Kingdom of Saudi Arabia – Ministry of Education

Center for Genetics & Inherited Diseases

INFORMED CONSENT FORM

Patient Information Physician/Clinic/Laboratory Information

Name: Date:
DOB: Name of Physician:
National ID: Name of Clinic/Lab:
Gender: ☐ Male ☐ Female Phone/Mobile:

Phone/Mobile: Address:

Please attach printed label if available

Obligatory Information for Specific Conditions: Sample Type

Only for: t(9;22) [bcr-abl (Mbcr) - Date of Initiation of Treatment: ☐ Amniotic Fluid
p210 (IS)] RT PCR …… /…… / 20……
☐ Bone Marrow
Only for:
☐ Cord Blood
Bone Marrow Chromosome WBC Count: …………………
☐ CVS
Analyses
☐ DNA
☐ Peripheral Blood
Only for: Week of Pregnancy: ………
☐ Product of Conception
Amniotic Fluid, Cord Blood and CVS Week
Other:
………………………………………………

Please print this information before distribution to the patients (ONLY for clinical research projects)
Was an ethical clearance obtained? ☐ Yes ☐ No
The ethical granting authority:
Ethical approval #:
Research project title:

ISO-15189 Quality Management System Document Number: QMS-2.3-A-003

© BndrGENE™ – Taibah University 11-Jul-2016 (Ver 1.4)
 The genetic test to be carried out is only for declared
disease/indication specified above. This test does not guarantee that
you and/or your newborn child will be totally healthy. Other genetic
or non-genetic diseases may appear, even though test results may be
found within normal limits. Genetic tests are rather new and subject
to improvement compared with other laboratory tests. Most of these
DNA-based tests are performed and/or interpreted on the basis of
mutation/polymorphism data present in international resources. For
this reason, accuracy of genetic testing limited by methods used, the
clinical diagnosis, and the nature of the specific test requested.
These tests represent the newest service currently available for
clinical laboratory testing; however, improvements will be made as
scientific knowledge advances. As with any complex genetic test,
there is always a small possibility of insufficient cell / DNA
amplification, a failure or error in sample analysis. Extensive
measures are taken to avoid these errors. The methods are not 100%
accurate due to the possibility of rare genetic variations in the DNA
of an individual or due to the complexity of the testing itself. A low
error rate, estimated to be approximately 1 in 1000 samples, is
thought to exist in any laboratory. (Ref:
http://genetics.emory.edu/egl/orders/index.php/1541). http://genetics.emory.edu/egl/orders/index.php/ 1541

If amount of DNA is insufficient and/or needed for confirmation,

repetition of sampling could be necessary.
The number of live cells must be at adequate level for genetic tests.
Re-sampling may be necessary if a satisfactory number of cells
cannot be obtained by culturing or the preparations fail to have the
required quality and tests may be repeated (free of charge). In case
of any finding requiring further studies, parents may be asked to
undergo additional tests (with charge).
The turn-around times are given according to average completion
period of the tests under normal conditions. Your analysis may result
earlier or later than expected due to factors depending on the
patient or on the laboratory. The sample will be used for medical
research in the field of genetics & inherited diseases given that all
relevant tests have carried out for. There may be cases where
biological relations determined by genetic tests do not coincide with
known/actual biological relations.
* I have been informed that per the “Cytogenetic Guidelines and
Quality Assurance” established by European Cytogenetic Association,
the success rate in cell culture of products of conception is expected
to be around 50-60% for selected samples. The risks, benefits and
limitations of DNA testing have been explained to me. I have read
this form and accepted the test.

Signature of Patient or Legal Representative Signature & Stamp of Physician

Agree to participate 
Disagree to participate 
- Your signature on this form indicates that you have understood to
your satisfaction the information regarding participation in the
research project and agree to participate as a subject.
- In no way does this waive your legal rights nor release the
investigators, sponsors, or involved institutions from their legal and
professional responsibilities.
- You are free to withdraw from the study at any time without
jeopardizing the health care you are entitled to receive.
- Your continued participation should be as informed as your initial
consent

ISO-15189 Quality Management System Document Number: QMS-2.3-A-003

© BndrGENE™ – Taibah University 11-Jul-2016 (Ver 1.4)