- EDR is the single centre for reporting of epilepsy-related deaths; will own the IP in the register and will lead on recruitment and involvement of families and professionals wishing to support research on epilepsy-related deaths. Researchers will own the IP on their research.
- Access to records in the repository is a resource to be shared collaboratively with teams working on different research questions. Decisions will be on merit but criteria will give preference to teams collaborating to address research questions and those who have involved SUDEP Action early on in the planning and design of the research so that the role of the EDR can be agreed and consideration can be given to any costs to the EDR.
- EDR Project Management Committee reporting to SUDEP Action will decide on requests from researchers.
- Expectation that access to tissues and records consented by bereaved families to the Epilepsy Tissue Bank are also subject to governance rules that involve SUDEP Action; enable access by interested research teams; and that SUDEP Action is consulted early on in any research aimed at prevention of deaths to enable consideration of collaboration.
- That research teams working with the register act as ambassadors signposting and promoting the register.
Ownership and IP
SUDEP Action owns the Intellectual Property (IP) in the EDR and the repository and researchers agree that the EDR will lead on dissemination of research to third sector and public audiences. Researchers working with the EDR will own IP relating to their research work, subject to specific agreement on particular projects. Arrangements can be varied on a case by case basis.
Requests from researchers
Requests from researchers wishing to work with the register will be considered on merit by the Project management committee of the epilepsy register which will make recommendations to SUDEP Action. Decisions will be discretionary but will be considered taking account of the criteria for access.
Criteria for access include:
- The principal investigators will normally have a track record in the field of SUDEP and epilepsy-related death with preference to multi-centre collaborations working with The Epilepsy Deaths Register
- Single researchers or teams and new investigators will be considered but are encouraged to explore with the register whether the research is a stand-alone project or whether it would be useful to consider liaising with an existing collaboration
- The proposed research will make a contribution to advancing the state of knowledge on SUDEP and epilepsy-related deaths
- The research is in keeping with the SUDEP Action Statement of Research Need
- The research team have demonstrated adequate consultation with the EDR team and have explored consideration of whether the role of the EDR in any project includes recruitment of research participants or consents; marketing of the research; dissemination to public audiences of results and whether this merits partnership; co-branding; co-authorship or some other form of acknowledgement as appropriate
- The budget includes any direct/indirect costs to the EDR
- The principal investigators include two peer reviews of the study
Conditions of Access
- Will depend on the project agreement but will generally include the following:
- Resources available for research and non-commercial purposes
- Ethical approval –SUDEP Action will need to see evidence –such as ethics committee reference number where needed. Researchers responsible for securing ethical approval for their project. SA will support applications for ethics approval if needed for the study.
- The researcher agrees to promote the EDR and to acknowledge the EDR in all publications
Access to confidential personal data
The EDR currently recruits consents for use of data reported to the register by families and will support the epilepsy tissue bank in recruiting consents for tissue retention where appropriate.
Approval and release of any confidential personal information or data will not be allowed without the prior consent of the person who has registered and that the role of recruiting consents will remain with The Epilepsy Deaths Register team.
Any data or information disclosed can only be used for the purposes of the research project which has been agreed with the EDR and in no circumstances will be disclosed to third parties.
Management of the Register
The Project management committee will include representatives from research teams working with the EDR on projects that support and develop the infrastructure of the register.
The Project Lead will report to the Project Management Committee and the Board of Trustees of SUDEP Action.
An Expert Advisory Group will provide advice and support as appropriate.