Consent Form for Evaluation of Huntington's Disease Status
Using DNA Analysis
I, ____________________________, request that an attempt be made by DNA analysis to assess the likelihood of my having inherited the abnormal gene ("mutation") for Huntington's Disease (HD). I have completed the requirements set forth by the Huntington's Disease Society of America in the "Guidelines for Predictive Testing for Huntington's Disease."
The procedure has been explained to me, and I understand that the testing procedure requires DNA analysis of my blood. I have been told that this test is highly accurate, but rare diagnostic errors can occur. I understand that there are three possible outcomes to my test:
1. Negative: I will be told that the CAG repeat size is in the normal range (35 or fewer repeats) and that I am not likely to develop HD.
2. Positive: I will be told that the CAG repeat size is expanded into the HD range (40 or more repeats) and that I am highly likely to develop HD at some point in my life.
3. Intermediate: I will be told that the CAG repeat size is in the intermediate range (36-39 repeats) and that it is unclear whether I will or will not develop HD at some point in my life.
I understand that this DNA analysis is specific to the diagnosis of Huntington's Disease and does not evaluate my risk for developing other genetic conditions. I understand that this test in no way guarantees my health or the health of my child. I understand that not every result is "informative" and therefore a diagnosis cannot always be made.
I understand that the accuracy of DNA analysis for HD is entirely dependent on the accuracy of the clinical diagnosis of the affected person(s) in my family. I further understand that the results of the DNA analysis are also dependent on the accuracy of the family history and relationships I have described. In particular, nonpaternity may be revealed by the analysis and lead to uninformative results.
I have read and understood this consent form. I, therefore, give my consent to participate in testing and to submit samples for DNA analysis for Huntington's Disease.
Signature:__________________________________________Date: _______________
Witness:__________________________________________Date: _______________
Individual obtaining consent:__________________________Date: _______________
12/02 University of Virginia Health System