A Study On Optimizing Operation Mechanism Of Hospital Ethics Committee In China

BackgroundsWith the rapid development of biomedicine, increasing awareness of patients’ autonomy and relatively backward of medical management model, doctor-patient relationship and physician-patient conflicts getting worse. The ethic problems confused medical staffs and biomedicine researchers. In order to resolve the problems mentioned above, a unique organization—Medical Ethic Instituation was set in many countries from1970s. Ethic committee was proposed in some general hospital for the first time in our country in1990s. For the past decades, ethic committee has been estibalished in97%general hospitals and played important role in medical practice and research. However, because of the ethic committee is still in its primiary stage, its main functions includes not only involving medical ethics construction, but also evaluating medical research involving human subjects, clinical trials of drugs and medical insruments, organ transplantation and assisted reproduction, many problems have emerged. Fully understanding the construction and operation model of the medical ethic committee in our country is very helpful not only in regulating the medical ethic committee, prompting it working more efficiently and scientificly, pretecting mecial staff and patiens privacy rights better, but also in providing guarantee for medical education, scientific research and medical work.PurposeTo evaluate the construction, operation model and functions of hospital ethics institutions in china, by surverying and retrospective analyzing its current status. The methods of optimizing hospital ethics institutions operation model were also discussed, as well as protecting the rights of both doctors and patients.Materials and MethodsOn the basis of retrospective analyzing the hospital ethics literatures, as well as related laws and regulations, we acknowledged the international hospital ethics current status. We designed three questionnaires to survey1、The constitution of a hospital ethics institution, and how it works;2、How to understand the medical ethic and hospital ethics for medical staff;3、How to understand the medical ethic and hospital ethics for admitted patients. The respondents of questionnaire1are the hospital ethic institution staffs. The content of questionnaire1includes the basis information of the hospital they are working for, the current working status of their department, the constitution of their department, the regulations they set, and how the ethic review works. The respondents of questionnaire2are the medical staffs working of the grade III-A general hospitals in Jiangsu province. The questionnaire2is about some basis information of the medical staff, how they understand the medical ethic and medical ethic institution. The respondents of questionnaire3are the patients admitted in the grade III-A general hospitals in Jiangsu province. The questionnaire3is about the basis information of the patients, how they understand the medical ethic and medical ethic institution.Statistical Analysis Software (SPSS, version15.0, Inc., Cary, North Carolina) was used for all data analyses. Categorical variables were presented as percentages, and continuous variables were presented as means and ranges. Spearman correlation and chi-square tests were used to assess differences between categorical variables. The Student’s t-test was used to determine significant differences between the means for two continuous data sets. A P-value of<0.05was considered to be a significant difference.Results1. Current construction and operation model of ethic instituationIn general, the current construction and operation model of hospital ethinic instituation is still on developments. Hospital ethic committees were estabilished mainly in grade iii general hospitals. Ethical review of clinical trials of drug (instrument) organizations, Organ transplant clinical and ethical review organization, Clinical application of assisted reproductive technology and ethics review organizations and Ethical review of clinical applications of new technology organization account for major form for hospital ethic committee in our country. Ethical review of clinical trials of drug (instrument) organizations is supersived by State Food and Drug Administration and local food and drug supervision and management departments. The other review organizations are supersived by healthy department abover the county level.The construction, member background and regulatrion of majority hospital ethic instituation are becoming more and more reasonable and consummate. Some instituation have been reached the international standard. The hospital ethic instituations in Shanghai and Beijing are the best in our country. Some hospital ethic instituations have joined in the Strategic Initiative for Developing Capacity in Ethical Review, which aimed at reguating hospital ethic instituation in developing country and was sponsored by world healthy organization. Compared with developed countries, there many limitations in the development of hospital ethic instituations in our country, especially in the following issues:(1) Absence of Certification instituation; No authority certification instituation can be employed to certificate hospital ethic instituation.(2) Naming varieties;(3) Affiliation management is complicated;(4) Execution can not be fully done;(5) Source of Funding is less;(6) Review capacity is limited, Scientific Review can not be fully guarantee.2. Results of surver about the construction of ethic instituation(1) Totally81questionnaires were sent out and68valid ones were retrieved with a response rate of84.0%. Sixty eight hospitals and102ethic institutions were enrolled in this study, which including19PLA hospitals,24hospital affiliated to NMC,25general hospital in Jiangsu province. There are6hospital affiliated to Nanjing Military Command and3hosptials in Jiangsu Province does not have any ethic institution. In the68hospital, ethic institutions work in4models:1、all ethic institutions of one hospital working as one department;2、the ethic institutions working as separate departments;3、many ethic institutions working as separate departments and one comprehend ethic institutions;4、the department is constituted by more than one ethic institutions.(2) Five hundreds and ninty seven ethic staff in45hospitals affiliated to PLA were enrolled in this study (mean,13people every hospital). The male:femal ratio is2.1:1. Medical staff, ethicists, communities accounts for65.7%,3.5%and4.9%, separately. There are304ethic staff in24hospital affiliated to NMC were enrolled (mean,12people every hospital). The male:femal ratio is2.5:1. Medical staff, ethicists, communities accounts for74.7%,2.3%and1.0%, separately. Four hundreds and fourty three ethic staff in25hospitals in Jiangsu Province were enrolled in this study (mean,14people every hospital). Medical staff, ethicists and communities accounts for63.7%,4.1%and5.6%, separately.(3) In the45ethic institution affiliated to PLA97.8%(44/45) got Organization’s articles of the association,82.4%(35/45) of them got informed consent,76.5%(36/45) got conflicts of interest withdrawal system, and75.6%(24/45) got Archive management system. The25ethic institution in24hospitals affiliated to NMC got Organization’s articles of association,92.0%(20/25) of them got informed consent,56.0%(14/25) got conflicts of interest withdrawal system,64.0%(16/25) got Members of the replacement system, and76.0%(19/25) got Archive management system. The32ethic institution in25hospital of Jiangsu province all got Organization’s articles of association,90.6%(29/32) got informed consent,90.6%(29/32) got conflicts of interest withdrawal system,78.1%(25/32) got Members of the replacement system, and84.4%(27/32) got Archive management system and other management system.(4) Totally350questionnaires were sent out to medical staff and325ones were retrieved with a response rate of92.6%. Three hundreds and tweleve of the325questionnaires were available, with an effective rate of96.0%. The responded medical staffs illustrated distinctive understanding to ethic training and ethic regulation according to different ages, department and record of schooling (p<0.05). Medical staffs at different ages have distinctive understanding on ethic rules (P<0.05); Patients have distinctive understanding to ethic review and ethic rights according to different ages, incoming and record of schooling (p<0.05).(5) Totally350questionnaires were sent out to admitted patients and335ones were retrieved with a response rate of95.7%. Three hundreds and twenty of the325questionnaires were available, with an effective rate of95.5%. The responded patients showed distinctive understanding to ethic consultation, review and their own rights according to different ages, education history and income (p<0.05).3. Optimization methods for the construction and operation model of ethic instituation(1) For the basic construction of hospital ethic instituation:the hosotial ethic instituation is needed in any hospital, it may be work as one department in one name or as a few departemts in various names. For the moderately or small hospital which has no clinical trials of drug (instrument), one hospital ethic department will meet the demand. For the hospital has clinical trials of drug (instrument) and/or clinical application of assisted reproductive technology, one general ethic department assoiated with ethic subunit will be needed. By building ethical organizations sharing platform, which can not only assistant deal with routine job, prompt communation between doctor and patients, and provide reference for managers, but also prompt integrated management of morden hospital ethic instituation and networking sharing. The members of hospital can be employed by recommendation and recruitment. The experts about both in hospital and other instituation can also be employed. The experts can be special on medicine or other discipline. In general, the hospital ethic instituation has one president, one secretary, several vice-presidents and commisions. It will be best for the president specialize in medicine.(2) For the operation mechanism:On the basis of clearly defined responsibilities and relizeation of responsibility, healthy management system, working regulations and review rules should be estibilished. To fully display the review, consultation, and education functions, it is essential to make hospital ethic instituation work standardization. It is critically important to estibalish withdrawal system and punishes regulations. As regard to the functions, the tracing review and education should be reinforced, to improve the communication and other functions.(3) Government policy support and monitoring and evaluation:Law or legal rank high ethical rules are needed. It is neeed to estabilish compulsory long-term effective training mechanism to ensure the scientific and review capability for ethic members. Appropriate funding supporting system should be established to ensure the ethic instituation function correctly and scientifically. Self-supervision department, other supervision insitruation and third-party evaluators should be employed.Conclusions1. Diversity and decentralized organization are the characters of the hospital ethic instituarion in our country. Varieties points of view about construction and operation model of hospital ethic instituation were found, as well as regulations.2. The numbers of hospital ethic instituation is insufficient. The construction and operation model of ethic instituation in some hospital are need refinement and optimization. The understanding of medical ethic is insufficient for both doctor and patients. The insufficient is related to age, eduation, and discipline for doctors, as regard to patients to age, eduation, and income.3. Optimized construction and operation model for medical ethic instituation which can adapt the reforms is urgently needed. It is also critically important to make uniformly standard regulation. The construction and operation model for hospital ethic instituation proposed in this article form the management points of view has strong flexibility and extensibility.Innovation Points1. This article systematically analyzed the current construction and operation model of hospital ethic instituation in our country for the first time.2. The construction and operation model for hospital ethic instituation adaping to the medical roform was proposed.Limittions1. This survery focused on enforcing management and make the ethic instituation work more efficiently from the managers’ points of view. The problems related to internationalize and locatize were not discussed. 2. The subjects of this survery including some general hospital affilicated to PLA, Nanjing military commond and Jiangsu province. The sample in Jiangsu province is small, which may cause some bias.