Version_29.March.2022

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1. Complete this web form
2. Sign the received copy of the completed form at your provided email address

You can view the complete form at https://ibdgenetics.org/uploads/IIBDGC_MOU_28jan2019_with_bookmarks.pdf

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Memorandum of Understanding

This Memorandum of Understanding (MOU)describes the arrangement by which members of the International IBD Genetics Consortium (IIBDGC) will submit data for the purpose of group projects, and in return have the opportunity to participate in those projects and propose projects of their own. Such data will be referred to below as “IIBDGC-managed data.” This MOU has been approved by the IIBDGC Management Committee (MC)—any changes will require approval of the MC.

1. Mission of the International IBD Genetics Consortium
The mission of the IIBDGC is to (1) identify the genetic risk factors for the inflammatory bowel diseases (IBD), Crohn’s disease (CD), ulcerative colitis (UC), and related clinical phenotypes, (2) to determine how these risk factors interact with non-genetic risk factors impact on an individual’s risk to develop IBD, CD, UC and related phenotypes, (3) perform these studies in a collaborative fashion and to broadly share the results with the international scientific community in a responsible fashion. While the original projects were limited to genomic DNA genotype data, the IIBDGC will incorporate all different data types generated on different sample types that are necessary to achieve its mission.

2. IIBDGC Management Committee (MC)
The Management Committee (MC) is responsible for (1) guiding the scientific direction of the IIBDGC, (2) providing oversight of IIBDGC projects, (3) communication with IIBGC members, (4) conflict resolution, (5) outreach to the broader IBD and general scientific communities.

3. General Requirements for IIBDGC Membership
Investigators wishing to participate in IIBDGC projects must comply with the following requirements:
• Submit data from a minimum of 500 research participants; exceptions to permit submitting fewer samples (at least 100) for cohorts of particular interest (e.g., rare phenotypes) will require approval by the MC and will be considered on a case-by-case basis.
• Submit corresponding core phenotype data as described in Cleynen et al. (PMID: 26490195), formatted according to the IIBDGC’s Core Sub-Phenotype Submission Guidelines (see Appendix-II); specific projects may have additional phenotype requirements.
• Submit individual-level genotype, sequence, and/or other genomic data; if that is not possible, the MC may approve submission of summary data on a case-by-case basis. Genetic/genomic data should be submitted in accordance with the requirements of the specific project(s) for which they are intended. These project-specific requirements are outlined in Appendices to this document.
• Provide a letter stating that you have authority from your Institutional Review Board (IRB) or equivalent to share the data with the IIBDGC and in a public repository such as dbGaP or EMBL- EBI; if you do not have authority to share individual-level genotype data, the MC will consider permitting you to share summary data instead. Those who have already submitted their data to a public repository need only affirm this below and indicate how the data may be accessed from that location.
• Adherence to the principles outlined in the current document.

4. IIBDGC Projects & Working Groups: Proposals, Inclusiveness, and Transparency
Access and use of IIBDGC-managed data is limited to projects that have obtained MC approval. Any IIBDGC member (or group of members) wishing to initiate a project must complete a Project Proposal form. All approved Project Proposals are made available to the full IIBDGC membership. Project Leaders are required to (1) form a Working group that ensures the successful completion of the project, (2) make Working Group activities open to all IIBDGC members, (3) report progress to the MC on a regular basis as defined by the MC, (4) ensure that all communications of research results (abstracts, manuscripts, etc.) obtain prior MC approval.

5. Publication Policy
IIBDGC Working Groups are responsible for drafting communication of research results (abstracts, manuscripts, etc.). IIBDGC Working Groups are responsible for drafting author lists. Author lists will reflect the contributions of IIBDGC members and IIBDGC Working Groups. Author lists should include the IIBDGC banner author. Working Groups must obtain MC approval of documents (e.g. manuscripts) and author lists prior to submission.

6. Intellectual Property
The IIBDGC aims to make all of its results and findings publicly available in a timely and responsible manner. The IIBDGC will not pursue the protection/filings of any intellectual property that it generates.  IIBDGC members are free to pursue intellectual property protection of their own data at any time, but such IP-related activities can’t prevent or delay the public release or publication of IBDGC results and findings.  Other than the members own data, use of IIBDGC-managed data or results in intellectual property filings is allowed only after public release.

7. Data Management Requirements
All IIBDGC-managed data (e.g. genotype, phenotype, demographic, etc.) will be securely stored and managed by the NIDDK IBD Genetics Consortium (IBDGC) Data Coordinating Center (DCC) on behalf of the IIBDGC members (see below for details regarding Data Commons). All data should be submitted with a local participant or sample ID containing no identifying information (identifying information such as names, medical record numbers, or other will not be accepted). Upon receipt of new data, the DCC will assign a unique ID that will be used for all subsequent distribution and analysis.  The DCC will submit data to dbGaP on behalf of the IIBDGC, under the direction of the IIBDGC MC, unless those data have already been deposited elsewhere (see section below on Data Sharing).  It is possible that for specific projects some data types (e.g. large-scale sequence data) may be stored on another data platform at the request of the IIBDGC MC. In such circumstances, equivalent Data Management Requirements will be respected and will be made transparent to IIBDGC members via Project description included as an Appendix to the current MOU.

8. Data Access
Data access will be provided through the NIDDK IBDGC Data Commons (https://ibdgc.datacommons.io/) that uses the resources of the University of Chicago’s Data Commons (https://ctds.uchicago.edu/datacommons/). Specific projects may also request access to compute resources within the commons. Before accessing the commons, users are required to provide proof that they have completed the required Human Subjects training at their local institution (e.g., a copy of their certificate) as well as complete the NIH Secure Remote Computing training course (https://irtsectraining.nih.gov/publicuser.aspx). Certificates of completion should be sent to Sondra Birch (sbirch@uchicago.edu), together with your Gmail address (authentication to the commons is through Google’s OAuth).

Investigators who have submitted data as well as other researchers and students working directly under their supervision may access IIBDGC-managed data for two purposes:

• Investigators may access and download their own data at any time without explicit permission from the MC. This MOU shall in no way limit an investigator’s ability to use and publish his or her own data.
• Shared data may be accessed ONLY as part of an MC-approved project. Project proposals must be submitted to the MC for approval before data are accessed. In some cases, a project may also require completion of one or more additional Data Use Agreements (DUAs). Data accessed for a specific project must be used solely for completing the objectives of that project as described in the project proposal. The project leader(s) are responsible for ensuring that data are being used for this purpose, and that they are being handled securely (including that any additional special restrictions attaching to a particular dataset are being followed). No sharing or use of IIBDGC- managed data outside of MC-approved projects is permitted. No publications of results obtained from IIBDGC-managed data is allowed without MC approval of the manuscript.  Investigators who have not submitted data but wish to use IIBDGC-managed data may also submit a project proposal to the MC.

IMPORTANT: Absolutely no redistribution of IIBDGC-managed data is permitted with the exception of an investigator’s own data. Any data downloaded for local analysis must be handled and stored securely.  In the event that other/additional data management/data access infrastructure is required in the future, such a modification would require IIBDGC MC approval. It is possible that for specific projects some data types (e.g. large-scale sequence data) may be stored on another data platform at the request of the IIBDGC MC. In such circumstances, equivalent Data Access procedures will be respected and will be made transparent to IIBDGC members via Project description included as an Appendix to the current MOU.

9. Data Sharing
Individual-level genetic and/or genomic data (or in cases where that is not possible, summary data) will be submitted to dbGaP by the DCC within one year of the date on which the data became available for analysis. Data that have already been deposited in a public repository will not be submitted to dbGaP, but instead instructions will be included on how the data may be accessed.

10. Use of the IIBDGC name
No Participant shall use the name or logo of the IIBDGC for any commercial purposes (e.g. promotional material or other public announcement or disclosure) without the prior written consent of the MC.

11. Conflict Resolution
If any unresolved conflicts arise, the MC must be informed. MC decisions will be final.

12. Electronic Execution
Each Member intends that an electronic copy of its signature stored in a PDF software application format shall be regarded as an original signature and agrees that this MOU may be executed in any number of counterparts, each of which shall be effective upon delivery and thereafter shall be deemed an original, and all of which shall be taken to be one and the same instrument.3 IIBDGC MOU 2019-01-28

Acknowledgement of Memo of Understanding
I understand and accept all of the requirements and responsibilities outlined above. I understand that failure to comply with this MOU may result in loss of access to IIBDGC-managed data as well as a notification being sent to my institutional representative.