Ethiks in research 7. Ethics in research.pdf

Ethics

1. Ethics in Research
Dr. Mital Buha

2. Ethical Issues
Thereareanumberofkeyphrasesthatdescribethesystemofethicalprotectionsthatthecontemporary
socialandmedicalresearchestablishmentshavecreatedtotrytoprotectbettertherightsoftheirresearch
participants.
Theprincipleofvoluntaryparticipationrequiresthatpeoplenotbecoercedintoparticipatinginresearch.
Thisisespeciallyrelevantwhereresearchershadpreviouslyreliedon'captiveaudiences'fortheirsubjects
--prisons,universities,andplaceslikethat.
Closelyrelatedtothenotionofvoluntaryparticipationistherequirementofinformedconsent.

3. Essentially,thismeansthatprospectiveresearchparticipantsmustbe
fullyinformedabouttheproceduresandrisksinvolvedinresearchand
mustgivetheirconsenttoparticipate.
Ethicalstandardsalsorequirethatresearchersnotputparticipantsina
situationwheretheymightbeatriskofharmasaresultoftheir
participation.Harmcanbedefinedasbothphysicalandpsychological.
Therearetwostandardsthatareappliedinordertohelpprotectthe
privacyofresearchparticipants.

4. Almostallresearchguaranteestheparticipant'sconfidentiality-they
areassuredthatidentifyinginformationwillnotbemadeavailable
toanyonewhoisnotdirectlyinvolvedinthestudy.

5. Ethical Aspects Related to Human
WorldMedicineAssociation(WMA)hasdevelopedthedeclarationof"Helsinki"as
statementofethicalprinciplestoprovideguidancetophysiciansandotherparticipantsin
medicalresearchinvolvingHumanSubjects.
1.ItisdutyofphysiciantopromoteandsafeguardtheHealthofpeople.
2.DeclarationofWMAofGenevabindsthephysicianwithwordsthatare"TheHealth
ofmypatientwillbemyfirstconsideration".Andphysicianshallactonlyinpatient's
interestwhenprovidingmedicalcarewhichmighthaveeffectweakeningthephysical
andmentalconditionofpatient.

6. 3.Primarypurposeismedicalresearchrelatedtohumanistoimprove
prophylactic,diagnosticandtherapeuticprocedureandunderstandingofetiology
andpathogenesisofdisease.
4.Itpromotestherespectforallhumanbeingandprotectstheirhealthandrights
5.AnInvestigatorshouldawareofethical,legalandregulatoryrequirementsfor
researchonhumansubjects.
6.Itisadutyofphysicianinmedicalresearchtoprotectlife,health,privacyand
dignityofhuman.

7. 7.AppropriatecautionmustbeexercisedinconductofResearchwhichmayaffectthe
environmentandwelfareofanimalsusedforResearchmustberespected.
8.Researchprotocolshouldalwayscontainstatementofethicalconsiderationinvolved.
9.Researchshouldbeconductedbyscientificallyqualifiedpersonundersupervisionof
clinicallycompetentmedicalperson.and
10.ResponsibilityofhumansubjectforResearchmustalwaysrestmedicallyqualified
personandneverrestonsubjectofresearch.
11.Physicianshoulddoalltheinvestigationsandmedicalcareasperrequirementbutif
anyemergencyoccursduringresearch,itshouldbetreated.

8. 12.SubjectmustbevolunteersandinformedparticipantsintheResearch
project.
13.RightofResearchsubjectstosafeguardtheirintegritymustalwaysbe
respected.
14.Researchermustbetakeprecautionandrespecttheprivacyofsubject
andpatient'sinformationshouldnotexpose.
15.PhysicianmustobtainaninformedconsentforResearchproject.

9. Ethical Aspects Related to Animal Experiment
TheMedicinalandScientificResearchcan'texistinisolation.
EachnewmedicinehastobetestedeitheronAnimalsorontissuecultureinlaboratory
beforetestedonhumanbeingsandeventuallyacceptedasatreatmentforanydisease.
TheGovernmentconstitutedaCommitteeforthePurposeofControlandSupervision
onExperimentsonAnimalsin1963(CPCSEA)AlsoanAnimalEthicsCommittee
(AEC)hasperformedamajorroleinEthicsprinciplesregardingAnimals.
EthicalaspectsorPrinciplesare–
1.TheproperhealthandhygieneofanimalsisrequirednotforthesakeofAnimalsbut
forthesakeofScience.

10. 2.Researchprojectinvolvinganimalsubjectsshouldtakeplaceonlywhentheaimof
projectisworthwhileanddesignoftheprojectissuchthat,thereisstrongpossibility
thatitwillachievetheaim.
3.BreedingandexperimentsofanimalscanperformundertheguidanceofAEC.
4.Theanimalsselectedforexperimentshouldbeofanappropriatespeciesand
quality.
5.Investigatorsandotherpersonsshouldtreatanimalswithkindnessandshouldtake
propercareofthem.
6.Investigatorshouldassumethatallprocedureswhichwouldcausepaininhuman
beingsmaycausepaininothervertebralspecies.

11. 7.Procedurethatmaycausemorepainordistressshouldbeperformedunderappropriate
sedation,analgesicoranesthesiabytakinghelpofveterinarydoctors.
8.NormallythecareofAnimalsshouldbetakenunderthesupervisionofveterinary
doctororapersonhavingadequateexperienceofanimalcare.
9.Researchstrategyandsmallpilotstudiesarereviewedbeforecommittingananimal.
10.TheunnecessaryrepetitionofAnimalprocedurescanbeavoided.
11.Inmanyareasofbio-medicalscience,invitromethodsareused.
12.AlsoSometimesrefinementalternativesencompassmethodscanbeusedandthat
methodminimizethepotentialpainordistressandwhichenhancesAnimalwell-being.

12. General Information of Institutional Ethics Committee
Ethicalcommitteeshouldbeconstitutedandoperatedsothatitstaskcanbeexecutedfreefrombias.
Ethicalcommitteeshouldhavedocumentedthepoliciesandtheproceduresasabasisofitswork.
TheDocumentsshouldalsostate-howfrequentlythecommitteewillmeetandhowitwillinteract
withtheinvestigator.
TheRoleofEthicalcommitteeistoensuretheprotectionofrightsandwelfareofhumansubjects,
participatinginclinicaltrial.
Ethicalcommitteelooksafterresearchprocessandkeepsthesafeguardrightsintactofallpossible
livingorganisms

13. Responsibilities:
•Safeguard rights, safe and well-being of trial subjects.
•Review suitability of investigator and site facilities.
•Review methods for obtaining and documenting consent.
•Thoroughly review the protocol.
•Review amount and method of payment to that subject.

14. Composition:
•At least 5-7 members are required.
•At least 1 is non-scientific or non-medical.
•At least 1 is from outside the institute.
•1 experienced lawyer or judge.
•Qualified and experienced scientist and clinician are taken.

15. FunctionsandOperation:
•TheFunctionsareaccordingtowrittenoperatingprocedure.
•Committeeshouldmeetatleastonceinmonthtoclearanypendingproposals
forethicsclearance,sothataninvestigatorneednothavetowaitforlongtime
beforestartingtheirproject.
•Minimumquorumatmeetingismust.
•Expertscanbeinvitedasperrequirementbuttheycannotvote.
•Maintaintherecordatleastfor3yearsaftercompletionoftrail.

16. GeneralInformationofAnimalEthicalCommittee(AEC):
•RoleofAECistoensurethatscientificuseofAnimalsforscientific
purposes.Thewelfareoftheseanimalsandincorporatesthe
principlesofreplacement,reductionandrefinement.
•ThechairpersonofAnimalEthicalCommitteeisDeputyVise
Chancellor.

17. Functioning:
•1.ApprovetheGuidelinesforcareofanimalsthatarebreed,heldand
usedforscientificpurposesonbehalfofuniversity.
•2.Monitor,acquisition,transportation,production,housingcareuse
andfateofsuchanimals.
•3.ApproveonlythoseprojectsforwhichAnimalsareessentialand
justified

18. •4. To withdraw an approval for any project.
•5. Authorize the emergency treatment.
•6. Maintain a record of proposal and projects.
•7. Committee usually meets 10 times in 1 year.
•8. AEC shall inspect annually all campus and other facilities for
keeping Animals used in approved protocols.