The GloBE-Reg registry is approved in the UK as a research database that archives information collected as part of routine clinical practice in people of all ages with a rare condition for which a new therapy has been discussed or started. In the UK, the database operates an opt-in policy for patient consent but this requirement may vary from one country to another. For research databases in the UK, a fresh application for ethics and data governance approval occurs every 5 years and the Registry was last approved in 2022 at its inception when the participant information sheets (PIS) and informed consent forms (ICF) were also created. All revisions to the UK PIS and ICF undergo institutional approval. Locally approved PIS and ICF in other languages are also provided below as samples from other centres. GloBE-Reg recommends that all PIS and ICF are reviewed every 5 years. If you have any queries about these information sheets or would like to develop information sheets in another language, please contact the GloBE-Reg team.
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