よむ、つかう、まなぶ。
参考資料4_Action plan for whole genome analysis 2022 (47 ページ)
出典
公開元URL | https://www.mhlw.go.jp/stf/newpage_38751.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20回 3/18)《厚生労働省》 |
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• Data users shall not provide or resell, etc. the relevant data to any third
party other than themselves unless 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.
• In principle, it would be preferable for the government to manage the data
quality at a guaranteed level within the framework of its budget, while other
operational costs are borne by users.
o Data Utilization Review Committee
The Data Utilization Review Committee will be established within the Project
Implementation Organization and will review applications for the utilization of
data to ensure fairness in granting licenses for data use to applicants. The
Data Utilization Review Committee will include both men and women, and the
members shall be subject to appropriate conflict of interest (COI) management.
They will also be bound by the obligation of confidentiality with respect to
information they obtain in their capacity as members.
Applications for data use will be reviewed in accordance with the following
review items.
• The purpose of use is academic research, development of pharmaceutical
products, etc., and use for preventive purposes based on scientific
evidence. The user may not use the data for any purposes other than those
for which authorization was received from the Data Utilization Review
Committee.
• The data do not permit identification of individuals or blood relatives, or
confirmation of the existence or non-existence of blood relatives, except in
cases where the purpose is to return results to patients, such as
participation in clinical studies. The research does not have the potential to
disadvantage individuals, small groups of people, or specific geographical
regions.
• The research plan is scientifically valid, and the scope of the data to be
used is appropriate.
• The applicant has sufficient experience or ability to carry out the research
plan.
• The applicant has sufficient research facilities and a management system
for the storage and disposal of information.
• Other items that the Data Utilization Review Committee members consider
necessary.
o Other items
• Intellectual property rights
Intellectual property and intellectual property rights arising from the use
of the data will belong to the user who created them.
• Publication
Users may publish the results of research using the data.
Clinical information of patients within these data may be included in
articles, etc. to the extent necessary for the publication of the results.
Users must give due consideration to the possibility that the published
material may lead to personal identification. If there is a possibility that
46
party other than themselves unless 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.
• In principle, it would be preferable for the government to manage the data
quality at a guaranteed level within the framework of its budget, while other
operational costs are borne by users.
o Data Utilization Review Committee
The Data Utilization Review Committee will be established within the Project
Implementation Organization and will review applications for the utilization of
data to ensure fairness in granting licenses for data use to applicants. The
Data Utilization Review Committee will include both men and women, and the
members shall be subject to appropriate conflict of interest (COI) management.
They will also be bound by the obligation of confidentiality with respect to
information they obtain in their capacity as members.
Applications for data use will be reviewed in accordance with the following
review items.
• The purpose of use is academic research, development of pharmaceutical
products, etc., and use for preventive purposes based on scientific
evidence. The user may not use the data for any purposes other than those
for which authorization was received from the Data Utilization Review
Committee.
• The data do not permit identification of individuals or blood relatives, or
confirmation of the existence or non-existence of blood relatives, except in
cases where the purpose is to return results to patients, such as
participation in clinical studies. The research does not have the potential to
disadvantage individuals, small groups of people, or specific geographical
regions.
• The research plan is scientifically valid, and the scope of the data to be
used is appropriate.
• The applicant has sufficient experience or ability to carry out the research
plan.
• The applicant has sufficient research facilities and a management system
for the storage and disposal of information.
• Other items that the Data Utilization Review Committee members consider
necessary.
o Other items
• Intellectual property rights
Intellectual property and intellectual property rights arising from the use
of the data will belong to the user who created them.
• Publication
Users may publish the results of research using the data.
Clinical information of patients within these data may be included in
articles, etc. to the extent necessary for the publication of the results.
Users must give due consideration to the possibility that the published
material may lead to personal identification. If there is a possibility that
46