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Ethics committe application form

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5 views

Ethics committe application form

Uploaded by

beneesh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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APPLICATION FOR ETHICS COMMITTEE APPROVAL

1. Title of Research Project :

2. Name, designation, Qualification :


& Experience of Principal Investigator

3. Name, designation, Qualification & : (1)


Experience of the Co–Investigators

(2)

4. Institution / Department where :


Research is carried out

5. Name of funding agency :


& address

6. Duration of study :

ETHICS COMMITTEE CONCERNS

1
a) Are the risks to the subjects minimized by using procedures which are
consistent
with sound research design and which do not unnecessarily expose the
subjects
to risk and whenever appropriate by using procedures already being
performed on
the subjects for diagnostic or treatment purpose ?

b) Are the risks to the subjects reasonable in relation to:


i) The benefits that might reasonably be expected as an outcome to the
subjects or to others ?

ii) Provision for free treatment for research related injury:

iii) Compensation of the subjects for disability or death resulting from such
injury
(details as to how the compensation if needed would be provided by the
Principal investigator or by an insurance firm or by funding agency) :

iv) The importance of the knowledge that may reasonably be expected to


result from the research project .

c) Will informed consent be sought from each positive subject or the subject’s
legally
authorized representative:

d) Does the research plan make adequate provision for confidentiality and
monitoring of the data collected to ensure the safety of the subjects :

2
DECLARATION AND SIGNATURE OF PRINCIPAL INVESTIGATOR

I hereby agree to abide by the rules and regulations of the

Institutional Ethics Committee and that of Government Medical College

Manjeri. I will not modify any aspect of research project submitted without

prior approval of the Ethics Committee.

Signature of the Principal Investigator

DECLARATION AND SIGNATURE OF CO-INVESTIGATORS

I hereby agree to assist the Principal investigator throughout the period

of research as per its protocol submitted for approval. I have the necessary

qualification and expertise to assist this research project.

Co-Investigators 1) (Signature)

2) (Signature)

Head of the Department

Signature

3
From

Dr…………………………………………………..

Designation/Dept. ………………………………

Government Medical College Manjeri


Ph.No:

To
The Chairman,
Institutional Ethics Committee,
Government Medical College Manjeri

(Through proper channel)

Sir,
Sub: Application for Institutional Ethics Committee – approval – reg.

I am enclosing herewith the detailed protocol of my research work

entitled

“.............................................................................................. ............................

.............................................................................. .. ..........................................

...............................................................” for favour of approval from the

institutional Ethics Committee”.

Thanking you,

Yours faithfully,

Manjeri
Date:

(Department Seal)

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