Transcript Document

Office for Responsible Research
Dr. Kerry Agnitsch
IRB Co-Chair
ORR Mission
The Office for Responsible Research (ORR)
provides administrative services and leadership
for ISU’s research compliance program. The
ORR’s mission is to assist the Vice President for
Research in providing a research environment
that fosters honesty, integrity, and a sense of
community.
Compliance Program Overview
▫ Ethics/compliance approvals
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Human research (IRB)
Animal research (IACUC)
Research involving biohazards (IBC)
Research involving radiation or radiation producing
devices (RSC)
▫ Conflicts of Interest
▫ Export Controls
▫ Responsible Conduct of Research Training
Compliance Committee Approval Basics
• Obtain appropriate approvals BEFORE
beginning research activities
▫ Forms and information about approval processes
can be found on the ORR website
▫ Training for PIs and research staff is required
• Strictly adhere to approved protocols
• If changes are needed, obtain approval before
implementation
• Continuing review at intervals established by the
committee
Compliance Committee Approval Basics
(cont.)
• Report any problems, adverse events, deviations
from an approved protocol, etc.
• Allow adequate time for approval
• We are here to help! Call or stop in if you have
questions.
Responsible Conduct of Research
Training
• Required for projects funded by NIH, NSF, and USDANIFA
• Requirements for who must be trained and format of
training vary by funding agency
▫ NSF – undergraduates, graduate students, and post-docs
▫ NIH – all individuals receiving support from NIH training,
career development awards, research education grants, or
dissertation research grants (or any others, if noted in
funding opportunity announcements)
▫ USDA-NIFA – program directors, faculty, students
(graduate or undergraduate), post-docs, and any staff
participating in the project
RCR Training
• Format of Training
▫ Online training – allowed for NSF and USDANIFA-funded projects
▫ Face-to-face training (8 hours) required by NIH
 GR ST 565
 Departments can create their own – must be
approved by ORR
Conflicts of Interest Basics
• Conflicts of Interest -- circumstances where an
individual's professional actions or decisions at the
university could be influenced by considerations of
personal gain, usually of a financial nature, as a result of
interests outside his/her university responsibilities
• Annual COI Disclosure – required for faculty, P&S
staff, post-docs, and graduate assistants
• Managing conflicts
▫ Department-level management
▫ University-level management – for conflicts involving
significant financial interests or management roles in
external entities
Export Controls
• Export controls (EC) are United States laws that
regulate the transfer of designated items to foreign
persons both within and outside of the United States
and to other countries.
• Carefully review agreements, contracts, awards,
communication, etc. for language about export
controls or restrictions on foreign-national
participation.
• If work is subject to export controls:
▫ Export Controlled Technology Management Plan
▫ Export Control License from the Federal government
Questions?
ORR Website: www.compliance.iastate.edu
Phone: 294-1515; email: [email protected]
IRB – 294-4566 or 294-4215 or [email protected]
IACUC – 294-9581 or [email protected]
IBC – 294-9581 or [email protected]
RSC – 294-7666 or [email protected]
COI – 294-7793 or [email protected]
Export Controls – 294-7793 or [email protected]