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With the development of modern medicine and the upgrading of China's medical development concept, the attributes of patients as the common carrier of human and life are increasingly valued, and at the same time, Chinese medical workers are also actively exploring medical ethics in line with China's national conditions on the basis of following internationally recognized ethical standards
.
Regarding the latest progress and challenges in clinical research ethics in China, Mofang had the honor to interview Professor
Li Jie, chief physician of the Department of Digestive Oncology of Peking University Cancer Hospital and chairman of the Hospital Ethics Committee.
At the same time, Professor Li Jie will also share
topics such as "centralized ethics" at the DIA China Annual Conference on December 10.
December 8, 2022, China International Drug Information Conference/2022
The DIA China Annual Meeting will be held
online.
The theme of this annual meeting is: Innovation for Health, Cooperation to Lead the Future
.
Focusing on the whole life cycle of drugs, it brings a rich conference agenda, including 13 thematic areas such as ICH theme day, drug clinical development, biostatistics, etc.
, with a total of more than 100 sub-venues, building a platform
for domestic and foreign exchanges.
Professor Li Jie
Professor Li JieMember of DIA China Advisory Board
Core Guidance Expert of DIA China Clinical Research Ethics Working Group
Chief physician, Department of Digestive Oncology, Peking University Cancer Hospital
Chairman of the Ethics Committee of Peking University Cancer Hospital
Chairman of the Biomedical Ethics Committee of Peking University
Chairman-elect of the Medical Ethics Committee of the Chinese Anti-Cancer Association (CACA).
Standing member of the Clinical Oncology Professional Committee of the Chinese Association of Women Physicians
Vice Chairman of the Neuroendocrine Tumor Committee of the Chinese Anti-Cancer Association (CACA).
Since 1993, he has been engaged in comprehensive diagnosis and treatment and clinical research of digestive system tumors, and has rich experience
in the design, implementation and ethical review of clinical research.
Continuous Evolution: Major Changes in Clinical Research Ethics in China
Continuous Evolution: Major Changes in Clinical Research Ethics in ChinaMedicine Cube: As the chairman of the Ethics Committee of Peking University Cancer Hospital, how do you view the major changes in the field of clinical research ethics in China in the past decade? On this basis, what soft and hard skills are needed to do a good job in ethical review?
Medicine CubeLi Jie: In the past decade, major changes have taken place in the field of ethics in clinical research in China: First, the height and breadth of ethics legislation have been significantly improved
.
Representative regulations include the 2015 Measures for the Administration of Clinical Research on Stem Cells (Trial),
The 2016 Measures for the Ethical Review of Biomedical Research Involving Humans, the 2019 Regulations of the People's Republic of China on the Administration of Human Genetic Resources, the 2020 New Version of the Good Clinical Trial Management Specifications for Drugs, the Personal Information Protection Law of the People's Republic of China that came into effect in November 2021, and the Opinions on Strengthening the Ethical Governance of Science and Technology issued by the General Office of the CPC Central Committee and the General Office of the State Council on March 20
, 2022 。 Relevant regulations put forward more and higher requirements for the ethical norms of clinical research, and the ethical governance of clinical research has been highly valued
by national ministries and commissions and relevant departments such as health departments, drug regulatory departments, Ministry of Science and Technology, and Ministry of Education.
Secondly, as the main body of innovation, all kinds of medical and health institutions, colleges and universities, scientific research institutes, etc.
at all levels have also strengthened the ethical review and ethical management
of clinical research.
"Gene-edited babies"
The incident has sounded the alarm for people to comply with ethics, and also promoted the construction of ethics committees of colleges and universities and scientific research institutions to a certain extent, and promoted the balanced development of ethical review and ethical governance in the process of deep interdisciplinary integration and deepening cooperation between scientific research institutions and clinical hospitals, which can ensure the ethical norms
of clinical research.
In recent years, the compliant use of biobanks and human genetic resources has become a hot topic, and the Biosecurity Law and other regulations have put forward clear requirements for this, which shows the importance attached to
the national level.
The strict management of biological samples and human genetic resources not only brings many new challenges to clinical research, but also brings new opportunities
for the standardized management of various institutions.
As an important measure to protect subjects, ethical review should ensure the quality and efficiency
of ethical review.
To do a good job in ethical review, the following requirements need to be met: First, attention must be paid to the capacity building
of the ethical review committee itself.
As a member of the ethics committee, students need to complete training related to ethical review of clinical research, including being familiar with national laws and regulations, the institutional level ethical review charter system, have an in-depth understanding of the ethical principles and norms of clinical research, and continuously improve the level of awareness through continuous training and work practice; Ethics committee members with professional backgrounds should also have rich research experience in related disciplines in order to be competent for their ethical review work
.
Second, at the institutional level, institutional attention and support are crucial
to the development of ethics committees.
Ethical review work is more unique than other scientific research management and service work
.
Ethical review must be independent of sponsors and researchers, and ensure that it is not disturbed or influenced
.
The institution must equip the ethics committee with corresponding human, financial and material resources to ensure the orderly and efficient implementation
of the institution's ethical review.
Major changes include:
Major changes include:The legal system has been continuously improved, and the level of regulation has been continuously improved
Continuous improvement of the ethical review system (establishment and construction of ethics committees)
Continuous improvement of ethical review capacity (gradual standardization of ethical review, training; International and domestic exchanges)
Growing awareness of ethics (ethics committees, researchers, subjects, institutional managers, government regulators)
Hard and soft power required for execution:
Hard and soft power required for execution:Ethical review: meet regulatory requirements and ethical requirements; The establishment and soundness of the legal system is the bottom line; It must not only conform to internationally recognized ethical norms, benchmark against international standards, but also conform to national conditions;
As the main body of the review, the ethics committee strengthens institutional construction and capacity building to ensure that the ethical review work is standardized, high-quality and efficient; Relevant personnel are competent;
Researchers: not only supervised, reviewed, but more active participation in training, self-discipline, active responsibility (submit high-quality ethical review applications, carry out research in strict accordance with the approved protocol of ethical review, timely report of safety problems found as required, etc.
)
From regulation to law: there is a law to follow, delineate the bottom line and guard the red line
From regulation to law: there is a law to follow, delineate the bottom line and guard the red lineMofang: How do you see the impact of the recently promulgated Interim Measures for the Management of Human Biological Samples for Scientific Research by Medical and Health Institutions (Draft for Comments) and the Detailed Rules for the Implementation of the Regulations on the Management of Human Genetic Resources (Draft for Comments) on the ethical review of clinical trials? In addition, what other laws and regulations are worth paying attention to by peers in the industry?
Medicine CubeLi Jie: The basic premise for a study to pass ethical review is to comply with national laws and regulations
.
For example, the Interim Measures for the Management of Human Biological Samples for Scientific Research in Medical and Health Institutions (Draft for Comments) emphasizes that activities such as the acquisition, transfer, storage, use and sharing of biological samples should strictly comply with relevant laws and regulations
。 The Draft for Comments clarifies that all levels and types of medical institutions, disease prevention and control institutions, maternal and child health care institutions, blood collection and supply institutions, etc.
are the responsible entities for the management of biological samples, and should comply with relevant laws and regulations, departmental rules, normative documents, the requirements of relevant ethical norms and technical standards in relevant fields, clarify the departments responsible for the overall management of biological samples, establish and improve the management organization system to ensure the safe, scientific, standardized and orderly development of work related to biological samples, and formulate detailed rules for the management of biological samples.
Establish mechanisms for preventing conflicts of interest in biological samples, mechanisms for protecting the rights and interests of biological sample donors, and effective restraint mechanisms for key links in the management of biological samples, and strengthen the management
of biological samples.
At the same time, the legally-designated representative of a medical and healthcare institution shall fully grasp the overall situation of the institution's biological samples, and supervise the biological sample management department to strengthen the management of
biological samples.
These have put forward higher requirements for the management of biological samples in medical institutions, and biological samples related to clinical trials should naturally follow the corresponding requirements for management
.
The Detailed Rules for the Implementation of the Regulations on the Management of Human Genetic Resources (Draft for Comments) refine the relevant provisions of the Regulations on the Management of Human Genetic Resources, especially on the management system, subject qualifications (especially the identification of foreign parties), international cooperation in intellectual property sharing, security review, and administrative law enforcement procedures
.
For clinical research involving biological samples and genetic resources, it is necessary to strictly comply with relevant laws and regulations and requirements
in all aspects of ethical review and implementation.
As mentioned earlier, the strengthening of the management of biological samples and genetic resources may intuitively bring new challenges to clinical research, including the time cost caused by strict approval procedures, but it also clarifies the standards and basis
for the standardized management of institutions.
In the long run, this must be an important measure
to promote the development of clinical trial standards and quality improvement.
In view of the management requirements of biological samples and human genetic resources, from an ethical point of view, I would like to remind that it is necessary to pay attention to the compliance of ethical review, and community members (or non-medical professional background members) should be among the ethics committee members participating in the review of the meeting, and community members should not be absent from the meeting review; The informed consent form should clearly inform the biological samples that need to be collected, the reason for the collection, the specific quantity collected, and how to dispose of them, including informing a third-party company to test the samples and destroy them
.
Do not fail to pass the application for human heritage because of medical ethics issues
.
In addition, the Biosecurity Law and the Eleventh Amendment to the Criminal Law have also added relevant content
on the management of human genetic resources.
These contents refine the management measures of human genetic resources, have stronger guiding value, and clarify the specific requirements for ethical review; The legalization of ethics has progressed, and top-level supervision and ethical review practices are forming a synergy
.
In terms of continuous improvement, we should pay attention to the consistency between different regulations and documents, and pay attention to regulatory efficiency while strengthening policy guidance (more policies are not better); In terms of other regulations, it is also necessary to keep following internationally recognized ethical guidelines and their latest developments
.
At the level of specific implementation, the new regulations also face practical challenges: laws and regulations are developing rapidly, and the practice of ethical review needs to be effectively implemented, but the number of clinical trials is growing rapidly, and the burden of ethical review has increased accordingly; Detailed division of labor in clinical trials, international multi-center collaborative research, multi-subject participation (CRO,
SMO), etc.
, also brings challenges to the whole process of all-round ethical supervision; It is very important to always maintain the independence of ethical review and supervision in the process of practical implementation to avoid the improper influence
of ethical review by commercial competition.
Taking tumor clinical research as an example, patients with advanced tumors, especially those who continue to progress after multi-line therapy, are typical vulnerable groups, and ethical review should strengthen the attention
to the protection of vulnerable groups.
In addition to informed consent and risk-benefit assessment, attention should also be paid to the scientific and social value of the research itself, whether it can meet unmet needs, research design, research methods, etc.
, to ensure the quality of research and reflect the spirit
of ethics.
Of course, while emphasizing the value of research, it is also necessary to avoid unnecessary research waste, additional ethical risks, etc
.
Academic exchanges are a catalyst for the progress of the industry
Academic exchanges are a catalyst for the progress of the industryMedicine Cube: It is understood that DIA China Clinical Research Ethics Working Group (Clinical Research Ethics
Community) in February of this year
Officially launched last month, two new sub-venues were added to the topic of "Clinical Needs and Platform Model Innovation" of this annual conference - ethics regulations and new ethical technologies
.
At a time when ethical topics are getting more and more attention from all parties, as one of the thematic leaders, how do you view this theme setting?
Li Jie: This year's DIA annual meeting set up an ethics module, and the special session discussed issues that should be paid attention to in ethics based on the Personal Information Protection Law of the People's Republic of China, and invited Japanese bioethics experts to share the "Japanese Bioethics Review and Regulatory Requirements"
.
There are two topics in terms of new technologies, one is cell immunotherapy (mainly introducing CAR-T), and the other is about "artificial intelligence brain-computer interface", which is in line with the "Opinions on Strengthening the Ethical Governance of Science and Technology" issued by the "two offices"
this year.
The panelists included representatives of law and ethics, as well as enterprises, researchers, and hospital managers, hoping to pay attention to supervision from different perspectives, raise awareness and strengthen ethical governance
.
DIA is an international platform, and in the future, we may invite more foreign experts in biomedical ethics to participate in our topics, expand their horizons through exchanges, and let them know us
better.
Combining Strength and Softness: Science, Morality and Humanistic Care
Combining Strength and Softness: Science, Morality and Humanistic CareThe ethical review work itself has the nature of "rigidity and softness", and "rigidity" is the bottom line of the law that we cannot violate, and it must be based on this in any review and cannot be violated; "Softness" is our grasp
of the specific requirements based on ethical principles for specific research projects.
For example, informed consent is a basic requirement for clinical trials and an important measure
to protect the rights and interests of subjects.
In principle, the informed consent of all subjects should be obtained, and attention should also be paid to the compliance of the informed consent process, which cannot be violated "rigidly"; For specific projects, the form of informed consent can be diversified, classic research uses the method of written signing of paper informed consent documents, in specific contexts, and does not affect the rights and interests of subjects, electronic informed consent, oral informed consent and other methods can be used based on the characteristics of the research, which is the "softness"
of the expression of ethical principles.
From another point of view, for communication with researchers, "rigidity and softness" is more important
.
Often some researchers do not understand the revision opinions proposed by the ethics committee, and think that the ethics committee deliberately "finds faults" and affects the progress of research, then they can explain the ethical principles that must be grasped clearly through communication with researchers at and after the review meeting, and at the same time help researchers improve the implementation methods, so that researchers can experience the "temperature"
of ethical review 。 I am also a researcher, I began to participate in or lead various clinical studies in 1997, I know all aspects of the research, and I really feel how difficult it is for a study to be designed from the beginning to the final conclusion, so I know that all parties involved in clinical research are doing their respective responsibilities in order to do the same thing, and ultimately for the early launch of research results or products to benefit the majority of patients
.
