Table 1 Classes of data and their access regulation

Class 1

Low risk survey/phenotype-only data, e.g. social, economic, psychological and health data.

UK Data Archive

Requires registered access—online (clickable) end-user licences.

Data is distributed by the UK Data Archive.

Class 2

Low sensitivity genetic-only data, e.g. genome-wide single nucleotide polymorphism [SNP] data generated from a standard chip with no phenotype information except gender and a coarse measure of area of residence.

European Genome-phenome Archive (EGA)

Requires application to the Sanger DAC, administrative decision based on algorithm of criteria for access.

Data are distributed by the EGA.

Class 3

Potentially disclosive survey/phenotype-only data, e.g. small geographic area. Requires application to a study-based Data Access Committee made up of study investigators and study technical staff.

Study DAC

Data may be issued on special licence or may be accessible only in on or off-site data safe havens.

Data is distributed, or the data safe haven hosted, by the study.

Class 4

New forms of genetic-only data, e.g. exome sequence and epigenetic data, are reviewed by METADAC until their ethical implication/sensitivity is established.

METADAC

Application requires review and approval from the METADAC Access Committee. Application includes signed agreement to conditions of use. Data use is monitored annually.

Data are distributed by the EGA.

Class 5

Genetic-only data with known ethical issues, e.g. incidental findings risk in exome data.

METADAC

Application requires review and approval from the METADAC Access Committee. Application includes signed agreement to conditions of use. Data use is monitored annually.

Data are distributed by the EGA.

Class 6

Biological samples. Use of biological samples will always require additional oversight for ethical and scientific reasons.

METADAC

Application requires independent scientific review and approval from the METADAC Access Committee.

Samples are issued by the relevant study under Material Transfer Agreements.

Class 7

Any combination of Classes 1 to 6, e.g. individual-level phenotype data linked to genotype data or samples, is potentially more disclosive than any one class of data alone.

METADAC

Application requires review and approval from the METADAC Access Committee. Application includes signed agreement to conditions of use. Data use is monitored annually.

Combined datasets are issued on unique IDs and distributed by the study and EGA.

Class 8

Non-research data. High risk when multiple variables are combined.

Various

Certain administrative datasets, e.g. education and criminal records, are available for research via the Administrative Data Research Network. Individual-level health data is available for research via NHS Digital).

Various