Clinical Research and Ethics

<p indent="0mm">A clinical trial is a key step in the process of pharmaceutical research and development (R &amp; D). It is a key indicator of the innovative potential of the pharmaceutical industry. ClinicalTrials.gov shows that the average annual growth rate of the total number of clinical trials globally in the past decade (2012–2021) was 20.7%, mainly distributed in Europe and the United States, and the total number of clinical trials registered in China accounted for 6% of the world. According to the statistics of IQVIA Institute for Human Data Science, the global proportion of early-stage R &amp; D pipelines from China-headquartered companies increased from 1% in 2005 to 12% in 2020, which was still far behind that of European and American companies. Among 871 new active substances approved for marketing globally in the past two decades, 522 were for marketing in China, with the high number driven by regulatory acceleration mechanisms from National Medical Products Administration, such as breakthrough and orphan designations and priority reviews. Considering the gap in clinical research strength between China and developed countries such as Europe and the United States, the clinical trial research capacity and level should be improved to assist China in the R &amp; D of innovative drugs. According to the Registration and Information Disclosure Platform for Drug Clinical Studies and the clinical trial institution filing management information platform in China, in the last five years (2017–2021), the average annual growth rates of the total number of new drug clinical trial registration and clinical trial units in China reached 26.9% and 12.6%, respectively. However, clinical trial resources are mainly concentrated in major institutions, municipalities, or provincial capital cities in the eastern and central regions of China, with distributions becoming increasingly polarised. Under the background of China’s new medical reforms, the strategic direction of national political support is to motivate equitable access to high-quality clinical trial resources and cross-regional collaborative development of medical institutions by means of medical unions, national clinical medical research centres, Chinese national major projects for new drug innovation and so on. In the context of this background, clinical trial research unions (CTRUs) have been built in China. A CTRU is defined as a consortium formed by medical institutions, sponsors and third-party service institutions of various levels and functions, led by a national clinical medical research centre or clinical trial medical institutions undertaking major national science and technology projects or supporting projects of national key R &amp; D plans, radiating and driving the improvement of clinical trial research capacity in multiple regions. CTRUs develop a multi-level clinical research centre system and collaborative network by vertically and horizontally combining multi-level medical institutions, sponsors and third-party service institutions. All participants of CTRUs are crucial. The leading clinical trial research medical institution, as the core, is responsible for establishing institutional system standards in CTRUs, designing and leading high-quality multi-centre clinical trials, central ethics and personality training. The major clinical trial research medical institutions are responsible for implementing high-quality, multi-centre, complex and high-risk clinical trials. The other member institutions are responsible for implementing basic clinical trials. The sponsors, contract research organizations (CROs), site management organizations (SMOs) and other enterprises are responsible for funding, supporting and promoting the construction of a clinical trial centre system and collaborative network. The specific construction contents of CTRUs include building a clinical trial research resource sharing platform, homogenising clinical trial quality management, constructing a rapid clinical trial process platform, diversified multi-level and multi-form talent training, information interconnection, deepening strategic cooperation and designing and leading high-level trials. CTRUs have established the selection criteria and assessment exit mechanism and conducted work performance assessments from the dimensions of organisation and implementation, division of labour and cooperation, the connection of clinical trial resources from top to bottom, efficiency and benefit and sustainable development to ensure their good and sustainable development. Through CTRUs, we can achieve high-quality clinical trial resource sharing, improve the clinical trial research capability of member institutions, cultivate high-level skills, such as principal investigators (PIs), sub-investigators, institutional managers and clinical research coordinators (CRCs), and promote the development of clinical trials, economically and with high-quality. Through the trial operation with one member of CTRUs, it was found that the key points should be strengthened in deepening resource sharing, implementing central ethics review, interconnecting information platforms and leading high-quality clinical trials. The construction of CTRUs is an effective means for China’s clinical trial research to solve the current problems and change from a ‘follow-on pattern’ to leading high-level and high-quality international multi-centre trials. However, the construction of CTRUs is a complex systematic project. In addition to performing an excellent job in the top-level design and overall planning, CTRUs’ specific implementation process and measures need to be continuously explored in the practice process.

Medical ethics has a long history and rich connotations. It has developed from the simple morality of ancient times to the modern medical ethics. The basic principles of medical ethics include autonomy, non-maleficence, beneficence, justice, and so on. Researchers often conduct clini-cal researches in the balance between achievements and ethical norms. Clinical researchers of surgery should have a deep understanding of medical ethical principles and strictly abide by medical ethics. Ethics committee should strictly perform their duties and play the role of inspection and supervision. Modern medical knowledges should be popularized throughout the society to make clinical research correctly understood. Adhering principles of ethics first, people orientation and cooperation practice, with patients′ benefit as evaluation criteria, balance of surgical Dao and Shu can be achieved. Key words: Clinical research; Surgery; Ethics; Bioethics; Decision

Medical ethics (ME) is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research based on a set of values that professionals can refer to in the event of any confusion or conflict. ME is particularly relevant in decisions regarding involuntary treatment and involuntary engagement. To practice medical ethics with many challenges from the patients right to autonomy, the patients beneficence and non-maleficence, the patients justice are included. Now, however, evidence-based medicine (EBM) is as important in the developing world as it is in the developed world. Evidence-based practice medicine is one of the ways to reduce health and knowledge gaps significantly. Patient autonomy is done after being explained by the physician based on the EBM. The other three principles also depend on EBM from weak level, average level to strong level. EBM meets the needs, the demands of all four principles of medical ethics. Through this article, the challenges of ME are highlighted below and we introduce ME that can be classified into 4 levels as in the 4 levels of EBM to contribute to an effective balance in the practice of ME.

The ethics of global clinical trials: In developing countries, participation in clinical trials is sometimes the only way to access medical treatment. What should be done to avoid exploitation of disadvantaged populations?

Clinical research can create a conflict between the quest for science and the quest for individualized best patient care. The researcher must balance the degree of uncertainty about a particular treatment with the risk of patient exposure to control therapy. This is known as clinical equipoise. Clinical research and clinical care are intricately linked, yet they differ significantly from each other. This is an important distinction to make for both patients and physicians. This overview of ethics in clinical research will discuss some of the key contentious issues: informed consent (including payment for participation in a clinical trial, use of a placebo, and defining "standard of care"), research in critically ill patients, dissemination of study results, race issues, and financial disclosure. More research is being conducted by more investigators, in more organizations, in more disciplines than ever before. While this environment creates enormous opportunities for advances in healthcare, it also poses numerous challenges to the ethical conduct of clinical trials and raises numerous heretofore unconsidered issues.

Objective In this paper, we analyzed the initial review projects of clinical research during past five years in a hospital, which aims to summarize the experience and analysis existent problems, in order to provide a reference for the future hospital ethics review. Methods Summarizing and analyzing the meeting records during past five years, which were also in the field of the initial review projects of clinical research. Results Clinical trials of drug and divice,and clinical research projects exist in varying degrees of problems, which express in these two aspects: research design and ethical rational. Conclusions Ethics Committee should stengthen review the following two parts, the scientific of research project and the informed consent form. Improve their own system constantly , and ensure the efficient operation of the Ethics Committee. Key words: Clinical research; Ethics; Initial review

The unintended ethics of Henry K Beecher

A quarter of a century ago ethics was an esoteric term, known to theologians and philosophers, but unknown as a discipline to the majority of doctors. Since then, however, ethics has become a substantial part of clinical medicine and health research. Ethics as an area of interest for Danish gastroenterologists appeared from several foci in the early days. One angle was an almost revival-like interest in research methodology and its ethical dimensions. Other angles were derived from Danish gastroenterologists' experiences transferred from other disciplines before the birth of Danish gastroenterology. From the time of these early incentives Danish gastroenterologists have constituted a platform for the implementation of the basic principles, lying behind medical ethics, now in collaboration with other parts of the medical profession. The topics are reflected in a number of publications and in the various practical diversions. An interest in information of patients appeared at an early stage. Publication ethics as a subdiscipline involved Danish gastroenterologists and has led to contributions within the framework of the International Group of Medical Journal Editors. Research ethics, a central topic throughout all years, has led to such important initiatives as the Second Helsinki Declaration and the establishment of a national control system for medical research in man. A further ramification of ethics is scientific dishonesty and good clinical practice. Here a recent initiative has led to the establishment of a national Committee on Scientific Dishonesty. Under the auspices of the OMGE (Organisation Mondiale de Gastroentérologie) Danish gastroenterologists have investigated transnational and transcultural differences in gastroenterologists' attitudes to information of patients and relatives and have unmasked considerable and important differences throughout the world. Medical ethics has, together with scientific methodology, to some extent reunited the sub-specialized fragments of the mother disciplines medicine and surgery and in this way has acted as partes pro toto.

As artificial intelligence (AI) technologies advance and become increasingly integrated into medicine and healthcare services, there is a growing consensus that it is necessary to prepare medical students to understand and utilize AI in medical education. Research and discussions are ongoing regarding the AI competencies that healthcare professionals should have. There are diverse opinions on how to integrate the necessary AI competencies for medical graduates into existing curricula. However, wide agreement exists regarding the importance of providing sufficient and appropriate education on the ethical aspects of using AI in clinical practice and research. In this paper, the authors aim to introduce practical educational principles, strategies, and methods for educators interested in teaching AI ethics in medicine. To achieve this, the paper (1) introduces the AI competencies and medical ethics competencies that medical school graduates should possess; (2) explains the necessity of fostering AI ethics competencies in medical education; (3) discusses the principles of developing AI ethics education and considerations for implementing such curricula; and (4) presents educational modules that can be utilized to cultivate AI ethics competencies in medical students and young physicians. The authors of the paper hope that the case-based module on medical AI ethics we have developed may contribute to prepare medical graduates who are familiar with the principles and guidelines of medical AI ethics, enabling them to make the best ethical choices in any given environment.

Most surgical patients are first seen by an anaesthetist after admission to hospital, either the evening before or on the day of surgery. Some medical ethicists believe that an approach by an anaesthesia researcher made after admission is unethical because the hospital itself is a coercive environment, and patients have insufficient time for reflection or consultation. Others believe that an approach prior to admission may be an invasion of the patient's privacy and confidentiality. The implications of these views for anaesthesia researchers may not be apparent to research ethics boards (REBs). To determine current practice, a questionnaire concerning the membership and function of REBs and the time of obtaining informed consent was sent to each research representative of the 16 Canadian university departments of anaesthesia. Membership of REBS was similar, but not identical, in all centres. Most representation was from medical disciplines. Consent was generally obtained following the patient's admission to hospital. In one centre, the REB always requested informed consent to be obtained before the patient's admission to the hospital. Surgeons had no involvement with consent for anaesthesia research in 14 centres while in the other two they gave permission for their patients to be studied and informed patients of the potential approach by anaesthesia researchers. We conclude that it is ethically acceptable to obtain informed consent for most low-risk clinical anaesthesia research after the patient's admission to hospital.

Objective Discussing the approach to design and implementation of ethical review information management system in clinical research involving human subject. Methods Systematic design and implementation based on ICH-GCP, Chinese GCP, Ethical review of biomedical research involving human subjects, Standard Operating Procedure compliant with Asia Pacific SIDCER certification standards, as well as the working experiences of author group. Results According to the specific working procedures in Beijing e-plugger Support Technology Co. Ltd, We implement ethical management system with real-time online interactive work model among investigators, ethical committee secretariat and ethical reviewers, which is prepared for further system optimization and upgrade. Conclusions The application of ethical review information management system make the ethical management work more reliable, efficient, and also improve the quality of ethical review, which helps a lot in safeguarding the development of medical science. Key words: Clinical research; Ethical review; Management information system

In Assisted Suicide and the Right to Die: The Interface of Social Science, Public Policy, and Medical Ethics, Barry Rosenfeld examines how social science can inform policy and practice issues in the ongoing debates on end-of-life issues. While some important elements of the arguments for advocacy or opposition to the legalization of assisted suicide, such as moral and ethical concerns, are not necessarily the domain of science, others are amenable to scientific study, including such questions as whether untreated pain or depression fuel requests for assisted suicide. This thoughtful, comprehensive, and balanced volume reviews and synthesizes what research has uncovered thus far, and provides rich context on the major legal, ethical, clinical, social policy, and psychological research issues involved in end-of-life decision-making. Topics include assessment of patient decision-making abilities, do-not-resuscitate orders, and advance directives. Chapters on experience with legalized assisted suicide in Oregon and the Netherlands supplement those devoted to reviewing the psychosocial and medical literature on who seeks assisted suicide and why. This book will be an invaluable resource for health psychology researchers interested in end-of-life policy research as well as for clinicians who treat terminally ill patients and struggle to understand the factors influencing their decisions.

Clinical ethics committees

In this article we examine ethical aspects of the involvement of children in clinical research, specifically those who are incapable of giving informed consent to participate. The topic is, of...

New York University School of Medicine