Human Disease Genes Website (HDGW) series Moderator role

Moderator role
When creating a website as part of the Human Disease Genes Website series the (lead) Moderator is responsible for the day-to-day management of the website. This includes providing information and collecting data. The responsibilities and rights of the Moderator are outlined below.

The HDGW series is governed by a Joint Data Registry Agreement (JDRA), which assigns primary responsibility for each website to a designated ‘Partner’ institution, rather than the (lead) Moderator. An institution (e.g. hospital or department) becomes a Partner by signing the accession document included as Appendix D of the JDRA.

Once your website is launched, the HDGW team will provide Appendix D along with instructions for your institution to formally become a Partner allowing the Moderator to initiate data collection. However, the (lead) Moderator or institution may also request Appendix D earlier in the process if preferred.

Moderator responsibilities and rights
After adopting a gene website, the Moderator gains responsibilities and rights for the information and data collection via this website. These involve:

Providing information for other professionals, families and/or caregivers:

•    The Moderator is responsible for providing content about the adopted gene and updating it annually. Information intended for professionals (under the ‘Professionals’ tab) may include scientific or technical language, while content for families (under the ‘Families’ tab) should be written in clear, layman’s terms.


Clinical data collection:
The provided webpage on the HDGW series allows for clinical data collection in HPO terms. The upload of information can be done by the Moderator and/or other professionals (Third Party Data Providers).

•    The Moderator curates the information that is provided and ensures informed consent, the privacy of the data subjects and the confidentiality of data.

•    The Partner/Moderator is responsible for ensuring that valid informed consent has been obtained for all patient data entered into the HDGW Registry, including data submitted by Third Party Data Providers. This must be done in accordance with the General Data Protection Regulation (EU) 2016/679 and applicable national laws. The website includes a checkbox through which the Third Party Data Provider confirms that the patient has given informed consent.

•    Each Moderator retains ownership on their gene-specific dataset in the HDGW Registry and has the right to extract the data for their own use without requiring approval of the Data Access Comittee (DAC).

•    If another professional than the Moderator wants to use the collected data, consent should be given by the DAC of the HDGW team, but only after consulting and with approval of the Moderator.

•    For any publication that uses clinical data from the HDGW Registry, the following acknowledgement must be included: “This publication was made using data provided by the HDGW series Registry.”

Natural history study:
The Moderator can allow patients, families, and caregivers to share clinical information through the 'HDGW patient portal,' where patients and caregivers can upload and update details annually. This enables a natural history study. If the Moderator opens a patient portal, the following applies:

•    The Moderator is responsible for contacting patients, families and other caregivers about the option to start data sharing via de HDGW series.

•    The Moderator will obtain informed consent using the patient information folder, the upload manual and the link to the privacy statement. These documents will be shared with the moderator by the HDGW team once the patient portal has been opened. The system includes a checkbox through which the patient or caregiver confirms that there is informed consent for data sharing.

•    The Moderator is responsible for the curation of the uploaded information.

•    Each Moderator remains the owner of its data subset in the HDGW Registry and is entitled to extract the data from the Database for its own use without the approval of the Data Access Comittee (DAC). Each Moderator shall be responsible and liable for the anonymous processing of its own data in accordance with applicable laws.

•    If another professional than the Moderator wants to use the collected data, consent should be given by the DAC of the HDGW team but only after consulting and with approval of the moderator.

•    For publications where HDGW natural history data is used, the following acknowledgement shall be made: 'This publication was made using data provided by the HDGW series Registry'.

Legal information
This document is an informal and non-legal binding summary of the responsibilities and rights of the Moderator. As mentioned the legal foundation for the HDGW series is described in a Joint Data Registry Agreement (JDRA). To read more about all formal responsibilities and rights this JDRA can be accessed via this link.