The National Health Commission, Ministry of Education, Ministry of Science and Technology, and National Administration of Traditional Chinese Medicine have released the “Measures for Ethical Review of Human Life Sciences and Medical Research.” This document establishes comprehensive guidelines to ensure ethical standards are met in all life science and medical research activities involving human participants.
Ethical Review Requirements
The document stipulates that all life science and medical research activities involving human beings should undergo ethical review. Medical institutions at or above the second level, health institutions at or above the municipal level (including disease prevention and control institutions, maternal and child health care institutions, blood collection and supply institutions, etc.), colleges and universities, and scientific research institutions are required to establish an ethics review committee.
Special Protection for Vulnerable Groups
To strengthen the protection of the rights and interests of specific research participants, the document introduces “special protection” in the basic requirements of ethical review. This includes providing special protection for research participants involving specific groups such as children, pregnant women, the elderly, and the mentally handicapped. Additionally, special attention is required for research involving fertilized eggs, embryos, and fetuses potentially affected by assisted reproductive technology.
Respect for Research Participants’ Rights
The document emphasizes the importance of respecting and securing the right to know and the right to participate in research for participants or their guardians. It prohibits the use of deception, inducement, coercion, and other means to obtain consent from research participants or their guardians. Participants or their guardians are allowed to withdraw from the research unconditionally at any stage.
Exemptions for Certain Research
To improve review efficiency and reduce unnecessary burdens, the document specifies that some cases involving human life sciences and medical research can be exempted from ethical review under certain conditions. These conditions include the use of human information data or biological samples without causing harm to the human body and not involving sensitive personal information or commercial interests.
Strategic Implications
These measures are designed to enhance the ethical standards of research involving human participants, ensuring that the rights and welfare of participants are protected. By establishing clear guidelines and oversight mechanisms, the Chinese government aims to promote responsible and ethical research practices in the life sciences and medical fields.-Fineline Info & Tech
