Study On Ethical Issues Of Protocol Deviation In Clinical Trials

Protocol is the fundamental procedure for clinical trials.It is crucial to formulate a scientific and sound protocol and follow the approved protocol,so as to ensure the scientificity and safety of clinical trials.However,because clinical trials usually involve human subjects,uncertainty becomes a feature of the trials.Many factors,such as the individual characteristics of the subjects,the change of the conditions in research process,and the experience of the investigators,will lead to the failure to follow the research protocol,which is regarded as protocol deviation.A protocol deviation is any change,divergence,or departure from the study design or procedures of a research protocol,which has not been approved by the ethics committee.Protocol deviation is a common problem in clinical trials,which has the characteristics of objectivity,risky and ethical harmfulness.On the one hand,research protocol is the systematic research methods and operation procedures,which always bases on scientific conclusions and foundations and follows the scientific principles.It is also the premise and key to find out scientific and reliable research results.Protocol deviation may compromise the scientific integrity of the collected data for the study and compromise the accuracy,reliability and credibility of the research findings and results.On the other hand,according to the requirements of research ethics,the research protocol must be approved by the ethics committee before the clinical trial can be carried out.However,clinical trials that do not follow the approved protocol and deviate from the original design will increase the risk of unexpected adverse events or serious adverse events,endanger the safety of participants and infringe their rights and interests.Therefore,how to reduce and avoid protocol deviation has always been the focus and difficulty of good clinical practice.However,to correctly evaluate the ethical problems of protocol deviation and to take measures to reduce the adverse effects of protocol deviation,it is necessary to accurately define the protocol deviation,clarify the relation between protocol deviation and protocol revision,and recognize the ethical justification and legitimacy of protocol deviation for individual subject in specific situation.At present,the study of protocol deviation mainly focuses on good clinical practice.There are few systematic studies on the ethical issues of protocol deviation.Ethical reflection on protocol deviation will provide an insight to deal with the harm of protocol deviation.From the ethical perspective,and based on medical ethics and ethics of responsibility,this study will conduct an in-depth investigation on the ethical issues of protocol deviation.Based on the analysis of the definition of protocol deviation,the ethical issues,root causes and ethical government approach of protocol deviation are discussed,which aims to further enrich and develop the existing research of protocol deviation,and also provide guidance for the effective regulation and management of protocol deviation in practice.There are many ethical issues in protocol deviation.First of all,protocol deviation infringes the interests of research participants.Secondly,protocol deviation is highlighted as potential conflict of interests,which are the conflict between individual interests and the interests of society,as well as the collision of multiple responsibilities of medical institutions.At the same time,the lack of accountability of all the stakeholders involved in the research is also the main ethical issue of protocol deviation.It highlights manifested in four aspects,including unsound protocol design,insufficient informed consent,poor implementation and non-compliance report of protocol deviation.There are several reasons that lead to the ethical problems of protocol deviation.First,because of the misunderstanding of the protocol deviation,researchers can not correctly recognize and deal with the protocol deviation,which influences the protocol deviation reporting in the trial process.Secondly,the lack of ethical responsibility consciousness of the participants is an important factor that causes the deviation of the protocol.Third,the absence of consistent regulations and the effective ethical oversight leads to the lack of effectiveness in the supervision of the protocol deviation.Fourthly,the insufficient interaction and ineffective communication between the stakeholders involved in the study make it difficult to form a strong resultant force within the study.Fifthly,the lack of high-quality ethics training restricts the improvement of ethical awareness and duty performance of participating researchers.To solve the above problems,first of all,we should strengthen the responsibility consciousness of the participants,improve the scientific spirit and integrity of researchers,and advocate responsible design of clinical trials and participatory scientific research.Secondly,we should improve the laws,regulations and supervision system of prevention and management of protocol deviation,strengthen ethical oversight as well as self-discipline,and promote an all-round and full cycle supervision system.Thirdly,we should standardize and optimize the ethical review,and improve the quality of ethical review.Finally,it is necessary to strengthen the training of good clinical practice and research ethics,establish a standardized training system,stimulate the enthusiasm and initiative of all participants in the training,promote the improvement of their ethical awareness and duty performance,so as to reduce the occurrence of protocol deviation,and jointly promote the scientific and responsible conduct of clinical trial.