ABSTRACT
Objective To promote the Institutional Review Board(IRB) construction and development via paying more attention to the detail management and providing better protection of subjects' rights and interests in ethical review of clinical trials and scientific research projects.Methods Assessment criteria were established according to the domestic and international laws and regulations on the management of ethical and scientific research project.Ethical site visit was performed on the 37 clinical trials/scientific research projects approved by IRB during the year 2012-2015.Results Clinical trials/scientific research projects were divided into tree types:the registered clinical trials,the post-marketing clinical trials and the researcher initiated scientific research project.All the types met with the following assessment criteria:satisfy the requirement of equipment,facilities and qualifications of drug preservation required for conducting clinical research;subjects were given compensation according to the protocol;informed consent were obtained.Among them,the registered clinical trials meet more criteria than other research types.Regarding to the standard of informed consent implementation,all types met with the following assessment criteria:all the subjects enrolled signed informed consent forms,informed consent forms are well documented;investigators and subjects/ the guardian signed the forms.However,during the site visit,some other criteria were also neglected more or less.Particularly,only few project recorded the consent process and time spots singed the forms.Conclusions Investigators should pay more attention to the activities and behaviors taken place during the research implementation process.Researchers and management staffs should pay attention to ethical detail management to guarantee better protection of subjects' rights and interests.
ABSTRACT
With the widely development of psychiatric clinical researches,the ethical issue has been concerned gradually.Although the ethical review has strict rules on informed consent,there are many problems and challenges on informed consent implementation because of the special mental illness population.According to the relevant laws and regulations,combined with the characteristics of clinical psychiatric researches,this paper discussed the protection of subjects' fights and interests during the implementation of informed consent in psychiatric clinical researches,from the following aspects:providing a quiet,comfortable,and relatively independent environment for the participants to ensure informed consent,guaranteeing full informed consent time,choosing qualified researchers for informed consent,ensuring the effective process of informed consent,and guiding the subjects to correctly sign their names and the date.
ABSTRACT
<p><b>OBJECTIVE</b>To describe the trend of multiple pregnancies and to compare the results with single pregnancy in Beijing from 1996 to 2010. Prevalence rates of pregnancy complications were compared between multiple and single pregnancies.</p><p><b>METHODS</b>In 1996, 1997, 1998, 1999, 2000, 2005, 2010, live births in two hospitals in Beijing were included to describe the trend of multiple and single pregnancy. Case-retrospective analyses were used. Information was collected, including maternal age, fetus number, delivery mode, with/without pregnancy induced diseases as hypertension, diabetes or anemia, gender of the baby, birth-weight and gestation etc. Linear regression analyses were applied to assess the trend of birth-weight and the rates of prevalence.</p><p><b>RESULTS</b>63 661 babies and 62 895 puerperal were involved in this study. From 1996 to 2010, prevalence of multiple pregnancies increased by 0.02%, prevalence of cesarean delivery among multiple pregnancy women increased by 2.25% and the proportion of women older than 30 years increased by 3.52% and 2.89% among multiple or single pregnancy women, annually. However, the birth-weight did not show obvious change in both multiple and single birth babies. No obvious change was observed in the prevalence of low birth weight. Prevalence rates of premature birth increased by 1.62% and 0.16% among multiple and single pregnancy women, annually. From 1996 to 2010, the mean values of birth-weight among single birth babies were larger than 3 250 grams and under 2 500 gram among multiple birth babies. Rates of prevalence on pregnancy induced hypertension and anemia were higher in multiple pregnancy women than in single pregnancy women. Differences of rates on prevalence rates of pregnancy diabetes between multiple and single pregnancy women were not statistically significant.</p><p><b>CONCLUSION</b>Prevalence of multiple pregnancies increased from 1995 to 2010 in Beijing. Mothers of multiples were more likely to get pregnancy complication than the single pregnancy women.</p>