Committee
Etlhics
I Heqlth
StandardOperatingProcedures
As per resolution passed from the SoMex R.esearch
& Health Prrt. Ltd. and orrler from the
Director of SoMex Research & Health Pv1..Ltd. Jaipur an Independent Ethi,c committee
neLmed
"SoMex Research& Health Ethics committee"was formed and further rnodified and
er:tendedconstitutingthe following :
l.
Dr. RakeshChandraAndley,Chairman,MedicalOfficer,EtemalHeartCareCenterAnd
Research
Institute,Jaipur
2. Dr. Rajkumari Somani, Member Secretary, Director, ConsultantGynecologist,
SomaniHospital & ResearchCenter,Jaipur
3. Dr. N.K. Gurbani, Member @iomedicalScientist& Pharmacologist),IrormerHead,
Public Health Training Institute,Jaipur
4. Dr. VishnuBhutia,Member(Clinician),
Internarl
Medicine,AgrasenHospital,
Sr.Consultant,
Jaipur
5. Dr. Prerna Updadhyaya, Member (Pharmacologist),Dept of Pharmacologyat
MahatamaGandhiMedicalCollege& Hospital,Sitapur4Jaipur
High court,Jaipur
6. Mr. Chandra Shekhar,Legal Expert, Advocate,Rajasthan
7. Mr. Niranjan Lal Sharma,LegalExpertl,Advocate,
Rajasthan
High Court,Jaipur
RIICO,Bhiwadi(Alwar.)
8. Mr. ShashikantGupta,LegalExpert,LegalAssistant
9, Dr. Asha Hingar, Social Member, FormerProfessor,Dept. Of Psychology,Rajasthan
University,Jaipur
10. Mrs. Abha Maheshwari, Social Member, Mission lHeart Operation (A NonGovemmentorganization)Jaipur
11. Mr. SatyaNarayan Modani, Member (Lay Person),SyamNagar,Sodala,Jaipur
Jaipur
12. Mrs. Tanvi Gupta,Member(Lay Person)80/59,PatelMarg,lvlansarover,
& Functions
! Constitution
&
A. SoMex Research& Health Ethics Committeeis authorizedunder SoMexResearch
HealthPw. Ltd. Registerunderthe companyAct 1956.CorporateIdentity no. of company
U2432R12007PTC025278
B. Ethics committeeis constitutedand functionsas per the scheduleY, ICH-GCP guidelines
and Good clinical practice guidelines issued by the Central Drug StandardsControl
on Human sulrjects,issued
Organizationand Ethical guidelinesfor BiomedicalResearclh
by the Indiancouncilof MedicalResearr;h.
C. The Ethics Committee shall be an independentEthics Committee for any Medical
College/ Ayurved College/ HomeopathicMedical College & ParamedicalInstitutions/
PharmaceuticalOrganizztions/Any ottLerorganization/Individual interestingbio-socio
Jai;pur,India
& HealthEthicsCommittee,
Vrlrsion5.0dated11Feb2013SOPs SoMexResearch
Somani,
SoMexResearch
& HealthEthicsCommittee
Prepared
& DraftedBy: Dr. Rajkumari
I oft2
& HealthEthicsCommittee PaEe
By: Dr.R.C.Andley,SoMexResearch
Reviewed
& Approved
Jaipur-302019
ByePass,
Gopalpura
80feetRoad,
ShriGopal
Nagar,
277,llndFloor,
10
Fax:0141-25041
2504996
:0141-3212996,
Phone
& HeolthtthicsCornmittee
Reseorch
SoMex
medical research.Epidemiologicalsurveysor any Clinical Trial for the benefit of the
Human being shall be evaluatedfor the scientificand ethical aspectsof all trials/ projects
researchworks proposedto be conductedandgrant approvalldisapprovalfor the same.
o
The SoMex Research& Health Ethics Committee,Jaipur will be an Independent
Ethics Committee,compliantwith the publishedguidelinesof the Indion Council of
Medical Research(IClvfR) related to the conduct of Clinical Trials on human
subjects.
o
This Committeewill examineand approveor disapprovesubmittedresearchprojects
asper their scientificand ethicalaspects,
o
It will be the responsibilityof the investigatorto adhereto the locally applicable
institutional/govemmentrulesandrcgulationwhile conductingtheir research/trial.
o
This ethicscommitteewill continueto be in effect till further ordersfrom the Office
of the Director, SoMex Research& HealthP\4.Ltd. Jaipur.
All projectsto be submittedwill be reviewedby the concemeddepartmentand forwarded
throughthe Headof the,Department
of the EthicsComrnitteeoffice.
The ProjecVProposalwill be submittedin Thirteen(13) copiesand can be submittedat
any time.
However for the same to be consideredin the next meeting of the EC, it needsto be
submitted,completein all respects,latestby the 02 weeksprior to proposedlEC meeting
date.
2. Meetinsof EthicsCommittee
o
The meetingof Ethicscommifteewill be convenedevery03 monthsregularly,preferablyon
the Friday/Saturdayof the month; in casethere is proposalbefore EC for review,EC
meetingcanbe calledearlierwith a priorsufficientperiodnoticeto all EC members.
r
If this is a governmentholiday or meetingnot being convenedon proposedmeetingdate
the EC will meeton the subsequent
Friday/ Saturday;
o
The Chairmanis empoweredto call the expeditemeetingof Ethics Committeeat a notice
Jaipur-302019
ByePass,
Gopalpura
80feetRoad,
Gopal
Nagar,
277,llndFloor,Shri
-25041
10
Fax:0141
2504996
:0141-3212996,
Phone
Committee
& HeolthEthics
SoMexReseorch
Members of the Ethics Committeeare appointedby directors of the organizationand
memberwill be appointedfor threeyearsalso willing to work accordingto Schedule-Y,
ICH-GCP Guidelinesand willing to work accordingto rules as and whenamended.
Quorumof EC minimum of 5 memberswith the following representations.
o
o
o
o
o
Basic medicalscientist(preferablyone pharmacologist)
Clinician (PostGraduate)
Legalexpert
Social scientist or representativeof non govemmental voluntary agency or
philosopheror ethicsor theologianor a similarperson.
Lay personfrom community,
New and existing members are trained by Member Secretaryregarding ICH-GCP,
Schedule-Yguidelinesaswell asnew clinicaltrial to be discussed.
a. IndependentEthics Committeemembersof SoMex Research& I{ealth Ethics
Committeeare qualifiedtechnicalmembers.
b. Committeemembersare conversantwith Drug and Cosmeticrul:s 1945 (3rd
amendment).
c. Committee membersare trainr:d and practices in accordancewith the ICMR
'good clinical guidelines'ensuringprotection rights,
of
sal'etyand 'well beingof
humansubjectsinvolve in clinical research.
d. They have experiencedin Clinical Researchand have been in such committees
for the lastseveralyears.
e. Committeemembersregularly organizingscientific meetingwhere clinical trials
arediscussed.
f. Every memberproactivelyparticipatesin annualworkshops.
g. A new memberwill be inducted I month prior and will be requestedto be an
'observer'for the first boardmeeting.
h. An introductorytraining will be impartedby the MemberSecretary
.
SOP Version 5.0 dated 11 Feb 2013 _SOPs_.Indepe;ndent
Ethics
Committeeof SoMexResearch
& HealthEthicsCommittee|SOP
i.
The IEC memberswill be encouragedto receiveongoing training by attending
workshopat leastonceeveryyear.
j.
The IEC will conductworkshopsfrom time to time to impart trainirrgto the IEC
membersand Institutionalfacully members.
k. The training programmesshouldbe scheduledand spreadover the yerar.
o
The chairmanof the EC will havethe right to canceltho meetingand re-convenethe same
after a period of 30 minutesin oasethe quorumis not complete.
Jaipur-302Ct19
ByePass,
Gopalpura
80feetRoad,
277,]lndFloor,ShriGopalNagar,
-25041
10
2504996Fax: 0141
Phonei 0141-3212996,
Committee
& HeolthEthics
Reseorch
SoMex
A sub-committeecomprising of ethicrscommittee membersnominated try the Ethics
Committeeto approveminor changesin ongoingtrials that have alreadybeen approved
by the EC-like a protocolamendmengIIJF updateetc- canbe constitutedby the Chairman
for expeditedreview of suchmatterswhich do not requirethe attentionof the full EC.
The EC will requestin writing that the PrincipalInvestigatoror his/herrepresentative
be
availablefor discussior/classificationduringthe time the commilleeis consideringthe
proposalfor approval.
The EC may invite as specialinvitee an expert on the subjectrelatedto the trial to be
presentduring the discussion.
Approval or disapprovalshall be by consensus.Reasonsfor disapprovalof a trial will be
conveyedto the Principal Investigatorin detailsand he/ shewill be given ar: opportunity
to rectiff the sameandsubmitthe projectfor re-consideration.
o
If one of the Ethics Committeemembersis submittinga trial for approval,during the final
discussionof approvalor otherwiseof the project,he/ shewill not be the part of decision
written submissionof resignationby any member.Replacement
or removrel
of member
irectorof organization,
afterconsulting
andapproval
of chairman
of EthicsCommittee.
o
The Project/Proposal
must havethe following enclosuresto be acceptedfor r;onsideration
for clearance:-
A. Signedand datedprotocol containingall detailsof how the trial is to be conductedwith
versionnumbersand dates.
B. Signed and dated Investigator and alll available clinical data of the trial drug with
adequatebibiolography.
C. Patient information and consentform- in Hindi and English, with version numbersand
dates.
D. Permissionletter from the Drug Controller Generalof India to conductthe trial of the
a trial may be grantedwith the condLition
that the
erethe permissionto conductedthe trial hasbeen
the DCGI.
Vefsion5.0dated11tr'eb2013 SOPs_SoMexResearch
& HealthEthicsCommittee,Jaipur,India
Prepared
& DraftedBy: Dr. RajkumariSomani,
SoM,ex
Rescarch& HealthEthicsCommitlee
Re{iewed
& Approved
By: Dr. R.C.Andley,SoMexResearch
ott2
& HealthEthics.Committee page4
Jaipur-302C119
ByePass,
Gopalpura
80feetRoad,
277,ltndFloor,ShriGopalNagar,
10
2501996Fax: 0141-25041
Phone: 0141-3212996,
Committee
& HeqlthEthics
SoMexReseorch
E. PrincipalInvestigator'scurrentsignedanddatedCV.
F . Copy of the Clinical Trials agreementbetweenthe investigatorand the Clirrical research
organization/sponsorofthe researchpnrject/trial, ifapplicable.
G. Undertakingby the Investigatoras per set format publishedin the Drug and Cosmetics
(IInd amendment)Rules 2005 of the Ministry of Health & Family Welfare (Copy of the
samemay be obtainedfrom the Office of the EC)
H. Compensationschemefor patients.
I.
Proposedfinancial/drug benefitto the patient
J. Insurancepolicy/ Indemnificationfor the investigator/Institution.
K. Any other relevantdocumentpertaining;tothe trial (Like subjectrecruitmentproceduresadvertisemenl& anyotherwritten infonnationto be provideto subjects)
L. The EC may requestadditionalinfotmationthan outlinedin the ICF to be give to subject
when, in the judgment of EC, the additional info would add meaninl;fully to the
protectionof the right, safety,andlor wr:ll beingof the subject.
Otherall documentsrelatedto studv.
0)
Processing fee for project sponsoredby pharmaceuticalcompany'will be Rs.
50000/- Rs (Fifty ThousandOnly) and the extra processingfee ol Rs. 20000/(Twenty Thousandonly) will be chargedif a specialmeeting is to be called for
the processingof the projectapartfrom the regularmeeting.
(II)
Processing fee for project sponsoredby Govt. agencies/Investigatorinitiated
trials/ Researchscholars/will be Rs. 20000i- (Twenty Thousandonly) and the
extra processingfee of Rs. 10000/- (Ten thousandonly) will be chargedif a
special meeting is to be called for the processingof the project apart from the
regularmeeting.
(IID
Processingfee for any amendmentin trial relateddocumentswill be 10000/-Rs.
(Ten thousand only )and the extra processing fee of Rs. 2000t0l- (Twenty
thousandonly) will be chargedif a specialmeeting is to be called for the
processingof the projectapartfi'om the regularmeeting.
GV)
The fee is to be paid by cheque/DDin favour of "SoMex Resear,ch& Health
Pvt. Ltd.'payable atJaipur. (PAN No. - AALCS4343Q)"
5.0 dated 11 Feb 2013 SOPs SoMexResearch& Health Ethics Committge,Jaipur,India
& DraftedBy: Dr. RajkumariSomani,SoMex Research& Health Ethics Commitl;ee
Page
5of 12
& ApprovedBy: Dr. R.C. Andley, SoMex Research& Health Ethics Committee
Jaipur-302019
ByePass,
Gopalpura
80feetRoad,
277,llndFloor,ShriGopalNagar,
Phone: 0141-3212996,2504996Fax: 0141-2504110
Comminee
Reseorch
SoMex
& HeolthEthics
ethics committeewill exercisepa(icular care to protect the rights, safbty and well
of all vulnerablesubjectsparticipptingin the studye.g.,membersof a groupwith
rarchical strucfure (e.g. prisoners,prnred forces personnel,staff and studentsof
who may not be able to make fi
and informeddecisionsabouttheir paLrticipation
in
or medicalcareareconsideredv
lationsmay be easily coercedor
le
limited freedomto choose.Personsidentifiedas
haveadditionalsafeguardsin the
informedconsentprocess
n
n
n
n
Childrenandwardsof the
Prisoners
PregnantWomenandfetuges
Cognitivelylmpaired
n
n
n
n
Non-English
speaking
Illiteratepersons
Financially
impaired
Terminally
lll
nformed Consent & Prisoners
ioners,due to the lack of controlof theif circumstances
are consideredvulneratrleDO NOT
,ll prisonersunlessyou checkwith the IRP first. ThereMUST be a prisonerrepresentative
on
IRB if a prisoneris enrolled.If a perso{rbr:comesa prisonerduring a tnal, notify the IRB
lm
Lediately.
Informed consentfor a prisonerwould statethat participationwill not be considered
in role consideration.
Muststatethatrisksfor prisonerin this studysameasfor a non-prisoner.
If
prisoneris treatedin a research
studyaridthe IRB is not awareor doesnot havea prisoner
on the committee,federalregulator! bodiesmust be notified.
t&P
should obtain informed
5.0 dated 11 Feb 2013 SOPs SoMex
& Drafted By: Dr. RajkumariSomani,
ewed& ApprovedBy: Dr. R.C.Andley,
fi:om both the pregnant woman ancl the father.
& Health Ethics Committee,Jaipur,India
Research& Health Ethics Committee
pase6of
Research& Health Ethics Committee
12
Jaipur-3OzCr19
ByePass,
Gopalpura
Road,
80
277,llndFloor,ShriGopalNagar,
-25041
1
0
4l
Fax
:
01
Phonei0141-3212996,
Comminee
SoMexReseorc HeqlthEthics
t ofthe father is not necessaryif:
n The purposeofthe study to meetthe healthneedsof the mother,
n Theidentityor
ofthe fathercannot be reasonablyascertained.
n The father is not reasona available.
n The pregnancyis the resu of rape.
: Researchtargetingpregnantwomen
subjects
doesnotqualifr for anexemptstatus.
Consenti
Utero ResearchStLrdy:personnelmay ay no part in determinationof fetal viability Many
latoryrestrictionsbaseduponviability fetus,Mother and father must be legally competent
havegiven their informedconsent.(
t of Fathermay not be required).lf anticipating
type of research,contactIRB or ORC
planningphases.
with diagnosedcognitiveimpa
such as mental retardation,dementiie,and coma,
participatein research.This type of
must specificallyaddresshow an individual's
ity to give informed consentwill be determined.The signatureof a legally authorized
tativewill be requiredResearch
wi
Cognitivelylmpairedsubjectscannottre considered
by the IRB. Documentcarefully the eru:ollmentof personswhose cognitive statusis not
Iy obviouse.g. strokepatients,
. lf a personis enrolledin a study
ability to give consent- he must be
investigatormay enroll individuals,
or
SU
iatricpatients
or persons
with speech
or language
ing a periodof cognitiveimpairmentandregains
sented.
can speakand understandEnglish, bu1;cannotread
ite. The potentialsubjectmustbe ab to place a written mark on the consentfonn. The
t must also be able to Comprehend
conceptsofthe study and understandthe risks and
ts of the study as it is explainedverball , and Be ableto indicateapprovalor dis;approval
for
y enrollment.Additionalitemsto
n what methodwas usedto
municate
theinformationaboutthestudy
n Whowaspresent
during
IrrformedConsentInterview
n The specific ways that the subject communicated agreement to study
participation
ncl
5.0 dated 11 Feb 2013 SOPs SoMex
& DraftedBy: Dr. RajkumariSomani,
& ApprovedBy: Dr. RC. Andley,
rch & Health Ethics Committee,Jaiprur,India
ex Research& Health Ethics Committee
p^ueloft2
Research& Health Ethics Committee
Jaipur-3020t19
ByePass,
Gopalpura
Road,
1
0
-25041
Fax:
0141
Phonei0141-3212996,
80
ShriGopal
Nagar,
Floor,
277,llnd
Committee
Reseorch
SoMex
& HeolthEthics
deviations from, or changesol the prfotocolshould be invited without prior written EC
vorable opinion of an appropriziteamendmentexcept when necessaryto eliminate
iate hazardsto the subjector when th{ changes(s)involvesonly logistical or a.dministrative
of the trial.
Investigatorshouldpromptly reportto
A. Deviation from or changesof, the
Ito eliminateimmediatehazardsof the trial
subjects.
B. Changesincreasingthe risk to the
rjectsand/oraffectingsignificantlythe conductof
the trial.
C. New informationthat may affect ad
ly the safetyofthe subjector the conductofthe
trial.
to conductthetrial shallbe
rmanand/or the Secretarvof the Ethics
aspera setPerformawith thesignatures
of the
ittee.
will be responsibilityof the investigator adhereto the institutional/sovemmentalrules and
while conductingtheir research./
permissionto conductthe trial is
to informtheEC aboutthe
by the EC, it is mandatory on the part of the
ofthe trial on a regularbasis,preferablyevery6
, any significantchangesin the
l/ patientinformationforms, any seriousor
adverseeffectsof the trial drug
to providea final reportafter the conclusionof the
compliance
withthismayincurthewi
I of approvalby the committee.
per ICMR guidelines,the investigatori mandatedto submittedan annualprogressreportof
trial to the EC along with any
in the Patient Informed Consent fonn or Patient
ion Sheet,if any.
On completionof the trial, the i
a summaryof the numberpatients
of the adverseeventsobservedduri
is requiredto submita completion
reportwith
the salientfindings of the trial and synopsis
thefial.
Non-compliancewith theseclausesi liable to renderto investigatorto be blacklistedand
banedfrom conductingclinical trials
thefuture.
5.0 dated 11 Feb 2013_SOPs_
SoMex
rch & Health Ethics Committee,Jaip,ur,India
& Drafted By: Dr. RajkumariSomani, Mex Research& Health Ethics Committree
pase
& ApprovedBy: Dr. R.C.Andley,
Research& Health Ethics Committee
8of 12
Jaipur-3020t19
ByePass,
Gopalpura
Road,
-25041
10
0141
Fax:
:0141-3212996,
Phone
80
ShriGopalNagar,
277,llndFloor,
SoMexReseqrch
& Heqlth[thicsComminee
ent of
, Ethics Committee will also monfltorfinancial interest and managemenlof principal
gatorin following standardway :
uity (Ownership)
or Investment
Interest
investment
in theresearch
sponsor
by thpprincipalinvestigator,
his or herspouse,
registered
is partner,or depenclent
children.*Nqte:an investmentis zurydirect,indirect,or.beneficial
I interestin a businessentity inclu{ing;stocks,bonds,warrants,ald options,including
held in rn in or brokerageaccounts.
the purposesof this policy, a financialinlprerstin the sponsorol'the researchmeans:
A. An equiry(ownership)or investmenlinterest;
B. A positionas director,ofticer, parttrer,trustee.enrployeeof or any other uranagement
position;
C. Incomefiom the sponsor.includingconsultingincome,receive<J
by or promiseclto the
principal investigatorwiflrin 12mon{rs prior to the tirne the awardis made.
D. A gift ttf (fair marketvalue).or multiple gifts promised(fair marketvalue) or more.
F
purposesof this policy,gill includesconlperrsation,
paymentor otherthingsof virluereceived
by facultymember.studentor statfof the $olvlexResearch& HealthEthicsCommittee,Jaipur,
fttnctioning within the researchpr{ect and scope of Ethics Committee roles and
ibilities. For purposes of this pol]icy, examples of "gifts" include the following:
focldand meals
notepads,
tour bags,etc.
or discounteditemswherethe individpalreceivingthe itern is not providinga serviceof
ilaror ereater
value
that
- r
not a part of a formal evalu4tionprocessand/ora Universityconlract
nt to attendmeetingsand travel or oflrer activities,when the individual or unit receiving
the: ,vmentis not providinga serv'ice
of equplor greatervalue.For purposesof this policy "gift"
not includereasonable
hottoraria,prizepor a'wards,payrnentof expenses
to speakerswho
icipatein an accreditededucationalmeetipgconsistentwith standardsfor commercialsupport
lopedby the relevzurtPharmaceutical/Sponsor or honorariaand other paynrentsi
allowed fbr
5.0 dated 11 Feb 2013_SOPs_
SoMex$esearch& Health Ethics Committee,Jaiprur,India
& DraftedBy: Dr. RajkumariSomani,S{Mex Research& Health Ethics Committree
pasee
d & ApprovedBy: Dr. R.C.Andley,SolV{exResearch& Health Ethics Committee
of t2
Jaipur-302019
ByePass,
Gopalpura
80 Road,
Nagar,
ShriGopal
Floor,
277,llnd
-25041
-3212996,
1
0
:
01
41
Fax
2504996
Phone
: 0141
Comminee
SoMexReseqrchHeqlthEthics
A
di
received,includingbut not liln
to any salary wage, honorarium,reimbursement,
, or advance,
mental sponsorof researchi
ions,prof'essional
associations
and
luding private andror publically hell companies,
luntaryhealthorganizations.
definedunder,includeadvancesand rei
mentsfor travel and relatedexpgllses,including
gingandmeals.
A. Travel paymentsmay not be classified gifts or as income,dependingon the c'ircurnstances.
'Iiavel
B.
paymentsare gifts if you did not providedserviceswhich were equalto or greaterin
VA ue thanthe paymentsreceived.
c , ravelpaymentsare incomeif the princi
or
in value than the paymentsrecei
pr
I investigatormust describethe serv
I investigatorprovidedserviceswlrichrvereequalto
When repofiing travel paymentsas income,the
he or sheprovidedin exchangefor the payment.
All personsemployedor empanelled
for SoMex Research& Health Ethics Comrnittee,
Jaipuq rvho have principal responsibiity for a researchproject funded or supported,in
whole or in paft, by a contractor
frorn a nongovemmentalentity, must discloseany
FinancialInterestin the sponsorof
Disclosurestatements
mustbe filed:
l. Before final acceptance
ofsuch a
h.
gtant,or gifi
2. When fundins is renewed.
In the caseof a disclosedFinancialInterest,the disclosurestatementand the research
project must be reviewed by the IndependentSoMex Research& Health Ethics
Committee,Jaipur. Tlie co
ittee akes a recommendationto the Director of SoMex
Research& Health Pvt. Ltd., Jaipur,
providea courseofaction,
5.0 dated 11 Feb 2013 SOPs SoMex
& DraftedBv: Dr. RaikumariSomani.
& ApprovedBy: Dr. R.C.Andley,
& Health Ethics Committee, Jaipur,India
Research& Health Ethics Committee
ex Research& Health Ethics Committee
277,llndFloor,ShriGopalNagar,80
Jaipur-302C119
ByePass,
Gopalpura
Road,
Phone
:0141-321299i6,
-2504110
Fax:0141
Committee
SoMexReseorchHeolthEthics
c,l
ub.iectto putrlicinspection,
UnderttTI of Cov. of India.
projectswhich are tunded in whole or in part by
or teammembershave a FinancialInterest.
L
DocumentationandArchival
and archived in a
have accessto the
periorlof 5 (Five)
Documentsthat will be filed andarctfivedincludebut arenot limitedto.
b.
c.
A
u.
e.
f.
0
h.
The constitution,written standardoppratingproceduresof IRB and regular( half yearly) reports
The CuniculumVitaeof all committoemembers
A recordof all incomeand expensespf IRB, includingallowancesand reimbursements
madeto the secretariatand committeemembers
The publishedguidelinesfor submisslion
established
by IRB
The agendaof the committeemeetin$s
The minutesof the committeemeetings
One copy of all materialssubmittedly an applicant
The correspondence
by IRB memberqwith applicantsor concemedpartiesregarding
application,
decision
andfollow-up.
A copyof thedecisionandmayadviqeor requirements
sentto anapplicant
All
written
documentations
received
the
foltow
J'
up
{uring
k. A notification
of thecompletion,
pre-pature
suspension
or pre-maturetermination
of a
study.
Finalsummaryor finalreportof thesfudy
Reqordkeepingand Archiving
The constitutionand compositionof tfie ethicsCommittee.
The Curriculum vitae of all the comm[tteemembers.
StandardOperatingProceduresfolloqiedby the committee.
Nationaland internationalguidelines
Copies of the Protocol, data collecltionformats, Case Report Forms,
brochuresetc. submittedfor review.
All correspondence with committee members and investigators regarding application
5.0 dated 11 Feb 20I3-SOPs- SoMex Rpsearch& Health Ethics Committee,Jaipur,India
& DraftedBy: Dr; RajkumariSomani,Soffiex Research& Health Ethics commitiee
& ApprovedBy: Dr. R,C.Andley,So\ttexResearch& Health Ethics Committee
Pagell
Jaipur-302019
ByePass,
Gopalpura
80fed,tRoad,
277,llndFloor,ShriGopalNagar,
Fax:0141-2504110
Phone:0141-3212996,2504996
of
t2
ruwSoMexReseorchHeolthEthicsCormmitte
'e
-'"%wJ
b
g
D
h
I
J
k
decisionand follow up.
Agendaof all ethicscommitteemer tngs.
Minutes of all ethicscommitteeme ing with signatureof the Chairperson
Copiesof decisionscommunicated r the applicants.
Recordof all notification issuedfo prematureterminationof a study with a summary
of
the reasons.
Final report of the study includingr crofilms,CompactDisks and/or Video-recordings.
All recordsmust be safely maintai ed after the completion/terminationof the studv
fo
not lessthan 15 yearsfrom the date f completionor terminationof the trial,
required,Subjectexperts may be invi
in the Ethics Committeeas far
to offer their views. Further. based
the also
possible.
T als on humansubjectsin present-day-tirnls are essentialfor the progressof scienrces
to serve
th humanitybetter. It will be the responsilility of both, the investigatoras well as this EC to
CI
ure that thesetrials are done accordingtr nationallyand intemationallylaid-downguidelines
er uring at all times that thesetrails are bei rg done in a most ethical ways and the patientsare
pr fened over societyand science.
) r ,
'ryWr'tt"aaY
RajkumariSomani
M nberSecretary
{ex Research
& HealthEthicsCommittee
v
ion 5.0 dated 1l Feb 2013_SOPs_
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SoMexResearch
& HealttrEthicsCommittee
:arch & Health Ethics Committee,Jaiprur,India
ex Research& Health Ethics Committ,ee
paser2of
x Research& Health Ethics Committee
Jaipur-3020t19
ByePass,
Gopalpura
80ft Road,
ShriGopalNagar,
277,llndFloor,
-25041
10
Phone:0141-3212996,04996Fax: 0141