Report on recommended language for broad informed consent in prospective studies, and best practice for waiver of consent by ethics committees for retrospective data sharing

Task 24 Report on recommended language for broad informed consent in prospective studies and best practice for waiver of consent by ethics committees for retrospective data sharingDescription and proposed research and workflow we will carry out a review of the legal regulatory and institutional environments of selected countries in the context of infectious disease preparedness and response plans that will inform the development of templates broadly construed and focused on the language and key terms forolanguage used in broad consent for future uses and data sharingorequests for Research Ethics Boards REB waiver for specific informed consent for retrospective use of data for access and sharingImplementation and Methodology Legal regulatory and institutional evaluations Bibliography review on regulatory and procedural standardization Examination of existing documents and their languageterms to propose better templates and empirical research to inform the development of templates when possibleResults expected We will generate a report that proposes appropriate sample language for obtaining informed consent for future prospective data sharing The McMaster team will develop a paper that proposes best practices for broad informed consent and waiver of consent to enable data sharing in partnership with WP2 members and ReCoDID project partner institutions in LMICs for instance the University of Ceara UECE and Fiocruz Foundation in Brazil This paper will leverage empirical research done by WP2 members and the experience of WP1 and WP2 in assisting ReCoDID project partner institutions to obtain waivers of consent to share data with the ReCoDID project and REB approvals in Colombia Nicaragua and Brazil