Registry Concept
The main concept behind the DMD Registry is to offer clinicians, health professionals and researchers an easier path to clinical trials in the.
Currently information held on participants is held in paper files. There is a lengthy, expensive, bureaucratic legal process that must be repeated for each clinical trial.
The concept behind the Registry is that:
- The DMD Registry allows people with DMD to ask their clinicians for access to their data under rights given to them by the Freedom of Information Act (2000).
- Participants then give their data to the DMD Registry who are under obligations place on them by the Data Protection Act (1990). This means that participants control their own data.
- The DMD Registry is run under the UK Charity laws which ensure that it is run for the purpose of treating DMD. The DMD Registry has strong governance procedures, controlled by audit, steering and and operations committees. Together these committees ensure the DMD Registry can work effectively for the purposes that the participants have consented.
- Access to the DMD Registry by Participants is controlled by the Computer Misuse Act (1990).
- Access to the DMD Registry by researchers is controlled by the Steering Committee, which is in turn controlled by the UK Research Governance Framework and EU Clinical Trials Directive (2001). All research done on the registry must be approved by an ethical committee under EU law. Access to data on the DMD Registry is controlled by the UK and EU copyright laws.
- The DMD Registry differs from existing genetic registries, because the participants have given consent, the data is of a high enough quality for clinical trials and the security model meets the requirements of the Data Protection Act and Health Service. The DMD Registry can help researchers, and health professionals to advertise for participants, search for participants and contact them via their clinician.
By creating the DMD Registry we hope to give researchers and health workers a world class, streamlined clinical trials system. As part of the race against time, we aim that more trials can be run, more quickly and more efficiently.
