Science publishes an article by faculty members of Peking University's School of Medical Humanities: "China's Personal Information Protection Law: Impact on Research"

On November 18, 2022, Science published Xiaojie Li (first author), Associate Professor Liu Ruishuang and Professor Cong Yali (co-author) of the School of Medical Humanities of Peking University and the Center for Ethics and Law Research of the National Research Institute of Health and Medical Big Data of Peking University Research under China's personal information law—The new law may present obstacles to some kinds of Research, the article analyzes the Personal Information Protection Law of the People's Republic of China (hereinafter referred to as the "Personal Information Protection Law").
The impact of medical scientific research and the impact of the law on medical scientific research In particular, the new challenges posed by big data research suggest solutions
.
The publication of this article in Science means Peking University Medicine Humanities A major breakthrough
in the international academic influence of the department.

The Personal Information Protection Law came into force on November 1, 2021, and its legislative purpose is to regulate personal information processing activities and promote the rational use of personal information on the premise of protecting the rights and interests of personal information
。 However, there is still an imbalance between the protection of personal information and the promotion of scientific research represented by health and medical big data research
.
The article is based on a literature study on personal information protection, through the EU GENERAL DATA PROTECTION REGULATION (GDPR), US FEDERAL SUBJECT PROTECTION (COMMONRULE).
and other representative extraterritorial legislation and China's Personal Information Protection Law , Regulations on the Management of Human Genetic Resources, Measures for the Ethical Review of Biomedical Research Involving Human Beings, and Comparative studies of laws, regulations, and rules involving human life sciences and medical research (2 021, solicitation of comments) were spun out Our country The PIPL has unique provisions on the use of health and medical data for research (especially big data and cross-border research).
, combined with the characteristics of informed consent requirements for personal information processing in the era of big data research, in recognized data Under the guidance of ethical guidelines, the possible impact of this law on big data research in China is analyzed
.

The study believes that the Personal Information Protection Law enables the secondary use of personal data for big data research (i.
e.
information or biological samples collected for specific research projects or personal healthcare purposes, Future use for research purposes different from the original purpose) lacks broad agreement legal basis; Strict purpose restriction principles, uniform specific consent rules, strict cross-border processing rules for personal information, etc.
provide medical scientific research in the era of big data, especially cross-border research (such as international multi-center research) It brings new challenges, which may lead to problems such as unfeasible specific consent methods, "subjects' exhaustion of knowledge", and inefficient scientific research and innovation in practice ； China's cross-border transmission of data and biological samples has put forward stricter requirements than the EU General Data Protection Regulation, which has increased the protection of China's biosecurity, but also brought challenges
to cross-border scientific research cooperation.

To this end, this article makes the following recommendations:

First, researchers should strictly abide by the Personal Information Protection Law in transnational scientific research work, fully protect the rights and interests of subjects' personal information, ensure the security of personal data, and respect the personal dignity of subjects;

Second, multinational research institutions should update the informed consent form in accordance with the requirements of the PIPL to ensure that personal information is processed within the purpose of processing, processing method and scope of personal information obtained for consent;

Third, research institutions (especially transnational research institutions) should carry out ethical review work in accordance with the requirements of the Personal Information Protection Law to effectively protect the legitimate rights and interests of
subjects.
For example, the Joint Institute of Translational Medicine and Clinical Research of Peking University Health Science Center-University of Michigan School of Medicine can take the lead in exploring scientific research ethics documents that fit the context of big data research.

Fourth, Chinese and foreign entities may seek to promote the formulation of a transnational research treaty with China or join a common international convention in accordance with Article 38, paragraph 2 of the PIPL;

Fifth, the scientific research community can combine the actual needs of research and the characteristics of big data research to promote the formation of an informed consent model for personal information that is consistent with big data research (such as broad consent, rather than limited to specific consent).

The article points out that in order to further promote China's big data research into the international frontier, and even lead international development, provide researchers and international cooperation with a broader and sustainable development space, and give full play to China's advantages in data research, relevant personnel such as the scientific community, scientific research ethics and legislators can establish a practical and effective communication platform.
Submit legislative proposals to the National People's Congress and other legislatures to grant "derogations of rights" in scientific research, especially the secondary use of personal data in big data research It refers to appropriately restricting the rights of individuals in personal information processing activities provided for in the Personal Information Protection Law according to the specific circumstances and in accordance with the principle of proportionality).
Big data research allows broad consent as an alternative method when specific consent is not feasible in the context of secondary use of personal information, and for the purpose of determining subsequent processing of Whether it is consistent with the original purpose and make flexible interpretations, etc Jointly promote the healthy and sustainable development of China's biomedical big data field, and ultimately improve human welfare
.

In the series of lectures held by the Ethics and Law Center of the National Research Institute of Health and Medical Big Data of Peking University, many front-line researchers who participated in the discussion shared online and some researchers from the team of Zhan Siyan of the School of Public Health of Peking University helped the author understand China and transnational Part of the current status of health and medical big data research, and the ethical review activities of the Biomedical Ethics Committee of Peking University have also been providing practical experience
for this research.
The questions and suggestions for revisions raised by Dr.
Brad Wible, the editor of this article, and the reviewers are crucial
to further clarify the article.
Thanks
in advance.

Written by: Li Xiaojie, Liu Ruishuang, Cong Yali