Chapter IV. Standards for Conducting Clinical Trials. Section 4.

Informed Consent of Subjects: 'Ministerial Ordinance on Good Clinical Practice for Drugs', PMDA Japan

Article 50. Providing Written Information for Explanation and Obtaining Written Informed Consent

1. Prior to a subject’s participation in the clinical trial, the investigators etc. shall obtain written informed consent from the subject by appropriately explaining in writing the trial-related information, such as the content of the clinical trial, to the subject so that he or she will understand the information.

2. Notwithstanding the provisions of the preceding paragraph, a subject who is incapable of giving consent may be enrolled in a trial on the consent given by the subject’s legally acceptable representative.

3. When the consent of the subject’s legally acceptable representative is obtained pursuant to the preceding paragraph, the investigators etc. shall prepare records of the consent and the relationship of the legally acceptable representative to the subject.

4. Notwithstanding the provisions of Paragraph 2, the investigator etc. shall not enroll any subject who is incapable of giving consent to participation in a clinical trial in which no clinical benefit of the investigational product to the subject is anticipated, excluding the cases stated in Article 7, Paragraph 2 or Article 15-4, Paragraph 2.

5. The investigators etc. shall give the prospective subject (or the legally acceptable representative if applicable; the same shall apply in Articles 51 though 53) the opportunity to make inquiries about the content of the written information and other trial-related matters. All inquiries should be answered to the satisfaction of the subject.

Article 51. Written Information

1. When providing written information as specified in Paragraph 1 of the preceding article, the investigators etc. shall give each subject the written information that should include the following information:
(1) That the clinical trial involves research
(2) The objectives of the clinical trial
(3) The name, title and contact information of the investigator
(4) Clinical trial design
(5) The expected benefits to the subject’s physical and mental health from using the investigational product (or that there is no intended clinical benefit to the subject, if applicable), and the potential disadvantages to the subject
(6) Description of alternative procedure(s) or course(s) of treatment
(7) Duration of the subject’s participation in the clinical trial
(8) That the subject may withdraw from the clinical trial at any time
(9) That the subject's refusal of or withdrawal from participation in the trial does not cause any disadvantage to the subject
(10) That the monitors, auditors, and IRB etc. are given direct access to the source documents on the condition that confidentiality of the subject is fully secured
(11) That the subject’s identity will be kept confidential
(12) The contact information of the medical institution in the event of trial-related injury
(13) That necessary treatment is available to the subject in the event of trial-related injury
(14) Description of compensation in the event of any trial-related injury
(15)Type of the IRB reviewing/deliberating the appropriateness of the clinical trial, etc., matters reviewed/deliberated by each IRB, and other matters concerning the IRB involved in the clinical trial
(16) Other necessary matters concerning the clinical trial

2. The written information shall not include any language that causes the prospective subject to waive or to appear to waive any legal rights, or any language that eliminates or reduces, or appears to eliminate or reduce, the liabilities of the sponsor, the sponsor-investigator, the medical institution or investigators etc.

3. Wording and expressions in the written information shall be as plain as possible.

Article 52. Signing Informed Consent Forms etc.

1. The informed consent specified in Article 50, Paragraph 1 or 2, shall not become valid unless both the investigators etc. who have given the explanation and the prospective subject (or if a witness is present as specified in Paragraph 3, then the prospective subject and the witness; the same shall apply in the following article) date, affix the name and seal, or sign the consent form in which the prospective subject has specified that he or she gives consent to participation in the clinical trial upon fully understanding the content of the clinical trial that are provided in the written information (hereinafter referred to as "informed consent form").

2. The informed consent specified in Article 50, Paragraph 1 or 2, shall not be obtained such a way that the investigators etc. coerce or unduly influence a subject or the subject’s legally acceptable representative to give consent.

3. The provision of written information to and the obtainment of written informed consent from a prospective subject, as specified in Article 50, Paragraph 1, who is incapable of reading the written information (excluding the prospective subjects specified in Article 50, Paragraph 2), shall be performed in the presence of a witness.

4. The witness specified in the preceding paragraph shall neither be the investigators etc. nor the clinical research coordinator.

Article 53. Delivery of Informed Consent Form

Investigators etc. shall give the subject (or the subject’s legally acceptable
representative, if applicable; the same shall apply in the following article) a copy of the informed consent form affixed with the names and seals, or signed by the investigators etc. and the prospective subject.

Article 54. Cases Where Information Influencing the Subject's Willingness Is Obtained

1. When any information that might influence the subject's willingness to continue to participate in the ongoing trial is obtained, the investigators etc. shall immediately provide the subject with such information, document the communication of the information and ascertain whether the subject is willing to continue his or her participation in the ongoing trial. In such cases, the provisions of Article 50, Paragraph 5 and Article 52, Paragraph 2 shall apply mutatis mutandis.

2. In the cases specified in the preceding paragraph, the investigator shall revise the written information promptly whenever it is deemed necessary.

3. When the written information is revised pursuant to the preceding paragraph, the investigator shall report the fact to the head of the medical institution and obtain the subject's consent to continue his or her participation in the clinical trial. In such cases, the provisions of Articles 51 through 53 shall apply mutatis mutandis.

Article 55. Life-Saving Clinical Trial in Case of Emergency

1. In the clinical trials specified in Article 7, Paragraph 3 or Article 15-4, Paragraph 3, the investigators etc. may enroll a subject without obtaining the consent of the subject or the subject’s legally acceptable representative only when the subject fulfills all the following conditions:
(1) The prospective subject is in an emergency and obviously at life-threatening risk.
(2) Currently available treatments are unlikely to achieve sufficient therapeutic effects in the prospective subject.
(3) There is a sufficient possibility of saving the life of the prospective subject in a life-threatening condition by using the test drug.
(4) The potential disadvantages which the subject may incur in the clinical trial are minimized.
(5) The prospective legally acceptable representative cannot immediately be contactedc for consent.

2. In the case specified in the preceding paragraph, the investigators etc. shall appropriately provide the subject or the prospective legally acceptable representative with the trial-related information promptly and obtain the written informed consent to participation in the clinical trial.

'Ministerial Ordinance on Good Clinical Practice for Drugs', source: Pharmaceuticals and Medical Devices Agency, Japan

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