2016-06-21-世界卫生组织-Optimal_Characteristics_of_an_Influenza_Genetic_Sequence_Data_Sharing_System_Under_the_PIP_Framework_45页_635kb

Optimal Characteristics of an Influenza Genetic Sequence Data Sharing System

This document outlines the recommendations of the Pandemic Influenza Preparedness (PIP) Framework Advisory Group's Technical Working Group on the Sharing of Influenza Genetic Sequence Data, focusing on establishing an optimal sharing system. Key recommendations include:

1. Benefit-Sharing Discussions and Data Access

• Benefit-sharing mechanisms were integrated into considerations, discussing potential approaches for tracking access or use of data for commercial products.
• The system should define access through two types of databases:
  • Databases with registered user access/controlled-access databases (DRUA/CADs) requiring user registration and data use agreements.
  • Databases without registered user access/open-access databases (DWRUA/OADs) allowing public access without registration.

2. Optimal Characteristics & Best Practices

• Submission: IVPP genetic sequence data should be submitted rapidly and systematically, ideally within one month of sequencing completion.
• Timeliness: New sequences should undergo a temporary submission embargo (up to four months) to allow public health use while protecting publisher rights.
• Quality Assurance: Databases must ensure data accuracy, provide quantifiable metrics, and tools for quality control, especially for incomplete or evolving data.
• Metadata and Completeness: Core metadata (strain name, collection location, isolate ID) and optional metadata (patient demographics, sample source) must be standardized and curated.
• Access and Use: Data should be downloadable in multiple formats, programmatic access enabled, and tools provided for analysis.
• Source Identification: Accession numbers must uniquely identify data origins to facilitate tracking for benefit-sharing purposes.
• Sustainability and Security: Systems should ensure long-term data accessibility, version control, and periodic mirroring across databases for resilience.
• Regulatory Support: Data access agreements must facilitate regulatory use during pandemic product approvals.

The discussions align with PIP Framework objectives, emphasizing timely sharing, transparency, and equitable benefit distribution.