To,

The Chairman
Institutional Ethics Review Committee (IERC) / Scientific Committee
MGM’s Medical College,
Kamothe, Navi Mumbai.
Subject: Submission of Dissertation Protocol for the course of Doctor in Medicine in
Pathology(through proper channel)
Sir/Madam,
I, DR. SOURADIP PURNASIS BHADURI, have registered for the course of DOCTOR OF
MEDICINE(M.D.) in Pathology at MGM’s Institute of Health Sciences, Navi Mumbai, for the
batch starting from Academic year 2023. I am submitting herewith my Dissertation Protocol in
quintuplicate (Five copies) for approval from Ethical Committee, MGM’s Institute of Health
Sciences, Navi Mumbai.

Thanking you,
Yours sincerely,
DR. SOURADIP PURNASIS BHADURI
Postgraduate Student

DR.Mgm
PRIYANKA NIMBALKAR JADHAV Mgm DR.
Navi Mumbai NaviADITYA
Mumbai NAYAK DR. SHILPI SAHU
Postgraduate student guide Co Guide Professor & Head
Associate Professor Associate Professor Department of Pathology
Department of Pathology Department of General Medicine MGM Medical College
MGM Medical College MGM Medical College Navi Mumbai
Navi Mumbai Navi Mumbai

1
 MGM’S MEDICAL COLLEGE
KAMOTHE, NAVI MUMBAI

“TO STUDY DIAGNOSTIC UTILITY OF IMMUNOFLUORESCENCE IN RENAL

DISEASES”

Protocol for M.D. (PATHOLOGY)

2023 – 2026

By

DR. SOURADIP PURNASIS BHADURI

Under the guidance of

DR. PRIYANKA NIMBALKAR JADHAV

Associate Professor

Department of Pathology

DR. PRIYANKA NIMBALKAR JADHAV DR. SHILPI SAHU DR. G.S.NARSHETTY

Postgraduate student guide Professor & Head Dean
Associate Professor Department of Pathology MGM Medical College
Department of Pathology MGM Medical College Navi Mumbai
MGM Medical College Navi Mumbai
Navi Mumbai

2
 Mahatma Gandhi Mission
MEDICAL COLLEGE
Sector-1, Kamothe, Navi Mumbai - 410 209,India
Ph: (022) 2 7433404, 27437992 Fax: (022) 27420320
E-mail: mgmmcnb@igmail.com, Web: www.mgmuhs.com

Date:
Through Proper Channel

To,
Chairman
Institutional SAC/IEC
MGM Medical College, Kamothe/Kalamboli
Navi Mumbai

Sub.: Submission of Thesis Protocol

Sir/Madam,

I, DR. SOURADIP PURNASIS BHADURI have a joined as PG Resident for MD/MS in subject of
PATHOLOGY under the PG Teacher DR.PRIYANKA NIMBALKAR JADHAV, Associate Professor, at
Mahatma Gandhi Mission’s Medical College, Kamothe, Navi Mumbai for 2023-26 Batch.

I am here by submitting my Thesis Topic & Protocol as given below:

“TO STUDY DIAGNOSTIC UTILITY OF IMMUNOFLUORESCENCE IN RENAL DISEASES”

Thanking you,
Yours sincerely,
Dr. SOURADIP PURNASIS BHADURI
(M.D. Pathology)

DR. PRIYANKA NIMBALKAR JADHAV DR. ADITYA NAYAK DR. SHILPI SAHU
Postgraduate student guide Co Guide Professor & Head
Associate Professor Associate Professor Department of Pathology
Department of Pathology Department of General Medicine MGM Medical College
MGM Medical College MGM Medical College Navi Mumbai
Navi Mumbai Navi Mumbai
INDEX
3
Sl. No. Particulars Page no.

1 Introduction 05

2 Aim and Objectives of study 06

3 Literature Review 06

4 Materials and Methods 07

5 Inclusion and exclusion criteria 07

6 Pro forma of the study 08

7 Ethical aspect of the project and funding details 09

8 Expected outcome of the study 11

9 References 12

10 Consent form 13

4
INTRODUCTION

The prevalence of chronic kidney disease (CKD) is estimated to be 8-16% worldwide with an
aging population, and rising levels of hypertension, diabetes and obesity, renal diseases pose an
increasing burden on public healthcare. Two million people worldwide are currently on renal
replacement therapy (RRT), dialysis or have a renal transplant. However, this figure makes up
only ∼ 10% of all individuals who actually need renal replacement therapy, with a greater number
dying due to the inadequate availability of therapies and skewed treatment towards affluent
countries with access to healthcare. Furthermore, kidney disease represents an independent risk
factor for cardiovascular mortality.

Individuals often present with complex renal pathologies resulting from numerous insults, both
genetic and environmental. The interactions of combined metabolic and cardiovascular factors
make it difficult to identify individuals who will benefit most from available treatments to slow or
prevent disease progression. It is therefore imperative that we develop new strategies to identify
those at high risk of progressive kidney disease and to discover new therapies to slow the rate of
disease progression in these individuals. (1)

In the diagnostics of renal medical diseases the direct immunofluorescence has become a
necessary morphological method for proving immunopathological glomerular, tubulo-interstitial
or vascular processes. On the basis of characteristic patterns of findings glomerular pathologies
and tubulo-interstitial pathologies may be differentiated by antibodies of basal membranes by
deposition of circulating or locally developed immune complexes. Apart from
immunopathogenetic characteristics localization, intensity and expansion as well as
immunochemical pecularities of depositions of immune complexes are of importance for further
characterization. As an indirect method the immunofluorescence is suitable for proving circulating
antibodies against renal constituents. (2)
Immunofluorescence (IF) is a powerful approach for getting insight into cellular structures and
processes using microscopy. Specific proteins can be assessed for their expression and location,
making immunofluorescence indispensable for scientists to solve many cell biological questions.
An immunofluorescence experiment is based on the following principal steps:
1. Specific antibodies bind to the protein of interest.
2. Fluorescent dyes are coupled to these immune complexes in order to visualize the protein of
interest using microscopy.
In direct immunofluorescence, the primary antibody is directly coupled to a fluorophore (also
called fluorochrome), allowing for easy handling and quick visualization. In indirect
immunofluorescence, a secondary fluorophore-coupled antibody, which specifically binds to the
primary antibody, is used to visualize the structure of interest.(3)
Immunofluorescence (IF) is an indispensable technique for rendering an accurate diagnosis in
renal pathology. Diseases such as IgA nephropathy, hereditary renal diseases, C1q nephropathy
and C3 glomerulopathy cannot be diagnosed without IF. Direct IF on tissue (IF-F) is the most
widely used IF technique. (4)
Thus immunofluorescence should be used on routine in clinical practice in medical renal diseases
to avoid misdiagnosis of cases with masked immune complex deposits, thus helping on timely
5
diagnosis and treatment of patients.

AIM OF THIS STUDY

 To study diagnostic utility of immunofluorescence in renal diseases.

OBJECTIVES OF THIS STUDY

1. To study the incidence, clinic pathological characteristics of patients
with medical causes of renal diseases.

2. To study the utility of direct immunofluorescence in renal medical diseases.

LITERATURE REVIEW
Immunofluorescence is the gold standard immunohistochemically technique for evaluation of
immune deposits in the kidney. When frozen tissue is not available or lacks glomeruli,
immunofluorescence can be performed on paraffin tissue after antigen retrieval (Paraffin
immunofluorescence). Excellent results can be obtained by paraffin immunofluorescence in most
immune complex–mediated glomerulonephritis, Polycystic kidney disease, hereditary renal
diseases and dysproteinemia-associated kidney lesions, and thus this technique has become a
valuable salvage technique in renal pathology.

Singh et al studied Immunofluorescence on paraffin embedded renal biopsies and concluded that
as a “salvage” technique, immunofluorescence on paraffin embedded renal biopsies is of great
diagnostic utility, however not without pitfalls.(5)

Malgortza Wągrowska-Danilewicz1 et al studied immunofluorescent evaluation of renal biopsy:

current point of view and concluded the immunomorphological evaluation of the renal biopsy
specimen should be done in all cases to avoid diagnostic mistakes. (6)

Julie D R Reimann Assessment of Clinical and Laboratory Use of the Cutaneous Direct
Immunofluorescence Assay and concluded that reflexive use of a 6-antibody direct
immunofluorescence panel is likely not necessary to diagnose diseases associated with positive
findings; pathologists may tailor antibodies used, and clinicians their decision to use direct
immunofluorescence, to the suspected clinical diagnosis, which may result in more cost-conscious
care. (7)
Geetika Singh et al studied Immunofluorescence on paraffin embedded renal biopsies and
concluded that Immunofluorescence (IF) is an indispensable technique for rendering an accurate
diagnosis in renal pathology. (8)
Ranjana Walker Minz et al studied Direct Immunofluorescence of Renal Biopsy and concluded
that DIF has distinct advantages. Diseases like IgA nephropathy, IgM nephropathy, C1q
nephropathy and anti-GBM glomerulonephritis can only be diagnosed by immunohistology,
whereas the diagnosis of other diseases is confirmed and refined by DIF.(9)

6
MATERIALS AND METHODS:
SOURCE OF DATA:
The prospective study of kidney biopsies, will be done in Department of Pathology during the
period of eighteen months at MGM Medical College and Hospital, Navi Mumbai.

COLLECTION OF DATA:
All the relevant clinical details including age, sex and clinical presentation will be acquired from
the requisition form and by interactions with the patient and concerned clinician.
All the renal biopsy specimens will be submitted for appropriate fixation in Michel’s medium,
Glutaraldehyde or 10 percent buffered formalin followed by processing as per the standard
protocols of gross and microscopic examination.
All biopsies samples will be processed further for immunofluorescence, also for light microscopy
and electron microscopy if indicated.
Hematoxylin and Eosin for staining the tissue sections. Special staining with Periodic Acid
Schiff’s (PAS), Mason’s trichrome, Methenamine silver stain will be performed on the biopsies, if
required.

SAMPLE SIZE

N = 35
� 2 ��
Formula: n = �2

p - proportion in the target population estimated to have a particular characteristics

q = 1-P (proportion in the target not having particular characteristics )
z – random normal variate
L – level of error or margin of error n – number of samples required for study
P = 10 %
q = 100 – p = 90%
z = 1.96 for 95% confidence interval
L = 10 % margin of error
(1.96) 2 x 10 x 90
Therefore, n = (10) 2

= 34.57

7
STUDY DESIGN AND PLACE OF STUDY
A prospective study of renal biopsies will be conducted in Histopathology Section, Department of
Pathology, in MGM Medical College and Hospital, Kamothe, Navi Mumbai.

INCLUSION CRITERIA

 All patients clinically suspected with medical cause of renal diseases,

 aged 18 years to 85 years,
 who are willing to provide informed consent

EXCLUSION CRITERIA

 Patients with inadequate renal biopsies,

 solitary kidneys,

 bleeding diathesis,

 uncooperative behavior,

 Or those who refuse consent

8
PROFORMA OF THE STUDY

Biopsy No. Date: Date:

OPD/IPD No:
Name of the Patient: OPD/IPD No.

Sex:
Age: Sex:

Contact No:
Address: Contact no.:

HISTORY:

History of present:

Illness:Past history:

Family history:

Personal History:

Treatment

History:

Clinical Findings:

Lab Findings:

9
GROSS FINDINGS:

…………………………………………………………………………………….

………………………………………….…………………………………………

……………………………….……………………………………………………

…………………….………………………………………………………………

…………..…………………………………………………………………………

MICROSCOPIC FINDINGS:

………………………………………………………………………………………

………………………………………………………………………………………

………………….……………………………………………………………………

………………………………………………………………………………………

…………………………………….…………………………………………………

…………………………………….…………………………………………………

HISTOPATHOLOGICAL DIAGNOSIS:

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

……………………………………………………………………………………

10
IMMUNOFLUORESCENCE MICROSCOPY FINDINGS:
Antibody Interpretation Pattern Location

IgA

IgG

IgM

C3

Fibrinogen

CIq

Kappa

Lambda

ELECTRON MICROSCOPY FINDINGS (if present)

………………………………………………………………………………………

………………………………………………………………………………………

……………………………………………………………………………………....

FINAL DIAGNOSIS:

………………………………………………………………………………………

………………………………………………………………………………………

…………………………………………………………………………………….…

…………………………………………………………………………………….…

…………………………………………………………………………………….…

11
ETHICAL ASPECTS OF PROJECT AND FUNDING DETAILS
Ethical Aspects:

• Institutional Ethical Committee Clearance will be taken before start of the study.

• Confidentiality of the patient will be maintained.

• There is no additional risk to the patient because of the study.

• Conflicts of interest none.

Funding Details:

No funding required-the investigation expenses will be borne by the patient themselves, as part of routine
investigations.

EXPECTED OUTCOME
 Immunofluorescence could be a very good tool or method for assessing various medical renal diseases along
with histopathological diagnosis and electron microscopy.

 Immunofluorescence could be done on routine basis along with histopathological examination to avoid
misdiagnosis of medical renal diseases.

12
 REFERENCES

1. Linda J. Mullins; Renal disease pathophysiology and treatment;

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5200898/.
2. Schneider W. Stellenwert der Immunfluoreszenz in der Diagnostik von Nierenerkrankungen
[Value of immunofluorescence in the diagnosis of kidney diseases]. Z Gesamte Inn Med. 1983 Feb
15;38(4):115-20. German. PMID: 6344465.

3. Im K, Mareninov S, Diaz MFP, Yong WH. An Introduction to Performing Immunofluorescence

Staining. Methods Mol Biol. 2019;1897:299-311. doi: 10.1007/978-1-4939-8935-5_26. PMID:
30539454; PMCID: PMC6918834.

4. Nasr SH, Fidler ME, Said SM. Paraffin Immunofluorescence: A Valuable Ancillary Technique in
Renal Pathology. Kidney Int Rep. 2018 Jul 7;3(6):1260-1266. doi: 10.1016/j.ekir.2018.07.008.
PMID: 30450452; PMCID: PMC6224795.

5. Singh G, Singh L, Ghosh R, Nath D, Dinda AK. Immunofluorescence on paraffin embedded

renal biopsies: Experience of a tertiary care center with review of literature. World J Nephrol. 2016
Sep 6;5(5):461-70. doi: 10.5527/wjn.v5.i5.461. PMID: 27648410; PMCID: PMC5011253

6. Wągrowska-Danilewicz M, Zeromski J. Immunofluorescent evaluation of renal biopsy: current

point of view. Pol J Pathol. 2010;61(2):83-8. PMID: 20924991.

7. Reimann JDR, Moynihan SP, Horn TD. Assessment of Clinical and Laboratory Use of the
Cutaneous Direct Immunofluorescence Assay. JAMA Dermatol. 2021 Nov 1;157(11)

8. Geetika Singh, Lavleen Singh, Ranajoy Ghosh. Immunofluorescence on paraffin embedded renal
biopsies: Experience of a tertiary care center with review of literature. World J Nephrol 2016; 5(5):
461-470 [PMID: 27648410 DOI: 10.5527/wjn.v5.i5.461]
9. Ranjana Walker Minz ; Immunofluorescence of Renal Biopsy: Perspective of an
Immunopathologist; https://www.jpmer.com/doi/JPMER/pdf/10.5005/jp-journals-10028-1136

13
 CONSENT FORM FOR RESEARCH STUDY

TITLE OF PROJECT: “TO STUDY DIAGNOSTIC UTILITY OF IMMUNOFLOUROSCENCE IN RENAL

DISEASES”

NAME OF STUDENT: DR. SO U R A D I P PU R N A S I S BH A D U R I , STUDENT OF DOCTOR OFMEDICINE

IN PATHOLOGY

NAME OF POSTGRADUATE STUDENT GUIDE: DR. PRIYANKA NIMBALKAR JADHAV, ASSOCIATE

PROFESSOR IN PATHOLOGY

Tick to Confirm
I confirm that I have read and understand the information sheet for the above study

I have had the opportunity to consider the information, ask questions and have had these answered
satisfactorily.

I understand that my participation is voluntary and that I am free to withdraw at any time, without
giving any reason, without my medicalcare or legal rights being affected.

I understand that relevant sections of any of my medical notes and data collected during the study, may
be viewed by responsible individuals from MGM Medical College [IERC]and the regulatory authorities,
as and when relevant. I give permission for these individuals tohave access to my records.

I agree to take part in the above research study of my own will.

Name of patient Signature/thumb impression

Date/Place

Student Name

Date/Place Signature

Witness Name

Date/Place Signature

14
 CONSENT FORM

• Patient identification number:

Title of project: “TO STUDY DIAGNOSTIC UTILITY OF IMMUNOFLOUROSCENCE IN RENAL

DISEASES”

• Name of Principal Investigator: Dr. Souradip Purnasis Bhaduri

• Tel. No.(s) : +91 74994 29728

• The contents of the information sheet dated………………………(version)………that was

provided have been read carefully by me /explained in detail to me, in a language that I
comprehend, and I have fully understood the contents. I confirm that I have had the opportunity to
ask questions.

• The nature and purpose of the study and its potential risks/ benefits and expected duration of the
study, and other relevant details of the study have been explained to mein detail. I understand that
my participation is voluntary and that I am free to withdrawat any time, without giving any reason,
without my medical care or legal right being affected.

• 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 individuals. I give permission
for these individuals to have access to my records. I agreeto take part in the above study.

• Name of the Participant:

• Son/Daughter/Spouse of:

• Date Place

• Complete postal address:

• This is to certify that the above consent has been obtained in my presence

• Signatures of the Principal Investigator

• Place

• 1) Witness-1 2) Witness -2 _

• Name: Name:

• Signature Signature
15
 अनुसंधान अध्न के लिए सहमलि प्र

्रि्ोजना का शीर्क: "गुर् की बीमारियों मे इम्योनोिोलेल की यैरानयक उपयोनगता का अधयय किया"

छार का नाम: डॉ. लौिरीप प्राण नलल भारु डी, पैथोलॉजी मे डॉकि ऑफ मेनडनलय के छात
सािकोकि छार गाइड का नाम: डॉ.न्यंका नयंबालकि जाधव, पैथोलॉजी मे एलोनलएट ्ोफेलि

्ु ल् किने के लिए लिक किे

मै पुन् किता हं नक मै ये उपिोक अधयय के नलए ल् चया पतक को पढ औि लमझ नलया है

मु झे जायकािी पि नवचाि किये , ्् प्छये औि इयका लं तोषजयक उति रे ये का अवलि नमला है ।

मै लमझता हं नक मे िी भागीरािी सैवैक है औि मै नकली भी लमय, नबया कोई कािर बताए, अपयी नचनकता
रे खभाल या काय्यी अनधकािों को ्भानवत नकए नबया इले वापल ले ये के नलए सतंत हं ।

मै लमझता हं नक मे िे नकली भी मे नडकल योट औि अधयय के रौिाय एकत नकए गए डे टा के ्ालं नगक
अयुभागों को एमजीएम मे नडकल कॉले ज [आईईआिली] के नजमेराि ववकयों औि नययामक अनधकारियों
दािा, जब भी ्ालं नगक हो, रे खा जा लकता है । मै इय ववकयों को मे िे रिकॉडण तक पहं च की अयुमनत रे ता हं ।

मै अ्नी इचा से उ्िोक शोध अध्न मे भाग िेने के लिए सहमि हं ं

िोगी का याम हसाति/अं ग्ठे का नयशाय

नरयां क/सथाय

छात का याम

नरयां क/सथाय हसाति

गवाह का याम

नरयां क/सथाय हसाति

16
 सहमलि ्र

•िोगी पहचाय लंखा: _______________________

परियोजया का शीषणक: "गुर् की बीमारि्ों मे इम्नोनोिोसेस की नैरालनक उ््ोलगिा का अध्न किना"

•्धाय अनेषक का याम: डॉ. लौिरीप प्रणनलल भारु डी

• र् िभाष. लं:

नरयां क………………………(लंसिर)……… ्राय की गई ल्चया शीट की लामगी को मेिे दािा धाय ले पढा गया है /मुझे नवसाि ले उल भाषा
मे लमझाया गया है नजले मै लमझता हं , औि मैये प्िी तिह ले लामगी को लमझा. मै पुन् किता हं नक मुझे ्् प्छये का अवलि नमला है ।

•अधयय की ्करनत औि उदे द औि इलके लंभानवत जोवखम/लाभ औि अधयय की अपेनतत अवनध, औि अधयय के अन ्ालंनगक
नवविर मुझे नवसाि ले लमझाए गए है । मै लमझता हं नक मेिी भागीरािी सै वैक है औि मै नकली भी लमय, नबया कोई कािर बताए,
अपयी नचनकता रे खभाल या काय्यी अनधकाि को ्भानवत नकए नबया इले वापल लेये के नलए सतं त हं ।

•मै लमझता हं नक इल शोध मे मेिी भागीरािी ले मेिे बािे मे एकत की गई जायकािी औि मेिे नकली भी मेनडकल योट के अयुभागों को
नजमे राि ववकयों दािा रे खा जा लकता है । मै इय ववकयों को मेिे रिकॉडण तक पहं च की अयुमनत रे ता हं । मै उपिोक अधयय मे भाग
लेये के नलए लहमत हं ।

•्नतभागी का याम:

•बेटा/बेटी/पनत/पती:

•नरयां क सथाय

•प्िा डाक पता:

•यह ्मानरत नकया जाता है नक उपिोक लहमनत मेिी उपवसथनत मे ्ार की गई है

•्धाय अनेषक के हसाति

•जगह

•1) गवाह-1______________ 2) गवाह-2 _______________

•याम याम:

•हसाति हसाति

17
 सं शोधन अभासासासी सं मिी फॉम्

पकराले शीर्क: "म् तनपंडाडा आजािां मधे इम् योनोिोले रडा नयराय उपयुकतेचा अभाल किरे"
लिदाया् ले नाि: डॉ. लौिरीप प्राण नलल भारु िी, डॉकि ऑफ मेनडनलयचे नवदाथा पॅथॉलॉजी
्रवुकि लिदाया माग्रश् काले नाि: डॉ. न्यं का नयं बाळकि जाधव, पॅथॉलॉजीमधील लहयोगी ्ाधापक

्ु ्ी किणासासी ख्ण किा

मी पु्ी कितो की मी विील अभालालाठी मानहती पतक वाचले आनर लमजले आहे

मला मानहतीवि नवचाि किणाची, ्् नवचािणाची आनर तां या लमाधायकािक उतिे रे णाची लं धी नमळाली आहे .

मी लमजतो की माझा लहभाग ऐवैक आहे आनर मी कोरतेही कािर य रे ता माझे उपचाि कधीही मागे घेऊ
शकतो. माझी काळजी नकंवा कायरे शीि अनधकाि ्भानवत य किता मी ते मागे घेणाल मोकळे आहे .

मी लमजतो की माझा लहभाग ऐवैक आहे आनर मी कोरतेही कािर य रे ता माझे उपचाि कधीही मागे घेऊ
शकतो.माझी काळजी नकंवा कायरे शीि अनधकाि ्भानवत य किता मी ते मागे घेणाल मोकळे आहे .

मी ििीि सं शोधन अभासाि सहभागी होणास सेचेने सहमि आहे.

रुाचे याव सातिी/ अं गठाचा ठला

तािीख आनर नठकार

नवदायाण चे याव

तािीख / नठकार सातिी

लातीरािाचे यावतािीख / नठकार सातिी

18
 किाि ्र

•रु ओळख कमां क:

्कराचे शीषणक: "म्रल्ंडाडा आजािांमधे इम्नोनोिोसेरडा लनरान उ््ुकिेला अभास किणे"

•मुख अनेषकाचे याव: डॉ. लौरीप प्नरणल भारु िी

•र् िधयी. याही.

नरयां क………………………(आवरती)………….्राय केलेला मानहती पतकाची लामगी मी काळजीप्वणक वाचली आहे /मला भाषा तपशीलवाि
लमजते मला ते लमजले मर्य ते मला लमजाव्य लां नगतले गेले आहे आनर मला लामगी प्रणपरे लमजली आहे . मी पु्ी कितो की मला
्् नवचािणाची लंधी नमळाली आहे .

•अभालाचे स्प आनर उनद्े आनर ताचे लंभाव धोके/फायरे आनर अभालाचा अपेनतत कालावधी आनर अभालाचे इति लंबंनधत
तपशील मला तपशीलवाि लमजाव्य लां नगतले आहे त. मी लमजतो की माझा लहभाग ऐवैक आहे आनर मी कोरते ही कािर य रे ता
माझे लरस् कधीही मागे घेऊ शकतो.माझा वैदकीय लेवा नकंवा कायरे शीि अनधकािां वि परिराम य किता मी माघाि घेणाल मोकळे
आहे .

• मला लमजते की या लंशोधयातील माझा लहभागादािे माझाबदल गोळा केलेली मानहती आनर माझा कोरताही वैदकीय योट् लचे
नवभाग जबाबराि वकींदािे पानहले जाऊ शकतात. मी या वकींया माझा िे कॉडण मधे ्वेश किणाची पिवायगी रे तो. मी विील

अभालात भाग घेणाल लहमत आहे .

• लहभागीचे याव:

•मुलगा/मुलगी/पती/पती:

• तािीख आनर नठकार

•लंप्रण पोसल पता:

• हे ्मानरत किणालाठी आहे की विील लंमती माझा उपवसथतीत ्ार झाली आहे

• मुख अनेषकाची सातिी

• नठकार

•1) लातीराि-1______________ 2) लातीराि-2 _______________

•याम याव:

•सातिी सातिी

19
 Mahatma Gandhi Mission
MEDICAL COLLEGE
Sector-1, Kamothe, Navi Mumbai - 410 209, India
Ph: (022) 2 7433404, 27437992 Fax: (022) 27420320
E-mail: mgmmcnb@igmail.com, Web: www.mgmuhs.com

Date:
Through Proper Channel
To,
Chairman
Institutional SAC/IEC
MGM Medical College, Kamothe/Kalamboli
Navi Mumbai

Sub.: Submission of Thesis Protocol

Sir/Madam,

I, DR. SOURADIP PURNASIS BHADURI have a joined as PG Resident for MD/MS in

subject of Pathology under the PG Teacher DR.PRIYANKA NIMBALKAR JADHAV
Designation Associate Professor at Mahatma Gandhi Mission’s Medical College, Kamothe, Navi
Mumbai for 2022-23 Batch.
I am here by submitting my Thesis Topic & Protocol as given below:
Diagnostic Utility Of Immunofluorescence In Renal Medical Disease
Thanking you,
YoursYours
sincerely,
sincerely,

_______________________
___________________________________________
(PG Resident Dr. SOURADIP PURNASIS BHADURI)

Sign
(Dr._____________________) (Dr. ______________________)
PG Guide Head of the Department

Enclosure:
1. All Enclosures as per IEC (page I to 14)
2. Swayam portal registration for ICMR Research Methodology Course

20
 Photograph of
PERSONAL DATA
the student

Name in full

(BLOCK LETTERS) BHADURI SOURADIP PURNASIS

(SURNAME) (NAME) (FATHER’s NAME)

Strictly as per MBBS Mark Sheet

Date of Birth 14/06/1994

Blood Group : 0 +VE

Permanent Address: HOUSE NO 187 SWARNASISH RESIDENTIAL COLONY SWAMI SAMRTH

NAGARI SONEGAON KHAMLA NAGPUR-25

Present residential address:- HOSTEL NO 409 KHARGHAR BOYS HOSTEL NAVI MUMBAI

Mobile No. Of the student : 7499429728

E-Mail address of the student : souradipbhaduri1994@gmail.com

Name of the Course :MD PATHOLOGY

Name of the PG Teacher-DR.PRIYANKA JADHAV

TOPIC -TO STUDY DIAGNOSTIC UTILITY OF IMMIUNOFLUOROSCENCE IN RENAL

DISEASES

Signature of Student:

21
 MGM MEDICAL COLLEGE& HOSPITAL
Sector-1, Kamothe, Navi Mumbai - 410 209, India
Ph: (022) 27427900, 7423404, Fax: (022) 27420320
E-mail: mgmmcnb@gmail.com, Web: www.mgmmumbai.ac.in
.MGM Medical College, Institutional Ethics Committee (IEC), Navi Mumbai
Format for Submission of Academic Research Protocol for IEC Review

IEC Form No 1
Full Title of Study :- TO STUDY DIAGNOSTIC UTILITY OF IMMUNOFLOUROSCENCE IN
1
RENAL DISEASES

2 Type of Study Original Research Case Report Case Series

Tick mark what is applicable (Based on Primary Investigator).

3
The submitted Research Study is a UG /Interns PG PhD Faculty Project

Is the study a thesis/Dissertation (MD/MS/M.Sc.): Yes No

4
If No directly go to Point 9

5 If Yes, Program: MD/MS/M.Sc.:MD Batch (Year) :- 2023-2026

Name of the students / PG researcher:-DR .SOURADIP PURNASIS BHADURI

6
Signature :- ______________________________ Department :- PATHOLOGY

Name of the Guide:-DR.PRIYANKA NIMBALKAR JADHAV

7
Signature :- ______________________________ Department :-PATHOLOGY

Name of the Co-Guide:-DR.ADITYA NAIK

8
Signature :- ______________________________ Department :-MEDICINE

Name of the Primary Investigator:-

9
Signature :- ______________________________ Department :-

Name of the Co- Investigator:- ________________________________________

9.1
Signature :- ______________________________ Department :- _______________________

22
 Name of the Co- Investigator:- ________________________________________
9.2
Signature :- ______________________________ Department :- _______________________

Name of the Co- Investigator:- ________________________________________

9.3
Signature :- ______________________________ Department :- _______________________

Is the study Inter-departmental Multi-disciplinary Not applicable

10 If Yes, specify collaborating departments/disciplines:- _________________________________________

_______________________________________________________________________________________

Is the study sponsored/funded/collaboration with outside Institutes Yes/No

11
If Yes, specify:- ________________________________________________

Is the study a Clinical Trial? Yes / No

12
The WHO definition for a clinical trial ‘any research study that prospectively assigns human participants or groups of human to one or more health-
related interventions to evaluate the effects on health outcome.

Is the test drug an Investigational New Drug? Yes / No

13
If yes submit copy of Investigators Boucher and DCGI permission.

14 What is the nature of the study? Interventional Non-Interventional/Observational

Primary Objectives of the Study-

1. To access the diagnostic utility of immunofluorescence.

15
2.To study the incidents of clinical pathological characteristics of patients with renal medical
disease.

Why this study is required? Please provide brief background / justification.

16 To improve the diagnostic knowledge of immunoflurescene which is the gold standard

immunohistochemical technique to diagnose immune deposits in kidney for proper and
confirmed diagnosis.

Methodology

Study Duration: 18 MONTHS

17
Number of Patients /Sample size:40

Inclusion criteria

23
A.PATIENTS CLINICALLY SUSPECTED WITH RENAL MEDICAL DISEASE

B.WHO ARE 18 YEARS OF AGE AND SIGNED INFORMED CONSENT

Exclusion Criteria

The patients having inadequate renal biopsies, solitary kidneys, bleeding diathesis, uncooperative
behavior and refused consent will be excluded from the study.

Study design: Prospective Retrospective

Study Groups : _________________________________________________

Vulnerable group :Yes No If yes mark appropriate boxes

Pregnant Women

Children

Elderly

Foetus

Illiterate

Handicap

Seriously or terminally ill

Mentally Challenged

Economically Socially backward

If any other specify:

Does the study involve collection of body fluids / tissue/ organs:Yes No

Investigation specifically related to Protocols:______________________________________

_____________________________________________________________________________

_____________________________________________________________________________________________________________________

Others :- ______________________________________________________________________

24
 Permission from Drug Controller General of India (DCGI)

1
1. Required 2. Not Required

3. Received 4. Applied When:

Safety measures for proposed interventions

_______________________________________________________________________________
19
________________________________________________________________________________

________________________________________________________________________________

A)Plan for provision of coverage for medical risk _________________________________

________________________________________________________________________________

B)Medical Insurance coverage for study participants Yes No

20

If Yes specify details: ______________________________________________________________

How you will maintain privacy of participants and Confidentiality of data?

21 _________________________________________________________________________________

_________________________________________________________________________________

Project Costs Involved (Appx . in Rs):_____________________________________________

S. No Items Cost

1 Drugs/Plant Products

2 Chemicals/Reagents
22
3 Investigations

Biochemical

Radiological

Pathological

Any Other

25
 4 Lab Equipment’s

5 Stationary

6 Travel

7 Miscellaneous

8 Total Cost

Who will bear the costs of the requirements?_________________________________________

Participant Information Sheet (Mark  if yes)

Attached English version-

Attached Hindi version-

23
Attached Marathi version-

Certificate that Hindi & Marathi version are true translation of English version

(Enclose copy)

Participant Informed Consent Form Sheet (Mark if yes)

Attached English version-

25 Attached Hindi version-

Attached Marathi version-

Certificate that Hindi & Marathi version are true translation of English version

Whether any work on this Protocol has started or not? (Mark  if yes, X if No)
26
Yes No

Attached documents (Mark  if yes)

Covering Letter, through proper channel.(Mandatory)

27
Research protocol (Mandatory)
Undertaking that the study shall be done in accordance with ICMR and GCP guidelines
(Mandatory)

26
 Participant Information Sheet
Participant Informed Consent Form
Case Record form/Questionnaires
Permission for the use of copyrighted scale/Questionnaire
Permission of Medical Superintendent/Competent authority for retrospective study
In case of multicentre study, IEC clearance of other centres must be provided
Definite undertaking as to who will bear the expenditure of injury related to the Trail
(separate copy)
In case insurance cover is intended, Insurance certificate must be provided as per ICMR
guidelines.
In case of Clinical trials, proof of registration of Clinical trial with regulatory body to be
submitted.
In case of Investigational New Drug DCGI approval letter and Investigators Brochure
Permission letter and MOU with Collaborating Institutes
MOU with Collaborating Institutes
Sanction/Invitation/Approval letter in case of sponsored/funded/collaborating Projects
Budget details in case of sponsored/funded/collaborating Projects
28 Are you applying for expedited review Yes No

We hereby declared the information given above is true and that we do not have any financial or
non-financial conflict of interest.

For UG/P G./PhD Research Projects

Name & Signature of UG/P G./PhD Researcher DR.SOURADIP PURNASIS BHADURI
Name & Signature of Guide DR.PRIYANKA NIMBALKAR JADHAV
For Faculty Research Projects
Name & Signature of Principal Investigator DR.SOURADIP PURNASIS BHADURI

Name & Signature of HOD Name & Signature of Dean

Date & Place

27
 MGM MEDICAL COLLEGE
Sector-1, Kamothe, Navi Mumbai - 410 209, India
Ph: (022) 27427900, 7423404, Fax: (022) 27420320
E-mail: mgmmcnb@gmail.com, Web: www.mgmmumbai.ac.in

MGM Medical College, Institutional Ethics Committee (IEC), Navi Mumbai

IEC Form No 2
UNDERTAKING BY THE INVESTIGATOR / RESEARCHER

1. Study Title: TO STUDY DIAGNOSTIC UTILITY OF IMMUNOFLUOROSCENCE IN RENAL

DISEASES

2. Researcher details

ForUG/P G./PhD Research Projects

Name of UG/P G./PhD Researcher DR.SOURADIP PURNASIS BHADURI

Name of Guide DR.PRIYANKA NIMBALKAR JADHAV

ForFaculty Research Projects

Name of Principal Investigator DR.SOURADIP PURNASIS BHADURI

3. Name and address of the medical college, hospital or other facility where the clinical
Study/trial will be conducted:-

Pathology laboratory, MGM Medical College and Hospital, Kamothe, Navi Mumbai.

3. Name and address of all clinical laboratory facilities to be used in the study.
Pathology laboratory, MGM Medical College and Hospital, Kamothe, Navi Mumbai.
4. Name and address of the Ethical Committee that is responsible for approval and
continuing review of the study.

MGM Medical College, Institutional Ethics Committee (IEC), Navi Mumbai

5. Name of the other members of the research team (Co-Investigators) who will be
Assisting the Investigator in the conduct of the investigation (s)

____________________________________________________________________________________________________________________________________________________________

___________________________________________________________________________________________________________________________________________________________

7. Commitments:
28
(i)I have reviewed the clinical protocol and agree that is contains all the necessary information to
conduct the study. I will not begin the study until all necessary Ethics Committee and
regulatory approvals have been obtained.
(ii) I agree to conduct the study in accordance with the current protocol. I will not implement any
decision from or changes of the protocol without agreement by the Sponsor and prior review
and documented approval from the Ethics Committee of the amendment, expect where
necessary to eliminate hazard(s) to the trial Subjects or when the chargers) involved are only
logistical or administrative in nature.
(iii) I agree to personally conduct and / or supervise the clinical trial at my site.
(iv) I agree to inform all subjects; that the drugs are being used for investigational purposes and I
will ensure that the requirements relating to obtaining informed consent and ethics
committee review and approval specified in Good Clinical practice (GCP) guidelines are
met.
(v) I agree to report to the sponsor (in case of sponsored study) all adverse experiences that occur
in the course of study.
(vi) I have read and understood the information in the Investigator’s brochure, including the
potential risks and side effects of the drug.
(vii) I agree to ensure that all associates, colleagues and employees assisting in the conduct of the
study are suitable qualified and experienced and they have been informed about their
obligations in meeting their commitments in the trial/ study.
(viii) I agree to maintain adequate records and to make those records available for audit /
inspection by the Sponsor, Ethics Committee, Licensing Authority or their authorized
representatives, in accordance with regulatory and GCP provisions. I will fully cooperate
with any study related audit conducted by regulatory officials or authorized representatives
of the Sponsor.
(ix) I agree to promptly report to the Ethics Committee all changes in the clinical trial / study
activities and all unanticipated problems involving risk to human Subjects or other.
(x) I agree to inform all unexpected serious adverse events to the Sponsor/College as well as the
Ethics Committee and Pharmacovigilance Committee within seven days of their occurrence.
(xi) I will maintain confidentiality of the identification of all study data.
(xii) I agree to comply with all other requirements, guidelines and statutory obligations as
applicable to clinical Investigators participating in clinical trials / study.
(xiii) I agree to submit the study completion report to the Ethics Committee once the study is
Completed

ForUG/P G./PhD Research Projects

Name & Signature of UG/P G./PhD Researcher DR.SOURADIP PURNASIS BHADURI

Name & Signature of Guide DR.PRIYANKA NIMBALKAR JADHAV

ForFaculty Research Projects

Name & Signature of Principal Investigator DR.SOURADIP PURNASIS BHADURI

Date & Place:

29
 MEDICAL COLLEGE
Sector-1, Kamothe, Navi Mumbai - 410 209, India
Ph: (022) 27427900, 7423404, Fax: (022) 27420320
E-mail: mgmmcnb@gmail.com, Web: www.mgmmumbai.ac.in
E-mail: mgmmcnb@gmail.com, Web: www.mgmmumbai.ac.in
MGM Medical College, Institutional Ethics Committee (IEC), Navi Mumbai

IEC Form No 3

Format for Detailed Protocol for Dissertation

A) Detailed Protocol for Research Studies

 Title with details of Investigators

 Introduction and Rationale:
 Review of Literature (Key Articles Only)
 Aims and Objectives of the study:
 Materials and Methods
o Study Design
o Sample Size
o Study Setting
o Type of Study and Study Duration
o Inclusion criteria for Participants enrolled for this study:
o Exclusion criteria for Participants enrolled for this study
o Details of Methodology
o Safety Measures and ADR Reporting
o Parameters to be analyses/Assessment
o Statistical Analysis
 Expected Outcome and Implications
 Ethical Aspects of Study
 Key References:
 Annexures: Informed Consent Documents (English, Hindi, Marathi), Case Rerecord Form,
Questionnaires & Scales and Permission letters if applicable

(Copy of same to be maintained in Department)

30
 MGM MEDICAL COLLEGE
Sector-1, Kamothe, Navi Mumbai - 410 209, India
Ph: (022) 27427900, 7423404, Fax: (022) 27420320
E-mail: mgmmcnb@gmail.com, Web: www.mgmmumbai.ac.in
MGM Medical College, Institutional Ethics Committee (IEC), Navi Mumbai

IEC Form No 4

Participant Information Sheet (PIS)for Research Study

version _______dated ____________

Title of Project: TO STUDY DIAGNOSTIC UTILITY OF IMMUNOFLUROSCENCE IN RENAL

DISEASES

Investigators
ForUG/P G./PhD Research Projects

Name of UG/P G./PhD Researcher DR.SOURADIP PURNASIS BHADURI

Name of Guide DR.PRIYANKA NIMBALKAR JADHAV

ForFaculty Research Projects

Name of Principal Investigator DR.SOURADIP PURNASIS BHADURI

You are invited to take part in this research study.

This Participant Information Sheet gives you important information about the study. It describes the
purpose of the study, and the risks and possible benefits of participating in the study.

If you have decided to take part in the study, you will be asked to sign the informed consent form which is
along with this Participant Information Sheet. Before you sign the informed consent form, be sure you
understand what the study is about, including the risks and possible benefits to you. You will be given a
copy of the Participant Information Sheet and signed informed consent form for your future reference.

An informed consent form must include the following:

1. Statement mentioning that it is research
2. Purpose and methods of the research in simple language
3. Expected duration of the participation and frequency of contact with estimated number of participants to
be enrolled, types of data collection and methods
4. Benefits to the participant, community or others that might reasonably be expected as an outcome of
research
5. Any foreseeable risks, discomfort or inconvenience to the participant resulting from participation in the
study
6. Extent to which confidentiality of records could be maintained, such as the limits to which the
researcher would be able to safeguard confidentiality and the anticipated consequences of breach of
confidentiality
7. Payment/reimbursement for participation and incidental expenses depending on the type of study
8. Free treatment and/or compensation of participants for research-related injury and/ or harm

31
9. Freedom of the individual to participate and/or withdraw from research at any time without penalty or
loss of benefits to which the participant would otherwise be entitled
10. The identity of the research team and contact persons with addresses and phone numbers (for example,
PI/Co PI for queries related to the research and IEC Office for appeal against violations of ethical
principles and human rights)

An Informed consent form must include the following:

1. Statement mentioning that it is research

My dissertation topic is a research study being conducted in the department

of Pathology,MGM Medical College, Navi Mumbai.

2. Purpose and methods of the research in simple language

A. PURPOSE OF RESEARCH: TO STUDY DIAGNOSTIC UTILITY OF

IMMUNOFLOUROSCENCE IN RENAL DISEASES

b. Method: The study includes patient who are clinically suspected with renal medical disease.

Purpose And Methods Of Research : To study Diagnostic utility of immunoflouroscence in

renal diseases.

Methods :

The study includes patients who are diagnosed with renal medical disease. The patients attending
the Medicine OPD (Nephrology department) of MGM Hospital, Navi Mumbai will be subjected to
renal biopsies for histopathological study. The renal biopsy specimens fulfilling the inclusion
criteria of the study will be received at the Central laboratory, Department of Pathology, MGM
Hospital, Kamothe. All the renal biopsy specimens will be submitted for appropriate fixation
followed by processing as per the standard protocols. Haematoxylin and Eosin for staining the
tissue sections. Special staining with Periodic Acid Schiff’s (PAS), Mason’s trichrome,
Methenamine silver stain and Congo red (if required) will be performed on all the biopsies.

3. Expected duration of the participation and frequency of contact with estimatednumber of

participants to be enrolled, types of data collection and methods.

Expected duration of the study : 18 months ( 1st May 2024 - 30th November 2025)
Frequency of contact : None
Data collection method : Convenient sampling
Data selection method : Primary

4. Benefits to the participant, community or others that might reasonably be expected

asan outcome of research

Diagnosis with immunoflouroscence helps in improving patient outcomes and treatment strategies.

5.Any foreseeable risks, discomfort or inconvenience to the participant

resulting fromparticipation in the study
There are no risks to the patient by being a part of this study.

Extent to which confidentiality of records could be maintained, such as the limits towhich the researcher
would be able to safeguard confidentiality and the anticipated consequences of breach of confidentiality.

Patient’s medical records that are related to this study will be maintained in confidentiality.No identity of
any specific participant in this study will be disclosed in any public records. The authority has the right
32
upon proper judicial order to pertinent medical records and otherdata with your name identified. They are
required by law however, the information will be handled in confidential manner.

7. Payment/reimbursement for participation and incidental expenses depending on the type of study.

Not Applicable

8. Free treatment and/or compensation of participants for research-related injury and/ or harm.

Not Applicable.

9. Freedom of the individual to participate and/or withdraw from research at any time without
penalty or loss of benefits to which the participant would otherwise be entitled.

The participation in any study is entirely voluntary and therefore it is necessary that written consent is
mandatory from the participant before the start of the research study. The participant is asked to read the
instructions carefully. The participant will be given ample of time and opportunity to enquire about details
of study and to decide whether or not to participate in this study. The doctor/researcher will be able to
answer their queries. Reading the information or asking question does not imply any obligation on the
participant to take part in this study. It is completely up to him/her whether or not to participate. It will not
affect their treatment in the future. The participant may withdraw from the study at any time and for any
reason or no reason. Information that has been collected from them prior to their withdrawal will continue
to be used in the data analysis. No new information will be collected or used after the participant has
withdrawn from the study.

10. The identity of the research team and contact persons with addresses and phone numbers (for
example, PI/Co PI for queries related to the research and IEC Office for appeal against violations of
ethical principles and human rights)

Please contact the researchers listed below to obtain more information about the study and ask question(s) about
the study procedures or treatment

Please contact the researchers listed below to:

Obtain more information about the study
Ask a question about the study procedures or treatments

Name of PI: Dr. Souradip Purnasis Bhaduri

Designation PG: student
Department: Pathology
Address: Department of Pathology, MGM Medical College, Navi Mumbai

Phone: 022-24737833, 24737966

Email: souradipbhaduri1994@gmail.com
Time to contact- anytime/ 9.00am to 5.00 pm

Additionally, if you have questions or concerns about your rights as a research participant or a concern about
the study, please feel free to address the Ethics Committee through the Ethics Office.

IEC Office
MGM Medical College, Navi Mumbai, Ethics Committee
Tel. No.: Direct- 022-27437888
Email: mgmethics@gmail.com
Time to contact- 10.00am to 2.00 pm
33
 MGM MEDICAL COLLEGE
Sector-1, Kamothe, Navi Mumbai - 410 209, India
Ph: (022) 27427900, 7423404, Fax: (022) 27420320
E-mail: mgmmcnb@gmail.com, Web: www.mgmmumbai.ac.in
MGM Medical College, Institutional Ethics Committee (IEC), Navi Mumbai

आईईसी फॉम् नंबि 4

अयुलंधाय अधयय के नलए ्नतभागी ल् चया पतक (पीआईएल)।

लं सिर _______ नरयां क ____________

परियोजया का शीषणक: गु र् की बीमारियों मे इम् योनोिोले ल की यैरानयक उपयोनगता का अधयय किया

जां चकताण

््जी/्ीजी/्ीएलडी अनुसंधान ्रि्ोजनाओं के लिए

य्जी/पीजी/पीएचडी शोधकताण का याम डॉ.लौिारीप पुयणलील बहारु िी

गाइड का याम डॉ.न्यंका नयमालकि जाधव

ForFaculty Research Projects

्धाय अनेषक का याम डॉ.लौिारीप पुयणलील बहारु िी

आपको इल शोध अधयय मे भाग लेये के नलए आमंनतत नकया जाता है ।

यह ्नतभागी ल्चया पतक आपको अधयय के बािे मे मह्प्रण जायकािी रे ता है । यह अधयय के उदे द औि
अधयय मे भाग लेये के जोवखमों औि लंभानवत लाभों का वरणय किता है ।

यनर आपये अधयय मे भाग लेये का नयरणय नलया है , तो आपले ल्नचत लहमनत ्पत पि हसाति किये के नलए कहा
जाएगा जो इल ्नतभागी ल्चया पतक के लाथ है । ल्नचत लहमनत फॉमण पि हसाति किये ले पहले, लुनयन्त किे नक
आप लमझते है नक अधयय नकल बािे मे है , नजलमे आपके नलए जोवखम औि लंभानवत लाभ भी शानमल है । आपको
आपके भनवष के लंरभण के नलए ्नतभागी ल्चया पतक औि हसातरित ल्नचत लहमनत ्पत की एक ्नत री जाएगी।

एक ल्नचत लहमनत ्पत मे नयमनलवखत शानमल होया चानहए:

1. यह कथय नक यह शोध है
2. लिल भाषा मे शोध का उदे द एवं नवनधयाँ
3. भागीरािी की अपेनतत अवनध औि यामां नकत ्नतभानगयों की अयुमानयत लंखा के लाथ लंपकण की आवरनत, डे टा
लंगह के ्काि औि तिीके
4. ्नतभागी, लमुराय या अन लोगों को लाभ जो अयुलंधाय के परिराम के ्प मे उनचत ्प ले अपेनतत हो लकते है
5. अधयय मे भाग लेये के परिरामस्प ्नतभागी को होये वाला कोई भी लंभानवत जोवखम, पिे शायी या अलुनवधा
6. नकल लीमा तक अनभलेखों की गोपयीयता बयाए िखी जा लकती है , जैले नक शोधकताण नकल लीमा तक गोपयीयता
की िता किये मे लतम होगा औि गोपयीयता के उलंघय के ्तानशत परिराम
7. अधयय के ्काि के आधाि पि भागीरािी औि आकव्क खच् के नलए भुगताय/्नतप्नतण

34
8. अयुलंधाय ले लंबंनधत चोट औि/या युकलाय के नलए ्नतभानगयों का मुफ इलाज औि/या मुआवजा
9. ववक को नकली भी लमय नबया नकली रं ड या लाभ की हानय के अयुलंधाय मे भाग लेये औि/या वापल लेये की
सतं तता, नजलके नलए ्नतभागी अनथा हकराि होगा
10. अयुलंधाय रल औि लंपकण ववकयों की पहचाय, पते औि फोय यंबि (उराहिर के नलए, अयुलंधाय ले लंबंनधत
््ों के नलए पीआई/लीओ पीआई औि यैनतक नलदां तों औि मायवानधकािों के उलंघय के वखलाफ अपील के नलए
आईईली कायाण लय)

एक ल्नचत लहमनत ्पत मे नयमनलवखत शानमल होया चानहए:

1. यह कथय नक यह शोध है
मेिे शोध ्बंध का नवषय एमजीएम मेनडकल कॉलेज, यवी मुंबई के पैथोलॉजी नवभाग मे आयोनजत एक शोध अधयय
है ।
2.अयुलंधाय का उदे द एवं नवनधयाँ लिल भाषा मे
ए. अयुलंधाय का उदे द: गुर् की नचनकता लंबंधी बीमारियों मे इम्योनोिोलेल की यैरानयक उपयोनगता का अधयय
किया
बी। नवनध: अधयय मे ऐले िोगी शानमल है नजने नचनकतीय ्प ले गुर् की नचनकता बीमािी का लंरेह है ।

अयुलंधाय का उदे द औि तिीके: गुर् की नचनकता लंबंधी बीमारियों मे इम्योनोिोलेल की यैरानयक उपयोनगता का
अधयय किया।

तिीके :

अधयय मे उय िोनगयों को शानमल नकया गया है नजयमे गुर् की नचनकतीय बीमािी का नयराय नकया गया है । एमजीएम
असताल, यवी मुंबई के मेनडनलय ओपीडी (येफोलॉजी नवभाग) मे आये वाले मिीजों को नहसोपैथोलॉनजकल अधयय
के नलए गुर् की बायोपी के अधीय नकया जाएगा। अधयय के लमावेशय मायरं डों को प्िा किये वाले गुर् की बायोपी
यम्ये केंीय ्योगशाला, पैथोलॉजी नवभाग, एमजीएम असताल, कामोठे मे ्ार नकए जाएं गे। लभी गुर् की बायोपी
यम्यों को मायक ्ोटोकॉल के अयुलाि ्लंसिर के बार उनचत नयधाण िर के नलए ्सुत नकया जाएगा। ऊतक वग्
को धुंधला किये के नलए हे मेटोव्नलय औि ईओनलय। लभी बायोपी पि पीरियोनडक एनलड नशफ (पीएएल), मेलय
ट् ाइकोम, मेथेयमाइय नललि से य औि कां गो िे ड (यनर आवदक हो) के लाथ नवशेष धुंधलापय नकया जाएगा।

3. भागीरािी की अपेनतत अवनध औि यामां नकत ्नतभानगयों की अयुमानयत लंखा के लाथ लंपकण की आवरनत, डे टा
लंगह के ्काि औि तिीके।

अधयय की अपेनतत अवनध: 18 महीये (1 मई 2024 - 30 यवंबि 2025)

लंपकण की आवरनत : कोई यहीं
डे टा लंगह नवनध: लुनवधाजयक यम्याकिर
डे टा चयय नवनध: ्ाथनमक

4. ्नतभागी, लमुराय या अन लोगों को लाभ जो अयुलंधाय के परिराम के ्प मे उनचत ्प ले अपेनतत हो लकते है

इम्योनोिोलेल के लाथ नयराय िोगी के परिरामों औि उपचाि िरयीनतयों को बेहति बयाये मे मरर किता है ।
5. अधयय मे भाग लेये के परिरामस्प ्नतभागी को होये वाला कोई भी लंभानवत जोवखम, पिे शायी या अलुनवधा
इल अधयय का नहसा बयये ले मिीज को कोई खतिा यहीं है ।
नकल लीमा तक अनभलेखों की गोपयीयता बयाए िखी जा लकती है , जैले नक शोधकताण नकल लीमा तक गोपयीयता की
िता किये मे लतम होगा औि गोपयीयता के उलंघय के अपेनतत परिराम।

इल अधयय ले लंबंनधत िोगी के मेनडकल रिकॉडण को गोपयीयता मे िखा जाएगा। इल अधयय मे नकली भी नवनश्
भागीराि की कोई भी पहचाय नकली भी लावणजनयक रिकॉडण मे ्कट यहीं की जाएगी। ्ानधकािी को उनचत नानयक

35
आरे श पि आपके पहचाये गए याम के लाथ ्ालंनगक मेनडकल रिकॉडण औि अन डे टा ्ार किये का अनधकाि है ।
हालाँ नक, ये काय्य दािा आवदक है , जायकािी को गोपयीय तिीके ले लंभाला जाएगा।

7. भागीरािी औि आकव्क खच् के आधाि पि भुगताय/्नतप्नतण

अधयय का ्काि.
लाग् यहीं

8. अयुलंधाय ले लंबंनधत चोट औि/ के नलए ्नतभानगयों का नयःशुल उपचाि औि/या मुआवजा
या हानय.

लाग् यहीं।

9. ववक को नकली भी लमय अयुलंधाय मे भाग लेये औि/या उलले हटये की सतं तता
नबया नकली जुमाण ये या लाभ की हानय के, नजलका ्नतभागी अनथा हकराि होगा।

नकली भी अधयय मे भागीरािी प्िी तिह ले सै वैक है औि इलनलए यह आवदक है नक नलवखत हो

शोध अधयय शु् होये ले पहले ्नतभागी की लहमनत अनयवायण है । ्नतभागी को नयर् शों को धाय ले पढये के नलए
कहा जाता है । ्नतभागी को पयाण र लमय नरया जाएगा
अधयय के नवविर के बािे मे प्छताछ किये औि इलमे भाग लेये या य लेये का नयरणय लेये का अवलि
अधयय। डॉकि/शोधकताण उयके ््ों का उति रे ये मे लतम होंगे। जायकािी पढया या
्् प्छये ले ्नतभागी पि इल अधयय मे भाग लेये का कोई रानय् यहीं बयता है । यह है
भाग लेया या य लेया प्िी तिह ले उल पि नयभणि है । इलले उयके इलाज पि कोई अलि यहीं पडे गा
भनवष। ्नतभागी नकली भी लमय औि नकली भी कािर ले अधयय ले हट लकता है
कािर। उयकी वापली ले पहले उयले जो जायकािी एकत की गई है वह जािी िहे गी
डे टा नवशेषर मे उपयोग नकया जाएगा। इलके बार कोई यई जायकािी एकत या उपयोग यहीं की जाएगी
्नतभागी अधयय ले हट गया है .

10. अयुलंधाय रल औि लंपकण ववकयों की पहचाय, पते औि फोय के लाथ

लंखाएँ (उराहिर के नलए, अयुलंधाय ले लंबंनधत ््ों के नलए पीआई/लीओ पीआई औि आईईली कायाण लय के नलए
यैनतक नलदां तों औि मायवानधकािों के उलंघय के वखलाफ अपील)

अधयय के बािे मे अनधक जायकािी ्ार किये के नलए करपया यीचे ल्चीबद शोधकताण ओं ले लंपकण किे
अधयय ्नकयाओं या उपचाि के बािे मे ्् प्छे

करपया यीचे ल्चीबद शोधकताण ओं ले लंपकण किे :

अधयय के बािे मे अनधक जायकािी ्ार किे
अधयय ्नकयाओं या उपचािों के बािे मे ्् प्छे

पीआई का याम डॉ लौिरीप प्रणनलल भारु डी

परयाम पीजी: छात
नवभाग: पैथोलॉजी
पता: पैथोलॉजी नवभाग, एमजीएम मेनडकल कॉलेज, यवी मुंबई
फोय: 022-24737833, 24737966
ईमेल: souradipbhaduri1994@gmail.com
लंपकण किये का लमय- कभी भी/ लुबह 9.00 बजे ले शाम 5.00 बजे तक

इलके अनतरिक, यनर एक शोध भागीराि के ्प मे आपके अनधकािों के बािे मे आपके कोई ्् या नचंताएं है या
अधयय के बािे मे कोई नचंता है , तो करपया बेनझझक यैनतकता कायाण लय के माधम ले यैनतकता लनमनत को लंबोनधत
किे । (
36
आईईली कायाण लय
एमजीएम मेनडकल कॉलेज, यवी मुंबई, आचाि लनमनत
र् िभाष लंखा: लीधा- 022-27437888
ईमेल: mgmethics@gmail.com
लंपकण किये का लमय- लुबह 10.00 बजे ले रोपहि 2.00 बजे तक

37
 MGM MEDICAL COLLEGE
Sector-1, Kamothe, Navi Mumbai - 410 209, India
Ph: (022) 27427900, 7423404, Fax: (022) 27420320
E-mail: mgmmcnb@gmail.com, Web: www.mgmmumbai.ac.in
MGM Medical College, Institutional Ethics Committee (IEC), Navi Mumbai

IEC फॉम् कमां क 4

संशोधन अभासासासी सहभागी मालहिी ्रक (PIS).

आिृकी _______ िािीख ____________

पकराले शीर्क: म्तनपंडाडा आजािां मधे इम्योनोिोलेरडा नयराय उपयुकतेचा अभाल किरे

अनेरक

UG/PG/PhD संशोधन पकरांसासी अनेरक

UG/PG/PhD लंशोधकाचे याव लौिरीप प्राण नलल भर् िी डॉ

मागणरशणक याव न्यां का नयंबाळकि जाधव यां यी डॉ

ForFaculty Research Projects

मुख अनेषकाचे याव लौिरीप प्राण नलल भर् िी डॉ

तुमाला या लंशोधय अभालात लहभागी होणालाठी आमंनतत केले आहे .

हे लहभागी मानहती पतक तुमाला अभालानवषयी महताची मानहती रे ते. हे अभालाचा उदे श आनर अभालात लहभागी
होणाचे धोके आनर लंभाव फायरे यांचे वरणय किते.

तुमी अभालात लहभागी होणाचे ठिनवलाल, तुमाला या लहभागी मानहती पतकालह ल्नचत लंमती फॉमणवि सातिी
किणाल लांनगतले जाईल. तुमी ल्नचत लंमती फॉमणवि सातिी किणाप्वा, तुमडालाठी जोखीम आनर लंभाव फायदांलह,
अभाल कशाबदल आहे हे तुमाला लमजले आहे याची खाती किा. तुमाला तुमडा भनवषातील लंरभाणलाठी लहभागी
मानहती पतकाची एक ्त आनर सातिी केलेला ल्नचत लंमती फॉमण नरला जाईल.

ल्नचत लंमती फॉमणमधे खालील गो्ी ंचा लमावेश अलावा:

1. हे लंशोधय आहे अले नवधाय

2. लोपा भाषेत उदे श आनर लंशोधयाडा पदती

3. लहभागाचा अपेनतत कालावधी आनर योंररी केलेला लहभागी ंची अंराजे लंखा, ्काि आनर डे टा लंकलयाडा
पदती ंलह लंपकाणची वािं वािता

4. लहभागी, लमुराय नकंवा इतिांया लाभ जे लंशोधयाडा परिरामी अपेनतत आहे

38
5. अभालात भाग घेतलामुळे लहभागी ंया होरािे कोरतेही लंभाव धोके, अससथता नकंवा गैिलोय

6. िे कॉडण ची गोपयीयता नकती ्मारात िाखली जाऊ शकते, जले की लंशोधक गोपयीयतेचे लंितर किणाल लतम अलेल
आनर गोपयीयतेडा उलंघयाचे अपेनतत परिराम.

7. लहभागालाठी रे य/्नतप्ता आनर अभालाडा ्कािायुलाि आयुषंनगक खचण

8. लंशोधय-लंबंनधत रु खापती आनर/नकंवा युकलायीलाठी लहभागी ंया मोफत उपचाि आनर/नकंवा भिपाई

9. वकीला कोरताही वेळी लंशोधयात भाग घेणाचे सातंत आनर/नकंवा रं ड नकंवा फायदांचे युकलाय य किता जाचा
लहभागी अनथा पात अलेल

10. लंशोधय कायणलंघ आनर लंपकण वकी ंची ओळख, पते आनर फोय यंबि (उराहिराथण, लंशोधय-लंबंनधत ््ांलाठी
PI/CO PI आनर यैनतक तते आनर मायवी हक उलंघयांनवरद अपील किणालाठी IEC कायाणलय)

ल्नचत लंमती फॉमणमधे खालील गो्ी ंचा लमावेश अलावा:

1. हे लंशोधय आहे अले नवधाय

माझा ्बंधाचा नवषय पॅथॉलॉजी नवभाग, एमजीएम मेनडकल कॉलेज, यवी मुंबई येथे केलेला लंशोधय अभाल आहे .

2.लोपा भाषेत उदे श आनर लंशोधयाडा पदती

ए. लंशोधयाचे उनद्: नकडयीडा आजािामधे इमुयोनोिे लेरडा नयराय उपयुकतेचा अभाल किरे .

बी. पदती: अभालात अशा रुांचा लमावेश होता जांया नकडयीचा आजाि अललाची वैदकीयीयदा शंका होती.

लंशोधयाचे उनद् आनर पदती: म्तनपंडाडा वैदकीय िोगांमधे इमुयोनोिे लेरडा नयराय उपयुकतेचा अभाल किरे.

पदती:

या अभालात वैदकीय नकडयीडा आजािाचे नयराय झालेला रुांचा लमावेश होता. एमजीएम हॉवसटल, यवी मुंबईडा
मेनडनलय ओपीडी (येफोलॉजी नवभाग) मधे येराऱया रुांची नहसोपॅथॉलॉनजकल अभालालाठी नकडयी बायोपी केली
जाईल. अभालाडा लमावेशाचे नयकष प्रण किरािे िे यल बायोपी यमुये केंीय ्योगशाळा, पॅथॉलॉजी नवभाग, एमजीएम
हॉवसटल, कामोठे येथे नमळतील. लवण िे यल बायोपी यमुये ्मानरत ्ोटोकॉलयुलाि ्नकया केलायंति योग नयधाणिरालाठी
लबनमट केले जातील. हे मॅटोव्नलय आनर इओनलय नटश् नवभागांया डाग रे णालाठी. लवण बायोपीवि पीरियनडक अॅनलड
नशफ (पीएएल), मॅलय ट् ायकोम, मेथेयामाइय नलल्ि से य आनर काँगो िे ड (आवदक अललाल) लह सेशल से नयंग केले
जाईल.

3. लहभागाचा अपेनतत कालावधी आनर योंररी केलेला लहभागी ंची अपेनतत लंखा, लंपकण वािं वािता, ्काि आनर डे टा
लंकलयाडा पदती.

अभालाचा अपेनतत कालावधी: 18 मनहये (1 मे 2024 - 30 यो्े बि 2025)

लंपकण वािं वािता: काहीही याही

डे टा लंकलय पदत: लोयीसि यमुया

डे टा नयवड पदत: ्ाथनमक

4. लहभागी, लमुराय नकंवा इतिांया लाभ जे लंशोधयाडा परिरामी अपेनतत आहे

इमुयोनोिे लेरचे नयराय रुाचे परिराम आनर उपचाि धोिरे लुधािणाल मरत किते.

39
5. अभालात भाग घेतलामुळे लहभागी ंया होरािे कोरतेही लंभाव धोके, अससथता नकंवा गैिलोय

या अभालाचा भाग बय्य रुाला कोरताही धोका याही.

िे कॉडण ची गोपयीयता नकती ्मारात िाखली जाऊ शकते, जले की लंशोधक गोपयीयतेचे लंितर किणाल लतम अलेल
आनर गोपयीयतेडा उलंघयाचे अपेनतत परिराम.

या अभालाशी लंबंनधत रुाडा वैदकीय योंरी गोपयीय ठे वला जातील. या अभालातील कोरताही नवनश् लहभागीची
कोरतीही ओळख कोरताही लावणजनयक िे कॉडण मधे उघड केली जाराि याही. योग नानयक आरे शायुलाि तुमडा
ओळखला गेलेला यावालह लंबंनधत वैदकीय योंरी आनर इति डे टा नमळवणाचा अनधकाि ्ानधकिराला आहे . कायदाये
आवदक अलले तिी, मानहती गोपयीयपरे हाताळली जाईल.

7. लहभाग आनर आयुषंनगक खचाणवि आधारित रे य/्नतप्ता

अभालाचा ्काि.

लाग् याही

8. लंशोधय-लंबंनधत जखमांलाठी आनर/नकंवा लहभागी ंया मोफत उपचाि आनर/नकंवा भिपाई

नकंवा युकलाय.

लाग् याही.

9. कोरताही वेळी लंशोधयात लहभागी होणाचे आनर/नकंवा मागे घेणाचे वकीचे सातंत

कोरताही रं डानशवाय नकंवा फायदांचे युकलाय य किता जाचा लहभागी अनथा पात अलेल.

कोरताही अभालात भाग घेरे प्रणपरे ऐवैक अलते आनर तामुळे तेथे नलवखत अलरे आवदक आहे

लंशोधय अभाल लु् होणाप्वा लहभागी ंची लंमती अनयवायण आहे . लहभागीला ल्चया काळजीप्वणक वाचणाल लांनगतले
जाते. लहभागी ंया पुिेला वेळ नरला जाईल

अभालाडा तपनशलांची चौकशी किणाची आनर तात भाग घायचा की याही हे ठिवणाची लंधी.

अभाल. डॉकि/लंशोधक तांडा ््ांची उतिे रे ऊ शकतील. मानहती वाचरे नकंवा

्् नवचािरे लहभागीला अभालात लहभागी होणालाठी कोरताही बंधयात ठे वत याही. हे आहे

भाग घायचा की याही हे लवणसी ताडावि अवलंब्य आहे . तामुळे तांडा उपचािांवि परिराम होराि याही

भनवष. लहभागी कधीही आनर कोरताही कािरासव अभालात्य माघाि घेऊ शकतो

कािर. पित येणाप्वा तांडाकड्य गोळा केलेली मानहती लु्च िाहराि आहे

डे टा नवशेषरात वापिले जाईल. यायंति कोरतीही यवीय मानहती लंकनलत नकंवा वापिली जाराि याही

लहभागीये अभालात्य माघाि घेतली आहे .

10. लंशोधय कायणलंघ आनर लंपकण वकी ंची ओळख, पते आनर फोयलह

40
कमांक (उराहिराथण, PI/CO लाठी PI आनर IEC कायाणलय लंशोधय लंबंनधत ््ांलाठी

यैनतक तते आनर मायवी हक उलंघयानवरद अपील)

अभालाबदल अनधक जार्य घेणालाठी, करपया खाली ल्चीबद केलेला लंशोधकां शी लंपकण लाधा
अभाल ्नकया नकंवा उपचािां बदल ्् नवचािा

करपया खाली ल्चीबद केलेला लंशोधकां शी लंपकण लाधा:

अभालाबदल अनधक जार्य घा
अभाल ्नकया नकंवा उपचािां बदल ्् नवचािा

पीआय डॉ लौरीप प्नरणल भारु िी यां चे याव

परयाम PG: नवदाथा
नवभाग: पॅथॉलॉजी
पता: पॅथॉलॉजी नवभाग, एमजीएम मेनडकल कॉलेज, यवी मुंबई
फोय: ०२२-२४७३७८३३, २४७३७९६६
ईमेल: souradipbhaduri1994@gmail.com
लंपकण वेळ- कधीही/ लकाळी 9.00 ते लंधाकाळी 5.00

यावनतरिक, जि तु माला लंशोधय लहभागी मर्य नकंवा अभालानवषयी तु मडा अनधकािां बदल काही ्् नकंवा
नचंता अलतील ति करपया यीनतशास कायाण लयादािे यीनतशास लनमतीला मोकळा मयाये लंबोनधत किा. ,

IEC कायाण लय
एमजीएम मेनडकल कॉलेज, यवी मुंबई, आचाि लनमती
र् िधयी कमां क: थेट- ०२२-२७४३७८८८
ईमेल: mgmethics@gmail.com
लंपकण वेळ- लकाळी 10.00 ते रु पािी 2.00

41
 MGM MEDICAL COLLEGE
Sector-1, Kamothe, Navi Mumbai - 410 209, India
MGM Medical College, Institutional Ethics Committee (IEC), Navi Mumbai

IEC Form No 5

Informed Consent Form (Research Study)

Study Title: TO STUDY DIAGNOSTIC UTILITY OF IMMUNOFLOUROSCENCE IN RENAL
DISEASES

Principal Investigator: DR. SOURADIP PURNASIS BHADURI

Department: PATHOLOGY

(Please tick mark the applicable)

1. I confirm that I have read and understood the information sheet version _______dated
____________ for the above study and have had the opportunity to ask questions.

2. I understand that my participation is voluntary and that I am free to withdraw at any time,
without giving reasons, without my medical care or legal rights being affected
3. I understand that the sponsor of the clinical trial, others working on the sponsors’ behalf, the
Ethics Committee, Legal and the Regulatory authorities will not need my permission to look at
my health records both in respect of the current study and further research that may be
conducted in relation to it, even if I withdraw from the trial. I agree to this access. However, I
understand that my identity will not be revealed in any information released to third parties or
published.
4. I agree not to restrict the use any data or results that arise from this study provided such a
use is only for scientific purpose (s)

5. I voluntarily agree to take part in the above study

Name of the Study Participant

Signature/Thumb impression of Study Participant with date

Name of the legally acceptable representative (LAR):

Signature of LAR with date

(Witness of the consent procedure if the Parent/ LAR is illiterate)

I have witnessed the consent procedure of the parent/ LAR and the individual has had the opportunity
to ask questions.
Name of the Witness
Signature of Impartial witness with date

Name of the Principal Investigator

Signature of Principal Investigator with date

42
 MGM MEDICAL COLLEGE
Sector-1, Kamothe, Navi Mumbai - 410 209, India
MGM Medical College, Institutional Ethics Committee (IEC), Navi Mumbai

आईईसी फॉम् नंबि 5

अध्न का शीर्क: गुर् की बीमारि्ों मे इम्नोनोिोसेस की नैरालनक उ््ोलगिा का अध्न किना

्धाय अनेषक: डॉ. लौिरीप भारु डी

नवभाग: पैथोलॉजी

(कृ््ा िाग् ्ि लनशान िगाएं )

1. मै पुन् किता हं नक मैये उपिोक अधयय के नलए ल्चया पत लंसिर _______नरयां क

____________ को पढ औि लमझ नलया है औि मुझे ्् प्छये का अवलि नमला है ।
2. मै लमझता हं नक मे िी भागीरािी सै वैक है औि मै नकली भी लमय, नबया कािर बताए, अपयी
नचनकता रे खभाल या काय् यी अनधकािों को ्भानवत नकए नबया इले वापल लेये के नलए सतं त हं ।
3. मै लमझता हं नक व्नयकल पिीतर के ्ायोजक, ्ायोजकों की ओि ले काम किये वाले अन,
आचाि लनमनत, काय्यी औि नययामक अनधकारियों को वतणमाय अधयय औि आगे के शोध के लंबंध
मे मेिे साव रिकॉडण को रे खये के नलए मेिी अयुमनत की आवदकता यही ं होगी। इलके लंबंध मे
कािण वाई की जा लकती है , भले ही मै मुकरमे ले हट जाऊं। मै इल पहं च ले लहमत हं . हालाँ नक, मै
लमझता हँ नक तीलिे पत को जािी या ्कानशत नकली भी जायकािी मे मेिी पहचाय उजागि यही ं की
जाएगी।
4. मै इल अधयय ले उत् नकली भी डे टा या परिराम के उपयोग को ्नतबंनधत यही ं किये पि
लहमत हं , बशत् नक ऐला उपयोग केवल वैजानयक उदे दों के नलए हो।
5. मै से ैा ले उपिोक अधयय मे भाग लेये के नलए लहमत हं

अधयय ्नतभागी का याम

िािीख सलहि अध्न पलिभागी के हसाति/अंग्से का लनशान

काय्यी ्प ले सीकायण ्नतनयनध का याम (LAR):

िािीख सलहि एिएआि के हसाति

(्लर मािा-ल्िा/एिएआि लनिति है िो सहमलि पलक्ा के साती बने)

मैये माता-नपता/एलएआि औि ववक की लहमनत ्नकया रे खी है

्् प्छये का अवलि.
43
गवाह का याम

लरनांक सलहि लनषत गिाह के हसाति

्धाय अनेषक का याम

लरनांक सलहि पधान अनेरक के हसाति

44
 MGM MEDICAL COLLEGE
Sector-1, Kamothe, Navi Mumbai - 410 209, India
MGM Medical College, Institutional Ethics Committee (IEC), Navi Mumbai

फॉम् कमांक 5

अभासाले शीर्क:म्रल्ंडाडा आजािांमधे इम्नोनोिोसेरडा लनरान उ््ुकिेला अभास किणे

मुख अनेषक: लौिरीप प्राण नलल भर् िी डॉ

नवभाग: पॅथॉलॉजी

(कृ््ा िाग् ललनांलकि किा)

1. मी पु्ी कितो की मी विील अभालालाठी मानहती पत आवरती ____________ नरयां क ____________

वाचली आनर लमजली आहे आनर मला ्् नवचािणाची लंधी नमळाली आहे .
1. मी पु्ी कितो की मी विील अभालालाठी मानहती पत आवरती ____________ नरयां क ____________
वाचली आनर लमजली आहे आनर मला ्् नवचािणाची लंधी नमळाली आहे .
3. मला लमजते की व्नयकल ट् ायलचे ्ायोजक, ्ायोजकां डा वतीये काम किरािे इति, यैनतकता लनमती,
कायरे शीि आनर नययामक अनधकािी यां या लधाचा अभाल आनर पुढील लंशोधयाडा लंरभाण त माझा
आिोग योंरींमधे ्वेश किणालाठी माझा पिवायगीची आवदकता याही. या ्किरात् य मी माघाि घेतली
तिी कािवाई होऊ शकते . मी या ीन्कोयाशी लहमत आहे . तथानप, मी लमजतो की तर तीय पतां या ्नलद
केलेला नकंवा ्कानशत केलेला कोरताही मानहतीमधे माझी ओळख उघड केली जाराि याही.

4. या अभालात् य उदवराऱया कोरताही डे टा नकंवा परिरामां चा वापि ्नतबंनधत य किणाबाबत मी लहमत

आहे , बशत् की अला वापि केवळ वैजानयक हे त्ंलाठी अलेल.
5. मी विील अभालात लहभागी होणाल से ैेये लहमत आहे

अभाल लहभागीचे याव

िािखेसह अभासाि सहभागी झािेला वकीली सातिी/अंगठाला ससा

कायरे शीिरिता सीकायण ्नतनयधीचे याव (LAR):

िािखेसह LAR ली सातिी

(जि ्ािक/एिएआि लनिति असिीि िि संमिी पलक्ेली सात दा)

मी पालक/LAR आनर वकीडा लंमती ्नकयेत्य गेलो आहे

्् नवचािणाची लंधी.

45
लातीरािाचे याव

िािखेसह लनषत सातीरािाली सातिी

मुख अनेषकाचे याव

िािखेसह मुख अनेरकाली सातिी

46