Principal Investigator Sname

EthicalReviewCommittee Foundation UniversityMedicalCollege Islamabad, Pakistan

APPLICATION FORM

PRINCIPAL INVESTIGATOR’SNAME:

DESIGNATION:

DEPARTMENT:

Checklist

A copyofERCApplication. A copyofResearch Protocol.

A copyof Drug Brochureor anysupplementaryinformation enclosed(ifapplicable).

AcopyofinformedconsentinEnglish,Urduoranyotherlocallanguageofthe population study.

A copyofQuestionnairebeing administered duringthe study(ifapplicable).

A List of Researchers Involved.

------Signature: PrincipalInvestigator Date

------Signatureof supervisor(if applicable) Date

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Signatureof Head oftheDepartment Date

GUIDELINES FOR APPLICANTS:

Thestudyproject shouldbesubmitted to president ERC for reviewbythecommittee. Following aretherequirementsforthe submission to ERC at least two weeks priorto ERC meetingwhich takes place everythird Tuesdayofthe month.

1. Pleaseanswerallquestions.Itistheresponsibilityofresearchertofilltheapplication formappropriately.Incompletely andinappropriately filledformwillnotbeaccepted forreviewanddiscussioninthecommitteeanditmayresultindelayinapprovalof the proposal.

2. Incaseofurgency,astrongjustificationshouldbeprovidedforanexpeditedreview andapprovalsuchasmeetingadeadlineforfunding etc.Evenincaseofexpedited review, itmaytake7-10days ingranting approvalif thereis no ethical issue.

3. ApplicationmustbesignedbyprimaryinvestigatorandHeadofDepartment.Incase

ofstudent’s/ resident’s application, itshould besigned bysupervisor also.

4. Onesoftcopyandthreehardcopiesofthestudy projectwithreferencesandanyother supporting documents have to be deposited. The research protocol must have followingimportant information:

a. A briefbackground ofthestudyindicatingthe need forthe study. b. Materials and methods used in thestudy

c. Expected duration ofthestudyperiod(to completion). d. Expected duration ofstudyon each individual subject.

e. Criteria forinclusion andexclusion ofpatients and controls

5. Alongwith research protocol followingother documents areneeded to bedeposited. a. Investigator’s Curriculum vitae

b. Informedconsentformgiventopatientsorstudysubjects(Ifapplicable)in English,Urduorany otherlocallanguagewhichresearchparticipantscan easilyunderstand. (A sample consent form isgiven within the application)

c. A filled copyof oneof questionnaire(Ifapplicable)

6. Whentheresearchinvolvesastudyproduct(suchasapharmaceuticalordeviceunder investigation),anadequatesummary ofallsafety,pharmacologicalpharmaceutical, andtoxicologicaldataavailableonthestudy product,togetherwithasummary of clinicalexperiencewiththestudy producttodateshouldbesubmitted(e.g.,recent investigator’s brochure,published data, asummaryofthe product’scharacteristics)

7. All significant previous decisions (e.g. those leading to a negative decision or modifiedprotocolwhetherinthesamelocation orelsewhere)by otherERCsorany otherregulatoryauthorities forthe proposed studyshould beprovided.

1) Titleof StudyProtocol ------

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2) Investigatorsdetails

3)Thisproject/researchinvolvestheuseof:

(Check allpertinent ones)

4)Pleaseindicatesourceoffundingandhasfundingbeenapproved?

5)Subject information.

a) Group: Patients Students Others

b) Age range:

c)Gender: Male Female Both

d) Ifsubjectsarechildren,pregnantwomen,mentally retarded,orprisoners,orifit includesfoetalresearch,give briefexplanationof needtouse these particular individuals.

6)Compensation:

a) To researchsubject:

b) Investigators:

Ifyes, then:

Yes No

Monetary: Travel: Gifts: Amount: Other Specify:

7)Adverse effects:

a) Describeadverse effects/risks expected to the subjects involved in the investigation duringthe study?

b) What is the provision for managingtheseeffects and if requiredwho is going to payfor them?

c) Incaseswhere therapeuticneedofthe researchsubjectisidentifiedduringthe course ofthestudy,whatistheprovisionfor managingthesecasesandwho will pay for them?

d) Willany testsbeperformedwhicharenotroutinelyincludedaspartofthe work-upforthesetypesofpatientsandwhoorwhatagencywillpayforthese tests?

8)Locationof study:

OPD: Inpatients

Wards:

FUMC/FFH Department:

9)

Other than FFH/FUMC (please specify the location):

10) Whatare theactualpotentialbenefitsifany,tobeobtained?

a) Byparticipants?

b) Bysocietyasa resultof this study?

c) Anybenefit of thestudytothe fundingagencyorsponsors?

d) Anybenefit of thestudyto institutionwherestudyis beingconducted?

11) How willconfidentialityof the subjectsbeensured?

12)How willthestudyfindingsbeshared with studysubjects, department andatinstitutionasawhole?

13) Any other information relevant to the study in context to

Pakistan?

14)Is thereany similar study conductedelsewhere earlier? If yes where? Please give positive and negative points in it.

Guidelinesfordraftinganinformedconsentform

1.Allstudiesinvolving humansubjectsshouldhaveaproperlydraftedconsentform.No study shouldbedoneonhumansubjectswithoutobtaininginformedconsentand sufficientlybeforethe start ofthe study,at anappropriatetime, and not at atime when he/sheisunderstresssuchassurgicalprocedure,andisunabletounderstandthe study.

2.Consent maybewrittenorverbal or telephonic.In caseofunwritten consent, it should besignedbythe person takingtheconsent and witnessed byasecond person.

3. Incaseof, consentfromguardian / parents is needed.

4.Incaseofamentallyorphysicallyincapacitatedsubjectorchildren,consentshould be obtainedfromparents/guardianorimmediaterelativesuchas,wifeor husband, fatheror mother,brotheror sisteretc.

5. In case of community studies, communityleaders, elders, local political leaders, religiousleaders(in certaincases), andgovernmentalofficialsshouldbetakeninto confidence, and awrittenconsent should be obtained.

6. In case of doing a study in other locations such as other hospitals and clinics, permission from appropriate authorityor physicians should also be obtained.

7. TheconsentformshouldbeinEnglish,Urduorotherlocallanguageifneeded.These shouldbeidenticalinsuchaway thatthetranslationofoneintootherissimilar.The languageshouldbeeasywhichcanbeunderstoodby studysubjects(uneducatedor primarypassed). Useof technical terms should be avoided.

8. A properlydraftedconsent form should contain the followingimportant points.

a) Informationsheet.Thereshouldbeoneparagraphorpagegivinginformation aboutthe nature of study,itspurpose andneed,possible benefitsof the study,and procedures to becarriedout on thestudysubjects.

b) Possible risksand benefits to the studysubjects

c) Availabilityof alternate treatment in caseof therapeutictrials

d) Voluntary participationwithoutanycompulsion,moralorotherwiseandwithout any financialincentiveorcoercion.However,financialassistanceor reimbursementfortimeandtravelingmay/shouldbeprovidedtostudy subjects; which should commensurate with the timespent,and should not be too high.

e) Righttowithdrawfromthestudy atany timewithoutaffectingtheirrightsand treatment.

f) Confidentiality

g) Ifanyspecimenistobestored,itstimeofstorageandpermissiontouseitin furtherresearch.

h) Nameandcontactnumberoftheinvestigatorincasethestudysubjectwants further clarification orinformation about study.

i)Authorization from study subjects with their signature, thumb impression, signatureof witness etc.

FOUNDATIONUNIVERSITYMEDICALCOLLEGE

CONSENTFORM

For MINIMALRISKMedical HumanSubject Research

(e.g., forblood draws, data collection, leftoverspecimens, interviews, surveysetc.)

-Instructional text appears in red and should be removed prior to submissionto theERC.

- Red text in parentheses( )should be replaced byinformation foryour study, e.g.,(your namehere)

CONTACT INFORMATION:

Name ofStudyprotocolDirector------Address and phonenumber ------

------

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DESCRIPTION: Youareinvited to participateina research studyon

(describeproject in non-technical language; includetypes of questions thatwillbe asked,if applicable;

 (Explain purposeofthe research).

(Describeprocedures, questions, survey, mention video/audio recording (if applicable),and what will become oftapes after use, e.g., shown at scientific meetings; describethefinal disposition ofthe material, data,recording).

RISKSAND BENEFITS:

The risksassociatedwith this studyare(describeforeseeable risksor discomfort to subjects;if none, state assuch).

 Thebenefits which mayreasonablybeexpected toresultfrom this studyare

(describe anybenefits;if none, state as such).

Yourdecision whether ornot to participate in this studywillnot affectyour employment/medical care.

TIME INVOLVEMENT:Yourparticipation in this experiment will takeapproximately

(amountoftime).

PAYMENTS: You will receive (describereimbursement; wherethereis none, state as such)as payment foryour participation.

PARTICIPANT’S RIGHTS:Ifyou haveread this form and havedecidedto participatein this project, pleaseunderstand that

Yourparticipation is voluntaryandyou havethe right to withdrawyourconsent or discontinueparticipationat anytime without penaltyor loss of benefits to which you areotherwise entitled.

 You havetheright to refuse to answer particularquestions.

Ifyou agree,your identitywillbemadeknown; otherwise your privacywill be maintained in all published and written data resultingfrom the study.

EXPERIMENTAL SUBJECTSBILL OFRIGHTS:As a research participantkindly check that whetheryourfollowingrightshavebeen fulfilled:

 Beinformed of thenature and purposeof the experiment;

begiven an explanationofthe procedures to be followed in themedicalexperiment, and anydrugor devicetobeutilized;

Begivenadescription of anyattendant discomforts and risks reasonablytobe expected;

Begivenan explanation of anybenefits to the subject reasonablyto be expected, if applicable;

Begivenadisclosureofanyappropriate alternatives, drugs or devices thatmight be advantageous to the subject, their relative risksand benefits;

Beinformed of theavenues of medical treatment, if anyavailableto thesubject after the experiment if complications should arise;

Begivenan opportunityto ask questions concerningtheexperiment or theprocedures involved;

Beinstructed that consent to participate in the medical experiment maybewithdrawn at anytime andyoumaydiscontinueparticipation withoutprejudice;

 Begivena copyof thesignedand datedconsent form;and

Begiven theopportunityto decide to consentornot to consent to amedical experiment without theintervention of anyelement of force,fraud,deceit, duress, coercion or undueinfluenceon the subject's decision.

The extra copyof this consent form is foryou to keep.

Signatureof Adult Participant Date

When consent is obtained from legallyauthorizedrepresentativeLAR (e.g., parent(s), guardian), includethesesignaturelines forrepresentatives and adescription of their authorityto act forthe participant:

Signatureof Parent, Guardian Date

PersonObtaining Consent

I attest that the requirements forinformed consent forthe medical researchproject described in this form havebeen satisfied– that the subjecthas been provided with theExperimental Subject’s Bill of Rights, if appropriate, thatIhavediscussed theresearch project with the subject and explained to him or her in non-technical terms allof theinformation contained in this informed consent form, includinganyrisksand adversereactions that mayreasonablybe expected to occur. Ifurther certifythatIencouraged thesubject to ask questions and that all questions askedwere answered.

Signatureof Person ObtainingConsent Date

The following witness lineis to besigned onlyifthe consent is provided as a summary form and accompanied bya short formforeign language consent.

Signatureof witness Date

(e.g., staff, translator/interpreter, familymember,orotherperson who speaks both English

and the participant’s language)

 Translated short form mustbesignedand dated by both theparticipant(andtheirLAR)

and the witness.

 TheEnglish consent form (summaryform) mustbesigned bythe witnessand the POC.

Thenon-English speakingparticipant does notsigntheEnglishconsent.