Ethical issues diverse in nature surround the Tohoku Medical Megabank Project, ranging from traditional issues to new ones. We need a unique governance system to review these issues. In addition to internal reviews, we have also engaged in many discussions, as well as received advice from many experts throughout Japan. We have also conducted various outreach activities to connect with local residents, including seminars and citizens' forums.
As a governance system that undergoes reviews conducted by experts from throughout Japan, we have established a Working Group for Ethical and Legal Issues and an ELSI Committee to review ethical issues.
To drive forward the Tohoku Medical Megabank Project at Tohoku University and Iwate Medical University, the two universities have established a governance system made up of the Presidents and Executive Directors from both universities (Joint Steering Committee for the Planning of the Tohoku Medical Megabank Project). An Ethical, Legal, and Social Issues (ELSI) Committee for the Tohoku Medical Megabank Project has also been established, which aims to oversee the Steering Committee and review the various ethical, legal, and social issues that need to be considered for the future of the Project. This Committee is made up of only external experts, who provide advice and oversee the activities the two universities undertake. Many opinions have been exchanged with respect to the legal and ethical aspects of discussions about the distribution of biological specimens and information, returning the genomic results, as well as the relationship between personal information and genetic information.
The Working Group for Ethical and Legal Issues (WG) is made up of experts in the fields of law, bioethics, epidemiological studies, and other areas, selected from all parts of Japan. These experts provide recommendations and advice on the Tohoku Medical Megabank Project from ethical and legal perspectives. This WG engages in many discussions on various issues the project will face as it continues.
Intensive discussions were conducted by the WG over a total of six sessions from October 2012 to November 2014. During discussions, reviews were conducted on matters including the contents of documents of consent for cohort studies, the ethics of distributing biological specimens and information from the biobank to be built, how genetic information is handled, and circulating (returning) research results. The WG will continue to hold meetings as necessary after 2015.
All Tohoku Medical Megabank Organization (ToMMo) research involving human subjects is conducted according to the guidelines stipulated by the Ministry of Education, Culture, Sports, Science and Technology (MEXT), and other such agencies. This research is carried out after being reviewed by the Tohoku University Research Ethics Committee, and upon its approval. The Committee's main objective is to review the scientific validity and value of the study and ensure the study subjects are protected, in accordance with separate conditions. From ToMMo's launch in February 2012 until June 2014, the ToMMo submitted all its research to the Ethics Committee of the Tohoku University Graduate School of Medicine for review. Since July 2014, it has submitted all research to its independently set-up Research Ethics Committee (ToMMo REC) for review.
All matters relating to the main ToMMo projects, which were reviewed and approved by the Ethics Committee of the Tohoku University Graduate School of Medicine from 2012 to 2013, have been transferred to the ToMMo REC.
Pursuant to the enactment of the Ministry of Health, Labor and Welfare "Ethical Guidelines on Medical Research Involving Human Subjects" from April 2015, the ToMMo REC will appropriately operate the Committee, and properly review studies in accordance with the Guidelines.
The Iwate Medical University Ethics Committee has approved the University's "Tohoku Medical Megabank Project Community-Based Cohort Study" and other studies.
A cross-organizational internal working group has been established within the structure of the Tohoku University Tohoku Medical Megabank Organization to conduct reviews on ethical issues. This Working Group also engages in many discussions and formulates various ethical and legal frameworks for the project, consulting with the above mentioned Committees and others. At the same time, it responds immediately and conducts reviews to tackle new problems that emerge during the project (characterized by quick reaction capability). To date, it has conducted ethical reviews on matters such as the immediate return of results system. It also serves as an organization providing prima facie response to other pressing issues.
The Tohoku University Tohoku Medical Megabank Organization (ToMMo) has been holding seminars featuring numerous invited experts to review and discuss a range of ethical issues. These seminars are opened to participants from outside of the university. Each time, participants engage in a lively exchange of opinions. There have been a total of 15 seminars held between December 2012 and March 2015.
The ToMMo has also been planning and holding citizens' forums as part of its outreach activities, as well as actively taking part (co-hosting) in public symposiums organized by other organizations. These serve to promote a deeper understanding of the ToMMo projects. In addition, the ToMMo ensures it has a presence at various academic meetings, with staff on hand to personally answer on a face-to-face level the ethical questions that are sure to be asked at such events.