ABSTRACT
Objective According to the discussion of investigator responsibilities for human subject protection,to provide possible reference for the construction of human subject protection framework calls for more collaboration between investigators and Institutional Review Board (IRB).Methods Systematically analyze the investigator responsibilities during the whole process of research including design,implementation and closure,identify key ethical issues that need attention at different stages.Results Currently,the culture of regulatory compliance,though good for the human subject protection from regulatory perspective,is still not optimal for encouraging more innovative protection from investigator perspectives.Conclusions Human subject protection is not only the responsibility of IRBs,investigators should also be more responsible and bring in more ethical considerations in human subject research.
ABSTRACT
The principal investigator responsibility system has been progressively under implementation at some of the domestic medical universities. However, since there are big differences between military medical universities and civilian ones in terms of organizational structures, tasks to be committed, functions and personnel systems, military medical universities have to consider own characteristics and well handle the following four pairs of relations in the process of implementing principal investigator responsibility system: the relation between the subject groups and the teaching and research sections, the relation between the subject research and the discipline construction, the relation between the subject research and the personnel training, and the relation between the collective assessment and the individual assessment in the process of performance assessment.