Whole genome sequencing in myasthenia gravis

Policy for study 'Whole genome sequencing data from South African individuals with myasthenia gravis'

The Neurology Research Group of the University of Cape Town (Hereinafter referred to as “NRG-UCT”) Data Access Agreement (DAC) This agreement governs the terms on which access is granted to the data generated by the NRG-UCT. The NRG-UCT has created a database containing whole genome sequencing data from 25 (twenty-five) South African participants with myasthenia gravis (average coverage over 30X). Phenotype data has been collected. In accordance with the Academy of Science of South Africa (ASSAF) guidelines [1], the H3Africa policy framework [2,3] and the original data-sharing consent obtained from the participants in this study, data access may be granted to interested parties for research related to myasthenia gravis. An additional 12 month publication embargo period for the shared data will be imposed until May 2020 to allow the NRG-UCT to publish their findings on the following “reserved research topics”: a) Investigation of the genetic basis of myasthenia gravis in Africans (case-control study) and b) HLA architecture in Africans with myasthenia gravis. In line with collaborative efforts to establish an African genetic database to serve the needs of African researchers and study subjects, African researchers may also apply for access to this dataset for research purposes unrelated to myasthenia gravis, i.e. population control data. Please Note: the terms of access set out in this Agreement apply both to the Recipient and the Recipient Institution (as defined below). The Recipient Institution and Recipient are referred to as “You”, and “Your” is construed accordingly. In signing this agreement, the Recipient, named below, agrees to be bound by the terms and conditions of access as set out in this Data Access Agreement (“Agreement”), and agrees to ensure that the Recipient Institution’s Data Users comply with the terms and conditions of this Agreement. This Agreement is made on the ____day of______________________20__ (to be inserted by NRG-UCT representative) BETWEEN: 1. The NRG-UCT represented by: Jeannine Heckmann and Melissa Nel 2. The Recipient (name)……………………………………………………………………………whose registered office/principal address is ........................................................................... (the “Recipient Institution”) Definitions: Agreed Purpose - means the research purpose(s) approved by the DAC in writing DAC – NRG-UCT Data Access Committee Data - the data within the Database (EGA) Database - the EGA NRG-UCT database containing genome sequence data on participants Data Participants - the individuals who have contributed their data to the Database Data Users - means those officers, employees and students of the Recipient Institution, who work directly with the Recipient and have a need to use the Data for the performance of their work with respect to the Agreed Purpose, and have agreed to comply with this Agreement Publications - means, without limitation, articles published in print journals, electronic journals, reviews, books, posters and other written and verbal presentations of research Recipient - means the principal researcher named above Recipient Institution - means the organisation named above at which the Recipient is employed, affiliated or enrolled IT IS AGREED that: 1. You understand and acknowledge that the Data are experimental in nature, and that access to the Data is provided without any representations or warranties of any kind in relation to the Database or the Data. The NRG-UCT members will NOT be liable in any way for any use made of the Data or the Database. You agree to hold the NRG-UCT and members of the NRG-UCT harmless from and to indemnify them against all and any losses, costs, fees, claims, demands and liabilities which may arise out of or occur in connection with Your use of the Data or the Database. 2. You will use the Data for the Agreed Purpose and will not use the Data in such a way that damage or distress is or is reasonably likely to be caused to any Data Participants. 3. The Data relate directly to individual Data Participants and are strictly confidential. You will only disclose the Data to Your Data Users. You will take all reasonable measures to ensure that Your Data Users will not make copies of the whole or any part of the Data without Your consent, and that they will keep a sufficient written record of any such copies to permit You to fulfil Your obligations under clauses 3 and 7 of this Agreement. You will not transfer or disclose any part of the Data to any other person or body. 4. Except as reasonably required to carry out Your research with the Data for the Agreed Purpose, You will not duplicate, or sell, or offer for sale or transfer or offer to transfer all or any part of the Data, via any media. 5. You agree at all times to keep strictly confidential, and to ensure that the Data Users keep confidential, the information and Data pertaining to Data Participants. In particular, You undertake not to use, or attempt to use, or permit anyone other than the Data Users to use the Data on their own or in conjunction with other data, to seek to discover the identity of any Data Participants, to compromise or otherwise infringe the confidentiality of information on Data Participants and their right to privacy. 6. You accept that the Data are protected by and are subject to national and international laws, and that You are responsible for ensuring compliance with all applicable laws. The DAC reserves the right to request and inspect data security and management documentation and procedures to ensure the adequacy of data protection measures. If the DAC makes any such request, You agree to cooperate and to procure the cooperation of all your Data Users. 7. You may publish Your results arising from the use of the Data for the Agreed Purpose, provided the Data themselves are not disclosed. Aggregate or generic information generated from the Data may be published provided that: • such aggregate or generic information does not allow Data Participants or groups of Data Participants to be identified through reasonable effort • no damage or distress is or is reasonably likely to be caused to any Data Participants or groups of Data Participants • the Data will not be used in any way that could reasonably be expected to lead to ethnic stigmatisation and • no attempt will be made to identify the Data Participants. 8. You agree to acknowledge in any work based in whole or part on the Data, the published paper from which the Data derive, the version of the Data, and the role of the NRG-UCT and the relevant primary collectors and their funders. Publication of research findings based on the NRG-UCT South African myasthenia gravis WGS dataset: Please site the following publication: Nel M, Mulder N, Europa TA, Heckmann JM. Using Whole Genome Sequencing in an African Subphenotype of Myasthenia Gravis to Generate a Pathogenetic Hypothesis. Front Genet. 2019;10. Suggested wording in the Acknowledgement: “Neurology Research Group of the University of Cape Town and their funders: the South African Medical Research Council, the AFM Téléthon (20049) and the CRG/Novartis African Mobility Fellowship Program”. 9. You agree that You will submit any information reasonably requested to the DAC for the purposes of monitoring data use. 10. You agree that, if Your application is approved by the DAC, information about the proposed research use may be posted on University of Cape Town’s Neuroscience Institute public website. This information may include Your name and institution, the title of the project, and a non-technical summary of the research question. 11. You recognise that nothing in this Agreement will operate to transfer to You any intellectual property rights relating to the Data. You have the right to develop intellectual property based on Your analysis of the data. 12. The Data were generated using funding from the above mentioned funding bodies with the objective of providing access to affordable health solutions for the benefit of people in the developing world, particularly those with neuromuscular disease, and to ensure the broad availability of data and information. If results arising from Your and/or Your Users’ use of the Data could provide health solutions for the benefit of people in the developing world, You agree to: • offer non-exclusive licenses to such results on a reasonable basis, should this be considered an appropriate request, for use in low income and low-middle income countries (as defined by the World Bank) by any party that requests such a license solely for use within these territories • provide preferential access to such results to South Africans. • We will enforce a 12-month embargo for data access so that we may complete our original analyses. 13. This Agreement is not transferable and You may not assign it (in whole or in part) without the written consent of the DAC. 14. If You commit a breach of this Agreement, the DAC may terminate this Agreement immediately by notice in writing, without prejudice to its accrued rights and remedies. 15. You accept that it may be necessary for the DAC to alter the terms and conditions of this Agreement from time to time to address new concerns. In this event, the DAC will contact You to inform You of any changes and You agree that Your continued use of the Data will be dependent on the parties entering into a written variation of this Agreement. 16. The DAC may terminate this Agreement at any time for whatever reason by giving one (1) month’s notice in writing to You. 17. Your duty to protect the confidentiality of the Data received under this Agreement will survive termination of this Agreement and will continue in full force and effect indefinitely. 18. This Agreement will be governed by South African Law, and the parties will appoint an arbitrator for resolution of any dispute which may arise out of this Agreement. 19. You and Your Users agree to be bound by the overarching policies as outlined by the Academy of Science of South Africa (ASSAF) [1] and the H3Africa policy framework guidelines [2,3] and You and Your Users agree to familiarise yourselves with this Policy. AS WITNESS the hands of authorised signatories for the parties on the date first mentioned above. SIGNED for and on behalf of the DAC: SIGNED for and on behalf of the Recipient Institution Name:-__________________________ Name:_____________________________ Position:________________________ Position:___________________________ Signature:_______________________ Signature:__________________________ Data Request code: Project Title: V01 April 2019 adapted from the SAHGP-DAC (EGAC00001000734) policy document References 1. Human Genetics and Genomics in South Africa: Ethical, Legal and Social Implications. 2018. 2. de Vries J, Tindana P, Littler K, Ramsay M, Rotimi C, Abayomi A, et al. The H3Africa policy framework: negotiating fairness in genomics. Trends Genet. 2015;31:117–9. 3. Mulder N, Adebamowo CA, Adebamowo SN, Adebayo O, Adeleye O, Alibi M, et al. Genomic Research Data Generation, Analysis and Sharing – Challenges in the African Setting. Data Sci J. 2017;16:1–15.