An overview of the basic processes of biomedical research: A narrative review

Conceiving a research idea (Problem identification)

Conceiving a research idea involves a creative and systematic approach. The initial and most important element of the research process is the recognition and defining a research problem. In any research context, identifying problems may comprise analysing them, describing them from many aspects, studying them using diverse theoretical concepts, and generating different opinions and ideas about how to solve them.^[6] Here are some steps to help you in the process:

Literature search and review

The process of finding and accessing current literature related to a specific topic or concern is referred to as a literature search, while the structured compilation of data from published studies is known as a literature review.^[7] Literature searches serve various purposes, such as gathering data for evidence-based recommendations, as a phase in a research study, or as a component of academic evaluations.^[8] Nevertheless, the major goal of an extensive literature review is to define the research hypothesis by analysing the current literature and identifying any gaps or deficiencies that may require further investigation or additional analysis. While literature searches might be tedious and exhausting, being focused and understanding the exact nature of the information sought can make the task easier. Two essential steps include formulating your research question and organising your search. PubMed is the most commonly used resource for literature searches, as many journals are indexed in PubMed and it is a freely accessible search engine. However, there are also other resources available for literature searches, although most of them require a subscription or payment. Detailed list of these resources and their website link are given in Table 1.

Formulating research hypothesis/question

Once the research topic has been chosen, the next step for the researcher is to develop a comprehensive research question or an overarching objective for the study, which can then be divided into more specific and focused research questions. Prior to formulating a research hypothesis, it is crucial to familiarise oneself with the chosen topic. This involves gathering sufficient information through reading articles, manuals, journals, or case studies, in order to narrow down and refine the topic into a research question. The study hypothesis is essentially the research question expressed in a concise single sentence.

Checking feasibility, novelty, ethical issues

Utilising the FINER architecture(feasible, interesting, novel, ethical, and relevant), research questions are created. When intending to address a research question, researchers must assess the immediate scientific and practical context. Researchers should also consider about the amount of money, time and effort they are ready to put in to a research project from conception through publication.

Deciding appropriate study design and methodology

Study design

When considering study design, it is important to recognize that there can be multiple suitable designs for the same research problem. The most relevant study design, however, is determined by how the research issue is phrased.^[9] Generally, there are two broad categories of study designs: descriptive and analytical. Descriptive study methods are used to describe the distribution of variables, characteristics or traits of the population under investigation, such as through case studies or case series that examine unique cases or groups of cases. On the other hand, analytical study designs can be further divided into observational and experimental designs. Observational study methods (eg: Cohort, cross-sectional and case control studies) primarily observe and analyse changes occurring in the study participants without any experimental interventions. In contrast, analytical experimental study methods involve comparing two or more groups, where one group receives a new intervention and the other group receives a conventional treatment or serves as a control. Additionally, within the experimental design, samples are collected from the groups based on the specific comparison being made, such as comparing the same group before and after receiving the intervention or comparing different groups receiving different interventions. Detailed classification of study designs is depicted in Figure 2.

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Figure 2:

Classification of the study designs.

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Selection of appropriate statistical methods

Choosing the correct statistical test is a key component of a well-designed research proposal, as inappropriate methods can compromise data interpretation and study conclusions. The selection should be guided by the study objectives, the type and distribution of data, and whether observations are paired or unpaired. Descriptive statistics are used to summarize data, while inferential statistics apply appropriate tests of significance to draw conclusions.^[14] Although statistical software has simplified analysis, careful selection of suitable tests remains essential, highlighting the need for basic biostatistical knowledge or early expert consultation.

Writing research proposal

The proposal serves as a “proper outline” or “template” for the planned analysis, therefore once it is finalised, the proposed research should continue ahead without any difficulties. A research proposal’s format and content are often provided by the institution or the review committee, depending on their specifications.^[15] A title page should typically include the following data- the title of the project, the names of the first author and co-authors, the degrees of the investigators, and the name of the institution where the research will be carried out and communication details such as contact numbers, mail address. The major body of the research proposal may be divided into the following sections: background and rationale, review of related literature, research question or hypothesis, aims and objectives, research methodology, ethical issues, plan of work and timeline, funding, and bibliography.

Applying for funding

Research funding is a subsidy granted for doing a research, frequently secured through process of contest. The ability to undertake the research study successfully depends on both the researcher’s work and the infrastructure that is accessible. If the researcher or institution has the required infrastructure, many research initiatives can be carried out without the need for additional funding.^[16] It may not be possible to undertake the study within the resources of the department or institution when projects like multi-centric studies, randomised controlled trials, experimental studies, or observational studies with high sample sizes are planned, and a source of outside financing is required. Ordering tests for study purpose that do not truly benefit patients or are not part of standard treatment is unprofessional. For the successful completion of research initiatives as well as to cover these costs, funding is required.^[16] Due to a lack of funds, many brilliant ideas never become successful research projects. Currently there are multiple funding opportunities available for Medical Researchers beginning from Medical Students onwards. To promote the research aptitude among Indian Medical students (MBBS & BDS students), Indian Council of Medical Research has been offering the stipend in the form of Short Term Studentship (STS) since 1979.

Obtaining IRC approval

Proposal in the prescribed format has to be sent to Institute Research Committee (IRC) and will be checked for scientific rigor of the article. If the methodology is appropriate to the research question, IRC approval will be obtained and then the proposal should be processed for IEC approval. If any corrections are needed, the committee will suggest the corrections and after the corrections approval will be obtained.

Obtaining IEC approval

Proposals will be submitted to the Institute Ethics Committee (IEC) in the appropriate format for consideration of their scientific quality and to ensure that subjects are protected from unneeded research hazards, the IEC will assess all subject recruiting protocols, with a focus on women, children, and healthy volunteers who will serve as controls. A thorough proposal must be submitted along with the appropriate Participant Information Sheet (PIS) and Participant Informed Consent Form (PICF) in both English and the local language. Generally, scheduled IEC meetings will happen every 1 to 2 months with a panel comprising of both Medical and Non-Medical personnel and Principal Investigator (PI). The proposal will be discussed and will be given approval certificate/review for corrections. If given for review, the proposal after the necessary corrections will be discussed in the next meeting and approval certificate will be given. After receiving the IEC approval only the data collection should be started.

Data collection

It is the process of gathering and evaluating information on relevant parameters in a defined and planned manner that makes it possible to address given research problems, test hypotheses, and assess results.^[17] Data gathering is a difficult task that requires meticulous planning, determination, dedication, and a many other abilities in order to be efficiently executed. The first step in data collection is defining the type of data that is needed, that is followed by the choosing of a sample from a specified group. The data from the chosen sample must then be collected using a specific tool. The unpublished information that is collected directly from a source without being altered by anyone is the primary data, whereas the information taken from published sources is the secondary data, which means it has already been collected for another purpose and may be used for other scientific reasons.^[17] Different types of Primary and secondary data collection methods are detailed in Table 2.

Performing statistical analysis and interpretation of data

The field of science that deals with acquiring, compiling, interpreting, and extrapolating data from samples to the entire population is statistics. Statistical analysis involves choosing of a suitable research sample, an appropriate research methodology, and acceptable statistical test. Using erroneous analytical techniques might lead to incorrect findings and malpractice. Data are summarised using descriptive statistics as mean, median, and mode which are the indices of central tendency.^[18] The central tendency defines how closely the data cluster around a centre. Inferential statistics use a random data sample from a group of people to characterise and draw conclusions about the entire population. The term ‘null hypothesis’ in inferential statistics represents that there exists no association between the population variables being analysed. An assertion between the variables is said to be substantiated by an alternative hypothesis. The P value represents the likelihood of the circumstance occurring randomly if null hypothesis is correct. Parametric tests are used to evaluate numerical data (quantitative variables) which are distributed normally.^[18] The Student’s t-test, analysis of variance (ANOVA), repeated measures analysis of variance are among the most frequently utilised parametric tests. To assess whether there is a disparity between the means of two separate groups, the Student’s t-test is carried out. ANOVA is utilised to assess if there is a substantial difference between the means of two or more groups. Non-parametric tests are used when the sample means do not follow normal distribution. Depending on how the variables are distributed, the Pearson or Spearman correlation test is used to assess the correlation between the variables. The association between variables in a sample or population is calculated using methods of Regression analysis. If the outcome or dependent variable is a quantitative variable, Linear regression analysis will be done and if the outcome variable is categorical, logistic regression analysis will be done. Different types of plots like histogram, bar chart, scatter plot, forest plot, etc., can be used for depicting the results of the study, depending on the distribution of variable, type of analysis, etc.,

Submitting report

Once the study is over, a detailed report is to be submitted to the funding agency, IRC and IEC in the stipulated time. Generally a period of three to six months will be given for the submission of report after the completion of the study.

Poster/paper presentation in conference

A research paper presentation at a conference can be intimidating for a beginner. You must select a suitable and genuine conference to write and present an abstract. The procedure for making a poster or paper begins with submission of abstract and getting approved by the conference research committee.^[18] After that, they will segregate the submissions into those accepted for conventional poster presentations or oral paper presentations based on the significance of the topics.

Drafting manuscript

The most essential component of the article, is the abstract, is often missed and drafted improperly. A short, self - contained abstract provides a synopsis for the article and enables viewers in assessing if it is related to their project.^[19] The abstract includes background and objectives, that must express the significance of the research, materials and methods to provide a short outline of the settings, design, variables to be measured, data analysis, the study results which should be brief, with an emphasis on the important findings and conclusions which should be concise but impactful.^[20] The general structure of manuscript should include Introduction which should be brief, avoiding lengthy summaries of the research topic, better to follow the funnel pattern, i.e., begin with the less important aspects of the study topic, then the important aspect and finally emphasizing on the prevailing information gap, the research hypothesis, methods section details on the study’s overall design, settings, sample size, inclusion and exclusion criteria, data collection, and analysis of data, statistical tests and software used, the results which express clearly and thoroughly the primary outcomes of the research, the discussion which gives a quick summary of the key findings with major emphasis on addressing the research problem. The subsequent sentences should focus on combining the results with existing knowledge from the literature. Citing the relevant prior original publications and similar studies that put the outcomes in context can help provide a fair categorisation of results of present study.^[21] If there are any discrepancies between our observations and earlier research that has already been published, such resemblance and distinctions must be mentioned, the conclusion that outlines the information that the research has contributed, and the citations, which are often in the Vancouver format in scientific publications. Many freely and paid-for software applications like EndNote, Zotero, Mendeley, etc., exist that make it easier to cite sources and create bibliographies by providing information for various citation formats.^[20] The best time to draft the manuscript is within 15 to 20 days of completion of the report/thesis. The more is the delay, the less are the chances of acceptance of manuscript by a good journal. General structure of the manuscript is given in Figure 3.

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Figure 3:

Picture representing general structure of manuscript.

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Submitting to journal for publication

Reading the criteria and limitations of journals in your chosen research subject is the next step, once the manuscript is written. Choosing the right journal for your paper can greatly enhance your likelihood of approval and make sure that it will be viewed by your intended users. The manuscript should be accompanied by a strong cover letter which should emphasise three key points the fundamental concept of the article, its uniqueness or innovation, and the suitability of manuscript to the selected journal.