Georgia Institute of Technology
Public Responsibility and
Research Commitments
Office of Sponsored Programs
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Public Responsibility and Research Commitments
Presenters:
Martha Patterson
Compliance Officer
Katia Peixoto
Research Associate
Rhonda Miller
Research Associate
Steve Grimm
Radiation Safety Officer
Shane Gillooly
Biosafety Officer
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Georgia Institute of Technology
Institutional Review Board
Presented by
Martha Patterson
Compliance Officer
Office of Research Integrity Assurance
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What is a human subject?
As defined by 45 CFR 46
Is a living individual about
whom an investigator
obtains either:
Data through intervention
or interaction with the
individual; or
Identifiable private
information
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What is research?
Research: As defined by
45 CFR 46, "a systematic
investigation, including
research development,
testing and evaluation,
designed to develop or
contribute to
generalizable knowledge"
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What is an IRB?
Faculty committee with the purpose of reviewing
research activities involving human participants
Constituted in accordance with federal law:
Minimum of five members
Community representation
Scientific and non-scientific members
Adequate expertise to review the proposed work
Consultants, when needed
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Federal and Other Regulations Governing Human Subjects Research
Title 45 Code of Federal Regulations Part 46, “Federal Policy for the
Protection of Human Subjects” and including Subparts A, B, C, and D.
Title 21 Code of Federal Regulations, Part 50 Protection of Human Subjects,
56 Institutional Review Boards, 312 Investigational New Drug Application, and
812 Investigational Device Exemptions.
Department of Health and Human Services, National Standards to Protect
the Privacy of Personal Health Information Health Insurance Portability and
Accountability Act (“HIPAA Privacy Act”).
State of Georgia Law
Additional Agency or Sponsor Requirements
Department of Defense Regulations
DoD Directive 3216.02, “Protection of Human Subjects and Adherence to
Ethical Standards in DoD-supported Research”
Title 10 United States Code Section 980 (10 USC 980), “Limitation on Use
of Humans as Experimental Subjects”
DoD Instruction 3210.07, “Research Integrity and Misconduct”
DoD Directive 6200.02, “Use of Investigational New Drugs in Force Health
Protection”
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1979: The Belmont Report Established Ethical
Principles and Guidelines for the Protection of
Human Subjects of Research
Respect for Persons
Individual autonomy
Protection of individuals with reduced autonomy
Beneficence
Maximize benefits and minimize harms
Justice
Equitable distribution of research costs and benefits
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Problems Continue
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Oh No!
The Feds Shut Us Down
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What does all this mean to YOU?
Georgia Tech takes seriously its obligation to ensure the
safety of all human research participants.
A study does not have to be a clinical trial in order to
pose risk to participants.
The inadvertent disclosure of personal, private
information can be damaging.
The Office of Research Integrity Assurance will assist
you in obtaining IRB approval.
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How to Secure IRB Approval at Georgia Tech
Ask the Office of Research Integrity Assurance for help,
if needed.
Complete mandated training
Submit protocol application online
Follow requirements for PI eligibility and departmental sign-off.
Utilize consent templates and guidance.
Flawed consent is most frequent cause of delay in approval.
Provide clear description of study. Apply the “grandmother” test.
Include study methodology.
Include recruitment plans, compensation scheme, justification for
number of subjects
Research plans incomplete at time of funding proposal
submission?
Ask Contracting Officer to seek a deferral of IRB approval.
IRB approval must be in place when the funding comes in.
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Lead Time for IRB Review
Full
The Central IRB meets the third Friday of the month; the Joint
Center for Advanced Brain Imaging IRB meets the third
Monday. Deadline is the first week of the month.
Expedited
Initial review is completed generally within 14 working days of
receipt date. Approval may not occur immediately.
Exempt
Investigators are notified, generally within 2 weeks of receipt
date.
NOTE: If you do not have a response from the Office of Research
Integrity Assurance within two weeks of submitting a protocol,
call! Email! Follow up! Sometimes protocols are not
submitted by the department head, but remain in their email inboxes.
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Important Information
http://www.researchintegrity.gatech.edu
IRBWISE information
Human Subjects Training
FAQs
Policy and Procedures
Consent templates
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Contact Information for Human Subjects Research
Melanie Clark, CIP, Associate Director
melanie.clark@gtrc.gatech.edu
404-894-6942
Kelly Winn, CIP, Research Associate
kelly.winn@gtrc.gatech.edu
404-385-2175
Barbara S. Henry, CIP, Executive Director
barbara.henry@gtrc.gatech.edu
404-894-6949
Dennis Folds, PhD, IRB Chair
dennis.folds@gtri.gatech.edu
404-407-7262
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Institutional Animal Care
and Use Committee
Katia Peixoto
Research Associate
Office of Research Integrity Assurance
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How are Research Animals
Protected? Regulatory Agencies
U.S. Department of Agriculture (USDA) –
Animal Welfare Act (A.W.A.) & Code of Federal
Regulations 9 CFR §1.1 – 4.11
Defined Animals - Any live or dead warmblooded animals used in research, teaching,
testing, experimentation. Currently excludes
rats, mice, birds bred for use in research.
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How are Research Animals
Protected? Regulatory Agencies
Public Health Service (PHS) Policy – Office of
Laboratory Animal Welfare (OLAW) – ALL PHS
funded / supported activities involving vertebrate
animals
Any live, vertebrate animal used or intended for
use in research, research training,
experimentation, or biological testing or for
related purposes.
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PHS Policy & USDA A.W.A.
Standard PHS funded
Federal Law
IACUC
IACUC
ALL live vertebrate animals
Defined Animals
Training
Training
Report Non-compliance
Report Non-compliance
Stop Research - Withdraw
funds
Stop Research – Large Fines
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Covered Animals
Mammals
Rabbits, Primates, Cows,
Mice, Rats, Sheep, Elephants
Fish
Sharks, Zebrafish & Goldfish
Amphibians
Salamanders, Frogs
Birds
Reptiles
Snakes, Lizards
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Institutional Animal Care & Use
Committee (IACUC)
Required by both PHS Policy and the Animal
Welfare Act (AWA)
Regulated by U.S. Department of Agriculture
(USDA) and the Office of Laboratory Animal
Welfare (OLAW)
Institutionally based with members designated
by the university chancellor or his/her designee
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Institutional Animal Care & Use
Committee (IACUC)
Primary mission is to foster humane care and
use of laboratory animals in research and
education
Composed of at least 5 members
Scientists, researchers, faculty, veterinarians,
and community members
Generally meet monthly
A no-go decision by IACUC cannot be overruled
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IACUC Responsibilities
Review and approve, require modifications in or withhold
approval of proposals or proposed changes in ongoing
activities.
Have authority to suspend any activity involving animals.
(Requires review and majority vote at convened meeting
with a quorum; Program Veterinarian authorized to halt
any study).
Conduct continuing reviews of activities at least annually.
Review and investigate noncompliance.
Make recommendations to the Institutional Official
regarding any aspect of the institution's animal program,
facilities, or personnel training.
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IACUC Review & Approval
Process
Submission of the IACUC protocol
Preliminary & veterinary review of the
protocol
Designated member review vs. Full
IACUC review
Continuing reviews
Three-year renewal of continuing projects
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Application to Use Animals
www.IACUC.gatech.edu
IACUC@gatech.edu
Also at this site:
Policies and Procedures
Protocol Application, Amendment, and Continuation Forms
Mandatory Training information (CITI courses)
Occupational Health Program Enrollment
Reporting Concerns Regarding Animal Use in Research
Other Resources: The Guide, Regulations, More
Anna Marie Lee, BS, Research Associate
Katia Peixoto, DVM, Research Associate
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Export Control
Rhonda Miller
Research Associate
Office of Research Integrity Assurance
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GENERAL OVERVIEW
Through various regulations, the U.S. Government
restricts the release of critical technologies, including
technical data, to foreign nationals.
U.S. entities are required to obtain an export license
before providing foreign nationals with access to
software or technology that is subject to export licensing
requirements.
Export control is a “team sport” at Georgia Tech.
Export Control Advisory Board
Over a dozen offices involved
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Foreign National
A foreign national is a person who is:
• NOT a U.S. Citizen
• NOT a permanent resident alien of U.S.
• Not a lawfully admitted refugee or political
asylee
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OFAC & TSC
Increasing
restrictions
ITAR
License
Required
Office of Foreign Assets
Control (OFAC) Regulations
Terrorist Supporting Countries
(TSC) list
EAR
for 22 Countries
EAR for Group
B Countries
International Traffic in Arms
(ITAR) Regulations
Export Administration
Regulations (EAR)
Including India and Israel
Fundamental Research
No License Required
OK for All but Embargoed Countries
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What is an export?
Expansive definition of “export” in this
context
Export: The transfer/disclosure of items,
materials, information, software, technology
or other unclassified but controlled data to
any person outside U.S. (including to
another U.S. citizen abroad)
NOTE: OFAC includes any services; ITAR
includes defense services as Exports
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What is a “Deemed Export?”
An export of controlled technology or code when
released to a foreign national within the U.S.
Release is making technology or software
available to non-U.S. persons, either visually,
orally or by practice or application under guidance
of persons with knowledge of the technology or
software
Includes “use technology” – information on the
operation, installation, maintenance, repair,
overhaul, and refurbishing of controlled
equipment. “Release” requires all six elements &
access to proprietary manual.
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Export Review Process
A determination is made by a Contracting Officer or
Research Associate that an export review is needed.
Research Integrity Assurance screens for denied
parties, and conducts export review.
Project Director/Principal Investigator (PI) completes
questionnaire.
Research Integrity coordinates with Export
Coordinators and Legal Affairs as needed.
USML or CCL are reviewed to determine if project is
eligible for the Fundamental Research Exclusion
(FRE).
Technology Control Plan put in place if needed.
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What is Fundamental Research
NSDD -189 NATIONAL POLICY ON THE TRANSFER OF
SCIENTIFIC, TECHNICAL AND ENGINEERING
INFORMATION
I. PURPOSE
• This directive establishes national policy for controlling the
flow of science, technology, and engineering information
produced in federally-funded fundamental research at
colleges, universities, and laboratories.
• Fundamental research is defined as follows:
"'Fundamental research' means basic and applied research in
science and engineering, the results of which ordinarily are
published and shared broadly within the scientific community, as
distinguished from proprietary research and from industrial
development, design, production, and product utilization, the
results of which ordinarily are restricted for proprietary or
national security reasons."
NSDD: National Security Decision Directive
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Policies
Georgia Tech policies and procedures generally reflect
the expectation that research will be performed under
the fundamental research exemption.
Georgia Tech policies have specific provisions for
compliance with export controls and classified research.
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Falling outside of the fundamental
research exclusion (FRE)?
PI/PDs goes after awards
with restrictive clauses that
may involve:
Unclassified Controlled
Information
Military/DoD contracts
Foreign National
Restrictions
Publication Restrictions
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Why the concern about awards
outside of the Fundamental Research
Exclusion (FRE)?
Non-U.S. persons generally may not work
on any project ineligible for FRE.
Students (including U.S. citizens)
generally may not work on any project
ineligible for FRE for their theses or
dissertations.
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Technology Control Plan (TCP)
Restrictions/Terms & Conditions
No Foreign Nationals
Publication Restrictions (DFAR 7000)
ITAR Clauses (DFAR 7008)
Funding from Department of Defense
appropriations: 6.1, 6.2, 6.3 …
Sensitive But Unclassified (SBU)
Export controlled information on the
unclassified portion of a classified project
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Hosting Visitors at GT
Visitor Policy under development
Visitors should be screened against the
Denied Parties & Denied Entities list
Consult Office of Legal Affairs
Lab tours should be “Clean” – No tours of
labs with Export Controlled information
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Common Areas of Concern
Foreign travel
Confer with Legal
What equipment are
you taking?
Laptop? Jump drive?
Shipping materials to
foreign destination
Use EHS
Foreign visitors
Confer with Legal
Plan ahead
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Violations & Penalties
Failure to comply with U.S. export control laws can result in
severe penalties, both for the individual (this means YOU
personally) and for Georgia Tech:
• Criminal Penalties1
Fines: $1,000,000 per violation and imprisonment of up to 10
years.
• Civil
Fines: $250,000 per violation, or twice the monetary amount
of the underlying transaction, which ever is greater
If ITAR=$500,000 per violation
• Debarment from working with export controlled information
• Negative Publicity
1. ITAR, EAR and OFAC all impose criminal and civil penalties, although the ranges of the penalties vary.
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A Timely Example
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Contacts
• Email: export@gatech.edu
• Web Site: www.export.gatech.edu
Ted Evans, MS, Compliance Officer
Rhonda Miller, M.Ed., Research Associate
Mary Beran, MA, Associate Director
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Office of Radiological Safety
www.ors.gatech.edu
Steve Grimm
RSO
4-3621
Cell 404-234-4360
Gary Spichiger
ARSO
4-8847
Laser Safety Officer
Christina Tabor
Darrell Neal
Senior HP 4-8846
HP
5-0779
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Georgia Tech Organization
ORS unit within EHS
RSO reports to
Director of EH&S
Dr. Steve Cross- Executive Vice President of
Research
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Regulatory Agencies
State of Georgia
Georgia Department of Natural Resources
Enforce Nuclear Regulatory Commission Rules
Radioactive materials
Radiation exposures (Occupational/Public)
Shipments of radioactive material
Georgia Department of Community Health
X-ray generating devices
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Broad Scope License-GA DNR
Largest license available
Allows for a variety of research projects
Only valid within the State of Georgia
Issued to the Georgia Tech President
Delegates to Radiation Safety Committee
Radiation Safety Officer-Named on License
• Weakest Link: One researcher can
jeopardize the license.
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Program Scope RAM/XRAY
95 Authorized Users
800 Radiation Workers
130 Labs
Only accept Georgia Tech training
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Radiation Usage at Georgia Tech
Used in various departments
throughout campus
Radioactive Material
Sealed Sources in devices
Unsealed Sources-liquid sources
Various types of x-ray producing
devices
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RAM Usage at Georgia Tech
Carbon-14 Low energy Beta
H-3 (Tritium) Low energy Beta
Iodine-125 Low energy Gamma
P-32 High energy Beta
External Hazard
Sulphur-35 Low energy Beta
UNSEALED SOURCES
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RAM Usage at Georgia Tech
Sealed sources in devices
Gas Chromatograph- GC
Electron Capture Device-ECD
Liquid Scintillation Counters
Mossbauer Spectroscopy
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X-Ray Generating
Devices
Crystal or powder x-ray diffraction unitMost Common--XRD
Transmission or scanning electron
microscope—TEM, SEM
X-ray fluorescence spectroscopy
equipment—XRF
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X-Ray Generating Devices
Diagnostic X-Ray- (Dental) Health Center
Non-Medical Flouroscopy UnitsCRB and Physics
Require lead shielding, scatter surveys
X-RAYS generated as byproduct
-need energy (greater than 5 kev) and current
E-Beam Evaporator
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X-Ray Generating
Devices
Have to be registered with GA DCH
ORS inspects all x-ray devices
annually
Annual Report sent to GA DCH
Any potential overexposures or
device failures also have to be
reported
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Process for AU/Rad Worker
Form A- Authorized User, approved by
Radiation Safety Committee
For RAM and X-Ray Units
Form B- Radiation Worker, Must complete
training
Emergency Response covered in training
All forms/training dates available on website
www.ors.gatech.edu
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Ordering, Shipping, and
Receiving
All orders go through ORS
AU must be approved for specific isotope
and physical form or x-ray unit, procedure,
and laboratory
Procurement will contact ORS for approval
before ordering high cost items
Contamination survey required
All RAM orders delivered to ORS
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Examples of RAM Packages
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ORS Responsibilities
Survey all RAM labs Quarterly
Radioactive Waste Pick-Ups
Radioactive Waste Shipments
Inventory of sources
Training of AU’s and Radiation Workers
Emergency Response
Training of GT Police and local Fire
Department
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RAM Spill Response
Workers are trained to respond to spills,
ALERT OTHERS
Can enter room for life saving activities
CONTAMINATION CONTROL IS THE
KEY
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Laser Safety Program
Comprehensive Program for over 400
Class 3B and 4 lasers
Includes a Laser Safety Policy Manual,
LSC, and online Laser Safety Training
LSO conducts hazard evaluations for laser
setups
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Injury Examples
~ 3 years ago – UV laser not properly
shielded. Resulted in “sunburn” to
user (research faculty-GT)
~1 year ago – IR laser beam path
modified with no laser protective
eyewear. Resulted in permanent
retinal damage (grad student-GT)
Various anecdotal reports of skin burns
at GT
July 2004 – Permanent central vision
loss in left eye; Improper or no
protective eyewear worn (grad studentLos Alamos)
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Laser Rated Barriers
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Call us, we’re here to help!
The earlier ORS is involved in acquisition
of RAM or X-Ray, the easier the process
will be for everyone, so call us when you
first decide.
Good luck with your research!
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recombinant DNA (rDNA) and Synthetic
Nucleic Acid Molecules
Shane Gillooly
Biosafety Officer
Environmental Health & Safety
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Institutional Biosafety Committee
Faculty Committee composed of
faculty, attorneys, community
members, biosafety officials, and
an ex-officio member
Chaired by Dr. Andres Garcia,
Mechanical Engineering
Meets quarterly or as needed
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Institutional Biosafety Committee
The role of the committee is to assure that laboratory
practices are safe and in accord with federal and state
regulations.
All activities involving recombinant DNA (rDNA) or
Synthetic Nucleic Acid Molecules, regardless of source
of funding, must be reviewed by the IBC.
The IBC has the responsibility and authority to review,
approve, disapprove, or require changes in activities
involving these materials.
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Office of Research Integrity Assurance
Maintains Georgia Tech’s registration with the National
Institutes of Health’s Office of Biotechnology Activities
(OBA)
Works closely with Georgia Tech’s Responsible Official and
Biosafety Officer in the Office of Environmental Health
and Safety
Provides administrative support to the Institutional
Biosafety Committee
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Training
NIH Guidelines, Section IV-B-1-h, the Institutional
Biosafety Committee requires that all personnel named
in rDNA registrations complete certain training.
Registration for the 1.5 hour course, presented by
Environmental Health & Safety (EHS), may be
accomplished online at http://www.orgdev.gatech.edu.
There is no charge for the course. Contact EHS at
404.894.6120 for more information regarding registration
and scheduling.
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Guidelines, Forms, More…
www.IBC.gatech.edu
National Institutes of Health Guidelines for Research
involving Recombinant or Synthetic Nucleic
Acid Molecules - Revised March 2013
Email: IBC@gatech.edu
Katia Peixoto, DVM, Research Associate
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Biosafety
• Shane Gillooly – Biosafety Officer
• Topics:





Bloodborne Pathogens
Biological Materials Safeguards Committee
Biosafety Occupational Health Program
Biological Select Agents & Toxins
Shipping
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Bloodborne Pathogen Laws
• FEDERAL LAW: 29 CFR 1910.103

Bloodborne Pathogen Standard
• PUBLIC LAW 106-430: H.R. 5178

Needle Stick Safety and Prevention Act
• GA. STATE LAW: H.B. 1448

Diseases; Bloodborne Pathogens; Sharps
Injury Protection
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Georgia Law
Public Law 106-430
•
Law applies to, but not limited, to: “Front-line health care workers”
 Includes anyone using needles in a research environment
•
Requires a written exposure control plan
•
Maintaining an injury log
•
Requires a training program
•
Requires use of personal protective equipment (gloves, mask, safety
glasses or other engineering controls)
•
Recommends using a needle-less system whenever possible
•
Law does state, the adopted standard be at least as prescriptive as
the standard promulgated by OSHA
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OSHA Federal Standard
Occupational Health and Safety Administration
29 CFR 1910.1030
The
Standard
requires
employers
establish an
Exposure
Control Plan
covering
Use engineering controls
Enforce work practice controls
Provide personal protective equipment (PPE)
Make Hepatitis B vaccinations available
Provide post-exposure follow-up
Use labels and signs
Provide information and training to employees
Maintain employee medical and training records
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BBP Law Applicability
• OSHA does not apply to State agencies
• If an individual performs research for an
outside firm, such as a co-op, the
researcher comes under OSHA
• Researchers working at Emory come
under OSHA, because Emory is private
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Biological Materials Safeguards Committee
•
The committee is
comprised of three faculty
and members from EHS
and ORIA
•
Reviews all bio materials
not covered by IBC
•
Submissions to the
committee are made
online via Onsite
•
Approvals last for 3 Years
•
Prerequisites for Approval:
•
Successful lab inspection
• All training is complete
• Personnel enrolled in the
Biosafety Occupational Health
Program
• Attachment of Biological
Hygiene Plan to the
submission
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Biosafety Occupational Health Program
• The Occupational Health Program aims to identify potentially hazardous
occupational tasks on an individual basis and mitigate potential risks
• The Biosafety Occupational Health Program (BOHP) is a subset of the
Occupational Health Program
 Concerned specifically with worker wellbeing and occupational exposures
associated with biological materials and animals
• The Biosafety Medical Monitoring Program (BMMP), part of the BOHP, is
a program which employs the use of medical monitoring as a means to
prevent occupational exposure
 This may include vaccinations, titer checks, and potential blood analysis
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BOHP Enrollment Process
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Select Agents & Toxins
• The Animal and Plant Health Inspection Service (APHIS) and the
Division of Select Agents and Toxins at the Centers for Disease
Control and Prevention (CDC) regulate the use and possession of
Biological Select Agents & Toxins
• To work with these agents, investigators and institutions must
follow very strict rules including background checks, CDC
inspections, and documentation requirements
• If we had approval to work with these agents, we would have a
“Responsible Official” designated to oversee the program
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Toxins in Exempt Quantities
• When maintained at quantities
below the exemption limit, the
toxins are exempt from the
Select Agent Regulations
Toxin
Exempt
Amount
Abrin
100 mg
Botulinum neurotoxins
0.5 mg
Short, paralytic alpha
conotoxins
100 mg
Diacetoxyscirpenol (DAS)
1000 mg
Ricin
100 mg
Saxitoxin
100 mg
Staphylococcal
enterotoxins (Subtypes
A, B, C, D, and E)
5 mg
T-2 toxin
1000 mg
Tetrodotoxin
100 mg
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Shipping Biological Materials
• There are regulations when shipping biologicals,
chemicals and radiological materials
• Failing to ship properly could result in fines for Tech, the
shipper, and possible criminal charges
• EHS ships hazardous materials for the Institute,
however, all shippers bringing items to EHS must be
trained and tested to transport items on campus
 The training is online and available through trains.gatech.edu
• Shippers must also complete documentation:
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•
•
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Biological Shipping Form (For Biological Shipments)
Material Transfer Agreement (MTA)
Inter-Departmental Sales and Services Authorization Form (IDSS)
Export Review Form (International Shipments Only)
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Biosafety Responsibilities
• Principal Investigator
 Taking Training
 Submitting protocol
applications to appropriate
committees
 Adhering to safety documents
and hygiene plan
 Reporting Accidents/Injuries
 Ensuring personnel are
trained and enrolled in OHP
 Oversee lab safety
• Researcher
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


Taking Training
Reporting Accidents/Injuries
Wearing appropriate PPE
Enrolling in the Occupational
Health Program
 Following GT Biosafety
Manual
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Biosafety Office Responsibilities
•
•
•
•
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Approve biological facilities for safe work
Provide training to GT community
Serve on biosafety related committees
Provide advice on laboratory security
Provide technical advice on laboratory safety procedures
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Any Questions?
• Contact the Biosafety Officer:
 404-894-6120
 biosafety@ehs.gatech.edu
• Visit our website!
 www.ehs.gatech.edu/biological
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