PARTICIPANT’S INFORMED CONSENT FORM
Serial no: ………………………………
Study title: “Surveillance of Health Care Associated Infections in high risk areas (ICUs
and burn ward) of a tertiary care hospital”
Principal Investigators:
Name: …………………………… Name: …………………………...
Email id: ………………………. Email id: ……………………….
Tel no: ………………………….. Tel no: …………………………..
I have received the information sheet on the above study and have read and/or understood the
written information. I have been given the chance to discuss the study and ask questions. I
consent to take part in the study and I am aware that my participation is voluntary. I
understand that I may withdraw at any time without this affecting my future care. I
understand that the information collected about me from my participation in this research and
sections of any of my medical notes may be looked at by responsible persons (ethics
committee members / regulatory authorities). I give access to these individuals to have access
to my records. I understand I will receive a copy of the patient information sheet and the
informed consent form.
I agree to take part in above study.
……………………………………… Date: ...………………..
Signature / left thumb impression Place: ………………...
Name of the Participant: …………………………………
Address: ………………………………………………….
…………………………….............................................
…………………………………………………..
This is to certify that the above consent has been obtained in my presence.
……………………………………….. Date: …………………
Signature of the Principal Investigator
Witness 1 Witness 2
Signature: ………………………... Signature:.………………………..
Name: …………………………….. Name: ………...…………………...
Add :………………………………. Add: ………………………………
…………………………………….. ……………………………………..
PARTICIPATION INFORMATION SHEET
STUDY TITLE: “Surveillance of Health Care Associated Infections in high risk
areas (ICUs and burn ward) of a tertiary care hospital”.
Hospital acquired infections in the hospital causes heavy disease burden, high morbidity and
mortality. I ………………, MBBS student of GMC, am performing a study to analyse the health care
associated infection (HCAI) rate, to identify the common pathogens associated with nosocomial
infections prevalent in various Intensive Care Units and burn wards and to study the resistance shown
by these micro-organisms.This will help in understanding the overall profile of health care associated
infection in our hospital.
Aim of the study: The aim of our study is to provide the HCAI rate, identify the common pathogens
associated with nosocomial infections prevalent in various Intensive Care Units and burn ward of this
hospital and to study the resistance shown by these micro-organisms.We also intend to estimate the
major related risk factors for acquiring HAIs.
Method of study: If you are willing to participate in the study, you will undergo a detailed clinical
examination. A detailed history and clinical examination should be done. Appropriate samples will be
collected from you to determine the HCAIs occurrence; HCAI site, micro-organisms responsible for
HCAI, antimicrobial susceptibility patterns when available, and antibiotic therapy will be identified
and recruited for the study. Samples may include Blood, swabs, urine, ET aspirate, and tracheal
aspirate depending upon the exposures to invasive devices (urinary catheter, central, intravascular
catheter and mechanical ventilation) on the day of, or during the 7 days before the survey will be
noted. The sample will then be send to the microbiology laboratory for further testing.
Duration of Participation: The expected duration of the subject participation is till discharge of the
patient.
Benefits of participating in the study: Your participation will help us to gather current data on the
incidence of HCAIs .This study will help us to identify the common nosocomial infection, HCAIs
site, antibiotic sensitivity shown by these pathogens.
Potential risk: The intended study procedures do not involve any risk.
Participating in this study is not mandatory for you, and is rather optional. If you agree to be a part of
this study, details regarding your clinical status and treatment and its outcome will be included in the
study. There is no adverse effect/added risk/discomfort of taking part in the study. There are no extra
costs of taking part in the study. You may however, withdraw from this study at any point of time as
you wish, without having to give any explanation for the same, and this is in no way going to hamper
your further treatment. Also, all your details will be kept in secrecy and will be made known only to
your care-givers, and will never be disclosed in public.
Principal Investigators:
Name: …………………………… Name: …………………………...
Email id: ………………………. Email id: ……………………….
Tel no: ………………………….. Tel no: …………………………..
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okMZ aesa izpfyr vLirky vf/kxzg.k laØe.k ds lkFk tqM+s jksxtudksa dh igpku djus vkSj bu lw{e thoksa }kjk
fofHkUu jksxk.kqjks/kh ,tsVa ksa ds izfr fn[kk;k x;k izfrjks/k dk v/;;u djuk gSA ge ;g v/;;u HCAIs lacf/kr
tksf[ke dkjdksa dk vuqeku yxkus ds fy, djuk pkgrs gSaA
v/;;u dh fof/k % vxj vki v/;;u esa Hkkx ysus ds fy, rS;kj gSa] rks vkidks ,d foLr`r uSnkfud ijh{kk ls
xqtjuk gksxkA ,d foLr`r bfrgkl vkSj uSnkfud ijh{kk ds fy, fd;k tkuk gksxkA HCAI ?kVuk dk fu/kkZj.k djus
ds fy, mfpr uewus vki ls ,d= fd;k tk,xk ftlds ek/;e ls HCAI lkbV] HCAI ds fy, ftEesnkj lw{e thoks]a
jksxk.kqjks/kh laosnu’khyrk iSVuZ dh tkudkjh fey tk,xh rFkk ,aVhck;ksfVd] laosnu’khyrk dh igpku vkSj v/;;u ds
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¼ tSls ew= dSFksVj] dsna zh; intravascular dSFksVj] vkSj ;kaf=d oaVs hys’ku½ esa 'kkfey fd;k tk,xkA midj.kksa ds
mi;ksx dh vof/k ntZ dh tk,xhA uewuk rks vkxs dh tkap ds fy, lw{e tho foKku iz;ksx’kkyk ds fy, Hkst fn;k
tk,xkA
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v/;;u esa Hkkx ysus ds ykHk % vkidh Hkkxhnkjh gekjh enn djsx
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v/;;u ds izlkj ij ekStwnk MsVk izkIr gksxkA
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bl v/;;u esa Hkkx ysuk vki ds fy, vfuok;Z ugha gS] cfYd oSdfYid gSA ;fn vki bl v/;;u dk ,d fgLlk
gksus ds fy, lger gSa] rks vkids fpfdRlh; fLFkfr vkSj mipkj vkSj mlds ifj.kke ds ckjs esa tkudkjh dks v/;;u
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Hkkx ysus ds fy, dksbZ vfrfjDr [kpZ ugha gksxkA rFkkfi] vki dksbZ Li"Vhdj.k fn, fcuk] bl v/;;u esa Hkkx ysus ls
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iz/kku tkapdrkZ %
uke % -------------------------------------------------------- uke % --------------------------------------------------------
nwjHkk"k % --------------------------------------------------- nwjHkk"k % ----------------------------------------------------
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lhfj;y uacj % -----------------------------------------------
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vf/kxzg.k laØe.k dh fuxjkuh**
iz/kku tkapdrkZ %
uke % -------------------------------------------------------- uke % --------------------------------------------------------
nwjHkk"k % --------------------------------------------------- nwjHkk"k % ----------------------------------------------------
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le>kk gSA eq>s v/;;u ij ppkZ vkSj loky iwNus ds fy, ekSdk fn;k x;k gSA eSa v/;;u esa Hkkx
ysus ds fy, lger gw¡ vkSj eq>s irk gS fd esjh Hkkxhnkjh LoSfPNd gSA eSa le>rk gw¡ fd eSa vius
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le>rk gw¡ fd bl 'kks/k vkSj esjh fpfdRlk i= dh fdlh Hkh oxksZ esa esjh Hkkxhnkjh ls esjs ckjs esa
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}kjk ns[kk tk ldrk gSA eSa vius fjdkWMZ ds mi;ksx djus ds fy, bu O;fDr;ksa dks vuqefr nsrk gw¡A
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eSa Åij v/;;u esa Hkkx ysus ds fy, lger gw¡A
--------------------------------------------------------- ------------ rkjh[k ---------------------------------------------
gLrk{kj@ ckbZ vaxwBs dk fu’kku LFkku
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irk% --------------------------------------------------------
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--------------------------------------------------------- rkjh[k ---------------------------------------------
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xokg 1 xokg 2
gLrk{kj % -------------------------------------------------------- gLrk{kj % --------------------------------------------------------
uke % --------------------------------------------------------------- uke % --------------------------------------------------------------
irk % ---------------------------------------------------------------- irk % ----------------------------------------------------------------
-------------------------------------------------------- ----------------------------------------------------------------
