Office of Research Compliance working to support Research Integrity Lisa Kelly, R-LATG Compliance Training Coordinator Quality Assurance Coordinator

Office of Research Complianceworking to support Research Integrity

Lisa Kelly, R-LATGCompliance Training CoordinatorQuality Assurance Coordinator

Office of Research Compliance 2

conformity in adhering to official requirements

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…An unwavering commitment to do the right thing


Reduce Burden

Streamline regulatory process Provide good customer service Reduce administrative burden Facilitate Science

42% of a Researcher’s time is consumed by administrative tasks


Departments and Program

Research Integrity

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Oversight of the use of animals in scientific investigation and instruction

managing the compliance activities of the IACUC administering the research support functions of URAR


Federal Laws and Guidelines

Animal Welfare Act / Regulations

PHS PolicyU.S.Govt Principles

The “Guide” The “Ag Guide”

LAW GUIDELINES


UGA’s Animal Care and Use Program

Biomedical and Veterinary Program are PHS-Assured – so UGA can accept federal funding

Biomedical and Veterinary Program are fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) – Gold Seal for ACU Program


Institutional Animal Care and Use Committee

5 Veterinarians7 Scientists

1 Animal Care Technician

2 Non-ScientistsUnaffiliated“Community Members”

1 Environmental

Safety Professional

1 Biosafety Professional


Animal Use Protocol

Must be faculty to submit an Animal Use Protocol (AUP).AUPs are categorized A-D depending on the potential for pain or distress.AUPs have a 3-year lifespan but are renewed annually.Training compliance is required prior to AUP approval.


Animal Care and Use Training

IACUC 101 (Refresher every 3 years) Staying Healthy

• Both found on the AALAS Learning LibraryNow access through the GEAR website at http://gear.ovpr.uga.eduUse UGA MyID and Password

1 hour of CE every 3 years

Occupational Health Questionnaire• Must return even if participation is declined

http://gear.ovpr.uga.edu/


You cannot use animals in research or instruction without an APPROVED Animal Use Protocol.


Office of Animal Care and Use

Dr. Chris King – Director Tammy Bridges– Administrative Specialist Eric Smith – IACUC Coordinator Chris Carter – Compliance IT Administrator Lisa Kelly – Compliance Training Coordinator


University Research Animal Resources

Provides appropriate husbandry and handling of laboratory animals through animal facility management, technical assistance, training and consultation

Life Sciences and Vet Med divisions are in the process of consolidating.


URAR Personnel

Life Sciences Veterinary Medicine Dr. Leanne Alworth (Dir/AV))

• Robin Kavanaugh (manager)• Lauren Luken (office)

Lisa Wilson – Coverdell Kristine Wilcox – Life

ADS

Psychology Todd McDaniel – Biosciences

• Other off campus facilities

Dr. Stephen Harvey (Dir/AV)• Angelia Chappelear (office)• Ben Bonner (manager)

Frank Waters – VBF Missy Waters – Central Jeffrey Martin – AHRC

• Greg Eidson (manager) – PDRC• Other off campus Vet Med

facilities

Will soon have a URAR Director

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624 BOYD GRADUATE STUDIESWWW.OVPR.UGA.EDU/OACU

(706) 542-5933(706) 542-7204 (EMERGENCY VET CARE)

[email protected]


Provides guidance and assistance to protect faculty, staff and students from exposure to

biohazardous materials and to guard against the release of these material. Biosafety also provides administrative

support to the IBC and administers the SA program for UGA.


Federal Laws, Guidelines and Programs NIH Guidelines for Research Involving Recombinant or Synthetic

Nucleic Acid Molecules National Select Agent Registry (SAP)

• Title 42 CFR Part 73, Title 9 CFR Part 121, Title 7 CFR Part 331• US Govt Policy for Oversight of Life Sciences Dual Use Research of Concern

Other state and federal laws that apply to biological research Biosafety in the Microbiological & Biomedical Laboratory (BMBL) OSHA Bloodborne Pathogens Standard Arthropod Containment Guidelines (ACG) Etiologic Agent Import Permit Program (EAIPP) USDA APHIS Permitting Program

• Animal and Animal Products• Veterinary Biologics• Biotechnology (e.g. genetically engineered organisms)• Plant, Organisms, and Soil


When is an IBC protocol required?For all research and teaching projects involving: Recombinant DNA (including transgenic animals and

plants) Select Agents and Toxins All human or plant pathogens, RG2 or greater Animal pathogens that cause diseases reportable to the

State Veterinarian Plant pathogens that are not indigenous to the state Any diagnostic testing that involves propagation of RG3

pathogens or Select Agents and Toxins for use as a test reagent


Questionnaire

Paper form found on the Biosafety website at www.ovpr.uga.edu/biosafetyMust be faculty to submit an IBC Protocol.

Post-docs may submit if faculty is listed as Co-PI.IBC Protocols must be renewed yearly using Annual Renewal Form for up to 5 years.Training dependent on Biosafety Risk Group assessment.

http://www.ovpr.uga.edu/biosafety


Institutional Biosafety Committee

5 Scientists1 Biosafety Professional

1 Laboratory Technician

2 Unaffiliated“Community Members”1 is an Occ Health Physician

1 Environmental

Safety Professional

1 Attending Veterinarian


Risk Groups and Biosafety Levels BSL1 – Well characterized agents not known to cause disease in

healthy adults BSL2 – Agents associated with human disease which is rarely

serious or for which preventive or therapeutic interventions are often available

BSL3 – Agents that are associated with serious or lethal human disease for which preventative or therapeutic interventions may be available (high individual risk, low community risk)

The correlation between Risk Group and Biosafety level depends on risk assessment (e.g. quantity, how it is used, etc.)


Biosafety Training Recommended for anyone working with biohazardous materials –

“Proficiency in Standard and Special Microbiological Practices” form on Biosafety website• Required of Select Agent Program personnel

Anyone working with human pathogens – PI-lead orientation prior to beginning work and annually thereafter

Human (maybe NHP) body fluids, tissues or cell lines – Board of Regents Bloodborne Pathogens Training – www.usg.edu/facilities/training/pathogens/

Select Agents – agent specific training as required by the Responsible Official

Occupational Health Questionnaire (same form as OACU)• Must return even if participation is declined

http://www.usg.edu/facilities/training/pathogens/


IBC Protocol Types

Full Committee• Recombinant DNA research• All BSL3 or higher work• Research involving a Select Agent or Toxin

Subcommittee• Research involving reportable animal pathogens• Research involving non-indigenous plants• Risk Group 2 human or zoonotic pathogens (not

Select Agents)


You cannot begin to work with rDNA, biological agents or toxins until you have an approved IBC protocol.


Other Reasons to Contact Biosafety

Shipping or receiving biohazardous material Applying for USDA permit Questions about use or certification of biological

safety cabinets or other primary containment devices

Questions about sharps safety or disposal Need assistance with a waste solution assessment To request Laboratory Operations Review

(new or existing lab: review not an inspection)(all RG levels)


BioSafety Office Patrick Stockton – Director / RO Manley Kiser – Associate Director / AHRC ARO Nancy Mead – IBC Coordinator / ARO Kelly Crumley – Select Agent Program Manager Chad Cheely – Biosafety Specialist Suzanne Cook – Administrative Specialist Chris Carter – Compliance IT Administrator Lisa Kelly – Compliance Training Coordinator

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110 RIVERBEND RD, ROOM 121WWW.OVPR.UGA.EDU/BIOSAFETY

(706) 542-5563(706) 542-5300 (EMERGENCY/BAT PHONE)

[email protected]


Works to provide a safe workplace for all personnel involved in research using animals

or biohazardous agents.


Occupational Health and Safety

The OHSP applies to any UGA employee (faculty, staff, students, volunteers, visitors) who…

• Works with vertebrate animals, or animal tissues, fluids, secretions, and/or excretions

• Works with biohazardous agents• Handles cages and related equipment contaminated by animal tissues,

fluids, secretions and/or excretions; or routinely enters into facilities where animals are maintained


Questionnaire

Must complete this section and return if you decline to participate


Professionally and administratively supports the IRB, the research oversight committee

charged with ensuring that human subjects research is conducted in compliance with applicable laws, policies and guidelines


Federal Agencies and Laws National Commission for the Protection of Human Subjects of

Biomedical and Behavioral Research (1974)• Belmont Report – Ethical Principals and Guidelines for the Protection of

Human Subjects of Research (1979) Codified in Federal Registry Title 45 CFR Part 46

• Subpart A – “Common Rule”• Subpart B – Protection for Pregnant Women, Human Fetuses and Neonates• Subpart C – Protection for Prisoners• Subpart D – Protection for Children• Subpart E – Institutional Review Board

Health Insurance Portability and Accountability Act (HIPAA) Family Educational Rights and Privacy Act (FERPA) The Office of Human Subjects Protections (OHRP)


UGA’s Human Subjects Program

Program has Federalwide Assurance (FWA) – so that UGA may accept federal funding

In the process of obtaining Association for the Accreditation of Human Research Protection Programs (AAHRPP) Accreditation


Institutional Review Board

7 Scientists3 Non-Scientists

1 alternatenon-scientistcommunity memberrepresents prisoners

1 Physician

1 Community Member


Human Subjects Training

Human Subjects Social & Behavioral Research or

Human Subjects Bio-Medical Research And additional modules as required by the IRB

• Examples: Modules on Children, International Research, Internet Research, Prisoners

Repeat Training every 5 years


• Training compliance is required prior to IRB Protocol submission.• Must be faculty or senior staff to submit an IRB Protocol.• Certain IRB Protocols must receive continuing review annually.• Approval is good for 5 years and then you must resubmit a new Protocol. • Review of Consent Documents, Recruiting Documents, and Data Collection

Instruments, not just Protocol, required.

IRB Protocol


IRB Protocol Types Exempt Examples (6 federal + 2 institutional):

• Minimal risk use of existing or prospective identifiable data/documents without sensitive information (no federal funding)

• Minimal risk research involving qualitative data collection procedures and non-physically invasive tasks or manipulations (no federal funding)

Expedited • No more than minimal risk and fits within certain

categories described in the federal regulations (9 categories)

Full Committee


You cannot begin to recruit volunteers until you have an approved IRB protocol.


Human Subjects Office

Dr. Benilda Pooser – Director Kim Fowler – Assistant Director Angela Bain – IRB Specialist Tammi Childs – IRB Coordindator Mysti Scheuer – IRB Coordinator Chris Carter – Compliance IT Administrator Lisa Kelly – Compliance Training Coordinator

41

624 BOYD GRADUATE STUDIESWWW.OVPR.UGA.EDU/HSO

(706) [email protected]


New to the University of GeorgiaProviding oversight to access of scientific instruments,

technologies, software and materials by foreign nationals in order to comply with federal export control regulations. In addition, this office will provide support and training to those individuals that conduct business

with the international community.


Export Control RegulationDepartment of State, Directorate of Defense Trade ControlsInternational Traffic in Arms Regulations (ITAR)

Relates to military and defense articles and services

Department of Commerce, Bureau of Industry and SecurityExport Administration Regulations (EAR)

Relates to “dual use” items, information or software

Department of Treasury, Office of Foreign Assets Control

Administers and enforces economic and trade sanctions


Fundamental Research Exclusion (FRE)

Basic and applied research in science and engineering conducted at a U.S. research institution, the results of which ordinarily are published and shared broadly within the scientific community, are typically exempt from many Export Control regulations.


Development of Export Control Program

Focal Point Administrators for units with export compliance risks

Training initiative to educate those in risk-sensitive research areas and operational groups

“Classification and Jurisdiction Determination” process and identify items that need a “Control Plan”

Working with International Education to link H1 VISA beneficiary assignment with EAR/ITAR access requirements for licensing and technology control purposes


High-Risk Departments

Marine Sciences Geography Physics/Astronomy Engineering Areas with Restricted Funding

UGA currently has no Restricted Funding.No UGA Policy on Restricted Funding.


Office of Export Control

Dan Runge – Export Compliance Officer Chris Carter – Compliance IT Administrator Lisa Kelly – Compliance Training Coordinator

48

626 BOYD GRADUATE STUDIES(706) 542-5933

[email protected]

Research ComplianceExport Control


Provides guidance to UGA faculty, staff and students on the safe use of chemical agents,

radiation safety and laser safety.


Research Safety

Chemical and Lab Safety Radiation Safety

New lab openingsRadiation X-Rays Lasers


Chemical SafetyPublic Employee Hazardous Chemical

Protection and Right to Know Act of 1988

Training: Initially When a new hazard is introduced Annually

http://www.usg.edu/facilities/rtk-ghs


OSHA

Must meet or exceed OSHA standards Considered as reasonable benchmarks or “Best Practices”


Radiation Safety

Each permit holder must designate an Advanced Radiation Safety Worker• 4 x 4hr live modules and annual online

Refresher Training All Radiation Safety Workers

• Training by Advanced Radiation Safety Worker with documentation and annual online Refresher Training

Additional online training for those working with X-Rays or Lasers


You cannot order radioisotopes until you have an approved Radioactive Material Permit and a designated Advanced Radiation Worker.


Research Safety Office Zeke Barrera - Director Regena Curry – Administrative Associate Wesley Kolar – HazMat Operations Coordinator Bruce Hild – Research Safety Specialist Ken McDaniel – Research Safety Specialist Star Scott – Research Safety Specialist Jody Jacobs – Radiation Safety Manager Dennis Widner – Radiation Safety Specialist Lauren Palmer – Radiation Safety Specialist John Pyle – Radiation Safety Technician Chris Carter – Compliance IT Administrator Lisa Kelly – Compliance Training Coordinator

56

105C ELECTRONICS SHOP(TEMPORARY)

[email protected]

RESEARCH.UGA.EDU/SAFETY/



Providing information and training on federal Good Laboratory Practices (GLP), the recognized rules governing the conduct of non-clinical safety

studies that ensure quality, integrity and reliability of study data. This office also conducts audits of facilities, data and research as required

under GLP regulations.



Federal Laws and Guidelines Good Laboratory Practice Regulations –

research intends to support applications for permits for products regulated by the FDA or the EPA• FDA – Title 21 CFR Part 58• EPA – Title 40 CFR Part 160

Currently UGA has no active GLP studies.


Quality Assurance

Lisa Kelly – Quality Assurance Coordinator

60

622C BOYD GRADUATE STUDIES(706) 583-0816

[email protected]


Research Integrity

Providing oversight and training to ensure the highest ethical standards in research at the

University of Georgia. provides instruction in Responsible Conduct of Research and

Conflict of Interest.The Research Integrity Officer investigates allegations of

research misconduct.


Research Integrity

Research Misconduct


RCR Focus Evolves Over Decades

1966

Animal Welfare

Act

2009

NSF requires

RCR

1989

IOM: RCR important for health sciences

1979

BelmontReport

1991

NRSA: Training grants require

RCR

2000

NIH requires

RCR


RCR Training Requirement National Science Foundation – anyone paid

(conference, travel, symposium and workshop grants are exempt)• CITI RCR Course (4 versions, 7 of 9 topics)

Physical Sciences Bio-Sciences Behavioral and Social Sciences Arts and Humanities

(Refresher required every 4 years)

National Institutes of Health (K and T Grants)• 8 hours of face-to-face education (CBIO 8080; Genetics 8650, GSRC 8550, Pharmacy 7230, Qualitative Research 8595, VetMed 8550)


RCR Topics1. Protection of Human Subjects2. Welfare of Animal Subjects3. Conflicts of Interest4. Research Misconduct5. Data Management and Data Sharing6. Mentor Responsibilities7. Authorship8. Peer Review9. Collaborative Research


Exception for RCR Training

Currently waivers or exemptions will only be given for:

• high school students/teachers paid a stipend, • employees working exclusively in an administrative role on an

NSF research project,• individuals who have completed a commensurate program of

RCR education that can substituted for the CITI program, and• employees whose project roles are deemed not related (for

example, washing glassware or animal care).

Email Chris King exception requests and keep records for NSF auditors.

67

Setting off on the road to the responsible conduct of research


What is Research Misconduct?

“Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results” OTSP Definition


Research Misconduct• Fabrication is making up data or results and recording or

reporting them.

• Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.

• Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit


Not Research Misconduct

Research misconduct does not include honest differences of opinion!


Legal Parameters Represents a “significant departure” from

accepted practices Has been “committed intentionally, or

knowingly, or recklessly” Can be “proven by a preponderance of

evidence.” (Burden rests with UGA)

NO STATUTE OF LIMITATION(even if person has left UGA employ)


Applicability

Everyone at UGA, including visitors/guests• Student might be an exception

If hired on restricted account, Misconduct Policy applies

If not hired on restricted account, Academic Honesty Policy applies


Reporting MisconductEveryone has a duty to report suspected misconduct!

Concern!(RIO

response)

in writing (e.g. email)

verbally to RIO

You are protected by Federal Whistleblower Protections!


If in Doubt, Don’t!


Conflicts of Interestare not

Research Misconduct!

Disclosure and Management are

REQUIRED!


Conflict of Interest Definitionsdef. – the simultaneous existence of conflicting primary and secondary interests whenever financial considerations may have the potential to compromise or have the appearance of compromising an investigator’s professional judgment and independence in the design, conduct, or publication of research.

COI’s occur whenever a reasonable person concludes that there is a probability that an individual might emphasize his or her personal interests over other interests for which he/she has responsibility.


3 Elements required for COIs

1. Acting in a professional or official capacity or having a position of trust (spiritual, fiduciary, etc.)

2. While having a personal interest (usually financial)

3. That interferes with objective decision making (or creates the appearance that decision making is compromised)


Typical COIs

Self-dealingActing in roles that conflictAccepting benefits and personal gratuities Influence peddlingUsing or disclosing confidential informationConflicting outside employment or other allegiances


Most Common Faculty COIs

Consulting

Procurement

Licensing Tech

Recruiting Research Participants

Mentoring


Conflict of Interest Snafu’s

Believing too moral or too wise to have COIs

Confident in wisdom and virtue to manage COIs on your own


Financial Conflict of Interest

Must complete Investigator Disclosure if submitting PHS units and you have a SFI (Significant Financial Interest)

• Retrospective for 12 months prior to proposal submission• Update within 30 days of discovering unreported SFI • Cover all financial interest >$5000, even if value is not readily

ascertainable• UGA employees disclose on eResearch Portal at

research.uga.edu/compliance-training/fcoi/• Non-UGA employee complete “Annual Disclosure of Financial

Interest for Non-University of Georgia Investigators” at research.uga.edu/compliance-training/fcoi/


Conflict of Interest Training

PHS grant or cooperative agreement Investigators must complete CoI Training

• Training must be complete prior to award• Through CITI

• Refresher required every 4 years


Reporting Fiscal Irregularities

Ethics and Compliance Reporting Policyresearch.uga.edu/docs/policies/ugarf/UGARF-Ethics-and-Compliance-Reporting-Policy.pdf All levels responsible for preventing and detecting Fiscal

Irregularities Obligated to report

• To immediate supervisor or Office of the UGARF General Counsel• Anonymously at 877-516-3467 or

www.tnwinc.com/uga/

84

DR. CHRIS KINGRESEARCH INTEGRITY OFFICER624 BOYD GRADUATE STUDIES

(706) [email protected]

Research Integrity (RCR, CoI)


Working to increase the knowledge of and facilitate the highest standards of responsible

research and compliance with federal, state and university regulations and guidelines.

624 BOYD GRADUATE STUDIES(706) 542-4016

[email protected]