Overview - ISO/TR 3985:2021 (Biotechnology - Data publication)
ISO/TR 3985:2021 provides preliminary considerations and concepts for data publication in biotechnology and related life‑science domains. The technical report reviews best practices that:
- respect existing life‑science standardization efforts;
- normalize key aspects of biological data description across domains;
- ensure data are findable and usable by other researchers; and
- provide guidance and metrics to assess the applicability of a data‑sharing plan.
This guidance applies across biotechnology, genomics (including sequencing, metagenomics, epigenomics), transcriptomics, proteomics, metabolomics, imaging, synthetic biology, systems biology/medicine and related fields. The report is intended to support consistent metadata, annotation and publication practices to increase the value of big biological data.
Key topics and technical requirements
ISO/TR 3985:2021 emphasizes practical, domain‑independent approaches to make life‑science data discoverable and interpretable:
- Findability: metadata and descriptions that enable locating biological data across repositories and domains.
- Machine and human interpretability: conventions that support automated parsing as well as human understanding.
- Controlled vocabularies & naming conventions: use of accepted ontologies and terms to reduce ambiguity.
- Biological annotation domain independence: a unified way to describe the biology represented so cross‑domain tools can search and integrate datasets.
- Data locatability: support for multiple query approaches and web‑searchable representations.
- Linkage requirements: linking data to published descriptions of experimental systems and to format documentation.
- Web‑friendly formats and search engine crawlability: guidance on structuring documents to be discoverable online.
- Practical considerations: timing and costs of publication, archival responsibilities, validation/verification of compliance, and stakeholder roles.
- Challenges identified: many existing ontologies and repositories, proprietary data, regional/legal differences, and a diversity of funder requirements.
Applications - who should use this standard
ISO/TR 3985:2021 is aimed at organizations and professionals involved in life‑science data publishing and reuse:
- Data producers and research labs creating datasets and metadata.
- Data repositories and archivists designing submission and discovery workflows.
- Funders and policy makers setting data‑sharing requirements and evaluating plans.
- Publishers and journals enforcing data availability and annotation standards.
- Bioinformatics platform developers and tool makers working on search, integration and interoperability.
- Biobanks and consortia coordinating multi‑site datasets and multi‑omics studies.
Practical uses include designing data‑sharing plans, improving dataset discoverability (FAIR compliance), enabling cross‑domain searches, and assessing whether a repository or format meets community expectations.
Related standards and references
- FAIR principles (Findable, Accessible, Interoperable, Reusable)
- Community standards cited as examples: MIAME, OME/OMERO, SBML, MIABIS
- ISO/IEC definitions and terminology resources (e.g., ISO/IEC 20546 for big data concepts)
- Developed by ISO/TC 276 (Biotechnology)
For implementation details and formal guidance, consult the full ISO/TR 3985:2021 text to align your data‑publication workflows with international best practices.
