Consent Form for Genomic Testing in Cancer
Mutation Search- when a gene mutation has not been identified in a relative
Genetic File No:
M MRN:
Surname
Given Name(s)
Address
Postcode
Date of Birth
PROVISION OF INFORMATION TO PATIENT
Telephone
To be completed by Health Professional
Step 1: Testing a Panel of Genes known to cause:_________________________ (Gene Panel Testing)
Step 2: Testing of all genes (Genomic Testing)
Possible Outcomes of Genetic Testing:
1. An informative mutation result means that my tumour is due to an inherited susceptibility and I therefore
have an increased risk of developing another tumour/cancer.
2. If a mutation is not found, the result is uninformative. This may be because a mutation is present but
could not be found using current technology. An uninformative result does not exclude an inherited cancer
susceptibility in my family.
3. Results of unknown significance: sometimes a variation in a gene is found but its meaning is unclear.
Such a variation may or may not be associated with an increased risk of cancer. In this situation, further
testing of other family members may be required. The interpretation of a result with unknown significance
may also alter as knowledge of genetics improves. I may be contacted if this occurs however the time frame
for any additional results is not known.
4. Testing may reveal non-paternity or non-maternity of a presumed natural parent
5. The information from my genetic testing will be stored by the laboratory according to government
regulations.
6. My de-identified genetic information may be placed in databases and shared with other researchers. The
chance of someone identifying me from these data is small. Results from research tests are rarely returned
to participants, and there is no promise of benefit to me.
7. Testing is voluntary and it is possible to withdraw from the testing process at any stage without influencing
my management /the management of my relatives. However, de-identified data that have already been
shared with other researchers cannot be retrieved.
8. Clinical testing results will be given to me in person.
9. The test result:
 Cannot predict whether I will develop another tumour/ cancer
 Cannot predict the age of onset or type of tumour/cancer that may develop
 May change the estimation of risk for developing a tumour/cancer for my blood relatives
PATIENT CONSENT
To be Completed by the Patient/ Guardian
1. I request that blood/DNA is tested for genes associated with tumours/cancers
 YES
 NO
2. If this initial testing does not identify a cause, I consent to testing of all genes (genomic analysis). I will be
informed if findings relevant to cancer susceptibility are identified. I am aware that there is a small chance
that co-incidental findings about my health not related to a cancer may be identified when genomic testing is
carried out. The medical significance of co-incidental findings will be assessed by an independent expert
committee. I will be informed of these co-incidental findings only if the committee, in consultation with my
v1-July 18 2012
doctor or genetic counsellor, assess that these findings could have a significant impact on my health / the
health of my blood relatives.
 YES, I consent to genomic testing
 NO, I do not consent to genomic testing
3. Sharing the result with blood relatives and family members:

My test result may have implications for the health care of my blood relatives. If it does, I consent to
my result being given to relevant blood relatives and health professionals involved in their care.
Yes
No, only the following people:...................................................................................................

In the event of my death, the test results may be given to:
Name:……………………………Relationship……………….Contact Details:……………………….........
…………………………………………………………………………………………………………………….
Name:……………………………Relationship……………….Contact Details:……………………….........
…………………………………………………………………………………………………………………….
4. I agree that my de-identified genetic data can be used for research
 YES
 NO
I request and consent to the test described above.
I have read the genomic testing information sheet and understand the potential benefits, limitations and
consequences involved in the testing and storage of this sample and information. I allow my de-identified
data to undergo genetic research activities that have been approved by a recognized ethics committee. I
have had the opportunity to ask additional questions and I am satisfied with the explanations. I understand
that genetic counselling will be available for me and my family.
Signature of Person being tested
Print Name
Signature of Parent/ Next of Kin / Guardian
Print Name
Date
I,
have informed this patient/parent/guardian as detailed
Name of Health Professional and Designation
above, about the nature, limitations, likely results and risks associated with the testing of genes related to cancer.
We have discussed the procedures and consequences of testing and the storage of patient data.
Signature of Health Professional
Signature of Interpreter (if present)
Date
v1-July 18 2012
Consent Form for Analysis of Genes Associated with Cancer
Predictive Test - when a gene mutation has been found in a relative
Person Being Tested
Genetic File No:
M MRN:
Surname
Given Name(s)
Address
Postcode
Date of Birth
PROVISION OF INFORMATION TO PATIENT
Telephone
To be completed by Health Professional
Possible Outcomes of Genetic Testing:
1. I have inherited the mutation


I have an increased chance of developing cancer
each of my children has a 50% chance of inheriting the same mutation.
OR
2. I have not inherited the mutation


my risk of cancer is not increased
the mutation cannot be passed on to my children.
3. The information from my genetic testing will be stored by the laboratory according to government
regulations.
4. My de-identified genetic information may be placed in databases and shared with other researchers. The
chance of someone identifying me from these data is small.
5. Testing is voluntary and it is possible to withdraw from the testing process at any stage without influencing
my management /the management of my relatives. However, de-identified data that have already been
shared with other researchers cannot be retrieved.
6. Results from research tests are rarely returned to participants, and there is no promise of benefit to me.
7. Clinical testing results will be given to me in person.
8. If I have inherited the mutation, the test result:
 Cannot predict whether I will develop cancer
 Cannot predict the age of onset or type of cancer that may develop
 May change the estimation of risk for my blood relatives

May affect applications for some types of life insurance
PATIENT CONSENT
To be Completed by the Patient/ Guardian
1. I consent to the collection of blood and DNA for testing of the mutation identified in a family member
 YES
 NO
5. Sharing the Result with Family Members:

My test result may have implications for the health care of my relatives. If it does, I consent to my
result being given to relevant family members and health professionals involved in their care.
Yes
No, only the following people:...................................................................................................
v1-July 18 2012

In the event of my death, the test results may be given to:
Name:……………………………Relationship……………….Contact Details:……………………….........
…………………………………………………………………………………………………………………….
Name:……………………………Relationship……………….Contact Details:……………………….........
…………………………………………………………………………………………………………………….
I request and consent to the test described above.
I have read the genomic testing information sheet and understand the potential benefits, potential limitations
and consequences involved in the testing and storage of this sample and information. I have had the
opportunity to ask additional questions I am satisfied with the explanations. I understand that genetic
counseling will be available for me and my family.
Signature of Person being tested
Print Name
Signature of Parent / Guardian
Print Name
Date
I,
have informed this patient/parent/guardian as detailed
Name of Health Professional and Designation
above, about the nature, limitations, likely results and risks associated with the testing of genes related to cancer.
We have discussed the procedures and consequences of testing and the storage of patient data.
Signature of Health Professional
Signature of Interpreter (if present)
Date
v1-July 18 2012