Download Client Informed Consent for Genetic Screening

Client Informed Consent for Genetic Screening
My Signature below acknowledges that a physician has ordered
genetic screening on my/my child’s specimen sample. I authorize
Baby Genes to perform the genetic screening that was ordered. I
understand the potential outcomes, including the benefits, risks
and limitations of the screening as described below. I have had
the opportunity to ask questions of a physician prior to giving my
informed consent, and my questions have been satisfactorily answered. I also acknowledge that it is my responsibility to contact
my personal physician, medical provider or genetic counselor and
discuss the reported results.
POTENTIAL TEST RESULTS
Results are examined by a team of scientists and Medical Doctors,
who determine if there are any pathogenic or likely pathogenic variants identified by this screening. In addition, variants of
unknown significance (VOUS) that are classified as synonymous
(predicted to cause a protein change) are identified. A written report that discusses each potentially disease-related variant will be
issued. Possible results are as follows:
1. No Findings – No reportable variants are identified.
2. Findings – Pathogenic and/or Likely Pathogenic Variants with
disease association are identified OR VOUS that result in non-synonymous protein changes but have no known clinical association
are identified.
I understand that when my/my child’s panel sequence is compared to a reference sequence, many variations or differences are
expected to be found. Based on currently available information
in the medical literature and in scientific databases, Baby Genes
Inc determines whether any of these variations are predicted to be
causative or related to a medical condition identified on the BG
Newborn Screening Panel. The classification and interpretation of
all variants identified in this screening reflects the current state of
scientific understanding at the time the report is issued. In some
instances, the classification and interpretation of variants may
change as scientific information becomes available.
LIMITATIONS OF THIS SCREENING
I understand that a “No Findings” result does not rule out all
genetic causes of disease. It is still possible that I/my child may
have a genetic condition that this technology is unable to detect
or that are caused by one or more genes that are not included as
part of this specific gene panel.
Some results are of uncertain clinical significance meaning that
while they may be related to disease, they may also be unrelated
to disease and, therefore, likely harmless changes.
A “Findings” result will not necessarily predict the prognosis
or severity of disease. While identifying a variant of clinical
significance may help direct management and treatment, it is also
possible that identifying a variant of clinical significance will not
affect management or treatment.
DNA SAMPLE AND RESULTS DISCLOSURE
I understand that DNA samples will only be used for screening
that is authorized by the ordering Physician or Physician of Record (POR). Any leftover DNA will be stored for six months.
I understand that some samples may be maintained indefinitely
after all screening has been completed for research purposes in
an effort to advance scientific knowledge. In such a case, all personal identifiers will first be removed, and I will not be informed
of any results, as Baby Genes will have no means to determine
the sample origin. Results may be released to any entity that,
by statute or law, has the legal authority to request and receive
genetic results. Baby Genes may discuss summaries of genetic
test results in scientific presentations, publications, or marketing
pieces. No names or personal identifiers will be revealed.
GENETIC COUNSELING
I understand that genetic screening results can be complex.
Genetic counseling, which involves an in-depth discussion of
the interpretation of this screening and the impact on me and my
family, may be useful and can be performed by a physician as
well as medical geneticists and genetic counselors. Baby Genes
is available to offer suggestions for such providers in my area
should I wish to see one.
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Client (or parent/guardian) signatureDate
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Client (or parent/guardian) name (printed)
More information is available on our website:
www.BabyGenes.net
last updated 1/2015
Baby Genes Inc
15000 W 6th Ave, Unit 150 Golden, CO 80401
[email protected] | Toll Free:(844) 213-2329
Local:(303) 865-3891 | Fax:(303) 865-3892