informed consent form

[Guest guest]

attatching here standard format of INFORMED Consent form as per guidelines given by schedule Y amendment jan 2005

PROFORMA:

(Informed consent form in English Language)

Ref: Schedule-Y (Amendment 20th Jan. 2005)

Format of informed consent form for Subjects participating in a Research Work

Study Title of Research Work:

Study Number of Research Work

Subject’s Name

Subject’s Initials:

Date of Birth or Age in years:

Mark “ √ †in every box

The details of the Research Work have been provided to me in writing and explained to me in my own language. I confirm that I have read, understood the information sheet dated ___________for the above Research Work and have had the opportunity to ask questions.

[ ]

I understand that my participation in the Research Work is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected.

[ ]

I understand that the Sponsor of the Research Work, others working on the Sponsor’s behalf, the Ethics Committee and the regulatory authorities will not need my permission to look at my health records both in respect of the current Research Work and any further research that may be conducted in relation to it, even if I withdraw from the Research Work. I agree to this access. However, I understand that my identity will not be revealed in any information released to third parties or published.

[ ]

I agree not to restrict the use of any data or results that arise from this Research Work provided such a use is only for scientific purpose(s)

[ ]

I agree to take part in the above Research Work

[ ]

Signature (or Thumb impression) of the Subject / Legally Acceptable Representative:_____________

Date: _____/_____/______ Signatory’s Name: ___________________________________________

Signature of the Research Worker : ____________________________

Date:___/_____/______ Study Research Worker Name: ___________________________________

Signature of the Witness ________________

Date:_____/_____/_______ Name of the Witness: ________________________________________

PROFORMA:

(Informed Consent form for participants in MARATHI Language)

oS|dh; la’kks/kukr Hkkx ?ks.;klkBh laerhi=

¼iqujZfpr ‘ksMw;qy Zok;^ P;k ikpO;k ifjf’kâ€Vkuqlkj½

vH;kl f’kâ€kZd% &

vH;kl dksM% &

ukao % &

v|k{kjs%

tUe rkfj[k @ o; %

d`i;k izR;sd pkSdksukr “ √ †v’kh [kw.k djk

1

eh izfriknu djrks@djrs dh] eh ojhy vH;klklaca/kh fn% @ @ jksthps ekfgrhi=d okpys vkf.k letkÅu ?ksrys] rlsp eyk ek÷;k ‘kadk fopkj.;kph la/kh feGkyh

2

eyk tk.kho vkgs dh] ek>k ;k vH;klkrhy lgHkkx Lo;aLQqrZ vkgs vkf.k dkfggh dkj.k u nsrk eh ek?kkj ?ksoqugh ek>h oS|dh; lqJqâ€kk vFkok ek>s dk;ns’khj vf/kdkj vckf/kr jkgrhy-

3

Ekyk tk.kho vkgs dh] tjh eh ek?kkj ?ksryh rjh] ;k vH;klkP;k izk;kstdkauk] R;kaP;korhus dke dj.kk & ;k brjkauk] vkpkj lfefryk vkf.k fu;aa=d laLFkkauk ;k vH;klklacva/kkrhy vf.k R;kP;k’kh fuxMhr HAfoâ€;dkfyu la’kks/kuklaca/kkrhy ek÷;k uksanhps voyksdu dj.;klkBh ek>h ijokuxh ?;koh ykx.kkj ukgh- eh g;kP;k’kh lger vkgs- ijUrq eyk tkf.ko vkgs dh] dksBY;kgh frl & ;k i+{kkl fnysY;k vFkok izdkf’kr dsysY;k ekfgrhr ek>h vksG[k m?kM dsyh tk.kkj ukgh-

4

;k vH;klkrwu fu?k.kk & ;k dks.kR;kgh ekfgrhpk vFkok ifj.kkekapk okij tj QDr oSKkfud dkj.kkalkBh gks.kkj vlsy rj rks okij izfrcfU/kr u dj.;k’kh eh lger vkgs-

5

Ek>h ofjy vH;klkr Hkkx ?ks.;klkBh lgerh vkgs-

lgHkkxh O;fDrph @ frP;k dk;nsekU; izfrfu/khph Lok{kjh

¼vFkok vxB;kpk Blk½

fn % & @ @

Lok{kjhdR;kZps uko

bUOgsfLVxsVjph Lok{kjh%

fn % @ @

bUOgsfLVxsVjps uko %

Lkkf{knkjkph Lok{kjh

fn % @ @

Lkkf{knkjkps ukao

PROFORMA:

(Informed Consent form –ICF-for participants in HINDI Language)

lqfpr lgefr QkWe ¼ iqujZfpr ‘ksMw;qy Zok;^ lwph ds vuqlkj½

v/;;u ‘khâ€kZd

v/;;u dksM %

jksxh dk uke %

jksxh ds vk|k{kj%

tUe frfFk@vk;q

gj pkSdksu es “ √ †fu’kku yxkos

1

Esak iqfâ€V djrk gWaq fd eSus mijksDr v/;;u ds fy, lwpuk i= frfFk @ @

iM vkSj le> yh gS vkSj eq>s iz’u iwNus dk volj fn;k x;k Fkk k

2

eS le>rk gWaw fd bl v/;;u essa esjh Hkkxknkjh LoSfPNd gsS vkSj eS fdlh Hkh le; fcuk dksbZ dkj.k cuk,a] esjh fpfdRlh; ns[kHkky ;k dkuwuh vf/kdkjksa ds izHkkfor gq, fcuk] ;g v/;;u NksMus ds fy, Lora= gq k

3

eS le>rk gWaw fd fpfdRlh; ijh{k.kksa ds izk;kstd] izk;kstd gsrq dk;Z djus okys vU;] vkpkj lfefr vkSj fofu;ked vf/kdkfj;ksa dks orZeku v/;;u vkSj dksbZ vkSj ‘kks/k tks blds laca/k es lapfyr fd;k tk ldrk gS] nksuks ds ekeys esa esjs LokLFk; vfHkys[kks dks ns[kus ds fy, esjh vuqefr dh t:jr ugh gksxh] pkgs esa bl ifj{k.k es ls ckgj gks tkÅ k eS bl igaWp ds fy, lger gWaw k gkykafd] eSa le>rk gWaw fd rhljs nyksa dks tkjh ;k izdkf’kr dh xbZ fdlh tkudkjh esa esjh igpku dk [kqyklk ugh fd;k tk,xk k

4

eS bl v/;;u es feyus okys fdlh Hkh MSVk ;k ifj.kke ds iz;ksx dks izfrcaf/kr u jdus ds fy, lger gWa c’krsZ fd ;s iz;ksx dsoy oSKkfud m|s’;ksa ds fy, gks

5

eS mijksDr v/;;u esa Hkkx ysus ds fy, lger gks k

jksxh ds gLrk{kj ¼ ;k vWaxwBs dk fu’kku ½ @dk;nsekU; izfrfu/kh Lok{kjh --------------

frfFk @ @

gLrk{kjdrkZ dk uke

v/;;u tkWapdrkZ ds gLrk{kj

frfFk @ @

v/;;u tkWapdrkZ dk uke %

Xkokg ds gLrk{kj

frfFk @ @

xokg dk uke %

regardsDr Prashant A ShirureAssistant Prof-PharmacologyDept Of PharmacologyDr S C Govt Med CollegeNanded

3 of 3 File(s)

H-ICF-Hindi.doc

F-ICF-Marathi.doc

D-ICF-Eng.doc