[new supporting resource] Technical Development SOP update?
WIN Technical Development SOP is used for scanning on physics projects.
SOP Number: OHBA_009_V1; 004-V4 (FMRIB) SOP Title: Ethical Considerations for Technical Development Scans
[This SOP] describe circumstances in which MR scanning of human volunteers is permissible for technical development purposes, without the need for explicit NRES/CUREC ethical approval, and to describe the procedures that should be followed in these cases.
Does this need to be updated to allow data sharing via XNAT? Relevant wording around data sharing:
4.1 Technical Development Scans Examples of technical developments, where it has been advised that ethics committee approval is not required include:
1. Evaluating, testing or fixing a sequence whose use will be for other studies running under their own ethics approval.
- Data collected will not be published.
- Acquiring a few data sets for demonstration of an image analysis methodology or optimising sequence parameters.
- Data may be published as proof of method.
- Developing and validating a new imaging sequence.
- Validation data may be published.
- Testing a device for use in the MRI scanner, including radiofrequency coils and stimulus delivery equipment.
- Data may be published.
4.2 Training scans A training scan is one performed for the purposes of training other researchers or scanner operators in imaging techniques, and should be logged accordingly. Individual subject log sheets should still include these scans, which count towards the total.
- Data will not be published
6.5 Data storage and protection Data storage will be on a password-protected computer. Any data that is shared outside the University of Oxford must be completely anonymised and no information about the subject disclosed.
Actions / suggested update options:
6.5 replace "completely anonymised" with "de-identified"
Add a section on open data sharing, copying the proposed amended wording to the AP17 (see issue #14)
System for identifying which basis (from the above) data were collected so this can be audited when preparing the data for sharing.