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.

At the same time, the Measures stipulate that the right to know and the autonomy to participate in the research of research participants or their guardians shall be respected and protected, and the use of deception, inducement, coercion and other means shall not be allowed to make research participants or their guardians agree to participate in the research, and the unconditional withdrawal of research participants or their guardians shall be allowed at any stage. In the special chapter on Informed consent, it is further stipulated that if the study participants are persons without or with limited capacity for civil conduct, they shall obtain the written informed consent of their guardians. In addition to obtaining the guardian's consent, the researcher should also inform and obtain the consent of the study participants within the scope of their understanding.

7. How do the Measures and the Measures for the Ethical Review of Biomedical Research Involving Humans apply?

In order to strengthen the legal construction of ethical review of biomedical research involving humans in medical and health institutions and clarify legal responsibilities, the former National Health and Family Planning Commission revised the normative document "Measures for Ethical Review of Biomedical Research Involving Humans (Trial Implementation)" issued by the former Ministry of Health in 2007. In the form of departmental regulations, the "Measures for the Ethical Review of Biomedical Research Involving Humans" (former Order No. 11 of the Health and Family Planning Commission) was issued in 2016. Order No. 11 applies to medical and health institutions at all levels and of all types that carry out biomedical research involving humans, and details administrative penalties for violations.

With the continuous increase of investment in scientific and technological innovation and the development of biotechnology, universities and research institutes are increasingly involved in human life science and medical research. The CPC Central Committee and The State Council attach great importance to safeguarding the rights and interests of research participants, and actively promote the construction of a unified ethical review system. To this end, the NHC, together with the Ministry of Education, the Ministry of Science and Technology, the Bureau of Traditional Chinese Medicine and other relevant departments, formulated the "Measures" to provide a unified ethical review system for medical and health institutions, universities, research institutes and other relevant research to follow, and clearly defined the division of supervision and inspection departments.

The main institutional framework, ethical review methods, informed consent, etc. of the Measures and Decree No. 11 are generally consistent, and some provisions are refined and improved in combination with the requirements of new laws and regulations issued by the State and the actual conditions of universities and research institutes. Within a certain period of time, the specific ethical review practices of institutions may be guided by the Measures; For violations of ethical review in medical and health institutions, health administrative departments at all levels may deal with them on the basis of Order No. 11. The Committee will conduct an in-depth summary of the parallel situation of the Measures and Order 11, and start the revision of Order 11 in a timely manner to further improve supervision. Any other institution violating the provisions shall be dealt with by its superior competent department in accordance with its administrative subordination.

8. Compared with the "Measures for the Ethical Review of Biomedical Research Involving Humans", what are the adjustments to the "Measures for the Ethical Review of Life Sciences and Medical Research Involving Humans"?

The Measures for Ethical Review of Life Science and Medical Research Involving Human Beings adhere to the basic principles and institutional framework of the Measures for Ethical Review of Biomedical Research involving Human beings, including: first, adhere to the main responsibility of institutions, requiring institutions to establish ethical review committees to conduct ethical review of life science and medical research involving human beings; Second, adhere to the two pillars of informed consent and ethical review; The third is to follow internationally recognized ethical norms and adhere to basic ethical requirements. At the same time, combined with the actual situation, it has been optimized and perfected, and put forward a unified follow for different research subjects to carry out life science and medical research involving people.

(1) Expand the scope of application of ethical review, and clarify the regulatory responsibilities of departments in accordance with administrative affiliations. Expand "biomedical research involving people" to "life science and medical research involving people", and bring life science research involving people into the scope of management. Expand the management objects to include medical and health institutions, universities, research institutes, etc., and clarify the regulatory responsibilities of ethical review in accordance with administrative affiliations.

(2) Establish a delegated review mechanism, allowing competent ethical review committees to conduct ethical reviews. First, establish a commissioned review mechanism to achieve comprehensive coverage of ethical review. An institution that does not have an ethics review committee may, in writing, entrust a regional ethics review committee or a competent institutional ethics review committee to conduct an ethics review; The second is to put forward the management requirements of regional ethics review committee, which is an important exploration to further improve the efficiency of ethics review. Third, to carry out research, enterprises can realize ethical review supervision by entrusting ethical review, and clarify supervision and management responsibilities.

(3) Optimize ethical review standards and refine informed consent procedures. The first is to refine the provisions on the informed consent process of the research participants with no capacity or limited capacity. The second is to expand the "subject" to "research participant" according to the progress of biomedical research and bioethics, strengthen the respect for people and expand the scope of protection. The third is to balance regulation and innovation, and set up an institutional arrangement of "exemption from ethical review". Fourth, the time limit for ethical review has been detailed to further improve efficiency.

9. How to balance the relationship between reducing the burden on researchers and ethical review? What research is exempt from ethical review?

Taking into account that most basic research activities do not directly involve human trials, and some studies do not directly involve clinical diagnosis and treatment information of research participants, drawing on internationally accepted practices, in order to improve review efficiency and reduce unnecessary burdens on researchers, The Measures provide that "under the premise that the use of human information data or biological samples does not cause harm to the human body, and does not involve sensitive personal information or commercial interests," some cases involving human life science and medical research can be exempted from ethical review. It mainly includes:

1) using publicly available data obtained legally, or data generated by observation that does not interfere with public behavior;

2) Using anonymized information data to conduct research;

3) Using existing human biological samples to conduct research, the source of the biological samples used conforms to relevant regulations and ethical principles, the relevant content and purpose of the research are within the scope of normative informed consent, and do not involve the use of human germ cells, embryos, reproductive cloning, chimerism, heritable gene manipulation and other activities;

4) Use human cell lines or cell lines from biobank to conduct research, and the relevant contents and purposes of the research are within the scope authorized by the provider, and do not involve human embryos, reproductive cloning, chimerism, heritable gene manipulation and other activities.