Office of Research Compliance
working to support Research Integrity
Lisa Kelly, R-LATG
Compliance Training Coordinator
Quality Assurance Coordinator
conformity in adhering to official
requirements
Office of Research Compliance
2
…An unwavering
commitment to do
the right thing
Office of Research Compliance
3
Reduce Burden
42% of a Researcher’s time is consumed by administrative tasks
Streamline regulatory process
 Provide good customer service
 Reduce administrative burden
 Facilitate Science

Office of Research Compliance
4
Departments and Program
Research Integrity
Office of Research Compliance
5
Oversight of the use of animals in scientific
investigation and instruction
managing the compliance activities of the IACUC
administering the research support functions of URAR
Office of Research Compliance
6
Federal Laws and Guidelines
LAW
GUIDELINES
PHS Policy
U.S.Govt Principles
Animal Welfare Act
/ Regulations
The “Guide”
Office of Research Compliance
The “Ag Guide”
7
UGA’s Animal Care and Use Program


Biomedical and Veterinary Program are
PHS-Assured – so UGA can accept federal
funding
Biomedical and Veterinary Program are
fully accredited by the Association for
Assessment and Accreditation of
Laboratory Animal Care International
(AAALAC) – Gold Seal for ACU Program
Office of Research Compliance
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Institutional Animal Care and Use
Committee
5 Veterinarians
7 Scientists
1 Animal Care
Technician
1 Environmental
Safety
Professional
1 Biosafety
Professional
2 Non-Scientists
Unaffiliated
“Community Members”
Office of Research Compliance
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Animal Use Protocol
Must be faculty to submit an Animal Use Protocol (AUP).
AUPs are categorized A-D depending on the potential for pain or distress.
AUPs have a 3-year lifespan but are renewed annually.
Training compliance is required prior to AUP approval.
Office of Research Compliance
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Animal Care and Use Training


IACUC 101 (Refresher every 3 years)
Staying Healthy
• Both found on the AALAS Learning Library
Now access through the GEAR website at http://gear.ovpr.uga.edu
Use UGA MyID and Password

1 hour of CE every 3 years

Occupational Health Questionnaire
• Must return even if participation is declined
Office of Research Compliance
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You cannot use animals in research
or instruction without an APPROVED
Animal Use Protocol.
Office of Research Compliance
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Office of Animal Care and Use





Dr. Chris King – Director
Tammy Bridges– Administrative Specialist
Eric Smith – IACUC Coordinator
Chris Carter – Compliance IT Administrator
Lisa Kelly – Compliance Training Coordinator
Office of Research Compliance
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University Research Animal Resources
Provides appropriate husbandry and
handling of laboratory animals through
animal facility management, technical
assistance, training and consultation
Life Sciences and Vet Med divisions are in the
process of consolidating.
Office of Research Compliance
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URAR Personnel
Will soon have a URAR Director
Life Sciences

Veterinary Medicine
Dr. Leanne Alworth (Dir/AV))
• Robin Kavanaugh (manager)
• Lauren Luken (office)



Lisa Wilson – Coverdell
Kristine Wilcox – Life
ADS
Psychology
Todd McDaniel – Biosciences
• Other off campus facilities

Dr. Stephen Harvey (Dir/AV)
• Angelia Chappelear (office)
• Ben Bonner (manager)
Frank Waters – VBF
 Missy Waters – Central
 Jeffrey Martin – AHRC

• Greg Eidson (manager) – PDRC
• Other off campus Vet Med
facilities
Office of Research Compliance
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16
Provides guidance and assistance to protect
faculty, staff and students from exposure to
biohazardous materials and to guard against
the release of these material. Biosafety also
provides administrative support to the IBC
and administers the SA program for UGA.
Office of Research Compliance
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Federal Laws, Guidelines and Programs


NIH Guidelines for Research Involving Recombinant or Synthetic
Nucleic Acid Molecules
National Select Agent Registry (SAP)
• Title 42 CFR Part 73, Title 9 CFR Part 121, Title 7 CFR Part 331
• US Govt Policy for Oversight of Life Sciences Dual Use Research of
Concern






Other state and federal laws that apply to biological research
Biosafety in the Microbiological & Biomedical Laboratory (BMBL)
OSHA Bloodborne Pathogens Standard
Arthropod Containment Guidelines (ACG)
Etiologic Agent Import Permit Program (EAIPP)
USDA APHIS Permitting Program
•
•
•
•
Animal and Animal Products
Veterinary Biologics
Biotechnology (e.g. genetically engineered organisms)
Plant, Organisms, and Soil
Office of Research Compliance
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When is an IBC protocol required?
For all research and teaching projects involving:
 Recombinant DNA (including transgenic animals
and plants)
 Select Agents and Toxins
 All human or plant pathogens, RG2 or greater
 Animal pathogens that cause diseases reportable to
the State Veterinarian
 Plant pathogens that are not indigenous to the state
 Any diagnostic testing that involves propagation of
RG3 pathogens or Select Agents and Toxins for use
as a test reagent
Office of Research Compliance
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Questionnaire
Paper form found on the Biosafety website at www.ovpr.uga.edu/biosafety
Must be faculty to submit an IBC Protocol.
Post-docs may submit if faculty is listed as Co-PI.
IBC Protocols must be renewed yearly using Annual Renewal Form for up to 5 years.
Training dependent on Biosafety Risk Group assessment.
Office of Research Compliance
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Institutional Biosafety Committee
1 Biosafety
Professional
5 Scientists
1 Laboratory
Technician
1 Environmental
Safety
Professional
1 Attending
Veterinarian
2 Unaffiliated
“Community Members”
1 is an Occ Health Physician
Office of Research Compliance
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Risk Groups and Biosafety Levels
BSL1 – Well characterized agents not known to cause disease in
healthy adults
 BSL2 – Agents associated with human disease which is rarely
serious or for which preventive or therapeutic interventions are
often available
 BSL3 – Agents that are associated with serious or lethal human
disease for which preventative or therapeutic interventions may
be available (high individual risk, low community risk)

The correlation between Risk Group and Biosafety
level depends on risk assessment (e.g. quantity, how it
is used, etc.)
Office of Research Compliance
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Biosafety Training

Recommended for anyone working with biohazardous
materials – “Proficiency in Standard and Special
Microbiological Practices” form on Biosafety website
• Required of Select Agent Program personnel




Anyone working with human pathogens – PI-lead orientation
prior to beginning work and annually thereafter
Human (maybe NHP) body fluids, tissues or cell lines –
Board of Regents Bloodborne Pathogens Training –
www.usg.edu/facilities/training/pathogens/
Select Agents – agent specific training as required by the
Responsible Official
Occupational Health Questionnaire (same form as OACU)
•
Must return even if participation is declined
Office of Research Compliance
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IBC Protocol Types

Full Committee
• Recombinant DNA research
• All BSL3 or higher work
• Research involving a Select Agent or Toxin

Subcommittee
• Research involving reportable animal pathogens
• Research involving non-indigenous plants
• Risk Group 2 human or zoonotic pathogens (not
Select Agents)
Office of Research Compliance
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You cannot begin to work with rDNA,
biological agents or toxins until you
have an approved IBC protocol.
Office of Research Compliance
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Other Reasons to Contact Biosafety






Shipping or receiving biohazardous material
Applying for USDA permit
Questions about use or certification of biological
safety cabinets or other primary containment
devices
Questions about sharps safety or disposal
Need assistance with a waste solution assessment
To request Laboratory Operations Review
(new or existing lab: review not an inspection)
(all RG levels)
Office of Research Compliance
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BioSafety Office








Patrick Stockton – Director / RO
Manley Kiser – Associate Director / AHRC ARO
Nancy Mead – IBC Coordinator / ARO
Kelly Crumley – Select Agent Program Manager
Chad Cheely – Biosafety Specialist
Suzanne Cook – Administrative Specialist
Chris Carter – Compliance IT Administrator
Lisa Kelly – Compliance Training Coordinator
Office of Research Compliance
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28
Works to provide a safe workplace for all
personnel involved in research using animals
or biohazardous agents.
Office of Research Compliance
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Occupational Health and Safety
The OHSP applies to any UGA employee (faculty, staff, students,
volunteers, visitors) who…
• Works with vertebrate animals, or animal tissues, fluids, secretions, and/or
excretions
• Works with biohazardous agents
• Handles cages and related equipment contaminated by animal tissues,
fluids, secretions and/or excretions; or routinely enters into facilities where
animals are maintained
Office of Research Compliance
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Questionnaire
Must complete this section and return if you decline to participate
Office of Research Compliance
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Professionally and administratively supports
the IRB, the research oversight committee
charged with ensuring that human subjects
research is conducted in compliance with
applicable laws, policies and guidelines
Office of Research Compliance
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Federal Agencies and Laws

National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research (1974)
• Belmont Report – Ethical Principals and Guidelines for the
Protection of Human Subjects of Research (1979)

Codified in Federal Registry Title 45 CFR Part 46
• Subpart A – “Common Rule”
• Subpart B – Protection for Pregnant Women, Human Fetuses and
Neonates
• Subpart C – Protection for Prisoners
• Subpart D – Protection for Children
• Subpart E – Institutional Review Board



Health Insurance Portability and Accountability Act (HIPAA)
Family Educational Rights and Privacy Act (FERPA)
The Office of Human Subjects Protections (OHRP)
Office of Research Compliance
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UGA’s Human Subjects Program


Program has Federalwide Assurance (FWA) –
so that UGA may accept federal funding
In the process of obtaining Association for the
Accreditation of Human Research Protection
Programs (AAHRPP) Accreditation
Office of Research Compliance
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Institutional Review Board
7 Scientists
3 Non-Scientists
1 Physician
1 Community
Member
Office of Research Compliance
1 alternate
non-scientist
community member
represents prisoners
35
Human Subjects Training



Human Subjects Social & Behavioral Research
or
Human Subjects Bio-Medical Research
And additional modules as required by the IRB
•
Examples: Modules on Children, International Research, Internet Research, Prisoners
Repeat Training every 5 years
Office of Research Compliance
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IRB Protocol
•
•
•
•
•
Training compliance is required prior to IRB Protocol submission.
Must be faculty or senior staff to submit an IRB Protocol.
Certain IRB Protocols must receive continuing review annually.
Approval is good for 5 years and then you must resubmit a new Protocol.
Review of Consent Documents, Recruiting Documents, and Data Collection
Instruments, not just Protocol, required.
Office of Research Compliance
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IRB Protocol Types

Exempt
Examples (6 federal + 2 institutional):
• Minimal risk use of existing or prospective identifiable
data/documents without sensitive information (no federal funding)
• Minimal risk research involving qualitative data collection procedures
and non-physically invasive tasks or manipulations (no federal
funding)

Expedited
• No more than minimal risk and fits within certain
categories described in the federal regulations
(9 categories)

Full Committee
Office of Research Compliance
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You cannot begin to recruit volunteers
until you have an approved IRB protocol.
Office of Research Compliance
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Human Subjects Office







Dr. Benilda Pooser – Director
Kim Fowler – Assistant Director
Angela Bain – IRB Specialist
Tammi Childs – IRB Coordindator
Mysti Scheuer – IRB Coordinator
Chris Carter – Compliance IT Administrator
Lisa Kelly – Compliance Training Coordinator
Office of Research Compliance
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41
New to the University of Georgia
Providing oversight to access of scientific instruments,
technologies, software and materials by foreign
nationals in order to comply with federal export control
regulations. In addition, this office will provide support
and training to those individuals that conduct business
with the international community.
Office of Research Compliance
42
Export Control Regulation
Department of State, Directorate of Defense Trade Controls
International Traffic in Arms Regulations (ITAR)
 Relates to military and defense articles and services
Department of Commerce, Bureau of Industry and Security
Export Administration Regulations (EAR)
 Relates to “dual use” items, information or software
Department of Treasury, Office of Foreign Assets Control
 Administers and enforces economic and trade sanctions
Office of Research Compliance
43
Fundamental Research Exclusion (FRE)
Basic and applied research in science and engineering
conducted at a U.S. research institution, the results of which
ordinarily are published and shared broadly within the scientific
community, are typically exempt from many Export Control
regulations.
Office of Research Compliance
44
Development of
Export Control Program
Focal Point Administrators for units with export
compliance risks
 Training initiative to educate those in risk-sensitive
research areas and operational groups
 “Classification and Jurisdiction Determination” process
and identify items that need a “Control Plan”
 Working with International Education to link H1 VISA
beneficiary assignment with EAR/ITAR access
requirements for licensing and technology control
purposes

Office of Research Compliance
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High-Risk Departments





Marine Sciences
Geography
Physics/Astronomy
Engineering
Areas with Restricted Funding
UGA currently has no Restricted Funding.
No UGA Policy on Restricted Funding.
Office of Research Compliance
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Office of Export Control



Dan Runge – Export Compliance Officer
Chris Carter – Compliance IT Administrator
Lisa Kelly – Compliance Training Coordinator
Office of Research Compliance
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Research Compliance
Export Control
48
Provides guidance to UGA faculty, staff and
students on the safe use of chemical agents,
radiation safety and laser safety.
Office of Research Compliance
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Research Safety
Chemical and Lab Safety
New lab openings
Radiation Safety
Radiation
Office of Research Compliance
X-Rays
Lasers
50
Chemical Safety
Public Employee Hazardous Chemical
Protection and Right to Know Act of 1988
Training:
 Initially
 When a new hazard is introduced
 Annually
http://www.usg.edu/facilities/rtk-ghs
Office of Research Compliance
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OSHA
 Must meet or exceed OSHA standards
 Considered as reasonable benchmarks or
“Best Practices”
Office of Research Compliance
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Radiation Safety

Each permit holder must designate an
Advanced Radiation Safety Worker
• 4 x 4hr live modules and annual online
Refresher Training

All Radiation Safety Workers
• Training by Advanced Radiation Safety Worker
with documentation and annual online
Refresher Training
Additional online training for those working with X-Rays or Lasers
Office of Research Compliance
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You cannot order radioisotopes until
you have an approved Radioactive
Material Permit and a designated
Advanced Radiation Worker.
Office of Research Compliance
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Research Safety Office












Zeke Barrera - Director
Regena Curry – Administrative Associate
Wesley Kolar – HazMat Operations Coordinator
Bruce Hild – Research Safety Specialist
Ken McDaniel – Research Safety Specialist
Star Scott – Research Safety Specialist
Jody Jacobs – Radiation Safety Manager
Dennis Widner – Radiation Safety Specialist
Lauren Palmer – Radiation Safety Specialist
John Pyle – Radiation Safety Technician
Chris Carter – Compliance IT Administrator
Lisa Kelly – Compliance Training Coordinator
Office of Research Compliance
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Research Compliance
Export Control
56
Research Compliance
Export Control
Providing information and training on federal
Good Laboratory Practices (GLP), the recognized
rules governing the conduct of non-clinical safety
studies that ensure quality, integrity and
reliability of study data. This office also
conducts audits of facilities, data and research as
required under GLP regulations.
Office of Research Compliance
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Federal Laws and Guidelines

Good Laboratory Practice Regulations –
research intends to support applications for
permits for products regulated by the FDA
or the EPA
• FDA – Title 21 CFR Part 58
• EPA – Title 40 CFR Part 160
Currently UGA has no active GLP studies.
Office of Research Compliance
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Quality Assurance

Lisa Kelly – Quality Assurance Coordinator
Office of Research Compliance
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60
Research Integrity
Providing oversight and training to ensure the
highest ethical standards in research at the
University of Georgia.
provides instruction in Responsible Conduct of Research and
Conflict of Interest.
The Research Integrity Officer investigates allegations of
research misconduct.
Office of Research Compliance
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Research Integrity
Research Misconduct
Office of Research Compliance
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RCR Focus Evolves Over Decades
NRSA: Training
grants require
RCR
Animal
Welfare
Act
1966
Belmont
Report
1979
IOM: RCR
important
for health
sciences
1991
1989
Office of Research Compliance
NIH
requires
RCR
NSF
requires
RCR
2000
2009
63
RCR Training Requirement

National Science Foundation – anyone paid
(conference, travel, symposium and workshop grants are exempt)
• CITI RCR Course (4 versions, 7 of 9 topics)




Physical Sciences
Bio-Sciences
Behavioral and Social Sciences
Arts and Humanities
(Refresher required every 4 years)

National Institutes of Health (K and T Grants)
• 8 hours of face-to-face education
(CBIO 8080; Genetics 8650, GSRC 8550, Pharmacy 7230,
Qualitative Research 8595, VetMed 8550)
Office of Research Compliance
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RCR Topics
1. Protection of Human Subjects
2. Welfare of Animal Subjects
3. Conflicts of Interest
4. Research Misconduct
5. Data Management and Data Sharing
6. Mentor Responsibilities
7. Authorship
8. Peer Review
9. Collaborative Research
Office of Research Compliance
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Exception for RCR Training
Currently waivers or exemptions will only be given for:
• high school students/teachers paid a stipend,
• employees working exclusively in an administrative role on an
NSF research project,
• individuals who have completed a commensurate program of
RCR education that can substituted for the CITI program, and
• employees whose project roles are deemed not related (for
example, washing glassware or animal care).
Email Chris King exception requests and keep records for NSF auditors.
Office of Research Compliance
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Setting off on the road to the responsible conduct of
research
67
What is Research Misconduct?
“Fabrication, falsification, or plagiarism in
proposing, performing, or reviewing research,
or in reporting research results” OTSP Definition
Office of Research Compliance
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Research Misconduct
• Fabrication is making up data or results and recording or
reporting them.
• Falsification is manipulating research materials,
equipment, or processes, or changing or omitting data or
results such that the research is not accurately
represented in the research record.
• Plagiarism is the appropriation of another person’s ideas,
processes, results, or words without giving appropriate
credit
Office of Research Compliance
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Not Research Misconduct
Research misconduct does
not include honest
differences of opinion!
Office of Research Compliance
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Legal Parameters
Represents a “significant departure” from
accepted practices
 Has been “committed intentionally, or
knowingly, or recklessly”
 Can be “proven by a preponderance of
evidence.” (Burden rests with UGA)

NO STATUTE OF LIMITATION
(even if person has left UGA employ)
Office of Research Compliance
71
Applicability

Everyone at UGA, including visitors/guests
• Student might be an exception
If hired on restricted account, Misconduct Policy
applies
 If not hired on restricted account, Academic
Honesty Policy applies

Office of Research Compliance
72
Reporting Misconduct
Everyone has a duty to report suspected misconduct!
Concern!
(RIO
response)
in writing (e.g. email)
verbally to RIO
You are protected by Federal Whistleblower Protections!
Office of Research Compliance
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If in Doubt, Don’t!
Office of Research Compliance
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Conflicts of Interest
are not
Research Misconduct!
Disclosure and
Management are
REQUIRED!
Office of Research Compliance
75
Conflict of Interest Definitions
def. – the simultaneous existence of conflicting primary and
secondary interests whenever financial considerations may
have the potential to compromise or have the appearance of
compromising an investigator’s professional judgment and
independence in the design, conduct, or publication of
research.
COI’s occur whenever a reasonable person concludes that
there is a probability that an individual might emphasize his
or her personal interests over other interests for which
he/she has responsibility.
Office of Research Compliance
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3 Elements required for COIs
1. Acting in a professional or official capacity or
having a position of trust (spiritual, fiduciary, etc.)
2. While having a personal interest (usually
financial)
3. That interferes with objective decision making (or
creates the appearance that decision making is
compromised)
Office of Research Compliance
77
Typical COIs
 Self-dealing
 Acting in roles that conflict
 Accepting benefits and personal gratuities
 Influence peddling
 Using or disclosing confidential information
 Conflicting outside employment or other allegiances
Office of Research Compliance
78
Most Common Faculty COIs
Recruiting
Research Participants
Consulting
Licensing Tech
Procurement
Mentoring
Office of Research Compliance
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Conflict of Interest Snafu’s
Believing too moral or too wise
to have COIs
Confident in wisdom and virtue
to manage COIs on your own
Office of Research Compliance
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Financial Conflict of Interest
Must complete Investigator Disclosure if
submitting PHS units and you have a SFI
(Significant Financial Interest)
• Retrospective for 12 months prior to proposal submission
• Update within 30 days of discovering unreported SFI
• Cover all financial interest >$5000, even if value is not readily
ascertainable
• UGA employees disclose on eResearch Portal at
research.uga.edu/compliance-training/fcoi/
• Non-UGA employee complete “Annual Disclosure of Financial
Interest for Non-University of Georgia Investigators” at
research.uga.edu/compliance-training/fcoi/
Office of Research Compliance
81
Conflict of Interest Training
PHS grant or cooperative agreement Investigators
must complete CoI Training
• Training must be complete prior to award
• Through CITI
• Refresher required every 4 years
Office of Research Compliance
82
Reporting Fiscal Irregularities
Ethics and Compliance Reporting Policy
research.uga.edu/docs/policies/ugarf/UGARF-Ethics-and-ComplianceReporting-Policy.pdf
All levels responsible for preventing and detecting Fiscal
Irregularities
 Obligated to report

• To immediate supervisor or Office of the UGARF General Counsel
• Anonymously at 877-516-3467 or
www.tnwinc.com/uga/
Office of Research Compliance
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Research Integrity (RCR, CoI)
84
Working to increase the knowledge of and
facilitate the highest standards of responsible
research and compliance with federal, state and
university regulations and guidelines.
Office of Research Compliance
85