TRE Satellite Event notes - Standardisation of information governance, certification & regulation#
How we do standardise sticky issues around ethics?
What definitely can/can’t be standardised?
Can certifications and governance reviews be done once for each TRE code-base?
Can information governance reviews be shared across TREs?
Standardisation is made difficult due to a large variety in data:
Types of data
Does this diversity make creating effective standards difficult
Cyber Essentials (+)
from M’s notes earlier!
What existing standards do builders of TREs attempt to adhere to?
What existing standards do data owners expect builders of TREs to adhere to
Is this likely/close to a complete set or are there gaps? What are those gaps?
R: Experience approaching ISO27001 certification. More ‘free form process’ rather than a prescriptive set of requirements
A: Lack of definition for ‘TRE’ also makes standardisation difficult from the perspective of data providers
Feedback from working on Goldacre report. Preference for a small number of TRE implementations
Alternatives could be many implementations of one (or small number of) specification, federated set of similar/compatible TREs
Small number of large TREs will likely made data access/sharing/linkage easier as it will be easier to develop trust between the TREs and between all TREs and data providers
NHSx (?) report on the future of TREs (SDEs) proposes ‘soft’ accreditation to make multiple projects on one TRE involve less friction
H: ‘Data lakes’ for storing very large amounts of data - accredited TREs could get ‘easy’ access to this data
How to get towards these ideas?
A single implementation which demonstrates the use of a data lake/passport
S: How flexible can a passport be? Researchers may be told where they will work and not be able to choose. The benefit of a passport will depend on who/what (people/organisation/TRE) the passport applies to
R: Easier to apply some kind of accreditation to a TRE rather than people. TRE can ‘guarantee’ some level of security through technical controls and processes. This can be aligned with the expectations/requirements of data providers
A: For health data, there also needs to be a consideration of protecting the interests and rights of data subjects
A: Observation from work with HRA, governance is difficult to enforce with code alone
R,A: Section 251 objection for a research project allows bypassing some GDPR requirement. Unclear if this kind of exception could apply to a whole TRE/secure data store.
Survey and take inspiration from what already works and is ‘acceptable’ in the UK. E.g. UK BioBank
Create a clear definition of what a TRE is (and is not). This is important for data providers.
Survey the ‘hard requirements’ for difficult organisations/types of data. E.g. Cyber Essentials + for MOD.