Guidelines for Genetic Counseling and Prenatal Diagnosis

- Japan Society of Human Genetics, December 199
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     The advancement of cytogenetics and molecular genetics have greatly contributed to the development of human genetics. However, on the other hand, it has been pointed out that this new knowledge has raised some new discussion points in addition to the bioethical problems which existed until now. These points are raised because of the fact that almost all of the biological information of a person is included in their genes, and using the technique available at present it is possible to determine a chromosomal abnormality and mutant gene, and even to identify an individual at gene level. The persons who are practicing genetic counseling and medical care should protect the basic human rights of the patient and family, and must endeavor that they are given appropriate medical care and support so that they do not suffer from unfair discrimination even if they have particular mutant genes or genetic type. For this purpose we declare to pay special attention to the following articles.

  1. Genetic counseling should preferably be conducted by a counselor (e.g. a medical doctor certified as a clinical geneticist) who has sufficient knowledge and experience of medical genetics and counseling.
  2. The counselor must provide accurate and current information to the visitor (from henceforth called the counsellee), to their best ability. This information includes the frequency, natural history, risk of recurrence (genetic prognosis), prenatal diagnosis, and presymptomatic diagnosis, and carrier detection. The counselor must use as easy language as possible so that the counsellee can understand, and must record the content in the medical record of the counsellee, as part of the history of their genetic disease, and preserve this for at least five years.
  3. The rights of the counsellee and family to know and to refuse the test (both the right not to know and the right to not want to know) must be respected. Therefore, the treatment and tests using live materials (henceforth called a diagnostic test) is performed according to the decision making based on the autonomy of the person who receives it (hereafter called the subject), and should be done avoiding strong suggestion or guidance of the counselor.
  4. It is necessary to obtain informee!cyiseyuauy!conduct testing. In that case, the information including content of the diagnostic test, method, accuracy, and risks must be precisely conveyed to the subject.
  5. In the case when the decision is made by a surrogate representative, because the subject is judged to be unable to exercise autonomous decision making, the decision for genetic testing must be made protecting the best interests of the subject.
  6. Even though a counsellee may desire genetic testing, the doctor can refuse to provide testing, if the request is against social and ethical norms, or against their personal principles.
  7. The personal genetic information related to the individual that was obtained is subject to the obligation of confidentiality. Especially, careful consideration is required in order that the information is not used for discrimination. However, in case that consent of the subject to reveal that information is obtained, if the disclosure of information to a third party will avoid risk to that person, and the reason is judged to be serious enough, the obligation of confidentiality can be broken. Such an exception must be following the judgment of the responsible ethics committee, not of only one person.
  8. Concerning prenatal diagnosis, it is possible to suggest this opinion attached below, considering the present diagnosis technology and medical standards. Following prenatal diagnosis the counselor should respect the subjects views and should not be involved in this decision making.




Attachment: Opinion on Prenatal Diagnosis


  1. Prenatal diagnosis which is done during the first half of pregnancy can be considered to be done when the fetus has a possibility to have a serious genetic disease and highly accurate diagnostic information can be obtained by a particular method. In addition to cytogenetic, biochemical, molecular genetic, and pathological analysis methods which analyze amniotic fluid, chorionic villi, and fetal cells, and other materials, instrumental diagnostic methods focusing on the fetus are considered available.
  1. nvasive prenatal diagnosis using amniotic fluid or chorion villus sampling is considered for pregnancies in cases a-g below:
  1. Either of the couple is a carrier of chromosomal abnormality.
  2. If there is a history or experience of giving birth to a baby with abnormal chromosomes.
  3. Pregnancies with advanced maternal age.
  4. The pregnant woman is heterozygous for a serious X-linked disease.
  5. Both of the couple are heterozygous for a serious autosomal recessive disease.
  6. Either of the couple is heterozygous for a serious autosomal dominant disease.
  7. In case of a risk of serious fetal abnormality.
  1.  Except for the case of diagnosis of an X-linked disease, the sex of the fetus should not be revealed.
  1. Effort should always be made to improve the accuracy of prenatal diagnosis technology.


Ichiro Matsuda MD
Kodo Saitoh MD
Kaoru Suzumori MD
Norio Niikawa MD
Yoshimitsu Fukushima MD
Norio Fujiki MD
Shiro Miwa MD