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Informed Consent

This document is an informed consent form for a study examining the effect of body mass index (BMI) on pulmonary function tests and heart rate variability in young medical students. [1] The 3-part form provides information about the study, risks/benefits of participation, and ensures voluntary and confidential participation through a certificate of consent. [2] Young, healthy medical students will undergo non-invasive heart rate and pulmonary testing to study the impact of BMI, with all results kept private and anonymous in published findings. [3] Contact information is provided for any questions about participating in the low-risk study.

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Muskaan Singh
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385 views4 pages

Informed Consent

This document is an informed consent form for a study examining the effect of body mass index (BMI) on pulmonary function tests and heart rate variability in young medical students. [1] The 3-part form provides information about the study, risks/benefits of participation, and ensures voluntary and confidential participation through a certificate of consent. [2] Young, healthy medical students will undergo non-invasive heart rate and pulmonary testing to study the impact of BMI, with all results kept private and anonymous in published findings. [3] Contact information is provided for any questions about participating in the low-risk study.

Uploaded by

Muskaan Singh
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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INFORMED CONSENT FORM

1. For Individuals Participating in the study “Effect of Body Mass Index (BMI) on
Pulmonary function tests and Heart Rate Variability (HRV) in young medical
students: A cross sectional observational Study”
This Informed Consent Form has two parts:

● Information Sheet (to share information about the research with you)

● Certificate of Consent (for signatures if you agree to take part)

PART I: Information Sheet

Introduction

1. We are conducting a research titled “Effect of Body Mass Index (BMI) on


Pulmonary function tests and Heart Rate Variability (HRV) in young medical
students: A cross sectional observational Study”.”
I am going to give you information and invite you to be a part of this research.
Purpose of the research

1. The study will aim to find Effect of Body Mass Index (BMI) on Pulmonary
function tests and Heart Rate Variability (HRV) in young medical students using
Polyrite D device and PFT machine.
Participant selection
Young healthy medical students will be included in the study.
Voluntary Participation
Your participation in this research is entirely voluntary. At any point of time, you may
change your decision and discontinue participation even if you might have had agreed
earlier.
For any clinical study (if relevant):

Side Effects
The heart rate variability parameters will be recorded using Polyrite D device / PFT
Device which is absolutely safe and has not been shown to have any side effects.
Risks
There are no risks anticipated in the course of the study from the evaluation procedures
used.

1
Confidentiality
The information that we collect from this research project will be kept confidential.
Information about you that will be collected during the research will be put away and no-
one but the researchers will be able to see it. It will not be shared with or given to anyone
except the researchers actively involved in the study.
Sharing the Results
The results of the tests done on you will be shared with you privately at the end of the
study. After this study, we will publish the results in order that other interested people may
learn from our research; however the data published will be kept anonymous.
Contact
If you have any questions you may ask them now or later, at any time after the study has
started. If you wish to ask questions later, you may contact us.
Contact details:
Student name & address
Muskaan Singh
Indira Hostel,
Sharda University
Greater Noida
Pin Code - 201310

Contact No: 8448932007

You can ask me any more questions about any part of the research study, if you wish to.
Do you have any questions?

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PART II: Certificate of Consent

I have read the foregoing information, or it has been read to me in a language that I understand. I
have had the opportunity to ask questions about it and any questions that I have asked to have been
answered to my satisfaction. I consent voluntarily to participate as a participant in this research.

Signature of Participant

Name of Participant

Date:

I have witnessed the accurate reading of the consent form to the potential participant in a language
that he/she/they understand, and the individual has had the opportunity to ask questions. I confirm
that the individual has given consent freely.

Signature of witness

Name of witness
Date:

Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant in a language that
he/she/they understand

I confirm that the participant was given an opportunity to ask questions about the study, and all
the questions asked by the participant have been answered correctly and to the best of my ability. I
confirm that the individual has not been coerced into giving consent, and the consent has been
given freely and voluntarily.  

Signature of Researcher /person taking the consent

3
Name of Researcher/person taking the consent

Date:

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