Section One: Definitions

• Human Embryo—The term “human embryo” means a distinct and living organism of the species homo sapiens conceived either in the human body or produced in an artificial environment other than the human body, from the moment of fertilization (including the single-celled stage) until natural death, including such embryos that are in a state of cryopreservation or are otherwise unused.
• Transfer—The term “transfer” means the process by which a medical professional places a fresh or frozen embryo within the uterus, fallopian tubes, or other part of a patient’s body for the purpose of initiating a pregnancy.
• Human Embryo Implantation—The term “human embryo implantation” means a human embryo has successfully attached itself to a patient’s uterine wall lining which marks the beginning of pregnancy.
• Assisted Reproductive Technology— The term “assisted reproductive technology” means any treatments or procedures that involve the handling of a human egg, sperm, and embryo outside of the body with the intent of facilitating a pregnancy, including artificial insemination, intrauterine insemination, in vitro fertilization, gamete intrafallopian fertilization, zygote intrafallopian fertilization, egg, embryo, and sperm cryopreservation, and egg, sperm, or embryo donation.
• Fertility Clinic—The term “fertility clinic” means a medical facility that is licensed, registered, or certified in accordance with the standards put forward by Federal or State laws or regulations and is responsible for the collection and preservation of human reproductive material (including egg, sperm, or embryos) responsible for the creation of human embryos, and/or the placement of human reproductive material (including egg, sperm, or embryo) into the prospective patient.
• Health Care Professional— The term “health care professional” means an individual licensed, registered, or certified under Federal or State laws or regulations to provide health care services.
• Human Reproductive Material—The term “human reproductive material” means all or any part of a sperm, ovum, or embryo at any stage of development.
• Prospective Patient—The term “prospective patient” means the patient who will undergo assisted reproductive technology treatments, including the transfer of human embryos for the purpose of initiating pregnancy.
• Infertility—The term “infertility” means a symptom of an underlying disease or condition within a person’s body that makes it difficult or impossible to successfully conceive and carry a child to term, which is diagnosed after 12 months of intercourse without the use of a chemical, barrier, or other contraceptive method for women under 35 or after 6 months of targeted intercourse without the use of a chemical, barrier, or other contraceptive method for women 35 and older, where conception should otherwise be possible.
• Cycle—The term “cycle” means a single procedure of in vitro fertilization, zygote intrafallopian transfer, gamete intrafallopian transfer, or egg retrieval. A complete cycle may only refer to egg retrieval if no eggs are fertilized and implanted into the patient or it may mean the complete process from egg retrieval to the transfer of human reproductive material.
• Egg Donor—The term “egg donor” means a person unrelated by marriage to the recipient who provides or agrees to provide ovum for the purpose of human reproduction, regardless of if the recipient has a diagnosis of infertility.
• Sperm Donor—The term “sperm donor” meansa person unrelated by marriage to the prospective parent(s) who provides or agrees to provide sperm for the purpose of human reproduction, regardless of if the prospective parent(s) has a diagnosis of infertility.
• Embryo Cryopreservation—The term “embryo cryopreservation” means that human embryos are frozen in an undisturbed environment for the purpose of saving these embryos for future procreative use.
• State Board—The term “state board” means the [Department].

Section Two: Prohibition Section

Overview

This law should be adopted and enacted by the [Department], either within the existing [Act] or within another statute that ensures the best enforcement and data collection mechanisms for this law.

Section Three: Parental Informed Consent Requirements for Assisted Reproductive Technology

• A physician providing assisted reproductive technologies, at least twenty-four hours before the physician obtains a signed contract for services, must provide patients with the following information in writing and obtain a signed informed consent form before services commence:
  • A description of the procedure;
  • The likelihood that the patient will become pregnant, based on experience of that particular physician with patients of comparable age and medical conditions;
  • If the physician operates out of a facility, statistics on the facility's success rate, including the total number of live births, the number of live births as a percentage of completed retrieval cycles, the rates for clinical pregnancy and delivery per completed retrieval cycle bracketed by age groups consisting of women under thirty years of age, women who are thirty through thirty-four years of age, women who are thirty-five through thirty-nine years of age and women who are at least forty years of age;
  • A description of alternative therapies and treatments, including adoption and natural cycling;
  • The likelihood of the patient having a live-born child based on a forthright assessment of her particular age, circumstances and embryo transfer options;
  • A statement that the patient retains the right to withhold or withdraw consent at any time before transfer of gametes or embryos without affecting her right to future care or treatment or risking the loss or withdrawal of any program benefits to which the patient would otherwise be entitled;
  • A description of the known and potential risks, consequences and benefits of assisted reproductive technology, including psychological risks associated with all drugs and procedures considered, the inherent risk of embryo loss due to aneuploidy, failure of implantation or thawing, the risks associated with the use of hormones and other drugs that may be used, egg retrieval, multiple pregnancies and selective reduction;
  • The most recent statistics reported by the facility to federal and state agencies, along with information on where to obtain reported statistics from all other fertility facilities in the state and national statistics as reported to the united states centers for disease control and prevention, along with an explanation of the relevance of the statistics;
  • The anticipated price to the patient of all procedures, including any charges for procedures and medications not covered in the standard fee;
  • The average cost to patients of a successful assisted pregnancy;
  • The likelihood that selective reduction might be recommended as a response to multiple gestation, along with a clear explanation of the nature of selective reduction and the associated risks for the mother and any surviving child;
  • Information about embryo conception and transfer, including the patient's right to determine the number of embryos or oocytes to conceive and transfer and the most recent scientific information on the number of embryos needed to be transferred for a successful pregnancy;
  • If the patient is using donor gametes, the psychological screening and the testing protocol used to ensure that gamete donors are free from known infection, including human immunodeficiency viruses, and free from carriers of known genetic and chromosomal diseases;
  • If the patient is using donor gametes, notice that use of an anonymous gamete donor will affect the genetic child and may have negative effects on the child, including tension, confusion and distress about the child's origins and ancestry;
  • The availability of embryo adoption for non-transferred embryos and information on agencies in the state that process or facilitate embryo adoption;
  • The risks of cryopreservation for embryos, including information concerning the current feasibility of freezing eggs rather than embryos, and any influence that may have on the likelihood of a live birth;
  • A description of the facility's practice regarding selecting embryos as viable to transfer, including whether embryos will be deemed not viable for transfer and the outcome for those embryos, including whether those embryos will be destroyed, used for training or used for research;
  • The current law governing disputes concerning non-transferred embryos;
  • Information concerning disposition of non-transferred embryos that may be chosen by the patient, the rights of patients regarding that disposition and the need to state their wishes and intentions regarding disposition;
  • The effect on treatment, embryos and the validity of informed consent of clinic closings, divorce, separation, failure to pay storage fees for non-transferred embryos, failure to pay treatment fees, inability to agree on the fate of embryos, the death of a patient or others, withdrawal of consent for transfer after fertilization but before cryopreservation, incapacity, unavailability of agreed on disposition of embryos or loss of contact with the facility;
  • That there may be foreseen or unforeseen legal consequences and that it is advisable to seek legal counsel;
  • That all existing confidentiality protections apply and what these confidentiality protections are; and
  • That a patient has access to all of the patient's medical information to the extent the law allows.
• A patient must be informed of the option of additional counseling throughout future procedures, even if counseling was refused in the past.
• Each time a new cycle is undertaken, informed consent must be obtained and information provided to the patient with the latest statistics and findings concerning the patient's status.
• The provider must document informed consent in a record for each participant that must:
  • Be in plain language;
  • Be dated and signed by the provider and by the participant;
  • State that disclosures have been made pursuant to this section;
  • Specify the length of time the consent remains valid; and
  • Advise the party signing the informed consent document of the right to receive a copy of the record.
• Except in an emergency, the record must be signed by the parties before informed consent is valid or the commencement of any assisted reproductive technology.
• This section does not require a physician to provide additional information or obtain additional informed consent if the physician's current practices relating to informed consent already meet the standards prescribed by subsections a through d of this section.
• A physician who knowingly violates this section commits an act of unprofessional conduct and is subject to license suspension or revocation.

Section Four: Required Disclosers in Assisted Reproductive Technology Procedures

• Before each retrieval and each transfer, a physician must disclose to all participants the following possible dispositions of embryos, together with a statement as to which are allowed under applicable law:
  • Storage, including length of time, costs and location;
  • Transfer;
  • Donation as follows:
    • To a known individual for transfer;
    • To an anonymous individual for transfer; and
    • For scientific or clinical research, including the institution conducting the research and the intended nature of the research, if known.
  • Destruction.
• A physician is not required to offer all possible dispositions, but the physician must inform the patient that other providers may offer other options and that the patient has the right to transport embryos to other providers.
• Before each transfer cycle, the provider must provide each intended parent with the following information in a record, where applicable:
  • The method used to achieve fertilization and the results of semen analysis, including, at a minimum, motility, count and morphology;
  • The number of eggs retrieved;
  • For the retrieval and transfer of fresh embryos:
    • The number created;
    • The number viable for transfer;
    • The outcome for embryos deemed not viable for transfer;
    • The number to be transferred;
    • The number preserved;
    • The quality of each embryo transferred; and
    • The quality of each embryo preserved.
  • For the transfer of preserved embryos:
    • The number of embryos thawed;
    • The number of embryos viable for transfer after thawing; and
    • The quality of embryos transferred.
• A statement that failure to adhere to drug administration schedules may affect the outcome of the treatment.

Section Seven: Severability Clause

If any provision of this Act, or the application of such provision to any person, entity, government, or circumstance, is held to be unconstitutional, the remainder of this Act, or the application of such provision to all other persons, entities, governments, or circumstances, shall not be affected thereby.