ARM-Net REGULATIONS
1 ARM-Net Consortium – Regulations
1.1 Objectives of the ARM-Net Consortium
The ARM-Net (AnoRectal Malformation – Network) Consortium aims to promote excellence by exchange of data and knowledge, to perform research on congenital anorectal malformations, to collaborate in researchand in clinical topics and to improve clinical standards. Thus, the ARM-Net Consortium develops guidelines and recommendations and performs epidemiologic and clinical research. The primary objective is toharmonize diagnostic classifications, possible interventions and follow-up, and thereby improving quality of care of ARM patients. The ARM-Net Consortium was founded in 2009 by a group of enthusiastic European professionals and patient support group members and in 2010 named as such. The ARM-Net Consortium is not funded financially by other parties. A website and a clinical data registry were built. The ARM-Net Consortium aims to be as inclusive as possible regarding the contribution of professionals from different specialties, without losing focus on the aforementioned goals. The members of the ARM-Net Consortium actively participate in working groups on various scientific studies, have intervision sessions and case-based discussions and collaborate with national patient-organizations or are supposed to establish one in their countries, if not present yet. The steering committee organizes an annual meeting, where at least a 2-year participation is mandatory for every member.
ARM-Net and the European Reference Network (ERN)
The European Reference Networks (ERN) are networks of expertise bringing together specialists from allacross Europe to concentrate knowledge and resources for complex or rare medical conditions that require highly specialized healthcare. Members of the ARM-Net Consortium are a driving force in the ERN eUROGEN, which stands for the ERN for rare urogenital diseases and complex conditions in both children and adults, since the establishment of the ERNs. At present, not all centers of the ARM-Net Consortium are part of eUROGEN, which is not a criterion of admission to the ARM-Net Consortium. The ARM-Net Consortium is a supporting partner of eUROGEN since December 2019. Through the virtual platform called ‘Clinical Patient Management System’ (CPMS), members of the ARM-Net Consortium can exchange information and upload difficult and complicated cases to share with other members of eUROGEN as well as with other ERNs.
Certain positions are held by ARM-Net members in eUROGEN such as a pediatric surgeon as Disease Area Coordinator for ARM, a patient representative in the ePAG (European Patient Advocacy Group), and pediatric surgeons and patient representatives in Working Groups or cross ERN Working Groups, especially when ARM is in the middle of the interest e.g. defining guidelines.
By the 22 nd of January, 2024, a ‘Memorandum of Understanding (MoU) – registry ERN eUROGEN & ARM-Net v. 2023-12-08’ has been signed between the ARM-Net Consortium and eUROGEN to state and define the intentions of the parties in collaborating on data collection for patients with anorectal malformations in the ERN eUROGEN registry. This collaboration aims to facilitate research and improve care for patients with anorectal malformations. The ARM-net Consortium and eUROGEN have common clinical, scientific and research interests and will cooperate in performing the activities as stated in the ‘MoU’.
This means, that the ARM-Net registry has stopped registration of data from new patients by the 31 st of December 2024. From the 1 st of January, 2025 onwards, data of new patients from ARM-Net members will be only inserted into the eUROGEN registry according to eUROGEN conditions as stated below (see for details paragraph 1.7 ‘Data input’).
1.2 Members of the ARM-Net Consortium
Current members of the ARM-Net Consortium are members of clinical centers (represented by referral clinicians), individuals (epidemiologists, geneticists, psychologists/sexologists) and patient organizations involved in care and research on anorectal malformations from different European and European associated countries.
Other international pediatric surgeons, obstetricians and gynecologists, geneticists, epidemiologists, psychologists, urologists, neurosurgeons, or other research groups and patient organizations may be involved in the Consortium for special research questions, as appropriate. The Steering group of the ARM-Net Consortium has the final vote in who may join the Consortium as full or associate member.
Despite the collaboration with eUROGEN, ARM-Net members are not automatically members of eUROGEN.
1.3 Memberships and criteria
There are two levels of membership in the ARM-Net Consortium: full member and associate member for clinical centers and membership for individuals or patient organizations. Additionally, there is an external expert-ship possibility.
1.3.1 Criteria for ARM-Net membership application (clinical center)
A clinical center can apply for membership of the ARM-Net Consortium by filling out the application form, on which he/she provides evidence of interest, experience, and expertise in the field of care and management of patients with ARM over the past two years, both clinically and scientifically. The center will initially be granted a two-year associate membership. After two years, all necessary criteria for full membership will be evaluated by the Steering Group. If fulfilled, the center will be granted full membership, finalized in a Steering Group meeting. The listed criteria below have to be fulfilled to become a new member.
A clinical center must fulfill all these criteria:
- The clinical center should refer to/have a Pediatric Surgery Unit.
- The clinical center should provide a “minimal volume” of five new reconstruction -ARM cases per year (redo surgeries are not considered as new reconstruction cases).
3. The clinical center should be (co)author of at least two publications regarding any aspects of ARM (genetics, epidemiology, surgery, radiology, psychology, management, follow-up, etc.) within the past 5 years
4. The clinical center is requested to demonstrate participation of at least two relevant international meetings on pediatric colorectal issues (i.e. Pediatric Colorectal Course and Workshop, International Meeting of Pediatric Colorectal Club, International Continence Children’s Society, Pediatric Colorectal and Pelvic Reconstruction Conference, etc.) in the past 3 years.
5. The clinical center should have a structured and multidisciplinary follow-up program for patients with ARM, including physiotherapy and psychology, with a minimum of 30 patients (second opinions are excluded in this number) on active follow-up/yr. ARM-Net centers are required to collect and report this data on yearly bases (ARM stratified by Krickenbeck classification).
6. The clinical center should have an active collaboration with a national patient organization on ARM. If a patient organization is not present yet, the center is requested to put efforts to form a patient organization or a patients’ social network, for example inviting representatives of patient organizations from other countries. This is especially true, if a new center joins the Consortium from a country not yet represented in the Consortium. The center further has to approach the patient organization for ARM patients in its own country (if present) to join the Consortium as a partner and is advised to set up a document with the patient representatives about what to expect from each other.
7. Because of legal implications regarding privacy of research subjects when transferring clinical data, full membership of the Consortium will only be provisionally possible for EU-member states or countries from Europe or European associated countries, not being part of the EU, which can be part of the Consortium, but it/he/she must be able to demonstrate that it/he/she can abide to EU-rules regarding privacy and patient-consent by signing a declaration of data confidentiality according to a form provided by the European Commission.
8. The clinical center is expected to be connected to a national network on ARM, provided it exists (e.g. as Cure-Net in Germany).
1.3.2 Full membership (clinical center)
Full membership can be awarded to a clinical center, once the duties for full membership are met. This means, that new centers are at first given an associate membership for two years, and can then be assigned as full members, when the duties are met.
· Duties:
o If the center is not already part of eUROGEN, it has to complete the process to comply with Ethical and legal issues to be able to insert data into the eUROGEN database (see for details the attachments ‘MoU’, ‘Data Access and Sharing Policy’, ‘ERN eUrogen Registry Protocol’, and ‘Data Sharing Agreement’).
o Entering data on all consecutive ARM-patients with informed consent from their respective center intothe eUROGEN registry according to eUROGEN ‘Data Access and Sharing Policy’. (see for details paragraph 1.7 ‘Data input’)
o The clinical center should provide a “minimal volume” of five new reconstruction -ARM cases per year (redo surgeries are not considered as new reconstruction cases).
o Keep records of total numbers of new ARM patients/yr according to the Krickenbeck classification, as well as their patient data on follow-up with a minimum of 30 patients (second opinions are excluded in this number) on active follow-up/yr for yearly monitoring rounds.
o Participating in one or more working groups and putting effort in research and publications on behalf of the ARM-Net Consortium (see for details paragraph 1.6 ‘Working Groups’)
o Putting effort in collaboration with Consortium members (e.g. attending the annual ARM-Net meeting and other international pediatric colorectal meetings such as the “International Meeting of the Pediatric Colorectal Club”, the “European Pediatric Colorectal and Pelvic Reconstruction Meeting), etc.)
o Putting effort in collaboration with national patient organizations or demonstrating the center’s promoting effort to establish a patient organization, if not present yet
· Rights:
o Voting rights regarding the election of Steering Group members
o Establishing a new working group on special research questions upon receiving agreement from the Steering Group
o Use data from the ‘closed’ registry of the ARM-Net Consortium for study purposes upon ARM-Net steering group agreement
o Use data from the eUROGEN registry upon ARM-Net steering group agreement and a positive eUROGEN agreement (see for details paragraph 1.7.3 ‘Data use’)
o Acquiring (co)authorship in publications based on data acquisition and manuscript-draft/revision (see for details paragraph 1.7.8 ‘Publications’)
o The representative of a center:
o is allowed to apply for the election to become a new Steering Group-member after a minimum of two years of full membership and demonstration of clinical and/or scientific activity regarding ARM with active involvement in the ARM-Net Consortium (e.g. working groups, etc.)
o will receive minutes of the Steering Group meetings
o will be the contact person and receive all the communications from the Steering group
o will be named at the ARM-Net website
· A clinical center nominates a representative, most commonly a pediatric surgeon, responsible for communication with the ARM-Net Consortium and eUROGEN.
· The representative and the head of the department will be asked to sign the Regulations of the ARM-Net Consortium and comply with them.
· When applying for membership of the ARM-Net Consortium, the representative from the new center is documented, stating that she/he is responsible for data accuracy and communications between the Consortium and her/his center. Each center can be represented at ARM-Net meetings by a maximum of 2 people per specialty (clinical, epidemiological, genetic, etc.).
· Every year full membership will be evaluated by the Steering Group to see whether members still meet the duties of full membership. If the duties cannot be met for 2 consecutive years, the membership will be downgraded to associate membership. There are also exclusion grounds for membership (see for details paragraph 1.4).
· If a representative of a clinical center changes center, there is a possibility to become an associated member of the new clinical center. The representative and the head of the department should put effort for the center he/she is leaving to stay as full member in the ARM-Net Consortium with a new assigned representative who is taking over to comply with the membership duties (see for details paragraph 1.7.2 ‘Data storage’)
1.3.3 Full membership (individuals and patient organizations)
· Full member epidemiologist: actively participates in the Consortium by attending meetings, and performs epidemiological research on ARM and/or is actively involved in designing (methodology) or performing studies or performing statistical analyses. He/she can be affiliated to a full member clinical center, but this is not obligatory.
· Full member geneticist: actively participates in the Consortium by attending meetings, and performs genetical research on ARM. He/she can be affiliated to a full member clinical center, but this is not obligatory.
· Full member psychologist/sexologist: actively participates in the Consortium by attending meetings, and performs psychological/sexological research on ARM. He/she can be affiliated to a full member clinical center, but this is not obligatory.
· Full member patient organization: is a member/representative of a patient organization/ support group for anorectal malformation and actively participates in the Consortium by attending meetings, organizes meetings for parents and patients, provides information about ARM-Net to their members, collaborates with other parent and patient organizations, helps establishing parent and patient organizations in other countries.
For all full member individuals and representatives of patient organization:
· Duties:
o Putting effort in collaboration with Consortium members (e.g. attending meetings)
o Putting effort in performing research and publish on behalf of the ARM-Net Consortium
· Rights:
o Voting rights regarding the election of Steering Group members.
o Participation in one or more Working Groups (see for details paragraph 1.6 ‘Working Groups’)
o Use data from the ‘closed’ registry of the ARM-Net Consortium and upon agreement from the ARM-Net Steering Group and eUROGEN also from the eUROGEN registry (see for details paragraph 1.7.3 ‘Data use’)
o Acquiring (co)authorship in publications based on data acquisition and manuscript-draft/revision (see for details paragraph 1.7.8 ‘Publications’).
o Will receive minutes and all the communications of the Steering Group meetings
o Will be named at the ARM-Net website
· All full member individuals and representatives of patient organization will be asked to sign the Regulations of ARM-Net Consortium and comply with them.
· Every year full membership will be checked by the Steering Group to see whether members still meet the duties for full membership of individuals and patient organizations. There are also exclusion grounds for membership (see for details paragraph 1.4).
1.3.3. Associate membership
Associate membership is reserved to a clinical center that applies for membership in general or is not able to meet all duties of full membership (see paragraph 1.3.2 ‘Full membership (clinical center)’).
· Duties:
o Entering data on all consecutive ARM-patients with informed consent from their respective center intothe eUROGEN registry as part of membership in the ARM-Net Consortium (see for details paragraph 1.7 ‘Data input’)
o Keep records of total numbers of new ARM patients/yr according to the Krickenbeck classification, as well as their patient data on follow-up/yr for yearly monitoring rounds.
o Putting effort in collaboration with Consortium members (e.g. attending meetings and/or being part of a Working Group)
· Rights:
o Participation in one or more Working Groups on a relevant subject or a Working Groups for a Study based on only new data (see for details paragraph 1.6 ‘Working Groups’)
o Acquiring (co)authorship in publications is only possible for a study on a relevant ARM subject, a study based on new data, or a consensus paper when the rules for publications are met (see for details paragraph 1.7.8 ‘Publications’).
o Will receive minutes of the Steering Group meetings
o Will be named at the ARM-Net website
· Once a year the Steering Group evaluates if associate members meet their duties of associate membership to see whether they can be upgraded to full members. There are also exclusion grounds for membership (see for details paragraph 1.4).
· All associate members endorsed by the head of their department will be asked to sign the Regulations of the ARM-Net Consortium together with the head of the department and comply with them.
1.3.4. External expert-ship
External expert-ship is reserved to colleagues from European and non-European countries from any specialty, well recognized in their field for contribution to diagnosis, research and care of ARM, that are interested in collaboration with the ARM-Net Consortium.
· Duties:
o None
· Rights:
o Allowed to join the yearly ARM-Net meeting
o Occasionally, participate in a Working Group on a relevant subject upon request or help performing clinical, epidemiological, psychological, and genetical research (see for details paragraph 1.6 ‘Working Groups’)
o Acquiring (co)authorship in publications is only possible for a study on a relevant ARM subject when the rules for publications are met (see for details paragraph 1.7.8 ‘Publications’).
· The criteria for exclusion grounds for membership also apply to external experts (see for details paragraph 1.4).
1.4 Exclusion grounds for memberships
1.4.1 Full membership of the ARM-Net Consortium is revoked if:
· It becomes clear that a member cannot comply with article 1.3. of the regulations, despite yearly notifications of the Steering Group. If either the “minimal volume” is not fulfilled, or no patient updating in the database is performed for two consecutive years, or no records for monitoring round is kept for two consecutive years, or inconsistence with the data is evident, the center is automatically withdrawn as fullmember, but may continue as associate member. Subsequent re-entering as full member cannot occur before two years.
· Misconduct is discovered. This is the case if:
o a full member enters cases in the database which do not correspond to the patients’ list of that center;
o a full member publishes research based on non-existing data;
o a full member publishes research which was done by somebody else, without disclosing the original researcher;
o a full member publishes research without mentioning co-researchers or co-authors who have contributed
o a full member makes inappropriate use of the provided data
The violation of these principles will downgrade the full membership to associate membership. Re-admissionwill be possible by fulfilling the criteria again for at least one year and upon decision of the Steering Group. The candidate needs to inform the Steering Group of his/her intention to be re-evaluated for full membership.
· Full membership is revoked, if a full member publicly offends the ARM-Net Consortium.
1.4.2 Associate membership of the ARM-Net Consortium is revoked if:
• An associate member does not fulfil its duties in the ARM-Net Consortium for more than 2 consecutive years or publicly offends the ARM-Net Consortium. The Steering Group will decide on this, notify by email the associate member, and inform other members during the general assembly.
1.4.3 External expert-ship of the ARM-Net Consortium is revoked if:
· An external expert is publicly offending the ARM-Net Consortium. The Steering Group will decide on this, notify by email the external expert-ship, and inform other members during the general assembly.
1.5 Steering Group
1.5.1 Tasks and responsibilities of the Steering Group:
All members of the Steering Group:
· Have an equal right to speak and vote
· Elect the Chair, co-Chair, secretary, and co-Secretary of the Steering Group
· Have regular meeting calls, preferably 8-10 times per year
· Members participate to at least 70% of scheduled meeting calls
· Decide on options for the collection and storage of data
· Have the final decision on new members of the Consortium on invitation or request
· Have the final decision on research proposals and open the database for the specific study protocol in agreement with eUROGEN policy
· Will remind full members 2 times a year to enter data into the eUROGEN registry
· Monitor membership rights and duties of centers that have full or associate membership, and notify those centers that do not comply
· Have contact with eUROGEN and will receive data on monitoring rounds to be able to evaluate membership duties
· Revoke membership of a member that does not comply with its appropriate duties as full or associate member after two years, provided the center has received notifications by the Steering Group and was asked to comply
· Revise Regulations of the ARM-Net Consortium
· Inform Consortium-members about ARM-Network activities (minutes of Steering Group meeting calls will be sent to full and associated members, invitations and minutes of the annual assembly will be sent to full members, associated members, and external expert-ships)
· When dealing with sensitive issues, use recent technologies to promote surveys among all full members
· Will organize at least once per calendar year an ‘online / in person’ meeting for all Consortium members and external expert-ships, provided that circumstances permit.
1.5.2 Members of Steering Group
In principle, every country involved in the ARM-Net Consortium can be represented in the Steering Group by a maximum of 3 persons and as many different professional backgrounds (clinician, epidemiologist, geneticist, psychologist, sexologist, and patient organization) as possible. The preferred and maximumnumber of Steering Group members is 12. When a country is represented by more than one person in the Steering Group, these persons should have different professional backgrounds. When the number ofSteering Group members does not reach 12, it is allowed to have more than 3 persons from 1 country (and in this case there may be up to 4 members from the same country) and to have more people from one professional background (max. 2) per country. Every member of the Steering Group is appointed for 3 years and has the opportunity to be re-elected for 3 more years. In case of no new nominations, the position can be held for the next 3-years. The members of the Steering Group are allowed or can be asked to step down before the end of their 3 years-term when they have no time and/or no motivation to be an active member of the Steering Group or when they do not succeed in filling in the complete information of the patients of theircenter into the eUROGEN registry. Ideally, but not compulsory, the replacement of the whole Steering Group every 3 years should be avoided.
The Consortium members can appoint (with a majority of votes) new members. Only full members that showed active participation in the ARM-Net Consortium activities can be elected in the Steering Group.
Three persons from different patient organizations and at least one epidemiologist are permanent members of the Steering Group.
At least 6 weeks prior to formal elections for members of the Steering Group the full members of the ARM-Net Consortium are informed and asked to apply for a vacant position. On request, the applicants are asked to present themselves and their motivations to the Steering Group in a scheduled meeting. Two weeks prior to the elections the application time frame closes.
The Chair of the Steering Group is preferably a pediatric surgeon and part of the Steering Group for at least a year. The members of the Steering Group decide who will be the Chair with equal rights to vote. On request, the position and tasks of Chair can be equally divided between two individuals, but one will act as the formal Chair and the other as co-Chair. The Chair and co-Chair will be in charge for 3 years and can be re-elected for another 3 years. Being members of the Steering Group they have the same rights of being in the Steering Group for a total of 6 consecutive years. In case of no new nominations, the position can be held for an additional 3-year turn.
Previous members of the Steering committee may newly be part of the Steering Group after at least 3 years with no active role in it. The same applies to Chair and co-Chair.
1.6 Working groups
A Working group (WG) is a group of members of the ARM-Net Consortium that collaborates on a specific topic related to ARM.
There are two types of working groups (WG):
1) Study – a WG designing a study, collecting data for this study, analysing data, discussing, and reporting about the study (presentations and manuscripts)
2) Relevant subject – a WG discussing (clinical) issues, gathering information about the subject, proposing guidelines, delivering information to ERNs, etc.
General rules for all WG:
· Only full members can initiate a WG for a Study, making use of data available in the ARM-Net registry and eUROGEN registry upon agreement of the Steering group and eUROGEN agreement according to their Data Access and Sharing Policy.
· All full and associated members can initiate a new WG for a Relevant subject.
· The Steering Group has to be informed to develop a new WG.
· Every full member can take part in one WG for a Study and one for a Relevant subject at the same time (to be able to be dedicated). When specific expertise is needed for a WG, the Steering Group can decide to have a person in more WGs.
· An associated member and an external expert can only be part of a WG for a Relevant subject, not of a WG for a Study. The only exception is when a Study WG is based only on new data or combined data (e.g. comparison with other registries).
· A WG is composed by at most 8 people.
· When there are more than 8 people applying for a WG, the WG leader will propose who will be in the WG, but a decision will be made by the Steering Group about the members of a WG, taking into account the following items (ordered by importance):
o performance of filling in data in the database
o number of times being part of WGs in the past (rotation of members is preferred)
o initiative for the subject / study
o knowledge and experience in the subject / study
· Each WG has a WG leader, who will initiate meetings (email, online, or live) within the WG, has the end responsibility for the WG, and is the first contact person for the Steering Group.
· Each WG is responsible for formulating clinical and research proposals/objectives and possibly acquiring funding for this research. The WG leader sends the research proposal using the “Application Form ERN EUROGEN Registry” (see Annex 2 of ERN eUROGEN registry Data Access and Sharing Policy, Version 05-12-2022) to the ARM-Net secretary to obtain approval from the Steering Group.
· Each WG meets as often as it is required.
· Each WG will share its progress with the Steering Group. This can take place by email and/or conference calling or during the yearly ARM-Net Consortium meetings.
· The Steering group will define the start and end data of a WG in agreement with the WG leader. A Study WG will close when the study is finished, a WG on a Relevant subject will close when some sort of outcome is reached.
Extra rules for a Study WG:
· All paediatric surgeons being a member of a Study WG should have provided data on which the study is based, and additional information may be requested
· When a Study WG will use data from the eUROGEN registry, with obtained approval of the ARM-Net Steering Group, the above mentioned “Application Form ERN EUROGEN Registry” will first need to be submitted to eUROGEN according ‘Data Access and Sharing Policy’. Once agreement from eUROGEN is achieved, the data can be extracted and used for further analyses according to eUROGEN ‘Data Access and Sharing Policy’.
· Data from the ARM-Net registry can be used for the Study upon approval from the ARM-Net steering group and will be delivered to the WG leader.
· If a Study WG will use data not already entered in the registries, then full and associate members can participate, as well as individual experts.
· All members of a Study WG should, apart from providing data, also help in designing, collecting, analysing, discussing and reporting of the study
Members of a Study WG are not automatically co-authors of the manuscript. A suggestion for co-authors need to be proposed to the Steering Group by the WG leader, taking into account regulations about co-authorships within ARM-Net Rules and Regulations and the effort of members taken for the study (see paragraph 1.7.8 ‘Publications’).
1.7 Data input
Data collected by the ARM-Net Consortium:
1) Clinical data on diagnostics, treatment, follow-up (obligatory to full and associate member clinical centers)
· Data from new patients is inserted into the ARM-Net registry until 31 st of December, 2024
· Follow-up data is inserted into the ARM-Net registry until 31 st of December, 2025
· From the 1 st of January, 2025 onwards all new patients from ARM-Net centers are only registered in the eUROGEN registry according to the eUROGEN Data Access and Sharing policy
· Only patients with informed consent can be registered in the eUROGEN registry
· The total numbers of new ARM patients/yr, according to the Krickenbeck classification, as well as records of ARM patients in follow-up (registered and not-registered patients) will be inquired in yearly monitoring rounds by eUROGEN
2) Epidemiological data, collected through questionnaires (optional)
Rules have been appointed between the ARM-Net Consortium and ERN eUROGEN concerning the ERN eUROGEN registry (see for further details the attachment ‘MoU’.
Data input into the eUROGEN registry follows the ‘Data Access and Sharing Policy’ of eUROGEN (see attachment ‘Data Access and Sharing Policy’). As a supporting partner from eUROGEN, the ARM-Net Steering Committee will be informed, whenever a research proposal on the topic of anorectal malformation within eUROGEN is proposed, to evaluate and propose possible involvement and collaboration of ARM-Net experts, as well as consider possible extension of the research to include the already stored data of the ARM-Net registry.
Conditions for data collection, storage and use of data
1.7.1 Data collection
The ARM-NET registry is replaced by the eUROGEN registry by the 1 st of January, 2025. Therefore, to collect data by ARM-Net members, the guidelines of eUROGEN have to be followed as written in the ‘Data Sharing Agreement’, the ‘Data Registry Castor Manual’ and ‘Patients Informed Consent Forms’, as created by eUROGEN.
In short:
· Before data are collected from patients and/or their parents:
o Permission is needed from an approved Medical Ethical Review Committee from each medical center to implement the ERN eUROGEN registry.
o Patients and/or their parents need to be informed about the consequences and burden of participation. General information consent forms in all languages can be used provided by ERN eUROGEN, as well as a short video with more simple information for patients and/or parents. Patients and/or their parents need to sign an informed consent form. This informed consent form is stored in the individual center.
o Legal approval for implementation of the ERN eUROGEN registry is needed from every participating clinical center by signing a ‘Data Sharing Agreement’ by an authorized representative of the center. ERN eUROGEN provides the documents for this approval and helps with this process.
1.7.2 Data storage
ARM-Net registry (data entry of new patients up to the 31 st of December, 2024 and data completion up to the 31 st of December, 2025):
· Clinical data are registered in a web-based database in which no identifiable data of the patients are stored. Pseudonymized record linkage is used. The linkage information (date of birth (d.o.b.) of child andmother) is stored on a separate server with access only to one data trustee (or data controller). Each center stores its own patient identifying information together with the corresponding informed consent forms.
· If a representative person from a clinical center of a full or associated member changes hospital the data will belong to the hospital in which the clinical center is situated. The representative person of that center, together with the head of the department, is responsible for finding another person who will replacehim/her in the former hospital to keep on working on those data.
· When inadvertently no successor can be found, data form this specific center cannot be updated, but will stay available for research purposes.
eUROGEN registry:
· The ERN eUROGEN registry is implemented in Castor using a Data Processing Agreement between the Radboudumc and Castor (see for further details attachments ‘Data Sharing Agreement’ and ‘Data Registry Castor Manual’). Only health care providers who signed the Data Sharing Agreement will obtain access to the online registry.
1.7.3 Data use
Every center can use its own entered data for research purposes without informing the other members of the Consortium. When members aim to use data of the ARM-Net or eUROGEN registry for their research project:
1. they need to send in a short study protocol “Application Form ERN EUROGEN Registry” (see Annex 2 of the attachment ‘ERN eUROGEN registry Data Access and Sharing Policy’) to the ARM-Net secretary which will be further discussed in the Steering Group. Only full members are given the possibility to initiate studies that use data available in the registries. Associate members can join this research as long as they provide data specifically needed for the actual study.
2. When the Steering Group approves the research proposal, the application can be sent to eUROGEN according to the Data Access and Sharing Policy. The ERN eUROGEN registry Project Steering Committee and Advisory Board will decide whether such an application can be granted based on:
· Compliance with the ethical approval that was obtained for the ERN eUROGEN registry
· Availability of sufficient personal data for the research
· Scientific quality of the planned research
· Relevance of the planned research
· Qualification of the Applicant and feasibility of the planned research
· Overlap with other planned, ongoing, or finalized research projects
After approval by the Project Steering Committee and Advisory Board, clinicians will be informed about the planned data sharing and they have the possibility to object to data of his/her patients to be shared. ARM-Net members (full and associate members) are expected to share their data from the eUROGEN registry. Data from the ARM-Net registry will be shared for ARM-Net studies without further consultation of the ARM-Net members.
Concerning eUROGEN registry data a “Data Transfer Agreement” will be made up between the applicant researcher and the Project Steering Committee.
The approved data provision will be published on the ERN eUROGEN website.
The Project Steering Committee will provide the data from the ERN eUROGEN registry and the ARM-Net Consortium the data from the ARM-Net registry as required for the research study.
The data are coded, thus without identifying data of the patients. Only the research center providing the data is able to retrace the donor of the data.
1.7.4 Data monitoring
eUROGEN is responsible for monitoring and quality assurance of the eUROGEN registry (see attachment ‘Data Sharing Agreement’). This includes, among others, data plausibility checks, data consistency evaluations and queries about inconsistencies.
Data on patients, who are not inserted in the eUROGEN registry will be requested in yearly monitoring rounds. These rounds further include the number of procedures of ARM patients and patients in follow-up. These patients are not eligible for scientific studies but serve for data representativeness.
1.7.5 Costs
Data input into the eUROGEN registry from eUROGEN members receive a small amount of imbursement on request. According to eUROGEN regulations ARM-Net members who are not eUROGEN members cannot be funded for data input.
1.7.6 Ownership / rights of control
ARM-Net registry:
The patients have the highest rights of control of their data. Parents/legal guardians/patients give their consent to use the data of the patient, if not routinely collected, for research purposes and they can minimize or withdraw his/her consent. When parents/legal guardians/patients give their full consent, they apply forany research done using their data.
Not routinely collected clinical data must be removed from all registries, if the parents/legal guardians/patients withdraw or limit their consent. When required, the center’s representative who filled in the data in the ARM-Net database is responsible for removing the data from the database.
Every research center decides for which research project their patient data are used within the boundaries of the consent of the parents/legal guardians/patients.
The ownership of the results emerging from a research project belongs to the principal investigators of that project. They have the right and duty to publish these results.
eUROGEN registry:
In the ERN eUROGEN registry, the patient participant (the ‘data subject’) is the primary owner of the data and will give consent to use such data for research and other purposes. In case the patient participant is under the age of majority, or subject physically or legally incapable of giving consent, parent(s) or legal representative(s), is/are the primary owner(s) of the data and will grant the consent to use such data for research and other purposes. The Radboudumc is the current owner of the ERN eUROGEN registry platforms. The health care provider of the clinician participant who has entered the data is responsible for the data of that patient participant and acts as the ‘data controller’ at the local center (see further details in the attachment ‘ERN eUROGEN Data Access and Sharing Policy’).
1.7.7 Data protection
Data collection, storage and usage of data follows the latest data protection rules. As mentioned above at 1.7.2 data are only inserted in the ARM-Net database in a pseudonymized form, which cannot be linked to a child. ln case of publications, only these pseudonymized forms of the data will be used.
Pseudonymized (encrypted) data referring to the identity of a child, e.g. a code, cannot be linked with a child without access to additional information and without disproportionate additional effort. The code for encryption will be strictly separated from the encrypted data sets and is stored only in each participating center. Only authorized staff of each participating center will have access to the non-encrypted data of a child. The data will be protected against unauthorized access. Authorized staff of national or international health authorities and the respective ethical commissions, as such obligated to secrecy, might also take insight into the data, as far as it is necessary to conduct and control of the studies. All professionals dealing with the encrypted and non-encrypted data of a child of each ARM-Net center subject to the latest data protection rules.
For any issue regarding data protection an E-mail can be sent to the ARM-Net Consortium to following E-mail address: info1.armnet@gmail.com
For all data submitted to the eUROGEN registry database, the Radboudumc and its principal investigator is responsible for the protection of the data, its storage, use and access (see attachment ‘Data Sharing Agreement’). When processed, the data become research data and are then the intellectual property of the investigator who is the ‘third party’.
This third party has to abide by the agreement reached in the Data Sharing Agreement whilst using the data supplied for the purpose stated in the Data Request form.
The data in the ERN eUROGEN registry will be deleted after 25 years if it was deemed by the ethical committee of the Radboudumc that there was no need to keep the data stored for a longer period of time. In addition, the data will be deleted if a patient or their parent/legal representative wishes so. The process of data deletion is described in the ERN eUROGEN registry protocol.
The types of data processing involved in the ERN eUROGEN registry are not considered as high risk.
1.7.8 Publications
The International Committee of Medical Journal Editors (ICJME) has recommended the following criteria for authorship:
· Authorship credit should be based on:
o substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; and
o drafting the article or revising it critically for important intellectual content; and
o final approval of the version to be published.
· Acquisition of funding, collection of data, or general supervision of the research group alone does not constitute authorship.
· Each author should have at least one-week time to consider his/her authorship in the publication. There should be no publication without informing the co-authors in advance and no acknowledgement of authorship after publication.
· Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content.
· When a large, multicenter group has conducted the work, the group should identify the individuals whoaccept direct responsibility for the manuscript. Increasingly, authorship of multicenter trials is attributed to a group.
· All persons designated as authors should qualify for authorship, and all those who qualify should be listed.
Additions by the ARM-Net Consortium:
· People from the WG designing the study, collecting and analysing the data and writing the manuscript, will be a so-called ‘writing committee’. Only those can be appointed as co-authors.
· The writing committee is urged to put “on behalf of the ARM-Net Consortium” at the end of the list of co-authors and provide a list of all full member names, in such a way that all full members can be found as a co-author in PubMed. If a journal does not accept this, then all the names (including titles, hospital name,city and country) should be listed in the acknowledgment. Only one person per full member clinical center can be mentioned here, preferably the representative person of a clinical center.
· Always put the ‘ARM-Net Consortium’ in the title of a paper.
· Associated members and external experts can only be co-authors on papers when they have put effort in the study by being part of the corresponding WG.
· Email the ARM-Net secretary with citation details for any newly-accepted ARM-Net abstracts or papers.
· When writing a consensus paper on behalf of all ARM-Net members, these members (possibly full members, associated members and external experts) should be informed timely and have the possibility to suggest modifications to the manuscript. When any member does not approve the content of the manuscript, the paper cannot be sent in as a formal ARM-Net consensus paper, but as a consensus paper by the involved and consenting centers.
Additions according to eUROGEN regulations:
• Any publication/abstract/poster arising from ARM-Net initiatives which include data from the eUROGEN registry must follow the “Data Access and Sharing Policy” from eUROGEN (see further details point 7 – Publication of the Results of the attachment ‘Data Access and Sharing Policy’).
1.8 Funding requirements
· Each WG is responsible for the acquisition of funds to aid its objectives.
· When applying for funds, the Working Group must consider:
o Funds to facilitate the organization of ARM-Net
o Funds to facilitate the participation of the patients in research
o Funds to facilitate the participation of the patient organizations in ARM-Net
ERN eUROGEN or ERN grants or funds or European Commission funding must be applied for and can generally only be used by EU member states.
eUROGEN registry costs will be sustained by ERN eUROGEN as stated in the ‘MoU’.
2. Use of the logo, dissemination of data and knowledge, procedures for
ARM-Net initiatives, and stimulus for collaboration on complex cases
2.1 Logo
The logo of ARM-Net must be shown anytime data from the Consortium are used. In case of presentation with slides, the author must clearly state she/he speaks on behalf of ARM-Net and the logo must appear on each slide. In case of advertisements, both on emails and paper, for meetings or courses the logo must be visible on the front page. The logo cannot be shown if full or associate members of ARM-Net present data belonging to their own institution. If a member presents an individual research, she/he may present her/his membership to the ARM-Net Consortium by showing the logo stating that she/he is a member.
When using data from eUROGEN:
According to the ‘MoU’ either Party is authorized to use the name or logo of the other Party or its employees in any advertisement, press release, or publicity with reference to the ‘MoU’ or any product or service resulting from activities contemplated by the MoU, without the prior written approval of an authorized representative of the other Party.
Either Party is restricted from disclosing the existence of any nature of this ‘MoU’ or from including the existence of and nature of this ‘MoU’ in the routine reporting of its activities.
2.2 Education
One of the aims of ARM-Net is to promote knowledge about anorectal malformations. Therefore, in thosecountries where a patient organization does not (yet) exist, the representative of a clinical center of that country is promoted to organize once a year an educational meeting for parents and patients. The meeting will be then posted on the website of the ARM-Net. The patient organizations will be happy to help in providing all information and, possibly, material to help the representative person.
2.3 Confidentiality and transparency of ARM-Net data
Transparency of ARM-Net data within the ARM-Net Consortium is needed. All documents circulating in theARM-Net cannot be sent outside or reported to other surgeons or other third parties, unless all membersinvolved agree.
2.4 Proposed procedures for so called ARM-Net initiatives
· Email all members about your ideas (via the secretary of the ARM-Net Steering Group)
· Form a working group when needed (see paragraph 1.6 for details)
· Use each other’s expertise
· Update the rest of the Consortium members at ARM-Net meetings or by email
· When surveys are set out within ARM-Net: explain intentions and output possibilities.
2.5 Stimulus to collaborate on complex cases in the Consortium
Pediatric surgeons of the consortium can ask for advice to other members of the consortium for the management of complex cases, ensuring protections of the patient’ privacy. The possibility to operate complex cases together with other surgeons of the consortium can also be considered by the members. However, funding, insurance and legal coverage must be at the expenses of the involved members/centers. ARM-Net therefore accept no responsibility related to clinical and surgical management of these patients.
As mentioned above at paragraph 1.1 ‘Objectives of the ARM-Net Consortium’ members of the ARM-Net Consortium can also upload difficult and complicated cases through the virtual platform “CPMS”, to share their case with other members of eUROGEN as well as with other ERNs.