Download Genotype Sample Informed Consent

NOT TO BE USED FOR SUBJECT ENROLLMENT
INFORMED CONSENT DOCUMENT FOR GENOTYPING TEST
NAME OF SPONSOR COMPANY:
PROTOCOL NUMBER AND TITLE OF STUDY:
NAME OF PERSON IN CHARGE OF
THE RESEARCH STUDY (STUDY DOCTOR/INVESTIGATOR):
TELEPHONE NUMBER(S), DAYTIME:
AFTER HOURS:
INTRODUCTION:
This consent form gives you information so that you can decide if you want to be in this portion of the
study. This consent form is in addition to the main consent form you signed for the research study.
People respond in different ways to drugs in their bodies. We believe this is at least partially because of
genes. You are being asked to take part in a sub-study that will look at whether there may be genetic or
inherited reasons for the different ways people respond to different drugs, and specifically to the study
drug.
You are being asked to allow collection of a sample of your blood to look at your genes (DNA). Having
your blood drawn for this genetic research is voluntary. You do/do not have to be in the genetic research
study to be in the main study.
PURPOSE:
The purpose of this sub-study is:
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To find out if there are inherited (genetic) differences in the way people respond to the study drug
To find out if there are inherited (genetic) differences that control the breakdown of study drug in the
body
To find out if there are inherited (genetic) differences in the risk of developing diseases
We also want to find out if there are genetic differences that change the chance of having a good response
to the study drug, or change the risk of having side effects from the study drug. To do this, we will look at
the DNA and genes of people participating in the main research study.
DNA is the inherited code that makes each person unique. DNA is arranged into different genes that
determine things like hair color, eye color and height. Genes also control how the body breaks down
drugs. For example, with some drugs, genetic differences change how long the drug stays in the body.
Scientists are learning more about differences in genes that may predict whether a subject will be at risk
for diseases. By learning about these differences in genes, we hope to be able to improve our
understanding and treatment of different diseases.
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Protocol Number ******
Genotyping Informed Consent
Investigator name and title
Page 2 of 4
NOT TO BE USED FOR SUBJECT ENROLLMENT
PROCEDURE:
If you agree to be in the genetic research, study staff will draw about insert # of tablespoon(s)
tablespoon(s) of blood from your arm. We will use that blood sample to study your genes. We will try to
draw this blood sample while we are drawing other blood from you; however, we might have to do
another needle stick to draw this blood. In the unlikely case that there is a problem processing your
sample, we may ask you to give a second sample.
RISKS:
There may be side effects of having blood drawn such as:
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Fainting
Redness
Pain
Bruises
Bleeding
Infection
If you feel faint, tell the study staff right away.
BENEFITS:
There will be no direct benefit to you. The results of this study may help find better ways to treat illness in
the future. This may also help scientists understand why people react to drugs differently. This research
may help identify who is more likely to respond to different drugs and who may experience side effects.
BEING IN THE STUDY:
It is your choice if you want to be in this genetic research. You can stop any further genetic research of
your DNA at any time. You can still be in the main study if you want to be. Tell the study
doctor/investigator if you no longer want to be in this genetic research. If you choose to stop being in the
genetic research, the Sponsor Company will destroy your blood sample, but it will keep and use any
research results it has already obtained from your blood up to that point.
A new Federal law, called the Genetic Information Nondiscrimination Act (GINA), makes it illegal for
health insurance companies, group health plans, and most employers to discriminate against you based on
your genetic information. This law will protect you in the following ways:
 Health insurance companies and group health plans may not request your genetic information that is
obtained from this research.
 Health insurance companies and group health plans may not use your genetic information when
making decisions regarding your eligibility or premiums.
 Employers with 15 or more employees may not use your genetic information that is obtained from
this research when making a decision to hire, promote, or fire you or when setting the terms of your
employment.
All health insurance companies and group health plans must follow this law by May 21, 2010. All
employers with 15 or more employees must follow this law as of November 21, 2009.
THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE
VERSION CONTROL
Initials/master or site: date
d:\582719172.doc
Protocol Number ******
Genotyping Informed Consent
Investigator name and title
Page 3 of 4
NOT TO BE USED FOR SUBJECT ENROLLMENT
Be aware that this new Federal law does not protect you against genetic discrimination by companies that
sell life insurance, disability insurance, or long-term care insurance.
INCLUDE IF APPROPRIATE:
DESTRUCTION OF SAMPLES:
The blood sample you give will be destroyed when the study is over.
CONFIDENTIALITY AND OTHER RISKS:
Once we have your blood sample, we will give it a code. This code will contain your age, sex, race, and
other information. It will not contain your name.
There are possible non-physical risks associated with this genetic research, such as the risks associated
with a breach of privacy or confidentiality.
Although this testing is supposed to be private, this cannot be guaranteed. For example, it is possible for
a court of law to get health or study records without your permission.
PAYMENT:
You will be paid *$0.00 for being in this additional research.
OR
You will not be paid for being in this additional research.
Required for Phase I studies or for studies compensating subjects more than $600:
You may be required to report the payment received for this study to the Internal Revenue Service as
taxable income.
Your blood sample may be used by the Sponsor Company to invent new medicines or treatments. You
will receive no payment from the Sponsor Company, even if the drug company makes money from the
invention.
THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE
VERSION CONTROL
Initials/master or site: date
d:\582719172.doc
Protocol Number ******
Genotyping Informed Consent
Investigator name and title
Page 4 of 4
NOT TO BE USED FOR SUBJECT ENROLLMENT
CONSENT:
I AGREE to give a blood sample for genetic research.
OR
I DO NOT AGREE to give a blood sample for genetic research.
_______________________________________________________
Printed Name of Adult Study Subject
Signature of Adult Study Subject
Date
_______________________________________________________
Printed Name of Person Explaining Consent Form
Signature of Person Explaining Consent Form
Date
The signature blocks below are also required when adult subjects are not able to legally give
consent.
_______________________________________________________
Printed Name of Guardian or Legally Authorized Representative
Signature of Guardian or Legally Authorized Representative
Date
Description/Relationship of Guardian or Legally Authorized Representative
You (and/or your legally acceptable representative) will receive a signed and dated copy of this consent
form.
THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE
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