Genetic consent form addendum
[insert IRB project # and consent vers. #]:
Page 1 of 3

INSTRUCTIONS:
Insert study-specific language in the areas designated by red text. Convert all of
the text into black text before submission to the IRB.

Delete any sections that are inapplicable to your study

Genetic testing will be performed by a research/clinical laboratory. Results from
research laboratories cannot be used for patient care. If from a research
laboratory, the results should not be made available to the patient. You may
want to inform patients that genetic testing through a CLIA-accredited laboratory
may be recommended.
Title of research study: [insert title of research study with protocol number, if
applicable]
Investigator and Department: [insert name and Department of investigator]
As part of the study, we would like to use your blood/tissue samples to look at your
body’s genes. Genes control how your body grows and changes and how your body
reacts to certain things. We want to find out how genes work in name the disease or
condition. It may be true that some people are more likely to have describe the
disease or condition because of their genes and we would like to learn more about
this issue. You are/are not required to take part in this genetic testing to take part in
the main study.
 Describe how the samples or tissues will be collected.
 Indicate whether collection of the samples will result in a change or modification of
a procedure.
o Are extra samples being collected during a procedure performed as part of
the patient’s routine clinical care?
o Will collection of the samples result in prolonging a procedure?
o Will all of the samples collected be sent to the pathology laboratory to
establish a diagnosis? Will the number or type of samples sent to the
pathology laboratory be different from clinical care?
o If some samples are not sent to the pathologist, could this potentially
affect the accuracy of the diagnosis?
 Explain who will have access to the samples.
 Explain how long the samples will be stored.
 Will the samples be tested for any known diseases? (Such as HIV, Hep A, Hep B)
The research could lead to a commercially valuable product, but you will/will not
receive a portion of the profits.
SUBJECT INITIALS: ________________
DATE: ______________
Genetic consent form addendum
[insert IRB project # and consent vers. #]:
Page 2 of 3
The results of the genetic testing will/will not be provided to you or your doctors.
Indicate whether incidental findings or the clinical relevance of the genetic testing
will be disclosed to the subject.
If findings will be disclosed, describe the disclosure procedures (e.g., genetic
counseling).
The risks of genetic research on your sample include a breach of confidentiality. This
risk is minimized by ______________________________________________. In
addition, the Genetic Information Nondiscrimination Act (GINA) generally makes it illegal
for health insurance companies, group health plans, and most employers to discriminate
against subjects based on their genetic information.
All documents and information pertaining to this research study will be kept confidential,
unless required by applicable federal, state, and local laws and regulations to be
disclosed. The records and data generated by the study may be reviewed by Temple
University and its agents, the study sponsor or the sponsor's agents (if applicable),
and/or governmental agencies, such as the Food and Drug Administration, to assure
proper conduct of the study and compliance with regulations
If the study involves a biobank, include the following information: A biobank is a
type of repository or bank which stores human biological samples for use in research.
Specimen types include blood, urine, skin cells, and organ tissue. The biobank keeps
these specimens in good condition until a researcher needs them to conduct a test, do
an experiment, or perform an analysis. Biobanks allow researchers to analyze data
representing larger numbers of individual people than could be otherwise analyzed.
Also, the same samples in biobanks and the data derived from those samples can often
be used by multiple researchers for multiple purposes. Your sample will be used for
genetic research and will be stored in a biobank for __________ years.
Include subject initial lines for subjects to choose how their stored blood is used:
My samples can be used only for research on______.
Yes _____
No _____
My samples can be used for research on (include related conditions). Yes ___ No ____
My samples can be used for research on any condition. Yes _______
SUBJECT INITIALS: ________________
DATE: ______________
No _____
Genetic consent form addendum
[insert IRB project # and consent vers. #]:
Page 3 of 3
Signature Block for Capable Adult
Your signature documents your permission to take part in this research.
DO NOT SIGN THIS FORM AFTER THIS DATE
DATE
Signature of subject

Date
Printed name of subject
Signature of person obtaining consent
Printed name of person obtaining consent
SUBJECT INITIALS: ________________
DATE: ______________
Date