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© 2003 Law Offices of Cynthia E. Fruchtman 1 Ethical Issues in Genetic Testing in Assisted Reproductive Technology
© 2003 Law Offices of Cynthia E. Fruchtman 2
© 2003 Law Offices of Cynthia E. Fruchtman 11 Movie
© 2003 Law Offices of Cynthia E. Fruchtman 12 TYPICAL OVA DONOR AGREEMENT The sole purpose and intent of this Contract is to provide a means for the Intended Parents to become the legal parents of a Child who is genetically related to the Intended Father or a sperm donor, and gestated and birthed by the Intended Mother or a surrogate, with Egg Donors egg(s). The Egg Donor warrants that all information provided to any professional, person, entity or Party, whether written or oral, with respect to her medical and mental condition, all social and genetic information and family histories, the egg donation and/or any and all matters contained in this Contract are true and correct to the best of her knowledge, and that she has not knowingly falsified or omitted any material information concerning these matters. Egg Donor further represents that, based on information and belief, she is capable of producing normal, healthy eggs. Egg Donor agrees that she will not attempt to form parent-child relations, nor any relationship, with any Child that may be born pursuant to this provisions of this Contract. The Parties agree that once Egg Donors egg(s) are removed and retrieved, the eggs shall immediately vest to and become the sole property of the Intended Parents. Intended Parents shall have complete custody and control of the egg(s) and the embryo(s) created from the eggs donated to them by Egg Donor, and shall have the sole and exclusive right to make any and all decisions regarding the disposition of the egg(s) and embryo(s) to medical research and/or destruction of the egg(s) and/or embryo(s) and/or donation to third parties.
© 2003 Law Offices of Cynthia E. Fruchtman 13 REQUEST FOR GENETIC TESTING The Egg Donor and Intended Parents have undergone, or agree to undergo, physical examinations under the direction of, and/or to the extent determined by, the Physician, to determine whether the physical health and well-being of the Parties are satisfactory. The extent and scope of the medical evaluation shall be at the sole discretion of the Physician. The medical evaluation shall include tests for all sexually transmitted diseases, including HIV and AIDS for Egg Donor. The Egg Donors testing shall also include drug screening and testing for chlamydia, as well as genetic testing for cystic fibrosis, fragile x syndrome, thalassemia, and a karyotype, at Intended Parents request. Egg Donors signature on this Contract constitutes said Partys authorization to permit Intended Parents to have access to non-identifying medical and genetic information and records which are related to the procedures contemplated herein and to discuss that information and records with Physician and/or a genetic counselor. Egg Donor agrees to execute separate Authorizations for Release of Information, if requested by Intended Parents. Intended Parents shall pay for said examinations and testing, and it is a condition to this Contract that Intended Parents approve the results of such physical evaluations and testing.
© 2003 Law Offices of Cynthia E. Fruchtman 14 ASSUMPTION OF MEDICAL AND PSYCHOLOGICAL RISKS Egg Donor, for herself and for her heirs and assigns, acknowledges that all medical procedures have been thoroughly explained to her by a physician, and that she has been advised of all medical risks, including death, which may result from the conduct contemplated by this Contract. Egg Donor further acknowledges that she has signed and/or will sign an informed consent regarding the possible medical risks associated with the medical procedures and the accompanying medications to be administered to Egg Donor. Egg Donor warrants that she is aware of the psychological risks associated with acting as an egg donor. Egg Donor agrees to assume all medical, financial and psychological risks and to release the Intended Parents, their attorney(s), the Egg Donors Attorney, the Physician, and other professionals contemplated herein and/or involved in any aspect of the egg donor arrangement, and each said persons agents and employees, from any legal liability except professional malpractice (malfeasance or negligence).
© 2003 Law Offices of Cynthia E. Fruchtman 15 FUTURE CONTACT AND EXCHANGE OF INFORMATION The Egg Donor agrees that she will not seek to view or contact the Child after the Childs birth, that she will not seek to ascertain the identities of the Intended Parents, nor seek to view or meet with Intended Parents or their families, without the express written consent of Intended Parents after their initial meeting. The Parties acknowledge that the sharing of genetic material when combined with anonymity creates the potential that children who are genetically related may meet in the future and inadvertently develop a relationship. Therefore, in order to avoid future inadvertent and inappropriate relationships between genetically-related individuals, the Parties agree to inform and/or release to the other Party, care of the Treating Physician, the gender and birth date of any and all Child(ren) born of the donated egg(s), as well as any child(ren) born to Egg Donor. Egg Donor further agrees to inform Intended Parents, through Physician, each time she donates egg(s) to a third party, of the identity of the agency through which she made such donation and, if known to her, the identity of such third party, the gender and birth date of any and all Child(ren) born of such donated egg(s), which information shall be maintained by Physician for the benefit of the Child. Since the Child is the genetic product of Egg Donor, it may in the future become necessary to obtain information of a medical or psychological nature from Egg Donor. Therefore, Egg Donor agrees to inform Physician of any change in address in perpetuity. If medical or psychological information must be obtained from Egg Donor, Egg Donor agrees to furnish the information through Physician.
© 2003 Law Offices of Cynthia E. Fruchtman 16 SHOULD DONORS BE GENETICALLY SCREENED OR TESTED? In the eyes of many, the increasing capacity to choose the genetic endowment of children brings with it a corresponding responsibility to do so. And when people - i.e., parents - do not do so, some accuse them of being irresponsible. Physicians may not appreciate their obligation to oocyte providers in the same way they appreciate their obligation to other patients... Recruitment has focused on young, fertile women, often university students, as younger women are more likely to produce large quantities of fertilizable eggs....physicians obligations to help their infertile patients distorts their obligation to the oocyte providers.
© 2003 Law Offices of Cynthia E. Fruchtman 17 American Society for Reproductive Medicine GUIDELINES (2002) The ASRM guidelines contain minimal genetic screening for gamete donors, who should not have: A.Major Mendelian disorders (autosomal dominant or homozygous recessive or X-linked disorders); A.Major malformation of complex cause (multifactorial/polygenic); B.Significant familial disease, especially with respect to first-degree relatives; C.Known karyotypic abnormality; D.Heterozygosity for high-risk ethinicity disorders: African-AmericansSickle cell anemia MediterraneanBeta-Thalassemia AsianAlpha-Thalassemia Ashkenazi JewsTay-Sachs or Canavan disease The Guidelines do not A.Define the information that needs to be provided to donors in order to obtain their informed consent for genetic testing. B.Discuss what information to provide in response to recipients requests for additional testing. C.Instruct physicians as to how to raise the medical, social, ethical and legal issues involved in genetic testing with their patients. D.Provide for referral to a genetic counselor.
© 2003 Law Offices of Cynthia E. Fruchtman 18 MEDICAL ISSUES IN GENETIC TESTING How to communicate concepts such as expressivity, penetrance, heritability, and the concepts of probability and statistics as they relate to the individual. Over 500 tests are available: it is not economically or socially feasible to test every person for every possible genetic disorder. Not all tests that are currently available are sufficiently accurate, sensitive or predictive to make them reliable bases for decisions. Even extensive genetic testing cannot provide a guarantee of perfect health that patients may expect. 2-3% of all babies are born with some birth defect or genetic condition, most without a prior family history. Every person is likely to harbor some lethal genetic variation. The presence of certain conditions does not necessarily preclude donation.; Not all abnormalities are truly undesirable. The perception of risk can be different for each individual. The implications and ramifications of genetic information can be far-reaching.
© 2003 Law Offices of Cynthia E. Fruchtman 19 PSYCHOLOGICAL ISSUES IN GENETIC TESTING Genetic information is laden with symbolic meaning Extra attention may be required to avoid having donors equate a defective gene or a genetic mutation with a death sentence for them and their families. Donors who are rejected because of the result of genetic testing may require ongoing care. Asymptomatic people in whom risk is identified should be counseled to be vigilant for phenotypic changes. By virtue of the genetic testing which is usually paid for by the recipients, donors may have access to sophisticated information that they might otherwise not be able to obtain; however, once they have that information, they will not be able to avoid learning its probable impact on them, their families and their offspring. The diagnosis itself could label the patient unnecessarily early in life: –Could cause them to experience anxiety for an extended time period; –Could lead to financial problems in obtaining or maintaining insurance; –Could decrease access to education or military service; –Could create impediments to employment.
© 2003 Law Offices of Cynthia E. Fruchtman 20 LEGAL ISSUES IN GENETIC TESTING Duty to warn: even if s/he does not want to inform family members of genetic test results, a donor s physician might have a legal obligation to do so. Confidentiality: the medical history of the child-to-be might include the results of the donor s genetic tests throughout the child s lifetime; genetic test results would likely be available to courts by subpoena if relevant to litigation; or they could be disseminated by mistake, either by the physician, his or her staff, or by the recipients (who are not bound by the duty of confidentiality to the donor that is intrinsic to the doctor-patient relationship). Discrimination by insurers, employers, schools, government or other social institutions. Disputes over insurance coverage: Most infertility patients pay for ART out-of-pocket; however, the courts are divided as to whether those costs, which could include the cost of genetic testing, are insurable. Liability for providing false information: Donors and their physicians could face actions for wrongful death if the child is stillborn or dies soon after birth, or if the child survives, that same injury could give rise to a claim for wrongful life, or the recipient could pursue a claim for wrongful birth for the harm suffered by delivering a child who would have been aborted had the relevant genetic tests been performed. Lack informed consent: liability for battery, willful or negligent injuries, breach of fiduciary duty, malpractice, or infliction of emotional distress.
© 2003 Law Offices of Cynthia E. Fruchtman 21 WHAT WOULD YOU ADVISE? breast cancer colon cancer fragile X Huntingtons neurofibromatosis polycystic kidneys
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