Common use of Review and Oversight Clause in Contracts

Review and Oversight. The Relying Institution will also oversee the safe and appropriate conduct of the Expanded Access IND at its institution and will ensure compliance with applicable federal, state, local or institutional requirements related to the protection of human subjects, which may include investigating and managing any incidence, experience, or outcome that may rise to the level of an unanticipated problem and/or serious or continuing noncompliance. Should any such requirements conflict with the decisions or requirements of the CDC IRB, the Relying Institution must raise those conflicts for consideration by the CDC IRB. The Relying Institution will also provide all information about conduct of the Expanded Access IND at the Relying Institution that the CDC IRB requires to meet its review and reporting requirements. The Relying Institution will establish a mechanism that allows human subjects and others to report concerns about the conduct of the Expanded Access IND.

Review and Oversight. The Relying Institution will also oversee the safe and appropriate conduct of the Expanded Access IND at its institution and will ensure compliance with applicable federal, state, local or institutional requirements related to the protection of human subjects, which . Requirements may include investigating and managing any incidence, experience, or outcome that may rise to the level of an unanticipated problem involving risk to human subjects or others or serious and/or serious or continuing noncompliance. Should any such requirements conflict with the decisions or requirements of the CDC IRB, the Relying Institution must raise those conflicts for consideration by the CDC IRB. The Relying Institution will also provide all information about the conduct of the Expanded Access IND at the Relying Institution that the CDC IRB requires to meet its review and reporting requirements. The Relying Institution will establish a mechanism that allows human subjects and others to report concerns about the conduct of the Expanded Access IND.