Sdudy On The Protetion Of Subjects’ Informed Consent Rights In Clinical Trials Of Medical Devices

ObjectivesAnalyzes the current situation of protection of informed consent rights and interests of subjects in medical device clinical trials by taking a third-class a hospital in chongqing as an example,finds out the problems in the protection of informed consent rights and interests of subjects in medical device clinical trials,and discusses the measures to strengthen the protection of informed consent rights and interests of subjects in medical device clinical trials,so as to effectively protect the rights and interests of subjects.MethodsThis research uses literature analysis,expert consultation,questionnaire survey research methods.Collect and read the relevant research data and policies through China Knowledge Network,Weipu and the management platform of national pharmaceutical administration department.Extract the design elements of informed consent forms and questionnaire items for clinical trials of medical devices.Investigating whether there were any elements missing in the design of 19 informed consent forms for medical devices in the hospital from 2012 to 2016,and analyzed the signing status of a total of 915 informed consent forms for 11 completed clinical trials of medical devices.By inviting experts from drug clinical trial institutions to screen the questionnaire items,we conducted a questionnaire survey on the cognition and protection of subjects’ informed consent right of doctors and ethics committee members participating in the clinical trial of medical devices in the first affiliated hospital of chongqing medical university.Finally,Descriptive analysis using percentages.ResultThe study found that from the lack of design elements of the informed consent for clinical trials of medical devices,it can be seen that there are many elements missing in the notification page,mainly including the description of the experimental grouping and the alternative treatment scheme,etc.The lack of these important information will lead to the subjects’ insufficient understanding and incomplete knowledge,and thus unable to protect their legitimate rights and interests.Analysis of 915 signed informed consents,Many normative problems of signature have been found.It mainly includes that the study doctor did not sign the correct version of informed consent for the subject,the date of the subject’s signature was selected,the contact information signed by the study doctor was landline,and even a few researchers did not sign their contact information,All these behaviors violate the informed consent rights and interests of subjects.Secondly,according to the questionnaire survey results of the study doctors’ subjective understanding of the subject’s informed consent right,it can be found that the medical device research doctors have insufficient understanding of the content of the informed consent and the signing of the informed consent form,and the training is not in place,thus the above behaviors of infringing the subject’s informed consent rights and interests occur.Thirdly,the questionnaire survey on the problems frequently encountered in the ethical review of informed consent shows that the problems focus on the lack of proper reasons to involve vulnerable groups,the absence of factors such as the risk of trial occurrence and alternative treatment scheme,and the use of professional medical terms in the informed consent form.In addition,the study doctors and the erc agreed with other regulatory authorities on the subject rights protection.Finally,in terms of the particularity of clinical trials of medical devices,95.00% of the research doctors and 88.89% of the ethics committee agreed that the inclusion of audio-visual information such as device introduction and operation of video in the informed consent materials would help the subjects to understand and be more conducive to their full knowledge.ConclusionAccording to the findings of this survey,the non-standard behaviors of violating the informed consent rights of subjects in the clinical trials of medical devices are mainly found to have defects in the design of informed consent forms for the sponsors,insufficient cognition of the informed consent rights of subjects by the research doctors and insufficient ability of ethical review.We should strengthen the effective training and assessment of the regulations and ethical knowledge related to clinical trials of medical devices for research doctors,Strengthen the supervision and management of the whole process of the test project,standardizing the establishment of ethics committees and improving the review capacity and improve the rules and systems of clinical trials of medical devices,so as to better protect the informed consent rights and interests of subjects.