Chapter 1 · Starting a study

What is research, really?

Types of research, the steps of the research process, and what makes research good.

12 TNMGRMU questions answered hereset 13 times, 2014–2025

The problem first

You are a first-year MD resident. Your guide asks you to do some research on dengue patients. You pull last year's case sheets, count how many had platelets below 50,000, and bring the numbers to the next meeting.

Your guide looks at the table and asks whether this is a research study or a record count. At the viva, the examiner asks the same thing in one question.

“What question did you set out to answer, and when did you decide how to answer it?”

Start here

How is research different from clinical experience?

Research is a planned, systematic investigation that answers a stated question and adds to knowledge that others can check and use. Experience is what you notice. Research is what you set out to test, with the method fixed before the results are known.

12 sailors with scurvy, the Salisbury, 20 May 1747similar cases, one place, one diet: only the remedy differedcider1 quart a dayelixir ofvitriolvinegarsea water2 oranges,1 lemon a daynutmeg-sizedelectuaryone was fit for duty after 6 days
James Lind did not rely on his impression of which remedy worked. He chose sailors whose cases were “as similar as I could have them”, kept them in one place on one diet, and gave a different remedy to each pair. Planning the comparison before seeing the result is what makes this research.

Features of scientific research:

  • A question stated in advance, with objectives.
  • A systematic method, chosen to fit the question and written down before data collection.
  • Empirical: based on observation or measurement.
  • Controlled for chance, bias and confounding as far as possible.
  • Reproducible: described well enough for others to repeat.
  • Generalisable beyond the people studied.
  • Ethical, and reported openly so that others can examine it.

The research process

What are the steps of the research process?

A thesis and a multicentre trial pass through the same steps. The report at the end usually raises the next question.

1. Problema gap you noticed2. Literaturewhat is known3. Questionand hypothesis4. Designsample, tools5. Protocolethics approval6. Datapilot, then collect7. Analysisand interpretation8. Reportthesis or papernew questions
Steps 1 to 5 are completed before the first participant is enrolled. A vague question at step 3 leads to a vague design at step 4, and analysis at step 7 cannot correct it. Each step has its own chapter. The step-by-step list links to them.

Interactive

Choose the steps of the research process in order and read why each comes where it does

Try this: choose the step that comes first, then each next step, and read why each one belongs where it does.

No steps chosen yet.

Which step comes first?

Two types of research

Is the study meant to explain something, or to be used?

Basic research seeks new knowledge without a particular use in view. Applied research seeks new knowledge for a specific practical aim. Some research does both.

Considers practical use?NoYesSeeks basicunderstanding?YesNoBasic researchhow does a cell divide?no particular use in viewUse-inspired basicunderstanding and usePasteurneitherApplied researchdoes this dressing reducewound infection?
Donald Stokes, in Pasteur's Quadrant (1997), argued that understanding and use are two separate questions, not two ends of one line. His model case was Louis Pasteur, whose fundamental yet use-inspired studies laid the foundations of microbiology. The OECD Frascati Manual adds a third type, experimental development: using existing knowledge to produce new products or processes or to improve existing ones.

Interactive

Answer two questions about each project and see where it appears in Pasteur's quadrant

Try this: answer the two questions for project 1, then see in which cell of the grid it appears.

Project

A laboratory study of which gene changes occur in one type of tumour, with no treatment question in view.

Does it seek basic understanding?
Does it consider practical use?

Answer both questions to place this project on the grid.

Considers practical use?NoYesSeeks basicunderstanding?YesNoBasic researchUse-inspired basicneitherApplied research

Numbered circles show where you placed each project. Red is the project shown above. Projects 3 and 4 are real studies named in this chapter. The others are teaching examples.

Two types of research

Did the researcher decide who received the exposure?

In observational research you measure what already happens to people. In experimental research you decide who receives the intervention.

Observationalyou record what already happensrecordssmokeddid not smokeExperimentalyou decide who gets whatRandomallocationstreptomycin+ bed restbed restalone
Observational: Doll and Hill (1950) compared smoking in people with lung carcinoma and people without it, a case-control study. Experimental: the Medical Research Council streptomycin trial (1948) allocated patients with pulmonary tuberculosis by a random process to streptomycin plus bed rest or bed rest alone. You cannot ethically assign smoking, so the smoking question needed an observational design.

Two types of research

Are you counting, or asking why?

Quantitative research measures and counts. Qualitative research collects words and observations to understand experiences and reasons. A mixed-methods study plans both together.

Quantitativehow many stopped treatment?38 of 12032%stoppedQualitativewhy did they stop?"The clinic is too far"distance"I felt well, so I stopped"felt cured"The tablets made me vomit"side effects
Teaching example. The count tells you how many patients stopped treatment. The interviews tell you why, and the reasons suggest what to change. See the qualitative research chapter.

Classification

How are research designs classified?

Two questions sort most quantitative designs: is there a comparison group, and did the researcher assign the intervention?

Research designsDescriptiveAnalyticalno comparison grouphas a comparison groupCase reportCase seriesCross-sectional surveyObservationalExperimentalCross-sectional (analytical)Case-controlCohortRandomised controlled trialNon-randomised trialgenerates hypothesestests hypotheses
Descriptive studies describe who is affected, where and when, and suggest hypotheses. Analytical studies test hypotheses by comparing groups. Qualitative designs sit alongside this tree. Each design is explained in the study designs chapter.

Experimental research

What makes an experiment a true experiment?

Three features: the researcher manipulates the intervention, there is a control group, and participants are allocated at random. Without random allocation the design is quasi-experimental. Without a control group as well, it is pre-experimental.

Rrandom allocationOmeasurementXintervention–no interventionPretest-posttest control grouptrue experimentROXORO–Oall 3 featuresPosttest-only control grouptrue experimentRXOR–Ono pretestNon-equivalent control groupquasi-experimental: no random allocationOXOO–Ono ROne-group pretest-posttestpre-experimental: no control groupOXOno comparison
Solomon four-group design combines the first two rows: four randomised groups, two measured before the intervention and two not, which shows whether the pretest itself changed the result. Factorial and crossover trials are also true experiments. See the clinical trials chapter.

Clinical research

What kinds of clinical research are there?

Clinical research studies patients, their samples or their records. The same study can be described in several ways at once.

Classified byTypesTeaching example
Researcher's roleObservational (descriptive, analytical) or interventional (clinical trials)Cohort of patients on dialysis, or a trial of two antibiotics
PurposeTreatment, prevention, diagnosis, screening, prognosis, quality of lifeAccuracy of a rapid test against a reference test (diagnostic)
Stage of drug developmentPhase I (first use in humans, safety and dose), II (effect and dose in patients), III (large comparative trials), IV (after marketing)Watching a marketed drug for rare adverse effects (phase IV)
TimeRetrospective or prospective, cross-sectional or longitudinalLast year's case sheets (retrospective)
SettingHospital, community, laboratoryDistrict survey of hypertension (community)
DataQuantitative, qualitative, mixed methodsInterviews on why patients miss dialysis (qualitative)
Other groupsHealth services research, outcomes research, translational researchWaiting times in an outpatient department

Quality

What makes research good?

Good research asks a question that matters, uses a method that can answer it, is done ethically, and is reported in full so that others can use and check it.

1. Questionschoice ofresearch questions2. Designquality of designand methods3. Publicationadequacy ofpublication4. Reportsquality ofresearch reports85% of research investment wastedChalmers and Glasziou's estimate, across all four stages
Chalmers and Glasziou (Lancet, 2009) described four stages at which research is wasted: the choice of research questions, the quality of design and methods, the adequacy of publication, and the quality of reports. They estimated that the losses across these stages add up to about 85% of research investment.

Criteria of good research:

  • Clear purpose: one stated question, with objectives and, where relevant, a hypothesis.
  • Based on what is known: the literature is reviewed, and the question has not already been answered.
  • Appropriate design: the design can answer the question, and the sample size is calculated.
  • Valid and reliable measurement: tools measure what they claim to, and give the same result when repeated.
  • Bias and confounding controlled by design and analysis.
  • Ethical: ethics committee approval, informed consent, and trial registration.
  • Analysis planned in advance, with all results reported, including negative ones.
  • Limitations stated and conclusions limited to what the data show.
  • Reproducible: methods described in enough detail to repeat.
  • Relevant: the answer can change practice or policy.

Health care

Why does health care need research?

Research shows which treatments work, which cause harm, what causes disease, and how to deliver care to people who cannot reach a hospital.

In Gadchiroli district, Maharashtra, Bang and colleagues trained village health workers to give home-based newborn care, including treatment of sepsis, in 39 villages, with 47 villages as controls. Baseline neonatal mortality in the intervention area was 62 per 1000 live births. In the third year of the intervention it was 25.5 per 1000, a net reduction of 62.2% compared with the control area (Lancet, 1999).

Research is also what clinicians use at the bedside. Sackett and colleagues defined evidence based medicine as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients” (BMJ, 1996).

Decide

What type of study is my project?

Answer a few questions about what you plan to do.

What is the aim of your project?

Type of study: all possible answers
  • Clinical audit: Audit measures practice against a standard set in advance. It is not research, although the audit may raise a research question.
  • Qualitative research: In-depth interviews, focus groups or observation, analysed into themes. Answers "why" and "how" questions.
  • Mixed-methods study: A quantitative part (how many, how much) and a qualitative part (why) planned together.
  • Randomised controlled trial (true experiment): Manipulation, a control group and random allocation. Register with CTRI before the first participant is enrolled.
  • Non-randomised trial (quasi-experimental): You assigned the intervention but not by chance, so the groups may differ at the start.
  • Descriptive study: Case report, case series or a cross-sectional survey. It describes and generates hypotheses but cannot test them.
  • Case-control study: Start from the outcome and look back for exposure. Suited to rare diseases.
  • Cohort study: Start from the exposure and follow people forward to see who develops the outcome.
  • Analytical cross-sectional study: Exposure and outcome measured at one point in time. It shows association, not which came first.

Comparison

Pairs of terms residents confuse

Basic or applied research

FeatureBasic researchApplied research
AimUnderstand how something worksSolve a specific practical problem
Use in viewNone in particularA specific practical aim
Usual settingLaboratory, animal and cell studiesClinics, community, health services
ExampleHow a bacterium becomes resistant to an antibioticWhether a new dosing schedule reduces treatment failure
ResultMechanisms, theoriesTreatments, methods, policies

Observational or experimental research

FeatureObservationalExperimental
Who decides the exposureThe patient, their doctor or circumstancesThe researcher
Groups formed byExposure or outcomeAllocation, ideally random
Confounding handled byMatching, restriction, statistical adjustmentRandom allocation
DesignsCross-sectional, case-control, cohortRandomised and non-randomised trials
Use whenThe exposure is harmful or cannot be assignedThe intervention can ethically be given or withheld
Early exampleDoll and Hill, smoking and lung carcinoma (1950)MRC streptomycin trial (1948)

Research or clinical audit

FeatureResearchClinical audit
QuestionWhat is the best practice?Are we doing what we should?
AimNew knowledge that can be generalisedCheck local practice against a standard
StandardNot known in advanceSet before the audit starts
InterventionMay test a new one and may randomiseOnly existing care, with no allocation
Ends withA thesis or paperA change in practice, then a repeat audit

Quantitative or qualitative research

FeatureQuantitativeQualitative
DataNumbersWords and observations
QuestionHow many? How much? Is there a difference?Why? How? What is it like?
SamplingProbability sampling where possible, with a calculated sample sizePurposive, until interviews stop adding new themes
AnalysisStatisticsCoding into themes
ResultEstimates with confidence intervals, P valuesThemes and explanations

Interactive

Decide whether each project is research, clinical audit or service evaluation

Try this: read project 1, choose one answer, and compare the explanation with the definitions below.

  • Research aims to produce new knowledge that can be generalised or transferred to other settings. It may allocate participants to interventions, including at random.
  • Clinical audit asks "Does this service reach a predetermined standard?" and measures practice against that standard.
  • Service evaluation asks "What standard does this service achieve?" and measures the current service without reference to a standard.
Project 1 of 7

You review last year's case sheets to find what proportion of patients having caesarean section received antibiotic prophylaxis within the time set by your hospital protocol.

Choose one answer to see the explanation.

Teaching examples. Definitions from the UK Health Research Authority table "Defining research" (2017).

By specialty

Types of research by specialty

You notice that three patients started on a new oral antidiabetic drug had low serum sodium.

Three cases make a case series. It raises a hypothesis. Testing it needs a comparison group.

Common myths

Common mistaken beliefs

  • Myth: Research means laboratory work.

    Most clinical research is done in wards, outpatient departments and villages. A well-planned survey or record review is research.

  • Myth: Collecting data is the first step.

    Data collection is step 6. The question, design and protocol come first and cannot be repaired afterwards.

  • Myth: If my patients improved after the treatment, the treatment works.

    Without a comparison group you cannot separate the effect of treatment from natural recovery or other care.

  • Myth: An audit and a research study are the same thing.

    Audit checks practice against a known standard. Research produces new knowledge that can be generalised.

  • Myth: Qualitative research is not scientific because it has no numbers.

    It uses systematic methods to answer "why" and "how" questions that numbers cannot answer.

  • Myth: A study with a negative result has failed.

    A well-designed negative study is useful evidence. Leaving it unpublished is one of the four stages of research waste.

Why this matters to you

Five consequences of not knowing what research is

  1. Protocol sent back

    A topic with no stated question, objectives or design is returned by the research committee.

  2. Data that answer nothing

    Case sheets collected before the question was fixed often lack the variables the question needs.

  3. Questions you cannot answer at the viva

    You cannot say whether your study is descriptive or analytical, observational or experimental.

  4. Misreading papers

    You treat a case series as proof that a treatment works.

  5. Harm to patients

    A poorly designed study exposes patients to risk and uses their time without producing usable evidence.

History

History of clinical research methods

  1. 1747

    James Lind

    On the Salisbury, gave six remedies to six pairs of sailors with scurvy. One of the pair given two oranges and one lemon a day was fit for duty after six days. Published in A Treatise of the Scurvy (1753).

  2. 1948

    Medical Research Council, UK

    Streptomycin trial in pulmonary tuberculosis: patients allocated by a random process to streptomycin plus bed rest or bed rest alone, with steps taken to prevent foreknowledge of the allocation.

  3. 1950

    Richard Doll and Austin Bradford Hill

    Reported the association between smoking and carcinoma of the lung in the BMJ, from a case-control study.

  4. 1964

    World Medical Association

    Adopted the Declaration of Helsinki at its General Assembly in Helsinki. The latest revision was adopted in October 2024.

  5. 1979

    The Belmont Report, USA

    Published on 18 April 1979. It named three basic ethical principles for research with human subjects: respect for persons, beneficence and justice.

  6. 1992

    Evidence-Based Medicine Working Group

    Published "Evidence-based medicine. A new approach to teaching the practice of medicine" in JAMA.

  7. 1997

    Donald Stokes

    Published Pasteur's Quadrant, arguing that research can seek understanding and practical use at the same time.

  8. 1999

    Abhay Bang and colleagues, Gadchiroli

    Home-based newborn care by village health workers reduced neonatal mortality by 62.2% compared with control villages.

  9. 2009

    Iain Chalmers and Paul Glasziou

    Estimated that about 85% of research investment is wasted across four stages: question, design, publication and reporting.

  10. 2009

    Drugs Controller General of India

    Made registration of clinical trials in the Clinical Trials Registry-India (CTRI) mandatory from 15 June 2009.

  11. 2017

    Indian Council of Medical Research

    Published the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants.

Guidelines

Definitions of research in guidelines

OECD Frascati Manual 2015, para 2.5

Research and experimental development “comprise creative and systematic work undertaken in order to increase the stock of knowledge – including knowledge of humankind, culture and society – and to devise new applications of available knowledge.”

OECD Frascati Manual 2015, para 2.7

To count as research and development, an activity must be “novel, creative, uncertain, systematic, transferable and/or reproducible.”

OECD Frascati Manual 2015, para 2.9

Basic research: “experimental or theoretical work undertaken primarily to acquire new knowledge of the underlying foundations of phenomena and observable facts, without any particular application or use in view.” Applied research: “original investigation undertaken in order to acquire new knowledge. It is, however, directed primarily towards a specific, practical aim or objective.”

WMA Declaration of Helsinki (2024)

Medical research involving human participants “must have a scientifically sound and rigorous design and execution that are likely to produce reliable, valid, and valuable knowledge and avoid research waste.” It “must be registered in a publicly accessible database before recruitment of the first participant.”

ICMR National Ethical Guidelines 2017, section 1.1

Twelve general principles: essentiality, voluntariness, non-exploitation, social responsibility, privacy and confidentiality, risk minimization, professional competence, maximization of benefit, institutional arrangements, transparency and accountability, totality of responsibility, and environmental protection.

CTRI (ctri.nic.in)

Since 15 June 2009, registration of clinical trials in the CTRI has been mandatory, as decided by the Drugs Controller General (India).

Steps

The research process, step by step

  1. Identify a problem: a gap you noticed in practice or in the literature.
  2. Review the literature to find out what is already known (literature search).
  3. Write the research question, hypothesis and objectives (research question).
  4. Choose the design, the sampling method, the sample size and the data collection tools.
  5. Write the protocol, obtain ethics committee approval, and register trials with CTRI.
  6. Pilot the tools, then collect and check the data.
  7. Analyse as planned (descriptive statistics, choosing a test) and interpret the results with their limitations.
  8. Write the thesis or paper and publish it (writing, publishing), including negative results.

Reading a paper

Five checks on what kind of research a paper is

  • What question did the authors set out to answer, and was it stated before the results?
  • Is the study observational or experimental, and does that design fit the question?
  • Is there a comparison group, and how was it formed?
  • Was it approved by an ethics committee and, for a trial, registered before enrolment?
  • Do the conclusions stay within what this design and these data can show?

Why is it called that?

Word surgery

“Research”

In everyday speech

Looking something up, such as reading reviews before buying a phone.

In research

A planned, systematic investigation that answers a stated question and produces knowledge others can check and use.

“Experiment”

In everyday speech

Trying something to see what happens.

In research

A study in which the researcher assigns the intervention and compares it with a control group, ideally with random allocation.

Memory trick

Did you assign the exposure? Yes: experimental. No: observational. Is there a comparison group? No: descriptive. Yes: analytical.

Research

Old French recercher: "seek out, search closely"

A close, systematic search for new knowledge.

Method

Greek methodos: "scientific inquiry", from meta ("in pursuit of") + hodos ("a way")

The planned way a study answers its question.

Experiment

Latin experimentum: "a trial, test, proof", from experiri ("to try, test")

A test in which the researcher applies the intervention.

Empirical

Greek empeiria: "experience"

Based on observation or measurement, not on theory alone.

Data

Latin datum: "(thing) given"

Plural of datum. The facts obtained by measurement and observation.

Audit

Latin auditus: "a hearing, a listening"

Examination of accounts was originally done orally. A clinical audit examines practice against a standard.

Exam answers

Model answer outlines

Define research. Types of research with examples, including applied research

Ph.D. RM 2017, 2020, 2023

Definition: research is a planned, systematic investigation that answers a stated question and adds to knowledge that can be checked and generalised. The OECD Frascati Manual (2015) defines research and experimental development as creative and systematic work undertaken to increase the stock of knowledge and to devise new applications of available knowledge.

BasisTypesExample
PurposeBasic (pure, fundamental), applied, experimental developmentMechanism of drug resistance, trial of a new regimen, a new diagnostic kit
Researcher's roleObservational or experimental (interventional)Case-control study of smoking, randomised trial
ObjectiveDescriptive or analyticalPrevalence survey, cohort study testing a risk factor
DataQuantitative, qualitative, mixed methodsBlood pressure survey, interviews on treatment default
TimeCross-sectional or longitudinal, retrospective or prospectiveOne-day survey, birth cohort followed for years
SettingLaboratory, clinical, community (field), health systemsCell culture, ward-based trial, village survey, OPD waiting times

Applied research: “original investigation undertaken in order to acquire new knowledge ... directed primarily towards a specific, practical aim or objective” (Frascati Manual 2015). Features: it starts from a practical problem, its results are used directly in practice or policy, and it is usually done in clinics, the community or health services. Examples: whether home-based newborn care by village health workers reduces neonatal mortality (Bang et al, Lancet 1999), and a comparison of two dressings for wound infection. Basic research, by contrast, has no particular use in view. The two overlap in use-inspired basic research (Stokes, 1997).

Different types of clinical research

Ph.D. RM 2019
  1. Definition: research with patients, their biological samples or their records, to understand disease or improve its prevention, diagnosis and treatment.
  2. By researcher's role: observational, either descriptive (case report, case series, cross-sectional survey) or analytical (case-control, cohort, analytical cross-sectional), and interventional (randomised and non-randomised trials).
  3. By purpose: therapeutic, preventive, diagnostic, screening, prognostic, quality of life.
  4. By phase (drug trials): phase I is first use in humans, for safety and dose. Phase II tests effect and dose in patients. Phase III is large comparative trials. Phase IV is post-marketing surveillance.
  5. By time: retrospective or prospective, cross-sectional or longitudinal.
  6. By data: quantitative, qualitative, mixed methods.
  7. Other groups: health services research, outcomes research, translational research (laboratory findings taken to patients).
  8. All need ethics committee approval. Trials also need CTRI registration before enrolment (mandatory since 15 June 2009).

Classification of research designs, and characteristics of true experimental designs, with examples

Ph.D. RM 2014, 2023

Define research as in the first answer. Then draw the classification tree:

  • Descriptive (no comparison group): case report, case series, cross-sectional survey. Describes and generates hypotheses.
  • Analytical, observational (comparison group, exposure not assigned): analytical cross-sectional, case-control, cohort. Example: Doll and Hill (1950), smoking and lung carcinoma.
  • Analytical, experimental (researcher assigns intervention): randomised controlled trial, non-randomised trial. Example: MRC streptomycin trial (1948).
  • Qualitative designs alongside: phenomenology, grounded theory, ethnography.

Characteristics of a true experiment: manipulation (the researcher applies the intervention), control (a comparison group without it), randomisation (allocation by chance).

CategoryDesignNotation
True experimentalPretest-posttest control groupR O X O / R O – O
True experimentalPosttest-only control groupR X O / R – O
True experimentalSolomon four-groupboth of the above together
True experimentalFactorial, crossovertwo interventions tested together, or each patient receives both in sequence
Quasi-experimentalNon-equivalent control group, time seriesO X O / O – O (no R)
Pre-experimentalOne-shot case study, one-group pretest-posttestX O, or O X O

R = random allocation, O = observation or measurement, X = intervention. Merits of true experiments: strongest evidence of cause and effect. Limits: cost, ethics, and results that may not apply outside the trial setting.

Steps of the research process, with examples

Ph.D. RM 2014, 2015, 2016

Running teaching example: anaemia in pregnant women attending your antenatal clinic.

  1. Identify the problem: many women remain anaemic at term despite iron tablets.
  2. Review the literature: what is known about adherence and dosing schedules.
  3. Formulate the question, hypothesis and objectives: does a twice-weekly schedule give a haemoglobin rise similar to daily dosing?
  4. Choose the design: a randomised controlled trial. Define the population, sampling, sample size, outcome and tools.
  5. Write the protocol: ethics committee approval, informed consent, CTRI registration.
  6. Pilot and collect data: test the forms, train staff, enrol and follow up.
  7. Analyse and interpret: the planned statistical test, confidence intervals, limitations.
  8. Report and publish: thesis and journal article, including negative results. New questions start the cycle again.

Criteria of good research

Ph.D. RM 2025
  1. Purpose clearly defined, with the research question, objectives and hypothesis stated.
  2. Based on a review of existing knowledge, and not a repeat of a question already answered.
  3. Design appropriate to the question, with a calculated sample size.
  4. Methods described in enough detail to be repeated (reproducible).
  5. Valid and reliable measurement tools.
  6. Bias and confounding controlled.
  7. High ethical standards: ethics approval, informed consent, confidentiality, registration.
  8. Analysis planned in advance and adequate for the data.
  9. Limitations stated frankly, and conclusions confined to what the data justify.
  10. Results published in full, including negative results.
  11. Relevant to practice or policy.

Frascati Manual 2015 criteria for any research activity: novel, creative, uncertain, systematic, transferable and/or reproducible. Declaration of Helsinki (2024): the design must be “scientifically sound and rigorous”, and the research must “avoid research waste”. Chalmers and Glasziou (2009): research is wasted at four stages (question, design, publication, report).

What is scientific research? Ethics involved

Ph.D. RM 2017

Scientific research: a systematic, empirical investigation of a stated question, using methods fixed in advance, whose results are reproducible, open to scrutiny and generalisable.

Ethics:

  • Belmont Report (1979): respect for persons, beneficence, justice.
  • Declaration of Helsinki (WMA, 1964, latest revision 2024): research ethics committee approval before the research begins, free and informed consent, and registration before the first participant is recruited.
  • ICMR National Ethical Guidelines 2017: twelve general principles, including essentiality, voluntariness, non-exploitation, privacy and confidentiality, risk minimization, and transparency and accountability.
  • In practice: ethics committee approval, written informed consent, confidentiality, care for vulnerable groups, compensation for research-related injury, disclosure of conflicts of interest, CTRI registration for trials.
  • Research misconduct (US Office of Research Integrity): fabrication, falsification or plagiarism. Honest error is not misconduct.

Details: research ethics chapter.

Significance of research in health care, and research methodology in health

Ph.D. RM 2014 · MD Community Medicine undated
  • Finds causes and risk factors: Doll and Hill (1950) linked smoking with lung carcinoma.
  • Tests treatments: the MRC streptomycin trial (1948) used random allocation.
  • Improves delivery of care: home-based newborn care in Gadchiroli reduced neonatal mortality by 62.2% compared with control villages (Bang et al, 1999).
  • Supports evidence based medicine: integrating the best research evidence with clinical expertise (Sackett et al, 1996).
  • Monitors safety of drugs and devices after they are marketed (phase IV).
  • Guides policy and programmes through surveys and operational research.
  • Reduces waste of money and of the time participants give, when studies are well designed and fully reported.

Research methodology in health is the set of methods for planning, conducting and reporting health research: the steps of the research process, study designs, sampling, sample size, data collection, analysis, ethics and reporting. Outline the steps as in the answer above and link each to its method.

The one thing to remember

Research starts with a stated question and a method chosen before the data are collected.

Examples labelled as teaching examples use made-up numbers.

Sources: Lind J. A Treatise of the Scurvy. Edinburgh; 1753. Hughes RE. James Lind and the cure of scurvy: an experimental approach. Med Hist 1975;19:342–51 (doi:10.1017/s0025727300020469). Medical Research Council. Streptomycin treatment of pulmonary tuberculosis. Br Med J 1948;2:769–82 (PMID 18890300). Johnson T. J R Soc Med 2019;112:438–41 (doi:10.1177/0141076819878968). Doll R, Hill AB. Smoking and carcinoma of the lung. Br Med J 1950;2:739–48 (doi:10.1136/bmj.2.4682.739). Paneth N, Susser E, Susser M. Soz Praventivmed 2002;47:359–65 (doi:10.1007/s000380200003). World Medical Association. Declaration of Helsinki. JAMA 2025;333:71–4 (doi:10.1001/jama.2024.21972). National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. 18 April 1979. Evidence-Based Medicine Working Group. JAMA 1992;268:2420–5 (doi:10.1001/jama.1992.03490170092032). Sackett DL et al. BMJ 1996;312:71–2 (doi:10.1136/bmj.312.7023.71). Stokes DE. Pasteur's Quadrant: Basic Science and Technological Innovation. Washington DC: Brookings Institution Press; 1997. Bang AT et al. Lancet 1999;354:1955–61 (doi:10.1016/S0140-6736(99)03046-9). Chalmers I, Glasziou P. Lancet 2009;374:86–9 (doi:10.1016/S0140-6736(09)60329-9). OECD. Frascati Manual 2015. Paris: OECD Publishing; 2015. Indian Council of Medical Research. National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. New Delhi: ICMR; 2017. ISBN 978-81-910091-94. Clinical Trials Registry-India, ctri.nic.in. US Office of Research Integrity. Definition of research misconduct, ori.hhs.gov. Health Research Authority (UK). Defining research table. October 2017, hra-decisiontools.org.uk.

Past papers

Every TNMGRMU question on what research is

Each one is answered in this chapter. Tap a sitting to open the university's own question paper.

  1. ×2Steps in research processPh.D. RM · Jan 2016Ph.D. RM · Jan 2015
  2. ×1Criteria of a good researchPh.D. RM · Jan 2025
  3. ×1Applied ResearchPh.D. RM · Jul 2023
  4. ×1Define research. Explain the classification of Research design and its concepts with examplesPh.D. RM · Jul 2023
  5. ×1Explain in brief about Types of Research with examplesPh.D. RM · Dec 2020
  6. ×1Describe the different types of clinical research?Ph.D. RM · Jan 2019
  7. ×1Types of ResearchPh.D. RM · Jan 2017
  8. ×1What is scientific research and write in brief about ethics involved?Ph.D. RM · Jul 2017
  9. ×1Define Research, list the characteristics of true experimental designs and explain the various experimental designs with examplesPh.D. RM · Jan 2014
  10. ×1Significance of Research in Health carePh.D. RM · Jan 2014
  11. ×1Explain the steps of research process with examplesPh.D. RM · Jul 2014
  12. ×1Research Methodology in healthMD Community Medicine