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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