No:
Dated: 20-01-2023
To,
Member Secretary,
Ethics Committee,
AIIMS Bathinda.
Subject: Submission of Research Project titled “Development and validation of a normative atlas
of the developing fetal brain using diffusion tensor imaging”
Dear sir,
I am submitting hard copies of research project titled “Development and validation of a normative
atlas of the developing fetal brain using diffusion tensor imaging” I am the principal investigator
for the said research project.
Thanking you,
Your’s sincerely,
Dr. Sameer Peer,
Assistant Professor,
Department of Radiodiagnosis, AIIMS Bathinda
Form 1
All India Institute of Medical Sciences, Bathinda
RESEARCH CELL
Form for Comments of Head of Department
To
Chairperson
Research Cell
AIIMS BATHINDA
Title of the Project: Development and validation of a normative atlas of the developing fetal brain
using diffusion tensor imaging
Principal Investigator: Dr Sameer Peer
Date of submission by CI to HOD:21-01-2023
I have gone through the Protocol along with Annexures submitted by PI for consideration of RC and
have following comments to offer:
1
2
3
4
5
6
Whether routine patient care would be compromised as a result of
This project?
Whether functioning of the department would be adversely affected?
Would the project lead to improvement in the skills of faculty/staff of
The Department
Whether PI/Co-PI has adequate capacity to undertake the Project?
Whether facilities and/or equipment available in the Department
Would be made available to PI and his team?
Any other comment on the Project
Yes/ No/NA
Yes/ No/NA
Yes/ No/NA
Yes/ No/NA
Yes/ No/NA
The Proposal is forwarded and
(a) Recommended for approval by RC/IEC
(b) Recommended subject to above comments
(c) Not-recommended due to following reasons:
Date
Signature
Form 2: To be filled by the Principal Investigator (PI) for submission to
Research Cell(RC)
ReferenceNo. (TobeenteredbyRC) Please fill the form completely . Incomplete forms are liable to rejection.
ProposalTitle:
Name,Designation&
Qualifications
PI
Dr. Sameer Peer
CoPI/Collaborato
rs
Dr. Paramdeep Singh
Address
Tel&FaxNos.Em
ailID
Department of Radiodiagnosis,
AIIMS Bathinda
Department of Radiodiagnosis,
AIIMS Bathinda
Signature
1.
Dr Lajja Devi Goyal
2.
Department of Obstetrics and
Gynecology, AIIMS Bathinda
3.
4.
PleaseattachbriefCurriculumVitaeofallInvestigators(withsubject specificpublicationslimitedto
previous5years).
Tickappropriately
SponsorInformation:
1.Indian
a)Government
Central
State
Institutional
b) Private
2.International
Government
Private
3.Industry
National
Multinational
UNagencies
Total Budget:
A. Doesthebudgetreflecta)Institutionaloverheads
B. Anypayments/benefitstotheinvestigator’s
1.TypeofStudy:
Epidemiological
StudiesClinical:
2.StatusofReview:
Y/NPleasegivedetails
Y/NIfYes,pleasegivedetails
BasicSciences
Singlecenter
Behavioral
New
Animal
Multicentric
Revised
3.ClinicalTrials:Drug/Vaccines/Device/Herbal Remedies:
Does thestudyinvolveuseof?
Drug
IndianSystemsofMedicine/
Devices
Vaccines
Anyother
NAAlternateSystemofMedici
ne
i.Isitapprovedandmarketed
In India
UK &Europe
USA
Othercountries,specify
iii.Doesitinvolveachangeinuse,dosage,routeofadministration?
Ifyes,whetherDCGI’s/AnyotherRegulatoryauthority’sPermissioniso
btained?
Ifyes,Dateofpermission:
iv.IsitanInvestigationalNewDrug?
If yes,INDNo:
a).Investigator’sBrochuresubmitted
Yes
No
Yes
No
Yes
No
Yes
No
b).Invitrostudiesdata
Yes
No
c). PreclinicalStudiesdone
Yes
No
d).ClinicalStudyis:PhaseI
PhaseII
PhaseIII
PhaseIV
e).Areyouawareifthisstudy/similarstudyis beingdoneelsewhere?
Yes
No
If Yes,attachdetails
i.Brief descriptionof theproposal –Introduction,reviewofliterature,aim(s)&objectives,justificationforstudy,
methodologydescribingthepotentialrisks &benefits,outcomemeasures,statisticalanalysisandwhetheritis
ofnationalsignificancewith rationale(Attachsheetwith maximum500 words):
5. Subjectselection:
i.
NumberofSubjects
:
ii.
Durationofstudy:
iii.
Willsubjectsfrombothsexesberecruited
Yes
No
iv.
Inclusion/exclusioncriteriagiven
Yes
No
v.
TypeofsubjectsVolunteers
vi.
Vulnerablesubjects(Tick)
Pregnantwomen
Elderly
Patients
Children
Fetus
Terminallyill
Seriouslyill
ChallengedEconomically& SociallyBackward
Handicapped
Mentally
anyother(specify)
6.Privacyandconfidentiality
i.Studyinvolves-
Direct Identifiers
Indirect
Identifiers/codedCompletelyanon
ymized/ delinked
ii.
Confidentialhandlingofdatabystaff
7. Useofbiological/hazardousmaterials
i.
Useoffetaltissueor abortus
Yes
Yes
No
No
Useoforgans orbodyfluids
Useofrecombinant/genetherapy
Ifyes,hasDepartmentofBiotechnology(DBT)approval
forrDNAproductsbeenobtained?
iv.
Useofpre-existing/stored/leftoversamples
Yes
Yes
No
No
Yes
Yes
No
No
v.
Yes
No
Yes
No
Yes
No
Yes
Yes
Yes
No
No
No
Yes
No
iii.
iii.
Collectionforbanking/futureresearch
vi.
Useofionisingradiation/radioisotopes
Ifyes,hasBhaba
AtomicResearchCentre(BARC)approvalforRadioactiveIsoto
pesbeenobtained?
vii.
UseofInfectious/biohazardousspecimens
viii.
Proper disposalofmaterial
ix. Willanysamplecollectedfromthepatients besentabroad?
IfYes,justifywithdetailsofcollaborators
a)Istheproposalbeingsubmittedforclearance from HealthMinistry’s
ScreeningCommittee(HMSC)forInternationalcollaboration?
b)
Samplewillbesentabroadbecause(Tickappropriatebox):Ifso,reasons…
Facility not available in
IndiaFacilityinIndiainaccessi
ble
Facilityavailablebutnotbeingaccessed.
8.Consent:
*Written
visualConsentform: (ticktheincludedelements)
Understandablelanguage
Oral
AudioAlternativestoparticipation
Statementthatstudyinvolvesresearch
Sponsorofstudy
Confidentialityofrecords
Contactinformation
Purposeandprocedures
Statementthatconsentisvoluntary
Risks &Discomforts
Righttowithdraw
Benefits
Consentforfutureuseofbiologicalmaterial
Compensationforparticipation
BenefitsifanyonfuturecommercializationCo
mpensationforstudyrelatedinjury
*Ifwrittenconsentisnotobtained,givereasons:
ii. Whowillobtainconsent?
PI/Co-PI
Nurse/Counsellor
Researchstaff
Anyother
9.Willany advertisingbedoneforrecruitment ofSubjects?
(posters,flyers,brochure,websites–ifso,kindlyattachacopy)
10. Risks&Benefits:
i. Istheriskreasonablecomparedtotheanticipatedbenefitstosubje
cts /community/country?
ii. Istherephysical/social/psychologicalrisk/discomfort?
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
If Yes,Less thanMinimal
riskMinimalRisk
MinorincreaseoverminimalriskorLowrisk
Morethan minor increaseor Highrisk
iii.Isthereabenefit a)tothesubject?
Direct
Indirect
b)Benefittosociety
11. DataMonitoring
i. Isthereadata&safetymonitoringcommittee/Board(DSMB)
ii. Isthereaplanfor reportingofadverseevents?
IfYes,reportingisdoneto:
Sponsor
EthicsCommittee
DSMB
iii.Isthereaplanforinterimanalysis ofdata?
vi.Arethereplansforstorageandmaintenanceofalltrialdatabases?
IfYes,forhowlong?
12.Istherecompensationforparticipation?
IfYes,
Monetary
In kind
Specifyamountandtype:
13.Istherecompensationforinjury?
IfYes,
bySponsor
byinsurancecompany
Yes
No
Yes
No
byInvestigator
byanyother
14.Doyouhave conflictofinterest?(financial/nonfinancial)
IfYes,specify:
In case the investigator(s) are receiving any payment or direct benefit due
tothe project, it may be considered a conflict of interest and should be
detailedhere.NOTE:Itshallbe the responsibilityofthe investigator(s)totake
Appropriateadministrativepermissionsforthepecuniarybenefitsapriori.
Checklistforattacheddocuments:4consolidatedcopiesofthefollowing
Form1,Form
2,Form3Projectproposal
PatientinformationsheetinEnglishandHindiInf
ormed Consent form in English and
HindiInvestigator’sbrochureforrecruitingsubje
cts
CurriculumVitaeofInvestigatorsB
riefdescriptionofproposal
Copyofclinicaltrialprotocoland/orquestionnaire
Noted
Form-3
UNDERTAKINGBYTHEINVESTIGATOR
1. Full name, address and title of the Principal investigator (or investigator (S) when there is no principal investigator): Dr
Sameer Peer, Assistant Professor, Department of Radiodiagnosis, AIIMS, Bathinda
2. Protocol Title and study number (if any) of the clinical trial to be conducted by the investigator: “Development and
validation of a normative atlas of the developing fetal brain using diffusion tensor imaging”
3. Commitments:A. I have reviewed the clinical protocol and agree that it 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. B. I agree to conduct the study in accordance with the current protocol. I will not implement any deviation from
or changes of the protocol without agreement by the Funding agency/Sponsor and prior review and documented approval)
and favorable opinion from the RC and Ethics Committee of the amendment, except where necessary to eliminate an
immediate hazard(s) to the trial Subjects or when changers involved are any logistical or administrative in nature.
C. I agree to personally conduct and / or supervise the clinical trial at my site.
D. 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 the OCP
guidelines are met.
E. I agree to report to the IEC all adverse experiences that occur in the course of the investigation(s) in accordance with
regulatory and GCP guidelines.
F. I have read and understood the information in the investigator’s brochure, including the potential risks and side effects
of the intervention.
G. I agree to maintain adequate and accurate records and t make those records available for adult / 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.
H. I ensure that all associates, colleagues and employees assisting in the conduct of the study are suitably qualified and
experienced and they have been informed about their obligations in meeting their commitments in the trials
I. I agree to inform all unexpected serious adverse events to the Funding agency/Sponsor as well as the Ethics Committee
within 24 hours of their occurrence.
J. I agree to promptly report the ethics Committee all changes in the clinical trial activates and all unanticipated problems
involving risks to human Subjects or others
K. I will maintain confidentiality of the identification of all participating study patients and assure security and
confidentiality of study data.
L. I agree to comply with all other requirements, guidelines and statutory obligations as applicable to clinical investigators
participating in clinical trials.
Signature of PI with date
Development and validation of a normative atlas of the developing fetal brain using diffusion
tensor imaging
Introduction:
Ultrasound is the preferred examination tool for fetuses, but due to the influence of various artifacts,
the diagnostic accuracy of fetal ultrasonography in the second and third trimester of pregnancy
declined. Magnetic resonance imaging (MRI) is considered as an important supplement to
ultrasonography [1]. The high-resolution and rapid imaging sequences of MRI are beneficial to the
recognition anatomical structure and carry out more accurate measurements [2]. Ultrasound study
emphasizes linear measurements including transverse cerebellar diameter and biparietal diameter of
the skull to evaluate gestational age (GA) [3]. Ventriculomegaly is defined as an atrial diameter of
more than 10 mm on prenatal ultrasound [4]. The simple linear measurement may not be able to fully
describe the dynamic changes in brain development [5]. Volume measurement can make up for the
limitations of linear measurement [6, 7]. The establishment of standardized fetal structure twodimensional (2D) and three-dimensional (3D) can transform the subjective interpretation of fetal MRI
into the quantitative analysis and will get a more accurate diagnosis. Because the previous normal
biostatistics data mainly come from ultrasound imaging, prenatal use of MRI is still uncommon, and
MRI is usually performed on suspicious abnormal fetuses, so it is necessary to reevaluate the MRI
data of normal fetuses.
Despite the technical challenges associated with in utero DTI, it is currently the only clinically viable
imaging modality capable of visualizing the developing white matter during the second and third
trimesters of gestation. The diffusion tensor approach provides added value to that of diffusionweighted imaging in that the fractional anisotropy, the eigenvalues and orientations of the tensor may
reflect many, thus-far not thoroughly studied, physiological and microstructural attributes of fetal
nerve tissue. DTI and tractography before birth therefore represent important approaches for basic and
clinical neuroscience research, especially since our current understanding of the transient morphology
of the emerging human brain pathways and its vulnerability during “risk periods” of development are
based on postmortem histology and imaging in a limited number of subjects.
Review of literature:
In a study to evaluate the within-subject reproducibility of in utero diffusion tensor imaging (DTI)
metrics and the visibility of major white matter structures, Jakab et al., analyzed images for 30 fetuses
(20-33. postmenstrual weeks, normal neurodevelopment: 6 cases, cerebral pathology: 24 cases)
acquired on 1.5 T or 3.0 T MRI. DTI with 15 diffusion-weighting directions was repeated three times
for each case, TR/TE: 2200/63 ms, voxel size: 1 ∗ 1 mm, slice thickness: 3-5 mm, b-factor: 700
s/mm2. Reproducibility was evaluated from structure detectability, variability of DTI measures using
the coefficient of variation (CV), image correlation and structural similarity across repeated scans for
six selected structures. The effect of age, scanner type, presence of pathology was determined using
Wilcoxon rank sum test. White matter structures were detectable in the following percentage of
fetuses in at least two of the three repeated scans: corpus callosum genu 76%, splenium 64%, internal
capsule, posterior limb 60%, brainstem fibers 40% and temporooccipital association pathways 60%.
The mean CV of DTI metrics ranged between 3% and 14.6% and we measured higher reproducibility
in fetuses with normal brain development. Head motion was negatively correlated with
reproducibility, this effect was partially ameliorated by motion-correction algorithm using image
registration. Structures on 3.0 T had higher variability both with- and without motion correction. Fetal
DTI is reproducible for projection and commissural bundles during mid-gestation, however, in 1630% of the cases, data were corrupted by artifacts, resulting in impaired detection of white matter
structures [8].
Khan et al. developed the first DTI atlas of the fetal brain computed from in utero diffusion-weighted
images. For this purpose an algorithm for computing an unbiased spatiotemporal DTI atlas, which
integrates kernel-regression in age with a diffeomorphic tensor-to-tensor registration of motioncorrected and reconstructed individual fetal brain DTIs, was developed. The new algorithm was
applied to a set of 67 fetal DTI scans acquired from healthy fetuses each scanned at a gestational age
between 21 and 39 weeks. The neurodevelopmental trends in the fetal brain, characterized by the
atlas, were qualitatively and quantitatively compared with the observations reported in prior ex vivo
and in utero studies, and with results from imaging gestational-age equivalent preterm infants. The
findings revealed early presence of limbic fiber bundles, followed by the appearance and maturation
of projection pathways (characterized by an age-related increase in FA) during late 2nd and early 3rd
trimesters. During the 3rd trimester association fiber bundles become evident. In parallel with the
appearance and maturation of fiber bundles, from 21 to 39 gestational weeks gradual disappearance of
the radial coherence of the telencephalic wall was qualitatively identified. These results and analyses
show that our DTI atlas of the fetal brain is useful for reliable detection of major neuronal fiber
bundle pathways and for characterization of the fetal brain reorganization that occurs in utero [9].
In a study by Millischer et al., 37 cases referred for fetal DTI at 30.4 weeks (range, 25-34 weeks)
because of an isolated short corpus callosum less than the 5th percentile by sonography at 26 weeks
(range, 22-31 weeks), were analyzed. Tractography quality, the presence of Probst bundles,
dysmorphic frontal horns, callosal length (internal cranial occipitofrontal dimension/length of the
corpus callosum ratio), and callosal thickness were assessed. Cytogenetic data and
neurodevelopmental follow-up were systematically reviewed. The authors found that fetal DTI,
combined with anatomic, cytogenetic, and clinical characteristics could suggest the possibility of
classifying an isolated short corpus callosum as callosal dysplasia and a variant of normal callosal
development [10].
Calixto et al. presented detailed anatomic labels for a spatiotemporal atlas of fetal brain Diffusion
Tensor Imaging (DTI) between 23 and 30 weeks of post-conceptional age. Additionally, they
examined developmental trajectories in fractional anisotropy (FA) and mean diffusivity (MD) across
gestational ages (GA). They performed manual segmentations on a fetal brain DTI atlas. They labeled
14 regions of interest (ROIs): cortical plate (CP), subplate (SP), Intermediate zone-subventricular
zone-ventricular zone (IZ/SVZ/VZ), Ganglionic Eminence (GE), anterior and posterior limbs of the
internal capsule (ALIC, PLIC), genu (GCC), body (BCC), and splenium (SCC) of the corpus
callosum (CC), hippocampus, lentiform Nucleus, thalamus, brainstem, and cerebellum. A series of
linear regressions were used to assess GA as a predictor of FA and MD for each ROI. The
combination of MD and FA allowed the identification of all ROIs. Increasing GA was significantly
associated with decreasing FA in the CP, SP, IZ/SVZ/IZ, GE, ALIC, hippocampus, and BCC (p < .03,
for all), and with increasing FA in the PLIC and SCC (p < .002, for both). Increasing GA was
significantly associated with increasing MD in the CP, SP, IZ/SVZ/IZ, GE, ALIC, and CC (p < .03,
for all) [11].
Rationale and justification:
Congenital disorders are one of the leading causes of infant mortality worldwide. In-utero MRI of
the fetal brain has started to emerge as a valuable tool for investigating the neurological development
of fetuses with congenital disorders. Automated segmentation and quantification of the highly
complex and rapidly changing brain morphology prior to birth in MRI data would improve the
diagnostic process, as manual segmentation is both time-consuming and subject to human error and
inter-rater variability.
Intention is to come up with normative fetal brain DTI values, that can be used as a comparison with
fetal MRI scan to assess fetal growth. To develop the brain segmentation algorithm utilizing the
normal fetal brain, which divides the brain into multiple regions. Fetal MRI can aid in the future
development of clinical risk stratification tools for early interventions, treatments, and clinical
counseling.
Safety Statement
The American College of Radiology and Society for Pediatric Radiology have collaborated on
practice parameters for the safe and optimal performance of fetal MRI [12]. The 2015 revised
practice parameters cited data from 11 studies, which showed no conclusive deleterious effects on
the developing fetus at 1.5-T MRI. More recent studies [13-15] have shown no evidence of an
increased rate of congenital anomalies, neoplasia, vision loss, or adverse effects on birth weight,
hearing, or neurodevelopmental outcomes compared with findings in neonates not exposed to MR.In
a study by Chartier et al., there were no adverse effects noted in fetuses exposed to 3T MRI [16].
Research Plan
Aim : To develop a normative atlas of DTI of fetal brain between gestational age of 20 – 34
weeks
Objectives:

To acquire DTI of developing fetal brain at various gestational ages and to use this
dataset to create a normative atlas of DTI of fetal brain

To validate the normative DTI atlas using additional fetal MRI scans after creation of
the atlas
Methodology:
The study shall include healthy pregnant females between 20 and 34 weeks of gestation.
After obtaining a written and informed consent to participate, the patients shall be scanned
using 3T MRI system (MAGNETOM, Skyra, Siemens Healthineers, Germany).
MRI sequences
1. Balanced single shot fast spin echo T2W image oriented transversally in relation to fetal
head ( Time of acquisition ~ 5 minutes)
2. 12 direction Diffusion tensor imaging (Time of acquisition ~ 5 minutes)
Data from each of the fetal head shall be used for manual segmentation and annotation at the
department of radiodiagnosis, AIIMS, Bathinda.
The data shall be shared with Siemens, Healthineers, who shall develop an automated
segmentation, volumetric and morphometric algorithm from the dataset.
Additional data set acquired from different fetal cohort shall be used for validation of the
developed algorithm
Sample size
For development of algorithm – for each gestational age between 20 weeks to 34 weeks, 10
normal fetal MRI shall be obtained – total of 150 fetal scans
For validation of algorithm – 50 fetal MRI shall be obtained. These may be normal and/or
abnormal
Exclusion criteria
1. High risk pregnancy
2. Any fetal developmental anomaly detected by USG or MRI (for development of
algorithm only)
3. Claustrophobic patients
4. Patients with cardiovascular diseases
5. No consent for participation
Duration of study – 1 year
Equipment available with the Institute/ Group/ Department/Other Institutes for the project
Equipment Available
Generic name of the
Model, Make and
Remarks including
equipment
year of purchase
current usage and
accessories
PI and His group
-----
------
-------
PI’s Department
MRI Scanner
Magnetom Skyra
Currently used for
clinical MRI scans in
3 Tesla, Siemens
the department
Healthineers
(Germany)
Year: 2020
Other institution (s)
in the region
Plan for publication of results: The study is planned to be published.
Reference:
1. Griffiths PD, Bradburn M, Campbell MJ, Cooper CL, Graham R,Jarvis D, Kilby MD, Mason G,
Mooney C, Robson SC, Wailoo A(2017) Use of MRI in the diagnosis of fetal brain abnormalities
inutero (MERIDIAN): a multicentre, prospective cohort study.LANCET 389:538–546
2. Gholipour A, Rollins CK, Velasco-Annis C, Ouaalam A,Akhondi-Asl A, Afacan O, Ortinau CM,
Clancy S,Limperopoulos C, Yang E, Estroff JA, Warfield SK (2017)A normative spatiotemporal
MRI atlas of the fetal brain forautomatic segmentation and analysis of early brain growth.Sci Rep
7:476
3. Katorza E, Bertucci E, Perlman S, Taschini S, Ber R, Gilboa Y,Mazza V, Achiron R (2016)
Development of the fetal Vermis: newbiometry reference data and comparison of 3 diagnostic
modalities3D ultrasound, 2D ultrasound, and MR imaging. AJNR Am JNeuroradiol 37:1359–1366
4. Fox NS, Monteagudo A, Kuller JA, Craigo S, Norton ME (2018)Mild fetal ventriculomegaly:
diagnosis, evaluation, and management. Am J Obstet Gynecol 219:B2–B9
5. Biegon A, Hoffmann C (2014) Quantitative magnetic resonanceimaging of the fetal brain in utero:
methods and applications.World J Radiol 6:523–529
6. Jarvis DA, Finney CR, Griffiths PD (2019) Normative volumemeasurements of the fetal intracranial compartments using 3D volume in utero MR imaging. Eur Radiol 29:3488–3495
7. Scott JA, Habas PA, Kim K, Rajagopalan V, Hamzelou KS,Corbett-Detig JM, Barkovich AJ,
Glenn OA, Studholme C (2011)Growth trajectories of the human fetal brain tissues estimated
from3D reconstructed in utero MRI. Int J Dev Neurosci 29:529–536
8. Jakab A, Tuura R, Kellenberger C, Scheer I. In utero diffusion tensor imaging of the fetal brain: A
reproducibility study. Neuroimage Clin. 2017 Jun 9;15:601-612. doi: 10.1016/j.nicl.2017.06.013.
9. Khan S, Vasung L, Marami B, Rollins CK, Afacan O, Ortinau CM, Yang E, Warfield SK,
Gholipour A. Fetal brain growth portrayed by a spatiotemporal diffusion tensor MRI atlas computed
from
in
utero
images.
Neuroimage.
2019
Jan
15;185:593-608.
doi:
10.1016/j.neuroimage.2018.08.030.
10. Millischer AE, Grevent D, Sonigo P, Bahi-Buisson N, Desguerre I, Mahallati H, Bault JP,
Quibel T, Couderc S, Moutard ML, Julien E, Dangouloff V, Bessieres B, Malan V, Attie T, Salomon
LJ, Boddaert N. Feasibility and Added Value of Fetal DTI Tractography in the Evaluation of an
Isolated Short Corpus Callosum: Preliminary Results. AJNR Am J Neuroradiol. 2022 Jan;43(1):132138. doi: 10.3174/ajnr.A7383.
11. Calixto C, Machado-Rivas F, Karimi D, Cortes-Albornoz MC, Acosta-Buitrago LM, Gallo-
Bernal S, Afacan O, Warfield SK, Gholipour A, Jaimes C. Detailed anatomic segmentations of a
fetal brain diffusion tensor imaging atlas between 23 and 30 weeks of gestation. Hum Brain Mapp.
2022 Nov 24. doi: 10.1002/hbm.26160.
12. American College of Radiology website. ACR-SPR practice parameter for the safe and
optimal performance of fetal magnetic resonance imaging (MRI). www.acr.org//media/ACR/Files/Practice-Parameters/mr-fetal.pdf. 2015.
12. Ray JG, Vermeulen MJ, Bharatha A, Montanera WJ, Park AL. Association between
MRI exposure during pregnancy and fetal and childhood outcomes. JAMA 2016; 316:952–
961
13. Strizek B, Jani JC, Mucyo E, et al. Safety of MR imaging at 1.5 T in fetuses: a
retrospective case-control study of birth weights and the effects of acoustic
noise. Radiology 2015; 275:530–537
14. Bouyssi-Kobar M, du Plessis AJ, Robertson RL, Limperopoulos C. Fetal magnetic
resonance imaging: exposure times and functional outcomes at preschool age. Pediatr
Radiol 2015; 45:1823–1830
15. American Academy of Pediatrics, Joint Committee on Infant Hearing. Year 2007
position statement: principles and guidelines for early hearing detection and intervention
programs. Pediatrics 2007;120:898–921
16. Chartier AL, Bouvier MJ, McPherson DR, Stepenosky JE, Taysom DA, Marks RM. The
Safety of Maternal and Fetal MRI at 3 T. AJR Am J Roentgenol. 2019 Nov;213(5):11701173.
PROFORMA
Age (years) Last Menstrual Period (LMP) –
Gestational Age (LMP)
Co-morbidities –
Fetal Biometry

BPD

AC

HC

FL
USG gestational Age
Estimated fetal weight
MRI segmentation

External CSF

Cortical gray matter

White matter

Deep gray matter

Cerebellum

Brainstem
DTI

Fractional anisotropy

Mean diffusivity

Axial diffusivity

Radial diffusivity

ADC
PARTICIPANTINFORMATIONSHEET(PIS)
Participant Information Sheet (PIS)
PROTOCOL NO:
PRINCIPAL INVESTIGATOR: Dr Sameer Peer
Name of the Institution: AIIMS, Bathinda
Name of Participant:
i)
Title of the Study/Project: “Development and validation of a normative
atlas of the developing fetal brain using diffusion tensor imaging”
ii)
Aims and methodsof the research:The aim of the study is to develop a
normative database of the volumetric and morphometric measurements of
developing fetal brain at various gestational ages, using MRI scan of the fetus.
Your MRI scan will be obtained once. The scan shall run for a total of 10
minutes. The data generated from your scan shall be used in developing a
normative database of fetal brain and shall be useful in detection of anomalies
of the fetal brain
iii)
Expected duration of the subject participation: You will be contacted
one time only during the scan. However, if required you will be contacted
again to verify some of the information and can be contacted again over
a period of 12 months.
iv)
The benefits to be expected from the research to the subject or to
others: There may not be a direct benefit of undergoing MRI scan for you.
However, the data can help in developing a computer program which in future
may assist in detecting abnormal fetal brain development and may help families
in taking informed decisions regarding management of pregnancies.
v)
Any risk to the subject associated with the study. You will not be exposed
to any risk and discomfort, and the sample and any interview will be conducted
only after completion of your consultation with physician.
vi)
Provision of free treatment for research related injury. Not Applicable.
You will not be exposed to any risk and discomfort, and the interview will be
conducted only after completion of your consultation with physician. However,
in case any adverse event occurs appropriate measures will be taken by the
project team and appropriate referral will be done
vii)
Compensation of subjects for disability or death resulting from such
injury. Not applicable
viii)
Maintenance of confidentiality of records: The information provided by you
will be kept confidential and will be accessed only by the project staff for project
needs only. All data will be stored in a password protected electronic format. To
help protect the participants’ confidentiality, and form will not contain
information that will personally identify you. The results of this study will be
used for research purposes and to inform policy makers if any change is
required for improving maternal care.
ix)
Freedom of individual to participate and to withdraw from
research at anytime without penalty or loss of benefits to which
the subject would otherwise be entitled: Your participation in the
study is voluntary. You may choose not to participate in the study at any
time. Refusal to participate will not involve any penalty
x)
Amount of blood sample in quantity,in TeaSpoon Full, to be
taken should be mentioned: Not applicable
xi)
Costsandsourceofinvestigations,disposables,implantsanddrugs/c
ontrastmediamustbementioned: You will not have to pay for MRI
scan.
xii)
Telephone
number/contactnumberofPrincipalInvestigatorandCoin
vestigatoratthetopofeachpage.attached
xiii)
In case of drug trials: a) The chemical name of the drug, date of
its manufacturing and batch number must be mentioned b)
Initial Bioequivalent study of the drug/references should be
provided: Not applicable
xiv)
Statement that there is a possibility of failure of Investigational
Product (IP) to provide intended therapeutic effect: Not
applicable
xv)
Statement that in case of placebo-controlled trials,the placebo
administered to the subjects shall not have any therapeutic
effect: Not applicable
xvi)
Plans for publication including photographs: The results of the
study are intended to be published.
प्रतिभागी सूचना पत्र (पीआईएस)
प्रतिभागी सूचना शीट (पीआईएस)
प्रोटोकॉल:
प्रधान अन्वेषक: डॉ समीर पीर
संस्थान का नाम: एम्स, बत ं डा
प्रतिभागी का नाम:
i) अध्ययन/पररयोजना का शीषषक: "तिसरण टें सर इमेतजंग का उपयोग करके तिकासशील भ्रूण
के मस्तिष्क के एक मानक एटलस का तिकास और सत्यापन"
ii) अनुसंधान के उद्दे श्य और िरीके: अध्ययन का उद्दे श्य भ्रूण के एमआरआई स्कैन का उपयोग
करिे हुए, तितभन्न गभाष ितध उम्र में भ्रूण के मस्तिष्क के तिकास के िॉल्यूमेतटि क और मॉर्फोमेतटि क
माप का एक मानक डे टाबेस तिकतसि करना है । आपका एमआरआई स्कैन एक बार प्राप्त
तकया जाएगा। स्कैन कुल 10 तमनट िक चलेगा। आपके स्कैन से उत्पन्न डे टा का उपयोग भ्रूण के
मस्तिष्क के एक मानक डे टाबेस को तिकतसि करने में तकया जाएगा और भ्रूण के मस्तिष्क की
तिसंगतियों का पिा लगाने में उपयोगी होगा।
iii) तिषय की भागीदारी की अपेतिि अितध: स्कैन के दौरान आपसे केिल एक बार संपकष तकया
जाएगा। हालााँ तक, यतद आिश्यक हो िो कुछ सूचनाओं को सत्यातपि करने के तलए आपसे तर्फर
से संपकष तकया जाएगा और 12 महीनों की अितध में आपसे तर्फर से संपकष तकया जा सकिा है ।
iv) अनुसंधान से तिषय या अन्य लोगों के तलए अपेतिि लाभ: आपके तलए एमआरआई स्कैन
कराने का प्रत्यि लाभ नहीं हो सकिा है । हालां तक, डे टा एक कंप्यूटर प्रोग्राम तिकतसि करने में
मदद कर सकिा है जो भतिष्य में भ्रूण के असामान्य मस्तिष्क के तिकास का पिा लगाने में मदद
कर सकिा है और पररिारों को गभषधारण के प्रबंधन के बारे में सूतचि तनणषय लेने में मदद कर
सकिा है ।
v) अध्ययन से जुडे तिषय के तलए कोई जोस्तिम। आप तकसी भी जोस्तिम और असुतिधा के संपकष
में नहीं आएं गे , और नमूना और कोई भी सािात्कार तचतकत्सक के साथ आपके परामशष के पूरा
होने के बाद ही आयोतजि तकया जाएगा।
vi) अनुसंधान संबंधी चोट के तलए तनिःशुल्क उपचार का प्रािधान। लागू नहीं। आप तकसी भी
जोस्तिम और असुतिधा के संपकष में नहीं आएं गे, और तचतकत्सक के साथ परामशष पूरा होने के
बाद ही सािात्कार आयोतजि तकया जाएगा। हालां तक, यतद कोई प्रतिकूल घटना होिी है िो
पररयोजना टीम द्वारा उतचि उपाय तकए जाएं गे और उतचि रे र्फरल तकया जाएगा
vii) इस िरह की चोट के पररणामस्वरूप तिकलां गिा या मृत्यु के तलए तिषयों का मुआिजा।
लागू नहीं
viii) अतभलेिों की गोपनीयिा का रिरिाि: आपके द्वारा प्रदान की गई जानकारी को गोपनीय
रिा जाएगा और पररयोजना कमषचाररयों द्वारा केिल पररयोजना की जरूरिों के तलए ही इसका
उपयोग तकया जाएगा। सभी डे टा को पासिडष से सुरतिि इलेक्ट्िॉतनक प्रारूप में संग्रहीि तकया
जाएगा। प्रतिभातगयों की गोपनीयिा की रिा करने में मदद करने के तलए, और र्फॉमष में ऐसी
जानकारी नहीं होगी जो व्यस्तिगि रूप से आपकी पहचान करे । इस अध्ययन के पररणामों का
उपयोग अनुसंधान उद्दे श्यों के तलए और यतद मािृ दे िभाल में सुधार के तलए कोई बदलाि
आिश्यक है िो नीति तनमाष िाओं को सूतचि करने के तलए तकया जाएगा।
ix) तकसी भी समय तकसी भी दं ड या लाभों की हातन के तबना अनुसंधान से भाग लेने और िापस
लेने की व्यस्ति की स्विंत्रिा, तजसके तलए तिषय अन्यथा हकदार होगा: अध्ययन में आपकी
भागीदारी स्वैस्तिक है । आप तकसी भी समय अध्ययन में भाग नहीं लेने का तिकल्प चुन सकिे
हैं । भाग लेने से इनकार करने पर कोई जुमाष ना शातमल नहीं होगा
x) मात्रा में रि के नमूने की मात्रा, भरे हुए चाय के चम्मच में, उल्लेि तकया जाना चातहए: लागू
नहीं
xi) जां च, तडस्पोजल, इम्प्ां ट्स और डिग्स/कंटि ास्ट मीतडया की लागि और स्रोि का उल्लेि
तकया जाना चातहए: आपको एमआरआई स्कैन के तलए भुगिान नहीं करना होगा।
xii) प्रत्येक पृष्ठ के शीषष पर प्रधान अन्वेषक और सह अन्वेषक का टे लीर्फोन नंबर/संपकष नंबर
संलग्न है ।
xiii) दिा परीिण के मामले में: क) दिा का रासायतनक नाम, इसके तनमाष ण की िारीि और बैच
संख्या का उल्लेि तकया जाना चातहए ि) दिा का प्रारं तभक जैि समकि अध्ययन/संदभष प्रदान
तकया जाना चातहए: लागू नहीं
xiv) यह कथन तक लतिि तचतकत्सीय प्रभाि प्रदान करने के तलए जां च उत्पाद (आईपी) की
तिर्फलिा की संभािना है : लागू नहीं
xv) यह कथन तक ्ेसीबो-तनयंतत्रि परीिणों के मामले में, तिषयों को तदए गए ्ेसीबो का कोई
उपचारात्मक प्रभाि नहीं होगा: लागू नहीं
िस्वीरों सतहि प्रकाशन की योजनाएं : अध्ययन के पररणाम प्रकातशि तकए जाने का इरादा है ।
ਭਾਗੀਦਾਰਜਾਣਕਾਰੀਸੀਟ (PIS)
ਭਾਗੀਦਾਰਜਾਣਕਾਰੀਸੀਟ (PIS)
ਪ੍ਰੋਟੋਕੋਲ:
ਪ੍ਰਮੁੱਖਜਾਾਂਚਕਰਤਾ: ਡਾ: ਸਮੀਰਪ੍ੀਰ
ਸੰਸਥਾਦਾਨਾਮ: ਏਮਜ਼, ਬਠ ੰ ਡਾ
ਭਾਗੀਦਾਰਦਾਨਾਮ:
i) ਅਠਿਐਨ/ਪ੍ਰੋਜੈਕਟਦਾਠਸਰਲੇ ਖ: "ਠਡਠਿਊਜ਼ਨ ਟੈਂਸਰ ਇਮੇਠਜੰਗ ਦੀ ਵਰਤੋਂ ਕਰਦੇ ਹੋਏ
ਠਵਕਾਸਸੀਲ ਭਰੂਣ ਠਦਮਾਗ ਦੇ ਇੁੱਕ ਆਦਰਸ ਐਟਲਸ ਦਾ ਠਵਕਾਸ ਅਤੇ ਪ੍ਰਮਾਠਣਕਤਾ"
ii) ਖੋਜਦੇਉਦੇਸਅਤੇਠਵਿੀਆਾਂ:
ਅਠਿਐਨਦਾਉਦੇਸਗਰੁੱਭਸਥਸੀਸੂਦੇਐਮਆਰਆਈਸਕੈਨਦੀਵਰਤੋਂਕਰਦੇਹੋਏ, ਵੁੱਖਵੁੱਖਗਰਭਅਵਸਥਾਵਾਾਂਠਵੁੱਚਭਰੂਣਦੇਠਦਮਾਗਦੇਠਵਕਾਸਦੇਵਲ
ੌ ਯੂ ਮੈਠਟਰਕਅਤੇਮੋਰਿੋਮੈਠਟਰਕਮਾਪ੍ਾਾਂਦਾਇੁੱਕਆਦ
ਰਸਡੇ ਟਾਬੇਸਠਵਕਠਸਤਕਰਨਾਹੈ। ਤਹਾਡਾ MRI ਸਕੈਨਇੁੱਕਵਾਰਪ੍ਰਾਪ੍ਤਕੀਤਾਜਾਵੇਗਾ। ਸਕੈਨਕੁੱਲ 10
ਠਮੰਟਲਈਚੁੱਲੇਗਾ। ਤਹਾਡੇ ਸਕੈਨਤੋਂਠਤਆਰਕੀਤੇਗਏਡੇ ਟਾਦੀਵਰਤੋਂਭਰੂਣਦੇਠਦਮਾਗਦੇਇੁੱਕਆਦਰਸਡੇ ਟਾਬੇ
ਸਨੂੰ ਠਵਕਸਤਕਰਨਠਵੁੱਚਕੀਤੀਜਾਵੇਗੀਅਤੇਭਰੂਣਦੇਠਦਮਾਗਦੀਆਾਂਠਵਗਾੜਾਾਂਦਾਪ੍ਤਾਲਗਾਉਣਠਵੁੱਚਉਪ੍ਯੋਗੀ
ਹੋਵੇਗੀ।
iii) ਠਵਸੇਦੀਭਾਗੀਦਾਰੀਦੀਸੰਭਾਠਵਤਠਮਆਦ:
ਸਕੈਨਦੌਰਾਨਤਹਾਡੇ ਨਾਲਠਸਰਿਇੁੱਕਵਾਰਸੰਪ੍ਰਕਕੀਤਾਜਾਵੇਗਾ। ਹਾਲਾਾਂਠਕ,
ਜੇਕਰਲੋ ੜਪ੍ਈਤਾਾਂਕਝਜਾਣਕਾਰੀਦੀਪ੍ਸਟੀਕਰਨਲਈਤਹਾਡੇ ਨਾਲਦਬਾਰਾਸੰਪ੍ਰਕਕੀਤਾਜਾਵੇਗਾਅਤੇ 12
ਮਹੀਠਨਆਾਂਦੀਠਮਆਦਠਵੁੱਚਦਬਾਰਾਸੰਪ੍ਰਕਕੀਤਾਜਾਸਕਦਾਹੈ।
iv) ਖੋਜਤੋਂਠਵਸੇਜਾਾਂਹੋਰਾਾਂਲਈਆਸਕੀਤੇਜਾਣਵਾਲੇ ਲਾਭ: ਤਹਾਡੇ ਲਈ MRI
ਾਂ ਸਕਦਾ। ਹਾਲਾਾਂਠਕ,
ਸਕੈਨਕਰਵਾਉਣਦਾਠਸੁੱਿਾਲਾਭਨਹੀਹੋ
ਡੇ ਟਾਇੁੱਕਕੰਠਪ੍ਊਟਰਪ੍ਰੋਗਰਾਮਨੂੰ ਠਵਕਸਤਕਰਨਠਵੁੱਚਮਦਦਕਰਸਕਦਾਹੈਜੋਭਠਵੁੱਖਠਵੁੱਚਅਸਿਾਰਨਭਰੂਣਦੇ
ਠਦਮਾਗਦੇਠਵਕਾਸਦਾਪ੍ਤਾਲਗਾਉਣਠਵੁੱਚਮਦਦਕਰਸਕਦਾਹੈਅਤੇਗਰਭਅਵਸਥਾਦੇਪ੍ਰਬੰਿਨਬਾਰੇਸੂਠਚਤਿੈਸ
ਲੇ ਲੈ ਣਠਵੁੱਚਪ੍ਠਰਵਾਰਾਾਂਦੀਮਦਦਕਰਸਕਦਾਹੈ।
v)
ਾਂ
ਅਠਿਐਨਨਾਲਜੜੇਠਵਸੇਲਈਕੋਈਵੀਖਤਰਾ। ਤਹਾਨੂੰ ਠਕਸੇਖਤਰੇਅਤੇਬੇਅਰਾਮੀਦਾਸਾਹਮਣਾਨਹੀਕਰਨਾਪ੍ਵੇ
ਗਾ, ਅਤੇਨਮੂਨਾਅਤੇਕੋਈਵੀਇੰਟਰਠਵਊਡਾਕਟਰਨਾਲਤਹਾਡੀਸਲਾਹਤੋਂਬਾਅਦਹੀਕੀਤੀਜਾਵੇਗੀ।
ਾਂ .
vi) ਖੋਜਨਾਲਸਬੰਿਤਸੁੱਟਲਈਮਫ਼ਤਇਲਾਜਦੀਠਵਵਸਥਾ। ਲਾਗੂ ਨਹੀਹੈ
ਾਂ
ਤਹਾਨੂੰ ਠਕਸੇਖਤਰੇਅਤੇਬੇਅਰਾਮੀਦਾਸਾਹਮਣਾਨਹੀਕਰਨਾਪ੍ਵੇ
ਗਾ,
ਅਤੇਇੰਟਰਠਵਊਡਾਕਟਰਨਾਲਸਲਾਹ-ਮਸਵਰੇਤੋਂਬਾਅਦਹੀਕੀਤੀਜਾਵੇਗੀ। ਹਾਲਾਾਂਠਕ,
ਜੇਕਰਕੋਈਮਾੜੀਘਟਨਾਵਾਪ੍ਰਦੀਹੈਤਾਾਂਪ੍ਰੋਜੈਕਟਟੀਮਦਆਰਾਉਠਚਤਉਪ੍ਾਅਕੀਤੇਜਾਣਗੇਅਤੇਉਠਚਤਰੈਿਰਲ
ਕੀਤਾਜਾਵੇਗਾ
ਾਂ
vii) ਅਠਜਹੀਸੁੱਟਦੇਨਤੀਜੇਵਜੋਂਅਪ੍ਾਹਜਤਾਜਾਾਂਮੌਤਲਈਠਵਠਸਆਾਂਦਾਮਆਵਜ਼ਾ। ਲਾਗੂ ਨਹੀਹੈ
viii) ਠਰਕਾਰਡਾਾਂਦੀਗਪ੍ਤਤਾਦੀਸਾਾਂਭ-ਸੰਭਾਲ:
ਤਹਾਡੇ ਦਆਰਾਪ੍ਰਦਾਨਕੀਤੀਗਈਜਾਣਕਾਰੀਨੂੰ ਗਪ੍ਤਰੁੱਠਖਆਜਾਵੇਗਾਅਤੇਠਸਰਿਪ੍ਰੋਜੈਕਟਲੋ ੜਾਾਂਲਈਪ੍ਰੋਜੈਕਟ
ਸਟਾਿਦਆਰਾਹੀਪ੍ਹੰਚਕੀਤੀਜਾਵੇਗੀ। ਸਾਰਾਡਾਟਾਪ੍ਾਸਵਰਡਨਾਲਸਰੁੱਠਖਅਤਇਲੈ ਕਟਰਾਠਨਕਿਾਰਮੈਟਠਵੁੱਚ
ਸਟੋਰਕੀਤਾਜਾਵੇਗਾ। ਭਾਗੀਦਾਰਾਾਂਦੀਗਪ੍ਤਤਾਦੀਰੁੱਠਖਆਕਰਨਠਵੁੱਚਮਦਦਕਰਨਲਈ,
ਾਂ ਵੇਗੀਜੋਤਹਾਡੀਠਨੁੱ ਜੀਤੌਰ
ਅਤੇਿਾਰਮਠਵੁੱਚਅਠਜਹੀਜਾਣਕਾਰੀਨਹੀਹੋ
'ਤੇਪ੍ਛਾਣਕਰੇਗੀ। ਇਸਅਠਿਐਨਦੇਨਤੀਠਜਆਾਂਦੀਵਰਤੋਂਖੋਜਦੇਉਦੇਸਾਾਂਲਈਅਤੇਨੀਤੀਠਨਰਮਾਤਾਵਾਾਂਨੂੰਸੂਠਚ
ਤਕਰਨਲਈਕੀਤੀਜਾਵੇਗੀਜੇਕਰਮਾਵਾਾਂਦੀਦੇਖਭਾਲਨੂੰ ਠਬਹਤਰਬਣਾਉਣਲਈਕੋਈਤਬਦੀਲੀਦੀਲੋ ੜਹੈ।
ix)
ਠਕਸੇਵੀਸਮੇਂਜਰਮਾਨੇਜਾਾਂਲਾਭਾਾਂਦੇਨਕਸਾਨਤੋਂਠਬਨਾਾਂਠਕਸੇਵੀਸਮੇਂਖੋਜਠਵੁੱਚਠਹੁੱਸਾਲੈ ਣਅਤੇਵਾਪ੍ਸਲੈ ਣਦੀਠਵਅਕ
ਤੀਗਤਦੀਆਜ਼ਾਦੀਠਜਸਦਾਠਵਸਾਹੋਰਹੁੱਕਦਾਰਹੋਵੇਗਾ: ਅਠਿਐਨਠਵੁੱਚਤਹਾਡੀਭਾਗੀਦਾਰੀਸਵੈਾਂ ਵੀਸਮੇਂਅਠਿਐਨਠਵੁੱਚਠਹੁੱਸਾਨਾਲੈ ਣਦੀਚੋਣਕਰਸਕਦੇਹ।ੋ ਠਹੁੱਸਾਲੈ ਣਤੋਂਇਨਕਾਰਕਰਨ
ਇੁੱਛਤਹੈ। ਤਸੀਠਕਸੇ
ਾਂ ਵੇਗਾ
ਠਵੁੱਚਕੋਈਜਰਮਾਨਾਸਾਮਲਨਹੀਹੋ
x) ਮਾਤਰਾਠਵੁੱਚਖੂਨਦੇਨਮੂਨੇਦੀਮਾਤਰਾ, ਚਾਹਦੇਚਮਚੇਠਵੁੱਚਪ੍ੂਰੀਮਾਤਰਾਠਵੁੱਚ,
ਠਲਆਜਾਣਾਚਾਹੀਦਾਹੈ: ਲਾਗੂ ਨਹੀ ਾਂ
xi) ਲਾਗਤਾਾਂਅਤੇਜਾਾਂਚਦੇਸਰੋਤ, ਠਡਸਪ੍ੋਸੇਬਲ, ਇਮਪ੍ਲਾਾਂਟਅਤੇਡਰੁੱਗਜ਼ /
ਕੰਟਰਾਸਟਮੀਡੀਆਦਾਠਜ਼ਕਰਕੀਤਾਜਾਣਾਚਾਹੀਦਾਹੈ:
ਾਂ
ਤਹਾਨੂੰ ਐਮਆਰਆਈਸਕੈਨਲਈਭਗਤਾਨਨਹੀਕਰਨਾਪ੍ਵੇ
ਗਾ।
xii) ਹਰੇਕਪ੍ੰਨੇਦੇਠਸਖਰ
'ਤੇਪ੍ਰਮੁੱਖਜਾਾਂਚਕਰਤਾਅਤੇਸਠਹਜਾਾਂਚਕਰਤਾਦਾਟੈਲੀਿੋਨਨੰਬਰ/ਸੰਪ੍ਰਕਨੰਬਰ। ਨੁੱਥੀ
xiii) ਡਰੁੱਗਅਜ਼ਮਾਇਸਾਾਂਦੇਮਾਮਲੇ ਠਵੁੱਚ: a) ਦਵਾਈਦਾਰਸਾਇਣਕਨਾਮ,
ਇਸਦੇਠਨਰਮਾਣਦੀਠਮਤੀਅਤੇਬੈਚਨੰਬਰਦਾਠਜ਼ਕਰਕੀਤਾਜਾਣਾਚਾਹੀਦਾਹੈ b)
ਦਵਾਈਦੇਸਰੂਆਤੀਬਾਇਓਬਰਾਬਰਅਠਿਐਨ / ਹਵਾਲੇ ਪ੍ਰਦਾਨਕੀਤੇਜਾਣੇਚਾਹੀਦੇਹਨ: ਲਾਗੂ ਨਹੀ ਾਂ
xiv) ਠਬਆਨਠਕਇੁੱਛਤਉਪ੍ਚਾਰਕਪ੍ਰਭਾਵਪ੍ਰਦਾਨਕਰਨਠਵੁੱਚਜਾਾਂਚਉਤਪ੍ਾਦ (IP)
ਦੀਅਸਿਲਤਾਦੀਸੰਭਾਵਨਾਹੈ: ਲਾਗੂ ਨਹੀ ਾਂ
xv) ਠਬਆਨਠਕਪ੍ਲੇ ਸਬੋ-ਠਨਯੰਤਠਰਤਅਜ਼ਮਾਇਸਾਾਂਦੇਮਾਮਲੇ ਠਵੁੱਚ,
ਾਂ ਵੇਗਾ: ਲਾਗੂ ਨਹੀ ਾਂ
ਠਵਠਸਆਾਂਨੂੰਠਦੁੱਤੇਗਏਪ੍ਲੇ ਸਬੋਦਾਕੋਈਇਲਾਜਪ੍ਰਭਾਵਨਹੀਹੋ
xvi) ਿੋਟੋਆਾਂਸਮੇਤਪ੍ਰਕਾਸਨਦੀਆਾਂਯੋਜਨਾਵਾਾਂ: ਅਠਿਐਨਦੇਨਤੀਜੇਪ੍ਰਕਾਠਸਤਕੀਤੇਜਾਣਦਾਇਰਾਦਾਹੈ।
PATIENT’S CONSENT FORM
I___________________________S/o,D/o,caretaker______________________
R/O___________________________________________________________________do hereby
willingly agree to participate in the study entitled, “Development and validation of a normative
atlas of the developing fetal brain using diffusion tensor imaging” I affirm that there has been no
compulsion or monitory reimbursement in my agreeing to give the consent. I have been duly
informed by attending doctor about the following:Nature and purpose of the study.
Duration of the Participation.
Procedure to be followed.
Investigations to be performed.
Foreseeable risk and discomfort.
Benefits to the participants, community and medical profession.
Availability of medical treatment for such risk / injuries.
Steps taken for ensuring confidentiality.
No loss or benefits on withdrawal.
Voluntary participation.
Option to out of study at any stage.
I am giving the consent without any fear, obligation, coercion and undue influence. All the facts have
been explained to me in clear, unambiguous and understandable language.
Signature of Witness
Signature of Parent or Guardian
(Particulars about the relationship with patient)
Signature of Doctor
ਮਰੀਜ਼ਦੀਸਹਿਮਤੀਫਾਰਮ
ਨਾਮ___________ ਹਿਤਾ /
ਮਾਤਾਦੇਖਭਾਲਕਰਤਾ/__________________________ਿਤਾ______________________________________
_ਹਨਰਦੋਸ਼ਖ਼ੁਸ਼ੀ-ਖ਼ੁਸ਼ੀਿੱਕਦਾਰਦਾਅਹਿਐਨਹ ੱਚਹਿੱਸਾਲੈ ਣਲਈਸਹਿਮਤਿੋ, “Development and validation of a
normative atlas of the developing fetal brain using diffusion tensor
imaging”ਮੈਨੂੂੰਮੇਰੇਸਹਿਮਤੀਦੇਣਲਈਸਹਿਮਤਹ ੱਚਕੋਈਮਜਬੂਰੀਜਿੈਸੇਦੀਅਦਾਇਗੀਉਥੇਕੀਤਾਹਗਆਿੈ,
ਜੋਹਕਇਿਹਨਹਸ਼ਚਤਕਰ. ਮੈਨੂੂੰਹ ਿੀ ੱਿਿੇਠਬਾਰੇਡਾਕਟਰਨੂੂੰ ਿਾਜ਼ਰਿੋਕੇਸੂਹਚਤਕੀਤਾਹਗਆਿੈ: ਕ਼ੁਦਰਤਅਤੇਅਹਿਐਨਦਾਮਕਸਦ
ਸ਼ਮੂਲੀਅਤਦੇਹਮਆਦ
ਹ ਿੀਦੇਮਗਰਜਾਕਰਨਲਈ
ਿੜਤਾਲਕੀਤੀਜਾਤੱਕ
ਨੇ ੜਲੇ ਨੂੂੰ ਖਤਰਾਿੈਅਤੇਬੇਅਰਾਮੀ
ਹਿੱਸਾਲੈ ਣ, ਭਾਈਚਾਰੇਅਤੇਮੈਡੀਕਲਿੇਸ਼ੇਨੂੂੰਲਾਭ
ਅਹਜਿੇਖਤਰੇ / ਸੱਟਲਈਡਾਕਟਰੀਇਲਾਜਦੇਉਿਲੱ ਬਿਤਾ
ਗ਼ੁ ਿਤਤਾਨੂੂੰ ਯਕੀਨੀਬਣਾਉਣਲਈਹਲਆ
ਕਢ ਾਉਣ 'ਤੇਲਾਭਦੇਹਕਸੇਨ਼ੁਕਸਾਨ
ਲੂੰ ਟਰੀਸ਼ਮੂਲੀਅਤ
ਹਕਸੇ ੀਿੜਾਅ 'ਤੇਅਹਿਐਨਦੇਬਾਿਰਕਰਨਦਾਹ ਕਲਿ
ਮੈਨੂੂੰਕੋਈ ੀਡਰ, ਫ਼ਰਜ਼, ਜ਼ਬਰਦਸਤੀਅਤੇਨਾਜਾਇਜ਼ਿਰਭਾ ਨੂੂੰ ਹਬਨਾਸਹਿਮਤੀਦੇਹਰਿਾਿੈ. ਸਾਰੇਤੱਥ,
ਆਸਮਾਨਸਾਫਸਿੱਸ਼ਟਿੈਅਤੇਸਮਝਆਉਣਭਾਸ਼ਾਹ ਚਮੇਰੇਲਈਸਮਝਾਇਆਹਗਆਿੈ.
ਗ ਾਿਦੇਦਸਤਖਤ
ਮਰੀਜ਼ਜਸਰਿਰਸਤਦੇਦਸਤਖਤਦੇਨਾਲ
ਡਾਕਟਰਦੇਦਸਤਖਤ
(ਮਰੀਜ਼ਦੇਨਾਲਹਰਸ਼ਤੇਦੇ ੇਰ ੇ ਾਰ)
मरीजकीसहमतिफॉमम
मैं ______________________तििा/माां /कार्मवाहक__________________
ििा____________________________________________इसकेद्वारास्वेच्छाहकदारअध्यर्नमें भागलेनेकेतल
एसहमिहैं ,“ Development and validation of a normative atlas of the developing fetal brain using
diffusion tensor imaging”तकवाणीहै ।मैं तवतिवििालनकेबारे में तितकत्सकभागलेनेकेद्वारासूतिितकर्ागर्ाहै : प्रकृतिऔरअध्यर्नकाउद्दे श्य
भागीदारीकीअवति
प्रतिर्ाकािालनतकर्ाजानाहै
जाां िप्रदर्म नतकर्ाजाएगा
तनकटजोखिमऔरबेिैनीप्रतिभातगर्ोां, समु दार्औरतितकत्साकेिेर्ेकेतलएलाभ
इसिरहकेजोखिम / िोटोांकेतलएतितकत्साउििारकीउिलब्धिा
गोिनीर्िासुतनतििकरने केतलएले जार्ा
वािसीिरलाभकाकोईनु कसान
स्वैखच्छकभागीदारी
तकसीभीस्तरिरअध्यर्नसेबाहरकरने केतलएतवकल्प
मैं तकसीडर,
दातर्त्व,औरअनुतििप्रभावकेतबनासहमतिदे रहाहूँ ।सभीिथ्ोांकोस्पष्टस्पष्टऔरसमझआने वाले भाषामें मुझेसमझार्ाग
र्ाहै ।
गवाहकेहस्ताक्षर
साथरोगीर्ाअतभभावकिररिरकेहस्ताक्षर
(मरीजकेसाथररश्ते केबारमें)तितकत्सककेहस्ताक्षर