Office of Sponsored Programs All rights reserved GTRC Georgia Institute of Technology Public Responsibility and Research Commitments

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  • Office of Sponsored Programs All rights reserved GTRC Georgia Institute of Technology Public Responsibility and Research Commitments
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  • 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:
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  • 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
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  • 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
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  • 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"
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  • 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
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  • 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
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  • Office of Sponsored Programs Public Responsibility and Research Commitments All rights reserved GTRC
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  • 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
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  • Office of Sponsored Programs Public Responsibility and Research Commitments All rights reserved GTRC
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  • Office of Sponsored Programs Public Responsibility and Research Commitments All rights reserved GTRC Problems Continue
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  • Office of Sponsored Programs Public Responsibility and Research Commitments All rights reserved GTRC Oh No! The Feds Shut Us Down
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  • 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.
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  • 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.
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  • 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.
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  • 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
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  • 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
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  • 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
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  • 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.
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  • 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.
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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.
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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.
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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.
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  • 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.
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  • 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
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  • 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.
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  • 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
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  • 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.
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  • 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
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  • 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
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  • 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
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  • 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.
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  • Office of Sponsored Programs Public Responsibility and Research Commitments All rights reserved GTRC A Timely Example
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  • 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
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  • Office of Sponsored Programs Public Responsibility and Research Commitments All rights reserved GTRC Research Integrity Speaker: Anita McKinney
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  • 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
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  • 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
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  • 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:
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  • 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
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  • Office of Sponsored Programs Public Responsibility and Research Commitments All rights reserved GTRC Research Misconduct
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  • 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
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  • 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
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  • 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
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  • 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.
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  • 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
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  • 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.
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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.
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  • 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/
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  • 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.
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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.
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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • Office of Sponsored Programs Public Responsibility and Research Commitments All rights reserved GTRC
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  • 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
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  • Office of Sponsored Programs Public Responsibility and Research Commitments All rights reserved GTRC
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  • 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
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  • 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
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  • 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
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  • Office of Sponsored Programs Public Responsibility and Research Commitments All rights reserved GTRC Examples of RAM Packages
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  • 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
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  • 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
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  • 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