OFFICE OF RESEARCH OVERSIGHT SITE VISITHuman Research Protection Program and

R&D Committee

August 11-15

What to Expect During Site Visit• A complete list of all protocols will be provided to ORO.• ORO will select protocols that they want to review in

depth. • This will include interviews with selected PIs. • ORO will review training records and Scopes of Practice.• ORO will walk through all research areas (including lease

space at University of Iowa.

What to Expect After Site Visit• ORO will send a report of all noncompliance issues 6-10

weeks after site visit.• We will have to respond with a Remedial Action Plan.• We will work with each PI on any protocol specific

noncompliance issues that need to be corrected• There may be programmatic issues that will impact

everyone.

Another Item – DEO/Department Chair Signatures on Assurance DocumentsVA Department Name

Research and Development Mark Yorek

HSR&D Eli Perencevich

Rural Health Peter Kaboli

Primary and Specialty Medicine Joseph Szot

Surgical/Specialty Care Joseph Cullen/Ronald Weigel

Mental Health Catherine Woodman

Radiology Stanley Parker

Pathology and Laboratory Thomas Haugen

Pharmacy Travis Tubbs