Office of Research Integrity Navigating the regulatory framework October 23, 2014.

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Presentation transcript:

Office of Research Integrity Navigating the regulatory framework October 23, 2014

ORI Units COIDSIACUC Int’l Comp. IRBIBC* Conflict of Interest program Scientific Diving and Small Boat Use Institutional Animal Care and Use Committee Export Control and International Compliance Institutional Review Board Institutional Biosafety Committee

F&A – RO Compliance Connections Interim VP for Research Ron Adams Director, ORI Adam Schultz IRB IACUC COI Scientific Diving & Boating VP for Finance & Administration Glenn Ford Asst. VP for HR, Facilities, Risk Mgmt, & Public Safety Dave Blake Asst. Director, Enterprise Risk Srvcs, EH&S Dan Kermoyan Biosafety Radiation Safety Chemical Safety University Health & Safety Chief Risk Officer, Enterprise Risk Srvcs Patrick Hughes Assoc. VP for Research Rich Holdren Int’l Compliance

Mission Promote a culture that fosters ethical research Maintain the integrity of OSU research Protect the public trust Provide guidance and support Partner with researchers to ensure compliance Require training to enhance personal safety*

Commitment from OSU Leadership “…[Research] activities undertaken by OSU faculty, staff, and students should be conducted in accordance with strict ethical principles and in compliance with institutional policies, federal and state laws and regulations, and other applicable requirements.” -Edward J. Ray, President

What? Assist researchers in complying with ethical, regulatory, and legal responsibilities in research involving: Live vertebrate animals Human subjects Scientific diving and small boat use Financial conflicts of interest International components or foreign nationals Recombinant nucleic acids and infectious agents Collaboration with committees in EH&S

Why? History.

Why else? “Public funding is based on the principle that the public good is advanced by science conducted in the interest of humanity.” -National Research Council

Conflict of Interest Nicole Wolf Administrator (541) A312 Kerr Admin Bldg

Conflict of Interest 1,826 Declarations in FY Managed Conflicts 25 Potential COIs under review

Conflict of Interest contact for Disclosure of financial interests COI training Managing conflicts of interest in research

Conflict of Interest Disclosures are required for Professorial faculty, Research Associates, and Post-Doctoral Fellows/Scholars Individuals who serve or intend to serve as an investigator on a sponsored project, including but not limited to Professional Faculty, Faculty Research Assistants, Senior Faculty Research Assistants, Instructors, and Emeritus, Courtesy and Visiting Faculty Other individuals as identified by the Conflict of Interest Officer, a college dean or unit head

Scientific Diving & Small Boats Kevin Buch Diving and Small Boat Safety Officer (541) B308 Kerr Admin Bldg

Diving & Small Boats 2013 Dive Statistics 2572 dives 88% research 12% training 40 divers 1600 hours 20+ projects

Diving & Small Boats contact for Scientific diver training Dive plan approval Approval to operate or crew small vessels

IACUC Administrator: Rebecca Henry Coordinator: Rob Gaebel Program Specialist: Mary Samuel Student:Max Gilbert (541) B308 Kerr Admin Bldg

IACUC 128New Submissions (FY 2014) 308Currently active protocols 154Principal Investigators 23Depts/Units Represented Triennial AAALAC accreditation site visit Recommended for continued full accreditation AAALAC site visitors noted campus-wide collegiality

IACUC contact for  Use of live vertebrate animals in research, teaching, testing and other use  Animal welfare concerns and incidents

International Compliance Mark Peters Export Control & Int’l Compliance Officer (541) A312 Kerr Admin Bldg

International Compliance contact for International travel or shipping Foreign visitors Restrictions on publication or foreign participation Fundamental Research Exemption (FRE)

IRB Administrator: Lisa Leventhal Coordinators:Cathleen Gal Jillian Grant Amy Neuman Specialist:Tiffany Cicerchi Student:Demi Sether (541) B308 Kerr Administration Building

IRB 1230 Active studies 200 Students advised annually 200 In-office reviews in CY 2014

IRB contact for Research determination Review of human subjects section of grant applications Pre-submission consultation Review of research protocols Presentations to faculty or students

EH&S Institutional Biosafety Committee Chemical Safety Committee Radiation Safety Committee University Health and Safety Committee Environmental Health & Safety 100 Oak Creek Building 3015 SW Western Blvd (541)

Committees & Boards Comprised of your peers Members from across the University Some include community members Some include students They want your research to be successful!

Most Frequently Asked Question How long does it take?