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Massachusetts General Hospital
NEUROGENETICS DNA DIAGNOSTIC LAB
CLIA #: 22D0883928
New York State #CQP 4866
Consent Form for DNA-based Analysis
Hyperkalemic periodic paralysis (HYPP)
I request and authorize Dr. Katherine B. Sims and associates at the Massachusetts General Hospital (MGH) Neurogenetics DNA Diagnostic Laboratory to analyze a sample of DNA, isolated from blood or tissue (type) ____________ obtained on (date) _____________ , to assess the probability that myself/ fetus/child (circle one) has inherited a genetic mutation associated with the disease/carrier state (circle one) for Hyperkalemic Periodic Paralysis (HYPP).
A. The test procedure has been explained to me, and I understand that one
of a number of outcomes might result:
1. The test results are positive and therefore indicate that it is likely
that myself/fetus/child will be affected with HYPP.
2. The test results are negative and therefore indicate that it is less likely that myself/fetus/child (circle one) will be affected with the disease. Current testing allows us to identify approximately 88% of mutations in affected individuals with HYPP1. Therefore, a negative result cannot guarantee that the individual tested will NOT be AFFECTED with the disease.
B. In the case of prenatal testing, maternal cell/DNA contamination of the fetal sample may occur. If not detected, maternal contamination could result in a misdiagnosis.
I understand that the diagnostic testing procedures performed by the MGH Neurogenetics DNA Diagnostic Lab will only indicate the likelihood that I/my child/my fetus (circle one) carry a mutation in the HOPP disease gene. I understand, if applicable, that the results of prenatal testing do not guarantee the birth of a normal child since this testing only applies to the genetic disorder HOPP. This testing has a low, but finite, total error rate which is estimated to be less than 1%.
The MGH Neurogenetics DNA Diagnostic Lab disclaims responsibility, and shall not be liable, for any individual including, but not limited to, the undersigned individual/parents or the fetus, for damages or otherwise for any action taken in response to the test results including termination of pregnancy where the fetus was found not to be affected, or failure to terminate the pregnancy in instances in which the child is affected.
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Results from this clinical genetic testing will be sent by written report
to the referring professional. They will discuss the results, the laboratory
interpretation and answer questions. We are available to discuss testing protocol/methodology,
test results and interpretation and to answer questions if needed.
Results will NOT be entered by us into your medical record and is stored in
our files with code number identifier only. Access to these records is restricted.
These records will be maintained in confidentiality in accordance with applicable
laws and the policies of the Massachusetts General Hospital (MGH). You should
be aware that genetic information, including molecular DNA test results, may
influence insurance and/or employers regarding your health status.
Despite the highly accurate nature of this testing and laboratory quality control measures, errors (false positives and false negatives) may occur at a frequency estimated to be less than 1%.
Signature ______________________________ (patient)
Date ___________________________
Signature _____________________________ (parent/legal guardian)
Date ___________________________
Signature _____________________________ (parent/legal guardian)
Date ____________________________
Signature _____________________________ (professional obtaining consent)
Date ____________________________
Signature _____________________________ (witness)
Date ____________________________
___________________________________________(address of witness)
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