Minimum requirements | Sponsors may not censor publications |
Research results may not be patented or commercialised |
Further factors for Institutional Review Board /Research Ethics Committee to consider | The magnitude of the potential social value of the research relative to its risks and burdens |
Whether the research addresses health inequities or the needs of disenfranchised or vulnerable patient groups |
Whether the research addresses the needs of groups traditionally excluded from clinical research and therefore lacking in robust evidence to guide clinical care |
Whether the research will be made publicly available and open access |
Whether the research has engaged with patient groups in terms of pre-research consultation, ongoing partnership and/or patient involvement with the research governance |