(The 7th Seminar Report) Ethical Guidelines and Review of Clinical Trials Act

On February 12, 2021, we welcomed Dr. Kyoko Yoshioka, Research and Development Division, Health Policy Bureau, Ministry of Health, Labor and Welfare (MHLW), to hold the 7th Academia Clinical Development Seminar online. 

 Dr. Yoshioka has been involved in the development of "Ethical Guidelines for Life Science, Medical and Health Research Involving Human Subjects" (hereinafter called "Integrated Guidelines"), which integrates " Ethical Guidelines for Human Genome/ Genetic Analysis Research" (hereinafter called "Guidelines for Genome") and "Ethical Guidelines for Medical and Health Research Involving Human Subjects" (hereinafter called "Guidelines for Medical and Health Research").  Based on her experience, she introduced key points related to the Integrated Guidelines in the seminar. 

 First, as a background, Ministry of Education, Culture, Science and Technology, MHLW, and Ministry of Economy, Trade and Industry discussed the two guidelines in terms of consistency between both guidelines and optimization of Guidelines for Genome at the joint meeting in August 2018. As a result, it was decided to consolidate both guidelines into Ethical Guidelines for Life Science, Medical and Health Research Involving Human Subjects based on Guidelines for Medical and Health Research. 

 Next, she explained the key points of "Structure of Integrated Guidelines," that included "Change from regulations by person in charge to regulations by action" She further described the "New items” as 

1) "Definition of Terms, 

2) "Electromagnetic informed consent,"  

3) "Handling of results obtained from research,"  

4) "Changes in the main person responsible for procedures, Centralized review in principles," and  

5) "Ethics review board (review and reporting). 

 Regarding "Structure of the Integrated Guidelines" and "Change from regulations by person in charge to regulations by action," the structure of the Integrated Guidelines has been substantially changed, with conceptual content such as "responsibilities and concepts to be observed in conducting research" in Chapter 2 and "specified research procedures which researchers should implement” between Chapters 3 and 7. 

 As for "New items," she explained the main points for each of the following items more in detail: 

1) "Definition of Terms" 

Terms such as "Life science/medical and health research involving human subjects" and "Research collaborating institution" etc. were defined. 

2) "Electromagnetic informed consent 

Considerations for using electromagnetic methods in obtaining informed consent (hereinafter called "IC") were discussed, and it was stipulated that "IC can be received by electromagnetic methods instead of written IC," assuming that  explanations and consents are obtained using digital devices, and  explanations and consents are obtained via networks. 

3) "Handling of results obtained through research 

The content related to "Disclosure of genetic information" were reconsidered, and the concept and procedures on how to properly explain the results obtained from research to research subjects were newly stipulated. 

4) "Changes in the main person responsible for procedures, Centralized review in principle” 

 The entity responsible for submitting research plans to the ethics review board and other procedures related to the conduct of the research was changed from "Head of the research institution" to "Principal investigator,  In principle, a centralized review was stipulated to optimize the procedures for ethics review in multi-institutional research. 

5) "Ethics review board (Review and reporting) 

Regarding the provision for expedited review, "Review of minor changes to research protocols" that the ethics review board has approved as requiring only prior confirmation can now be treated as reportable matters. 

 She also introduced the review of the "Clinical Trials Act " that is currently under review. 

The main points of discussion include “Reducing the burden of administrative procedures (reducing the workload related to notificationschanges and reducing the burden on COI control)," "Problem of off-label use, which has become a major issue in the oncology and pediatric fields," "Positioning of observational studies in Clinical Trials Act," and "Introduction of concepts of “Sponsor required for consistency with international regulations." 

 Dr. Yoshioka gave us a very useful and valuable lecture in detail, and as many as 225 people attended the seminar. The meeting ended with many questions and lively discussions. 

 We were able to invite highly respected lecturers on research and development in the medical field this year. Thanks to their lectures from a variety of perspectives, we were able to provide a fulfilling seminar for all participants. 

The secretariat will make every effort to provide useful information to researchers next year as well. As soon as the schedule for next year is finalized, we will announce it on our website.  

We look forward to your participation. 

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