Japan Supportive, Palliative and Psychosocial Oncology Group
This policy is applicable to all members in J-SUPPORT
1. Basic Policy
1.1. Scope of this policy
This policy was established because J-SUPPORT recognizes that information related to individuals’ privacy, such as personal and medical information, should be protected strictly and handled with caution under the philosophy of respect for individuals. J-SUPPORT will protect the privacy of members by establishing well-planned security measures.
1.2. Laws, standards, and policies concerning personal information and privacy protection
In principle, laws and standards concerning personal information and privacy protection that J-SUPPORT conform to are as follows:
(1) Act on the Protection of Personal Information (Act No. 57 of 2003; May 30, 2003)
(2) Declaration of Helsinki (as interpreted by the Japan Medical Association)
(3) Ethical Guidelines for Biomedical Research Involving Human Subjects (Ministry of Education, Culture, Sports, Science and Technology / Ministry of Health, Labour and Welfare)
(4) Ethical Guidelines for Human Genome/Genetic Analysis Research (Ministry of Education, Culture, Sports, Science and Technology / Ministry of Health, Labour and Welfare / Ministry of Economy, Trade and Industry)
It should be noted that the latest (when revised) version of the Declaration of Helsinki (2) is applied regardless of the phase of a research project. As for the laws and guidelines in 1, 3, and 4, a research project is conducted in compliance with the version that was in effect at the time of initiating the project (that is, the day the project was approved by the J-SUPPORT Protocol Review Meeting).
Research projects also conform to other laws (such as medical and pharmaceutical laws) and standards (different ethical principles and relevant guidelines) when applicable.
1.3. Range of application of this policy
This policy is applied when J-SUPPORT members handle patients’ private information for research purposes.
1.4 Definition of terms
The terms used in this policy are defined as follows:
1) Personal information: name, date of birth, and other information that can be used to identify/specify individuals (personally identifiable information)
2) Medical information: name of disease (based on the diagnosis or treatment), specifics of treatment, and test results
3) Privacy: Freedom to live a private life without interference from others
＊1) is defined based on the laws concerning personal information protection and the ethical guidelines concerning clinical research.
＊2) is cited from the ethical guidelines related to clinical studies (the phrase of “treatment drugs” is changed to “specifics of treatment“）
＊3) is cited from the Japanese dictionary Kōjien.
2. Handling of patient information for research at J-SUPPORT
Each director and group leader shall comply with the laws and standards described under 1.2., which is supported by J-SUPPORT.
First approved by the Executive Committee on: October 14, 2016