Responsible Conduct
of Research &
Research Compliance
Adam J. Rubenstein, Ph.D.
Director of Research Compliance
Old Dominion University Office of Research
Responsible Conduct of Research
(RCR)
“The responsible conduct of research means the
functioning of the research process meets the
professional obligations of scientists and contributes
to the perpetuation of science as a social institution
held in high regard.”
Lawrence Rhodes, Office of Research Integrity
RCR Core Elements
 Human subjects
 Animal subjects
 Data acquisition, management, sharing, ownership
 Publication practices/responsible authorship
 Peer review
 Mentor/trainee responsibilities
 Conflict of interest/commitment
 Collaborative science
 Research misconduct
AMERICA Competes Act,
signed into law in 2007
SEC. 7009. RESPONSIBLE CONDUCT OF RESEARCH.
 The Director shall require that each institution
that applies for financial assistance from the
Foundation for science and engineering research
or education describe in its grant proposal a plan
to provide appropriate training and oversight in
the responsible and ethical conduct of research to
undergraduate students, graduate students, and
postdoctoral researchers participating in the
proposed research project.
New NSF Requirements
 Effective January 4, 2010 all new proposal
submissions must certify that the institution has in
place an RCR training & oversight plan for
undergraduates, graduate students and postdoctoral
researchers supported by NSF.
 Training plans need not be submitted with the
proposal, however, they must be provided for review
upon request.
New NSF Requirements
 Institutions are responsible for verifying that their
undergraduate students, graduate students and
postdoctoral scholars receive training.
 Institutions are provided maximum flexibility in
creating and implementing RCR programs to meet
this new requirement.
 These requirements do not apply to existing NSF
awards.
New ODU Requirements
 On January 7, 2010 President Broderick approved
an Institutional RCR Program requiring all
graduate students to complete the Collaborative
Institutional Training Initiative (CITI) seven core
RCR training modules within twelve months of
enrollment.
 http://www.citiprogram.org
Tracking RCR Completion
 Grant requirement
 PIs are responsible for submitting documentation of
completion to ODURF
 ODU graduate student requirement
 Tracking done via Registrar’s Office
 Failure to complete requirement by the end of the
student’s first 12 months will result in a registration hold
Research Compliance
• Conformance with Federal, State, and Local Regulations
and University Policies
• Protection of human subjects
• Institutional Review Board
• Welfare of laboratory animals
• Institutional Animal Care and Use Committee
• Safe use of radioactive material and radiation-producing
machines
•
Radiation Safety Committee
• Safe conduct of recombinant DNA research
• Institutional Biosafety Committee
• Attention to safety and integrity issues
Human Subjects Research
ODU policy is guided by federal regulations requiring
the review of federally-supported research
• Institutional Review Board – meets monthly
• All research if a university chooses to apply 45CFR46
to research (ODU does)
ODU Human Subjects Review
Research must be reviewed & approved prior to
data collection
Is the study federally-supported?
yes
no
Does the study meet
exemption criteria?
no
(See 45CFR46)
yes
Submit to College Committee
(There are 6 college committees at ODU)
Submit to IRB
(There is 1 IRB at ODU)
Human Subjects Training
• All Responsible Project Investigators (RPIs),
proposing non-exempt research must document
on-line training within the past 12 months from:
• http://www.citiprogram.org
• A copy of the completion certificate must accompany
proposal applications to the IRB (and NIH)
• RPIs must ensure training of all personnel
IACUC
Reviews proposed teaching and research
protocols involving the use of live animals
Review Process
• Two Mechanisms
• Designated Member Review
• Utilized for simple studies with “non-inspectable”
animals (e.g. mice, rats, reptiles, amphibians)
• Full Board Review – reviewed at monthly meetings
• Utilized for “inspectable” animals (e.g. rabbits,
hamsters) and complex procedures
Training
 Multiple paths for satisfying training requirements
 Laboratory Animal Training Association (LATA) online
modules
 Documentation of expert training (consultant; faculty
training student)
 Training by animal facility manager
 Training by attending veterinarian
RSC
• Reviews all applications for the possession and use
of sources of ionizing radiation
• Establishes the policies and procedures for conduct
of the Radiation Protection Program
Radiation Safety Training
• Required for faculty or students who have little or no
experience with radioactive materials
• Radiation Safety Officer (RSO) teaches a 6-hour
course
• Users are required to pass test
• There is a shorter course for those using radiation
producing machines
IBC
Reviews teaching and research protocols involving
recombinant DNA that are considered non-exempt
under the NIH “Guidelines for Research Involving
Recombinant DNA Molecules.”
Training
 Less standardized than other areas
 Training plan is coordinated with ODU Biological
Safety Officer
Other Compliance Issues
Activities are strictly regulated and may require review
by EHSO or the Office of Research
• Specialized waste disposal
• Controlled Substances
• Bloodborne Pathogens
• Laser Safety
• Hazardous Materials
• Electrical Safety
Contact info
Adam J. Rubenstein, Ph.D.
Director of Research Compliance
683-3686
arubenst@odu.edu
http://www.odu.edu/ao/research/compliance/index.shtml