Exploring the protection of participants'compensation under new regulations

Aijuan Sheng; Xiaoqi Wang; Sha Meng; Meixia Wang; Liyan Sun; Cuiling Zhao; Guizhen Sun; Dongxiang Zheng; Fang Liu

Abstract：Medical progress is based on research. Life sciences and medical research contribute to the improvement of people's health, alleviation of suffering, and increases in well-being. Life sciences and medical research involving human participants cannot be undertaken without the support and dedication of participants. The safety, health, and welfare of participants are primary considerations in clinical research, taking precedence over the benefits to science and society. The rights and interests of participants include the right to health, the right to informed consent, the right to compensation, the right to privacy protection, the right to voluntary participation, the right to withdraw at any time, the study/trial free right, and the right to timely treatment. Protecting the rights of participants is the responsibility of sponsors, contract research organizations, medical institutions, researchers, ethics review committees, and other research parties. In life sciences and medical research involving humans, participants typically expend time and energy, and participating in clinical research involves a degree of inconvenience in participants' work and life. When participating in studies in which safety and effectiveness have not been fully and effectively verified, participants are often exposed to uncertain types and levels of risk. Participants in such studies bear known and unknown risks, and may suffer research-related damages. Guaranteeing, protecting, and implementing participants' right to compensation are essential responsibilities in life sciences and medical research involving human participants. The current paper examines the right of compensation for research participants. We undertook in-depth analysis of the concepts, categories (conventional compensation, research-related damages), principles (necessity, timeliness, appropriateness, fairness), and elements (method, amount, plan, consent, notification, reference) of compensation, as well as compensation under special circumstances (people who have not given informed consent, participants with impaired informed consent capacity, participants who withdraw from a study). Additionally, we examined processes for research-related damages (claims, opinions, negotiation, implementation). This paper proposes measures for the compensation rights of participants, which cover five domains (sponsor/contract research organizations, research institutions, research management departments, the principal researchers and their teams, and ethics review committees), to ensure the implementation of compensation and strengthen the protection of the compensation rights of participants.