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 research and in clinical topics and to improve clinical standards. For this purpose, the Consortium created a registry of ARM patients and referenced there various biobanks, which serve as a base for the research on ARM. Local and new database collections are combined to create opportunities for larger scaled research. The primary objective isto harmonize diagnostic classifications, possible interventions and followup and thereby improving quality of care of ARM patients. The second objective is to identify genetic and environmental risk factors in the etiology of syndromic and non-syndromic anorectal malformations. The Consortium aims to be as inclusive as possible regarding the contribution of professionals from different specialties, without losing focus on the aforementioned goals.
1.2 Members of the ARM-Net Consortium
Current members of the ARM-Net Consortium are clinical centers (represented by referral clinicians), epidemiologists, geneticists, psychologists/sexologists and patient organizations involved in (care and research on) anorectal malformations from different European and European associated countries. In the future, 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. The Steering group of the ARM-Net Consortium hasthe final vote in who may join the Consortium as full or associate member.
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 for individuals or patient organizations. Additionally, there is an external expert-ship possibility.
1.3.1 Full membership (clinical center)
• Full membership can be awarded to a clinical center. For criteria to apply for full membership see paragraph 1.3.5. ‘Criteria for full members (clinical center)’.
• Duties:
– Entering data on all consecutive ARM-patients from their respective center into the registry of the ARM-Net Consortium (see for details paragraph 1.7 ‘Data input’)
– Putting effort in collaboration with Consortium members (e.g. attending meetings)
– Putting effort in performing research and publish on behalf of the ARM-Net Consortium
• Rights:
. Voting rights regarding the election of Steering Group members
– Apply as potential new member of the Steering Group
– Participation in one or more Working Groups (see for details paragraph 1.6 ‘Working Groups’)
– Use data from the registry of the ARM-Net Consortium (see for details paragraph 1.7.3 ‘Data use’)
– Acquiring (co)authorship in publications based on data acquisition and manuscriptdraft/revision is recommended (see for details paragraph 1.7.8 ‘Publications’)
– The representative of a center:
- is allowed to apply for the election to become a new Steering Groupmember after a minimum of two years of full membership and demonstration of clinical and/or scientific activity regarding ARM (see for details criteria full membership paragraph 1.3.4)
- will receive minutes of the Steering Group meetings
- 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; more than one person, even from different specialties, can enter data under the responsibility of this representative.
– The representative and the head of the department will be asked to sign the Regulations of ARM-Net Consortium and comply with them.
– When applying for membership for ARM-Net, 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 checked by the Steering Group to see whether members still comply with the criteria. 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 representative and the existing data (see for details paragraph 1.7.2 ‘Data storage’)
1.3.2 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/sexuological 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:
– Putting effort in collaboration with Consortium members (e.g. attending meetings)
– Putting effort in performing research and publish on behalf of the ARM-Net Consortium
• Rights:
– Voting rights regarding the election of Steering Group members.
– Participation in one or more Working Groups (see for details paragraph 1.6 ‘Working Groups’)
– Use data from the registry of the ARM-Net Consortium (see for details paragraph 1.7.3 ‘Data use’)
– Acquiring (co)authorship in publications based on data acquisition and manuscript draft/revision is recommended (see for details paragraph 1.7.8 ‘Publications’).
– Will receive minutes of the Steering Group meetings
– 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 comply with the criteria. 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 (yet) able to meet all criteria (see paragraph 1.3.5).
• Duties:
– Entering data on all consecutive ARM-patients from their respective center into the registry of the ARM-Net Consortium (see for details paragraph 1.7 ‘Data input’)
– Putting effort in collaboration with Consortium members (e.g. attending meetings and/or being part of a Working Group)
• Rights:
– 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’)
– 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’).
– Will receive minutes of the Steering Group meetings
– Will be named at the ARM-Net website
• Once every year the criteria for full membership will be checked by the Steering Group for associated members to see whether they can be upgraded to full members. There are also exclusion grounds for membership (see for details paragraph 1.4).
• All associated members and the head of the department will be asked to sign the Regulations of ARM-Net Consortium 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:
– None
• Rights:
– Allowed to join the yearly ARM-Net meeting
– 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’)
– 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).
1.3.5. Criteria for full members (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 an one-year associate membership. After one year, 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 are valid for new as well as existing full members.
Hard criteria (a clinical center must fulfill these criteria):
1) The clinical center should refer to/have a Pediatric Surgery Unit.
2) The clinical center should provide a “minimal volume” of five new ARM cases per year.
3) The clinical center should enter data on all consecutive ARM-patients from their center into the registry of the ARM-Net Consortium, including at least the one-year follow-up data (see for details paragraph 1.7 ‘Data input’)
Soft criteria: (a clinical center is urged to fulfill these criteria):
1) The clinical center should aim to have a structured and multidisciplinary follow-up program available, including physiotherapy and psychology or have plans to create such a program
2) The clinical center should be (co)author of at least one publication regarding any aspects of ARM (genetics, epidemiology, surgery, radiology, psychology, management, follow-up, etc.) per two years
3) The clinical center should attend (bi)annually one relevant international meeting 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.).
4) If a new center joins the Consortium from a country not yet represented in the Consortium, it must approach the patient organization for ARM patients in its own country (if present) to join the Consortium as a partner or to put efforts to form a patient organization or a patients’social network, for example inviting representatives of patient organizations from other countries. It is advised to set up a document with the patient representatives about what to expect from each other.
5) The clinical center is expected to join a national network on ARM, provided it exists (e.g. as Cure-Net in Germany)
6) Because of legal implications regarding privacy of research subjects when transferring clinical data and/or biomaterials, full membership of the Consortium will only be provisionally possible for centers from EU-member states or countries who are able to meet the EU privacy criteria, such as currently Argentina, Canada, Guernsey, and Switzerland.
7) Exceptionally, a center /individual from Europe or European associated countries, not being part of the EU, 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[1]consent by signing a declaration of data confidentiality according to a form provided by the European Commission.
1.4 Exclusion groundsfor memberships
1.4.1 Full membership of the ARM-Net Consortium is revoked if:
• It becomes clear that a member cannot comply with article 1.3.4 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, the center is automatically withdrawn as full member, but may continue as associate member. Subsequent re-entering asfull member cannot occur before one year.
• Misconduct is discovered. This is the case if:
– a full member enters cases in the database which do not correspond to the patients’ list of that center;
– a full member publishes research based on non-existing data;
– a full member publishes research which was done by somebody else, without disclosing the original researcher;
– a full member publishes research without mentioning co-researchers or coauthors who have contributed
– a full members makes inappropriate use of the provided data
The violation of these principles will downgrade the full membership to associate membership. Re-admission will 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.
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 offending the ARM-Net Consortium publicly. 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 offending the ARM-Net Consortium publicly. 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 (and biomaterials)
• 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
• Will remind full members 2 times a year to enter data into the ARM-Net registry
• Monitor membership rights and duties of centers that have full or associate membership, and notify those centers that do not comply
• 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 expertships)
• When dealing with sensitive issues, use recent technologies to promote surveys among all full members
• Will organize at least once per calendar year a ‘live / in person’ meeting for all Consortium members and external expert-ships, provided that circumstances permit.
1.5.2 Members 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 and patient organization) as possible. When a country is represented by more than one person in the Steering Group, these persons should have different professional backgrounds. The maximum number of Steering Group members is 12. 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 their center into the ARM-Net 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 can be elected in the Steering Group.
When the maximum number of Steering 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. The pediatric surgeons should fill in the complete information of the patients of their center into the ARM-Net registry to be able to become and remain member of 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 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 Studies, making use of data available in the registry (see also paragraph 1.7.3)
• All full and associated members can initiate a new WG for a Relevant subject.
• A new WG should be mentioned to the Steering group.
• 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.
• 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):
– performance of filling in data in the database
– number of times being part of WGs in the past (rotation of members is preferred)
– initiative for the subject / study
– 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 to the Steering Group for approval.
• 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
• If a Study WG will use data not already entered in the database, 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 and the effort of members taken for the study (See paragraph 1.7.8 ‘Publications’).
From June 2012 onwards the following WGs have been introduced:
WG 1 – clinical research
WG 2 – epidemiologic research
WG 3 – genetic research
WG 4 – public information
WG 5 – database management
WG 6 – ERN
WG 7 – Transitional care
WG 8 – Follow-up data and sexuality
Names of present WG-leaders are known to the secretary of the Steering Group and are available on request.
Working Group 1 is a collective WG for all clinical research projects in the ARM-Net Consortium. Per research project a group of people will be involved, either in data collection or in designing and executing the project.
Working Group 4 aims to provide patients and others (e.g. parents, nurse practitioners, psychologists, etc.) with information concerning ARM-Net (research) and is responsible for maintaining the public part of the website, together with the webmaster.
1.7 Data input
Data collected by the Consortium:
1) Clinical data on diagnostics, treatment, follow-up (obligatory to full member clinical centers)
2) Epidemiological data, collected through questionnaires (optional)
3) Biomaterial – blood/saliva for DNA isolation from ARM patients and parents (optional)
Conditions for data collection, storage and use of data and biomaterials
1.7.1 Data collection
• Before data are collected from patients and/or their parents:
– Permission is needed from an approved Medical Ethical Review Committee from each medical center, when data is not collected routinely in clinical care
– Patients and/or their parents need to be informed about the consequences and burden of participation when the Medical Ethical Review Committee decides about this
– Patients and/or their parents need to sign an informed consent form, when data are not collected routinely in clinical care. This informed consent is stored in the individual center.
1.7.2 Data storage
• Clinical data are registered in a web-based database in which no identifiable data of the patients are stored. Anonymized record linkage is used. The linkage information (date of birth (d.o.b.) of child and mother) isstored 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.
• Collection and storage of biomaterials are registered in a virtual biobank. All participating Consortium members who collect blood or saliva of patients with ARM and their parents will store the blood in their own center storage facilities if possible. The storage of the samples is then registered in the clinical database.
• 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 replace him/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.
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 registry for their research project, they need to send in a short study protocol to the Steering Group describing: the aim of project and research question, type and number of data needed and the relevance for the patients. Only centers entering data themselves (full members) can initiate studies that use data available in the registry. Associate members can join this research as long as they provide data specifically needed for the actual study. Entering data in the registry will automatically make them available for future research. When the Steering Group approves the research protocol, the study can be performed.
When the collaborating parties agree to share data, then data and biomaterials can be transported to the principal investigator. The data and biomaterials 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. The data from the separate registers will be sent by email to the investigator and a fraction of the DNA will be sent by post.
1.7.4 Data monitoring
The quality of data will be checked on a regular basis, organized by the Steering Group and all members and participants are obliged to respond to these requests. Data monitoring: preferably all centers will be monitored every 3 years for data quality. The process of this monitoring of quality assessment will be determined by the WG database management. Monitoring among same language centers is preferred. Centers are obliged to provide open access to their data for monitoring.
1.7.5 Costs
Costs for data collection and storage of DNA in storage facilities are at the expenses of the recruiting member of the Consortium. Costs for sending DNA samples are payable by the principal investigator after agreement on the price with the sender. The goal of the Consortium is to apply for extramural funding in the near future.
1.7.6 Ownership / rights of control
The patients have the highest rights of control of their data and biomaterials. Parents/legal guardians/patients give their consent to use the data of the patient, if not routinely collected, and biomaterial for research purposes and they can minimize or withdraw his/her consent. When parents/legal guardians/patients give their full consent, they apply for any research done using their data and biomaterials. Limited consent can occur when they consent to clinical data use, but not biomaterials. Not routinely collected clinical data must be removed from all registries and/or biomaterials must be destroyed 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 and responsible for destruction of biomaterials when collected.
Every research center decides for which research project their patient data and biomaterial 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.
1.7.7 Data protection
Data collection, storage and usage of data and biomaterials follows the latest data protection rules. As mentinoned above at 1.7.2 data are only inserted in the ARM-Net database in an anonymized form, which cannot be linked to a child. ln case of publications, only these anonymized 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
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:
– substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data;
– drafting the article or revising it critically for important intellectual content;
– final approval of the version to be published.
• Acquisition of funding, collection of data, or generalsupervision 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 who accept 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 coauthors.
• Every full member can request data for research and/or a paper and can be in the ‘writing committee’. These requests will be sent to the ARM-Net secretary and need approval from the Steering Group.
• 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 put all the names (including titles, hospital name, city and country) 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. 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:
– Funds to facilitate the organization of ARM-Net
– Funds to facilitate the participation of the patients in research
– Funds to facilitate the participation of the patient organizations in ARM-Net
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.
2.2 Education
One of the aims of ARM-Net is to promote knowledge about anorectal malformations. Therefore, in those countries 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 the ARM-Net cannot be sent outside or reported to other surgeons or other third parties, unless all members involved 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
3. ARM-Net and the European Reference Network (ERN)
The European Reference Networks (ERN) are networks of expertise bringing together specialists from all across Europe to concentrate knowledge and resourcesfor complex or rare medical conditions that require highly specialized healthcare. Members of the ARM-Net Consortium are a driving force in the eUROGEN ERN since the establishment of the ERNs. At present, not all centers within ARM-Net are part of e-UROGEN, and it is not a criterion of admission to the ARM-Net Consortium. The ARM-Net Consortium is a supporting partner of eUROGEN. Through the virtual platform called Clinical Patient Management System (CPMS), members of the ARM-Net can exchange information as guests and upload difficult and complicated cases to share with other members of the eUROGEN ERN as well as with other ERNs.
It is important that there are positions held by ARM-Net members in the ERN. E.g. 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, such as when defining guidelines.