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
Processing time: 133 Days and 1.9 Hours
Research background

With the increase in research studies involving human subjects, there arises a need to have certain guidelines in place to protect human subjects. Additionally, the review of research by the research ethics committee has been mandated by international standards. A lack of guidelines can lead to misuse of participants as well as other resources. Good clinical practice (GCP) provided by the international conference on harmonization sets ethical and scientific standards and guidelines for conducting research involving human participants. The two important principles of these guidelines include protecting the rights of human participants and the credibility of the data generated. The level of understanding of these GCPs among researchers is the real question to assess.

Research motivation

GCP is an essential part of research life, and assessing this will have both awareness and accountability among researchers. One method of implementation is to assess first.

Research objectives

The objective of our study was to estimate the knowledge and practices of GCP among researchers in a tertiary care institute in India.

Research methods

A self-structured questionnaire about GCP, after expert validations, was circulated among researchers, at a tertiary healthcare institute. 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 All India Institute of Medical Sciences, Rishikesh. We used descriptive analysis and the Chi-squared test to analyze data. P value < 0.05 was considered significant.

Research results

Out of 59 participants, only 18.6% were certified for GCP. Sixty-four-point-four percent 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 (IRB) (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).

Research conclusions

This study concluded that most of the researchers (except faculty and residents) in the medical college are not certified for GCP. Individuals with more research experience are more likely to pursue GCP certification. There was a gap in the knowledge and practices of GCP among the researchers. The understanding of IRB, informed consent, and recruitment & retention was good compared to that of confidentiality & privacy, quality assurance, participant safety and adverse events, and research misconduct.

Research perspectives

There is a lack of knowledge about the 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 through organising training sessions or workshops which throw light on the principles of GCP.