Approaches to ethical review of life sciences and medical research involving humans

First, why the Measures?

Adhering to the philosophy of "people first and life first", in order to protect human life and health, safeguard human dignity, respect and protect the legitimate rights and interests of research participants, promote the healthy development of life science and medical research, and regulate the ethical review of life science and medical research involving human beings, The Measures have been formulated in accordance with the Civil Code of the People's Republic of China, the Law of the People's Republic of China on the Promotion of Basic Medical Care and Health, the Law of the People's Republic of China on Science and Technology Progress, the Law of the People's Republic of China on Biosafety, and the Regulations of the People's Republic of China on the Management of Human Genetic Resources.

What specifically does life science and medical research involving human beings include?

The term "life science and medical research involving humans" as mentioned in the Measures refers to the following research activities carried out with human subjects or using biological samples and information data of people (collectively referred to as research participants) :

1) Research activities on human reproduction, growth, development and aging by means of physics, chemistry, biology and traditional Chinese medicine;

2) Research activities on human physiology, psychological behavior, pathological phenomena, etiology and pathogenesis of diseases, as well as the prevention, diagnosis, treatment and rehabilitation of diseases by means of physics, chemistry, biology, traditional Chinese medicine and psychology;

3) The use of new technologies or new products to conduct experimental research on human beings;

4) The activities of collecting, recording, using, reporting or storing biological samples, information data (including health records, behaviors, etc.) and other scientific research materials related to human life science and medical problems by means of epidemiological, sociological, psychological and other methods.

Which organizations should set up ethics review committees, and what are the main considerations?

The Measures stipulate that medical institutions at or above the second level that carry out human life science and medical research, health institutions at or above the municipal level with districts (including disease prevention and control institutions, maternal and child health care, blood collection and supply institutions, etc.), institutions of higher learning, and scientific research institutes should set up ethical review committees.

The main consideration is that the establishment of the ethics review committee is not only a recognition of the research management capacity of the institution, but also a policy obligation that the institution should fulfill. In order to effectively protect the rights and interests of research participants, and fully reflect the professional requirements of ethical review of life science and medical research involving people, the above provisions are made.

Whether and how ethical reviews are required for other institutions to conduct life science and medical research involving humans?

The conduct of life science and medical research involving human beings shall be subject to ethical review as required. In order to achieve comprehensive coverage of the above research ethics review, the Measures provide that if an institution conducts life science and medical research involving human beings without an ethics review committee or if the ethics review committee is unable to meet the needs of the review, the institution may entrust a competent institutional ethics review committee or a regional ethics review committee to conduct an ethical review. It also requires that the commissioned ethics review committee should conduct follow-up reviews of the reviewed studies.

In view of the fact that medical and health institutions mainly carry out clinical research and have higher requirements for risk control, the Measures also require that medical and health institutions should entrust ethical review committees or regional ethical review committees of medical and health institutions not lower than their level to carry out ethical review requirements.

5. How can enterprises conduct ethical review of life science and medical research involving human beings?

The Measures stipulate that where enterprises and institutions cooperate in conducting research, the institutions shall fully understand the overall situation of the research, pass ethical reviews, and carry out follow-up reviews. Companies that conduct research independently can entrust institutional ethics review committees or regional ethics review committees, and achieve extended supervision through follow-up reviews.

6. Are there any special provisions for specific groups in the Measures?

Specific groups of people are the focus of ethical review. In order to strengthen the protection of the rights and interests of specific research participants, the Measures clearly put forward the requirement of "special protection" in the basic requirements of ethical review, and stipulate that special protection should be given to research participants involving specific groups such as children, pregnant women, the elderly, people with intellectual disabilities, and people with mental disabilities. Special attention should be paid to those involving fertilized eggs, embryos, fetuses, or those that may be affected by assisted reproductive technology.