Objective Tissue engineering advance in supplying the reparative and reconstructive medicine with promising tissue engineered medical products(TEMPs) and the new therapy alternative. The related supervision and administration of TEMPs is being developed and the standard research of TEMPs is also in progress. The Food and Drug Administration(FDA) of the United States has treated TEMPs as combined products and supervised them according to the level of risk to patients. Lately, FDA has determined that the Center for Devices and Radiological Health (CDRH) should take charge of examination and approval of TEMPs, with the cooperation of the Center for Biological Evaluations and Research(CBER). The regulatory controls have been established respectively in European Union and Japan. In China, TEMPs are identified as medical devices combined with cells. The Department of Medical Device of the State Food and Drug Administration (SFDA) is responsible for the examination and approval of TEMPs, and National Institute for the Control of Pharmaceutical amp; Biological Products(NICPBP) is responsible for evaluation tests. The standards of TEMPs are formulated mainly by the American Society of Testing Materials(ASTM) and International Standardization Organization(ISO).
ObjectiveTo carry out the work of overseeing transparent administration of clinical department affairs, have clear knowledge on the progress of making clinical department affairs public, and find out problems the staff focus most. MethodQuestionnaire survey was used, combined with the participation of various meetings, interviews with staff, access to documents and other ways between November and December 2013. ResultsIt showed that the rate of transparent administration of clinical department affairs was (78.39±18.55)%. Among all the affairs, policy ones had the highest scores (over 85%), while the rates of research and academic tenure, financial transactions and remuneration allocation, personnel arrangements and training were the lowest (below 75%), and faculty focused on these affairs. ConclusionsFive methods can improve the rate of transparent administration of clinical department affairs effectively:enough attention from clinical departments, concerning what employees focus on, utilizing methods rationally, strong supervision and making full use of monitoring.
Medicine bears the responsibility for human health. Technical competence, service standards, professional ethics and social accountability constitute the soul of this profession. The principles of nonmaleficence, beneficence, respect for autonomy and justice help to establish good doctor-patient relationship and regulate medical services, which has been fixed by international and domestic professional norms. Besides to ensure its truth, effectiveness and safety, medical research also should require certain rendering of subject's autonomy, minimizing risks and maintaining social justice. Some procedures have established for supporting it. Modern medical education furnishes suitable human resources for medical profession, which directly affects the accessibility and outcomes of health services. Its objectives, operations and assessments are increasingly taking shape. Faced with the current issues of healthcare equity, worsening doctor-patient relationship, scandals and ethical controversies in medical research, and the failing of medical education to fully match social needs, evidence-based medical methodology is extending to policy and social sciences for identifying and creating high-quality scientific evidence to improve the quality of decision-making.