RZ_FC INFORMED CONSENT 10.4. UK.indd - KAIROS

AT (EN) TransMIT GmbH
Projektbereich für männliche Fertilität
Am Biomedizinischen Forschungszentrum Seltersberg
Justus-Liebig-Universität Gießen
Head of department: Prof. Dr. Klaus Steger
Prof. Steger (FertiCert) at
Biomedical Research Centre Seltersberg
Schubertstr.81
35392 Gießen/Germany
INFORMED CONSENT IN DIAGNOSTIC GENETIC TESTING
by RNA-analysis (Ribonucleic Acid - Assay)
Physician (STAMP)
PATIENT
Family name:
Family name:
Personal name:
Personal name:
Phone:
Date:
Date :
Signature:
TESTING ITEM:
I have received genetic counselling according to §69 GTG about the content and
possibilities of RNA-analyses from my physician. I was informed about the
predictive value and possible risks of RNA-analyses.
YES
I agree to have samples of my ejaculate or TESE-material taken for genetic
testing.
YES
No
NO
Enough time for reflection has been provided after the counselling and before my
consent in above mentioned analysis. At any time I have the right to withdraw my
consent in written form and/or may waive any information about the results. In
this case the results will remain in above mentioned institute.
YES
NO
I agree that remaining test samples will be kept in the above mentioned FertiCertlaboratory to verify results, to answer my physician’s questions and for scientific
purposes till revocation.
YES
The order to test may be transferred to a specialised partner laboratory.
YES
NO
NO
I agree that test documentation and the result of the analysis can be stored longer
than the set time of 10 years.
YES
NO
A summary report will be sent to above mentioned physician (§71 GTG).
YES
NO
_______________________
CITY
____________
DATE
_________________________________________________
SIGNATURE, KEEPER OF TEST SAMPLES, REPRESENTATIVE
TransMIT Gesellschaft für Technologietransfer mbH, Sitz der Gesellschaft Gießen Amtsgericht Gießen HR8 3036 Geschäftsführere Dr. Peter Stumpf
Sparkasse Gießen 200 613 260 (BLZ 513 500 25) Volksbank Mittelhessen 3.3888 (BLZ 513 900 00) Ust-INr. DE 188 685 037
AT (EN) CONTRACT F OR TransMIT GmbH
Projektbereich für männliche Fertilität
Am Biomedizinischen Forschungszentrum Seltersberg
Justus-Liebig-Universität Gießen
Head of department: Prof. Dr. Klaus Steger
Prof. Steger (FertiCert) at
Biomedical Research Centre Seltersberg
Schubertstr.81
35392 Gießen/Germany
My order number:
The conduction of an RNA-analysis (Ribonucleic Acid-Assay) with the sample provided.
To be completed by the client
Name, family name: __________________________________________________________________________
Street: ____________________________________________________________________________________
Postcode:________________City:_______________________________________________________________
Tel: ________________________________________ Country: _______________________________________
I confirm that samples provided originate from myself and have been taken to conduct the RNA–analysis
requested and that removal of samples was done according to instructions
City: ________________ Date: _________________Signature:_______________________________________
Please, send test results to my physician:
To be completed by the physician
Confirmation by physician:
Address/Stamp:
Email/fax for diagnostic findings (!):__________________________________
Sampling on:_______________________________
City:__________________ Date:_________________ Signature:______________________________________
Your VAT-number (if existent and relevant for this contract):________________________________________
Assuming the following contract conditions:
1.
After delivery of test samples for RNA-analysis, TransMIT GmbH will perform the analysis within 10 working days
(laboratory work and diagnostic findings). In case the analysis will provide no result due to insufficient sample material
or other issues caused by TransMIT GmbH, the analysis will be performed once more with newly provided samples. 2.
The responsibility for the accuracy of the information to come with the samples is with the sender. A guarantee for
therapeutic decisions based on our results, cannot be issued. Also any liability for manipulations resulting from
improper or illegal sampling, has to be excluded. For damages we limit our liability in case of simple negligence to the
contractually foreseeable type of damage. In case of injury to life, body and health, we are fully liable.
3.
Data protection advise: The TransMIT GmbH declares, that it cannot recognize from which person the sample
originates. The test results are only informative about sperm quality. The collection, storage, sending and processing,
deletion of your patient related data (below: processing as agreed) is exclusively used for implementation of this
contract for RNA-/sperm-analysis in accordance with existing data protection rules and other legal provisions. By
sending of test samples, incl. contract documents, you declare your consent with the processing of your person-related
data according to the previous Information as agreed.
Herewith TransMIT GmbH has informed me, about my right to obtain access to my person-related data free of charge.
4.
The place of jurisdiction is Gießen. The laws of the Federal Republic of Germany shall apply. TransMIT Gesellschaft für Technologietransfer mbH, Sitz der Gesellschaft Gießen Amtsgericht Gießen HR8 3036 Geschäftsführere Dr. Peter Stumpf
Sparkasse Gießen 200 613 260 (BLZ 513 500 25) Volksbank Mittelhessen 3.3888 (BLZ 513 900 00) Ust-INr. DE 188 685 03