Study on good clinical practices among researchers in a tertiary healthcare institute in India.

Abstract

Background: Good clinical practice (GCP) is put in place to protect human participants in clinical trials as well as to ensure the quality of research. Non-adherence to these guidelines can produce research that may not meet the standards set by the scientific community. Therefore, it must be ensured that researchers are well-versed in the GCP. But not much is known about the knowledge and practices of the GCP in the medical colleges of North India.

Aim: To assess the knowledge and practices of researchers about GCP and analyze these with respect to the demographics of participants.

Methods: This is a cross-sectional study. A self-structured questionnaire about GCP, after expert validations, was circulated among researchers, at a tertiary healthcare institute, All India Institute of Medical Sciences (AIIMS), Rishikesh. A total of 59 individuals, who were selected by universal sampling, participated in the study. All healthcare workers who have been investigators of Institutional Ethics Committee-approved research projects, except residents and faculty, and are still a part of the institute have been included in the study. The study was approved by the Institutional Ethics Committee of AIIMS, Rishikesh. We used descriptive analysis and the Chi-squared test to analyze data. P value < 0.05 was considered significant.

Results: Out of 59 participants, only 11 (18.6%) were certified for GCP. Most of the participants (64.4%) had "Average" knowledge, 33.9% had "Good" knowledge and 1.7% had "Poor" knowledge. Only 49% of participants had satisfactory practices related to GCP. There was a significant difference in the knowledge based on the current academic position for the items assessing knowledge of institutional review board (P = 0.010), confidentiality & privacy (P = 0.011), and participant safety & adverse events (P < 0.001). There was also a significant difference in knowledge of research misconduct (P = 0.024) and participant safety & adverse events (P = 0.011) based on certification of GCP. There was a notable difference in the practices related to recruitment & retention on the basis of current academic position (P < 0.001) and certification of GCP (P = 0.023). We also observed a considerable difference between the knowledge and practices of GCP among the participants (P = 0.013).

Conclusion: Participants have basic knowledge of GCP but show a lack thereof in certain domains of GCP. This can be addressed by holding training sessions focusing on these particular domains.