Research methodology in medical research

Research Methodology In Medical Research. This presentation gives an comprehensive overview of research methodology in biomedical research also includes different types of medical research and ethics in medical research.

1. Research Methodology
In Medical Research
Dr Asish Kumar Saha
PharmD Intern
JSS Academy of Higher
Education & Research, Mysuru
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 1

2. What Is Research?
❑
❑
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 2

3. Types of Research
❑Conventionalresearchincludesdescriptivestudiesandanalyticalstudies.
❑Unconventionalresearch,whichisgainingmoreimportancenowadays,
includesoperationalresearch,evaluationofhealthsystems,economicstudies
(costbenefit,cost-effectiveness,etc.),qualitativeresearch,andresearch
synthesis(reviewsandmeta-analysis)
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 3

4. What are the Objectives of Research?
The prime objectives of research are:
1.To discover new facts
2.To verify and test important facts
3.To analyze an event or process or phenomenon to identify the cause and effect
relationship
4.To develop new scientific tools, concepts and theories to solve and understand
scientific and nonscientific problems
5.To find solutions to scientific, nonscientific and social problems
6.To overcome or solve the problems occurring in our every day life
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 4
Laake,P.,Benestad,H.andOlsen,B.(2018).ResearchMethodologyintheMedicalandBiologicalSciences-1stEdition.[online]Elsevier.com.Availableat:https://www.elsevier.com/books/research-methodology-in-the-
medical-and-biological-sciences/laake/978-0-12-373874-5[Accessed1Oct.2018].

5. Basis of RM In Medical Research
Everypatientisdifferentinthewaythediseasemanifestsandalsointheresponseto
treatment
❖Aneffectivetreatmentfor90%ofthepopulationmaynotworkfortheother10%.
Thus,medicineissaidtobeinherentlyexperimental
❖Eventhemostwidelyacceptedtreatmentsneedtobemonitoredandevaluatedto
determinewhethertheyareeffectiveforspecificpatientsorforpatientsingeneral.
❖Thisisoneofthefunctionsofmedicalresearch
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6. Basis of RM In Medical Research
❑Eventhebestprovenprophylactic,diagnostic,andtherapeuticmethodsmust
continuouslybechallengedthroughresearchfortheirefficacy,accessibilityandquality
❑Anotherfunctionisthedevelopmentofnewtreatments,especiallynew
investigationaldrugs,medicaldevicesandsurgicaltechniques
❑Inotherwords,thepurposeofmedicalresearchinvolvinghumansubjectsisto
improveprophylactic,diagnosticandtherapeuticproceduresandunderstandingofthe
etiologyandpathogenesisofdisease
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7. Steps in Medical Research
1.Research
2.Identify the problem
3.Formulating a research question
4.Refining the research question: Literature review
5.Formulate hypotheses and research objectives
6.Decide the study population and setting
7.Decide on the study design & methodology
8.Writing the protocol
9.Collecting the data
10.Analyze the data and apply statistical significance
11.Write the report
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 7
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

8. 1. Identify the problem
❑Interestandexpertise:
❖Thetopicshouldbeinterestingtotheinvestigator,funding
agency,andthemedicalcommunity
❑Relevanceandapplicability:
❖Researchshouldaddnewinformationtothescientificsociety
orexpectedresultislikelytoalterclinicaldecisionsinfuture
❑Feasibility:
❖Shouldbefeasibleintermsoftime,manpowerandmoney
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 8
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

9. 2. Formulating a research question
❑Researchquestionisaformalstatementofthegoalofthestudy
❑Foremostamongtheseiswhetherthequestionisinteresting
❑Itisimportantthattheinvestigatorisgenuinelycuriousaboutthe
questionbeinginvestigated,sothatheorshecanremainmotivatedtill
thesuccessfulcompletionofthestudy
❑Curiosityisalsoanassetintermsofstimulatingquestionsforfuture
studies
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 9
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

10. 2. Formulating a research question
❑Nextisfeasibility
❖Thethirdconsiderationisthenoveltyfactor,or
thepotentialofthestudytocontributesomething
newtotheknowledgebase
❖Relatedtonoveltyistherelevanceofthe
researchquestion.
❑Itshouldaddtoexistingknowledge,guidefuture
studies,orhaveimplicationsforeducation,clinical
practiceorhealthcarepolicy.
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 10
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

11. 2. Formulating a research question
❑Finally,theideamustbeethical
❖Studiesthatinvadepeople’sprivacyor
createpossiblephysicalorpsychological
risksareethicallyunacceptable
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 11
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

12. A good research question could thus be
described by the acronym
F: Feasible
I: Interesting to the investigator
N: Novel
E: Ethical
R: Relevant
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 12
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.KualaLumpur:InstituteforHealthSystemsResearch.

13. An useful format to use in the development of
a specific research question is the PICO format
❑Format the population (P) of interest the intervention (I) being studied,
the comparison (C) group (the intervention being compared) and the
outcome of interest (O)
❑Often timing (T) is added to PICO, indicating the time frame in which the
study will be completed
❑In patients with pneumonia (P) whether treatment with X (I) compared
to Y (C) reduces the number of days of hospital stay (O)
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14. 3. Refining the research question:
Literature review
Once the problem or question is specified, the next step is to collect as much
related information as possible
❑Literature review will help to determine
❑To what extent the issue or research question has been previously researched,
❑To identify the past relevant studies as well as methods used,
❑To refine the research question and
❑Also to put the project and methodology into A relevant context
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 14
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.KualaLumpur:InstituteforHealthSystemsResearch.

15. 4. Formulate hypotheses and research
objectives
The research hypothesis is developed from the research question
❑For example, in the research study comparing treatment X versus treatment Y
in patients with pneumonia, the experimental group would be treatment X and
the control/ conventional group would be treatment Y
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 15
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.KualaLumpur:InstituteforHealthSystemsResearch.

16. 4. Formulate hypotheses and research
objectives
❑Theinvestigativeteamwouldfirst
statearesearchhypothesis.
❑Thiscouldbeexpressedasasingle
outcome,e.g.,treatmentXleadsto
improvedfunctionaloutcome
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 16
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.KualaLumpur:InstituteforHealthSystemsResearch.

17. 5. Decide the study population and
setting
Thedefinitionofthesubjectofstudyandthetargetpopulationshouldbeclearlyspelt
out
❖Theinclusionandexclusioncriteriashouldbedecidedinthebeginningitself
❖Samplesizeisveryimportant
❖Thesmallerthesample,themorewillbetheuncertainty
❖Samplesizeshouldbechoseninsuchawaythatthefindinginthestudyaccurately
reflectswhatisgoingoninthepopulation
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 17
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

18. 5. Decide the study population and
setting
❑Awelldesignedstudy,poorlyanalyzed,canberescuedbyreanalysisbuta
❑Poorlydesignedstudyisbeyondtheredemptionofevensophisticated
statistics
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 18
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

19. 5. Decide the study population and
setting
❑Togetvalidandreliableanswertothequestions,appropriateresearchdesign
andmethodisaprerequisite
❖Studydesignistheframeworkinwhichinvestigationisplannedandcarried
out
❖Selectionofdesignisnecessarilybasedontypeofresearchquestion
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 19
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

20. 6. Research designs
Observational
Studies in which subjects are observed-includes:
❖Case study/case series
❖Case-Control
❖Cross Sectional
❖Cohort/Longitudinal
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 20
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

21. 6. Research designs
Experimental
Studies in which the effect of an intervention is observed
❖Controlled trials
❖Diagnostic Test
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 21
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

22. Research Study Designs
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23. 1.CaseReports
2.CaseSeries
3.AnalysesofSecularTrends
4.Case–ControlStudies
5.CohortStudies
6.RandomizedClinicalTrials
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 23
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

24. Case Reports
•Aresimplyreportsofeventsobservedinsinglepatients.
•Usefulforraisinghypothesesaboutdrugeffects.Leadstothedrugtestwithmore
rigorousstudydesign.
•Veryraretousetomakeastatementofcausation.
•Exceptiontothisiswhentheoutcomeisveryrareandsocharacteristicthatoneknows
thatitisduetotheexposure.
•Isacceptedwhenchallengesituationisveryfatal.
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 24
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

25. Case Series
•Collectionsofpatients,allofwhomhaveasingleexposure,whoseclinicaloutcomesare
thenevaluatedanddescribed.
•Alternativelycaseseriescanbecollectionofpatientswithasingleoutcome,lookingat
theirantecedentexposure.
•Usefulforquantifyingtheincidenceofanadversereactionorwhetheroccursinlarger
population.
•Justprovidesclinicaldescriptionsofadiseaseorofpatientswhoreceiveanexposure.
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 25
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

26. Analyses of Secular Trends
•Calledasecologicalstudies.
•Examinestrendsinanexposurethatisapresumedcauseandtrendsinadiseasethatisa
presumedeffectandtestwhetherthetrendscoincide.
•Vitalstatisticsandrecordlinkageareoftenusedinthesestudies.
•Usefulforrapidlyprovidingevidencefororagainstahypothesis.
•Unabletocontrolconfoundingvariables.E.g.lungcancermightbethecauseofcigarettes
butchanceofoccupationalhazardscanstillnotberuledout
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 26
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

27. Case –Control Studies
•Comparecaseswiththediseasetocontrolswithoutthedisease,lookingfordifferencesin
exposure.
•Multiplepossiblecausesofasinglediseasecanbestudied.
•Helpsinstudyingrelativelyrarediseaserequiressmallersamplesize.
•Informationsaregenerallyobtainedretrospectivelyfromthemedicalrecords,byinterviewsor
questionnaires.
•Limitationsarevalidityofretrospectiveinformationandselectionofcontrolischallenging
task.Inappropriatecontrolselectioncanleadtoincorrectconclusion.
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 27
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

28. Cohort Studies
•Identifysubsetsofadefinedpopulationandfollowedthemovertime,lookingfordifferences
intheiroutcome.
•Usedtocompareexposedpatientstounexposedpatients,canalsobeusedtocompareone
exposuretoanotherorwhenmultipleoutcomesfromsingleexposureistobestudied.
•Eitherdoneprospectivelyorretrospectively.
•Morereliablecausalassociation.
•Butrequireslargesamplesize(evenforanuncommonoutcome)andcanrequireprolonged
timeperiodtostudydelayedoutcomes.
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 28
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

29. Differences between Cohort study and
Case –Control study
Case –Control Studies
Disease
Cohort
studies
Factor
Present
(Cases)
Absent
(Controls)
Present
(Exposed)
Absent
(Unexposed)
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 29
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedical
researchhandbook.KualaLumpur:InstituteforHealth
SystemsResearch.

30. Randomized Clinical Trials
•Anexperimentalstudy–theinvestigatorcontrolsthetherapythatistobereceivedby
eachparticipant.
•Majorstrengthistherandomization.
•Problemsmightincludetheethicalissuesandareexpensive.Theyarenotofbig
importanceaftermarketing.
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 30
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

31. Meta-Analysis Studies
DEFINITION
Meta-analysis has been defined as the statistical analysis of a collection of analytical results for the
purpose of integrating the findings
USE OF META-ANALYSIS ?
Identify sources of variation among study findings
To provide an overall measure of effect as a summary of those findings
Meta-analysis is most often used to assess the clinical effectiveness of healthcare interventions;
it does this by combining data from two or more randomized control trials.
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 31
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

32. Meta-Analysis Studies
Meta-analysis of trials provides a precise estimate of treatment effect,giving due
weight to the size of the different studies included.
Important:Studies chosen for inclusion in a meta-analysis must be sufficiently
similar in a number of characteristics in order to accurately combine their results.
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 32
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

33. Where does meta analyses fit in the
research process ?
❑The graphical elements of the meta-analysis, such as the forest plot, provide a mechanism for
presenting the data clearly, and for capturing the attention of the reviewers.
❑Some funding agencies now require a meta-analysis of existing research as part of the grant
application to fund new research.
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 33
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

34. Evidence Based Medicine
EBMisanapproachtomedicalpracticethatusestheresults
ofpatientcareresearchandotheravailableobjective
evidenceasacomponentofclinicaldecisionmaking.
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 34
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

35. RESEARCH METHODOLOGY IN MEDICAL RESEARCH 35

36. Need for Evidence based medicine
1)Dauntingnumberofdiseases.
2)Availabilityofbroadnumberoftherapeuticoptions
3)ToKeepourselvesupdatedinthefieldofexpertise.
4)Additioninnumberofinformationsources.
5)Toremaincompetentthroughoutthecareers.
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 36
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

37. 7. Writing the protocol
❑Alltheeffortsputintoprecedingstepsculminatesintothedraftofthe
researchprotocolthatincorporatesalltheinformationregardingtheresearchin
aconcisemanner
❑Theprotocolshouldcontainbackgroundinformationonthestudy,objectives,
ethicalaspects,studydesign,studyprocedures,methodofassessment,statistics
andevaluation,administrativeissuesandreferences
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 37
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

38. 7. Writing the protocol
❑Oncetheprotocolisready,approvalfromtheEthicscommittee
shouldbeobtainedbeforethestartofthestudy
❑Alongwiththeprotocol,theinformedconsentformandother
documentsrequiredshouldalsobesubmittedtoEthicscommittee
forapproval
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 38
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

39. 8. Collecting the data
❑Oncetheprotocolisfinalized,thedatashouldbecollected
❑Thedataformsshouldbelegiblyfilled,andtheyshouldbefullycompleted
❑Ethicalissuesmustbetakencareoffromthebeginningtotheendofstudy
❑Indrugtrialscaremustbetakentodocumentthedetailsofadverseeventsifany
❑Properdocumentationthroughoutthestudyisimportanttoensurecredibilityof
data
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 39
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

40. 9. Analyze the data and apply statistical
significance
❑Thedatashouldbescrutinizedforinternalconsistencyandexternal
validity
❖Datashouldbeanalyzedusingthealreadydecideddata
managementplan
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 40
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

41. 10. Write the report
❑Thereportshouldbesufficientlydetailedthatcanremoveanydoubtareader
mighthaveaboutanyaspectoftheresults
❑Itshouldbeproperlyworded,shouldbeadequatelyillustratedbychartsor
diagramsortableswhichenhancetheclarity
❑Allthelimitationsneedtobedescribedopenly
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 41
Singh,A.,Bakar,A.andSararaks,S.(2008).Themedicalresearchhandbook.Kuala
Lumpur:InstituteforHealthSystemsResearch.

42. Ethical Considerations in Medical Research
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43. Definition of Scientific Misconduct
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44. The Basics of Ethics in Research
Dishonest,fraudulent,orunethicalresearcherscancircumventthe
scientificmethod
Notableexamples:
1.NaziGermanyExperimentation
-Chargesbroughtagainst23GermanphysiciansintheNuremberg
WarCrimeTrialsfortheirmedicalexperiments–included:
1.FreezingExperiments
2.MalariaExperiments
3.High-AltitudeExperiments
-Ledtothedevelopmentof
NurembergCode
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45. The Basics of Ethics in Research
2.TheTuskegeeSyphilisStudy
Wasinvestigationoflong-termeffectsofuntreated
syphilisonAAmalesinMaconCounty,AL
Decisionwasmadetodolong-termprospectivestudy
andfollowlong-termeffectsuntildeath
Participantswerenevertoldrealnatureofstudy–were
notaffordedinformedconsent
Treatmentforsyphiliswaswithheld(evenafter
discoveryofpenicillintotreatsyphilis)–study
continuedfor40yrs.
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46. Regulation of research and protection of
research participants:
Proponents of situational ethics argue that no general rules can be
applied to all situations –each action is unique
Belmont report–serves as a fundamental document for current
federal regulations for protection of human subjects –3 principle:
1.Respect for Persons
2.Beneficence
3.Justice
*Code requires that protocols involving human subjects be reviewed by an IRB.
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47. Informed Consent
Inherent to this principle are 4 elements:
1. Subjects are made fully aware of the nature and purpose of the research project
2. Consent is voluntarily given
3. The person involved has the legal capacity to give consent
4. The responsibility for obtaining consent rests with the researcher
* Sometimes, because of the Hawthorne Effect, it may be necessary to use some deception in
telling subjects about the study.
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48. Privacy and Confidentiality
Privacyreferstocapacityofindividualstocontrolwhenandwhatconditions
othershaveaccesstotheirbehaviors,beliefs,andvalues.
Confidentialityreferstolinkinginformationtoaperson’sidentity
◦CANYOUTHINKOFEXAMPLESWHERECONFIDENTIALITYWOULDBEIMPOTANT?
Informedconsentshouldindicatehowresearcherwillprotectconfidentialityof
participants
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49. Privacy and Confidentiality
Someproceduresthatcanensureconfidentiality:
◦Obtaininganonymousinformation
◦Codedatasothatidentifyinginfoiseliminated
◦Substituteothernames
◦Donotreleaseorreportindividualdata
◦Limitaccessthatcouldrevealindividualidentity
◦Reportdataonlyingroupform
◦Usedcomputerizedmethodsforencryptingdata
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50. Six Areas of Scientific Dishonesty
1.Plagiarism—usingtheideas,writings,anddrawingsofothersasyour
own
2.Fabricationandfalsification—makinguporalteringdata
3.Nonpublicationofdata,alsocalled“cookingdata”
4.Faultydata-gatheringprocedures
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51. Six Areas of Scientific Dishonesty
5.Poor data storage and retention
6.Misleading authorship—who should be an author?
➢Technicians do not necessarily become joint authors.
➢Authorship should involve only those who contribute directly.
➢Discuss authorship before the project!
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52. CONSTITUTION OF IRB
The IRB should consist at least SEVEN members, who collectively have the qualifications and experience to
review and evaluate the science, medical aspects, and ethics of the proposed trial. viz.
1.Chairperson –Appointed (who is from outside the institution)
2.1-2 basic medical scientists (i.e. Clinical Pharmacologist)
3.1-2 clinicians from same institute
4.One legal expert
5.One social scientist
6.One philosopher or ethicist
7.One lay person from community
8.Member secretary –Appointed
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Drugs & Cosmetic Act 1940, Schedule Y

53. QUORUM OF IRB
For reviewing and making decision on each protocol the quorum of
IRB should be at least FIVE members with the following
representations:
1.Basic medical scientists (preferably one pharmacologist)
2.Clinicians
3.Legal expert
4.Social scientist / Representative of non-governmental voluntary
agency / Philosopher / Ethicist / Theologian or a similar person
5.Lay person from the community
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 53
Drugs & Cosmetic Act 1940, Schedule Y

54. QUORUM OF IRB
Inanycase,theIRBmustinclude
1.Atleastonememberwhoseprimaryareaofinterest/specializationis
nonscientific
2.Atleastonememberwhoisindependentoftheinstitution/trialsite
3.Besides,thereshouldbeappropriategenderrepresentationontheIRB
4.Ifrequired,subjectexpertsmaybeinvitedtooffertheirviews
5.Further,basedontherequirementofresearcharea,e.g.AIDS,genetic
disordersetc.Specificpatientgroupsmayalsoberepresentedinthe
IRB
RESEARCH METHODOLOGY IN MEDICAL RESEARCH 54
Drugs & Cosmetic Act 1940, Schedule Y

55. Conclusion
➢Research is a scientific method used to collect and analyse information to
increase our understanding or solve issue on particular field.
➢The research topic should be Feasible, Interesting, Novel, Ethical and Relevant.
➢The ethical consideration should be taken care of conducting the research.
➢The research result should not be biased, both the negative and positive results
should be reported/published.
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56. RESEARCH METHODOLOGY IN MEDICAL RESEARCH 56