Common use of Human Subjects Clause in Contracts

Human Subjects. Sponsoring Institution will ensure that Grantee obtains prior written approval from the Sponsoring Institution’s Institutional Review Board (or equivalent institutional authority) (“IRB”) for the protection of human subjects before undertaking any form of human subject research. An original executed copy of this approval must be submitted to LLS within ten (10) days after such approval is obtained. With respect to research projects that do not deal with human subject research, Sponsoring Institution must furnish to LLS a letter executed simultaneously with this Agreement stating that: “The research project does not involve the use of human subjects or human tissue.” Sponsoring Institution agrees, and will ensure that Grantee agrees, that any deviation from such research projects that will involve human subject research will not be undertaken unless prior written approval from the IRB is obtained. Any such approvals must be forwarded to LLS within ten (10) days of approval. If the IRB disapproves of any changes from the original Application, then LLS in its sole discretion reserves the right to modify or terminate this Agreement.