Ethical guidelines for commissioned genetic testing

Sekisui Medical Co., Ltd. (Hereinafter referred to as "our company".) has established these Guidelines for the purpose of conducting genetic tests commissioned by our company with ethical, legal, and social justification in accordance with relevant laws, regulations, and guidelines.

1.Subject of genetic testing

The genetic tests in this guideline are as follows.
A test that uses genetic analysis of the human germline to reveal the genetic information an individual has inherently (It includes tests to detect possible human germline mutations.)

2.Protection of personal information

We will comply with laws and regulations concerning the protection of personal information, our company guidelines, rules and guidelines, and endeavor to protect personal information when we undertake genetic testing. In addition, when conducting genetic tests, medical institutions will only handle information on subjects anonymized by code or number.

3.Voluntary consent (informed consent), etc.

Before conducting a genetic test, it is assumed that the physician at the medical institution fully explains the purpose, method, accuracy, and disclosure method of results of the test to the subject, and obtains the subject's free consent (informed consent). In addition, it is assumed that a medical institution has a genetic counseling system in place before and after genetic counseling is performed.

4.Handling of samples

Specimens received for genetic testing are used only for that test. Specimens used for testing are stored for a specified period of time, and specimens that have passed the storage period are promptly and appropriately disposed of or returned to the facility from which the testing was requested. Specimens will not be distributed to third parties.

5.Improvement of inspection technology

Individuals who conduct genetic testing will endeavor to improve their medical knowledge and skills necessary and sufficient to conduct the testing, and to familiarize themselves with relevant laws, regulations, and guidelines in order to deepen their consideration of ethical, legal, and social issues.

6.Ethics review committee

When genetic testing is performed, the ethical review board discusses and approves the use of genetic testing with ethical, legal, and social justification. At our company, these issues are discussed by the R & D Ethics Committee.

Established January 1st, 2020
Sekisui Medical Co., Ltd.