Knowledge–Practice Gaps of Good Clinical Practice amongst MBBS Student Researchers

Sir, A study assessing knowledge and practices about research ethics was conducted in a tertiary healthcare institute in North India.1 Out of more than 450 researchers in the institute, the study was able to include only 59 researchers who have research experience of at least 1 year, most of whom were pursuing MBBS. As per the directions of the institute's research review board, faculties and residents were excluded from the study. The rising popularity of research makes research participants more vulnerable to exploitation. To ensure the quality of a study and prevent exploitation of the research participants, guidelines, such as good clinical practice (GCP), have been put in place.2 Before the study, students were not sensitised about GCP as the study aimed to assess their baseline knowledge of GCP. The majority (81.4%) of the participants of the study were not certified for GCP despite having conducted research. This could be due to the lack of awareness about the GCP in general amongst researchers or inadequate resources. The latter is unlikely in a tertiary healthcare institute where each junior researcher conducts research under the guidance of a faculty/guide. The awareness of specific domains of research ethics including confidentiality, participant safety, research misconduct and research protocol was particularly lacking amongst the study participants. Hence, these lacunae may be due to the lack of guidance by the guides. In contrast, knowledge and practices of informed consent were admirable. Medical students have a good amount of clinical exposure, which could have equipped them with proficiency in informed consent, resulting in this difference in awareness. During medical school, students encounter various clinical scenarios that help them grow as physicians. The same cannot be said in the context of research, as most of the students are not exposed to research. In the early phases of research, an individual is usually assigned to a supervisor. Good research outcome requires personal supervision with continuous feedback along with adequate student–supervisor interactions.3 The disheartening results of the study could also be attributed to weak communication between the students and their supervisors, resulting in ineffective propagation of knowledge to the students. If this is the case in a tertiary apex healthcare institute, which is considered an integral part of the country's healthcare, what about the institutes at the lower strata? Research by undergraduate students promotes critical thinking skills and problem-solving abilities. Early exposure to research enhances independent thought as well as active learning.4 Involvement in research publishing can also motivate the students and boost their confidence, thus equipping them for future endeavours. Therefore, measures must be taken to increase the awareness, knowledge and real-life experience of undergraduate students in research. We suggest an introductory lecture on research and research ethics. Workshops on topics such as evidence-based medicine, types of research, research methodologies, GCP, Good Clinical Laboratory Practice (GCLP) and good health research practice can lead to the active participation of students in research-related activities. This would acquaint individuals with research early in their academic careers and thus lead to greater enthusiasm amongst the undergraduates in conducting research. At least one research project can be made compulsory for an undergraduate student to complete before they pass medical school. Supervisors can be assigned to the students based on their interests, and credit points could be given to the supervisors to promote student–faculty collaboration in the right way after assessing whether students are being truly supervised or not. GCP and GCLP may be advocated to each research institution to ensure that the researchers have adequate knowledge and practice skills before enrolling the first participant/sample in their study. Interestingly, another fact emerged from this study that residents and faculties were not allowed to participate by the research cell, and this may hinder the growth of the research institute if we block anonymous assessment of the major researchers towards their GCP knowledge and practice. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.