Consent To Collect And Store Tissue For Future Research When Identity Of Subject medical questions that are not necessarily related to _ (cancer, diabetes, etc. …
Consent To Collect And Store Tissue For Future Research When Identity Of
Subject Is Coded And The Codes Are Kept In Locked Files By The Person
Conducting The Research
As part of the research project
_________________________________________, _______________ Name of
Principal Investigator would like to store some of your __________tumor,
muscle, etc tissue that is not needed for your medical treatment and that
would otherwise be thrown away If you agree, ________ Principal
Investigator will keep the samples in a specimen bank so that they may be
used in future research to learn more about __________cancer, diabetes,
etc and other medical problems Researchers are trying to learn more
about ____________ list the disease, such as what causes________ list
the disease, how to prevent it, how to treat it better, and how,
hopefully, to cure it Even if the research that is done on your tissue
cannot be used to help you, it might help other people who have ___________
disease or other medical problems
Many medical problems may arise due to the environment or from genetic
factors Your ___________ disease, medical problem may come from one or
both of these causes Genetic factors are
those that people are born with
and that can affect other family members There may be genetic testing
done in the future that would provide information about traits that were
passed on to you from your parents or from you to your children
______________ Name of Principal Investigator, or his/her successor,
will be responsible for making sure that your samples are protected in the
specimen bank and that your medical information is kept confidential Your
samples will not be stored with your name or other identifying information
but instead will be given a code number to protect your identity The
samples and this code number will only be given to researchers whose
research is approved by the Institutional Review Board IRB An IRB is a
group of people who are responsible for looking after the rights and
welfare of people taking part in research The researchers will not be
told who you are Because the nature and value of any future research
cannot be known at this time, any results obtained from using your tissue
will not be given to you or your doctor
The people who use your samples to do research may need to know more about
your health If researchers ask for reports about your
health information
from your medical records, __________ Name of Principal Investigator
will not give them or anyone else your name, address, or phone number
unless you are willing to be contacted in the future to take part in more
research Although every effort will be made to keep your information
confidential, there is a small risk that an unauthorized person may review
your information Therefore, there is a very slight risk that a test result
could be linked to your identity and inadvertently disclosed to you or to a
third party If you were to receive the result of a genetic test that
indicated a problem, it could cause anxiety or other psychological
distress In addition, you might have to decide whether or not to discuss
the findings with members of your family If a third party like your
employer or insurer learned the results, there is a risk of discrimination
that could affect your employability or insurability, of stigma, and of the
unpredicted disclosure of this information to others You can discuss
these issues further with your doctor or nurse and you can request a
consultation with a genetic counselor if you wish to discuss these possible
risks In addition, there
are laws that require that research records that
have your name on them may be shown to people who make sure that the
research is being done correctly As mentioned in the accompanying consent
form, the _________NIH, company sponsor, FDA, and the Institutional
Review Board have the legal right to review and copy your medical records
related to this research
There will be no cost to you for any specimens collected and stored in the
_____________ type of specimen specimen storage bank Your tissue will
be used only for research and will not be sold Some new products might be
made because of the results of the research that uses your samples These
products might be sold sometime in the future, but, should this occur, you
will not get paid
The choice to let ____________ Name of Principal Investigator keep your
tissue for doing research is entirely up to you No matter what you decide
to do, it will not affect your care If you decide that your tissue can be
kept for research but you later change your mind, tell ______________ Name
of Principal Investigator who will remove and destroy any of your tissue
that he/she still has Otherwise, the samples may be kept until they are
used
up, or until __________ Name of Principal Investigator decides to
destroy them
Please review statements 1, 2, 3, and 4 and then circle the answer that is
right for you If you have questions, please talk to your doctor or nurse
1 I agree that my samples may be stored, coded to protect my identity,
and that my identity will not be disclosed to anyone without my
permission, except when required by law
YES NO Initials_____________
2 I agree that some excess___________tumor, muscle, blood tissue may
be kept by ____________ Principal Investigator for use in future
research to learn about, prevent, treat, or cure
___________cancer, diabetes, etc
YES NO Initials______________
3 I agree that my _________ tumor, muscle, blood tissue may be used
for research to answer other medical questions that are not necessarily
related to ________ cancer, diabetes, etc
YES NO Initials______________
4 I agree that my doctor or someone he/she chooses can contact me in
the future to ask me to take part in more research
YES NO
Initials______________
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