Opt-out/Opt-in
The term "opt-out," widely used on the Internet, refers to "choosing not to participate in an activity or arrangement or to stop participating," and "opt-in" refers to "deciding to participate in an activity or arrangement," but in the case of medical care and medical research it may be used in a different sense. In the case of medical research, opting out is sometimes used in a different sense.
In the case of opt-out in medical research, it is "a method of notifying patients or making the information readily available to them and ensuring that they have the opportunity to refuse that the research will be conducted or continued" ( Guidance on Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects (See "Guidance on Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects").
If data will be used by opting out, the patient will be notified via the medical institution's website or a bulletin board in the hospital. If you do not indicate your refusal, your data will be used in accordance with the notice. Opt-in, on the other hand, refers to "the method by which patients obtain permission to participate in research and for their data to be used before the research is conducted. The patient's data will only be used if he or she has been informed of the details of the use of his or her data and has given his or her consent. The choice between opt-out and opt-in is generally made after an ethical review based on laws and guidelines set by the national or local government.
In addition, Personal Information Protection Law requires careful handling of personal information and does not permit the provision of such information to third parties on an opt-out basis (Article 27, Paragraph 2 of the Revised Personal Information Protection Law (effective April 1, 2023)). Personal information requiring special consideration includes medical history, disabilities, and the results of medical examinations conducted by doctors, etc.
