INSTITUTIONAL ETHICSCOMMITTEE

NIZAM’SINSTITUTE OF MEDICAL SCIENCES PANJAGUTTA

HYDERABAD INDIA

Protecting PatientsGuiding Doctors

1

GENERAL INFORMATION

IECGENERAL INFORMATION

This document for

Institutional Ethics Committee

Of

Nizam's Institute of Medical Sciences

Is

Prepared by Dr.M.U.R.Naidu and Dr.P.Usha Rani Department of Clinical Pharmacology and Therapeutics

INDEX

S.No / SubjectTitle / PageNo.
1 / Composition and Responsibility of IEC / 4
2 / Consentletter of IEC member / 5
3 / Applicationform / 6
4 / Listof essential documents / 7
5 / Acknowledgement of project application / 8
6 / Meetingrequirement / 9
7 / Elements for review / 10-12
8 / Quorumrequirement / 13
9 / IECReview letter format / 14-15
10 / Bibliography / 16

Composition of IEC

IECwill have a chairman , the member secretary and members nominated by the

Director.

IECwill have minimum eight (8) members including:

*2 medical scientists ,

*2 non medical scientists,

*1 nonscientist ( lay person,)

*1legalexpertorretiredjudge.

Responsibilitiesofthe IEC

1. To protect and safeguard the dignity, rights, safety and well being of all actual or potential research participants.

2.To consider the principle of justice, that the benefits and burdens of research be distributed fairly among all groups and classes in societytaking into account age, gender, economic status, culture and ethic consideration.

3.To provide advise to the researchers on all aspects of the welfare and safety of research participantsafter ensuring the scientific soundness of the proposed research.

To

TheDirector,

Nizam's Institute ofMedical Sciences, HYDERABAD- 500 082.

Sir,

Sub:Consent to be a member of IEC

** * *

Iacceptthe invitationtobecomeamemberofIECofNizam'sInstituteofMedical Sciences. Ishall regularlyparticipateintheIECmeetingtoreviewandgivemy unbiased opinion regarding the ethical issues.

Ishall be willingto publicize my full name, profession and affiliation.

Ishall made available to the public on request, allreimbursement for work and expenses if any related to IEC.

Ishall not keep any literature or study related document with me after the discussion and final review.

Ishall maintain all the research project related information confidential and shall not reveal the same to any one other than project related personnel.

Iherewith enclose my CV. Thanking You,

Yourssincerely,

Signature------

Name of Member.------Date

Addressand Telephone No:

Applicationfor Ethical Reviewof Biomedical Research Proposal

To

TheChairman

InstitutionalEthics Committee

Nizam's Institute ofMedical Sciences, Hyderabad.

Full name of applicant :

Date:

Designation:

Complete Postal Address:

Tel.No:(O)® (Fax)

e-mail: Site of study:

ProtocolNO.Version:Date: AmendmentNo.Version: Date:

TitleofProject:

SponsorName: Address:

PrincipalInvestigator: Co-investigator : 1)

2)

3)

NameSignature:

Typeof study: National / International

TypeofTrial:Single center / multi center

Name & Signature of applicantDate:

(Applicationmust be submitted alongwith all essential documents for the review in FORM I. FROM II)

Listof documents to be submitted along withapplication for the IEC Review

ProtocolNo.

Dated:

1) Signed and dated application formon prescribedformat In (FROM I And II)

2) Theprotocoloftheproposedresearch(clearlyidentified,numberedanddated),together with supporting documents and annexes;

3) Asummary(asfaraspossibleinnon-technicallanguage,synopsis,ordiagrammatic representation (flowchart) of the protocol;

4) Adescription(usuallyincludedintheprotocol)oftheethicalconsiderationsinvolvedin the research;

5) Case report forms diary cards and other questionnaires intended for research participants.

6) Incase theresearchinvolvesastudyproduct(suchasapharmaceuticalordeviceunder investigation,an adequatesummaryofallsafety,pharmacologicalpharmaceuticaland toxicologicaldataavailableonthestudyproduct, togetherwithasummaryofclinical experiencewiththestudyproducttodate(e.g.:recentinvestigator'sbrochurepublished data, a summary of the product's characteristics); (Product information)

7) Investigator(s) curriculum vitae (updated, signed and dated)

8) Materialtobeused(includingadvertisements)fortherecruitmentofpotentialresearch participants;

9) A description of the process to be used to obtain and document consent;

10)Written and other forms of information for potential research participants (clearly identifiedanddated)inthelanguage(s)understoodbythepotentialresearchparticipants and, when required, in other languages;

11)Informedconsentform(clearlyidentifiedanddated)inthelanguage(s)understoodbythe potential research participants and when required in other languages.

12)Astatementdescribinganycompensationforstudyparticipation(includingexpensesand access to medical care) to be given to research participants;

13)A description of the arrangements for indemnity, if applicable;

14)Adescriptionofthearrangementsforinsurancecoverageforresearchparticipants,if applicable

15)A statement of agreement to comply with ethicalprinciplessetoutinrelevantguidelines.

16)AllpreviousIEC'sdecisions(e.g.,thoseleadingtoanegativedecisionormodified protocol)by otherECSorregulatoryauthoritiesfortheproposedstudy(whetherinthe samelocationorelsewhere)andanindicationofmodification(s)totheprotocolmadeon that account. The reasons for previous negative decisions must be provided.

Institutional Ethics Committee

Nizam's Institute of Medical Sciences, Hyderabad

Acknowledgement

Date:

*Study Proposal Registration No.NIMS - IEC/2002/0------

Received copies of study proposal.

ProtocolNo. VersionDated: AmendmentNo.: Version : Dated:

Entitled:

FromDr.

Designation

Address

------

Forethical review:

*Name of IEC Staff* Signature:

receiving application:

*Date:

------

* For official use only. Not to be filled by the applicant. (To filled by the applicant in duplicate)

Meetingrequirements

*All the IEC meetings will be held regularly on scheduleddates that are announced and notified in advance.

* Additional review meetings can also be heldwith short notice as and when required.

* Meetingswill be planned in accordance with the need of the work load.

* Member will be given 10 days time in advance to reviewstudy proposals and the relevant documents.

* Minutes of the IEC meetings, all the proceedings and deliberation will be documented.

* Signatures ofall the members who have participated in the meeting will be obtained on the minutes of the meeting document.

* Applicant, sponsor or investigator may be invited to present the proposal or elaborate on specific issues.

* Independent expert may be invited to the meeting or to provide written comment, subject to applicable confidentiality agreement.

ElementsFor Review

Following are the element to be reviewed by the IEC members

Scientific design and conduct of the Study.

1) Theappropriatenessofthestudydesigninrelationtotheobjectivesofthestudy,the statisticalmethodology(includingsamplesizecalculation),andthepotentialforreaching sound conclusions with the smallestnumber of research participants.

2) Thejustificationofpredictablerisksandinconveniencesweighedagainsttheanticipated benefits for the research participants and the concerned communities;

3) The justification for the use ofcontrol arms;

4) Criteria for prematurely withdrawingresearch participants;

5) Criteria for suspending or terminating the research as a whole

6) The adequacy of provisions made for monitoring and auditing the conduct of the research, including the constitution ofa data safety monitoring committee (DSMC).

7) The adequacy of the site, including the supporting staff, available facilities and emergency procedures;

8) The manner in which the results of the research will be reported and published..

Recruitmentof research participants:

1) The characteristics of the population from which the research participants will be drawn(including gender, age, literacy,culture, economic status and ethnicity).

2) The means by which initial contact and recruitment is to be conducted.

3) Themeansbywhichfullinformationistobeconveyedtopotentialresearchparticipants or their representatives.

4) Inclusion criteria for research participants

5) Exclusion criteria for research participants.

Careand protection of research participants

1.Thesuitabilityoftheinvestigator(s)'squalificationsandexperienceforthe proposed study;

2.Anyplanstowithdraworwithholdstandardtherapiesforthepurposeofthe research andthe justification for suchaction;

3.Themedicalcaretobeprovidedtoresearchparticipantsduringandafterthe course of the research;

4.The adequacy of medical supervision and psycho-social support for the research participants.

5.Stepstobetakenifresearchparticipantsvoluntarilywithdrawduringthe course of the research.

6.The criteria for extended access to the emergency use of and/or the compassionate use of study products;

7.The arrangements, if appropriate for informing the research participants general practitioner (family doctor), including procedures for seeking the participant's consent to do so.

8.Adescriptionofanyplanstomakethestudyproductavailabletotheresearch participants following the research;

9.A description of any financial costs to research participants.

10.Therewardsandcompensationsforresearchparticipants(includingmoney, services, and /or gifts).

11.Theprovisionsforcompensation/treatmentinthecaseoftheinjurydisability/

deathof a research participant attributable to participation in the research.

12.The insurance and indemnity arrangements.

Protectionofresearchparticipant confidentiality

1.A description ofthe persons who will have access to personal data of

theresearch participants,including medical records and biological samples.

2.The measures taken to ensure the confidentiality and security ofpersonal information concerning research participants.

Informedconsent process

1. A full description of the process for obtaining informed consent, including the identification of those responsible for obtaining consent;

2.The adequacy, completeness, and understandability of written and oral information to be given to the researchparticipants and when appropriate, their legally acceptable representative(s).

3.Clear justification for theintention to include in the research individuals who cannot consent, and a full account of the arrangements for obtaining consent or authorization for the participation of such individuals;

4.Assurances that research participants will receive information that becomes available during the course of the research relevant to their participation (including their rights, safety and well-being).

5.The provisions made for receiving and responding to queries and complaints from research participants ortheir representatives during the course of a research project.

CommunityConsiderations

1) Theimpactandrelevanceoftheresearchonthelocalcommunityandontheconcerned communities fromwhich the research participants are drawn.

2) The steps taken to consult with the concerned communities during the course of designing the research;

3) The influence of the communityon the consent ofindividuals.

4) Proposed community consultation during the course of the research

5) The extent to which the research contributes to capacity building, such as the enhancementof localhealthcare,researchandtheabilitytorespondtopublichealth needs;

6) Adescriptionoftheavailabilityandaffordabilityofanysuccessfulstudyproducttothe concerned communities following the research.

7) Themannerinwhichtheresultsoftheresearchwillbemadeavailabletotheresearch participants and the concerned communities.

Quorumrequirements

1.Minimum5membersare requiredtocomposethe quorum

2.Noquorumshouldconsistentirelyofmembersofoneprofession.

Quorumwill include at least one member as non scientific(lay person),atleastone whois independent oftheNizam'sinstituteof

medicalsciences andat least onemedical scientist.

3.Forexpeditedreview,minimumof3membersarerequiredofwhichone mustbeexpertinthe areaofresearchproposal.

InstitutionalEthics Committee

Nizam's Institute ofMedical Sciences, Hyderabad,India

"ProtectingPatients, Guiding Doctors"

Review letter No. IEC/NIMS/ Date:

To

Ethics Committee of Nizam's Institute of Medical Sciences, Hyderabad, India, in its_

Meetingheldonathoursinthemeetingroom------reviewed and discussed the study proposal with Protocol No.

Version dated.Amendment No.version

dated

Entitled"

.

Submitted by Dr.,

Members present:Members Absent:

Name Affiliation Gender Name Affiliation Gender

1.1.

2.2.

3.

4.

5.

6.

Members reviewed the following documents:

1Protocol ()2. Amendment() 3. Written informed consent ()

4.Investigator's Brochure ()5. Available safety information ()

6.Subject recruitment procedure() 7. Payments and compensation to subject ()

8.Subject information sheet ()9. Investigator's C.V. ()10.Others ()

Thememberspresent, presentedaquorum,beingatleast50%plusoneofallthemembers,and havingatleastonmedicallyqualifiedpersonandatleastonelaypersonpresentfromoutsidethe institute.

Issues discussed and reviewed:

Ofmembers present, voted of approval, voted against and were absent.

After consideration, the committee has decided to approve / not to approve/ suggested resubmmission after required modification / subject to . Thepresent approval is valid only for one year, investigator must take the reapproval after one year.

Theinvestigatorisrequestedtosubmittheprogressreportafter6monthstoIECforreview. Anychange,modificationordeviationintheprotocol,oranyadverseeventmustbeinformedto ethics committee. Any protocol modification or amendment must receive IEC approval. Investigator should conduct the study as per the recommended GCP guidelines.

Chairman

InstitutionalEthics Committee

Name: Signature: Date:

APPLICATION PROCEDURE

AllPrincipalInvestigatorsarerequestedtosubmit(notmorethan3)newproject proposalsforthe review ofEthicsCommittee onor beforescheduledate as published to theInstitutionalEthics CommitteeOffice,Room.No.13,Opp.toDean’sOfficein prescribed proforma in 11 setsforconsideration.

ApplicationshouldbesentalongwithdulyfilledProformaIandII.Principal InvestigatorsarerequestedtoprovidetheinformationinthisProforma-Iforreview alongwithprotocolproposal. PrincipalInvestigatormustfilltherelevantinformationin proformaIIandencloseforEthicscommitteemeeting.AlltheProformaeareavailable atIECOfficeandPrincipalInvestigatorsarerequestedtocopythe proformaeintheir floppy.

Thenew projects will be taken upon first come first basis.

NIMS-IEC/AP-01PROFORMA–I

INSTITUTIONALETHICS COMMITTEE (IEC) NIZAM’S INSTITUTE OF MEDICAL SCIENCES PANJAGUTTA , HYDERABAD – 500 082

PROTOCOLSUBMISSIONFORMIECProjectRegistrationNo: Date:

1.Title of the Project, ProtocolNumber,VersionDate:

2.PrincipalInvestigator:

2.1NameoftheInvestigator:

2.2.Qualifications

MDDMMSMChPhD

Others

2.3FacultyResidentother

2.4Designation:

2.5Department:

3.Co-Investigators or Guides / Co-Guides:

3.1.1.Name of the Co- Investigator 1 Guides / Co-Guide

3.1.2 Qualifications

MDDMMSMChPhD

Others

3.1.3 Department:

3.1.4 Name ofthe Institution:

3.2.1.Name of the Co- Investigator 2, Guides / Co-Guide

3.2.2 Qualifications

MDDMMSMChPhD

Others

3.2.3 Department:

3.1.4 Name ofthe Institution:

3.3.1.Name of the Co- Investigator 3, Guide or Co-Guide;

3.3.2 Qualifications

MDDMMSMChPhD

Others

3.3.3 Department:

3.3.4 Name ofthe Institution:

3.4.1.Name of the Co- Investigator 4, Guide or Co-Guide;

3.4.2.Qualifications

MDDMMSMChPhD

Others

3.4.3 Department:

3.4.4 Name ofthe Institution:

Note:If more co-investigators/ Co-Guides are involved, please photocopy thisformanduse

4.Levelofreviewrequired:

FullExpedited / Amendment
cademicProjects).
5.
5.1 / Fundingsource:
InternalFunding(Only forA
5.2 / ExternalFunding
5.2.1 / National / International
5.2.2 / NationalAgency / CRO / Industry
OtherSpecify
Name ofthe Funding Agency

Addressand Contact Details ofFunding Source

6.0Performance Sites:

Hasapplicationbeenreviewedbyany other hospital/ Institute / DCGI/

appropriateregulatory authority:

YesNoUnder reviewNot applicable

6.1AdditionalPerformanceSites /Collaborating Centers

Anyothersites are involved in the present study? YesNoN/A

Ifyes, Please fill thefollowingtables:

S.No. / Listofothersites

7.Purpose of the study:

Pleasesummarize the purpose of the study using non-technical language

8.DescriptionofHumanSubjectPopulation:

Humansubjectmeansalivingindividualaboutwhomaninvestigator

(whetherprofessional or student) conductsresearchandobtains

a.Data through intervention on interactionwiththeindividual,or

b.Identifiable private information (i.e, pathological specimens, medical recordsetc.,)

Pleaseanswerthequestionsbelow forthe subject population tobe enrolled at Nizam’s

Instituteof MedicalSciences,Hyderabad.

8.1Proposed number ofresearchparticipants required/randomised:

8.2Estimated total number of individuals who would be consented and screened for the study to obtainthe number of evaluable subjects.

8.2Age Range

1-6yrs.7-17 yrs

18-60yrs>60yrs

8.3Typesofsubjects

Inpatients

Out patients

HealthyVolunteers

Others:Specify:

8.4Will the study be formed on both genders?

YesNo

IfNojustify

8.5Willspecialpopulationbeincludedintheresearch?

YesNo

Ifyes, complete thefollowing:

Minorunder age 18 / Pregnant women / Fetus/fetaltissue
Prisoners / Economicallydisadvantaged

Individuals with mentalretardationElderly subjects (>70yrs)

Others(specify:

8.6Providerational for usingspecialpopulation:

Thegroupslistedinabovesection8.6areconsideredvulnerableandrequire special consideration by federal regulatory agencies and/or IEC.

9.Recruitment Procedures:

9.1Will advertisement be used to recruit subjects?

YesNo

Ifyes, will the following:

BrochuresNewslettersFlyers Posters

RadioTelevisionReferral letters

InternetOther (Specify:)

9.2Describewhowillmakeinitialcontact with the potential subject:

10Informed Consent:

10.1. Will informed consent be obtainedfrom the subjects participating in this

Study?

YesNo

IfNo submitsupplementalWaiver of content / Authorization

10.2How will informed consent be obtained frompotential study Participants?

OralWritten

10.3Willbe informedconsentbe translatedina locallanguage?

YesNo

11.Informed Consent Process:

Thefollowing questions pertaining to the informed consent processhavetobe answered:

11.1Will subjects have the capacity to give informed consent?

YesNo

IfNo,describethelikelyrangeofimpairmentand explainhow, andby whom their capacity to consent will be determined. Individuals who lackthecapacitytoconsent may participate in research only if a legallyauthorizedrepresentativegivesconsenton

theirbehalf.

11.2In relation to the actual data gathering,whenandwherewillconsentbe discussed and documentation obtained (for example, pre-operativelyor severaldays

beforestudyprocedures commence)?Specificanswer

11.2How will you determine whether the subject understands the study? By Questionnaire: FeedBack Others

12.Description of Study

12.1Describetheproceduresortasks/teststhesubjectswillbeaskedto complete or undergo using non-technical language.

(Explainstep by step whatthe subjectswill beaskedtodo and distinguish those which are experimental from those comprisingroutine clinicalcare.)

12.1Doestheresearchinvolve the use of any drugs?

YesNo

Ifyes, please submit the Drug information Brochure/ Investigator’s Brochure

12.2Doestheresearchinvolve the use of any device?

YesNo

Ifyes, Please submit the device information Brochure

12.3Does the research involvethefollowing?

AnySurgicalProcedure

Useofradioisotopesorradioactiveagents (if so please submit detail

Information)

Invasivetechniques

Changesin diet or exercise

Useof medical records

DeprivationofPhysiologicalrequirements such as nutrition or sleep.

Collectionof personal or sensitiveinformation

Others(Pleasespecify:)

12.4Doesthestudy involveblooddrawing,bioipsyof tissue,marrowbiopsy, etc? If Yes, mention how much an how often the samples are drawn and also statethe rational behind these sampling.

12.5Willmaterialbecollectedforgeneticanalysis?

YesNo

Ifyes, describe procedureinvolvedforanalysisandsubmitapprovalfromthe appropriateregulatory body.

13.ProtectedInformation:

Indicatethe personal information that will be collected about study subjects during the participationinthisstudy

NameAddressAge / Date of birth

Legallyacceptedrepresentative’sNameandAddress

Telephone/Mobile/Fax/Emailaddressnumbers

MedicalRecord Numbers

Others(PleaseSpecify:)

14.Confidentiality:

14.1Where and how will the data be stored, and who willsupervise access to the datetoensurethatconfidentialityismaintained?

14.2Describe how, where and howlong the datais stored?

Ifelectronic data (eg. ECRF, audio orvideotapes) are used howlong they will be stored, and if they aremeant fordisposal how will they be disposed?

15.Risks of the Research

15.1Identifytherisks(current and potential)and describethe expected frequency, degreeofseverity,potentialreversibility. Include any potentiallate effects.

15.2Describetheprecautionstakentominimizetherisk

15.3Pleasejustifytherisksin relation to the anticipated benefits to thesubjects and inrelationtotheimportanceoftheknowledge that may reasonably be expected to resultfromtheresearch

15.4Describe the standard medical care provided to the subjects duringandafter the researchperiod.

15.5Willtheinvestigationalproduct bemadeavailable tothe study subjects after the completionoftheresearch?

YesNoN/A

15.6Is there any insurancecoverage fortrialsubjectsandtrialparticipants?

YesNoN/A

Ifyes, provide their details.

15.7Describetheprocedures forsubjectwithdrawal.

15.8Describetheproceduresfor studysuspension/termination.

15.9Are there any plans for withholding the standard medication during the research?

ifyes, justify

YesNo

16Data and safety Monitoring Plan

16.1Is there a data safety monitoring board or committee toreview this study for safety and adherence to the study protocol?

YesNo

16.2Provide a general description of the dataandsafety-monitoringplanwhichmust include, at a minimum,adescriptionof thereportingmechanismof serious/unexpectedadverseeventstoIEC, the sponsor and DCGI(ifapplicable)

16.3Describetheproceduresformanagingthe studyrelatedinjuries (adverse Events)

17Benefits of Participation

Listany anticipated direct benefits of participationinthisresearchproject.

18AlternativestoParticipation.

Listappropriatealternativeclinicalprocedures of courses of treatment available to subjects.

19.Compensation for Participation

Willthe subjects be paid or otherwisecompensatedforparticipation?

YesNo

Ifyes, what incentives,compensation, travel money, orother reimbursement will be giventothesubjects?Isthereclauseoncompensation due to study related injury Please provide the detailed information.

20.Doestheprotocolrequireanyissuesto be answered by a specific community?

YesNo

Ifyes, describe

21.Detailsofcontactpersonsofresearchteamforanyqueriesduring research period.

22.Investigator’sAssurance

ICertify that the information providedbymeiscompleteandcorrect.

IunderstandthatasprincipalInvestigator,Iwilltakefullresponsibilityforthe protectionofrightsandwelfareofalltrialsubjectsincludingtheconductofstudy andethicalperformanceoftheproject.

IagreetocomplywillallrulesandregulationsofIECandNizam’sInstituteof

MedicalSciences of the conduct ofthe trial. I here by declare.

 Qualifiedpersonnelaccordingto IEC will conduct thestudy.

 Nochangewillbemadeintheprotocolorconsentformuntilapprovedbythe

IEC.

 LegallyeffectiveinformedconsentwillbetakenfromHumansubjectsif applicable.

 AdverseeventswillbereportedtoIECasperICHGCP/DCGIAdverseevent reporting policy.

Ifurthercertifythattheproposedresearchisnotcurrentlybeingconductedandwill notbegin until IEC approval has been obtained.

Investigators / Name / Signature / Date
PrincipalInvestigator
Co-Investigator1/Guide/ Co-Guide
Co-Investigator2/Guide/ Co-Guide
Co-Investigator3/Guide/ Co-Guide
Co-Investigator4 / Guide/ Co-Guide

NIMS-IEC/AP-02PROFORMAII

IECRegnNo: Protocol Title: Name ofPI:

Markandcomment on whatever items applicable to thestudy

1 / Objectivesof the Study
clearunclear / Whatshould be improved?
2 / Methodology:
clearunclear / Whatshould be improved?
3 / BackgroundInformationand Data
sufficientinsufficient / Comment:
4 / Risks and Benefits Assessment
acceptableunacceptable / Comment:
5 / Inclusion Criteria
appropriateinappropriate / Comment:
6 / Exclusion Criteria
appropriateinappropriate / Comment:
7 / Discontinuation and Withdrawal Criteria
appropriateinappropriate / Comment:
8 / Involvement of Vulnerable Participants
YesNo / Comment:
9 / Sufficient number of participants?
YesNo / Comment:
10 / Control Arms (placebo, if any)
YesNo / Comment:
11 / Contents ofthe Informed Consent / Comment:
Document
clearunclear
12 / Language of the Informed Consent
Document
clearunclear / Comment:
13 / Privacy& Confidentiality in Informed
Consent Document
YesNo / Comment:
14 / Inducement for Participation
UnlikelyLikely / Comment:
15 / Provision for MedicalSupport
appropriateinappropriate / Comment:
16 / Provision for Treatmentof Study-Related
Injuries
appropriateinappropriate / Comment:
17 / Provision for Compensation
appropriateinappropriate / Comment:
18 / Studydesign
appropriateinappropriate / Comment:
19 / Randomisation and Blinding
appropriateinappropriate / Comment:
20 / Statistical analysis
appropriateinappropriate / Comment:

Anyspecificcomments:

Name of the reviewer:

Signature:Date:

SOPNo.: NIMS-IEC-016FORM–I

Amendment ReportingForm

1. IEC project registration no:

2. Titleofthe Project:

3. ProtocolNumber,version& date: