Observational Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Methodol. Dec 20, 2023; 13(5): 466-474
Published online Dec 20, 2023. doi: 10.5662/wjm.v13.i5.466
Study on good clinical practices among researchers in a tertiary healthcare institute in India
Harshita Harshita, Prasan Kumar Panda
Harshita Harshita, Medical School, All India Institute of Medical Sciences, Rishikesh 249203, Uttarakhand, India
Prasan Kumar Panda, Department of Medicine, All India Institute of Medical Sciences, Rishikesh 249203, Uttarakhand, India
Prasan Kumar Panda, Department of Medicine, College Block, All India Institute of Medical Sciences, Rishikesh 249203, Uttarakhand, India
Author contributions: Harshita H designed, collected data, analyzed, wrote, reviewed, approved the manuscript; Panda PK gave concept, designed, analyzed, critically reviewed, and approved the manuscript.
Institutional review board statement: The study was reviewed and approved by Institutional Ethics Committee of All India Institute of Medical Sciences, Rishikesh, India.
Informed consent statement: All study participants provided informed written consent before enrolling in the study.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: Will be available in communication with the corresponding author at motherprasanna@rediffmail.com.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Prasan Kumar Panda, MBBS, MD, Associate Professor, Department of Medicine, All India Institute of Medical Sciences, Room No. 409, Rishikesh 249203, Uttarakhand, India. motherprasanna@rediffmail.com
Received: August 9, 2023
Peer-review started: August 9, 2023
First decision: September 19, 2023
Revised: September 25, 2023
Accepted: October 23, 2023
Article in press: October 23, 2023
Published online: December 20, 2023
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.

Keywords: Clinical trial, Ethics, Good clinical practice, Knowledge, Research, Research subjects

Core Tip: There is a lack of knowledge about the good clinical practices (GCP) in the researchers of medical colleges. In order to improve the quality of research, as well as, make research a better experience for the participants of research, we must work on improving awareness of the GCP among researchers. This can be done by organising training sessions or workshops which throw light on the principles of GCP.