Objective:This article aimed to explore and establish a systematic, progressive and standardized training content and path for ethics committee members, and also wants to continuously maintain and improve the quality and efficiency of ethical review, and at last wants to provide reference for the future formulation of ethics committee members training direction and system.Methods:This article analyzed the dilemma and the causes in the training process for ethics committee members through literature review, questionnaire survey, and policy researches, and at last focused on exploring the training content, timing, and methods.Results:We should begin with 3 dimensions: the ethics committee and its office, medical institutions, and higher government departments. We should also strengthen the training of ethics committee members through developing training plans, evaluating training effectiveness, improving training content, establishing training systems, reserving training teachers, leveraging the training functions of expert committees, promoting the construction of information exchange platforms, and strengthening international exchanges.Conclusions:It is imperative to strengthen training of ethics committee members, improve their competence, so as to improve the review quality of each ethics committee, and ultimately to safeguard the legitimate rights and interests of research participants.

In the implementation of exemption from ethical review,medical institutions equate exemption from ethical review with no ethical review or simple review,misunderstand the scope of exemption from ethical review,confuse the concepts of de-identification and anonymization,and equate privacy with personal information.The implementation faced challenges such as the coordination of conditions for exempt review with other regulations,the lack of clear decision-making subjects for exempting from ethical review,the legality and compliance of using general informed consent for biological samples and information data,as well as non-traceability and the risk of being re-identified of anonymous information for exemption from ethical review.Measures such as improving relevant laws and regulations,perfecting the construction and management of information databases and biological sample libraries,strengthening the project management and process supervision of exemption from ethical review,and implementing scientific review can ensure the legal and compliant implementation of exemption from ethical review by medical and health institutions.

Investigator-initiated clinical trials （IIT） are an important part of scientific and technological activities involving human study participants. Among them， high-quality IIT can be used to support the marketing and registration application of drugs， medical devices， and other products when conditions permit. Currently， there is a huge gap between IIT and industry-initiated clinical trials. The use of unlisted products in IIT has problems， such as lack of regulatory support， insufficient research funding support， the need to improve the ability of clinical research management departments， the weakness of professional clinical research teams， and the difficulty of ethics review to match the demands. The challenges could be addressed by improving regulations and conducting pilot trials on a small scale， guaranteeing adequate research funding， strengthening the construction of clinical research management systems， building professional clinical research teams， ensuring the quality of ethical reviews and strict follow-up reviews， shifting from ethical reviews to a system for protecting research participants， and reinforcing training for researchers. Ethics committees should strictly review key points， such as the risk-benefit ratio， informed consent， research funding， compensation for damages， qualifications and equipment of research team members， and management of conflict of interest.

OBJECTIVE To study the components of ethyl acetate fraction in Qubai tablet ，and its pharmacodynamics on de melanocyte model ，and explore the material basis for anti-vitiligo effect of Qubai tablet. METHODS The ethyl acetate fraction of Qubai tablets was obtained by extraction ，and its components were analyzed by ultra performance liquid chromatography-mass spectrometry（UPLC-MS）. Model control group ，vehicle control group and 8-methoxypsoralen（8-MOP）administration groups （10，50，100，150，200 μmol/L），ethyl acetate fraction administration groups of Qubai tablet （10，50，100，150，200 μg/mL） were set up in the experiment. By establishing the de melanocyte model ，the effects of ethyl acetate fraction of Qubai tablet on de melanocyte were studied from four aspects ：cell number ，cell viability ，melanin formation and tyrosinase activity. RESULTS UPLC-MS component analysis preliminarily determined the structure of 64 compounds in the ethyl acetate fraction of Qubai tablet ， of which 14 compounds were detected in positive and negative ion mode ；psoralen compounds accounted for the largest proportion ， and the content of psoralen chromone chalcone was the highest in positive and negative ion mode. The results of pharmacodynamic study showed that the ethyl acetate fraction of Qubai tablet could increase the number of de melanocytes ，and significantly improve the cell proliferation rate ，the rate of promoting melanin formation and the rate of promoting tyrosinase activity in the process of melanin formation （P＜0.01）. CONCLUSIONS Psoralen compounds may be the material basis for the anti-vitiligo effect of ethyl acetate fraction of Qubai tablet ；good anti-vitiligo effect of ethyl acetate fraction of Qubai tablet may be related to the promotion of tyrosinase activity.

OBJECTIVE To stud y the chemical cons tituents of n-butanol part of Qubai tablet and its pharmacodynamic effect on the model of de melanocyte. METHODS The n-butanol part of Qubai tablet was prepared. The chemical constituents were analyzed by ultra-high performance liquid chromatography-mass spectrometry （UPLC-MS）. Taking mice B 16 melanoma cells as the research object ，the de melanocyte model was established and divided into model group ，positive control different concentration groups（8-methoxypsoralen 10，50，100，150，200 μmol/L），solvent group （diluted with DMSO ）and Qubai tablet n-butanol part different concentration groups （10，50，100，150，200 μmol/L）. The number of cells were observed by inverted microscope ，and the cell proliferation rate ，the rate of melanin production and promotion rate of tyrosinase activity were also detected. RESULTS In the positive and negative ion mode ，53 compounds in the n-butanol part of Qubai tablet were preliminarily determined （29 in the positive ion mode ，33 in the negative ion mode ，overlapping 9），of which coumarins accounted for the largest proportion ， followed by flavonoids. The n-butanol part of Qubai tablet could significantly increase the number of cells ，which was positively correlated with the action time and administration concentration. It could significantly increase the proliferation rate of cells ，the rate of melanin production and promotion rate of tyrosinase activity （P＜0.01）. CONCLUSIONS Coumarins and flavonoids may be the material basis for the anti-vitiligo effect of n-butanol part from Qubai tablet ；anti-vitiligo effect of n-butanol part of Qubai tablet may be realized by promoting tyrosinase activity.