Post graduate thesis protocol to research cell and insitute ethical committee

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FORMAT FOR SUBMISSION OF PROTOCOL INVOLVING RESEARCH IN HUMAN
SUBJECTS FOR CLEARANCE BY INSTITUTE ETHICS COMMITTEE FOR POST
GRADUATE THESIS OF AIIMS, BHUBANESWAR FOR MD/MS/MCh/DM STUDENTS
General Instructions
1. PG Students are required to submit three copy of thesis protocol to research cell office. One copy
should be addressed to Sub Dean (Research and Examination) and two copies should be addressed
to Chairperson, Institutional Ethics Committee.
2. In addition, a soft copy (in CD) must be submitted. The soft copy should be submitted in PDF
format only. The CD should contain only two PDF files (one signed copy and one un- signed
copy). Student’s name and department should be written on the CD with OHP marker.
3. Formatting; Font - Times New roman, Font size - 12, Bold for main heading, Bold Italic for sub
heading, Margin 2.54 cm all sides. One side printing. All the pages should be numbered. Each
copy with spiral binding.
4. No research Protocol should be/ can be started unless ethics clearance/approval is obtained. Please
understand that no retrospective / post facto ethical clearance can be provided to research Protocols
which were neither submitted nor vetted by the ethics committee.
Content of thesis protocol
1. Covering letter addressed to Sub Dean (Research)/Chairperson IEC forwarded through guide
and HOD.
2. Name and designation of guide, co-guide and student (on separate page)
3. Table of content with page number
4. IEC format (Page No 2-4.)
5. Main protocol (Divided in following sections as detailed on Page No.5 )
6. Annexures: Questionnaire, interview schedule, data extraction form, laboratory data extraction
form, Participant Information Sheet (PIS) and Participant Informed Consent Form (PICF) in
English and Odia (in understandable lay man’s language) as given on Page No. 6 & 7. Please
note that just a template of PIS is provided here, it has to be modified suitably so that it is in
narrative form addressed to the participant.

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IEC FORMAT FOR PG THESIS PROTOCOL
1. Full Title of Study:
2.1 Name & signatures of the candidate
2.2 Department
2.3 Degree/course
2.4 Batch of admission to course
2.5 Month & year of submission of thesis
2.1_____________________ Signatures________________
2.2_____________________________________
2.3 B.Sc/MBBS/M.Sc/MD/MS/MHA/MDS/M.Biotech/MCh/
DM/ Ph.D (encircle)
2.4 January/July ________ (year)
2.5 June/November ________(year)
3. Name of Faculty & Department
(Guide/Co-guide)
3.1______________________________
3.2 _____________________________
3.3 _____________________________
3.4 _____________________________
3.5______________________________
(Expand if any more co-guides)
Signatures (Guide/Co-Guides)
3.1_____________________________________________
3.2 ____________________________________________
3.3 ____________________________________________
3.4 ____________________________________________
3.5_____________________________________________
4. Objectives of the study 4.1_____________________________________________
4.2_____________________________________________
4.3_____________________________________________
4.4_____________________________________________
4.5_____________________________________________
5. Why this study is required?
Please provide brief justification.
(Maximum 1000 words)
6. Methodology 6.1. Number of Patients:
6.2. Inclusion criteria
a)______________________________________________
b)______________________________________________
c)______________________________________________
d)______________________________________________

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6.3. Exclusion criteria
a)______________________________________________
b)______________________________________________
c)______________________________________________
d)______________________________________________
6.4. Control(s)
6.5. Study design
6.6. Dosages of drug
6.7. Duration of treatment
6.8. Investigation specifically related to Protocols
6.9 Permission to use copyrighted Questionnaire/profroma
6.9. Others
7. Permission from Drug Controller
General of India (DCGI)
1. Required 2. Not required
3. Received 4. Applied when:
8. Permission from DGFT , if required 1. Required 2. Not required
3. Received 4. Applied when:
9. a) Safety measures for proposed
interventions
b) Results of relevant laboratory tests
c) Result of studies in human
a)_____________________________________________
b)_____________________________________________
c)_____________________________________________
10. Plans to withdraw standard therapy
in research Yes No
Remarks:_______________________________________
11. Plan for provision of coverage for
medical risk
12. How you will maintain
Confidentiality of subject?
13. Costs Involved (Appx. in Rs.)
13.1 Investigations
13.2 Disposables
13.3 Implants
13.4 Drugs / Contrast Media
Who will bear the costs of the
requirements? (mark √ )
13.1_____________________________________________
13.2_____________________________________________
13.3_____________________________________________
13.4_____________________________________________
1. Patient 2. Protocol 3. Exempted
4. Other Agencies (Name)________________________
14. Participant Information Sheet
(mark √ if yes)
Attached English version
Attached Odia versiom
Certified that Odia version is a true translation of English version

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15. Participant Informed Consent Form
(mark √ if yes)
Attached English version
Attached Odia versiom
Certified that Odia version is a true translation of English version
16. Whether any work on this Protocol
has started or not?
(mark √ if yes, X if no)
(Please enclose a separate certificate to this effect).
17.Attached documents
(If any)
17.1 Covering letter, through proper channel.
17.2 Copy of the detailed protocol is mandatory
17.3 Undertaking that the study shall be done in accordance
with ICMR and GCP guidelines
17.4_ In case of multi-centric study, IEC clearance of other
centres must be provided
17.5 Definite undertaking as to who will bear the
expenditure of injury related to the Protocol
17.6 In case an insurance cover is intended, Insurance
certificate must be provided (as per ICMR guidelines)
17.7 : Permission as mentioned in 6.9
17.8: Certificate/undertaking as mentioned in 16
17.9 In case of Clinical trials, proof of registration of
Clinical trial with ICMR needs to be submitted.
17.10 Others:

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General Guidelines for Preparation of Thesis Protocol (Main Document)
Section General Guideline
Introduction Briefly covering background information related to research
question, gaps in knowledge, need and relevance of the study.
Study objectives Objectives should be based on SMART criteria. Can be divided
into primary and secondary objectives, if required.
Review of literature ROL should start with search strategy along with key words. ROL
should be preferably divided into two sections; International studies
(done outside India) and Indian studies. A table having the key
highlights of ROL is desirable.
Material and methods It should be sub divided into study setting, study design,
population, inclusion and exclusion criteria, sample size
calculation, laboratory methods, data collection tools, statistical
analysis plan etc.
Ethical issues This heading should address ways to maintain confidentiality of
study participants, action taken by the researcher in case of any
study related complications. It should be stated explicitly that study
will commence only after clearance from IEC.
Timelines A timeline of each important activity related to thesis should be
given preferably in Gantt chart format.
References Referencing should be done throughout in any one reference style,
preferably Vancouver style

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PARTICIPANT INFORMATION SHEET (PIS)
The protocol must be accompanied by the Participant Information Sheet addressed to the patient or
participant or parent/guardian, in case of minor. While formulating the participant information sheet,
investigator must provide the subjects with the following information in simple understandable
layman’s language, in English & Odia, in a narrative form, directed to participant / LAR, covering
all the points following points
i) Title of the study/project.
ii) Aims and methods of the research.
iii) Expected duration of the subject participation.
iv) The benefits to be expected from the research to the subject or to others.
v) Any risk to the subject associated with the study.
vi) Maintenance of confidentiality of records.
vii) Provision of free treatment for research related injury.
viii) Compensation of subjects for disability or death resulting from such injury.
ix) Freedom of individual to participate and to withdraw from research at any time. without penalty
or loss of benefits to which the subject would otherwise be entitled.
x) Amount of blood sample to be taken should be mentioned in PIS in Tea Spoon Full.
xi) Costs and source of investigations, disposables, implants and drugs / contrast media must be
mentioned in the PIS.
xii) Telephone number/contact number of the candidate and one of the investigators must be
mentioned in the PIS.
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 Bio equivalent study of the drug / references should be provided
xiv) Self-certification should be given that translation to vernacular is accurate.

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PARTICIPANT INFORMED COSENT FORM (PICF)
Participant identification number for this study: _______________________
Title of Thesis:_________________________________________________________________
_____________________________________________________________________________
Name of Principal Investigator: _________________________Tel.No(s).__________________
The contents of the information sheet dated ……………….. 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 me in detail. I understand that my
participation is voluntary and that I am free to withdraw at 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 from AIIMS, Bhubaneswar. I
give permission for these individuals to have access to my records.
I agree to take part in the above study.
--------------------------------------------- Date:
(Signatures / Left Thumb Impression) Place:
Name of the Participant: ____________________________________
Son / Daughter / Spouse of:__________________________________
Complete postal address: _____________________________________
This is to certify that the above consent has been obtained in my presence.
------------------------------
Signatures of the Principal Investigator Date: Place:
1) Witness – 1 2) Witness – 2
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Signatures Signatures
Name: Name:
Address: Address:
B Three copies should be made, for (1) patient, (2) researcher, (2) Institution
(Students are requested to prepare the translation in simple understandable Odia on their own.)