3.0 Administrative Roles and Responsibilities

3.1 THE INSTITUTIONAL OFFICIAL
The President of the Drake University serves as the Institutional Official for the IRB.  The President signs the Institution's Federal-Wide Assurance of Protection for Human Subjects (FWA) that is required by DHHS.  The President has designated the Provost of the University the authority to further review research projects following IRB review.  The Provost can approve or disapprove research projects with the following exception: the Provost independently cannot approve any research that has been disapproved by the IRB. 

3.2 THE IRB CHAIR
 The IRB Chair ensures that the IRB carries out its responsibilities in accordance with federal requirements and these policies and procedures.

The Chair keeps the President and Provost informed of IRB activities as required and a letter will be prepared yearly summarizing the research approved, disapproved and tabled and actions taken on policy and program issues.

3.3 THE IRB
 The IRB reviews and approves, requires modification in, or disapproves all research activities conducted under the jurisdiction of Drake University.  The IRB conducts continuing review of previously approved research at appropriate intervals based on risk, but not less than once a year.  The IRB has authority to suspend or terminate previously approved research that is not conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to research subjects.  The IRB has authority to place any restrictions on an approved project as necessary to ensure protection of human subjects.

3.4 THE PRINCIPAL INVESTIGATOR
 The Principal Investigator has the primary responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of the University's FWA, federal laws and regulations and the University's policies and procedures as set forth in this manual.

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