Registry Working Party
ESID Registry - Newsletter August 2020
by Mikko Seppänen
The ESID Registry comprises data of > 30,000 patients and is one of the pillars of our society. Many research efforts have derived from it. However, ESID Board feels that the registry has not risen to its full potential. Therefore ESID Board and ESID Registry Working Group (WG) are actively scanning ways to improve its services to all of its members. Moreover, several actions need to be urgently taken.
Absolutely needed actions due to GDPR
First, all reporting centers need to act according to the European General Data Protection Regulation (GDPR) and re-consent or at least inform all recorded and reachable patients. The deadline WG and Board have jointly agreed upon will be February 2021.
Sadly, this is imperative even despite all the extra work to us currently caused by Covid-19. Like we all know, GDPR has been in force since 2016 and applied since 2018. However, only a small fraction of our patients has been consented according to the GDPR. We thus strongly and urgently recommend that all patients (or legal guardians) sign the new patient informed consents (PIC) without further delay, otherwise we would be in the unsatisfying and catastrophic need to exclude these entries! If, for example due to the Covid-19 pandemic, you have not been able to see all previously consented patients but the patient has signed a previous version of the consent, you urgently need to send the 'Supplement to data protection' to the last known address of the patient and document this in the system.
If you need to document a PIC version that has not been activated for your center by the ESID Registry Team, please let us know about this and send an unsigned copy of this new form (to ). The local Ethics Committee should in beforehand approve the new GDPR-compliant version. Thus, please also send to the Team a copy of the document, which states this. The Team can then promptly activate the new PIC in the system for you.
Recruiting documenting centers into your study
In practice, during my two past years as the chair of the Registry, the leading barrier against effective use of our registry has been the fact that in the present contract between the Registry and documenting centers applies an OPT IN option. In practice, replies to requests have frequently been extremely delayed, hampering and preventing highly motivated members in launching important new registry studies. This problem has now actively been discussed in the ESID Board and the ESID Registry WG. We are in the process of modifying these contracts. After this, all national and local documenting centers will be contacted and agreements will be renewed. The upcoming version will only include an OPT OUT option. This of course means that all staff responsible for the inclusion of local patients into studies will need to stay alert and respond promptly to such requests, should they choose to opt out. We hope that this will ease the path to more registry studies in our invaluable registry and alleviate the task of those trying to launch new studies as well as of those managing our registry.
Management of our registry
The second most important barrier to increasing the number of studies our members are able to launch by using our registry is the lack of workforce and efficiency for the management of requests. The reason for this is clear. Over the years, the number of people in Registry’s data and technical study management team has slowly dwindled, most likely due to a high demand for bioinformaticians in many branches. The Board is actively looking into various ways to help our registry, which the present Board strongly and unanimously feels to be our Society’s most valuable tool, for all of its Working Groups and members to utilize. We hope that these planned changes will in future effectively ease the path of all of our highly motivated members to use our Registry!
Registry is active
Many important studies are currently running in our registry. New level 2 studies are under way, while ongoing level 3 studies have received further funding. Novel features like Immune Deficiency and Dysregulation Activity (IDDA) Score is being implemented into the Registry. Our Society and its members have actively promoted inborn errors of immunity Human Phenotype Ontology (HPO) development. In 2019, five new publications were published using our Registry ( https://esid.org/Working-Parties/Registry-Working-Party/Registry-publications). All this has happened thanks to the vision, activity and tenacity of our members. We do hope that you will attend the joint Genetics and Registry WP session during the upcoming ESID 2020 Meeting!