Knowledge and practices regarding informed consent process for research among junior doctors of a tertiary-care institution in Northeast-India: a cross sectional study

Background: Medical research involving human participants needs to be guided by fundamental ethical principles to ensure the protection of their rights and welfare. Informed consent is one of the fundamental ethical principles. This study was conducted to assess the knowledge and practices regarding informed consent process for research among junior doctors and to determine the association between level of knowledge and their practices regarding informed consent process with certain socio-demographic variables. Methods: A community-based cross sectional study was conducted among the junior doctors of a medical college and tertiary-care institution in Northeast-India. A pretested, peer reviewed, semi structured questionnaire was used. Descriptive and analytical statistics like chi square test and fisher exact test were generated taking a p<0.05 as level of significance. Ethical approval was obtained from the institutional ethics committee. Results: Out of 350 participants, males constituted 47%. More than half of the participants (196, 56%) have good knowledge of informed consent process. Around two-fifth (148, 42.3%) of the respondents were involved with some kind of research work and out of them majority of the participants showed good practice (141, 95.3%) of research. Participants from pre and para clinical departments have significantly higher level of knowledge as compared to those from clinical department. Conclusions: Only around 56% of the junior doctors had good knowledge of informed consent process. As part of continuing medical education program there is a need to organise seminars and workshops for the junior doctors on the informed consent process for ethical conduct of research.