RESUMEN
Clinical studies are reviewed by clinical research ethics committees (CRECs) in order to ensure that they are conducted within the framework of good clinical practice and that the rights of volunteers are respected. Research type, department, status, scope, principal investigator's characteristics and CREC decisions were all evaluated. A total of 1044 research applications were found to have been submitted. In addition, 14.6% of the applications were clinical trials and 48.8% were retrospective studies. Of all the researchers, 50.4% of them were found to have indicated an incorrect type of research. The very low number of interventional clinical trials suggests that researchers tended to be hesitant about conducting such trials or did not have the means to do so. The fact that the applications were often submitted by indicating a wrong type of research method also signifies the investigators' lack of knowledge in this regard.
RESUMEN
Background: The detection of hepatitis B surface antigen positivity in pregnant women before delivery is crucial to preventing mother-to-child transmission of hepatitis B virus. Aims: This study aimed to evaluate the status and rate of testing for hepatitis B surface antigen, rate of hepatitis B surface antigen positivity, hepatitis B surface antigen positivity distribution rate by age, and changes in hepatitis B surface antigen positivity rate in pregnant women over the study period. Methods: We conducted a multicentre, cross-sectional, descriptive study covering the period January 2005 to June 2019 for 2 145 668 pregnant women from 27 provinces in all 7 regions of Turkey, collected using Microsoft Excel before statistical analysis. Results: We found that 1 012 593 (47.1%) pregnant women were tested for hepatitis B surface antigen over the 15-year period, out of which 11 471 (1.1%) were hepatitis B surface antigen-positive. Overall, 97% of the hepatitis B surface antigen positive women were born before 1998, the year that national HBV vaccination was launched in Turkey. The rate of hepatitis B surface antigen positivity in that group was 1.1%, compared with 0.3% among women born after 1998. Conclusion: There was a downward trend in the hepatitis B surface antigen positivity rate among pregnant women in the younger age groups, especially among those born after universal hepatitis B vaccination was inaugurated, and low rate of HBsAg testing during pregnancy.