Chapter 3 Protection of Research Subjects Rights
Where the research subjects are other than a fetus or corpse, such subjects shall consist only of adults capable of communication. However, where the research obviously benefit specific groups or the subjects are irreplaceable, is not subjected to this rule.
Research protocol shall obtain the consent of participating research subjects as approved by the IRB. But the research protocol within the scope of exemption categories for consent requirements, as announced by the competent authority, shall not apply.
Where the research subject is a fetus, the consent specified in the first Paragraph shall be obtained from the mother; where the subject has been judicially declared to be of limited legal capacity or under assistance, consent shall be obtained from both the individual and their legal representative or assistant; where the person is incompetent or under guardianship, consent shall be obtained from their legal representative or guardian; where the proviso in the first Paragraph is applicable, consent shall be obtained in the following order of precedence from an appropriate relation:
1. A spouse
2. An adult child
Where the consent is provided in writing by a relation pursuant to the preceding Paragraph, such written consent may be sufficient where obtained from any such individual; where the express intent of such persons is not unanimous, the order of precedence above shall apply to determine the matter. In the preceding order of precedence, among the same order, closer relatives shall be accorded priority; where the relatives are of the same degree of closeness, cohabitation shall be accorded priority; and in case of non-cohabiting relatives, the elderly shall be accorded priority.
Where the research subject is a corpse, one of the following conditions must apply:
1. The deceased had consented in writing prior to death or in a will.
2. In accordance with Paragraph 3 of the preceding Article, written consent is obtained from a relation. But such consent may not vitiate the express intent of the decedent prior to death.
3. The decedent expressly intended prior to death to permit research use, and two or more physicians attest thereto in writing. Where the decedent’s identity is unknown or consent is refused by the relations under Paragraph 3 of the preceding Article, this provision shall not apply.
Where the principal investigators have yet to obtain the consent under Article 12, they shall ensure that the human subjects or their relations, legal representatives, guardians, or assistants understand the following matters:
1. The research entity name and source of funds
2. The research purpose and methods
3. The principal investigator’s name, title and responsibilities
4. The person’s name and ways of contact related to the research
5. Protection of human research subject’s rights and mechanisms for their personal data protection
6. The fact that research subjects may revoke their consent at anytime and the ways of revocation
7. Foreseeable risks and ameliorative measures in the incidence of any damages
8. Research material preservation limits and plans for uses thereof
9. Agreed derivative commercial benefits and agreed uses of the research results relating thereto
The principal investigator must obtain consent, without resort to any duress, solicitation or other improper means.
Where the research purpose involves indigenous people, then besides the requirements of Article 12 through 14 supra, there shall additionally be required consultations to obtain the consent of their indigenous group; any publication of research results shall require the same consent.
The Central Council of Indigenous Peoples shall stipulate the consultation mentioned in the preceding Paragraph, as well as consent, agreed commercial benefits, and other agreed uses in conformity with the competent authority.