VIKHE PATIL INSTITUTE OF MEDICAL SCIENCES (VIMS)

(Institutional Ethics Committee (IEC) for Medical, Nursing and

physiotherapy Colleges of vims)

Project Proposal for Approval of Ethics Committee:

Summary Sheet
(NB: This is not supposed to be a detailed protocol of the study.)

Proposal Registration Number

Version No- 1/ 2/ 3/ 4/ 5

PART-A

“Study of Functional and Radiological Outcome of

1. Title:
Anterior Cervical Discectomy and Fusion by Smith Robinson
Approach”

2. Address/s of Institutions where the study will be undertaken

Department Of Orthopaedics,
PDVVPF’S Medical college and Hospital,
Ahmednagar, Maharashtra 414111

3. Status of Review: New ✔ Revised in compliance with IEC

4. Investigators:

Name Designation Dept. Mobile e-mail

PI Dr. PG ORTHOPAEDICS 966590818
SHAILESH RESIDENT 3
S. SHEVALE
Co- Dr.JAYANT PROFESSOR ORTHOPAEDICS
PI-1 D. & HOD
THIPSE
Co-
PI-2
Co-
PI-3
Co-
PI-4

5. Number of ongoing projects with;NO

6. Does the project require any additional / separate budget:NO

7. Study duration :
From:date of approval To:December 2018

8. Aims & Objectives

1.To evaluate the functional and radiological outcomes of anterior

cervical fusion
2.To compare the results of this study with reported studies.
3.To study the advantages and disadvantages of this technique.
 9. Research Question/s
i.Does the patient have pain in neck ?
ii.Does the patient have tingling/numbaness?
iii.Does the patient have weakness in his upper extremity?
iv.Does the patient have bowel bladder incontinence?

10. Research Hypothesis (Where ever applicable)

i.
ii
iii
iv.
11. Population (Subjects) in whom study will be undertaken

Inclusion criteria Exclusion criteria

1.age:20 to 60 years both sexes 1.bleeding/coagulation disorders
2.cervical spine trauma and resulting
instability
3.radiculopathy secondary to cervical
disc prolapsed
4.cervical compressive myelopathy
5.cervical myelomalacia

12. Study Design: (Tick in appropriate cell)

Descriptive–Cross sectional Descriptive-Longitudinal ✔
Cross sectional-Analytical Case-control study
Cohort study Experimental drug trial (RCT)
Experimental :other than drug trial
Viz: Trial of new surgical procedure Phase: I/ II/ III/ IV
Animal study
Evaluation of diagnostic test Qualitative study
Any other (Specify)
NB: For Drug trial / Experimental interventions like new surgical technique Appendix-D
is mandatory
 13. Variables to be studied/ measured (Mention main variables first and
demographic and other variables later. Mention only those variables that you are
actually going to analyze):

(Note: Measurement scale of variable include: Nominal, categorical, interval and ratio
type. Measurement method may include questionnaire, interview, information from
records or making actual measurement on/in patient. Measurement method may differ
for different variables)

SNO Variable name Measurement scale Measurement method

1
2
3
4
5
6
7
8
9
10

14. Sample size : 50

a. Assumptions for calculation:

i. Alpha (α) error (usually 5%)
ii. Beta (β) error (Usually 20%)
iii. Variables assumed (Main variables in table at point No-10)
iv. Precision expected:
v. Design effect
vi. Hypothesis (wherever applicable): One sided/ two sided/ not applicable
vii. Any other (Specify)
b. Calculated minimum sample size:
c. Provision for loss to follow-up / Attrition:
 d. Total sample size (b+c)

15. Sampling method:

Simple random sampling method

16. Expected outcome/s

i.Early symptomatic relief & early mobilization of patient

Part-B
17. Information about subjects included in the study
i. Type of special subjects if any in the study
Pregnant women Fetus Children
Lactating mothers Elder persons Handicapped
Terminally ill Handicapped MLCs
Mentally challenged Others (Specify)

ii. Hospitalized / OPD patients only ✔ Healthy individuals

18. Mention if following tools will be used (with reasons if answer is NO)
i. Informed consent of subjects: YES ✔ NO
If YES: Written ✔ Audio-visual
If NO; Reason:
 Patient information brochure: NO
Reason:
ii. Patient Record Sheet: YES
(NB: Patient record sheet is supposed to be different from the usual record of the
patient like OPD/ IPD case paper. It is an important document supposed to be
prepared especially for the purpose of study)
Reason:
iii. Questionnaire/ Interview Proforma YES NO
Reason:

Will the patients/ participants be required to bear any additional expenditure due to
participation in the study? YES NO ✔
If YES:
i. Approximate amount per participant
ii. Is any financial provision made for this additional expenditure? YES/ NO
If YES: briefly explain the nature of provision.
19. Does the study involve use of :
SN Use of Y/N SN Use of Y/N
1 Fetal tissue or abortus N 5 Collection for banking/ future use N
2 Use or organ / body fluids N 6 Ionizing radiation/ Radio-isotopes N
3 Use of recombinant gene N 7 Use of infectious / bio hazardous N
therapy products material
4 Use of pre-existing stored N 8 Sending samples abroad N
samples
NB: For S. No-4; approval from Bhabha Atomic Research, Mumbai is required. For
S.No 3, 7, 8 permission from Department of Bio-technology is required.If answer to any
one of the above is YES; give details of collection, storage and transport

If answer to any of the above is YES; does it involve any risk to study
participants?

20. Study end point (When will the study terminate?)

31ST DECEMBER 2018

21. Mention probable benefits and risks to participants

Probable risks Probable benefits

NONE Early symptomatic relief & early
mobilization
 22. Privacy and confidentiality
i. Does the study involve:
Direct identifiers indirect identifiers complete anonymity
ii. Confidential data handled by staff: Y / N
iii. Briefly mention the arrangements made to protect privacy and
confidentiality

23. What are your plans of publication? (Mention the names of authors in
sequence; PI should be first author)
Dr.Shailesh S. Shevale

Checklist for documents: (Y = Yes, N=No, NA= Not applicable)

SN Document Y/N/ SN Document Y/N/

NA NA
1 Undertaking by PI: Y 9 Informed consent form Y
Appendix-A
2 CVs of PI and CO- Y 10 Questionnaire/ Interview Y
PIs: Appendix-B proforma
3 Declaration of HOD/ Y 11 MOU from sponsors** NA
HOI- Appendix-C
4 A Copy of detailed Y 12 Permission from authorities NA
protocol as per format like FDA, BARC etc
 of IEC/MUHS/ICMR
etc.
5 Appendix-D/E (For NA 13 Insurance documents** NA
Experimental study
only)
6 Copy of NA 14 Adverse event reporting NA
advertisement for protocol
patient recruitment
7 Patient record sheet Y 15 Patient information Brochure NA

8 Budget Details NA

Appendix-A
(Declaration cum undertaking by the principle investigator)
Proposal Title:“Study of Functional and Radiological Outcome of Anterior Cervical
Discectomy and Fusion by Smith Robinson Approach”
Proposal Number
Name of PI:Dr.Shailesh S. Shevale
Designation:PG Resident
Department Of Orthopaedics,
Institution:
PDVVPF’S Medical college and Hospital,
Ahmednagar, Maharashtra 414111
 1. I undertake that I will initiate the project only after the clearance from the IEC of
VIMS (herein after mentioned as IEC)
2. I declare that necessary permissions from participating departments in my
institution and outside my institution have been taken.
3. I will not implement any deviations from protocol without prior approval of IEC
4. I declare that I am competent by way of qualification and experience to work as
PI in this project.
5. I declare that all the CO-PIs in this study are competent by way of qualification
and experience to work as CO-PI in this project.
6. I will personally supervise the project and will obtain all necessary legal and
administrative permissions required for this project.
7. I will ensure complete and accurate recording in all documents related to the
study.
8. I will inform in writing IEC within 24 hours about occurrence of any serious
adverse event (SAE) and any un-expected adverse event (UAE) in this project.
9. I and my colleagues would respect the privacy and confidentiality of the
information given by the participants in this study.
10. I will inform about the actual starting date of the project within 7 days of the start.
11. I would submit 6 monthly progress reports within 4 weeks of the completion of
respective 6 moths.
12. I assure strict compliance with all legal and administrative procedures.
13. The information provided in the proposal is correct and accurate to the best of my
knowledge and belief.

Signature
Name
Date Place
Appendix-B

(CVs of PI and CO-PIs)

Study of Functional and Radiological Outcome of Anterior
Proposal Title:
Cervical Discectomy and Fusion by Smith Robinson Approach.
Proposal Number
(Use this sequence for PI and All Co-PIs; add if required)

Name Dr.Shailesh S.Shevale

Designation PG Resident Department
Institution DEPT OF ORTHOPAEDICS.
DVVPFS MEDICAL COLLEGE & HOSPITAL,VILAD GHAT,
AHMEDNAGAR414111,MAHARASHTRA
Qualification MBBS
Teaching experience (yrs): Asst. Professor Asso. Professor Professor
Research Experience in years: (as PG guide):
Publications in indexed journal: National International

Co-PI-1
Name Dr.Jayant D. Thipse
Designation Prof & HOD Department
Institution DVVPFS MEDICAL COLLEGE & HOSPITAL,VILAD GHAT,
AHMEDNAGAR414111,MAHARASHTRA

Qualification D.Ortho,M.S. Ortho

Teaching experience: Asst. Professor Asso. Professor Professor
Research Experience:
Research Publications in indexed journal: National International
Co-PI-2
Name
Designation Department
Institution
Qualification
Teaching experience: Asst. Professor Asso. Professor Professor
Research Experience:
Publications in indexed journal: National International
Co-PI-3
Name
Designation Department
Institution
Qualification
Teaching experience: Asst. Professor Asso. Professor Professor
Research Experience:
Number of Publications in indexed journal: National ------ International ------

Appendix-C
(Declaration by HOD/ HOI)
Study of Functional and Radiological Outcome of Anterior
Proposal Title:
Cervical Discectomy and Fusion by Smith Robinson Approach.
Proposal Number

1. I certify that I have read the protocol of this project and I permit the study to be
undertaken in my department/ Institution.
2. I assure of all administrative help required for the project which is within my
administrative and financial powers.
3. I will report to IEC any Serious Adverse Event/ Un-expected adverse event within
24 hours if it comes to my notice.
4. I will report to IEC any major deviation in protocol of this project within 48 hours if
it comes to my notice.

Signature of HOD
Name
Date
Place
Rubber Stamp:

(NB: A similar undertaking is required if the project requires help from other institution or
if the study is multi-centric. It is advised to include as Co-PI at least one person from
other department/ other institution if the project is inter-departmental/ multi-centric. )

Remarks of Head/ Principle of Institution

Recommended/ Not recommended (with reasons)

Signature of HOI/ Principle

Name
Date
Place
Stamp:

Appendix-D
(Only for Experimental drug trial vaccine trial.)
Study title:
Name of PI
 1. Is the study sponsored by any external agency? YES/ NO
If YES; submit the copy of MOU to IEC

2. Is the drug you propose to try licensed for use by FDA for the condition/
disease under study ?

YES NO

3. Is the drug you propose to try licensed for use by FDA in the dose you
propose?

YES NO

4. Is the drug you propose to try licensed for use by FDA by the route you
propose?
YES NO

5. Is the drug you propose to try licensed for use by FDA in formulation yoy
propose ?
YES NO

6. If answer to any of the question number 2-5 is No: Is the permission from
FDA authorities obtained? (Reasons if answer is NO)
YES NO
Reason:

7. Have the safety studies for the drug in doses/ route and formulation you
propose been done before?
Dose: YES NO
Route: YES NO
Formulation: YES NO
If answer to any of the above is YES: Attach references separately, If answer to any of
the above is above question is NO; is your department/ institution capable/ competent to
conduct such safety studies?

8. Mention known serious adverse events (SAE) of the drug/ interventions

you propose to study from medical literature with its frequency range.

SAE Incidence SAE Incidence

 Mortality

9. Will the CONTROL group be deprived of any treatment during study

period? (Placebo) YES/NO
If YES; give justification

10. If it is a double blind trial; what is the protocol for breaking the code in the
event of SAE?

11. Mention arrangements made for management of known SAEs

12. Mention arrangements like compensation/ insurance to the participants (in

the event of SAE) made with documentary proof thereof.

Appendix-E
(Only for Trial of New Surgical Procedure/ Intervention)
1. Is the study sponsored by any external agency? YES/ NO
a. If YES; submit the copy of MOU to IEC

2. Does the study involve use of new instrument / equipment?

YES NO

If YES: Give the details of FDA approval

3. Has the procedure/ intervention tried earlier elsewhere? YES/ NO

If YES: Give details

4. If answer to q-no 3 is YES: Give information about its safety and complications.

5. Give details of training received by PI / CO-PI about the procedure / intervention /

instrument

6. Have any pilot studies been done for the procedure/ intervention/ instrument?
YES/NO
If YES: Give details

Re-submission of Proposal

To
The Member Secretary
VIMS-IEC,
Ahmenagar

Sub: Resubmission of The Research Proposal

Ref: Project No Titled:

Dear Sir
The aforesaid project was submitted to you / IEC. It is hereby resubmitted again
with required corrections made as suggested. The corrected original proposal is
enclosed herewith.

Signature of PI
Name of PI
Department
Institute

Re-submission of Proposal
Compliance Report

Project No
Project Title
 PI:

S Comments of Research Compliance Compliance on

No Cell/ IEC Page No of the
proposal

Signature of PI
Name of PI
Department
Institute

Annexure: B
Institutional Ethical Committee – VIMS, Ahmednagar
Voting sheet
Proposal Title:
Principle Investigator:
Registration No:
 Department:
Date:
Vote
S.No Member Observation Signature
(Y/N)

Members to give observation and decision for acceptance in Yes/No

1 Dr. S.N.Mhaske

2 Dr. Gadekar J.M.

3 Dr. ArunTyagi

4 Dr. Rahul Kunkulol

5 Dr. Mrs. Ganvir S.S.

6 Dr. AbhijitDiwate

7 Dr. Mrs. Raut A.M.

8 Mr. Veerabhadrappa G.M

9 Mr. Ajit Mane

10 Mr. C.P. Patil

11 Mr. G.S. Bharadi

12 Mr. Rohidas Shawale

13 Secretary
Dr. B.B.Nayak
14 Chairman
Dr. S Manjunath
Total members present

Total votes in favour (Y):

Total votes in negative (N):

Final Decision
Accepted Accepted with observation
Revision Rejected

Signature of Member Secretary Signature of Chairman