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【Meeting of the Committee on MHLW】 Discussing genome analysis systems including – integrating informed consent, and so on.

2020年11月04日 (水)

On October 27th, the Ministry of Health, Labor and Welfare (MHLW) held a “Coordination Meeting for Cancer Analysis of Whole Genome.” They discussed the system maintenance necessary for the full-scale analysis of the whole genome. They also generally accepted the draft policy to integrate informed consent forms for patients, proposed by the meeting’s working group. To develop new drugs and obtain comprehensive consent for future additional analyzes, they will prepare a draft to integrate the patient’s informed consent form and aim to complete it considering the patient’s problems that have arisen for the implementation period of preliminary analysis. They will report it to the “Subcommittee on Promotion for Cancer Analysis of Whole Genome” by the end of this year.

MHLW is working on a preliminary analysis of about 92,000 cases of cancer and intractable diseases for up to three years. For full-scale cancer analysis, it was decided on at the meeting that the requirement for system maintenance would be considered specifically. At the meeting on this day, a draft policy was presented and approved for some considerations to be reported by the end of this year, such as integrating informed consent acquisition for the patient to withstand new drug development utilization.

For integrating patient informed consent, the meeting’s working group arranged the explanations required for taking highly effective consent and drafted a template of the patient’s informed consent form.

It addresses various issues such as the scope of research objectives, the purpose and measures expected for industrial use, and the classification of essential items and possible opt-out items. They committed to improve it based on the issues that will arise in the future during the preliminary analysis period.


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