Consent form for follow-up Study of Next-of-Kin: Follow-up Study
the Central and Eastern European RCC study
INTRODUCTION
You are being
asked to participate in a study to follow-up cases that were
previously enrolled in the European Kidney Cancer Case-Control
Study. The purpose of this study is to investigate lifestyle
factors, medical conditions, occupation and diet, and their effects
on the outcome of kidney cancer patients in Europe. The study is
being conducted by the Name
of Local Collaborating Center
and the International Agency for Research on Cancer located in Lyon,
France EU and the National Cancer Institute, National Institutes of
Health in Bethesda, MD, USA. His/her participation in this study was
voluntary and you are
being asked to participate in this follow-up study to, answer
questions about your family member, as they are no longer able to do
so. You may refuse to
participate or withdraw in this study at any time. Please read this
consent form thoroughly, and ask the interviewer any questions that
you may have about the study before deciding to sign this consent
form.
EXPLANATION OF PROCEDURES INVOLVED IN THE STUDY
If you agree
to participate in this study, you will be asked to participate in an
interview survey about
your family member that
will not take more than 40 minutes. In addition, we will ask your
permission to collect relevant information from your family
member’s hospital
and cancer registry records. No penalties will result if you decide
not to respond, either to the information collection as a whole, or
to any particular question.
QUESTIONNAIRE
An interviewer
will come to administer the questionnaire while you are in the
hospital or at home. The interview takes approximately one hour and
consists of questions related to your family member’s
lifestyle, environment, and health. We
will study your answers given about your next-of-kin, their medical
records, and the genetic and other information we found out about
them from the earlier study. This will help us learn more about
kidney cancer outcomes.
NOTIFICATION COST, AND COMPENSATION
The research
results are not suitable for use as clinical tests for your medical
care. Therefore, the results of these studies will not be available
to you. There will be no cost to you for participating in the
study, other than your time, and there is no compensation or payment
for completing the questionnaire.
POTENTIAL DISCOMFORT AND RISK
During the
interviews, you may feel some discomfort when asked some questions.
If you feel this way, you may refuse to answer them.
POTENTIAL BENEFITS
This is a
research study and there will be no direct benefits to you other
than the satisfaction of participating in this research for the
possible benefit of future generations. Your participation is very
important to the success of this scientific research.
ASSURANCE OF CONFIDENTIALITY
The
information concerning your participation in the study will be kept
confidential and used only for scientific purposes, in accordance
with applicable Lab of (Czech Republic, Poland, Romania, or Russia)
and the United States state and federal law. No one except members
of the research team will have access to your answers and test
results. Your employer will not be given any test results or
information you provide us. Your questionnaire will not be labeled
with your name. Your name will not be used in any report or
released in any way.
RIGHTS AS A PARTICIPANT
Your
participation in this medical research is voluntary and you may
refuse to participate and/or withdraw your consent and discontinue
participation at any time without penalty or less of benefits to
which you are otherwise entitled. Your decision on this matter will
not affect your medical care or employment. We will keep all
information we obtain from this interview secure and safe from
access or use for any other intent but this research study. While
the information collected as part of this research study continues
to be linked to personally identifying information, it will be
protected from access by anyone except those directly responsible
for patient recruitment and contact. After this study is completed,
all personal identifiers will be removed in place of study
identifiers. Any documents containing linkage between identifiers
with the study identifying codes will be kept under lock and key at
the International Agency for Research on Cancer, and destroyed as
soon as the study has been completed.
CERTIFICATION
I have read
the explanation about this study and have been given the opportunity
to discuss it and to ask questions. By agreeing to participate in
this study, I do not waive any rights that I may have regarding
access to and disclosure of my family member’s records. I
hereby consent to take part in the study components marked “yes”
and refuse to consent to participate in the components marked “no”.
A copy of this consent form has been given to me.
YES NO Study
Component
_________________________________
[ ] [
] Interview
[ ] [ ]
Access to hospital records
_____________________ _________ ________________
__________
Signature of
Participant Date Signature of Witness Date
________________________________
______________________________
Print
Name Print Name
We appreciate
your cooperation in this important research project concerning the
health history of your family member. If you have further questions
about this study, you may call Dr. (Name
of Local Investigator)
at (Local Phone Number)
or you may write to
him/her at the following address:
Name of Local
Collaborating Center and Address