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a sample research information-sheet with consent form

a sample research information-sheet with consent form

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Published by nomoredoc
this is to help the budding researchers to prepare their 'research info sheet' along with the 'subject consent form' , both in the internationally prescribed format------absolutely required for appropriate regulatory approval.
this is to help the budding researchers to prepare their 'research info sheet' along with the 'subject consent form' , both in the internationally prescribed format------absolutely required for appropriate regulatory approval.

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Published by: nomoredoc on Aug 27, 2009
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05/11/2014

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1
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) betweenthem. You are being invited to take part in this research-study. Before youmake a decision, it is important for you to have a prior knowledge aboutwhy this study is being done and what it will involve. Please take time tounderstand the following information carefully. Please do not hesitate toask us if there is anything that is not clear or if you would like moreinformation. 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 DiabeticPopulation.
What is the purpose of the study ???
 
Both diabetes and thyroid disorders involve adysfunction of the endocrine system, which is a group of glands that helpto regulate various aspects of the body’s metabolism. Diabetes is adisorder characterized by an overabundance of glucose (sugar) in theblood due to insufficient insulin production by the pancreas
 
(a gland whichlies 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 alongwith 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 producesand releases thyroid hormone. Thyroid hormone affects every cell in thebody and controls many of the body’s functions. Thyroid disorders arealso 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 tofind 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 ???
 
2
If you agree to take part in this study , at first youwill 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, clinicalexamination. Later some routine & special laboratory investigations willbe performed from your blood & urine samples—collected by us.
This is to emphasize that,after deciding to take part you will havethe 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 beviewed by the investigator and the research team (if required) & willremain 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 acopy of any papers published, please let us know.
What about the expenditure or remuneration for theparticipation 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 isDr.XXXXXXX , & the study is being run between 3 departments at  ___________ Medical College -- Physiology , Biochemistry & Medicine.
Who has reviewed this study??
 
3
 
The study has been reviewed by theappropriate ethical committee in accordance with standard regulations.
What are the probable risk if someone participates in thisstudy ???
 
There is virtually no risk because this study is a non-interventional one & is minimally invasive when it comes to theblood 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 thestudy will definitely help your health-status. However, as underlyingthyroid 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 fromthis 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 thestudy, please contact Dr.XXXXXXX at:
Department of ___________ _________ Medical CollegeDistrict Pin codeStateTel : ______________ E-mail :xxxxxxxxxxxx@yahoo.co.in 

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