よむ、つかう、まなぶ。
参考資料４_Action plan for whole genome analysis 2022 (38 ページ)
出典
| 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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studying concrete proposals for commencement. Furthermore, rather than
simply computerizing the process of explanation, obtaining consent, and
storing the records, the introduction of e-consent should be examined
together with the creation of an online platform in which the patient can take
a lead role in managing information.
Advantages of e-consent
• Increased efficiency through easier modification, tracking, and
centralized management of the content of the ICF.
• The use of explanatory contents matched to the pace of the individual,
review and confirmation of consent details, and ease of sharing with
family members improve understanding by patients.
• Increase in the rate of participation in the project.
• Recontacting patients is more convenient.
Points to note regarding use
• Difficult for patients who are unfamiliar with ICT to understand the
content and express their intentions.
• Fewer opportunities for questions than when patients are dealt with in
person, which can often impede attentive patient care.
• Difficulty in handling cases and confirming requirements when a proxy is
needed.
Points for examination when introducing e-consent
• Methods of IC information transfer and management at the hospital
• Means of cooperation with the Analysis and Data Center
• Creation of an online platform in which the patient can take a lead role in
managing information
2) Collection, processing, transfer, storage, and management of samples
Collection, processing, transfer, storage, and management of samples will
be conducted using standardized methods that comply with international
norms, so that specimen quality can be assured. In addition, all processes
will be completed in Japan.
o Collection, processing, and transfer of samples (transfer within facilities,
transport between facilities)
Collection and processing of samples will be carried out in line with the
Rules for Handling Pathological Tissue Samples for Genome Research
stipulated by the Japanese Society of Pathology. Standard operating
procedures for each research group and each field will be drawn up
during FY2022 to ensure that collection and processing are carried out
according to standardized methods that comply with international norms.
o Storage and management of samples
As a general rule, sample storage and management will be carried out
as centralized management at the Centralized Sample Management
Center managed by the Analysis and Data Center. The methods for
37
simply computerizing the process of explanation, obtaining consent, and
storing the records, the introduction of e-consent should be examined
together with the creation of an online platform in which the patient can take
a lead role in managing information.
Advantages of e-consent
• Increased efficiency through easier modification, tracking, and
centralized management of the content of the ICF.
• The use of explanatory contents matched to the pace of the individual,
review and confirmation of consent details, and ease of sharing with
family members improve understanding by patients.
• Increase in the rate of participation in the project.
• Recontacting patients is more convenient.
Points to note regarding use
• Difficult for patients who are unfamiliar with ICT to understand the
content and express their intentions.
• Fewer opportunities for questions than when patients are dealt with in
person, which can often impede attentive patient care.
• Difficulty in handling cases and confirming requirements when a proxy is
needed.
Points for examination when introducing e-consent
• Methods of IC information transfer and management at the hospital
• Means of cooperation with the Analysis and Data Center
• Creation of an online platform in which the patient can take a lead role in
managing information
2) Collection, processing, transfer, storage, and management of samples
Collection, processing, transfer, storage, and management of samples will
be conducted using standardized methods that comply with international
norms, so that specimen quality can be assured. In addition, all processes
will be completed in Japan.
o Collection, processing, and transfer of samples (transfer within facilities,
transport between facilities)
Collection and processing of samples will be carried out in line with the
Rules for Handling Pathological Tissue Samples for Genome Research
stipulated by the Japanese Society of Pathology. Standard operating
procedures for each research group and each field will be drawn up
during FY2022 to ensure that collection and processing are carried out
according to standardized methods that comply with international norms.
o Storage and management of samples
As a general rule, sample storage and management will be carried out
as centralized management at the Centralized Sample Management
Center managed by the Analysis and Data Center. The methods for
37