Office of Sponsored Programs All rights reserved GTRC Georgia
Institute of Technology Public Responsibility and Research
Commitments
Slide 2
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Melanie Clark, CIP Associate
Director Mary Beran, CPIA Associate Director Rhonda Miller Research
Associate Anita McKinney Assistant to the VPR Gary Spichiger
Associate Radiation Safety Officer Shane Gillooly, Biosafety
Officer Presenters:
Slide 3
Office of Sponsored Programs All rights reserved GTRC Georgia
Institute of Technology Institutional Review Board Presented by
Melanie Clark, CIP Associate Director Office of Research Integrity
Assurance
Slide 4
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 5
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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"
Slide 6
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 7
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 8
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC
Slide 9
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 10
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC
Slide 11
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Problems Continue
Slide 12
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Oh No! The Feds Shut Us
Down
Slide 13
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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.
Slide 14
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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.
Slide 15
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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 in- boxes.
Slide 16
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Important Information
http://www.researchintegrity.gatech.edu IRBWISE information Human
Subjects Training FAQs Policy and Procedures Consent templates
Slide 17
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Contact Information for Human
Subjects Research Melanie Clark, CIP, Associate Director
[email protected] 404-894-6942 Kelly Winn, CIP,
Research Associate [email protected] 404-385-2175 Barbara
S. Henry, CIP, Executive Director [email protected]
404-894-6949 Dennis Folds, PhD, IRB Chair
[email protected] 404-407-7262
Slide 18
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Institutional Animal Care and
Use Committee Mary Beran, MA, CPIA Associate Director Office of
Research Integrity Assurance
Slide 19
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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 warm-
blooded animals used in research, teaching, testing,
experimentation. Currently excludes rats, mice, birds bred for use
in research.
Slide 20
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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.
Slide 21
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC PHS Policy & USDA A.W.A.
Standard PHS funded IACUC ALL live vertebrate animals Training
Report Non-compliance Stop Research - Withdraw funds Federal Law
IACUC Defined Animals Training Report Non-compliance Stop Research
Large Fines
Slide 22
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Covered Animals Mammals
Rabbits, Primates, Cows, Mice, Rats, Sheep, Elephants Fish Sharks,
Zebrafish & Goldfish Amphibians Salamanders, Frogs Birds
Reptiles Snakes, Lizards
Slide 23
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 24
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 25
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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.
Slide 26
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 27
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Application to Use Animals
www.IACUC.gatech.edu [email protected] 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
Slide 28
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC recombinant DNA (rDNA) and
Synthetic Nucleic Acid Molecules Mary Beran, MA, CPIA Associate
Director Office of Research Integrity Assurance
Slide 29
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 30
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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.
Slide 31
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Maintains Georgia Techs
registration with the National Institutes of Healths Office of
Biotechnology Activities (OBA) Works closely with Georgia Techs
Responsible Official and Biosafety Officer in the Office of
Environmental Health and Safety Provides administrative support to
the Institutional Biosafety Committee Office of Research Integrity
Assurance
Slide 32
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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.http://www.orgdev.gatech.edu
Slide 33
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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: [email protected]@gatech.edu Katia
Peixoto, DVM, Research Associate
Slide 34
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Export Control Rhonda Miller,
M. Ed. Research Associate Office of Research Integrity
Assurance
Slide 35
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 36
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 37
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC EAR for 22 Countries EAR for
Group B Countries B Countries Including India and Israel OFAC &
TSC Increasing restrictions International Traffic in Arms (ITAR)
Regulations Fundamental Research Export Administration Regulations
(EAR) ITARLicenseRequired No License Required OK for All but
Embargoed Countries Office of Foreign Assets Control (OFAC)
Regulations Terrorist Supporting Countries (TSC) list Office of
Foreign Assets Control (OFAC) Regulations Terrorist Supporting
Countries (TSC) list
Slide 38
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 39
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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.
Slide 40
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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.
Slide 41
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 42
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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.
Slide 43
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 44
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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.
Slide 45
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 46
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 47
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 48
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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 Penalties 1 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.
Slide 49
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC A Timely Example
Slide 50
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Contacts Email:
[email protected]@gatech.edu Web Site:
www.export.gatech.eduwww.export.gatech.edu Ted Evans, MS,
Compliance Officer Rhonda Miller, M.Ed., Research Associate Mary
Beran, MA, Associate Director
Slide 51
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Research Integrity Speaker:
Anita McKinney
Slide 52
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Research in the Public
Interest What is the criteria? the results of the research are made
available to the public on a non- discriminatory basis Shared on
the web, in print, tv, on air Shoemaker-Levy real time it aids in
the scientific education of college or university students Class
curriculum, fellowships, internships, MOOCs it obtains scientific
information that is published Data archives, NIH PubMed, patents,
licenses, internet, print, reports to sponsoring agencies, etc. it
aids a community or geographic area by attracting new industry or
by encouraging the development or retention of an industry Additive
Manufacturing initiative in Southeast
Slide 53
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC How did we get here & why?
Research misconduct surfaced as a public issue in 1970s & 80s
CASES: John Darsee Robert Slutsky Thereza Imanishi-Kari David
Balitmore Margo OToole Researchers insisted that: they could self-
regulate research misconduct was seen as the exception Any policies
should concentrate on the few
Slide 54
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Responsible Conduct of
Research NIH began in 1990 to require all recipients of
institutional training grants to include a description of formal
and informal activities related to the instruction of responsible
conduct of research; Over a span of many years, the NIH/PHS policy
set 9 core instructional areas By 1997, NSF following suit by
requiring responsible conduct in research training for all
participants in their IGERT awards By 2010, all NSF proposals must
contain a plan for training and oversight in the responsible and
ethical conduct of research to undergraduates, graduate students
and post doctoral researchers supported by NSF funding The two
largest granting agencies to academic institutions began to
formulate policy:
Slide 55
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Responsible Conduct of
Research* 1.Data acquisition, management, sharing and ownership
2.Mentor/trainee responsibilities 3.Publication practices 4.Peer
review 5.Collaborative science *NIH core areas for ethical behavior
6.Human subjects 7.Intellectual property 8.Research misconduct
9.Conflict of Interest 10.Animal care and use 11.Export
12.Classified research
Slide 56
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Research Misconduct
Slide 57
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Research Misconduct
Falsification, Fabrication, Plagiarism "Misconduct" Misconduct in
Science,or Scholarly Misconduct" is the fabrication or
falsification of data, plagiarism, or other practice that seriously
deviates from those that are commonly accepted within the academic
or research community for proposing, conducting or reporting
research or scholarly activity. It does not include honest error or
honest differences in interpretation or judgments of data.* *NIH
definition of Research Misconduct
Slide 58
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Research Misconduct Types of
scientific misconduct: Failing to fairly scrutinize research
Overlooking flaw in publication of colleague, friend or mentor
Failing to be honest Throwing out research results because does not
fit theory Failing to assign credit fairly Taking credit for a
students work Failing to work within ethical guidelines
Circumventing recruitment guidelines for research participants
Slide 59
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Findings of Research
Misconduct: What Happens: Hurts the individual Lost of job, revoked
PhD, revoked awards, lawsuits and questioned integrity Hurts the
reputation of the Institute Damaged reputation, loss of other
faculty, retractions, lawsuits and legal costs Increases the
publics distrust for science; Eroding the publics belief in
scientific information Potentially jeopardize future sponsor
funding; Considered a bad risk, more injunctions
Slide 60
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Reporting Research Misconduct
All employees or individuals associated with Georgia Tech shall
report observed, suspected, or apparent misconduct in science to
the Provost or the Executive Vice President for Research.
http://researchintegrity.gatech.edu/policy-for-responding-to-
allegations-of-scientific-or-other-scholarly-misconduct/ The
Provost will monitor the treatment of individuals who bring
allegations of misconduct or of inadequate institutional response
thereto, and those who cooperate in inquiries or investigations.
Employees should immediately report any alleged or apparent
retaliation to the Provost.
Slide 61
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Reporting Research Misconduct
Compliance concerns in the Georgia Tech Research Institute may also
be reported via the hotline at (404) 385-0311. Compliance concerns
can be entered in Ethicspoint at:
https://secure.ethicspoint.com
Slide 62
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Intellectual Property A
product of the intellect that has commercial value, including
copyrighted property such as literary or artistic works, and
ideational property, such as patents, appellations of origin,
business methods, and industrial processes.
Slide 63
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Technology Transfer: The
Capstone of Research How do we get our intellectual property out of
the Institute and to the benefit of the public? Peer reviewed
publications Students Continuing Education Consulting Licenses to:
existing & start-up companies Patent Inventions Copyright
Original Works Trademark Recognizable Images
Slide 64
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Why? New technology is
commercialized to: Ensure public benefit from Georgia Tech research
Provide inventor satisfaction and motivation Meet Georgia Techs
obligations to sponsors for compliance with technology transfer
provision Generate revenue to support research and research
infrastructure
Slide 65
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC "Conflict of Interest (COI)
means any situation in which: designconductreporting It reasonably
appears that a significant financial interest could affect the
design, conduct, or reporting of activities funded or proposed for
funding by a sponsor; or The personal interest of an Employee or
his or her Family may prevent or appear to prevent the Employee
from making an unbiased decision with respect to the Employees
Institutional duties Conflict of Interest
Slide 66
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC As most institutions view the
federal regulations, design, conduct, and reporting includes both
technical and financial aspects of: proposal and bid preparation
hiring, retaining, promoting project staff recruiting, supervising,
and advising students working on the project procurement of goods
services, consultants & subcontractors project management use
of facilities access to cost-sharing
Slide 67
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Conflict of Interest Faculty
Start-Ups License Technology from the Institution Equity interest
in or payments (e.g. consulting fees, gifts, or other remuneration)
from a company/entity whose products or services are being studied
Sponsor Research at the Institution Intellectual property rights in
the subject matter being studied Involve students of the
Institution Delay graduation, change theme of research to benefit
company Conduct human studies
Slide 68
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Conflict of Interest
Institutional Conflict of Interest If the institution owns equity
in the company, its decisions may not be viewed as unbiased If an
institution accepts funding from a company its research and
decisions may not be viewed as unbiased A conflict of interest is
institutional rather than individual if research at the institution
could affect its investment holdings, patents, or funding
sources.
Slide 69
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Conflict of Interest
Disclosure to the Institution Annually, every Employee of the
Institute must complete a disclosure using the online Conflict of
Interest system. Employees must update their disclosures on an
ongoing basis when circumstances change. Disclosure to Sponsors In
addition, any person involved in the design, conduct, or reporting
of research (technical and financial) or educational activities
proposed for funding by a sponsor must complete the Investigator
Financial Interest In Research Report via the online Conflict of
Interest System. http://coi.research.gatech.edu/
Slide 70
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Consulting Consulting: Is an
outside professional activity Is a private relationship between the
faculty member and the client Limited to 1 day/week May make only
incidental use of Institute facilities or resources Is not research
Consulting is NOT: Publication Professional service Moonlighting
The Institute encourages and intends to assist all of its faculty
members in the practice of their professions. It especially
encourages them to consult.
Slide 71
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Consulting may not Full time
Ga Tech employees may not be on the payroll of other organizations
except as a consultant. Organizing or generating any continuing or
professional educational program not affiliated, sponsored or
endorsed by the Institute, must obtain permission from the Dean for
PE In general, may not consult for services performed for other
state offices
Slide 72
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Bibliography Conflict of
Interest Faculty Handbook 38.1-4 Consulting Faculty Handbook
38.5.1-10 Intellectual Property Policy Faculty Handbook 50.1-11
Policy on Scholarly Misconduct Faculty Handbook 35.1-13 Office of
Research Integrity Assurance
Slide 73
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Bibliography (Contd) Conflict
of Interest AAU Report on Individual and Institutional Conflict of
Interest http://www.aau.edu/policy/conflicts_of_interest_
2.aspx?id=6850 Intellectual Property Policy THE BAYH-DOLE ACT: A
GUIDE TO THE LAW AND IMPLEMENTING REGULATIONS
www.cogr.edu/Pubs_intellectual.cfm Policy on Scholarly Misconduct
Government wide Policy http://ori.dhhs.gov
Slide 74
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Office of Radiological Safety
www.ors.gatech.edu Nazia Zakir RSO 4-3621 Cell 404 384-8719 Gary
Spichiger ARSO 4-8847 Laser Safety Officer Christina Tabor Senior
HP 4-8846 Darrell NealHP 5-0779
Slide 75
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Georgia Tech Organization ORS
unit within EHS RSO reports to AVP of EH&S Dr. Steve Cross-
Executive Vice President of Research
Slide 76
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 77
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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.
Slide 78
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Program Scope RAM/XRAY 95
Authorized Users 800 Radiation Workers 130 Labs Only accept Georgia
Tech training
Slide 79
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 80
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 81
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC RAM Usage at Georgia Tech
Sealed sources in devices Gas Chromatograph- GC Electron Capture
Device-ECD Liquid Scintillation Counters Mossbauer
Spectroscopy
Slide 82
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC X-Ray Generating Devices
Crystal or powder x-ray diffraction unit- Most Common--XRD
Transmission or scanning electron microscopeTEM, SEM X-ray
fluorescence spectroscopy equipmentXRF
Slide 83
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC
Slide 84
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC X-Ray Generating Devices
Diagnostic X-Ray- (Dental) Health Center Non-Medical Flouroscopy
Units- CRB and Physics Require lead shielding, scatter surveys
X-RAYS generated as byproduct -need energy (greater than 5 kev) and
current E-Beam Evaporator
Slide 85
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC
Slide 86
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 87
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 88
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 89
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Examples of RAM Packages
Slide 90
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC ORS Responsibilities Survey
all RAM labs Quarterly Radioactive Waste Pick-Ups Radioactive Waste
Shipments Inventory of sources Training of AUs and Radiation
Workers Emergency Response Training of GT Police and local Fire
Department
Slide 91
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC RAM Spill Response Workers are
trained to respond to spills, ALERT OTHERS Can enter room for life
saving activities CONTAMINATION CONTROL IS THE KEY
Slide 92
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 93
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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 student- Los Alamos)
Slide 94
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Laser Rated Barriers
Slide 95
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Call us, were 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!
Slide 96
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Biosafety Shane Gillooly
Assistant Biosafety Officer Topics: Bloodborne Pathogens Biological
Materials Safeguards Committee Biosafety Occupational Health
Program Biological Select Agents & Toxins Shipping
Slide 97
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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 Bloodborne Pathogen
Laws
Slide 98
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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 Georgia Law Public Law 106-430
Slide 99
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 100
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 101
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 102
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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
Slide 103
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC BOHP Enrollment Process
Slide 104
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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 Select Agents & Toxins
Slide 105
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Toxins in Exempt Quantities
When maintained at quantities below the exemption limit, the toxins
are exempt from the Select Agent Regulations Toxin Exempt Amount
Abrin100 mg Botulinum neurotoxins0.5 mg Short, paralytic alpha
conotoxins 100 mg Diacetoxyscirpenol (DAS)1000 mg Ricin100 mg
Saxitoxin100 mg Staphylococcal enterotoxins (Subtypes A, B, C, D,
and E) 5 mg T-2 toxin1000 mg Tetrodotoxin100 mg 105
Slide 106
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC 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:
Biological Shipping Form (For Biological Shipments) Material
Transfer Agreement (MTA) Inter-Departmental Sales and Services
Authorization Form (IDSS) Export Review Form (International
Shipments Only)
Slide 107
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Biosafety Responsibilities
Researcher Taking Training Reporting Accidents/Injuries Wearing
appropriate PPE Enrolling in the Occupational Health Program
Following GT Biosafety Manual 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
Slide 108
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Biosafety Office
Responsibilities 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
Slide 109
Office of Sponsored Programs Public Responsibility and Research
Commitments All rights reserved GTRC Any Questions? Contact the
Biosafety Officer: 404-894-6120 [email protected][email protected] Visit our website!
www.ehs.gatech.edu/biological www.ehs.gatech.edu/biological