NEDA NATIONAL EMBRYO DONATION ACADEMY Reference Manual Jeffrey Keenan, MD, Dean Kate Little, RN NEDA Regional Education Coordinator National Embyo Donation Academy Reference Manual Dean: Jeffrey Keenan, MD NEDA Regional Education Coordinator: Kate Little, RN Embryology Consultant: Carol Sommerfelt, M.Sc., ELD (ABB) Project Manager: Chet Hunt Faculty: Reginald Finger, MD, MPH Robert D. Visscher, MD Curtis Harris, MS, MD, JD Debra Peters, LMSW, LPC, MBA William Cutrer, MD Editor: Beth D. Motto Book / Cover Design: Thomas Carver Content may be accessed on the web at www.embryodonation.org/neda Copyright © 2011 National Embryo Donation Academy This material was prepared and distributed with support from the U.S. Department of Health and Human Services under grant # 1EAAPA091014-01-00. The statements expressed are those of the National Embryo Donation Academy and do not necessarily represent the views of the Department. Table of Contents Letter From Dr. Keenan ............................................................................................................. vii Introducation to NEDA ............................................................................................................. viii Section 1 Embryo Donation and Adoption: A Comprehensive Introduction Dr. Reginald Finger .................................................................................................................... 1 Embryo Donation and Adoption: A Comprehensive Introduction ................................... 5 Table 1 - Number of Embryo Donations by Outcomes and Year ................................ 18 Table 2 - Comparisons of Embryo Adoption Outcomes to Those of Other Fertility Treatments, 2006-2010 .........................................................................18 Table 3 - Synopsis of Global Laws on Embryo Donation .............................................19 Table 4 - SART Member Clinic statistics .......................................................................21 Section 2 Embryo Donation for Procreation / Adoption Table of Contents of Table Dr. Robert D. Visscher ..............................................................................................................23 Embryo Donation for Procreation/Adoption ........................................................................27 Biology of In Vitro Fertilization ....................................................................................27 Preimplantation Stage of Development .......................................................................27 IVF Cycle .........................................................................................................................28 Ethical Considerations of the Assisted Reproductive Technologies ........................30 Primary Ethical Issue: The moral status and value of human Preimplantation embryos ..............................................................................................31 Biblical References about Human Life .........................................................................31 Scientific Facts about Embryos .....................................................................................32 Secondary Ethical Issues ................................................................................................34 State of the Art of the Assisted Reproductive Technologies .....................................34 Fertility Clinic Success Rate and Certification ACT ..................................................35 FDA Regulations .............................................................................................................36 ASRM Statement on Moral and Legal Status of the Preembryo ...............................36 Dr Ricardo Asch Story ...................................................................................................37 State of the Art ................................................................................................................37 Percentage of ART Cycles that Result in Pregnancies & Live Births ......................38 iii Embryo Donation to another Infertile Couple for Procreation / Adoption ...........39 Introduction ....................................................................................................................39 ASRM Practice Committee 2006 Guidelines for Gamete and Embryo Donation .39 SART Informed Consent for Assisted Reproduction ................................................40 Cryopreservation of Embryos .......................................................................................40 Number of Embryos in Storage ....................................................................................41 Donor Options ................................................................................................................41 Dave and Laurie’s Story ..................................................................................................42 Embryo Disposition Decisions .....................................................................................42 Donor Issues and Obstacles ..........................................................................................44 Frozen Embryo Transfer Success Rates .......................................................................44 Embryo Donation/Adoption .........................................................................................45 The Language Problem: Embryo Donation versus Embryo Adoption ....................45 Professional Organizations ............................................................................................46 Government .....................................................................................................................46 Embryo Donation versus Embryo Adoption ..............................................................46 Embryo Donation/Adoption; Conclusions .................................................................47 Section 3 Contents of Table Embryo Adoption: Adoption Law and Custody Law Applied and Expanded Dr. Curtis Harris ........................................................................................................................51 Embryo Adoption: Adoption Law and Custody Law Applied and Expanded ..................53 An Introduction to the History of Family Law ...........................................................53 Adoption Law and Custody Law: Response to IVF/ART .........................................55 The Legal Status of the Human Embryo: Medical Practice and the Law ................55 The Legal and Political Response ..................................................................................58 Proposed Concepts To Be Included in Future Legislation ........................................59 Conclusion .......................................................................................................................60 Endnotes ..........................................................................................................................61 Table 1 - Number of Embryo Donations by Outcomes and Year ................................65 Table 2 - Nations That Have Embryo Donation ...........................................................69 Section 4 Embryo Adoption Program the Assessor/Counselor Component Debra Peters, LMSW, LPC, MBA ........................................................................................... 71 Embryo Adoption Program the Assessor/Counselor Component .................................... 72 The Embryo Donation Process .....................................................................................72 How Does Embryo Donation Differ From Traditional Adoption? ..........................72 The Importance of Genetic and Medical Histories ....................................................74 Are Traditional Adoption Practices Relevant to Embryo Donation? ......................75 iv The Importance of Identity ............................................................................................76 What Defines “Openness” and How Can it be Integrated into Embryo Donation? .........................................................................................................78 The Importance of Education and Psychological Assessment Prior to and in Conjunction with Embryo Donation ................................................80 Preparing Embryo Donors and Recipients for Embryo Donation ..........................80 Preparing Embryo Donors ............................................................................................81 Preparing Embryo Recipients for Embryo Adoption ................................................83 Section 5 Bioethical Prospectives on Embryo Donation/Embryo Adoption Dr. William Cutrer ....................................................................................................................87 Bioethical Prospectives on Embryo Donation/Embryo Adoption .....................................91 Introduction ....................................................................................................................91 Bioethics ...........................................................................................................................91 Epistemology – Theory of Knowledge: How do we know what we know? .............92 Bioethical Systems .....................................................................................................................93 Utilitarianism ..................................................................................................................93