Dissemination on ICMR National Ethical

Guidelines by ICMR Bioethics Unit

Between 2017-2019

ICMRBIOETHICSUNIT

NationalCentreforDiseaseInformaticsandResearch

(IndianCouncilofMedicalResearch),Bangalore

CONTENTS

PageNo.

23

i

v

9-22

iii

1

2-6

7

7-8

23

24-31

24

25-31

7. References

ForewordbyDirector

Acknowledgements

5. Results

MessagefromChairperson,EthicsAdvisoryCommittee

1. ExecutiveSummary

2. Introduction

3. Aim/Purpose

4. Methodology

6. FutureSteps

8. Annexures

a)PosterofICMRNationalEthicalGuidelines

NationalEthicalGuidelines b)PamphletwithsalientfeaturesoftheICMR

FOREWORDBYDIRECTOR,NCDIR,BANGALORE

IampleasedtopresenttheconsolidatedreportofthedisseminationandtrainingprogramsonICMR

NationalEthicalGuidelinesconductedacrossthecountryduring2017-2019.Itisveryencouragingtosee

that6751participantsincludingethicscommitteemembers,students(medical/non-medical),nurses,

clinicians, faculty, scientists, lawyers and others from across the country covering 649 institutes

benefittedfromtheseprograms.Thedisseminationprogramsdiscussedallthesectionsintheguidelines,

resolvedseveralqueriesandwasabletoencouragebettertransparencyintheethicalreviewprocess.

Participants from various disciplines of health research benefitted fromdissemination cum training

programs.

Disseminationprogramsofsuchcomprehensivenaturewasplannedandimplementedforthefirsttimein

thecountrytocreateawarenessaboutethicalstandardsandtoimprovethequalityofhealthresearch

outcomes.Withtheinclusionsofclausestogovernbiomedicalandhealthresearchintherecentlynotified

NewDrugsandClinicalTrialsRules2019,allthestakeholdersarerequiredtofollowtheICMRNational

EthicalGuidelinesforBiomedicalandHealthResearchInvolvingHumanParticipants,2017.Therefore,

drivenbytheneedforgreateroutreachandmoresuchprogramstocovertheentirepopulationofour

country,manysuchprogramsarebeingplannedacrossthecountrybytheICMRBioethicsUnit,NCDIR,

Bangalore.

Wewouldencourageresearchers,academicians,ethicscommitteemembers,institutionalheads,funding

agenciesandotherkeystakeholderstospreadawarenessonneedforethicalconductofbiomedicaland

healthresearch.

DrPrashantMathurDirector,

ICMR-NCDIR,Bangalore

January,2020Bangalore

i

During2017–2019,12disseminationandtrainingprogramswereconductedacrossthecountrytoreach

outtomaximumpossiblestakeholders.AseriesofprogramswereheldatAIIMS,NewDelhi;PGIMER,

Chandigarh;SriRamachandraMedicalCollege,Chennai;AIIMS,Bhubaneswar;AMCMETMedicalCollege,

Ahmedabad; Andhra Medical College, Visakhapatnam; Amrita Institute of Medical Sciences, Kochi;

GauhatiMedicalCollege,Guwahati;GadagInstituteofMedicalSciences(GIMS),Gadag;KalingaInstituteof

Medical Sciences (KIMS), Bhubaneswar, Jawaharlal Institute of Postgraduate Medical Education &

Research(JIPMER),PuducherryandSt.John’sMedicalCollege,Bangalore.Thefourprogramswereheldin

collaboration with Clinical Development Services Agency (CDSA), Translational Health Science and

TechnologyInstitute(THSTI),FaridabadandanotherfourprogramsweresupportedbyDepartmentof

HealthResearch(DHR),NewDelhi.

MESSAGEBYCHAIRPERSON,ETHICSADVISORYCOMMITTEE

The Ethical Guidelines developed by the Indian Council ofMedical Research (ICMR) for biomedical

researchinvolvinghumansubjects/participantsin2000/2006arelookeduponbystakeholdersallover

thecountry,suchasresearchers,students(UG/PG),facultymembers,ethicscommitteesandregulatorsas

goldstandardforprotectionofsafetyandwelfareoftheresearchparticipantsinthiscountry.Thelatest

revision of the National Ethical Guidelines for Biomedical and Health Research Involving Human

ParticipantswasreleasedbyICMRinOctober2017afterwidenationalandinternationalconsultations.

Sincethencontinuedeffortsarebeingmadetodisseminatetheguidelinesnotonlytothebiomedicaland

healthresearchers,butalsotoNGOs,industry,andvariousotherrelevantstakeholders.

OverviewoftheICMRNationalEthicalGuidelinesforBiomedicalandHealthResearchInvolvingHuman

Participants,2017andNationalEthicalGuidelinesforBiomedicalResearchInvolvingChildren,2017and

NationalGuidelinesforStemCellResearchwerepresentedintheprogramsfollowedbypanelandopen

housediscussion.Theparticipantsgotanopportunitytointeractwiththeexperts,thepaneldiscussions

wereinteractiveandtheexpertsrespondedtothequestionsraisedbytheparticipants.Theinteraction

includedreal-lifeethicalissuesandscenariosencounteredduringtheconductorreviewofthebiomedical

andhealthresearch.Itwasoverwhelmingtoseetheenthusiasmoftheparticipants.Itwasalsorealised

thatmany stakeholders are still unaware about theNational Ethical Guidelines and these programs

helpedtocreateawarenessamongstthemaswell.Thesesessionswereplannedwiththeaimofspreading

awarenessaboutethicalconductofbiomedicalandhealthresearchacrossthecountrysothatthedignity,

rights,safetyandwell-beingofthehumanresearchparticipantsareprotected.

Manymoresuchprogramsareneededtocovertheentirebiomedicalandhealthresearchsectorofthe

country.Theenthusiasmoftheparticipantsandthegrowingdemandformoreofsuchprogramsisa

welcometrendbeingwitnessedandtheefforttakenbytheICMRinthisregardispraiseworthy.

January,2020Bangalore

DrVasanthaMuthuswamyChairperson,

EthicsAdvisoryCommitteeICMR-NCDIR,Bangalore

iii

ACKNOWLEDGEMENTS

SpecialthanksareextendedtotheClinicalDevelopmentServicesAgency(CDSA),TranslationalHealth

ScienceandTechnology Institute (THSTI), Faridabad,Haryana fororganizing the fourdissemination

programsconductedatAhmedabad,Visakhapatnam,KochiandGuwahati.IamparticularlygratefultoDr.

SuchetaBanerjeeKurundkarforfacilitatingtheconductandtoallthefacultymembersforsharingtheir

knowledge,experiences,andperspectivesduringtheprogram.IwouldliketothankDepartmentofHealth

Research(DHR)forprovidingfundingforDisseminationandTrainingProgramsonICMRNationalEthical

Guidelines.

Itgivesmeimmensepleasuretothanktheparticipantsandinstitutionsthatcontributedtowardsthe

successfulorganizationandconductofDisseminationprogramsatvariouslocationsacrossthecountry.I

would liketothankProf.BalramBhargava,DG, ICMRandSecretary,DHRforhisencouragementand

supportandsincerethankstoDr.SoumyaSwaminathan,FormerDG,ICMRandSecretary,DHRandDr.

GagandeepKang,ExecutiveDirector,THSTIwhoseinterestandimmensesupportcontributedgreatlyto

thedevelopmentanddeliveryof theseprograms.Myspecial thankstoall themembersof theEthics

AdvisoryCommittee,ICMR-NCDIR,fortheirvaluableguidance.

Iwouldliketoacknowledgetheproactivesupportbythelocalorganizers,Dr.YKGuptaandDr.Vijay

PrakashMathuratAIIMS,NewDelhi;Dr.BikashMedhi,PGIMER,Chandigarh;Dr.BanuRekhaV(ICMR-

NIRT)andDr.T.SanthaDevi,SriRamachandraMedicalCollege,Chennai;Dr.ArvindKumarSingh,AIIMS,

Bhubaneswar for ICMR organized programs and also local organizers at AMCMETMedical College,

Ahmedabad; Andhra Medical College, Visakhapatnam; Amrita Institute of Medical Sciences, Kochi;

GauhatiMedicalCollege,GuwahatiforCDSAfacilitatedprograms.

IwouldalsoliketothankDr.RavindraPN,GadagInstituteofMedicalSciences(GIMS),Gadag;Dr.SKRath

andDr.SoumyaMishra,KIMS,Bhubaneswar;Dr.RakeshAggarwalandDr.JayanthiM,JIPMER,Puducherry

andDr. Karuna Rameshkumar andDr. Jayanthi Savio, St. John’sMedical College, Bangalore for DHR

supportedprograms.

IwouldliketothankDr.PrashantMathur,Director,NCDIR,Bangaloreforhiscontinuousguidanceand

support.IthankDr.KalyaniThakurwhosupportedmeinanalysis,writingandpublicationofthisreport.I

alsothankallmembersofICMRBioethicsUnit,NCDIRwhowereinvolvedinorganizingtheeventsand

especiallyDr.RajibKishoreHazam,andMr.Bhyregowda.

ThiswasthelargesteverprograminIndiaonICMRNationalEthicalGuidelinesandwehopethatitwas

abletofulfilthemandateofreachingouttoalargenumberofstakeholdersandcreatingawarenessabout

theethicalrequirementsforbiomedicalandhealthresearch.

DrRoliMathurScientistFandHead,ICMRBioethicsUnit,

ICMR-NCDIR,Bangalore

January,2020Bangalore

v

UponthereleaseoftheNationalEthicalGuidelines,ICMRplannedaseriesofDisseminationcumTraining

Programswhichwereheldacrossthecountry.Thisisthelargesteverinitiativeinthecountryintheareaof

researchethicssofartosensitizethevariousstakeholdersabouttheNationalEthicalGuidelines.

The Indian Council of Medical Research (ICMR) issued the first “Policy Statement on ethical

considerations involved in research on human Subjects” in 1980. The ethical guidelines were

prepared in 2000 and revised in 2006,with the latest revision in 2017 as ICMR “National Ethical

GuidelinesforBiomedicalandHealthResearchInvolvingHumanParticipants”.Atthesametime

‘NationalEthicalGuidelinesforBiomedicalResearchInvolvingChildren’wasalsoreleased.

1.EXECUTIVESUMMARY

EventhoughICMREthicalGuidelineswerepresentwaybacksince1980,theirwiderdisseminationis

requiredinordertocreateawarenessabouttheethicalrequirementsforbiomedicalandhealthresearch.

Participants from variousmedical colleges, biomedical research institutions, paramedical institutes,

universities, colleges, industry personnel, etc. were identified and contacted through email, online

advertisement,socialmedia,brochuresetc.andencouragedtoparticipate.Therewasnoregistrationfee

to attend the program. The attendees were required to e-register and were given e-Certificates of

attendanceafterconfirmingattendanceduringtheprogram.

Duringtheprogram,keyhighlightsofICMRNationalEthicalGuidelinesweresharedandanexpertpanel

addressedquestions from the audience to clarify doubts.Details could be sharedwith 6751people

including Ethics Committee members, students (medical/ non-medical), nurses, clinicians, faculty,

scientists,lawyersandotherinterestedstakeholders.Withinaperiodof2017-2019,ICMRBioethicsUnit,

NCDIRwasabletoconduct12programs,4oftheseprogramsweresupportedbyICMR;andanother4

weresupportedbyClinicalDevelopmentServicesAgency(CDSA)duringtheyear2017-2018andthelast

4disseminationandtrainingprogramswereorganizedwithfundingsupportreceivedfromDepartment

ofHealthResearch (DHR) in theyear2019.Participants from24States/Union territories, covering

around649institutesfromthecountrybenefittedfromtheseprograms.Theoutreachprogramswere

successful as the dissemination reached to the large number of expected stakeholders involved in

biomedicalandhealthresearch.

1

Inspiteofhavingethicalguidelinessince1980,itwasrealizedthat,theguidelineshadnotbeenableto

reachalltherequiredorinterestedstakeholders.Understandingtheneed,ICMRBioethicsUnitplanned

disseminationprogramsforNationalEthicalGuidelinesforBiomedicalandHealthResearchInvolving

HumanParticipants,2017andNationalEthicalGuidelinesforBiomedicalResearchInvolvingChildren

andtrainingprogramsforrelevantstakeholdersacrossthecountry.

2.INTRODUCTION

TheICMR“NationalEthicalGuidelinesforBiomedicalandHealthResearchInvolvingHumanParticipants,

2017”havebeendevelopedafter longandcarefuldeliberationswithexpertsandstakeholders, from

variousbackgroundsacrossthecountry,whohavecarefullydealtwithdifficulttopics,topreparethe

document in linewithNationalaswellas Internationalguidelines, frameworksandregulations.The

revisedguidelinesarenotonlyanupdateof theearlierguidelinesbutalsoaddressemergingethical

concerns.

Thereare12sectionsintheguidelinesandthatincludesnewsectionssuchasResponsibleConductof

Research, Informed Consent Process, Vulnerability, Public Health Research, Social and Behavioral

Sciences Research for Health, Biological materials, Biobanking and Datasets and Research during

HumanitarianEmergenciesandDisasters.Manynewissueshavebeenaddedupassubsectionse.g.sexual

minorities(LGBT),multicentricstudies,researchusingdatasetsetc.Thesectiononethicsreviewprocess

hasbeenelaboratedupontohelptheethicscommitteesinimprovingtheirfunctions.Theguidelinesalso

highlighttheneedforcapacitybuildingintheareaofethicsinordertoimprovetheethicalconductof1,2,3

research.

The ICMRNationalEthicalGuidelineswasreleasedbyShri JPNadda,FormerMinisterofHealthand

FamilyWelfareandSmt.AnupriyaPatel,FormerMinisterofStateforHealthandFamilyWelfareinthe

presenceofvariousotherdignitaries,Dr.SoumyaSwaminathan,FormerDGICMRandSecretaryDHR,Dr.

PNTandon,FormerChairperson,CentralEthicsCommitteeonHumanResearch(CECHR)andDr.Henk

Bekedam,CountryRepresentative,WHO-WRon12thOctober,2017atICMRHeadquarters,NewDelhi.

ICMRNationalEthicalGuidelinesforResearchInvolvingChildrenhavealsobeenpreparedandreleased

onthesamedayandguidesresearchonchildren.

Dissemination and training programs were organized across the country for relevant stakeholders

involvedinbiomedicalandhealthresearchsuchasresearchers,ethicscommitteemembers,students,

faculty, nurses, clinicians, scientists, lawyers, representatives from pharmaceutical industries,

representatives fromgovernmentalaswellasnongovernmentalorganizations.Fourof theprograms

werefundedbyICMRandcoordinatedbyNationalCentreforDiseaseInformaticsandResearch(ICMR-

NCDIR)andanother fourof thedisseminationprogramswereconductedwith fundingsupport from

Clinical Development Services Agency (CDSA), under Translational Health Science and Technology

Institute(THSTI),Faridabadduringtheyear2017-2018.Another4disseminationandtrainingprograms

wereorganizedin2019withfundingsupportreceivedfromDepartmentofHealthResearch(DHR).

2

Each dissemination event was conducted and coordinated by an eminent panel of experts from

biomedicalandhealthresearchethicsbackgroundwhowerepartofthegroupthatdraftedandreviewed

theguidelines.ThesessionsincludedoverviewoftheICMRNationalEthicalGuidelinesfollowedbypanel

discussion. Key issues related to the ICMRNational Ethical Guidelineswere highlighted during the

programand the expert panel addressedquestions from the audience. The openhouse discussions

enabledinteractionofparticipantswiththeexpertstoclarifytheconcernsrelatedtovariousethical

aspectsofbiomedicalandhealthresearch.During2017-2019,12dissemination/trainingprogramswere

conductedandtotal6751stakeholderswereinformedandbriefedaboutethicalguidelines.Thiswasthe

largest initiative in India to reachout to thepublicwith the goal to create awarenessof the ethical

requirementsforbiomedicalandhealthresearchandtherebytoimproveprotectionofthedignity,rights,

safetyandwell-beingofhumanresearchparticipants.

Stakeholders fromvariousmedicalcolleges,biomedicalresearch institutions,paramedical institutes,

universities, colleges, industrypersonnel, etc.were contacted and informedabout thedetails of the

programviaemail,phone,posters,pamphlets,visitstothenearbyinstitutionsbythelocalorganizing

teamaswellasusingthesocialmediaplatforms(Facebook,Twitteretc).Anonlineportalwasdeveloped

forregistrationoftheparticipantsandthelinkforonlineregistrationwaspostedonthewebsitesofICMR

Headquarters,NewDelhi;NCDIR,Bangalore;CDSAandlocalorganizinginstitutesforwideroutreach.For

CDSA,THSTI supportedprograms, similarwebportal developedbyCDSA and alsopostedon ICMR

website. To encourage maximum participation, the registration was made free of cost and spot

registrationswerealsofacilitatedforinterestedparticipants.Theparticipantswereprovidedwithan

information brochure highlighting the salient features of the ICMRNational Ethical Guidelines. The

attendeesweregivene-Certificatesofparticipationafterconfirmingattendanceduringtheprogram.

3

Figure1.Disseminationprogramsinvariouspartsofthecountry

NEW DELHI

CHANDIGARH

CHENNAI

BHUBANESWAR

4

AHMEDABAD

VISAKHAPATNAM

KOCHI

GUWAHATI

5

GADAG

BHUBANESWAR

PUDUCHERRY

BENGALURU

6

In order to create awareness about the ICMRNationalEthicalGuidelines forBiomedical andHealth

Research InvolvingHumanParticipants amongst all the stakeholders suchas clinicians, researchers,

ethicscommitteemembers,students,nursesaswellasfacultyinvolvedinbiomedicalandhealthresearch,

aseriesof12dissemination/trainingprogramswereplannedacrossthecountry.

3.AIM/PURPOSE

Themainpurposeofthedisseminationprograms:

a) tosharetheinformationregardingICMRNationalEthicalGuidelineswithrelevantstakeholders,and

b) topromotetheethicalconductofbiomedicalandhealthresearchinthecountry.

4.METHODOLOGY

c.Registration:

Theseprogramswereheldacrossthecountryoveraperiodoftwoyears(November,2017toSept,2019).

ICMR-NCDIRsupportedprogramswereheldatAIIMS,NewDelhi;PGIMER,Chandigarh;SriRamachandra

Medical College, Chennai and AIIMS, Bhubaneswar and CDSA, THSTI supported programs held at

AMCMETMedical College, Ahmedabad; AndhraMedical College, Visakhapatnam; Amrita Institute of

MedicalSciences,KochiandGauhatiMedicalCollege,Guwahati.DHRsupportedprogramswereheldin

theyear2019atGIMS,Gadag;KIMS,Bhubaneswar;JIPMER,PuducherryandSt.John’sMedicalCollege,

Bangalore.

a.SelectionofSites:

Allinterestedstakeholdersinvolvedinbiomedicalandhealthresearchfromthegivencityornearbyareas

wereprovidedopportunitytoregisterandattendtheprogram,suchasfaculty,clinicians,researchers,

ethics committee members, students (medical/non-medical/paramedical), UG/PG/Post-

Doctoral/SeniorResidents,nurses,dental,pharmacy,physiotherapy,traditionalmedicine,biotechnology,

socialsciencesandotheralliedsciences,NGOs,sponsors,regulators,patientrepresentativesetc.

b.Participants:

Anonlineportalwasdevelopedforregistrationoftheparticipantstotheprograms.Thelinktotheonline

registrationportalwaspostedon relevantwebsites to ensuremaximumparticipationandoutreach.

Registrationwasmadecompletelyfreeofcostandalsomadeavailableon-spot.Informationwithrespect

to name, designation, affiliation, participant profile etc., was collected from the participants during

A total of 12 programs (half-day/one-day/two-day) was conducted to update and sensitize the

stakeholdersabouttheICMRNationalEthicalGuidelinesacrossthecountry.Eachdisseminationprogram

targetedparticipationofapproximately500to1000participantsand50-100participantsfortraining

programs from medical colleges, research institutions and other interested stakeholders from

surroundingareasdrawingfromvariousbackgroundsincludingstudents,faculty,nurses,researchers,

pharmacy,dentalandotheralliedparamedicalstaffandethicscommitteememberswhoareengagedin

biomedicalresearchorinthereviewofsuchresearchstudies.

7

8

e.Conduct:

Priortoconductoftheseprograms,widespreadpublicitywasgivenandabrochurewithdetailswas

designed for each program. Relevant stakeholders were contacted and informed via email, phone,

posters,pamphlets,Facebook,Twitter,etc.andalsobypersonalvisittothenearbyinstitutionsbythelocal

organizing team. ICMR Bioethics Unit also wrote letters to various medical colleges and research

institutionstopublicizetheprogram.

d.Priorarrangements:

registration. Brochures and banners were designed with registration link, contact information and

completedetailsoftheprogramandpostedonthewebsites.Posterswerealsopreparedtosharecontents

ofICMRNationalEthicalGuidelines(Annexure–a).

AstalltodisplaytheICMRNationalEthicalGuidelinesandacounterforpurchaseofguidelineswasalso

setupforinterestedstakeholders.PostersofICMRNationalEthicalGuidelinesweredisplayedatthe

venueoftheprogram.

The registeredparticipantswereprovidedwith an informationbrochure/pamphlet highlighting the

salientfeaturesoftheICMRNationalEthicalGuidelines(Annexure–b).Theyweregivene-Certificatesof

participationafterconfirmingattendanceduringtheprogram.

ScientificcontentandconductofprogramwereledbytheICMRBioethicsUnit,NCDIR,Bangalore.The

localorganizersplayedanimportantroleinalllocalarrangementsandinassistingICMRBioethicsUnitto

reachouttoaverylargenumberofstakeholdersfromthelocalregionsandinthesuccessfulconductof

theevents.

Theprogram forDisseminationof ICMRNationalEthicalGuidelineswas implementedas ahalf day

program.DisseminationcumTrainingprograms/Trainingprogramswereorganizedforonedayortwo

daydependingupontherequestreceivedfromthelocalorganizers.Apanelofexpertswithexperiencein

biomedicalandhealthresearchethicscoordinatedandconductedthesessionsateachcentre.TheEthics

Advisory Committee, ICMR-NCDIR played an important role in planning, selection of venue and

implementationoftheseprograms.

An Open House Discussion was organized which enabled active discussions and Question-Answer

sessioninordertoclearthedoubtsofparticipantsonthenewlypublishedguidelines.Duringthetraining

programs,variouscasestudies(relatedtoECreviewchallenges, informedconsentprocess,research

involvingvulnerableparticipants,publichealthresearchandresearchduringemergenciesanddisaster,

etc.)werepresentedanddiscussedindetailedwiththeparticipants.Theparticipantsgotanopportunity

tointeractwiththeexpertsandreceivethelatestupdates.

AnoverviewoftheNationalEthicalGuidelinesforBiomedicalandHealthResearchInvolvingHuman

ParticipantsandNationalEthicalGuidelinesforBiomedicalResearchInvolvingChildrenwasprovided.

An overview of the National Guidelines for Stem Cell Research was also provided in CDSA, THSTI1,4,5supportedprograms.

9

a.GeographicCoverage

5.RESULTS

Thelocationsfortheprogramswereselectedwithcaretomakesurethatnationwideoutreachisattained.

Therenownedinstitutesintherespectiveareaswereselectedashostinstitutionsfortheconductofthese

programs.Thisensuredeaseofaccessofthelocationsforparticipantstoattendtheprogram.Detailsof

theprogramsconductedatvariousplacesacrossthecountryaregiveninTable1.

In order to study the pattern of topographical participation, the data was analysed for state-wise

participation which included 6751 participants. The region/state the institution of the participant

belongsto,weretakentoconsideration,andasperanalysis,649institutesrepresenting21statesand3

unionterritoriesattendedthedisseminationprogram.Itwasalsoobservedthatmaximumparticipation

was seen from the state ofGujarat,NewDelhi andTamilNadu. 7 programswere organized atGovt

institutionsand5wereheldatprivateinstitutions.

Two international participants attended the program. The Editor in Chief of The BMJ, London, UK

attendedthedisseminationprogramheldatAIIMS,NewDelhion16thNovember,2017andoneProject

CoordinatorfromJohnHopkinsUniversity,Baltimore,USAattendedtheprogramheldatSriRamachandra

MedicalCollege,Chennaion7thFebruary,2017.

Table1:DetailsofDisseminationProgramsconductedacrossthecountry

Sl.No. Date Venue Panelist No.ofParticipants

2. December14,2017

Dr.NandiniKKumarDr.RoliMathurDr.BikashMedhiDr.NaveenSankhyanDr.NalinMehtaDr.MedhaJoshiMr.B.K.SamantarayDr.SuvasiniSharmaDr.ReetaRasaily

1201

4. February17,2018

Dr.NandiniKKumarDr.SanghamitraPatiDr.NalinMehtaDr.BikashMedhiDr.M.JeevaSankarDr.RoliMathur

642

DisseminationProgramsorganizedduring2017-2018

PostgraduateInstituteofMedicalEducationandResearch(PGIMER),Chandigarh

AllIndiaInstituteofMedicalSciences(AIIMS),Bhubaneswar

ICMR–NCDIR

1. November16,2017

AllIndiaInstituteofMedicalSciences(AIIMS),NewDelhi

Dr.VasanthaMuthuswamyDr.YKGuptaDr.NKAroraDr.VijayKumarDr.RoliMathurDr.UrmilaThatteDr.ReetaRasaily

650

3. February72018

939

SriRamachandraMedicalCollege,Chennai

TotalParticipants 3432

Dr.NandiniKumarDr.UrmilaThatteDr.NalinMehtaDr.BikashMedhiDr.P.PaulKumaranDr.GeetaJotwaniDr.RoliMathur

10

Sl.No. Date Venue Panelist No.ofParticipants

2. December21,2017

Dr.VasanthaMuthuswamyDr.NandiniKKumarDr.AlkaSharmaDr.RoliMathurMr.Bangarurajan

322

4.

Dr.NandiniK.KumarDr.RoliMathurDr.BikashMedhiDr.SuvasiniSharmaDr.SantanuK.TripathiDr.GayatriBezboruah

785

AndhraMedicalCollege,Visakhapatnam

GauhatiMedicalCollege,Guwahati

ICMR-NCDIR&CDSA

1. November30,2017

AMCMETMedicalCollege,Ahmedabad

Dr.VasanthaMuthuswamyDr.NandiniKKumarDr.AlkaSharmaDr.RoliMathurDr.NKMehra

669

752

TotalParticipants

2528

3. February22,2018

March8,2018

AmritaInstituteofMedicalSciences,Kochi

Dr.NandiniK.KumarDr.RoliMathurDr.BikashMedhiDr.P.PaulKumaranDr.R.KrishnaKumar

Sl.No. Date Venue Panelist No.ofParticipants

2. June28–29,2019

Dr.VasanthaMuthuswamyDr.NandiniKKumarDr.UrmilaThatteDr.PadmajaMarathe

245 KalingaInstituteofMedicalSciences(KIMS),Bhubaneswar

ICMR-NCDIR&DHR

DisseminationProgramsorganizedduring2019

1. March7,2019

GadagInstituteofMedicalSciences(GIMS),Gadag

Dr.VasanthaMuthuswamyDr.NandiniKKumarDr.UrmilaThatteDr.PadmajaMaratheDr.S.L.HotiDr.RajibKHazamDrP.N.Ravindra

259

80

3. September16–17,2019

JawaharlalInstituteofPostgraduateMedicalEducationandResearch(JIPMER),Puducherry

Dr.VasanthaMuthuswamyDr.RakeshAggarwalDr.NandiniKKumarDr.BikashMedhiDr.PPaulKumaranDr.ShubhaKumarDr.MJayanthiDr.RebaKanungoDr.R.RaveendranDr.NarayananPDr.CSuthakaranDr.PrasanthPenumaduDr.PrasanthGanesanDr.MedhaRDr.SSandhiya

TotalParticipants

791

GrandTotal

6751

4. September19–20,2019

St.John’sMedicalCollege,Bangalore

Dr.VasanthaMuthuswamyDr.NandiniKKumarDr.UrmilaThatteDr.BikashMedhiDr.PratibhaPereiraDr.KarunaRameshkumarDr.PremPaisDr.JohnsonPradeepDr.ManjulikaVazDr.ArvindKasthuriDr.SavithaD

207

11

b.Institutes/organizationsparticipatedintheDisseminationPrograms:

Theinformationprovidedbytheparticipantsregardingtheirprofileandaffiliationduringregistration

were used for the analysis. The participants belonged to 471 Educational institutions (72%), 37

Industries-Pharma/CRO/SMO/Devices/Others(6%),56Governmentagencies(9%),9NGOs(2%)and

21otherrelatedorganizations–notspecified(11%).Outof471Educationalinstitutes(MedicalColleges/

Hospitals/ Research Institutes/ Universities), approximately 235 institutes were public sector

organizations and 236 were from private sector. The Geographical distribution of institution wise

participationinvariouspartsofthecountryaregiveninFigure2.Detailsoftheinstitutionsrepresented

bytheparticipantsaregiveninTable2.Apiechartdemonstratingthedistributionofinstitute’sprofiles

aregiveninFigure3.

Figure2.Geographicaldistributionoftheinstitutions(ofparticipants)invariouspartsofthecountry

17

Table5:SummaryofDisseminationPrograms

S.No.

Participants/Institutes

ICMR-NCDIRICMR–

NCDIR&CDSADHR&

ICMR-NCDIRTotal

Number

Thedataanalysisshowsthatpeoplefromvariousbackgroundsattendedthedisseminationandtraining

programsconductedacrossthecountry.Outof6751,590ethicscommitteemembers(9%)suchasBasic

MedicalScientist,Clinicians,Pharmacologists,LegalExperts,SocialScientists,Philosopher/ethicist/

Theologian,Laypersonattendedtheprogram.16Chairperson/Co-chairsand63MemberSecretaries/

JointSecretariesoftheEthicsCommitteesalsoparticipatedintheprogramsconductedatvariousplaces

acrossthecountry.TheFaculty/ScientistgroupcomprisedofClinicians,Biomedical,Dental,Pharmacy,

AYUSH and Others and represented 1456 (24%) of the total participants. The student group who

participatedinvariousprogramsincludedUG/PG/Ph.D/PostDocfromMedical,Non-medical,Dental,

Pharmacy,AYUSHorothersandconstituted42%ofthetotalparticipants.

The dissemination programs could cover 6751 participants (students, faculty, scientists, ethics

committeemembers,etc.)from649Institutes(public,private,industry,govtagencies,NGO,etc.)across

thecountry(Tables2,3&4).Thesummaryoftheparticipants/institutesisgiveninTable5.

1. Participants 3432 2528 791 6751

2. ECMembers 191 160 239 590

3. Faculty/Scientists 960 496 335 1791

4. Students 1650 981 179 2810

5. Institutes 268 214 167 649

Summaryoftheeightdisseminationprogramsaregivenbelow:

1.AIIMS,NewDelhi

ThefirstdisseminationprogramonICMRNationalEthicalGuidelineswasheldatAIIMS,NewDelhion

16thNovember,2017afterthereleaseofguidelineson12thOctober,2017.Theprogramwasinaugurated

byDr.PNTandoninthepresenceofDrSoumyaSwaminathan,theFormer,DGICMRandSecretary,DHR;

Dr.VinodPaul,MemberNITIAayogandDrRandeepGuleria,DirectorAIIMS.Thehalfdayprogramwas

attendedby650participantsfrom83institutions.30ethicscommitteemembers,193Faculty/Scientists

and357Students(Medical/Non-medical)aswellaspeoplefromvariousotherbackgroundssuchas

representativesfromIndustry,NGO,Govtofficials,etc.attendedtheprogram.

2.AMCMETMedicalCollege,Ahmedabad

TheseconddisseminationprogramwasconductedatAMCMETMedicalCollege,Ahmedabadon30th

November,2017.Itwasattendedby669participantsfrom88variousorganizationsrepresenting76EC

members,86Faculty/Scientists,119Students(Medical/Non-medical).

3.PostGraduateInstituteofMedicalEducationandResearch(PGIMER),Chandigarh

ThethirddisseminationprogramwasorganizedatPostGraduateInstituteofMedicalEducationand

Research(PGIMER)Chandigarhon14thDecember2017.Atotalof1201participantsfrom106institutes

attended the program. The stakeholders included 41 EC members, 270 Faculty/Scientists and 627

Students(Medical/Non-medical).

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4.AndhraMedicalCollege,Visakhapatnam

ThefourthintheserieswasorganizedatAndhraMedicalcollege,Visakhapatnamon21stDecember,2017

jointlybyICMR-NCDIRandCDSA.322participantsrepresenting17ECmembers,99Faculty/Scientists,

114Studentsalongwithotherstakeholdersfrom28differentinstitutionsattendedthedissemination

program.

5.SriRamachandraMedicalCollegeandResearchInstitute,Chennai

ICMR-NCDIRorganizeditsfifthdisseminationprogramatSriRamachandraMedicalCollegeandResearch

Institute,Chennaion7thFebruary,2018.939participantsfrom43institutionsattendedtheprogram.

Total95ECmembers,267Faculty/Scientistsand395Students (Medical/Non-medical)attended the

awarenessprogram.

6.AIIMS,Bhubaneswar

ThesixthintheserieswasorganizedatAIIMSon17thFebruary,2018.Thedisseminationprogramwas

attendedby642participantsfrom34institutesrepresenting25ECmembers,230Faculty/Scientistsand

271Students.

7.AmritaInstituteofMedicalSciences(AIMS),Kochi

ThiswastheseventhintheseriesforthedisseminationoftheICMRNationalEthicalGuidelinesorganized

atAmritaInstituteofMedicalSciences(AIMS),Kochion22ndFebruary,2018.752participantsincluding

48 EC members, 176 Faculty/Scientists and 360 Students from 50 institutions attended the

dissemination.

8.TheGauhatiMedicalCollegeandHospital,Guwahati

TheeighthdisseminationprogramwasorganizedatGuwahatiinGauhatiMedicalCollegeandHospitalon

08thMarch,2018andattendedby785participantsfrom48institutes.Thestakeholdersincluded19EC

members, 135 Faculty/Scientists, 388 Students aswell as representatives from Industry, NGO, Govt

officials,etc.

9.GadagInstituteofMedicalSciences(GIMS),Gadag:

ThefirstDHR-supportedonedaydisseminationcumtrainingprogramwasorganizedon7thMarch,2019

atGadagInstituteofMedicalSciences(GIMS),Gadag.Theprogramwasattendedby259participantsfrom

40institutes.Total47ECmembers,97faculty/scientist,108studentsandothersattendedtheprogram

10.KalingaInstituteofMedicalSciences(KIMS),Bhubaneswar:

OnedaydisseminationandahalfdaytrainingprogramwasorganizedatKalingaInstituteofMedical

Sciences (KIMS),Bhubaneswaron28th-29th June,2019.The trainingprogramwasattendedby245

participantsfrom61institutes.

11.JawaharlalInstituteofPostgraduateMedicalEducation&Research(JIPMER),Puducherry:

Two-dayworkshopwasorganizedon16th-17thSeptember,2019atJawaharlalInstituteofPostgraduate

MedicalEducation&Research(JIPMER),Puducherry.TheprogramwasdirectedtotrainECmembersand

faculty from JIPMERandnearbymedical collegesand research institutes.The trainingprogramwas

attendedby80participantsfrom18institutes.

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12.St.John’sMedicalCollege,Bangalore:

Half day dissemination and one day training program was organized at St. John’s Medical College,

Bangaloreon19th-20thSeptember,2019.Thetrainingprogramwasattendedby45ECmembersand

faculty/scientistsanddisseminationprogramwasattendedby162participants.Total207participants

attendedbytheprogramfrom48institutes.

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KIM

S,Bhuban

eswar-Training

PGIM

ER,C

han

digarh-Dissemination

AIIMS,Bhuban

eswar-Dissemination

SRMC,C

hen

nai-Dissemination

AMCMET,Ahmed

abad

-Dissemination

AMC,V

isak

hap

atnam

-Dissemination

AIM

S,Koc

hi-Dissemination

GMC,G

uwah

ati-Dissemination

21

GIM

S,Gad

ag–DisseminationcumTraining

KIM

S,Bhuban

eswar-Dissemination

KIM

S,Bhuban

eswar-Training

JIPMER,P

uduch

erry-Training

SJMC,B

anga

lore-Dissemination

SJMC,B

anga

lore-Training

Program:

1. ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human

Participants:

The participantswere updated about the addition of new sections in the ICMRNational Ethical

Guidelines for Biomedical and Health Research Involving Human Participants, 2017 such as

ResponsibleConductofResearch,InformedConsentProcess,Vulnerability,PublicHealthResearch,

SocialandBehaviouralSciencesResearchforHealth,Biologicalmaterials,BiobankingandDatasets

andResearchduringHumanitarianEmergenciesandDisasters.Apartfromthese,manynewissues

havealsobeenaddedupassubsectionse.g.sexualminorities(LGBT),multicentricstudies,research

usingdatasetsetc.

2. ICMRNationalEthicalGuidelinesforBiomedicalResearchInvolvingChildren:

Theoverviewofthe ‘NationalEthicalGuidelinesforBiomedicalResearchInvolvingChildren’was

presentedduringtheprogram.Theparticipantswereinformedabouttheimportanceofincluding

childreninbiomedicalresearchandtheguidelineshavebeenspecificallydevelopedtosafeguard

children,who are potentially vulnerable and carry a greater risk of harmduring research at all

settings:hospitalandcommunitysettings,childreninemergencysituations,school-basedresearch,

internet-basedresearch.Itwasexplainedtotheparticipantthatthebenefitofresearchcarriedoutin

adults cannot be applied to children, as the doses and duration of therapy, pharmacodynamics,

adverseeffectsofdrugsinchildrenvaryfromadults.

3. ICMR-DBTNationalGuidelinesforStemCellResearch:

The highlights of the ICMR-DBT National Guidelines for Stem Cell was also presented and the

participantswereupdatedaboutthevariousrequirementforconductingresearchonStemCellsuch

asapproval fromEC, InstitutionalCommittee forStemCellResearch(IC-SCR)andNationalApex

CommitteeforStemCellResearchandTherapy(NAC-SCRT).TheIC-SCRshouldberegisteredwith

NAC-SCRT.ClinicaltrialsforstemcellstobeundertakenatinstituteswithregisteredIC-SCR,ECand

onlyatGMPandGLPcertifiedfacilities.

4. PanelDiscussions:

OneofthemajorhighlightsofthedisseminationprogramsweretheOpenHousediscussions.Open

endedquestionswereaddressedbythePanelandatimeofaboutoneandhalfhoursallowedample

discussion.Thesessionwasgreatlyappreciatedbytheparticipants.Thepanelistsweremembersof

ICMREthicsAdvisoryCommittee,representativesfromCDSCOoritsexpertcommittees,eminent

experts,proficientinethicalandregulatoryaspectsofbiomedicalandhealthresearchandclinical

trialsinIndia.Thequestionsraisedbytheaudiencemainlypertainedtoethicscommitteefunctions

andupdatesrelatedtoethicalandregulatoryaspectsofbiomedicalresearchaswellasacademic

clinicaltrialsandthoseclinicaltrialsthatareregulatedbyCDSCO.Therewerequestionsrelatedto

CTRI, EC accreditation, collaborative research, authorship issues, transfer of data and samples,

changeofPI,studentresearch,etc.whichthepanelexplainedindetail.Theparticipantsbenefittedto

agreatextentfromthevastexperienceoftheexpertpanel.

Limitations

Asperfeedbackreceived,anumberofparticipantsindicatedtheneedforfulldayprogram.Itwasalso

found that there was a need to improve the participation of ethics committeemembers as well as

representativesfromGovernmentagenciesandNGOs.

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6.FUTURESTEPS

These outreach dissemination programs helped to create awareness and knowledge of relevant

stakeholdersabouttheupdatedrequirementsasspecifiedintheNationalEthicalGuidelineswhichwould

eventuallyhelptoimprovequalityofbiomedicalandhealthresearchinIndiaandensurebetterprotection

isimpartedtoresearchparticipantstosafeguardthedignity,rights,safetyandwell-being.Thereisaneed

forsimilarprogramsinnon-metropolitancitiesorrural/semi-urbaninstitutions.Needfulstepswillbe

plannedinthisdirection.

7.REFERENCES1. ICMRNationalEthicalGuidelinesforBiomedicalandHealthResearchInvolvingHumanParticipants,

2017(http://ethics.ncdirindia.org//asset/pdf/ICMR_National_Ethical_Guidelines.pdf)

2. NationalEthicalGuidelinesforBiomedicalandHealthResearchInvolvingHumanParticipants,2017:

Acommentary.IndianJournalofMedicalEthics.2018Jul-Sep;3(3):201-20

3. Nationalethicalguidelinesforbiomedical&healthresearchinvolvinghumanparticipants,2017:A

commentary.IndianJournalofMedicalResearch.2018Mar1;148(3):279

4. ICMR National Ethical Guidelines for Biomedical Research Involving Children, 2017

(http://ethics.ncdirindia.org//asset/pdf/National_Ethical_Guidelines_for_BioMedical_Research_In

volving_Children.pdf)

5. NationalGuidelinesforStemCellResearch.IndianCouncilofMedicalResearchandDepartmentof

Biotechnology(ICMR-BDT),2017

6. ICMRBioethicsUnit-http://ethics.ncdirindia.org/Default.aspx

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8.ANNEXURES

Annexure-A:PosterofICMRNationalEthicalGuidelinesforBiomedicalandHealthResearchInvolving

HumanParticipants

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Annexure-b):PamphletwithSalientfeaturesofICMRNationalEthicalGuidelinesforBiomedicalandHealthResearchInvolvingHumanParticipants&NationalEthicalGuidelinesforBiomedicalResearchInvolvingChildren

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