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Research Information Sheet

Name of the investigator ---

Designation ---

We are conducting a study to review the effect of Diabetes mellitus (DM)

on thyroid function & thereby analyze the relationship (if any) between
them. You are being invited to take part in this research-study. Before you
make a decision, it is important for you to have a prior knowledge about
why this study is being done and what it will involve. Please take time to
understand the following information carefully. Please do not hesitate to
ask us if there is anything that is not clear or if you would like more
information. Take time to decide whether or not you wish to take part.

• What is the title of the study ???

Clinical & Biochemical Assessment of Thyroid status in Diabetic
Population.

• What is the purpose of the study ???

Both diabetes and thyroid disorders involve a
dysfunction of the endocrine system, which is a group of glands that help
to regulate various aspects of the body’s metabolism. Diabetes is a
disorder characterized by an overabundance of glucose (sugar) in the
blood due to insufficient insulin production by the pancreas (a gland which
lies across the back of the body between the kidneys) or the inability of
the body to utilize insulin to transport glucose into the cells. Thus along
with different important organs of our body like kidneys, cardiovascular
system, nervous system etc., other glands of the endocrinal system may
also be affected in patients suffering from Diabetes.
The thyroid is a butterfly-shaped gland located at
the base of the neck that lies on either side of the windpipe. It produces
and releases thyroid hormone. Thyroid hormone affects every cell in the
body and controls many of the body’s functions. Thyroid disorders are
also common among general population.
Now, it is already found that diabetes & thyroid
disorders tend to co-occur in patients. In the present study , we will try to
find out upto what extent the diabetic patients are prone to thyroid
dysfunction & whether it is related to the degree and duration of
hyperglycaemia.

• What will happen to me if I participate in this study ???

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If you agree to take part in this study , at first you

will be asked to sign a consent form (prepared in the standard prescribed
format).
Then you will be interviewed regarding your past &
present health-status (i.e. medical history), apart from the general
personal information.
After that you will have to undergo a general
physical assessment along with a relevant ,systematic, clinical
examination. Later some routine & special laboratory investigations will
be performed from your blood & urine samples—collected by us.

 This is to emphasize that, after deciding to take part you will have
the right to among other things to:
(i) Refuse to answer any particular question,
(ii) To withdraw at any time, without giving a reason, and without your
medical care or legal rights being affected,
(iii) Ask any further questions about the study that occurs to you during
your participation ,
(iv) Be given access to a summary of the findings from the study, when it
is concluded.

• Will my taking part in this study be kept confidential ???

All information collected during the study will only be
viewed by the investigator and the research team (if required) & will
remain strictly confidential. You will not be identified in any written or
verbal reports of the study , without your explicit consent.

• What will happen to the major outcomes of the study ???

The results will be represented in the form of a
‘Thesis’ & is expected to be published in medical journals & disseminated
at research seminars and conferences. If you would like us to send you a
copy of any papers published, please let us know.

• What about the expenditure or remuneration for the

participation in this study ???
You will neither have to pay or will be paid for
your participation.

• Who is organising this study ???

The principal investigator of this study is
Dr.XXXXXXX , & the study is being run between 3 departments at
___________ Medical College -- Physiology , Biochemistry & Medicine.

• Who has reviewed this study??

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The study has been reviewed by the

appropriate ethical committee in accordance with standard regulations.

• What are the probable risk if someone participates in this

study ???
There is virtually no risk because this study
is a non-interventional one & is minimally invasive when it comes to the
blood sample collection, which will be done cautiously following proper
aseptic measures & sterile techniques. There may be mild, transient
discomfort/pain at the site from where the blood sample is collected.

• What will be the advantage of participation in this study ???

We can not assure that the outcome of the
study will definitely help your health-status. However, as underlying
thyroid disorders can have a major impact on glucose control & untreated
thyroid-malfunctioning can lead to potential harmful consequences ;
revelation of an undiagnosed thyroid dysfunction (if any) will not only
provide important corrective inputs in devising appropriate management
of diabetes but will also enable the healthcare-provider to initiate early
curative measures in restoring the normal thyroid status,even in the non-
diabetics (included in the study to serve as ‘controls’).
Moreover, the knowledge obtained from
this study will contribute in future to formulate the protocol for thyroid-
screening in diabetics.

 Contact for further information:

If you have any other questions about the
study, please contact Dr.XXXXXXX at:

Department of ___________
_________ Medical College
District – Pin code
State
Tel : ______________ E-mail :
xxxxxxxxxxxx@yahoo.co.in
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Date : ___ /___ /______

Investigator’s Signature

Place : ______________

Patient Identification Number for this Study :

CONSENT FORM

Title of the Project : CLINICAL AND BIOCHEMICAL

ASSESSMENT OF THYROID STATUS IN DIABETIC POPULATION

Name of the Investigator : DR.XXXXXXXX

(please write your initials in each box)

1) I confirm that I have read and understood the information

sheet (dated - ___ /___ /_______) containing information
(language --_____________ ) about the above study ,and have
had the opportunity to consider the information , ask
questions and have had these answered satisfactorily.

2) I understand that my participation is voluntary and that I

am free to withdraw at any time, without giving any reason
, and without my medical care or legal rights being affected.

3) I also understand that relevant sections of any of my

medical notes & data collected during this study , may be
looked at and analyzed by responsible individuals from the
research team or from the regulatory authorities . I give
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permission to the said individuals to have access to my

records for the sake of this study .

4) I agree to take part in the above study .

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Name of the person Signature/Thumb
impression Date

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------------------Name of the consent-taker/ investigator
Signature Date