Professional Documents
Culture Documents
COVERING LETTER
To,
The Dean Research
AIIMS Bhopal
Respected Sir,
Hereby, I am submitting proposal for intramural research for review titled “An audit of male factor
infertility at a newly established tertiary care centre in Central India”. Kindly accept by submission
for the needful.
Thanking You,
Regards,
Dr Tanya Sharma
Assistant Professor,
Department of Pathology and Lab Medicine
Date: 10.8.19
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
N Documents Attached
(Yes/No/NA)
1 Covering letter duly forwarded by Head of Department √
2 Completed Proforma of IHEC, AIIMS Bhopal V
3 Detailed protocol with the budget √
4 Brief 2 page CV of Investigators (including number of projects with Principal √
Investigator)
5 Investigator Assurance form √
6 Undertaking that the scales/questionnaires/scores to be used are not √
copyrighted or permission to use them has been obtained
7 In case of multicentric study, IEC clearance of other centres must be provided NA
8 Definite undertaking as to who will bear the expenditure of injury related to √
the project
9 In case an insurance cover is intended, insurance certificate must be provided NA
(as per ICMR guidelines)
10 Investigator should provide undertaking what they will do with the leftover √
sample tissue.
11 Soft copy of all the documents in PDF format by email √
(ihec@aiimsbhopal.edu.in)
12 Any other document
Thanking you,
Name
Dr Tanya Sharma
Signature
Submit a print copy and email PDF (single scanned copy) to ihec@aiimsbhopal.edu.in
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
Investigator Assurance
I understand that as Principal Investigator, I will take full responsibility for the protection of
rights and welfare of all trial subjects including the conduct of study and ethical performance
of the project.
I agree to comply will all rules and regulations of IHEC and All India Institute of Medical
Sciences Bhopal regarding conduct of the trial/ research project. I hereby declare.
I further certify that the proposed research is not currently being conducted and will not
begin until IHEC approval has been obtained.
Principal Investigator
Dr Tanya Sharma
Co – Investigators
Dr Hemlata Panwar
Dr Sheetal Rathi
Dr Garima Goel
Dr Deepti Joshi
Dr Neelkamal Kapoor
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
SL. ITEM
NO
1 Full title of the study: “An audit of male factor infertility at a newly established tertiary care
centre in Central India”
Co – Investigators
Name- Dr Hemlata Panwar
Designation and department-Assistant Professor, Pathology and Lab Medicine
Role- Literature search, manuscript preparation
Signature:
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
6 STUDY PROTOCOL
Methodology:
Inclusion criteria:
All semen samples received for analysis in Department of Pathology and Lab Medicine for
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
infertility.
Exclusion criteria:
All semen samples received for semen analysis for cause other than infertility like post-
vasectomy specimens.
Sample collection:
Semen specimens collected by masturbation after 3–5 days of sexual abstinence in standard
sterile container will be collected by patient. The patient will be given instructions concerning
the collection of the semen sample that the sample needs to be complete and that the man should
report any loss of any fraction of the sample. Sample collection should be done in laboratory
premises.
Transport to laboratory: The specimen is then submitted by patient within half an hour of
collection.
Semen Analysis:
Sample is analysed following liquefaction, using automated semen analyzer SQA-
Vision,
as per standard operating procedure
Relevant clinical details of patient will be noted by pathology technician /pathologist
o Age of husband and wife
o Years of marriage
o No. of children
o Obstetrics history of wife
o Mode of contraception used previously/presently
o History of alcohol and smoking
o Any other medications
o History of chronic illness-TB, Diabetes, Hypertension, etc
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Institutional Human Ethics Committee
Statistical analysis:
All statistical analyses will be performed by using SPSS21.0 version software for Windows. P
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
11 Plan(s) for provision of coverage of medical risks during the study period. NOT
APPLICABLE
13 Funding : None
14 Participant information sheet: Retrospective study
Attached Hindi version No
Attached English version No
Other regional languages as applicable
Certified that Hindi version is true translation of English version
REFERENCES:
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Institutional Human Ethics Committee
Annexure 1
Project report
Date: 31.07.2018
LOP Number: LOPSTS0148
Project Title: Utility of scrape cytology in rapid diagnosis of tumors
Duration of the project: STS project of 2Months duration Report: (Annual/Final)
Name and affiliation of the investigators:
PI- Sheetal Singhal (MBBS Student)
Guide- Dr Tanya Sharma, Assistant Professor, Pathology and Lab Medicine
Introduction: Rapid diagnosis of tumors is crucial as it decides upon the surgical management to be
undertaken. Frozen section, intraoperative fine needle aspiration cytology and imprint cytology are
used by the surgical pathology laboratories for rapid and intraoperative diagnosis of tumors. Facility to
perform frozen sections may be lacking in many setups. Further, intraoperative FNAC may not be
feasible or conclusive in all cases.
Objectives:
Brief Methodology:A prospective study was conducted to evaluate the utility of scrape cytology for
rapid diagnosis of tumors and to correlate the findings of scrape cytology with histopathological
findings. A total of forty cases with clinicoradiological diagnosis of neoplasia were included in the
study. Scrape smears were prepared from specimens received either in formalin or in normal saline and
stained by rapid Hematoxylin and eosin technique
Results and conclusion: There were 30 (75%) cases of benign lesions and 10 (25%) cases of malignant
lesions. Overall, the diagnostic accuracy of scrape cytology was found to be 95% with a sensitivity of
90 % (CI-55.50 to 99.75) and specificity of 96.7 %( CI-82.78 to 99.92). In the present study, we found
that scrape cytology is a reliable, cost-effective and fairly accurate cytodiagnostic technique for rapid
intraoperative diagnosis of tumors. The study highlights the merits and pitfalls of scrape cytology. The
material and knowledge obtained can be utilized as a teaching material and may help unveil diagnostic
cytopathological features of cytologically less encountered lesions.
Work remaining: None
Outcome: Publications, presentations (poster or platform), patents, others. Attachments of the same
Poster presentation at ICP-AIPNA 2019 at AIIMS Bhopal.
The project was (tick whichever is applicable with brief reason)
a) not initiated
b) discontinued before completion
The brief report shall not exceed two A4 size pages (excluding attachments) and submitted to IHEC,
AIIMS Bhopal through proper channel.
Font shall be Times New Roman, size 11, line spacing 1.
One hard copy signed by the PI shall be provided to the IHEC office and scanned copy (with signatures)
mailed to ihec@aiimsbhopal.edu.in.
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
Budget Page- NA
A. Contingency:
B. Consummables:
C. Minor equipment:
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
UNDERTAKING
This is to declare that the project titled “: “An audit of male factor infertility at a newly
established tertiary care centre on Central India” .The study does not include any
procedure which is injurious to the patient or breaches the confidentiality of the patient. Also,
residual human tissue will be discarded according to waste discarding policy of our institute.
Dr Tanya Sharma
Assistant Professor
AIIMS Bhopal
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
Brief CV of Investigators
Principal Investigator
LIST OF PUBLICATION
9. Bhatt GC, Sharma T, Agrawal PK, Dhingra B. Not a typical urinary tract infection: A
case of urethritis due to an exogenous oil instillation in penile urethra of an infant. Annals
of Tropical Medicine and Public Health2014. 7 (2), 148.
10. Bhatt GC, Bondre VP, Sapkal GN, Sharma T, Kumar S, Gore MM, Kushwaha KP,
Rathi AK. Changing clinico-laboratory profile of encephalitis patients in the eastern Uttar
Pradesh region of India. Trop Doct. 2012 Apr. 42:106-8.
11. Bhatt GC, Sharma T, Kushwaha KP. Concurrent infection of JE and mixed malarial
infection. J Pediatr Neurosci.2012 ;7 :52-4.
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
12. Bhatt GC, Sharma T*. Letter to editor “Aseptic meningitis following intravenous
immunoglobulin therapy of common variable immunodeficiency. J Pediatr Neurosci
2012; 7:242-3.
13. Bhatt GC, Sharma T. Author reply. J Pediatr Neurosci 2013; 7: 241-2.
14. Bhatt GC, Sharma T. Letter to editor “Outbreak of hand, foot and mouth disease in
Bhubaneswar, Odisha. Indian Pediatr 2013; 50:250.
15. Sharma T, Singh B, Bhatt GC. Profile of deferral of blood donors at regional blood
transfusion centre in north India. Asian Journal of Transfusion Science 2013; 7:156-
157.
16. Bhatt GC, Sharma T, Kushwaha KP. Enterovirus 76 associated severe acute
encephalitic syndrome complicated by myocarditis and successfully treated with
intravenous immunoglobulin. Annals of tropical medicine and public health 2013;
5:594-596.
17. Sharma T, Joshi D, Khurana A,Vikas Gupta, Kapoor NK. Bilaterally enlarged parotids
and sicca symptoms as a presentation of sarcoidosis: Pivotal role of aspiration
cytology in diagnosis. J Cytol. 2015 ; 32: 281–83.
18. Khurana U, Joshi D, Santosh JA, Sharma T, Kapoor NK. Oligosecretory multiple
myeloma: a case report. Blood Res. 2016 Mar; 51: 63–65
19. Khurana U, Majumdar K, Kapoor NK, Joshi D, Goel G, Sharma T et al. Spectrum
of parasitic infections in centrifuged urine sediments from a newly developed
tertiary care centre in Central India.Journal Of Parasitic Dis. 2018, DOI:
10.1007/s12639-018-1043-6
CO-INVESTIGATORS
List of Publications:
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Institutional Human Ethics Committee
Dr Sheetal Rathi
Publications:
1) Jindal R, Jain P, Joseph M, Krishnan S, Malpani S, Yadav J, Kaur K. Idiopathic calcinosis cutis of
the medial canthus of eye: A case report. European journal of pharmaceutical and medical
research.2017; 4 :478-480
2) Jindal R, Krishnan S, Jain P, Malpani S, Joseph M. Endometrial stromal sarcoma masquerading
as uterine fibroid. Sch J Med Case Rep 2017; 5:17-19
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
Dr Garima Goel
Email.Id. garima.atho@aiimsbhopal.edu.in
Publications:
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
Dr Deepti Joshi, Additional Professor, Department of Pathology and Lab Medicine, AIIMS
Bhopal
Email : deepti.patho@aiimsbhopal.edu.in
Publications:
1. Joshi D, Beuhring GC. Are Viruses associated with human Breast cancer ? Scrutinizing
the molecular evidence. Breast Cancer Research and Treatment. 2012. DOI
10.1007/s10549-011-1921-4
2. D Joshi, P Singh, Y Zonunfawni, N Gangane.Metaplastic carcinoma of the breast:
cytological diagnosis and diagnostic pitfalls. Actacytological 2011; 55 (4):313-31
3. Deepti Joshi , Munira Quadari , Neha Gangane , Rajnish Joshi, Nitin Gangane.
Association of Epstein Barr Virus Infection (EBV) with Breast Cancer in Rural
Indian Women. PLoS One. 2009 Dec 4;4(12):e8180
4. Upadhye V, Majumdar A, Gomashe A, Joshi D, Gangane N, Thamke D,
Mendiratta D, Harinath BC. Inhibition of Mycobacterium tuberculosis secretory
serine protease blocks bacterial multiplicationboth in axenic culture and in
human macrophages. Scand J Infect Dis. 2009 May 27:1-8.
5. Meena M, Joshi D, Joshi R, Sridhar S, Waghdhare S, Gangane N, Kalantri SP.
Accuracy of a multispecies rapid diagnostic test kit for detection of malarial parasite
at the point of care in a low endemicity region. Trans R Soc Trop Med Hyg. 2009
Dec,103(12):1237-44.
Dr Neelkamal Kapoor,
Recent Publications:
Books
Bhopal.
Citations: Nil
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
2018 Dec;42(4):608-615
Citations: Nil
Citations: Nil
Citations: Nil
Citations: Nil
PMCID:PMC5795733
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All India Institute of Medical Sciences Bhopal
Institutional Human Ethics Committee
Citations: 01
Citations : Nil
Citations: 02
Citations: Nil
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Citations: Nil
PMID: 29237972
Citations: Nil
PMID:26801006
Citations: 01
PMCID: PMC4828533
Citations: 05
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2016;44(5):410-2
PMID: 26879040
Citations: Nil
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