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

ARTICLE HIGHLIGHTS

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.