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参考資料4_Action plan for whole genome analysis 2022 (48 ページ)

公開元URL https://www.mhlw.go.jp/stf/newpage_35569.html
出典情報 厚生科学審議会 科学技術部会全ゲノム解析等の推進に関する専門委員会(第17回 10/3)《厚生労働省》
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the published material may lead to personal identification, this must be
reported to the Data Utilization Review Committee for reviewing again
before publishing.
• Confidentiality
 Data users shall manage the information they receive from the relevant
data as confidential information, and they may not disclose or provide
this information to third parties unless it is disclosure or provision to an
outsourcing company, and the user imposes on the third party the same
confidentiality obligations that are imposed on the user by the data
utilization policy, the rules on data sharing, and the licensing agreement,
and provides the data within the scope of the specified purposes of use.
 When handling the data, the user shall take all reasonable safety
measures with regard to risks such as unauthorized access, loss,
destruction, leakage, etc.
• Disclosure of information
 The Data Utilization Review Committee will disclose the names of parties
who have been licensed to use the data.
(b) Rules on data sharing (data sharing policy)
FASTQ data, etc. generated after sequencing by the sequencing company are
to be sent to the Analysis and Data Center within two weeks. To ensure prompt
utilization of the data, including clinical information, that are collected, the
Analysis and Data Center will share the data with the Industry Consortium and
the Academic Consortium simultaneously. This aims to promote academic
discussions relating to whole genome analysis, facilitate clinical
understanding of cancer based on whole genome analysis, and improve
cancer prevention and prognosis by academe, as well as to promote research
and development for drug discovery, diagnostic technology, and prevention
by industry.
The rules on data sharing stipulate the following items, which are
necessary for the above purpose.
The rules will be revised as necessary in accordance with international
trends and the progress of research.
o Basic items
• The data to be shared are genome data, which are clinical information and
sequencing information collected from medical institutions, analyzed in
detail by the Analysis and Data Center, and compiled into a database.
• An Industry Consortium hosted by industry and an Academic Consortium
hosted by academe will be formed for sharing the data.
• In principle, data users will bear the costs associated with utilization of the
data. However, a mechanism will be examined to reduce the burden for
data that the Data Utilization Review Committee recognizes can only be
used in the Academic Consortium.
• The Analysis and Data Center will register genome data and basic clinical
information in public databases after a limited period (24–30 months) has
elapsed. However, detailed clinical information will not be registered in
public databases because it may lead to the identification of individuals.
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