Dataset consent types
This data item indicates the type of consent for re-use and sharing, associated with the data, usually obtained at the beginning of the primary study. It is composite, consisting of a categorised response that indicates in broad terms the range of activities covered by the consent, plus additional boolean data items that can be used to indicate additional specific requirements, and a textual description of the consent that can be used to provide further detail. The categories and the additional requirement items are both based on the Data Use Ontology (DUO) classification of biomedical consent types - see https://github.com/EBISPOT/DUO, which has been approved by the Global Alliance for Genomics and Health (GA4GH). The main categories are:
| id | name | description | source |
|---|---|---|---|
| 0 | Not known | No clear information available about consent for secondary use, or if any exists. | ECRIN |
| 1 | No explicit consent | No specific consent was given for the sharing of data or its re-use beyond the study in which it was originally collected. | ECRIN |
| 2 | No restriction | No explicit restriction in the consent documents, though a broad consent to re-use is assumed, or this category is meaningless. | DUO |
| 3 | General research use | Consent indicates that use is allowed for general research use for any research purpose. | DUO |
| 4 | Health/medical/biomedical research | Consent indicates that use is allowed for health/medical/biomedical purposes; does not include the study of population origins or ancestry, or the development of methods / algorithms (e.g. for ML) | DUO |
| 5 | Disease-specific research | Consent indicates that use, for health/medical/biomedical research is allowed provided it is related to a specified disease (area). The disease (area) must be named or coded in the associated comments field. | DUO |
The additional requirements (source = DUO) that can be recorded are:
- Non-commercial research only?: Additional restriction limits to research carried out by non-commercial agencies.
- Geographical restrictions?: Research must be carried out in a specified geographical area. The areas must be specified in the associated comments field.
- Specified research types?: Research must be of a particular type or types. The types must be specified in the associated comments field.
- Genetic studies only?: Use is limited to genetic studies only (i.e. no phenotype-only research).
- No general methods research?: Indicates that use includes methods development research (e.g., development of software or algorithms) only within the bounds of other use limitations
Please note: We recognise that obtaining information on consent at the level of detail described above will be unusual during the retrospective 'harvesting' of such data for the ECRIN metadata repository - at least at the moment when consent information, if present at all, is usually very limited. The data points are provided, however, for use prospectively, by repositories and others who wish to structure such information in the future. The categories here should be used in conjunction with other parts of the DUO system (e.g. additional requirements from data generators, expressed within Data Transfer Agreements).
