Regulations of Informed Consent: University Supported Research Processesand Pitfalls in Implementation

Abstract

Background: The main responsibility of the Deanship of Scientific Research (DSR) is not only to fund the research but more importantly to protect and promote the rights and benefits of research participants and to monitor and review research projects for compliance. To this date, the Deanship of Scientific Research has designed a qualitative research study to find out the level of adherence to the National/International Regulations while administrating informed consent to determine its process and pitfalls. Methodology: The qualitative research study was undertaken in which 40 Principal Investigators administrated a questionnaire through Qualtrics online survey software to find the satisfaction level on the grant process in The University of Dammam and evaluate the informed consent process of The University of Dammam Standing Committee for Research Ethics on Living Creatures (SCRELC) approved research projects. Results: The results were presented as simple proportions, means, frequencies, bar charts, and odds ratios with 95 % confidence intervals. The level of statistical significance was set is at P ≤ 0.05. Results showed that 80% of the participants were satisfied with the support being offered through DSR by the University of Dammam. Whereas, responding to questions on informed consent process, it was noted that there is a significant gap between knowledge and practice of obtaining informed consent from the research participants. Conclusion: The findings warrant a strong need to disseminate national and international codes and conduct and national law and build a capacity of researchers in Research Integrity and informed consent process in Saudi Arabia