CONSENT FREEZING OF SUPERNUMERARY EMBRYOS

Transcription

1 CONSENT FREEZING OF SUPERNUMERARY EMBRYOS Between: University Hospital Gent, with headquarters at 9000 Gent, De Pintelaan 185, hereafter named UZ Gent, And Mrs./Mr. born in on living at And her/his partner Mr. / Mrs. born in on living at Hereafter named the intended parent(s), it is agreed as follows: The intended parent(s) declares (declare) to have been sufficiently informed about the medically assisted reproductive treatment (hereafter called the treatment) and about the possibility of obtaining the necessary psychological counselling before and during treatment in accordance with the Law of July 6, The intended parent(s) declares (declare) to freeze all supernumerary embryos of good quality, to fulfil the existing or subsequent wish for a child. If a positive serology was determined in the blood of the intended parent(s), the intended parent(s) declares (declare) to have been informed in an adequate and understandable manner concerning the preservation of the embryo s in separate storage devices for reproductive material derived from patients with positive serology. The intended parent(s) declares (declare) to expect that the frozen embryos will remain available for a maximum legally determined period of 5 years from the date of freezing as is mentioned in the report of the treatment and in the letter which will be sent to them. The intended parent(s) may notify by signed registered letter, to shorten or prolong this time period in case of special circumstances. UZ Gent will answer to such a request by registered letter within the period of one month. If UZ Gent agrees with this question, the request of the intended parents will be added to this agreement. If UZ Gent indicates not to agree with the question of the intended parents to shorten or prolong the conservation period, UZ Gent will execute the last instructions of the intended parents at the end of the maximum legal conservation period of 5 years. The intended parent(s) has (have) been informed and accepts (accept) that during this period of storage the embryos can only be thawed and used in order to induce a pregnancy and that this decision has to be taken by both intended parents, if this consent is under scribed by a couple. Versie: ARG-F IC embryo's invriezen (ENG.).doc 1/5

2 The intended parent(s) has (have) been informed and accepts (accept) that not all embryos are equally resistant to the process of freezing and that they therefore can be damaged. Furthermore, for one reason or another, the stored material can undergo changes over the years. The intended parent(s) has (have) been informed and accept that UZ Gent is not able to guarantee or cannot be held responsible for the quality of the frozen embryos and understand that it is possible that embryo transfer cannot take place because of changes in the biological material. Expiry maximum legal storage period If the maximum legal storage period of 5 years has expired and the intended parent(s) does (do) not notify by means of registered letter UZ Gent within a period of one month that she (they) want to use the embryos, UZ Gent and the intended parents agree: Signature/initials that these supernumerary embryos may be donated to scientific research SECOND POSSIBILITY Exceptional circumstances In case of: 1. divorce, separation, when one of the intended parents is no longer able to make decisions or when both intended parents have an unsolvable disagreement the intended parent(s) agrees (agree): that these supernumerary embryos may be donated to scientific research Signature / initials SECOND POSSIBILITY Versie: ARG-F IC embryo's invriezen (ENG.).doc 2/5

3 2. death of the intended parent or one of the intended parents in case of a couple the intended parent(s) agrees (agree): that these supernumerary embryos may be donated to scientific research Signature / initials SECOND POSIBILITY THIRD POSSIBILITY that these supernumerary embryos can be further used by one of the intended parents. Post-mortem implantation can according to the law of July 6, 2007 at the earliest take place six months after the death and at the latest two years following the death of the intended parent. Remarks: The intended parent (s) may change this agreement until the last instruction is executed, except if the storage period for the conservation of supernumerary embryos has expired. The agreement may be amended by - according to the law of July 6, 2007 asking a new contract to be signed by the intended parent(s). Any changes to this document which are not in agreement with the law of July 6, 2007 are automatically and legally invalid. Prepared in Gent, on... /... / in two copies, of which each party declares to have received one. The intended parent(s), Read and approved, Name: Name partner: Name treating doctor: Stamp + Signature: Versie: ARG-F IC embryo's invriezen (ENG.).doc 3/5

4 Information regarding donation of frozen surplus embryos for scientific research. Miss, Mrs, Sir, With this information we would like to clarify what scientific research can be performed with frozen surplus embryos that you no longer wish to keep for yourself. This information should enable you to decide whether you can accept the use of your frozen supernumerary frozen embryos for scientific research, and thus to choose destination of your frozen embryos for scientific research at the end of the retention period. The research is conducted by or in collaboration with the Department for Reproductive Medicine. If you choose to donate your surplus frozen embryos for scientific research, the department can use them to develop and study new techniques in assisted reproduction. For this research, the use of frozen donated embryos is essential. The following issues are important: The confidentiality of the names and other personal details of the couple are strictly guaranteed. If the results of the study are published, your anonymity will thus be assured. Each research for which the embryos can be used, received a favorable approval of the Ethics Committee, University Hospital Ghent and the Federal Commission for medical and scientific research on embryos in vitro. All research on human embryos and gametes strictly subject to the act on research on embryos in vitro from May 11, 2003, published in the Official Gazette of May 28, 2003, which states that it is forbidden to use gametes and embryos for the following purposes: research on embryos after the first 14 days of development, the period of freezing is not included; human reproductive cloning; creating chimeras or hybrid creatures; replacing human embryos in animals; commercial purposes; Research interventions that would bring genetic changes. Participation in this study does not provide a financial benefit and causes no additional costs The donated frozen embryos will not be used in any way for achieving a pregnancy. The research covers: Development of new procedures to improve the IVF/ICSI and freezing program: "supernumerary" embryos can be used for the optimization of the techniques used in the IVF program for optimization of freezing and thawing of embryos, for optimization of the culture media, for an optimization of non-invasive selection of embryos, such as time-lapse imaging. Embryonic stem cell research: supernumerary embryos can be used to develop, study and use of human embryonic stem cells. Stem cells are progenitor cells that, under certain conditions, can develop into a cell type of choice such as nerve cells, muscle cells, blood cells, precursors of gametes. There is hope that in the future these stem cells provide a solution for the treatment of severe degenerative diseases like Parkinson's, heart failure, diabetes. These embryonic cell lines can never become a living fetus, and thus involve merely the culture of stem cells. The research Versie: ARG-F IC embryo's invriezen (ENG.).doc 4/5

5 focuses on the molecular characterization of early differentiation of the human embryo and the obtained stem cells. Investigation of (epi-)genetic and transcriptome changes during embryo development. We will evaluate the influence of different culture conditions on (epi-)genetic and transcriptomic changes during embryo development. Next, in female embryos, where two X chromosomes are present (one from the mother and one from the father), at a certain time one X chromosome is inactivated. The point in time when this occurs is has already been studied in animal models, but not yet in humans. Therefore, we want investigate the dynamics of the XX activity during early human embryo development and stem cell derivation. Research on analytical techniques for embryos in the pre-implantation period: embryos can be used to refine existing techniques to diagnose genetic disorders or chromosomal abnormalities. This could potentially lead to new diagnostic applications in couples with fertility problems and eventually possibly lead to better treatments. Increase the chance of implantation of the embryos: study which factors are important for the further implantation of the embryo. Prepared in Gent, on... /... / in two copies, of which each party declares to have received one. The intended parent(s), Read and approved, Name: Name partner: Name treating doctor: Stamp + Signature: Versie: ARG-F IC embryo's invriezen (ENG.).doc 5/5