A structured, mentored experiential clinical research programme for undergraduate students

INTRODUCTION

Research plays a pivotal role in paving the way for advancements in modern medicine. Introduction to medical research early in the undergraduate years contributes to building a robust foundation for students during medical education, instilling critical thinking and reasoning skills from the beginning of their careers.^1,2 The knowledge and competencies acquired also contribute to enhancing students’ interest in research, boosting their confidence in conducting studies, improving their understanding of research principles and methodology, and improving their skills in writing scientific papers, subsequently leading to increased publications and presentations.³

The uptake of research opportunities among Indian undergraduates is found to be unsatisfactory, and there is a limited understanding of the challenges students encounter when engaging in research activities.⁴ In India, due to the lack of a proper platform and a structured curriculum incorporating research in medical undergraduate education, a window opens for many unsuitable practices including predatory journals, unguided exposure to research, no checkpoints for unethical practices and reduced productivity of the student and the system alike.^5–7

There are currently no established guidelines regarding research in the curriculum of Indian medical graduates. It is essential for medical colleges to encourage and enhance research interest amongst undergraduate students. During the course of study, undergraduates tend to prioritize core subjects and specialties, with research being given less emphasis.⁸ However, studies show that a number of students demonstrate the ability to recognize various aspects of research and acknowledge its importance in professional practice and personal growth. Thus, practical applications to encourage early involvement in research during the initial stages need to be provided.⁹

Previous studies have highlighted that endeavours to create research programmes have been initiated in some parts of India, but they have been directed primarily towards the medical faculty.¹⁰ Furthermore, mentoring is a key element in professional growth, and functional mentoring is a pragmatic method that yields measurable outcomes across multiple levels.¹¹ We evaluated the implementation of a structured, mentored clinical research programme (CRP) targeting undergraduate medical students at our institute using the context, input, process and product model of evaluation.¹²

METHODS

This educational intervention study was aimed at formulating and implementing a formal institutional programme with the goal of fostering a culture of ethical clinical research among the undergraduate students of a government medical college in western India. A group of three Phase IV MBBS students took the lead, under the guidance and support of the Postgraduate Director of the institute and other faculty members, to develop a central research unit at our medical college. Planning for this began in May 2023, and its implementation took place in the form of a novel, progressive, 4-month structured CRP from August 2023. This programme’s objectives were:

1. To guide undergraduate students regarding biomedical research, ethics and publication practices through a series of lectures and conduct of hands-on research.

2. To facilitate student–faculty interaction with regard to biomedical research.

3. To conduct biomedical research in various specialties by forming a dedicated student-mentors team. Initially, a protocol outlining the programme was formulated and validated by the college authorities, and permission was granted for its conduct.

Following the approval, all departments of the institute were notified about the initiative, and interested faculty members were invited to join the programme as mentors. Fifty mentors (2 to 4 from each department) joined the programme. For the selection of mentees, a screening test was administered to interested undergraduate students, from 2nd-year MBBS to interns. To ensure an appropriate selection, an online multiple-choice question (MCQ)-based test was conducted for the students. The questionnaire was validated by internal reviewers for face and content validity. The questionnaire was divided into 4 themes: participant details, study design and ethics, methodology and bias, and statistics. It consisted of 52 MCQs of the single best response type with no negative marking. Of the 299 participants who appeared in the quiz, 88 students were selected based on their scores. The selected students were then asked to list their preferences for a specialty or department for the research. After stratifying preferences, one student from each level of undergraduate medical training was assigned to a different department under the selected mentor. Thus, a well-stratified student mentee–mentor team was formed for 22 departments.

Mentor team: Mentors were selected based on suggestions from their respective department heads, as well as their interests and experience in research and scientific writing.

Curriculum: The training spanned 4 months. The two major components of the programme were lecture series and concomitant research (Fig. 1).

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Fig 1.

Programme schedule of the clinical research programme

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Training methodology: The participants were exposed to 7 weekly, specially curated interactive lectures by internal and external experts. The lectures were designed to sensitize students to the basics of biomedical research, ethics, and publication practices, ensuring that the crucial aspects of research were clarified. The topics of these lectures were as follows:

1. Need for research and selection of a research topic;

2. Literature review, databases and reference managers;

3. Types of research and methodologies - part I;

4. Types of research and methodologies - part II;

5. Preparing a proposal and seeking ethics committee approval;

6. Data entry, preparation of data charts and statistical analysis

7. Scientific writing and publishing research.

The lectures were arranged to accommodate the students’ regular teaching schedule and clinical postings. Mentoring sessions on that specific aspect of the research process followed each lecture. These sessions occurred at the mutual convenience of the mentors and mentees, as well as the team’s and project’s needs. For example, after completing the first lecture on ‘The need for research and selection of a research topic’, the mentees approached their respective mentors and selected a research topic during that week. The students thus walked through the entire research process under the guidance of their respective team mentors, ensuring that the teams aligned with the sequential lectures and achieved the time-bound milestones. All undergraduate students and faculty members, regardless of their participation in the programme were allowed to attend these lectures. The state council granted each lecture session two credit points.

All the protocols designed and implemented for this programme were scrutinized and approved by the local Institutional Ethics Committee (IEC).

Validation of the training programme: The draft of the training curriculum was reviewed by internal experts with experience in biomedical research, and the programme was modified based on their input.

Process: The programme followed a group mentoring model. Its process and implementation were overseen through regular meetings of the core team and feedback from the teams.

Participants’ feedback: Each lecture was followed by an online test used to assess the knowledge gained by the attendees. A feedback form was also shared, assessing the lectures on the following: information delivered, clarity of delivery, how engaging the session was found to be, relevance of the content to the tasks of CRP, practical implementation of the knowledge imparted, and overall rating.

Regular mentor meetings: Feedback was also solicited from the mentors through a specially created WhatsApp group and personally to learn of any deviations and make modifications as needed. During the entire training programme, mentors maintained regular communication with the mentees. The students were allowed 3 months for data collection and analysis after obtaining ethical approval.

Product: We categorized products as outcomes. The identified outcomes included each team submitting a project report to the IEC, preparing a poster of the research work, presenting it in a competitive session, and submitting the manuscript for publication. The postgraduate trainees of the respective departments were also briefed about the projects to assist undergraduate students in understanding the clinical or other data, as well as in orienting them to the departmental equipment and infrastructure. Each team was requested to submit their work report to the IEC and design and present a poster summarising their research work. In studies where the data collection and/or analysis remained incomplete, an interim report was to be presented. All the posters were independently judged and rated on a scale of 1 to 50 by four distinguished external judges. The rubric for scoring was decided by the core team based on aesthetics, content, organization, importance of research, and overall impression. The best 3 posters were awarded prizes. The student who secured the highest marks in the online MCQ assessment was also awarded a prize.

RESULTS

We received 299 responses through the online MCQ screening test. Of these, 88 students were selected based on their scores. Thirteen participants were interns and Phase IV students each, while 31 participants were from Phase III and Phase II each. Sixty-two (70.4%) students were male. Eight of the 88 students studying in the final year had some research experience, including poster presentations, research paper presentations, and/or publications.

Product

The number of teams achieving programme outcomes is presented in Fig. 2. All the teams designed the final versions of the protocols within the stipulated time, except for two, who were unable to submit due to personal reasons. Based on the input from the IEC, modifications were made to some of the protocols. Approval from both the IEC and the respective department heads was sought to ensure compliance with ethical standards and departmental protocols for every project. This meticulous process was undertaken to establish a strong foundation for the ethical conduct of research endeavours.

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Fig 2.

Programme milestones

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One team dropped out of the programme due to personal reasons. Seventeen teams participated in the poster competition, with each team represented by one of its members speaking about their project for 3 minutes. Three teams from the Psychiatry, Paediatrics, and Tuberculosis and Chest Diseases departments successfully achieved all the programme outcomes within the designated time frame and submitted their work to indexed journals for publication.

Initially, the students had expressed apprehension and difficulty in identifying a research topic. Subsequently, all participants appreciated the programme’s structure, specifically the theoretical sessions followed by hands-on work. At the culmination of the programme, the students felt a sense of accomplishment and gained confidence in a systematic research process. The mentors also had a great learning experience through the lecture sessions and mentoring.

DISCUSSION

The distinguishing feature of this programme is the multilevel, voluntary participation of undergraduate students and mentors alike, as well as its structured nature, wherein every theory session was followed by the execution of that step, thereby bridging the gap between theory and practice.

Numerous studies have been done globally to examine the impact of mentoring on the professional and personal growth of students. However, these studies are not explicitly focused on research training.² Our programme is an exclusive effort dedicated to nurturing students in the field of research, a crucial step in implementing the principles of evidence-based medicine into clinical practice.

Undergraduate students have often expressed a need for guidance and hand-holding in research. Efforts are made by the National Medical Commission to strengthen the research aptitude amongst faculty and postgraduate trainees by making the ‘Basic course in biomedical research’ mandatory.^13,14 Unfortunately, no such training is provided to the undergraduate students who form the foundation as healthcare professionals. This project was therefore proposed to provide novice researchers with a formal framework for conducting research, engaging in scientific writing, and building their portfolios. It also helped the students to familiarise themselves with the practices of poster presentation and publication. Theory-driven training programmes have limitations, as the acquired knowledge is short-lived and students struggle to initiate research studies. The requirement for mentorship becomes essential for providing close guidance and support.⁷ The CRP promoted interaction between students and faculty in the context of biomedical research. This functional mentoring programme is an approach to incorporating learning elements through research projects, facilitating hands-on experience, and fostering the acquisition of practical skills and knowledge in a research setting. True to the characteristics of a functional and group mentorship, mentors with specific skills were chosen to match the research needs of the mentee and the relationship was focused on a tangible outcome in the form of a project, poster and publication.

Another unique feature of our programme was the engagement of local faculty to serve as mentors and the formation of small groups with a limited number of mentees per mentor. This mentoring relationship continues to exist beyond the programme. The resource persons also guided students in the use of various resources and shared useful material. Furthermore, the inclusion of students from all years of undergraduate medical training fostered an environment for peer mentoring, sharing diverse perspectives on a unified platform, and offered junior students the chance to learn, engage, and collaborate with their seniors. The essential element of working on a research project within a stipulated timeframe helped the mentees overcome their research inertia. Our experience suggests that defining milestones and timelines, along with a community of practice of peers, helped the programme to be successful. Amidst the prevailing belief that research is not possible with the busy schedules, our programme helped faculty secure protected time for compulsory research.¹⁵ Splitting the programme into well-spaced theoretical and practical sessions provided breathing space for all participants to absorb the knowledge and translate it into practice. Furthermore, since all the participants had enrolled voluntarily, the lectures were arranged keeping in mind the teaching schedule and clinical postings and the mentoring sessions happened at a mutually convenient time; there was no adverse influence on the students’ attention and engagement in other subjects or on the other duties of the mentors. During an informal feedback session held at the last session, the students reported gains in skills related to protocol preparation, data collection, and data analysis, as well as overall satisfaction with the content and organization of the program.

We plan to conduct the CRP involving more undergraduate students and faculty, which can help lead to more research projects. Few modifications have been identified, mainly regarding the timing of the programme’s execution. The institute might opt for a similar programme for paramedical students such as nursing, physiotherapy and occupational therapy. Our model of a mentorship-based structured CRP can serve as a valuable blueprint, offering a versatile and effective approach with the potential to be replicated easily and successfully. The inclusion of locally available mentors can ensure the sustainability of the programme.

In conclusion, we could successfully design and implement a well-structured mentorship programme for undergraduate students in the field of biomedical research. An effort has been made to inculcate a sense of ethical research among undergraduate students and help them appreciate the symbiotic relationship between research and clinical care.