity requests the ethical review committee to continue to make reviews after the committee
p.000027: has made reviews on the same research, the said ethical review committee shall make reviews and present its
p.000027: opinions.
p.000027:
p.000027: Chapter 5 Informed Consent, etc.
p.000027: Part 12 Procedures for Obtaining Informed Consent, etc.
p.000027: 1. Procedures, etc. for obtaining informed consent
p.000027: The investigator, etc. who intends to carry out any research and the individual providing existing
p.000027: specimens or information who intends to provide any of those shall, in principle, obtain informed
p.000027: consent beforehand in accordance with specifications prescribed in the research protocol approved by the chief
p.000027: executive of the research implementing entity and following procedures as defined below,
p.000027: respectively. This, however, shall not apply to
p.000027:
p.000028: 28
p.000028:
p.000028:
p.000028: providing of existing specimens or information pursuant to the provisions of laws and ordinances.
p.000028: (1) Informed consent for research to be carried out by acquiring new specimen or information:
p.000028: A. Research involving invasiveness:
p.000028: The investigator, etc. shall obtain informed consent in writing which includes information to be provided pursuant
p.000028: to the provisions in Section 3 below.
p.000028: B. Research not involving invasiveness:
p.000028: (a) Research involving intervention:
p.000028: The investigator, etc. shall not necessarily be required to obtain informed consent in writing. When any written
p.000028: informed consent is not obtained, however, the investigator, etc. shall obtain oral informed consent,
p.000028: with respect to the information provided pursuant to the provisions in Section 3 below, and maintain records
p.000028: of methods for providing and content of such information as well as details of consent obtained.
p.000028: (b) Research not involving intervention:
p.000028: (i) Research utilizing human biological specimens:
p.000028: The investigator, etc. shall not necessarily be required to obtain informed consent in writing. When any
p.000028: written informed consent is not obtained, however, the investigator, etc. shall obtain oral informed
p.000028: consent, with respect to the information provided pursuant to the provisions in Section 3 below, and
p.000028: maintain records of methods for providing and content of such information as well as details of consent
p.000028: obtained.
p.000028: (ii) Research not utilizing human biological specimens:
p.000028: The investigator, etc. shall not necessarily be required to obtain informed consent, but when any informed
p.000028: consent is not obtained, the investigator, etc. shall notify the research subjects, etc. of, or make public,
p.000028: information concerning the research, including the purpose of utilization of information utilized in the research,
p.000028: and opportunities to refuse that the research is commenced or continued on the research subject shall be
p.000028: ensured for the research subjects, etc.
p.000028: (2) Informed consent in cases where the research is to be carried out utilizing
p.000028:
p.000029: 29
p.000029:
p.000029:
p.000029: existing specimens or information retained by the research implementing entity:
p.000029: A. Research utilizing human biological specimens:
p.000029: The investigator, etc. shall not necessarily be required to obtain informed consent in writing. When any
p.000029: written informed consent is not obtained, however, the investigator, etc. shall obtain oral informed consent,
p.000029: with respect to the information provided pursuant to the provisions in Section 3 below, and maintain
p.000029: records of methods for providing and content of such information as well as details of consent obtained. If it is
p.000029: difficult to follow these procedures and the case corresponds to any of the following, however, the
p.000029: investigator, etc. may utilize existing specimens or information retained by his/her research implementing
p.000029: entity without these procedures.
p.000029: (a) Cases in which human biological specimens to be utilized in the research have been anonymized (limited
p.000029: to cases in which anonymization has been made, whether linkable or unlinkable and the research implementing
p.000029: entity does not have any decoding index)
p.000029: (b) Cases in which human biological specimens to be utilized in the research do not correspond to above (a), and
p.000029: if any consent has been obtained for other research that no indication for utilization in the relevant research is
p.000029: clearly made when the said consent was obtained, each of the following are required:
p.000029: (i) That information including the purpose of utilization of the human biological specimen has been notified to
p.000029: the research subjects, etc. or made public, with respect to implementing the research; and
p.000029: (ii) That above-mentioned other research for which consent has been obtained is reasonably considered as
p.000029: having a significant relation with the purpose of the research;
p.000029: (c) Cases in which human biological specimens to be utilized in the research do not correspond to either of (a) and
p.000029: (b) above, all of the following are required:
p.000029: (i) That information including the purpose of utilization of the human biological specimen has been notified to
p.000029: the research subjects, etc. or made public, with respect to implementing
p.000029:
p.000030: 30
p.000030:
p.000030:
p.000030: the research;
p.000030: (ii) That opportunities to refuse that the research is implemented shall be ensured for the
p.000030: research subjects, etc.; and
p.000030: (iii) That the research is particularly necessary for improvement of public health and it is difficult to
p.000030: obtain consent of the research subjects, etc.
p.000030: B. Research not utilizing human biological specimens:
p.000030: The investigator, etc. shall not necessarily be required to obtain informed consent. When any informed
p.000030: consent is not obtained, however, excepting cases in which information utilized in the research has been
p.000030: anonymized (limited to cases in which anonymization has been made, whether linkable or unlinkable
p.000030: and the research implementing entity does not have any decoding index), the investigators,
p.000030: etc. shall notify to the research subjects, etc. of, or make public, information concerning the research,
p.000030: including the purpose of utilization of information utilized in the research, and opportunities to refuse that the
p.000030: research is implemented shall be ensured for the research subjects, etc.
p.000030: (3) Informed consent when existing specimens or information are to be provided to other research implementing
p.000030: entity(s):
p.000030: The individual providing existing specimens or information to other research implementing entity shall not
p.000030: necessarily be required to obtain informed consent in writing. When any written informed consent in is not
p.000030: obtained, however, the individual providing existing specimens or information shall obtain oral
p.000030: informed consent, with respect to the information provided pursuant to the provisions in Section 3
p.000030: below (including the fact that existing specimens or information are to be provided) and maintain records
p.000030: of methods for providing and content of such information as well as details of consent obtained. If it is
p.000030: difficult to follow these procedures and the case corresponds to any of the following, however, the individual may
p.000030: provide existing specimens or information without these procedures.
p.000030: When existing specimens or information are provided (not including the cases as defined in B and C below), the
p.000030: director of the institution to which the individual providing existing specimens or information belongs
p.000030:
p.000031: 31
p.000031:
p.000031:
p.000031: (hereinafter referred to as “institution providing existing specimens or information”) shall be aware
p.000031: of the content of such specimens or information to be provided.
p.000031: A. Cases in which existing specimens or information to be provided have been anonymized (limited to cases
p.000031: in which anonymization has been made, whether linkable or unlinkable and the institution does not provide any
p.000031: decoding index).
p.000031: B. Cases in which the existing specimens or information to be provided do not correspond to A above and the
p.000031: director of the institution providing existing specimens or information has given approval after relevant ethical
p.000031: review committee deliberation, with respect to the compliance status with each of the following requirements;
p.000031: (a) That the following information has been notified to the research subjects, etc. or made
p.000031: public, with respect to implementing the research or providing existing specimens or information.
p.000031: (i) The fact that the provision to an individual outside the institution providing specimens or
p.000031: information is the purpose of utilization;
p.000031: (ii) The items of personal information, etc. to be provided to an individual outside of the institution providing
p.000031: existing specimens or information;
p.000031: (iii) The means or method of provision to an individual outside of the institution providing existing
p.000031: specimens or information; and
p.000031: (iv) The fact that the provision of such personal information, etc., as will lead to the identification of
p.000031: the research subjects, to individuals outside of the institution providing existing specimens
p.000031: or information will be discontinued at the request of the research subject or his/her representative.
p.000031: (b) That opportunities to refuse that the research is implemented have been ensured for the research
p.000031: subjects, etc.
p.000031: C. When information utilized in research is to be provided for the research of socially high
p.000031: significance and on condition that the provisions in A and B above cannot be complied with for the reason
p.000031:
p.000032: 32
p.000032:
p.000032:
p.000032: of the method and content of the research, the content of information utilized in research and others, it is required
p.000032: that the director of the institution providing existing specimens or information has approved after relevant ethical
p.000032: review committee deliberation, with respect that other appropriate measures will be taken to the extent necessary.
p.000032: In this case, all requirements as defined in Section 6 (1) (i) to (iv) below shall be met. In addition, of measures
p.000032: as defined in Section 6
p.000032: (2) (i) to (iii) below, appropriate measures shall be taken.
p.000032: (4) Informed consent for research to which existing specimens or information are to be provided in accordance
p.000032: with the procedures as defined in (3) above:
p.000032: The investigator, etc. shall not necessarily be required to obtain informed consent. When any
p.000032: informed consent is obtained, however, the investigator, etc. shall confirm, with respect to utilization in the
p.000032: research of such specimen or information, that the individual providing existing specimens or information
p.000032: has followed the procedures as defined in (3) above, and the details of such consent obtained from the research
p.000032: subject, etc. (excepting cases in which the specimens or information are provided pursuant to the provisions of laws or
p.000032: ordinances).
p.000032: In addition, when existing specimens or information which have not been anonymized are utilized (excepting
p.000032: cases in which the investigator, etc. obtains informed consent for the utilization), the investigator, etc. shall
p.000032: make public information concerning the implementation of the research, including handling of such existing
p.000032: specimens or information, and with regards that the research is implemented, opportunities to withdraw such
p.000032: consent shall be ensured for the research subject, etc.
p.000032:
p.000032: 2. Revising research protocol
p.000032: When the investigator, etc. is carrying out the research of which protocol has been revised, the investigator, etc.
p.000032: shall, anew in principle, follow procedures concerning informed consent pursuant to the provisions in Section 1
p.000032: above. Any informing of such revision and subsequent consent may be omitted, however, when the chief
p.000032: executive of the research implementing entity gives approval for that after by relevant ethical review committee
p.000032: deliberation.
p.000032:
p.000032: 3. Information to be provided to research subjects, etc.
p.000032:
p.000033: 33
p.000033:
p.000033:
p.000033: When obtaining informed consent from a research subject, etc., Information to be provided to the research subject, etc.
p.000033: shall, in principle, include the items below. Any of those items may be omitted, however, when the chief executive of
p.000033: the research implementing entity gives approval for that after relevant ethical review committee deliberation.
p.000033: (i) Title of the research and the fact that approval of the chief executive of the research implementing
p.000033: entity has been given concerning its implementation;
p.000033: (ii) Names of the research implementing entity and the principal investigator (including names of the
p.000033: collaborative research implementing entity(s) and principal investigators of such collaborative research
p.000033: implementing entity(s), when the research is conducted collaboratively with other research implementing
p.000033: entity(s));
p.000033: (iii) Objectives and significance of the research;
p.000033: (iv) Method and time period of the research (including purpose of the utilization of specimens or
p.000033: information acquired from the research subject);
p.000033: (v) Reasons why asked to be enrolled in the research;
p.000033: (vi) Burdens to be caused on the research subjects and predictable risks and benefits;
p.000033: (vii) The fact that research subjects, etc. may withdraw their consent at any time even after they have
p.000033: given consent with regard that the research is commenced or continued (when it can be difficult to take measures that
p.000033: follow the withdrawal made by the research subject, etc., a statement to that effect and the reason for the
p.000033: difficulty);
p.000033: (viii) The fact that the refusal or withdrawal of consent by a research subject, etc. with regard that the research
p.000033: is to be commenced or continued does not cause any disadvantage to such research subject, etc.;
p.000033: (ix) Means to make information on the research public;
p.000033: (x) The fact that research subjects, etc. can request and obtain or read the research protocol and
p.000033: documents concerning method of the research, to the extent it does not interfere the protection of personal
p.000033: information, etc. of other research subjects, etc. or the originality of the research, as well as the procedure to
p.000033: obtain or read such protocols and documents;
p.000033: (xi) Handling of personal information, etc. (including process of anonymization, when
p.000033: anonymization is conducted);
p.000033:
p.000034: 34
p.000034:
p.000034:
p.000034: (xii) Means for storage and disposal of specimens and information;
p.000034: (xiii) Status of research-related conflicts of interest of the research implementing
p.000034: entity, such as research fund resources, as well as research-related conflicts of interest of each
p.000034: investigator, etc., such as his/her individual income;
p.000034: (xiv) Response to consultation, etc. made by research subjects, etc. and other individuals concerned;
p.000034: (xv) When the research involves any financial expenditure on or remuneration for the research subject, etc., a
p.000034: statement to that effect and details of such;
p.000034: (xvi) When the research involves any medical technique beyond usual medical practice, description of alternative
p.000034: procedure(s) or course(s) of treatment;
p.000034: (xvii) When the research involves any medical technique beyond usual medical practice, response related to the
p.000034: healthcare delivery to the research subjects after the research;
p.000034: (xviii) When any significant finding concerning the subject’s health or generic characteristics which may be inherited
p.000034: by his/her offspring, etc. may be obtained through implementing the research, handling of the research results
p.000034: related to the research subject (including incidental findings);
p.000034: (xix) When the research involves any invasiveness, whether or not compensation will be
...
p.000036: (ii) The omission of procedures pursuant to the provisions in Section 1 and 2 above is not against research
p.000036: subjects’ interests;
p.000036: (iii) If procedures pursuant to the provisions in Section 1 and 2 above are not omitted, it will be difficult to
p.000036: implement the research or the value of the said research will be significantly undermined; and
p.000036: (iv) The research to be implemented is recognized as being of socially high significance.
p.000036: (2) When any procedure(s) pursuant to the provisions in Section 1 and 2 above is to be omitted pursuant to the
p.000036: provisions of (1) above, the investigator, etc. shall take appropriate measures among those defined below.
p.000036: (i) To make announcement for the population to which the research subjects, etc. belong, with respect
p.000036: to the purpose of collection and utilization of the specimens or information as well as details
p.000036: (including the method) of such collection and utilization;
p.000036: (ii) To offer an ex-post explanation to the research subject, etc. promptly (including such explanation made to the
p.000036: group to which the subjects, etc. belong); and
p.000036: (iii) In the case that the specimens or information are collected or utilized continuously for a long period, the
p.000036: investigator, etc. shall endeavor to make public announcement, with respect to such situation of collection
p.000036: or utilization, including the purposes and methods of collection or utilization of the said specimens or
p.000036: information, in order to make it widely known to society.
p.000036:
p.000036: 7. Withdrawal of consent, etc.
p.000036: When a research subject, etc. offers a withdrawal or refusal of consent corresponding to any of the
p.000036: following, the investigator, etc. shall, without delay, take appropriate measures in accordance with the withdrawal or
p.000036: refusal as well as provide explanation on such measures to the research subjects, etc. The investigator,
p.000036: etc., is not necessarily required to take such measures, however, when it is difficult and the chief executive
p.000036: of the research implementing entity approves that such measures should not be taken after relevant ethical
p.000036: review committee deliberation. In this case, the investigator, etc. shall endeavor to provide explanation
p.000036: to the research subject, etc. concerning the fact that
p.000036:
p.000037: 37
p.000037:
p.000037:
p.000037: measures in accordance with the said withdrawal or refusal will not be taken, along with the reasons, and
p.000037: to obtain understanding of the research subject, etc.
p.000037: (i) Withdrawal of all or part of the given consent that the research is commenced or continued;
p.000037: (ii) Refusal of all or part of with regard that the research is commenced or continued, based on
p.000037: the information concerning the research, which is notified or made public (including refusal pursuant to
p.000037: the provisions of Part 13.1 (1) B (a) (ii));
p.000037: (iii) Refusal of all or part of with regard that the research is commenced or continued, in the
p.000037: course of procedures for obtaining informed consent pursuant to the provisions in Section 5 above; or
p.000037: (iv) Refusal by a research subject, concerning the research to which his/her legally acceptable
p.000037: representative has given consent, of all or part of with regard that the research is commenced or continued, in
p.000037: the course of procedures for obtaining informed consent from the said research subjects.
p.000037:
p.000037: Part 13 Procedures, etc. for Obtaining Informed Consent from Legally Acceptable Representatives, etc.
p.000037: 1. Requirements for obtaining informed consent from legally acceptable representatives, etc.
p.000037: (1) When the investigator, etc. or the individual providing existing specimens or information obtains informed
p.000037: consent from a legally acceptable representative, etc. pursuant to the provisions in Part 12 above,
p.000037: all requirements as defined below shall be met.
p.000037: A. The research protocol has description on the following matters:
p.000037: (i) Criteria for selection of legally acceptable representatives, etc.;
p.000037: (ii) Information to be provided to the legally acceptable representative, etc. (including
p.000037: information on (iii) below, when research subjects are those who correspond to either (a) or (b) in
p.000037: B. below); and
p.000037: (iii) When the research subject is an individual who corresponds to either (a) or (b) in B. below, the
p.000037: reason why such an individual shall be the research subject.
...
p.000043: or delete (hereinafter referred to as “correction, etc.”) such retained personal information as may
p.000043: lead to the identification of the person on the grounds that the retained personal information is contrary
p.000043: to the fact, the said chief executive shall, except in cases in which special procedures are prescribed
p.000043: by any laws and ordinances for such correction, etc., make a necessary investigation without
p.000043: delay within the scope necessary for the achievement of the purpose of utilization and, on the basis of
p.000043: the results, execute relevant correction, etc. of the retained personal information.
p.000043: (4) Where the chief executive of research implementing entity is requested by a person to discontinue using or
p.000043: to erase (hereinafter referred to as “discontinuance, etc.”) such retained personal information as may lead to the
p.000043: identification of the person on the grounds that the retained personal information has been acquired against the
p.000043: provisions of Part 14.2 (1) or is being handled against the provisions of Part 14.2 (2), and where it is
p.000043: considered that the request is reasonable, the said chief executive shall execute relevant discontinuance,
p.000043: etc. of the retained personal information, without delay, to the extent necessary to correct such breach of
p.000043: the relevant provisions. This, however, shall not apply to cases in which it is
p.000043:
p.000044: 44
p.000044:
p.000044:
p.000044: difficult to execute such discontinuance, etc. of the retained personal information and in which the
p.000044: said chief executive takes necessary alternative measures to protect the rights and interests of the person.
p.000044: (5) When the chief executive of research implementing entity has decided not to take all or part of requested measures
p.000044: pursuant to the provisions of (1) above, or has taken all requested measures pursuant to the provisions of
p.000044: (3) or (4) above or decided not to take such measures, the said chief executive shall, without
p.000044: delay, notify to the claimant to that effect (including the content of correction, etc., if any).
p.000044: In addition, when the chief executive of research implementing entity notifies, with respect to all or part of
p.000044: measures requested by a person, etc. pursuant to the provisions of (1), (3) or (4) above, that he/she will not take
p.000044: such measures or will take different measures, the said chief executive shall endeavor to explain the reasons and to
p.000044: obtain understanding of the claimant.
p.000044: (6) Where the chief executive of research implementing entity is requested by a person, etc. to discontinue
p.000044: providing to other research implementing entity(s) (including collaborative research implementing
p.000044: entity(s); the same shall apply hereinafter) such specimens or information not anonymized as may lead
p.000044: to the identification of the person on the grounds that the non-anonymized specimens or information are being provided
p.000044: to other research implementing entity against the provisions of Part 12 above, and where it is considered that
p.000044: the request is reasonable, the said chief executive shall, without delay, discontinue providing such
p.000044: specimens or information to other research implementing entity(s). This, however, shall not apply to cases in
p.000044: which it is difficult to discontinue providing such specimens or information to other research implementing
p.000044: entity(s) and in which the said chief executive takes necessary alternative measures to protect rights and
p.000044: interests of the person.
p.000044: (7) When the chief executive of research implementing entity has discontinued providing all
p.000044: or part of the non-anonymized specimens or information to other research implementing entity as requested
p.000044: pursuant to the provisions of (6) above, or has decided not to discontinue providing such specimens or
p.000044: information to other research implementing entity, the said chief executive shall, without delay, notify to the
p.000044: claimant to that effect. In addition, when the said chief executive notifies that he/she will not discontinue
p.000044: providing to other research implementing entity, or will
p.000044:
p.000045: 45
p.000045:
p.000045:
p.000045: take different measures from discontinuance, the said chief executive shall endeavor to explain the reasons and
p.000045: to obtain understanding of the claimant.
p.000045: (8) The chief executive of research implementing entity may determine the following matters on procedures for
p.000045: receiving requests for disclosure, etc. In such case, the said chief executive shall endeavor to mitigate burdens
p.000045: caused on the person, etc. so that the procedures will not impose excessively heavy burdens.
p.000045: In addition, when any person, etc. makes a request for disclosure, etc. not in accordance with relevant
p.000045: procedures, the said chief executive may notify to the claimant that it is difficult to grant such a request for
p.000045: disclosure, etc.
p.000045: (i) The place where requests for disclosure, etc. are to be filed;
p.000045: (ii) The format of the documents (including records made by an electronic method, magnetic
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| disability | Mentally Disabled |
| education | education |
| emergency | Public Emergency |
| family | Motherhood/Family |
| helsinki | declaration of helsinki |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| incapacity | Incapacitated |
| language | Linguistic Proficiency |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| physically | Physically Disabled |
| property | Property Ownership |
| schooling | education |
| single | Marital Status |
| trauma | Victim of Abuse |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| disability | ['mentally'] |
| education | ['schooling'] |
| illness | ['physically'] |
| mentally | ['disability'] |
| physically | ['illness'] |
| schooling | ['education'] |
Trigger Words
capacity
consent
ethics
harm
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input