The informed consent form shall be signed and dated by the subject or the subject’s legal representative, assistant, or guardian as well as the investigator or the coinvestigator.
A copy of the aforementioned informed consent form shall be given to the subject.

The subjects of clinical trial shall comprise only adults with disposing capacity. However, the preceding provision does not apply to clinical trial that is apparently beneficial to the health rights of specific populations or patients with special diseases.
Where a subject described in the proviso of the preceding paragraph has been judicially declared to be of limited capacity or under assistance, consent shall be obtained from both the subject and his/her legal representative or assistant. Where the subject is a person with no disposing capacity, consent shall be obtained from his/her legal representative or guardian. Situations applicable to Paragraph 3, Article 12 of the Human Subjects Research Act can be handled as per the regulation.
When the subject is a person with no disposing capacity as described in the previous paragraph, the investigator shall inform subject of clinical trial-related information within his/her ability to understand.
When changes occur in a subject’s legal capacity or status of being under assistance, informed consent shall be reobtained.

Paragraph 2, Article 37 in this Act refers to emergency situations where all of the following situations are fulfilled, and where the clinical investigation plan has specified that the clinical trial may be conducted prior to obtaining informed consent form from the subject, or the subject’s legal representative, assistant, or guardian.
1. The subject in a life-threatening emergency situation,
2. No sufficient clinical benefits are anticipated from the currently available treatment,
3. There is a fair possibility that the life-threatening risk to subject can be avoided if the investigational medical device is used,
4. anticipated risks are outweighed by the potential benefits of applying the investigational medical device, and
5. The subject is inability to communicate with, and their legal representative, assistant, or guardian cannot immediately be contacted for consent.
For situations specified in the previous paragraph, the informed consent from the subject, or the subject’s legal representative, assistant, or guardian shall be obtained as soon as possible. The subject’s relevant information may not be used if the consent has not been obtained.

The subject, or the subject’s legal representative, assistant, or guardian, referred to the previous article may withdraw their consent at any time.
The clinical trial institution shall continue to provide standard medical care to patients who decline to participate in the trial or who later withdraw their consent, as stated in the preceding paragraph. These individuals’ legitimate right to medical care shall not be infringed upon.

If the subject or the subject’s legally acceptable representative is unable to read the inform consent form and other written information provided to the subject, an independent witness shall be present throughout the entire discussion of informed consent.
The witness shall read the previously mentioned informed consent form as well as the other written information and witness the investigator or the investigator’s authorized designee providing a comprehensive explanation to the subject or the subject’s legal representative, assistant, or guardian.
The witness shall ensure that the subject, or the subject’s legal representative, assistant, or guardian, fully understands the clinical trial and the subject’s rights and obligations as well as that their decisions are made according to their free will.
After completing the preceding three procedures, the subject; the subject’s legal representative, assistant, or guardian; and the witness shall personally sign and date the informed consent form. Except for the witness, finger print is an acceptable substitute for signature.
Members of the investigation site team shall not serve as witnesses.

The informed consent form shall include the following information:
1. The name of the sponsor and the clinical trial institution;
2. The name, title, and contact information of the investigator;
3. The purpose and method of the clinical trial;
4. The expected risks and side effects;
5. The expected result of the clinical trial;
6. Other possible therapeutic methods and explanations;
7. The subject’s right to withdraw their consent at any time;
8. Loss compensation, damage compensation, or insurance mechanisms related to the trial;
9. Prohibition against charging the subjects any fees for the clinical trial;
10. That the subject’s information will be kept confidential, and the right of the sponsor, IRB, and central competent authority to examine the information at any time deemed necessary;
11. The preservation and reutilization of the subject’s biological specimen, personal information, and the derivatives; and
12. The domestic registration status or the license status of the investigational medical device.

If the informed consent form is amended in a manner that affects the rights of the subjects, signed and dated informed consent form shall be obtained from the subjects, or from their legal representative, assistant, or guardian before the trial is conducted in accordance with the amended informed consent form.

The sponsor, clinical trial investigator, and other relevant personnel shall not entice subjects to participate in the clinical trial through unjustifiable means such as coercion or monetary incentives.
The sponsor, clinical trial investigator, and other relevant personnel responsible for payments to the subjects, such as compensation for transportation and nutrition-related expenses, shall be specified in the inform consent form.

The sponsor or clinical trial institution shall not charge subjects for any fees related to the clinical trial.