IAP Textbook of Research Methodology Dheeraj Shah
INDEX
Page numbers followed by b refer to box, f refer to figure, fc refer to flowchart, and t refer to table.
A
Abstract 311
Accuracy and precision 101f
Acute flaccid paralysis surveillance 36
Addressing ethical issues 231
Administration 181
Adoptive cell transfer 53
Allocation concealment 122
Alpha-errors
two-sided 210
Z-statistic values of 210, 210t
Analysis
management of 21
of variance 250, 289
Analytical studies 90
Analyzing diagnostic accuracy studies 109t
Annexure 306
Appendices 306
Appropriate test 251b
Archiving trial documents 228
Assigning study group 120
Associative hypotheses 83
Asthma
proforma on screening for 256b
schoolchildren screened for 257t
Attend conferences 336
B
Background knowledge, richness in 82
Baseline data 302
Basic research 5
Beneficence 231
Beta-errors, Z-statistic values of 210, 210t
Bibliographic databases 70t
Bivariate distribution 255
Blinding 123
Block randomization 205
Blood 72
Body mass index 257, 272
Boolean operators 73
Budgetary allocations 222
C
Case control
design 97
studies 92, 93b, 95
Case record form 21, 179f, 181, 181f, 226, 305
contents of 306
development of 21
Case reports 333
Case series 333
Categorical data 248
Categorical variable 240, 242
comparing 249
Causal hypotheses 83
Central limit theorem 268
Cerebrospinal fluid 72
Chi-square test 290
assumptions for 249b
Clinical data sheet 305
Clinical research 6, 234
Clinical trials 234
design of 113
phases of 115t
registry 69
list of 296t
scenarios 228
Clinico-anthropometric information 256b
Cluster sampling 195, 198, 198fc
Clustered column 54f
Cohort study 94, 95, 96b
design 96
Co-investigator 181
Collaborative research 36, 336
Collaborative ventures 36
Command, sources of 189b
Complex research hypothesis 83
Computer spreadsheet 243, 244f
data entry in 240
Conceptualizing study 13
Conducting clinical trials 221
steps of 221
Confidence interval 266, 269, 289, 290
Confidentiality 233
Congenital rubella 36
Consecutive sampling 204
Consent, certificate of 306
Continuous data 248
Continuous variable 240, 243
Contract research organisation 234
Control group 118
Convenience sampling 203
Coronavirus disease 2019 (COVID-19) 26, 73, 74, 142, 333
infection 19, 100
pandemic 5, 15
pneumonia 208
severity of 239
Council of Scientific and Industrial Research 325, 327
Cover page 296
C-reactive protein 24
Critical appraisal 76, 76b
Critical sampling 202
Cross-over trial 114fc
Cross-sectional studies 90, 91b, 95, 98
Cumulative index 69
D
Data 254
based evidence 277
check for normality of 262
extraction and analysis 156
inappropriate presentation of 54f
management 21, 237, 239, 303
manager 181, 181f
poor quality of 50
safety monitoring boards 227
sources of 137
tabulation of 255
types of 248
Data analysis 125, 254, 277
stage 131, 132, 133
Data collection 124
stage 131, 132
Data entry 227, 239
ethical considerations in 244
poor quality of 50
role of 240, 240b
Dengue 73
Department of biotechnology 323, 325, 326
Department of electronics and information technology 325
Department of science and technology 323, 325, 327
Department of scientific and industrial research 326
Dependent variable 278, 278b
type of 288
Descriptive cohort 94
Descriptive statistics 255, 266t
Descriptive study 62f, 90, 213
framing research question for 61
Develop study plan, six reasons to 171b
Diagnostic accuracy 104t, 106t
studies 100
quality assessment of 155
Diagnostic tests, validity of 272
Dichotomous index test, diagnostic accuracy of 104t
Directional hypotheses 83
Discussion 313
Disease frequency, measures of 270
Drafting research 22
Drug Controller General 234, 235
E
Echocardiography 15
Electronic search strategies 75
Epidemiological studies, validity of 128
Epidemiology 270
Errors, type of 281, 281b
Estimation, errors in 130
Ethical aspects 301
Ethical practice, pillars of 231f
Ethical research, fundamental principles of 5t
Exclusion criteria 301
Execution 182
phase planning 171
Exhaustive categories 255
Experimental study 61
classification 18fc
design 111
framing research question for 60
External validity 128
F
Factorial design trial 114
Feedback 224
Fengue 74
Fetus, special case of 8
Finer criteria 335t
Fisher's and Yate's tables 196
Font 307
Force-field analysis 137
Forest plot, step-wise interpretation of 158
Forming idea and framing research question 14
Formulating hypothesis 82
Formulating research question and hypothesis 57
Framing research question 60
Freedom, degrees of 289, 290
Friedman test 290
Funded research 328
and funding agencies 319
Funding resources 322
G
Good clinical practices 234
Good hypothesis, criteria for 26b
Good research 24
basic characteristics of 25b
basic requisites of 25b
criteria of 24
design 27
objective, characteristics of 27b
question, characteristics of 59, 62
Grants and funds scheme 336
Gross domestic product 33
H
Health and medicine, research in 4
Health insurance portability and accountability 5
Health ministry's screening committee 234, 235
Health research 9, 319, 172
project 181f
Heart septal defects, pubmed mesh tree structure for 71f
Hereditary multiple exostoses 39
High dependency unit 19
Homogeneous sampling 201
Hyaline membrane disease 37
Hypothesis 8082, 278, 280
formulation 82
in research 80
testing 247, 277
errors in 280
Hypothetical data 258t
I
Ideation phase planning 171
Implementation 103, 167
Independent variable 278, 278b
Indian Council of Medical Research 5, 223, 233, 234, 326
Information bias 131
Informed consent
document 179f, 181, 181f
form 306
contents of 307b
Infrastructure grants 326t
Institutional Ethics Committee 36, 179f, 181, 181f, 234
role of 234
Institutional Review Board 21, 232
Instrument bias 132
Interactive voice response system 206
Interest, lack of 46
Internal validity 128
International collaborations 325t
Interpret forest plot 160
Intervention 302
Interviewer bias 132
Intravenous immune globulin 15, 20
Introduction 298, 311
Intussusception 36
Investigation, direction of 89
K
Kangaroo mother care 334
Kaplan-Meier survival analysis 287
Keywords 311
Knowledge, attitude, and practices 39
Kruskal-Wallis test 290
L
Literature
review of 299
writing review of 68fc, 77
Literature review 16t
advantages of 335
steps of 67
Literature search 15, 67, 69
and review 67
steps of 68fc
Lottery method 195
Low birth weight 96
Lung cancer 28
M
Magnetic resonance imaging 6
Major study designs 28t
Mann-Whitney U test 290
Margins 307
Maximal variation sampling 201
McNemar's test 290
Mean difference 157
Mean, standard error of 268
Medical research 248fc
Medical subject headings 71
Medicine, types of research in 5
Meningitis 36
Meta-analysis 145, 157
Methodology 311
Metric data, tabulation of 255
Monitoring 183
Motivation, lack of 46
Multiphase sampling 195, 199
Multistage sampling 195, 199
Multisystem inflammatory syndrome 15, 15b, 16
Multivariable analysis 287, 287b
Multivariable model 287
choice of 288, 288t
N
National Institute of Health 221, 322
Negative predictive value 104
Neonatal and childhood illness, integrated management of 7
Neonatal intensive care unit 37, 39
Neonate, special case of 8
Nested case-control study 92, 93b
Networking 336
Newcastle Ottawa scale 155
Nondirectional hypotheses 83
Nonparametric tests 290t
Nonprobability sampling 200
method 21
N-terminal-pro-B-type natriuretic peptide 15
Nuclear magnetic resonance 6
Null hypothesis 83
Numerical variable, descriptive study of 213
O
Objectives 17, 26, 113
Observation, period of 89
Observational analytical study 61b
framing research question for 61
Observational study 89, 333
categorization of 89t
classification 18fc
Observer bias 131
Office practice
research in 32
types of research feasible in 36
One-sided alpha-errors 210
One-way analysis of variance 250b
One-way frequency distribution 255, 258t
Opportunistic sampling 202
Oral rehydration solution 6
Organizing meetings 327t
P
Paired data 249
Parallel-group trial 114
Parametric tests 289t
Participant/patient/parent information sheet 306
Participants
randomization of 225
types of 149
Participatory action research 137
Patient information sheet 306, 307b
Peak expiratory flow rate 37
Pediatric disease annotation and medicine 69
Pediatric intensive care unit 19
Pediatric research 7
in office setting 34
Perform univariate analysis 282
Performance bias 132
Performing research during office practice, benefits of 35b
Personal research support 323t
Pharmaceutical/vaccine company, research projects for 36
Pie chart 54f
Planning
lack of 49
study 17
Pneumonia 36
Poor conclusion 52
Poor data representation 53
Poor monitoring 50
Population 301
Positive test, likelihood ratio of 105
Postgraduate thesis programs 334
Preliminary information 301
Primary data 254
Primary outcome measures 302
Principal investigator 181
Probability proportional sampling 199
Probability sampling method 21
Procedure 302
Program management processes 187t
Programmatic research 7
Project management 169, 172, 186
body of knowledge 174
institute 174
processes 174t
software programs 190
Project manager 181
power for 189b
responsibilities of 189b
role of 189
Proportion, standard error of 268
Proposal, summary of 297
Prospective cohort studies 94
two-group 96
Pulmonary function test 257, 258t
Purposive sampling 200
P-value 290
Q
Qualitative data analysis 139
Qualitative methods 135
Qualitative outcome variable, statistical test for 285fc
Qualitative research 135, 334
approaches to 138
findings, rigor in 140
methods 135, 137
sampling in 139
Qualitative variables 254
Quality improvement research 7
Quantitative outcome variable, statistical test for 284fc
Quantitative variables, comparing 250
Quasi randomization 205
Quota sampling 203
R
Random errors 130, 208
Random number method, table of 196, 196t
Random sampling 206
Randomization 121, 204, 206
types of 204fc
Randomized clinical trial 111
Randomized trials, types of 114fc
Recall bias 132
Receiver operating characteristic curve 107, 107f
Reduce information bias 132t
References 303, 314
Rehabilitation 72
Research 3, 24, 309
completion of 30
cycle 169
design 27
funding, issues of 44
grants 324t
hypothesis 83
importance of 10
in paediatrics, career opportunities in 11
place of 19
process 13, 14f
protocol, structure of 296
reasons for poor state of 33
scopes of 24t
type of 332
Research project
elements of protocol of 295
life cycle and stages 170f
planning, two phases of 171
risk breakdown framework for 182b
Research question 15b, 25, 113, 147, 286
assess smartness of 65t
origins of 59
Resources, lack of 48
Retrospective cohort study 95, 96
Review process 314
S
Sample
cover page 297b
Gantt chart 181f
selection of 194fc
Sample size 20, 139
calculation 211, 213, 214, 216, 218
need for 209
formulas 218t
Sampling 192
breakdown 193f
concepts in 193f
distribution and standard error 267f
frame 193
scheme 193
types of 193
unit 193
Sampling method 192
software used for 206
types of 194fc
Sampling technique 20
terminologies used in 28t
Science and Engineering Research Board 325
Science, research in 3
Scientific methods 3
Scientific writing 293
Secondary data 254
Selecting research problem 335
Selection bias 130
Severe acute malnutrition 24
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic 34
Simple experimental studies 333
Simple random 121, 205
sampling 195, 195f
Simple research hypothesis 83
Single analytic cohort 94
Single group prospective cohort study 96
Snowball sampling 201, 202f
types of 202fc
Social desirability bias 132
Social media 336
Social sciences
spreadsheet, statistical package for 262b, 262f
statistical package for 258, 259f, 261t, 272f
Standard error 267
Standard normal distribution 263
Standard operating protocols 223
Statistic 254
Statistical analysis 29, 228, 303
poor understanding of 51
Statistical comparisons, basics of 246
Statistical hypothesis 83
Statistical power 220
Statistical test 284fc, 285fc, 288, 289t, 290t
choice of 282
Stratified random 122, 205, 206f
sampling 195, 197
Structured operational research training initiative 48
Student T-test 250
assumptions for 250b
Study
duration 301
exclusion of 154
flow diagram 304fc
flowchart 302
hypothesis 113
identification of 153
inclusion of 154
objective of 17
participants, size, and sampling 28
plan, relevance of 170
planning 169
population 20, 193
rationale of 16
tools, standardization of 49
types of 149
Study design 17, 87, 89, 254
stage 131, 132, 133
types of 17fc
Summarizing skills 52
Summary sheet, sample of 298b
Surgery 72
Surveillance projects 36
Survey research 333
Systematic error 130, 208
Systematic random sampling 195, 196
Systematic review 145
key aspects of 147t
making sense of 146
T
Teamwork 337
Theoretical replication 203
Theory-based sampling 203
Tippet's random number 196
Title 310
Title page 297
sample of 297b
Translational research 7
Travel grants 326t
Trials, characteristics of 222
Triglyceride data, box plot for 265f
normal Q-Q plot on 265f
Two-group analytic cohort 95
Two-way classification 255
Two-way table 258t
spreadsheet for 259f
U
Unfunded research 332, 333b, 334
advantages of 337
Unique values, displaying list of 243f
Univariate analysis 287b
University grants commission 326
Unpaired data 249
V
Vancouver style 305b
Variables, classification of 279fc
Variances 250
Venn diagram 137
Virology 72
Vulnerable group 8
W
Wilcoxon signed rank test 290
Write hypothesis 84
Writing introduction, funnel approach for 299f
Writing literature review 77
Writing paper, hour-glass model of 310f
Z
Z-statistic values 210, 210t
×
Chapter Notes

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1Getting Started with Research
Section Editor: Akash Bang
  • What is Research and Why to do it?
    Reena Gulati, Piyush Gupta
  • Research Process
    NC Gowrishankar
  • Criteria of Good Research
    Nedunchelian Krishnamoorthy
  • Research in Office Practice
    Vipin M Vashishtha, Ipsita Vashishtha
  • Problems Faced by Researchers in India
    Meenakshi Girish, Sujiv Akkilagunta2

What is Research and Why to do it?Chapter 1

Reena Gulati,
Piyush Gupta
 
WHAT IS RESEARCH?
In ordinary language, research means an effort to find valid answers to questions by systematic use of scientific methods.
 
Definition
The word comes from the obsolete French word “recherche” that was used in the latter part of 16th century. The word was also used as a verb as it is done today, from the same old French where “re” indicates intensive force and “cerchier” means “to search” or “to search intensively”.
Though research is carried out in all spheres of human activity, there is no single definition of research. The answers may vary greatly depending upon the person who answers the apparently simple question.
Oxford Dictionary defines the term as “systematic investigation into and study of materials and sources in order to establish facts and reach new conclusions”.
According to the American sociologist Earl Robert Babbie, “research is a systematic inquiry to describe, explain, predict, and control the observed phenomenon. It involves inductive and deductive methods.”
Research was explained as “seeing what everybody else has seen and thinking what nobody else has thought” by Albert Szent-Györgyi, the Hungarian biochemist who won the Nobel Prize for first isolating vitamin C and discovering the citric acid cycle.
 
Research in Science
Research conducted for the purpose of contributing toward science by the systematic collection, interpretation and evaluation of data in a planned manner by scientific methods is called scientific research. The same applies to medical or clinical research.
 
What are “Scientific Methods?”
These are standardized techniques used to generate scientific knowledge that include generating a theory or hypothesis, making valid observations, 4interpreting results, and generalizing the results obtained. The results may or may not have direct applicability at the time the research is conducted.
When scientific methods are used to look for answers to a question, other researchers in the field should be able to independently and impartially test the theories and findings generated by the initial researchers. Such ideas, observations and results can be contested or subjected to discussion and debate, and can be modified or improved upon.
The methodology is considered “scientific” when certain conditions are fulfilled (Table 1).
 
Research in Health and Medicine
It is imperative that medical research is conducted through proven scientific methods as it deals with human health and life. It is also imperative that it is ethical.
The concept of ethics has changed over time. In the early 20th century, unbridled misuse of research subjects was carried out by scientists of the colonial era. The most glaring examples were the “eugenics” practiced in Europe for elimination of the “physically and the mentally challenged”, and the torture and murders committed in the name of science under Nazi Germany on concentration camp prisoners that led to the Nuremberg trials and establishment of “Nuremberg Code” in 1948.
TABLE 1   Conditions to be fulfilled for scientific methodology.
Condition
Application
Replicable
When the same research is conducted by other independent researchers under similar conditions and following the same methods or techniques, the results obtained by them should be replicated. In other words, they should be able to obtain similar if not identical results
Precise
The concepts should be clearly defined, objectively measurable, and methods or techniques used should be precise to the extent that later researchers can apply without any ambiguity to test similar concepts and theories. It is imperative that the terms or concepts used are not imprecise and are amenable to accurate measurement
Falsifiable
A concept or hypothesis should be presented in a manner that it is possible to disprove it, as it is yet to undergo testing and research. It is scientific research only when these have the possibility to -be falsified or disproven by appropriately applied methods
Parsimonious
It is the concept of “keeping it simple” and cutting away any frills, historically associated with the scientific law of parsimony or “Occam's razor”. When a condition can be explained in many different ways, the scientific enquiry should accept the simplest and the most logical explanation
5
TABLE 2   Fundamental principles of ethical research in humans.
Principle
Application
Beneficence
Research should be beneficial to the individual or society
Nonmaleficence
It should do no harm to the participant whose safety is prime
Autonomy
Participation should be informed and voluntary with the right to withdraw at any time
Justice
The benefits and burden of research should be fairly distributed
In 1964, the “Declaration of Helsinki” of World Medical Association (WMA) provided formal guidelines for biomedical research. Since then it has been repeatedly revised to provide protection to persons on whom research is conducted. Four principles were provided to guide any research undertaken on human participants that still guide the present day researchers (Table 2).
Under the federal government of the US, the two major rules govern the health of citizens of US, i.e., Health Insurance Portability and Accountability Act (HIPAA) privacy Rule and the Common Rule. For their purpose, the term “research” is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”, a broad definition encompassing all subject matter directly or indirectly related to human health.
In India, guidelines for health and biomedical research are provided by Indian Council of Medical Research (ICMR) that are periodically revised. The latest guidelines were published in 2017 with update in 2020 in view of the coronavirus disease 2019 (COVID-19) pandemic.
 
Types of Research in Medicine
 
Basic Research
Basic research is a type of research approach that is aimed at gaining a better understanding of a subject, phenomenon or basic law of nature. This type of research is primarily focused on the advancement of knowledge rather than solving a specific problem.
Experiments are performed to further scientific knowledge without an obvious or immediate benefit. The goal is to understand the function of newly discovered molecules and cells, strange phenomena, or little-understood processes. In spite of the fact that there may be no obvious value when the experiments are performed, many times this new knowledge leads to breakthrough methods and treatment years or decades later.
Basic biomedical research is conducted to understand the basic and fundamental processes of human biology. Many watershed discoveries made 6in medical field in the past century were achieved as researchers fervently worked to unravel the structure and functioning of the human body. This led to understanding of disease processes, dispelled the prevalent myths, and provided the framework for progress toward improved human health, discovery of ABO blood groups, and description of DNA and RNA molecules being prime examples among many others.
Nuclear magnetic resonance (NMR) was initially developed to determine the structure of chemicals with no apparent connection to the medical field. Later the scientists realized its potential to look inside the human body without exposure to radiation and provide images never thought possible before, and evolved it into magnetic resonance imaging (MRI) that revolutionized the field of radiodiagnosis.
 
Applied Research
Applied research is the scientific investigation conducted to answer specific clinical questions or solve practice-related problems.
It is a type of research design that seeks to solve a specific problem or provide innovative solutions to issues affecting an individual, group or society. It is often referred to as a scientific inquiry as the purpose of applied research is to find a practical solution to everyday problems by the application of scientific methods. A particular health-related problem is identified, a research hypothesis is generated which is then tested to be true or false through one or more appropriate experiments. Sometimes this type of research utilizes empirical methods for solving a practical problem.
Applied research in many cases utilizes the results obtained from basic research and investigates the possibility of their application to solve health problems in order to provide the proof of its viability or otherwise in real life.
Advent of oral rehydration solution (ORS) in early years of 1970s decade dramatically changed the way acute infectious diarrhea and resultant dehydration, the number one killer of children under 5 years of age, was treated. It saved the lives of thousands of young children around the globe. The research that proved the unequivocal efficacy of ORS was based on the findings of basic research which proved that presence of sodium was required for absorption of glucose in the lumen of small intestine of mammals and absorption of sodium itself was greatly increased when glucose was available.
 
Clinical Research
Clinical research refers to studies, or trials that are done in people. According to WMA Declaration of Helsinki, “Medical progress is based on research that ultimately must include studies involving human subjects”.
7It can be “observational” or “interventional”, the terms being self-explanatory. The most rigorous type of research carried out on humans in clinical settings is a clinical trial.
The World Health Organization (WHO) defines a clinical trial as “a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, and preventive care”.
 
Translational Research/Quality Improvement Research
To quote Louis Pasteur, “to him who devotes his life to science, nothing can give more happiness than increasing number of discoveries, but his cup of joy is full when the results of his studies soon find practical applications”.
Sometimes research is carried out to find out how certain hypotheses that have already been proven or discoveries made can be applied in real life to manage health conditions or improve the already existing management strategies. It is also popularly known as “bench to bedside” research.
An important early example of translational research in medicine was the application of the knowledge that persons who had cowpox were protected against smallpox to mass vaccination drives leading to eradication of smallpox from the world. Discovery of penicillin by Alexander Fleming in the laboratory, when applied to clinical medicine saved millions of lives and changed the course of practice of medicine in the world.
 
Programmatic Research
Programmatic research examines, describes or addresses a fundamental or challenging complex issue, problem, phenomena, or outcome of interventions in place. It studies the why and how of things, evaluates the interventions or programs to analyze their efficacy and ways for further improvement.
SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis is an example of programmatic research that helps to prepare strategies for maximum utilization of available resources. Surveillance programs are created to analyze the impact, drawbacks, and alternate strategies for successful outcome of implemented programs, e.g., evaluation of Integrated Management of Neonatal and Childhood Illness (IMNCI) program for improvement of health at primary level.
 
Research in Pediatrics: What is Unique?
Children were considered to be small adults 4–5 decades ago. Research related to children's health took off after their special needs were recognized 8and pediatrics came to be recognized as an independent branch of medicine.
Childhood (including neonates) is a unique stage of life when growth and development take place and hence their health needs and problems are very different from adults. Hence, results of any research conducted on adults cannot be extrapolated and directly applied to children.
Though it is considered necessary to include children (from birth to completed 18 years of age) in research for progress in their health care, being a “vulnerable group” more at risk of harm than adults, they should be involved in research only when it directly addresses their problems and the results are expected to be beneficial to their health.
Research in children is guided by the WMA Declaration of Helsinki that provides guidelines for ethical conduct of research where the interest of the person participating in research is considered paramount. It considers inclusion of a group of people, especially “vulnerable groups” that include children, to participate in research specific to their health interests and who stand to benefit from such research as necessary and ethical by stating “groups that are under-represented in medical research should be provided appropriate access to participation in research”.
An important current example is initial guidelines on vaccination of pregnant mothers against COVID-19 where some countries including India had advised against vaccinating them as no data were available on its safety in the mother-fetus dyad. The reason was their noninclusion in research protocols looking at the safety profile of the new vaccines under evaluation around the world.
 
Special Case of Neonate
Just as children cannot be considered “small adults”, neonates cannot be considered “small children” and require research into their unique problems associated with the process of birth and immature physiology. Due to their fragility, utmost care is required to plan and execute research where their participation is unavoidable.
Any research that can be conducted with children as participants, with results directly applicable to neonates should not include them as participants.
 
Special Case of Fetus
The fetus becomes a participant in research as one member of a mother-fetus “dyad”. In view of its extreme vulnerability, effort is always required to find methods to conduct tests on the mother as a proxy, if possible, and spare the direct involvement of her fetus.
9Under circumstances where inclusion of a fetus is absolutely necessary, research is first conducted on animal fetuses and extended to human fetus only when found safe, e.g., fetal surgery for early correction of congenital abnormalities that are uniformly fatal after birth.
 
WHY DO RESEARCH?
 
Is Research Necessary or Just a Fad?
About 300–400 years ago, health care was provided on the basis of accumulated wisdom over centuries and handed down the generations of experts. There was no way to confirm whether a particular way of treating patients was useful. There was an overlap with occult practices in different parts of the world, some of which were actually harmful. The increased longevity of humans over the past century can be significantly attributed to advances resulting from medical research. Experimentation and research have helped us to develop our understanding and knowledge of human body, and its functioning in health and disease.
According to Declaration of Helsinki, “the primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic, and therapeutic interventions (methods, procedures, and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility, and quality”.
 
Health Research and its Importance
There are some undertakings that have had high value for the society. Health research is one such undertaking. The benefits it has provided to societies all over the world have far outweighed the inputs and costs. Research that provides important information regarding the basis of diseases, trends in problems related to public health, identifies risk factors for highly prevalent diseases, growth and development patterns of children, and more, is as important as research into discovery of drugs, new and more effective treatments, and invention of technologically advanced diagnostic and management strategies.
Discovery, strategies of implementation and continuing progress in vaccination has been the single most effective public health intervention undertaken by the medical researchers. It has saved billions of lives for a century and is continuing to do so, preventing an enormous avoidable loss of young lives. The average span of human life that hovered around 40 years a century ago is expected to extend to around 120 years for the millennials.
More and newer vistas are opening up and research in human health is undergoing a paradigm shift with the continuous advent of new technologies, 10both individual and mass levels of implementation. Gene therapy, novel concepts of drug delivery, use of artificial intelligence, etc. are taking the research community by storm, promising an unprecedented array of solutions to problems that were considered unsurmountable till recently.
Health economics is an area of research that assesses and continues to report the cost and benefit analysis of medical research in the highly commercialized present day society. The enormous impact it can have on human health and longevity, the resultant increase in the productivity of members of the society has proven to provide an equally enormous boost to economies both at the national and international level.
 
Importance of Research in Children
Children are the most important asset of the world and future bearers of the human race. Research focused on children in the past 4–5 decades has led to dramatic reduction in the under-five and neonatal mortality, ensuring their survival into adulthood, improving quality of life, and providing them opportunities to become productive work force of the world. However, the journey is not complete and much more remains to be done.
Why a pediatrician/student of pediatrics should do research?
Though an academic career in clinical or biomedical research can be challenging, it can be extremely gratifying, especially when discoveries made change the lives of children and their families. As clinicians, pediatricians can help one child at a time, but as a researcher, they have the potential to improve and save the lives of many children, help them to bloom and fulfill their potential. The pediatrician researchers can thus make a place for themselves in the history of successes through application of their published research for future generations to remember.
Pediatricians have a vast canvas of opportunities like never before to choose their area of interest and make real difference to the lives of children and by extension, their families.
Research does not always have to be very high end requiring extensive laboratory settings and large amounts of funds. Dr HS Bawaskar, in a remote village in the mid-1980s, sat by the side of his patients with a stethoscope and a manometer meticulously monitoring his patients, recording his findings with paper and pen and informed the world that prazosin was a wonder drug that saved children with scorpion bites when death was almost certain, translating into saving millions of lives all over the world.
The present day opportunities to improve the quality and save lives through research are almost limitless, extending from community pediatrics, pediatric subspecialties to intensive care in children. India is a country with 11its own unique problems while others that are shared with other developing countries and some shared across the globe. Its huge population, multitude of ethnicities, and geographic diversity are assets to a researcher as the number of children who can be enrolled for investigation of a health issue is the envy of the Western world where most of research takes place.
Our predominant health issues are different, the treatment protocols developed in the West many times do not work in our patients, acute leukemias being a prime example and “rare diseases” are not rare at all. All these factors offer a fascinating opportunity to make a difference to the lives of children and simultaneously have a great career in research.
With the availability of new technologies, high end research has also become possible in India. The possibilities in translational research were never so high. Insights into the human genome, its functioning, bioinformatics and lately, artificial intelligence in medicine are opening up new areas of research that were not available to the previous generations of researchers. The opportunities are out there to grab, it only needs an investigator's mind to make the most of it.
Career opportunities in research in pediatrics
Opportunities available to clinicians have exponentially increased during the past decade. The concept of the “clinician researcher” is an age old one, but has caught on as a career option in India in the past two decades.
There are career opportunities for a pediatrician both in the public and the private sectors. Advancement in technology, rapid growth in number of medical research institutes, availability of research funds at national and international level and entry of multinational players in this area has opened up new vistas for career development in this field.
Pediatricians can conduct research as faculty in various medical schools and institutes, clinical research physicians as part of industry, or as independent researchers. They can initiate clinical trials or participate in clinical trials conducted by other institutes or industry. Multicentric research projects are called for by public sector funding agencies from time to time. Pediatric epidemiology, health economics, and social pediatrics are some of the many other areas that may interest pediatricians.
 
12ACKNOWLEDGMENT
None.
Sources of funding/conflict of interest: None.
SUGGESTED READING
  1. Bawaskar HS, Bawaskar PH. Prazosin in management of cardiovascular manifestations of scorpion sting. Lancet. 1986;1(8479):510-1.
  1. Bhattacherjee A. Science and Scientific Research. In: Social Science Research: Principles, Methods, and Practices. Tampa, Florida: University of South Florida; 2012.
  1. ICMR. National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. New Delhi: Indian Council of Medical Research; 2017.
  1. ICMR. National Guidelines for ethics committees reviewing biomedical and health research during COVID-19 pandemic. New Delhi: Indian Council of Medical Research; 2020.
  1. Koopman W, Schultz SG. The effect of sugars and amino acids on mucosal Na+ and K+ concentrations in rabbit ileum. Biochim Biophys Acta. 1969;173(2):338-40.
  1. Rosenberg LE. Exceptional economic returns on investments in medical research. Med J Aust. 2002;177(7):368-71.
  1. The Value, Importance, and Oversight of Health Research. In: Institute of Medicine (US) Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule; Nass SJ, Levit LA, Gostin LO (Eds). Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington (DC): National Academies Press (US); 2009.
  1. University of Nevada. Division of research: History of Research Ethics. Las Vegas: University of Nevada; 2021.
  1. World Health Organization. (2021). Clinical trials. [online]. Available from https://www.who.int/health-topics/clinical-trials/#tab=tab_1 [Last accessed September, 2022].
  1. World Medical Association. (2022). WMA Declaration of Helsinki—Ethical principles for medical research involving human subjects. [online]. Available from https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ [Last accessed September, 2022].
  1. World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191-4.