Every year the number of genetic conditions which can be diagnosed by DNA analysis (hereafter referred to as genetic diagnosis) is increasing, which is broadly acknowledged as being useful clinically.  However, on the other hand, already some problems have arisen, such as the necessity for genetic counseling before and after genetic diagnosis, and the storage and handling of personal genetic information and the sample materials obtained for the purposes of genetic diagnosis.  In addition to the purpose of confirmation of known and expressed diseases, genetic testing is also performed for purposes of carrier detection, presymptomatic diagnosis and prenatal diagnosis in the counsellee and families, who may be aymptomatic, based on the genetic information obtained.  Genetic testing can directly determine the gene mutation responsible for the disease, or can indirectly find the causative genetic elements with high probability using DNA polymorphism.   When conducting these diagnoses, appropriate methods must be chosen, depending upon the disease, genetic information, and the collected samples.  In genetic testing the human rights of the person who is examined (henceforth called the subject), and his/her family, must be protected, and proper and appropriate genetic testing should be promoted. In accordance with these principles, and with the Japan Society of Human Genetics "Guidelines for Genetic Counseling and Prenatal Diagnosis" of December 1994, we declare to pay special attention to the following 12 articles in the practice of genetic testing using DNA analysis. 

1. There is variety of genetic mutation, phenotype, prognosis, response to treatment, etc., within the same genetic disease.  Genetic testing must take sufficient account of this variety.
2. In the case of counseling prior to genetic testing, the counselor must draw attention to the provision of accurate information concerning the purpose, method, accuracy, and especially the unavoidable limitations of testing to the subject, beyond ordinary genetic counseling.  In addition to oral explanation, written disease-specific information should be provided to ensure no omissions.
3. Genetic testing can only be performed after obtaining informed consent from the subject.  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.  Especially for presymptomatic diagnosis of adult onset genetic disease there need to be multiple counseling sessions prior to any tests, and the decision of the subject must be shown to be the result of their own autonomous decision making.  For this case, counseling by different counselors would be preferable.
4. 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.
5. 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.
6. Genetic testing must be only performed using established and practiced techniques.  In order to obtain accurate results, tests may be performed by more than one laboratory or organization.  The laboratories or organizations that are providing testing services should be monitored according to a minimum standard, and they should conduct their own follow-up research and always strive to improve accuracy of diagnosis.
7. The results of testing must be determined by multiple specialists who are sufficiently knowledgeable in genetic analysis and who are experts with the particular disease.
8. The results of the genetic testing must be explained in easily understandable language to the subject.  This must include the prognosis for the subject, such as the relationship between the mutant gene and disease condition.  Even if the testing was unsuccessful or the result was inconsistent, the results must be told to the subject.
9. Under some circumstances the counselor may consider it is preferable to tell the results to the subject when they are accompanied by a person whom the subject trusts rather than on their own, and the counselor should suggest this possibility to the subject.  The subject can terminate the analysis of the sample at anytime, including in the middle of the analysis, and they can also decide not to know the results.
10. Counseling after testing is essential, and should be continued as long as it is understood to be necessary.
11. All personal identifying information obtained from genetic analysis must be stored by the person who directly counseled, in accordance with their obligation of confidentiality, and can not be told to another person.  In the case when the subject was understood not to have the ability for decision making and a surrogate made the decision, the result must be only told to that surrogate.However, if the sharing of information to another specific person(family member at present or in the future) will avoid serious injury to that person, it is necessary to seek the consent of the subject to reveal that information, and even if agreement can not be obtained, if it is judged necessary the obligation of confidentiality can be broken.  Such an exception must be following the judgment of the responsible ethics committee, not by the counselor.
12. The remainder of the samples obtained for genetic testing can be stored for the future benefit of subject and/or family.  The samples should not be used for purposes other than the original one.  The personal information related to the samples is subject to the obligation of confidentiality.  In the case that the sample may provide useful information in the future on this or related disease, written agreement from the subject must be obtained after clearly explaining that identifying personal information will be deleted for such potential use.