Governance & Ethics
Governance & Ethics
Use of the Registry
The registry can be used by clinical users and researchers approved by a Registry panel within the Steering Committee.
Once approved the following actions can be completed using the registry:
- Uploading clinical information to be shared within the network
- Editing own centre records - records can be deleted only by Centre leads
- Searching other registered users
To Access the Registry
Access to the registry is applied following completion of the on-line registration through the link ‘Create A New Account’.
There are currently 2 levels of access.
1. Clinical Users are often part of team in a centre with one centre lead. Clinical Users can upload and edit their own cases but only the centre lead can delete cases and maintains responsibility for all clinical data in their centre. Clinical Users can view and edit records in their centre.
2. Network Users can search other registered users profiles for networking purposes. These users have no access to patient data.
In order to maintain an active registry, Clinical User accounts are converted to Network User accounts after 12 months of inactivity and suspended completely after a further 12 months of inactivity.
Since April 2016, Research User accounts are no longer available. To access registry data for research purposes, please see the Research section
Patients can also be provided with access to the core part of their own record. For step-by-step instruction go to the Participant Access section.
Rules and Responsibilities
Use of the registry is subject to certain rules and responsibilities constituting fair usage and protecting the rights of patients whose details are contained within the registry, as well as the clinicians. In summary these include:
- Only summary patient information allowing potential collaborations will be held in the registry; detailed information that could allow identification will not be held.
- Users will only be allowed to access to regsitry data following approval from the Steering Committee and completion of a data search form and a data sharing agreement.
- Users should only log on with their username.
- Audit tracking software monitors access patterns, machine locations and user IDs. With this information it is possible to accurately track and identify any illegal usage.
- All information stored in the registry, and access to that information, conforms to the UK Data Protection Act (1998).
REC favourable ethical opinion for I-DSD registry SOP v4.0 (020215)
(including I-DSD infosheet & consent form v4.0 and I-CAH infosheet & consent form v2.0)
Previous Ethical Approvals
Approval for ESPE DSD Registry (180609)
Approval of amendment to Infosheets and Consent Form v2.0 (061112)
Participant (Patient) Access – Step-by-step guide
Registry participants or their guardian (if under 16) are able to access a portion of their record on the I-DSD/I-CAH Registry. Access to the anonymised data is via a secure login page on the Registry website (ww.i-dsd.org). Access is set up according to the following step-by-step process.
- At the clinical centre where the participant is registered, the participant or their guardian should complete the relevant section of the Consent Form (‘I request access to my own record Y/N’) with the assistance of the clinician.
- The clinician shall record the e-mail address of the participant on the consent form.
- In the registry, the clinician shall open the participant’s record and select ‘PROVIDE PARTICIPANT ACCESS’.
- The portion of the record that the participant can view will appear and the clinician should enter the participant’s e-mail address in the box and click ‘Provide Participant Access’.
- An e-mail will be sent to the participant confirming the user account with an activation link.
- Upon following the activation link, the participant will be prompted to create a password.
- The participant’s record will be immediately available to view.
- For access at other times, use the following link: http://www.i-dsd.org/patient/index.actionand insert username (e-mail address) and password.
- Queries relating to the record should be directed to the clinician at the clinical centre in the first instance.
- Queries relating to the Registry, or assistance with the participant access process, should be directed to the Project Manager Jillian.Bryce@glasgow.ac.uk
Once access has been provided to the patient participant they will see a view like this and will be able to choose a preferred language: