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**Consent in Open Science Report** Report Authors: Anne-Marie Tasse and Myriam Koayes (McGill Centre for Genomics and Policy) Considering that working with an open and collaborative vision could accelerate medical discoveries, the Montreal Neurological Institute (MNI) and its associate Tanenbaum Open Science Institute (TOSI) announced, in the spring of 2016, their commitment to Open Science. This initiative is expected to attract new private partners as well as companies in the Montreal region leading to innovation in the way scientific research is conducted. However, adopting the Open Science concept raises various issues, including those related to consent, the focus of this memorandum. There is clearly a conundrum surrounding the implications that come with meaningful consent in an Open Science environment, specifically when it comes to understanding how to facilitate the free flow of data while respecting participants’ rights and the security of their personal information. In this context, the Centre of Genomics and Policy (CGP) received the mandate to scrutinize the current legal and ethical framework surrounding consent in Open Science. This memorandum will feed into the discussion on Open Science by, first, presenting Open Science definitions and key concepts. Second, we outline key elements from our review of laws and policies adopted at an international, European and national (Canadian, and American) level. Third, in light of our review, we provide best practices. Finally, a consent information pamphlet and a consent form promoting Open Science are provided as an appendix to this memorandum (Appendix A). **Information and Consent Form Template** Important notes for the reader: (1) This appendix is intended to provide general guidance for consent language in Open Science research projects. (2) This appendix aims at partially implementing Open Data and Open Sharing of Biological Samples in the sense that coded samples and coded research data collected are not all, by default, shared freely and publicly accessible. (3) Open Science encompasses other fields such as Open Access, Open Intellectual Property and Open Commercialization, all of which require the adoption of internal policies at the outset, with respect to, but not limited to, publication and intellectual property. (4) This information pamphlet and consent form should be reviewed and approved by a Research Ethics Board (REB)/Institutional Review Board (IRB). (5) Provincial and local legislation, as well as REBs/IRBs may require additional/different clauses. (6) Special considerations for the consent of minors, vulnerable populations and deceased persons are not included. (7) Special considerations for clinical trials are not included.
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