ABSTRACT
ObjectiveThe aim is to construct an evaluation framework for clinical research benefits， and provide a reference for the formulate of evaluation standards for clinical research benefits. MethodsThe Delphi method was used to carry out expert consultation， and the mean， score of importance， coefficient of variation and coordination， etc. of evaluation indicators were summarized and calculated， to screen evaluation indicators for clinical research benefits. ResultsTwenty-three experts in this field were selected for correspondence， and their enthusiasm was 100% in both rounds， the authority coefficients were≥0.90， and Kendall’s coefficients of concordance were<0.25 （P<0.001）. By referring to the mean and coefficient of variation of the indicators， as well as combining them with expert suggestions， an evaluation framework for clinical research benefits was ultimately formed with 2 primary indicators， 5 secondary indicators， and 8 tertiary indicators. ConclusionThe evaluation framework for clinical research benefits constructed in this paper can comprehensively evaluate the research benefits， as well as provide a basis for reasonably determining the research risk-benefit ratio and developing quantitative evaluation tools for clinical research benefits.
ABSTRACT
Life science and medical research involving human beings cannot be separated from the support of research participants. The safety， health， and rights and interests of research participants are the primary considerations in clinical research， and their rights and interests include the right of compensation， privacy protection， health and so on. Protecting the compensation rights of research participants is a necessary responsibility of the research-related departments and personnel. Based on laws and regulations and literature review， and combined with practical experience， this paper made an in-depth discussion on compensation rights. It puts forward the types of compensation （conventional compensation， research-related damage compensation）， compensation principles （necessity， timeliness， appropriateness， fairness）， compensation elements （method， amount， plan， consent， notification， and reference of compensation ）， compensation under special circumstances （compensation for participants without or with limited informed consent ability and withdraw from the study midway）， protection measures of compensation right （sponsor/contract research organizations， research institutions， research management departments， （main） researchers and research teams， ethics （review） committee）. The compensation rights should be implemented to protect research participants.
ABSTRACT
Objective:Currently,the medical Institutional Review Board(IRB)mainly rely on experience to analyse the risks and benefits of clinical research,lacking an assessment framework of risks and benefits.Methods:Using grounded theory,interviews were conducted on 29 ethical review workers in China.Through open coding,spindle coding,and selective coding,the framework of risks and benefits for clinical research in China was constructed.NVivo11 software was used for data storage,organization,encoding,and analysis.Results:A framework of risks and benefits for clinical research was proposed based on China's national conditions.Clinical research risks consisted of physiological risk,psychological risk,economic risk,and social risk.Research benefits consisted of subject benefits and society benefits.Conclusion:This paper systematically explained the connotation of the risks and benefits of clinical research,and constructed a framework of the risks and benefits of clinical research applicable to China.It has certain innovations in theoretical research,and also provides use for reference for researchers and ethics committees to evaluate risks and potential benefits in clinical research.
ABSTRACT
The seventh article of Measures for the Ethical Review of Biomedical Research Involving Humans (2016) stipulated that medical and health institutions without an ethics committee shall not carry out biomedical research involving Humans. The Opinions on Strengthening the Governance of Ethics in Science and Technology, issued in March 2022, clearly stated that the institutions that do not meet the conditions for establishing a scientific and technological ethics (review) committee should entrust other institutions to conduct the review. The fourteenth article of Measures for Ethical Review of Life Science and Medical Research Involving Humans (2023) proposes that if an institution, which carries out life science and medical research involving humans, has not established an ethics committee or its ethics committee is not competent for ethics review, it can entrust a competent ethics committee or regional ethics committee in writing to carry out ethical review. Most medical institutions at or above the second level in China have set up ethics committees. While most universities and colleges, scientific research institutions, enterprises and grass-roots medical and health institutions have not set up ethics committees, which lack a working system to protect the safety and interests of the participants, and is difficult to conduct life sciences and medical research involving humans. At present, there is a need for some research institutions that do not have the conditions to establish ethics committees to entrust their projects of life science and medical research involving humans to other institutions for ethical review. The entrusted review is still in the exploratory stage, and there is no relevant specification. The hasty implementation of entrusted review may not achieve the goal of effectively protecting the safety and interests of the participants, and even cause legal disputes. Based on the thematic discussion, with reference to the relevant laws and regulations, departmental rules, ethical standards, and the experience of the ethics committees of some domestic institutions in implementing the entrusted review, the guideline was formulated for the reference of the current entrusted review to ensure the safety and interests of the participants.
ABSTRACT
The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.
ABSTRACT
Items of design and signature from clinical trial drugs were made , the occurrence ratio of every item in 2265 informed consent form ( ICF) from 63 clinical trial drugs in Beijing Youan Hospital affiliated to Capital U-niversity of Medical Sciences were analyzed , and items with lower occurrence ratio were explored .Generally , the design and signature of ICF met the requirement of GCP .However , there were some defects of ICF and antonym of signature .Based on the analysis on the problems , some measures were put forward:formulate relevant standard op-erating procedures , strengthening the management of informed consent , and strengthen the system construction and education training , promote the hospital ethics construction , to protect the rights and interests of the subjects .