IGPP Consortium GWSS Summary Results Data

IGPP Consortium GWAS Summary Results Data Access Policy

INTERNATIONAL GENETICS OF PARKINSON DISEASE PROGRESSION (IGPP) CONSORTIUM IGPP SUMMARY STATISTICS V2020 DATA USE AGREEMENT To obtain approval for use of any IGPP Data represented in the EGA database send the (1) completed form (signed by your institutional signing official and the PI) and (2) a 1-2 page research proposal to the IGPP Data Access Committee (DAC) at ykuras@bwh.harvard.edu and cscherzer@rics.bwh.harvard.edu I. For purposes of this IGPP Data Use Agreement (“Agreement”), the “IGPP Data” refers to data generated by the Scherzer Neurogenomics Lab of The Brigham and Women’s Hospital, Inc. (“BWH”). IGPP Data comprise the summary statistics from the combined analysis of discovery and replication populations as described in Liu et al., Nature Genetics, 2021. All IGPP Data are de-identified within the meaning of the United States Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and its accompanying regulations, including but not limited to the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) at 45 CFR 160 and 45 CFR 164. IGPP Data are owned by BWH. No transfer of ownership is intended or conferred by operation of this Agreement. II. The Principal Investigator receiving access to IGPP Data for the Project (“Project” as defined in the Appendix below) is _____________________ (“Recipient”), a staff member or employee of______________________________________________ (“Institution”), with a principal place of business at _________________________. III. Recipient requests access to the IGPP Data for a scientific research project specifically outlined in Recipient’s IGPP Data request application to the IGPP Data Accesss Committee (the “Application”). IV. The period of this Agreement is from the date of signature to the conclusion of Recipient’s research project as outlined in the Appendix below (“Project”) unless earlier terminated by the parties in accordance with section V(23) below.Upon expiration or early termination of this agreement, Recipient shall follow the disposition instructions provided in section V(23) of this agreement accordingly. V. In consideration of BWH making available the IGPP summary statistics Data to Recipient, Recipient and Institution agree to the following: Publications 1. If Recipient publishes manuscripts using any IGPP Data, Recipient agrees: a. To submit the manuscript for IGPP review. All manuscripts including any IGPP Data must be submitted to the IGPP DAC for review (including appropriate IGPP Data analysis, data use and integrity) comment, scientific input, and sign off three weeks prior to manuscript submission for publication. The IGPP will review manuscript(s) to ensure that any IGPP Data is appropriately protected and to protect proprietary or patentable information. The IGPP DAC may request that the proposed publication or other disclosure be delayed for up to thirty (30) additional days as necessary to protect such proprietary information. The IGPP DAC can be reached through Dr. Clemens Scherzer at cscherzer@rics.bwh.harvard.edu and Dr. Yuliya Kuras at ykuras@bwh.harvard.edu. b. To include a co-author byline. During the review process the IGPP DAC will decide whether key member/s of the IGPP investigative team warrant inclusion as coauthor/s on any manuscript including IGPP data. Qualification for authorship shall be in keeping with generally accepted academic criteria. This will take the form of a brief note indicating review and approval of the final manuscript within two weeks. c. To include the IGPP name in the co-authors byline. d. To include the list of IGPP Consortium Members and their affiliations as shown below in the Appendix of the manuscript: International Genetics of Parkinson Disease Progression (IGPP) Consortium members: Ganqiang Liu1,2,3, Jiajie Peng1,2,4, Zhixiang Liao1,2, Joseph J. Locascio1,2,5, Jean-Christophe Corvol6, Xianjun Dong1,2, Jodi Maple-Grødem7,8, Meghan C. Campbell9, Alexis Elbaz10, Suzanne Lesage6, Alexis Brice6, Graziella Mangone6, Bernard Ravina12, Ira Shoulson13, Pille Taba14, Sulev Kõks15,16, Thomas G. Beach17, Florence Cormier-Dequaire6, Guido Alves7,8,18, Ole-Bjørn Tysnes19,20, Joel S. Perlmutter9,21,22, Peter Heutink24, Jacobus J. van Hilten26, Meike Kasten27, Brit Mollenhauer28, Claudia Trenkwalder29, Christine Klein30, Roger A. Barker31,32, Caroline H. Williams-Gray31, Johan Marinus26, Clemens R. Scherzer1,2,5,11* 1 Center for Advanced Parkinson Research, Harvard Medical School, Brigham and Women’s Hospital, Boston, MA 02115, USA 2 Precision Neurology Program of Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA 3 School of Medicine, Sun Yat-sen University, Shenzhen, Guangdong, 518107, China 4 School of Computer Science, Northwestern Polytechnical University, Xi’an, Shaanxi, 710072, China 5 Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA 6 Sorbonne Université, Paris Brain Institute – Institut du Cerveau – ICM, Institut National de Santé et en Recherche Médicale, Centre National de Recherche Scientifique, Assistance Publique Hôpitaux de Paris, Département de Neurologie et de Génétique, Centre d’Investigation Clinique Neurosciences, Hôpital Pitié-Salpêtrière, F-75013, Paris, France 7 The Norwegian Centre for Movement Disorders, Stavanger University Hospital, 4068, Stavanger, Norway 8 Department of Chemistry, Bioscience and Environmental Engineering, University of Stavanger, 4021, Stavanger, Norway 9 Departments of Neurology and Radiology, Washington University School of Medicine, St. Louis, MO 63110, USA 10 Paris-Saclay University, UVSQ, Inserm, Gustave Roussy, "Exposome and heredity" team, CESP, F-94805, Villejuif, France 11 Department of Neurology, Brigham and Women’s Hospital, Boston, MA 02115, USA 12 Praxis Precision Medicines, Cambridge, MA 02142, USA 13 Department of Neurology, Center for Health + Technology, University of Rochester, Rochester, NY,14642, USA 14 Department of Neurology and Neurosurgery, University of Tartu, Tartu, 50406, Estonia 15 Centre for Molecular Medicine and Innovative Therapeutics, Murdoch University, Murdoch, Perth, WA 6150, Australia 16 Perron Institute for Neurological and Translational Science, Nedlands, Perth, WA 6009, Australia 17 Banner Sun Health Research Institute, Sun City, AZ 85351, USA 18 Department of Neurology, Stavanger University Hospital, 4068, Stavanger, Norway 19 Department of Neurology, Haukeland University Hospital, 5020, Bergen, Norway 20 Department of Clinical Medicine, University of Bergen, 5020, Norway 21 Department of Neuroscience, Washington University School of Medicine, St. Louis, MO 63110, USA 22 Program of Physical Therapy and Program of Occupational Therapy, Washington University School of Medicine, St. Louis, MO 63110, USA 24 German Center for Neurodegenerative diseases (DZNE), Tübingen, 72076, Germany 25 Translational Genomics Core of Partners HealthCare Personalized Medicine, Cambridge, MA 02139, USA 26 Department of Neurology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands 27 Institute of Neurogenetics, University of Lübeck, University Hospital of Schleswig-Holstein, Lübeck, 23562, Germany, Department of Psychiatry and Psychotherapy, University of Lübeck,23562, Germany 28 Department of Neurology, University Medical Center Göttingen, Göttingen, 37075, Germany and Paracelsus-Elena-Klinik, Klinikstraße 16, 34128 Kassel, Germany 29 Department of Neurosurgery, University Medical Center Göttingen, Göttingen, 37075, Germany and Paracelsus-Elena-Klinik, Klinikstraße 16, 34128 Kassel, Germany 30 Institute of Neurogenetics, University of Lübeck, University Hospital of Schleswig-Holstein, Lübeck, 23562, Germany 31 John Van Geest Centre for Brain Repair, Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0PY, UK 32 Wellcome - MRC Cambridge Stem Cell Institute, University of Cambridge, Cambridge, CB2 0AW, UK e. To include a IGPP funding acknowledgements paragraph in the manuscript: IGPP funding acknowledgements. IGPP was funded in part by a philanthropic support (to Brigham & Women's Hospital and C.R.S.) for Illumina MEGA chip genotyping. C.R.S.' work was supported by NIH grants NINDS/NIA R01NS11144, U01NS095736, U01NS100603, and the American Parkinson Disease Association Center for Advanced Parkinson Research. f. To reference the primary IGPP publication in the bibliography of the manuscript: Liu et al., (2021). Genetic divergence of cognitive progression and susceptibility in Parkinson's disease, Nature Genetics. Data Use and Distribution 2. To not distribute IGPP Data to anyone other than the Recipient and research staff under the direct supervision of the Recipient that require access to the IGPP Data in connection with the Project. . 3. To permit only the above-specified individuals to receive the IGPP Data. 4. To not transfer the IGPP Data outside of Recipient’s Institution. Investigators at other institutions must apply directly to the IGPP DAC to obtain IGPP Data. 5. By accepting this Agreement, Recipient warrants that all Institution-required approvals are in place for the use of the IGPP Data. Such approvals may include, as applicable, Institutional Review Board (“IRB”) approval and approval of the terms and conditions of this Agreement. 6. Use and disclose the IGPP Data only as permitted by this Agreement and the IRB-approval, as applicable, or as required by law. 7. To use and disclose the IGPP Data only for the research purpose stipulated in Recipient’s Application. 8. To use appropriate safeguards to prevent use or disclosure of the IGPP Data other than as provided for by this Agreement. 9. Throughout the Term, to warrant compliance with all applicable Federal, State, and local laws and regulations. 10. To not attempt to re-identify the IGPP Data. If such re-identification occurs, Recipient shall immediately inform BWH and destroy all copies of the IGPP Data. Any attempt to re-identify IGPP Data will result in the Recipient being barred from further access to IGPP Data. 11. To refrain from using the IGPP Data to identify or to contact individuals. 12. To not sell IGPP Data or otherwise use or disclose IGPP Data for a commercial, marketing, or fundraising purpose. 13. To report to BWH and to Federal and State agencies, as appropriate, any use or disclosure of the IGPP Data not provided for by this Agreement of which it becomes aware, including, without limitation, any unauthorized disclosure to subcontractors, within five (5) days of its awareness. 14. Except as otherwise provided herein or prohibited by law, it is understood that any IGPP Data delivered pursuant to this agreement is being provided AS IS. BWH MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE DATA WILL NOT INFRINGE ON ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS. Notwithstanding, BWH, to the best of its knowledge and belief, has the right and authority to provide the IGPP Data to the Recipient for use in the Project. Neither BWH nor its employees, staff members, or agents shall have any liability whether in contract, tort, and statute or otherwise in connection with Recipient’s use of the IGPP Data. Recipient uses the IGPP Data at Recipient’s own risk. Inventions, Discoveries and Patents 15. It is expressly agreed that neither BWH nor Recipient transfers by operation of this Agreement to the other Party any intellectual property, patent right, data, copyright, or other proprietary right owned, conceived and reduced to practice as of the commencement date of this Agreement or arising outside of the Research conducted under this Agreement. 16. BWH and Recipient Institution shall have joint ownership to any inventions, algorithms, polygenic scores, drug targets, discoveries, and other developments conceived or reduced to practice or validated during and in the course of the performance of the Research by the Recipient from the use of the Data (together, “Joint Inventions”), subject to the provisions of 37 CFR § 401, et. seq., including, but not limited to, applicable government march-in rights. The Parties will mutually agree in writing regarding the management and commercialization of the Research Results and Joint Inventions. Termination, Governing Law and Other Obligations 17. The Recipient Institution will notify BWH within 30 days of any changes or departures of Data Recipients. 18. The Recipient Institution will notify BWH prior to any significant changes to the protocol for the Project. 19. The Recipient Institution will notify BWH as soon as it becomes aware of a breach of the terms or conditions of this agreement. 20. If requested, the Recipient Institution will allow data security and management documentation to be inspected to verify that it is complying with the terms of this agreement. 21. The Recipient Institution agrees to distribute a copy of these terms to the Data Recipients. The Recipient Institution will ensure that the Data Recipients comply with the terms of this agreement. 22. This agreement (and any dispute, controversy, proceedings or claim of whatever nature arising out of this agreement or its formation) shall be construed, interpreted and governed by the laws of the United States of America. 23. This agreement may be terminated for any reason by either party with thirty (30) days written notice to the other party. Upon expiration or early termination of this agreement, Recipient shall securely destroy the IGPP Data provided. [Signature Page Follows] Agreed by the parties through their authorized signatories below: 1. Recipients Institution Signing Official Signature Name Date Institution: Email: Data Recipient(s) Signature Printed Name Title Email Date 2. BWH Signing Official: Signature Name Date Institution: 3. IGPP Coordinating Investigator Co-signature: Signature Name Date Institution: APPENDIX Project Title: Project Summary (1 page limit):