Consensus Release Event Medical Institutions Exempt from Ethical Review Implementation Expert Consensus

On February 18, 2023, the National Health Commission, the Ministry of Education, the Ministry of Science and Technology, and the State Administration of Traditional Chinese Medicine jointly issued the Measures for the Ethical Review of Life Sciences and Medical Research Involving People (hereinafter referred to as the Measures). For the first time, research projects that meet certain conditions can apply for exemption from ethical review.

In order to implement the national spirit of accelerating scientific and technological innovation, improving efficiency and reducing burden, standardizing ethical review work, and promoting the healthy development of research, based on the newly issued regulations, combined with the "Measures for Ethical Review of Biomedical Research Involving People", "Regulations for Quality Management of Drug Clinical Trials", "the People's Republic of China Personal Information Protection Law", "Helsinki Declaration", "International Ethical Guidelines for Health-related Research Involving People" and other relevant domestic and foreign ethical review policies and regulations, as well as ethical review practices, china Clinical Research Capability Improvement and Subject Protection Practice Platform (CCHRPP) organizes industry experts to jointly draft, review and form this expert consensus, providing expert-level work guidelines for medical institutions in the implementation of the construction and operation of the exemption from ethical review system.

Article 1 "Exemption from ethical review" and "No need for ethical review"

This consensus only aims at the research within the scope of application of the measures, and gives suggestions and references on how to determine and implement the "exemption from ethical review", so as to form the corresponding system construction.

The Measures are only applicable to restrict research activities involving human life sciences and medicine. For research that does not fall within the above-mentioned categories of medical institutions, such as monitoring and evaluation of regular medical quality or medical teaching required to perform statutory duties, With reference to international practice, there is currently no need to refer to these Measures for ethical review, and there is no need to implement exemption from ethical review.

 

Article 2 General Requirements for Exemption from the Scope of Ethical Review

Exemption from ethical review requirements:

"One regulation": the "Measures" is the first domestic regulatory document that can be exempted from ethical review;

"Two categories": research that is limited to the use of information data or existing biological samples;

"Three premises": no harm to the human body, no sensitive information, no commercial interests;

"Four situations": use "public data" and or "observe and do not interfere with the data generated by public behavior" to carry out research; Use "anonymized data" to carry out research; Use "existing human biological samples" to carry out research; Use "human cell lines or cell lines from biological sample banks" to carry out research. The specific requirements of each situation are detailed in Chapter 3 of this article.

 

Article 3 Exemption from Non-Mandatory Ethical Review

The exemption from ethical review system is not mandatory for medical institutions and is a policy orientation. As the main body responsible for ethical review, medical institutions can still retain the right to independently carry out ethical review of all life science and medical research involving people on the premise of ensuring quality and efficiency.

 

Article 4 Exemption from strict restrictions on ethical review

Only research involving "two categories" (information data or existing biological samples) can be included in the framework of exemption from ethical review. Collecting information data or biological samples directly through interaction with individuals for research purposes does not fit this category.

Article 28 of the Measures requires cooperation with enterprises and other institutions or the provision of human biological samples and information data for research carried out by them, ethical review shall be conducted and the proper disposal of biological samples and information data shall be supervised after the research is completed, and ethical review shall not be exempted.

Refer to the decision chart of exemption from ethical review in Annex 1, and gradually confirm the research scope, research premise and research application situation before finally making the decision of exemption from ethical review. If any link is inconsistent, ethical review shall be carried out.

 

Chapter II Prerequisites

The exemption of life science and medical research from ethical review must meet the "three prerequisites" at the same time before the applicable situation can be evaluated.

 

Article 5 "No harm to human body"

Harm here refers not only to physical, but also to social, economic, psychological and reputational injuries. Therefore, clinical studies that intervene directly in humans, or collect biological samples and information data through interaction with participants, have a higher risk, or pose a risk of discrimination against the subjects and their ethnic groups, shall be considered to be harmful and shall not meet the prerequisites of this paragraph.

 

Article 6 "No Sensitive Personal Information"

The "the People's Republic of China Personal Information Protection Law" stipulates that sensitive personal information includes biometrics, religious beliefs, specific identities, medical and health, financial accounts, whereabouts and other information, as well as personal information of minors under the age of 14. Therefore, if medical institutions do not have the ability to anonymize sensitive personal information, or directly collect and use medical and health data, this premise is not met.

 

Article 7 "No commercial interest"

In the field of life science and medical research, commercial interests may result in excessive or non-compliant use of sample/information by research participants, which may adversely affect the research or harm the interests of research participants. Therefore, clinical trials initiated or funded by the company for registration purposes, or research to support post-marketing product change instructions/increase indications, or projects that may have potential conflicts of interest, do not meet the conditions of this paragraph.

 

Chapter III Application

After the "three prerequisites" are fully satisfied, a judgment is made as to what kind of situation is involved in the study. Sometimes a study may be applicable to multiple situations, at which time all the requirements of the corresponding situation should be met separately. For example, research on the use of existing biological samples in medical institutions usually involves the matching use of sample-related information and data. Such research must meet the requirements of "using anonymized data" in "situation 2" and "biological samples of existing people" in "situation 3" in order to be exempted from ethical review.

 

Article 8 Case 1: Use of "public data" and or "data generated by observation and not interference with public actions"

The Measures propose that research using legally obtained public data, or data generated through observation without interfering with public behavior, can be exempted from ethical review.

Here, the public data refers to "data for which an access right is not set" or "data disclosed to the public". Researchers in medical institutions use public data to conduct research, such as collecting individual and group data from public websites or public databases such as the Internet, online platforms, social media, etc., and should comply with the terms of use published on the website and the legal source.

Public behavior, which is how someone behaves in public, should happen in a place where people don't expect privacy. Observing and not interfering means not to actively guide the subject's behavior or interfere with his decision-making, and not to affect the natural state of public behavior, such as changing the lighting or sound of public places. Due to the special environment of medical institutions, it is necessary to follow the principles of privacy protection between doctors and patients. Therefore, observing the behavior of others in the diagnosis and treatment environment of medical institutions can not be regarded as "public behavior". In addition, the "Measures" clearly put forward "special protection requirements for specific groups of people (vulnerable groups), so it is not easy to implement exemption from ethical review.

 

Article 9 Scenario 2: Use of "anonymized data" for research

The Measures propose that research using anonymized information data can be exempted from ethical review.

Anonymization refers to the process by which personal information cannot be identified by a specific natural person and cannot be recovered. The direct use of data in the medical history system of medical institutions to conceal their initials or not extract personally identifiable information, rather than using anonymized data for research, does not meet this situation. If you want to use medical data containing sensitive personal information for research, you need to ensure that the institution has the ability to anonymize and obtain prior informed consent, and ultimately provide anonymized data in a compliant manner.

 

Article 10 Scenario 3: Research using "biological samples of pre-existing persons"

The Measures emphasize that the use of existing human biological samples must be legal and ethical, and the content of the research purpose must be within the scope of the informed consent at the time of the original sample collection, and does not involve germ cells, embryos and reproductive cloning, chimerism, and inheritance. Acts that may be affected by assisted reproductive technology, such as genetic manipulation, can be exempted from ethical review.

Existing biological samples from medical institutions, whether collected for previous scientific research purposes, surplus from treatment-related activities, or obtained from other partners, need to ensure that their sources are legal and ethical. The second use of existing samples shall not exceed the scope of informed consent at the time of collection. However, research involving scientific and technological activities that may be affected by assisted reproductive technology and involve high ethical risks should be given special attention and should not be exempted from ethical review.

 

Article 11 Case 4: Research using "human cell lines or cell lines from biological sample banks"

The Measures propose to use human cell lines or cell lines derived from biological sample banks to carry out research. The relevant content and purpose of the research are within the scope of the provider's authorization, and do not involve human embryo and reproductive cloning, chimerism, heritable gene manipulation, etc. Activities.

In this case, it is only applicable to apply to the sample bank manager for cell lines or cell lines for research, not direct application for tissue samples. Researchers shall truthfully explain the content and purpose of the research when applying, and shall not change the scope without authorization. The sample library shall have a standardized management system to ensure that the relevant content and purpose of the study are within the scope of authorization of the provider. Research involving "high ethical risk" (including, but not limited to, germ cell, embryonic and reproductive cloning, chimerism, heritable genetic manipulation, etc.) is also not exempt from ethical review.

 

Chapter IV Operational Recommendations

 

Article 12 Prudent implementation of exemption from ethical review

Different from colleges and universities and scientific research institutes, medical institutions usually involve sensitive personal information, privacy protection between doctors and patients, risky diagnosis and treatment interventions due to their own particularity. Therefore, there are very few projects that fully meet the requirements of exemption from ethical review for life science and medical research involving people carried out in medical institutions! It is necessary to strictly determine the "two major categories", "three prerequisites", and "four situations" in accordance with the provisions of the "Measures", and carefully implement the "exemption from ethical review"!

 

Article 13 Clarify the subject of responsibility

Medical institutions need to designate the management department to be exempted from ethical review (the following is a temporary example of the ethical review committee), and the exemption conclusion should be made by qualified professionals, which cannot be decided by the researchers themselves. Relevant personnel should pay attention to avoid potential conflicts of interest. In addition, exemption from ethical review does not mean that other aspects of research such as project review, scientific argumentation, and process management can be exempted.

 

Article 14 Formulation of Exemption from Ethical Review Process

If the ethical review committee accepts the designation of the medical institution, it can formulate the process and division of responsibilities for exemption from ethical review by referring to the process of exemption from ethical review system in Annex 2 and the responsibility chart of all parties.

 

Article 15 Application by Researchers

After completing the project review and scientific demonstration stipulated by the medical institution, the researcher can complete the self-assessment with reference to Annex 1 and submit an application for exemption from ethical review to the ethics review committee. For any protocol change during the study, the researcher must actively apply to the corresponding management department for change.

 

Article 16 Confirmation and Communication of Final Opinion by the IRB

The director of the ethics office or the ethics committee (or the professional personnel of the designated department) can confirm the "two categories", "three prerequisites" and "four situations" of the applied research, and if necessary, can request additional information data or opinions of the biological sample management party. Research that fully meets the requirements of exemption from ethical review in the Measures shall issue a written conclusion, and those that do not meet or consider it necessary to conduct ethical review shall be submitted for ethical review.

 

Article 17 Supervision and Management

Research that is exempt from ethical review does not exempt medical institutions from regulatory responsibility, and medical institutions should still implement process supervision for such research. Researchers follow the requirements of scientific research norms and integrity, and must not lower the standard because of exemption from ethical review.