Comparative analysis of medical, legal, and ethical considerations for establishing a standard operating protocol for artificial insemination by donor

Min Jung Park

doi:10.5124/jkma.2018.61.7.383

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Park: Comparative analysis of medical, legal, and ethical considerations for establishing a standard operating protocol for artificial insemination by donor

Focused Issue of This Month

Ideal Operation for Public Sperm Bank in Korea

Journal of the Korean Medical Association 2018; 61(7): 383-391.

Published online: 18 July 2018

DOI: https://doi.org/10.5124/jkma.2018.61.7.383

Comparative analysis of medical, legal, and ethical considerations for establishing a standard operating protocol for artificial insemination by donor

Min Jung Park, PhD

Korea Institution for Public Sperm Bank, Busan, Korea.

Corresponding author: Min Jung Park. ohnsa@naver.com

Received 4 June 2018 Accepted 18 June 2018

Korean Medical Association

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Artificial insemination by donor is an important means of improving the likelihood of pregnancy in couples affected by male factor infertility, but it poses medical, legal, and ethical issues due to the involvement of third parties, such as the sperm donor. In Korea, the Bioethics and Safety Act was enacted for the purpose of preventing and eliminating unethical research on germ cells, and such research was limited to matters related to the use of assisted reproductive technologies, centering on embryos, oocytes, and protecting the health of oocyte donors. However, this law is incomplete in terms of specific standards or regulations relating to the donation and receipt of sperm. In Korea, artificial insemination by donor has been carried out without a standard operating protocol for donation and receipt of sperm, which would include testing sperm donors for diseases, limiting the number of donor offspring, compensation for donations, and the role of anonymity and non-anonymity. The diversity of policies worldwide shows that each country has its unique set of guidelines tailored for its own specific needs and practical considerations. Herein, I present a standard operating protocol of medical, legal, and ethical principles for artificial insemination by donor that is suitable for domestic circumstances, along with a comparison of recommendations and guidelines of other countries concerning sperm donation issues.

Keywords: Artificial insemination by donor, Male infertility, Sperm donation, Standard operation protocol

Figures and Tables

Fig. 1

Laws and ethics guidelines for artificial insemination by donor in each country. SOP, standard operating protocol. ^a)Score 5, guidelines by government; score 4, guidelines by public instrument; score 3, guidelines by academic institutions; score 2, guidelines by institutional review board; score 1, no regulation. ^b)Score 5, religious law; score 4; bioethics Law; score 3, organ transplant law; score 2, regulations of government; score 1, constitutional law.

Table 1

Comparison of characteristics of ethical declaration, ethical guidelines and standard operating guidelines

AID, artificial insemination by donor; IVF-ET, in vitro fertilization–embryo transfer NA, not applicable; HIV, human immunodeficiency virus HTLV, human T-lymphotropic virus.

^a)No specific criteria for sperm donors, but according to egg donation. ^b)Non-mention.

Table 2

Comparison of medical screening of sperm donor in individual country

Law and guideline by country: USA (Guidelines for gamete and embryo donation, Committee American Society for Reproductive Medicine/Society for Assisted Reproductive Technology), England (Human Fertilisation and Embryology Authority code of practice), Japan (Japan Institute of Standardizing Assisted Reproductive Technology), South Korea (Ethical guidelines for assisted reproductive of The Korean Association of Obstetricians and Gynecologists and Standard Operating Procedure of in Human IVF-ET Center of Ministry of Health and Welfare).

NA, not applicable; IVF-ET, in vitro fertilization–embryo transfer

Table 3

Medical requirements of sperm donors in individual country

Law and guideline by country: USA (Guidelines for gamete and embryo donation, Committee American Society for Reproductive Medicine/Society for Assisted Reproductive Technology), England (Human Fertilisation and Embryology Authority code of practice), France (Bioethics Law), Japan (Japan Institute of Standardizing Assisted Reproductive Technology), China (Basic standards and basic norms of human sperm bank, 2015), Germany (Sperm Donor Registry Act), Australia (Reproductive Technology Code of Ethical Clinical Practice Regulations), Taiwan (Artificial Reproduction Act), South Korea (Korean Association of Obstetricians and Gynecologists).

NA, not applicable.

^a)Recommendation of psychological counseling. ^b)Preference of childbirth or parental status. ^c)A limit of 25 children per population of 800,000 for a single donor. ^d)The exception is when there are more than 10 live births from a single donor to provide genetically related brothers or sisters for children previously born from a donation. ^e)Difference of according to state in Australia (New South Wales: 5 families, South Australia: 10 families, Victoria: 10 families, Western Australia: 5 families).

Table 4

Requirements of sperm receipts in individual country

NA, not applicable.

^a)South Korea follows the criteria of Korean Medical Association and Korean Association of Obstetricians and Gynecologists.

Table 5

Ethical requirements of sperm donors in individual country

NA, not applicable.

^a)According to individual sperm bank. ^b)Japan: $150 at Keio University Hospital.

Table 6

Recommended standard operating protocol for artificial insemi- nation by donor in Korea

BUN, blood urea nitrogen; SGOT/SGPT, serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase; HTLV, human T-lymphotropic virus; HIV, human immunodeficiency virus; CMV, cytomegalovirus; IgG, immunoglobulin G; IgM, immunoglobulin M.

^a)HIV-1/2 see sections HTLV-1/2, hepatitis B, hepatitis C, syphilis, chlamydia, gonorrhea, CMV, family medical history, karyotpying, and hereditary disease. ^b)Including of food, transportation, and lodging expenses.

Table 7

Comparison of legal standing of children born under AID in individual country

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ORCID iDs: Min Jung Park
https://orcid.org/0000-0002-9205-078X
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