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Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

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Page 1: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Non-Financial Compliance Overview

Non-Financial Compliance Overview

CReATEPresented by: Amber L. Pursley, Grants Compliance Analyst

Page 2: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Topics to DiscussTopics to Discuss Intellectual Property

Responsible Use and Welfare of Animals in Research

Protecting Human Research Subjects

Environmental Health & Safety

Federal Requirements for Working with Select Agents and Toxins

Classified Research – EAR, ITAR, and OFAC

Page 3: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Intellectual Property 101Intellectual Property 101

Office of Intellectual Property Development and Commercialization

Page 4: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

What is Intellectual Property? What is Intellectual Property? Inventions and their protection (e.g., patents)

Literary and artistic works and their protection (e.g., copyright)

Trade names, trademarks, service marks

Trade secrets and their protection

Know-how

Page 5: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

PatentsPatents Form of protection for inventions Invention = a solution to a specific

technological problem if it is novel, useful, and not obvious Examples: Taxol®, Gatorade®

Patent owner can prevent others from: Making, using, selling, or importing an infringing

product or service without permission FSU protection process includes:

Disclosure, provisional application, patent application, examination, patent issuance, enforcement

Page 6: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Copyright © Copyright © A form of protection provided to the authors of

“original works of authorship,” including literary, dramatic, musical, artistic, and certain other intellectual works, both published and unpublished

The 1976 Copyright Act gives owner of a copyright exclusive right to:

reproduce work prepare derivative works distribute copies/phonorecords of work perform/display work publicly

The copyright protects the form of expression rather than the subject matter of the work

Page 7: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

TrademarkTrademark A distinctive word, phrase, symbol or design,

or a combination of words, phrases, symbols or designs, that identifies and distinguishes the source of the goods of one party from those of others

Examples Trademark – Big Mac®, Happy Meal® Trade name – McDonald's Corporation

“Service marks” do the same for services

Page 8: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Trademark Protection TM SM ®Trademark Protection TM SM ® Trademark Law is governed by the

Lanham Act (1946) – 15 U.S.C. § 1051 et seq.

Established and maintained by use Must be policed by owner May be registered in USPTO

Page 9: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Importance of IP RightsImportance of IP Rights

FSU works to protect faculty IP rights for future educational and research use

When things go wrong… Professor now paying for a research tool he

developed Grad student assigned rights to parts of

dissertation prior to graduation – could have prevented degree award

Third party posted faculty research report on web – potentially jeopardized publication in journal and graduate student's thesis project

Page 10: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

IP Ownership under Florida Law and FSU Policy

IP Ownership under Florida Law and FSU Policy State Law (FS 1004.23) provides universities:

The right to claim ownership of employees' inventions and other works in the name of the university

An obligation to establish a policy for external use and revenue sharing

FSU IP Policy is contained in the Faculty Handbook, Section 6

Policy amendments are approved by the Faculty Senate

Page 11: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

More HelpMore Help www.techtransfer.fsu.edu http://www.research.fsu.edu/techtransfer/

facultystaff.html http://www.research.fsu.edu/techtransfer/

resources.html

Also: Campus-wide IP seminars (Fall & Spring) Department/program presentations Individual consultation

Page 12: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Responsible Use and Welfare of Animals in Research

Responsible Use and Welfare of Animals in Research

Page 13: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Why Use Animals In Research?Why Use Animals In Research?

To learn more about basic mechanisms of physiology, biology and psychology

To investigate mechanisms of disease in both animals and humans

To develop new diagnostic methods and medicines to improve health of both animals and humans

Where required, to test for toxicity of novel compounds

Page 14: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Why Use Animals?Why Use Animals?

Chimpanzee – 98.7%

Mouse – 85%

Fruit Fly – 60%

Yeast – 46%

Banana – 50%

DNA Homology With Man

Page 15: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Outside Oversight AgenciesOutside Oversight Agencies

There are two primary federal and one voluntary oversight

mechanisms:

U.S. Department of Agriculture (USDA)

Public Health Service (PHS), Office of Laboratory Animal Welfare (OLAW)

Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)

Page 16: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Animal Welfare Act (1966)Animal Welfare Act (1966)

Administered by the USDA Covers warm-blooded animals such as dogs, cats,

non-human primates, hamsters, guinea pigs & rabbits The definition of animal includes dead, as well as

alive Covers use of animals in research, teaching, testing

and exhibition Excludes farm animals used for agricultural and food/

fiber research Excludes mice of the genus Mus (lab mice), rats of

the genus Rattus (lab rats), birds bred for research, and all cold-blooded animals

Page 17: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

The Animal Welfare Act, cont.The Animal Welfare Act, cont.

Requires establishment of Institutional Animal Care & Use Committees (IACUCs)

USDA officers conduct annual unannounced inspections

Institution is required to submit an annual report on the use of covered species by pain category

USDA promulgates standards governing certain animals by dealers, research facilities, exhibitors (e.g., circuses), operators of auction sales and carriers and intermediate handlers

Page 18: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Health Research Extension Act – Animals in Research

Health Research Extension Act – Animals in Research

Public Law 99-158 (1985)

Requires institutions to establish and maintain proper measures to ensure the appropriate care and use of all animals involved in research, research training, and biological testing activities which are conducted or supported by the PHS

Applies to all vertebrate animals used in research, testing and education – this includes ALL species not covered by the USDA Animal Welfare Act

Page 19: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Uses the Guide for the Care and Use of Laboratory Animals as its general guidelines for animal research programs

Requires all institutions receiving PHS funds for animal research to file an Animal Welfare Assurance Statement

Oversight is by OLAW (NIH Office of Laboratory Animal Welfare)

Health Research Extension ActHealth Research Extension Act

Page 20: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

OLAW relies on institutional assurances to monitor institutional compliance with the regulations

Assurance confirms that institution will: Comply with applicable rules and policies Provide a description of their program for animal

care and use Maintain an appropriate IACUC Appoint a responsible Institutional Officer for

compliance (at FSU, this is the Vice President for Research)

OLAW-approved assurances and compliance with PHS policy are considered terms and conditions of receiving PHS funds

Office of Laboratory Animal WelfareOffice of Laboratory Animal Welfare

Page 21: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

AAALAC is a private non-profit organization that promotes the humane treatment of animals

in science through a voluntary accreditation program

AAALAC is considered the gold standard in animal care

FSU is an AAALAC-accredited program

Page 22: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Other RegulationsOther Regulations USDA Animal Care Policies NIH & CDC Biosafety & Hazardous Agents

Regulations and Policies FDA Good Laboratory Practices Department of Defense regulations Veterans Administration Other applicable federal laws (Endangered

Species Act, FWS regulations, EPA regulations, etc.)

All applicable state laws Local ordinances, as required

Page 23: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Responsible for animal use protocol review Responsible for animal research program review Responsible for the development and review of institutional

policy on use of animals Performs inspection of animal housing and procedural facilities

twice yearly Investigates and addresses concerns from all sources with

regard to the animal research program Evaluates the qualifications of research personnel and provides

appropriate training and education, as deemed necessary Recognized as the university's self-regulatory body for animal

research by all regulatory agencies Has the authority to suspend an activity involving the use of

animals which is not being conducted in accordance with applicable laws, regulations and institutional policies

Institutional Animal Care & Use Committee (IACUC)Institutional Animal Care & Use Committee (IACUC)

Page 24: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

IACUC ProtocolsIACUC Protocols Must be approved PRIOR to ordering or use of animals

Required of anyone, including those on regional campuses, who use live vertebrate animals in teaching, testing or research (this includes field studies, even observational ones)

All animal use protocols are required to be submitted as an original re-write once every 3 years

Researchers must justify the use of animals in their project – one way is by showing that the research is likely to bring benefits either by (a) improving medical care of humans or animals or (b) contributing to new scientific information

Some granting agencies may require approval from the IACUC prior to proposal submission, so check your agency guidelines carefully

Page 25: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Knowing what activities are subject to regulation

Understanding and following the rules for project approval

Obtaining appropriate training prior to using animals

Accepting continuing responsibility for compliance through all stages of a project

Researcher Responsibilities and Obligations

Researcher Responsibilities and Obligations

Page 26: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

IACUC Protocol

Know the animal protocolRefer to the protocol oftenMake no deviations from the protocolMake sure everyone in the lab has read the protocol and knows where it is locatedThere is no such thing as a pilot study that does not need IACUC approval

Research Team ResponsibilitiesResearch Team Responsibilities

Page 27: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Review Prior to Release of FundsReview Prior to Release of Funds SRS submits the following to Laboratory

Animal Resources (LAR): SRS Animal Subjects Use Form Copy of the Award Copy of the Proposal

LAR reviews these documents along with the ACUC Protocol Review Form submitted by the PI, which is used to determine if all procedures described in the grant have been reviewed and approved

See appendix:

LAR ANIMAL USE FORM AND PROCEDURES

Page 28: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Forms

Page 29: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Animal Care and Use Forms

Page 30: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Compliance aside, it is the personal responsibility of every individual, especially principal

investigators working with animals, to see that these animals

are treated with respect and handled humanely

Remember…Remember…

Page 31: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Protecting Human Research Subjects

Protecting Human Research Subjects

Human Subjects Committee

Page 32: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Nazi Experiments – War Crimes and Crimes Against Humanity (1946 – WW II)

Nazi Experiments – War Crimes and Crimes Against Humanity (1946 – WW II) Freezing Experiments

Infectious Diseases

High and Low Altitude Experiments

Pharmacological Experiments

Surgical Experiments

Traumatic Injuries

Page 33: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Thalidomide Tragedy (1961)Thalidomide Tragedy (1961) Approved sedative in Europe in late 1950s –

given to pregnant women to ease morning sickness

Not approved by FDA, but the manufacturer gave samples to U.S. physicians and paid them to study its safety and efficacy

By 1961, there was evidence of damage to the fetus if given to a pregnant mother during the first trimester

Page 34: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

U.S. Government-Funded Syphilis Study in African American Men (1932-1972) – “Tuskegee”

U.S. Government-Funded Syphilis Study in African American Men (1932-1972) – “Tuskegee”

400 Syphilitic men and 200 control group recruited in 1932-33 to study “bad blood”

Subjects offered free exams, medical care, and “therapeutic” spinal taps

In 1943, Penicillin is established as an effective treatment for syphilis

By 1951, Penicillin is widely available for treatment – continued to withhold from study subjects because of “never again” scientific opportunity

1972 – exposed in media 1973 – surviving subjects treated with Penicillin 1974 – National Research Act is enacted

Page 35: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

DefinitionsDefinitions

Human Subjects: Living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information

Institutional Review Board: A specially constituted review body established or designated by an entity to protect the welfare of the human subjects recruited to participate in biomedical or behavioral research – also known as the “IRB” or Human Subjects Committee

Page 36: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Definitions, cont.Definitions, cont.

Protocol: The formal design or plan of an experiment or research activity; specifically the plan submitted by the PI to an IRB for review and to the agency for research support

The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen, and the proposed methods of analysis that will be performed on the collected data

Page 37: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Research on Human Subjects is Regulated by:Research on Human Subjects is Regulated by:

45 CFR 46 (Public Welfare – DHHS – Office of Human Research Protections) Protection of Human Subjects

21 CFR 50, 21 CFR 56 (FDA) Protection of Human Subjects Institutional Review Boards

Page 38: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Federal Regulation Requirements (The Common Rule)

Federal Regulation Requirements (The Common Rule)

Review of research by an IRB

Institutional assurance of compliance

Informed consent of subjects

Page 39: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

IRB AuthorityIRB Authority Approve research

Require modification (conditional approval)

Disapproval

Conduct continuing review of approved research

Suspend or terminate previously approved research not in compliance with IRB's requirements or federal regulations, or associated with unanticipated serious harm to subjects

Page 40: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Types of IRB ReviewTypes of IRB Review

Full Committee – vulnerable populations, greater than minimal risk

Expedited/Exempt – no more than minimal risks, criteria described in regulations

Page 41: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Voting Process for IRBVoting Process for IRB Except for expedited reviews, the IRB

must review research at convened IRB meetings at which a majority of the IRB members are present

A non-scientific member must always be present at meetings

Page 42: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Documents Required for IRB ReviewDocuments Required for IRB Review

Completed IRB application Protocol Proposed informed consent document(s) Grant application Copies of surveys, questionnaires, or videotapes Advertisement/recruitment flyers Continuing Review

Application (Request for Renewal) Progress report Adverse events Current approved informed consent document Amendments or changes to protocol requests

Page 43: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

IRB ConsiderationsIRB Considerations

The risks to the subjects

The anticipated benefits to the subjects and others

The importance of the knowledge that may reasonably result

*The informed consent process to be employed

Page 44: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

IRB ResponsibilitiesIRB Responsibilities

Must report any of the following to the appropriate institutional officials, DHHS OHRP, FDA, and/or any other sponsoring agency of the federal government:

Any injuries to human subjects or other unanticipated problems involving risks to subjects or others

Any serious or continuing noncompliance with regulations or requirements of IRB

Any suspension or termination of IRB approval of research

Page 45: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Institutional Responsibilities (FSU)Institutional Responsibilities (FSU) Full legal responsibility pursuant to Assurance

FSU's Assurance commits the University regardless of sponsorship

Designates IRB to review and approve research

Sets the tone for an institutional culture of respect for human subjects

Page 46: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Investigator Responsibilities (PI)Investigator Responsibilities (PI) Has primary duty for protecting the rights and welfare of

human research subjects and for complying with all applicable provisions of the Assurance

Conducts all research according to the IRB-approved protocol and complies with all IRB determinations

Ensures that each potential subject understands the nature of the research, participation, and the consent process

Provides a copy of the IRB-approved informed consent document to each subject at the time of consent

Page 47: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Investigator Responsibilities, cont.Investigator Responsibilities, cont.

Retains all signed consent documents for at least 3 years beyond completion of the research

Reports proposed changes/amendments to IRB for review and approval

Reports progress of research as required by IRB, not less than once per year

Promptly reports to IRB any unanticipated problems involving risks to subjects or others

Page 48: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Consequences of Noncompliance with Federal Regulations

Consequences of Noncompliance with Federal Regulations

Suspension/shut down of research and funding

Investigation, reporting, increased oversight

Overhaul and reorganization of institutional reporting structure, offices, etc.

Massive expenditures and lost efforts

Initiation of legal actions by federal government, research subjects

Payment of fines, penalties, damages, findings of liability for negligence and other malfeasance

Page 49: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Human Subjects WebsiteHuman Subjects Website

Page 50: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Human Subjects StaffHuman Subjects Staff

Carolyn Sims, Program Coordinator (Full Committee)

Jennifer Dion, Administrative Assistant (Exempt/ Expedited Committee)

Julie Haltiwanger, Specialist Computer Research, Secretary to IRB

Jane Mostoller, Associate General Counsel, Legal Counsel to IRB

Page 51: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

ContactContactOffice of Research

Human Subjects Committee

Physical Address2010 Levy Avenue

Building B, Suite 276Tallahassee, FL 32310

Mailing AddressFlorida State University

Human Subjects Committee Tallahassee, FL 32306-2742

Campus Mail Code: 2742

Phone: (850) 644-8673Fax: (850) 644-4392

http://www.research.fsu.edu/humansubjects/

Page 52: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

FSU Department of Environmental Health & Safety

FSU Department of Environmental Health & Safety

Page 53: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Research Support SectionResearch Support Section

Responsible for ensuring that research activities involving potentially hazardous materials or activities are conducted in accordance with all rules, regulations and guidelines

The safety offices within this section are:

• Biological Safety

• Chemical Safety

• Laboratory Safety

• Radiation Safety

Page 54: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

MiscellaneousMiscellaneous

Environmental Compliance Fire Safety Emergency Management Industrial Hygiene Food Safety Diving Safety Special Event Reviews Training Review of proposals which may require

environmental impact statements

Page 55: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

ContactContactwww.safety.fsu.edu

(850) 644-6895

Page 56: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Federal Requirements for Working with Select Agents and Toxins

Federal Requirements for Working with Select Agents and Toxins

Page 57: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

What are select agents and toxins?What are select agents and toxins?

Select agents are viruses, bacteria, rickettsiae, fungi, and toxins that, according to DHHS, have the potential to cause substantial harm to public health

High Consequence Livestock Pathogens and Toxins are agents that are considered by the USDA to have the potential to pose a severe threat to animal or plant health, or to animal or plant products

“Overlap Agents” are agents and toxins that appear on both the DHHS and the USDA lists

Page 58: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Public Health Security and Bioterrorism Preparedness and Response Act of 2002

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Implements enhanced controls on dangerous

biological agents and toxins

Requires improved regulatory oversight

Requires that access to these agents be limited to people who have a legitimate need to handle and use them

Page 59: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

What materials are excluded from the regulations?What materials are excluded from the regulations?

The following categories of select agent materials are excluded under the new laws; however, you

should verify with EHS at FSU before proceeding with any work

Agents or toxins present in their naturally occurring environment (not intentionally introduced)Nonviable agents or fixed tissuesCertain vaccine strainsAttenuated strains or forms of agents or toxins (must apply for an exclusion)Toxins below the aggregate limits

Page 60: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Who is subject to the regulations?Who is subject to the regulations?

Entities that possess biological agents and toxins must:

Register with the DHHS agency, the CDC, and/or the USDA Animal and Plant Health Inspection Service (APHIS)

Demonstrate compliance with specific safety and institutional and personnel security standards for handling these agents

Page 61: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Who is exempt from the regulations?Who is exempt from the regulations? Diagnostic or clinical laboratories which

perform diagnostic, verification, or proficiency testing, if identified select agents are reported to DHHS or USDA and subsequently destroyed or transferred

Investigational or licensed products used as authorized under a Federal Act

Page 62: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Why do I need to register in order to possess or use select agents?

Why do I need to register in order to possess or use select agents?

Registration of entities and individuals possessing and using select agents or toxins is part of the government's efforts to improve the ability of the U.S. to prevent, prepare for, and respond to bioterrorism and other public health emergencies

Page 63: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Security Risk AssessmentSecurity Risk Assessment A determination regarding whether an

individual is a “restricted person”

Based on criteria set forth in the USA Patriot Act (2001)

A “restricted person” may not be granted ANY access to covered agents

Page 64: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Restricted PersonRestricted Person

Indicted of a crime punishable by imprisonment exceeding 1 year

Convicted of a crime punishable by imprisonment exceeding 1 year

A fugitive from justice An unlawful user of any controlled substance Adjudicated a mental defective or committed to a

mental institution An illegal alien An alien from a country determined to support

terrorism Dishonorably discharged from the U.S. military

Page 65: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Unauthorized PersonnelUnauthorized Personnel May not have direct access to agent/toxins

Must be escorted by authorized personnel

Must register arrival and departure in visitor's log

May not be issued access control devices

Includes custodial and maintenance personnel

Page 66: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Authorized/Approved PersonnelAuthorized/Approved Personnel May handle and work with agents/toxins

May have unescorted access to work and storage areas

May be issued access control devices

May serve as escort for unauthorized individuals

Are responsible for maintaining security

Page 67: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Penalties for NoncompliancePenalties for Noncompliance

Violations of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and implementing regulations can result in civil money penalties of $250,000 for individuals and $500,000 for an entity, and/or imprisonment for up to 5 years

Page 68: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

What do I do to work with Select Agents?What do I do to work with Select Agents?

If you wish to initiate studies and need to obtain these agents, you must first declare your intentions with EHS at FSU, and fill out the appropriate forms provided at http://www.safety.fsu.edu/

Plan well in advance – the entire registration and approval process is lengthy and takes several months to complete

Page 69: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

ContactContactJane Mostoller, Associate General Counsel, Office Of Research

E-mail: [email protected]: (850) 644-0284Fax: (850) 644-4392Address: 2010 Levy Avenue

Building B, Suite 276Tallahassee, FL 32310

Mail Code: 2742

Tom Jacobson, Director, Environmental Health and SafetyE-mail: [email protected]: (850) 644-7687Fax: (850) 644-8842Address: 1200 Carothers Hall

Tallahassee, FL 32306Mail Code: 4481Website: http://www.safety.fsu.edu

Page 70: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Classified Research – EAR, ITAR and OFAC

Classified Research – EAR, ITAR and OFAC

Page 71: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Classified projects are not published in open literature – information is transferred only

between those who obtain the required clearance

Many universities do not accept classified projects; many of those that do conduct research in facilities separate from the main campus

FSU recently amended its policy to allow classified research to be performed in limited cases; FSU has also applied for a facilities security clearance

Classified Research – Executive Order 12958 (1995)

Classified Research – Executive Order 12958 (1995)

Page 72: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Classified theses or dissertations (or research for them) are not permitted

Classified theses or dissertations (or research for them) are not permitted University personnel or students who are

considering conducting classified research or who require access to classified data for the pursuit of academic research are urged to make this decision with great care

This restricts the ability to communicate freely with colleagues, research students and classes, and may inhibit and diminish participation in the academic community

Page 73: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Classified ResearchClassified Research

Export Administration Regulations (EAR)

International Traffic in Arms Regulations (ITAR)

Office of Foreign Assets Control (OFAC)

Page 74: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

The Department of Commerce implements EAR, which bar the export of items, technology, and technical information found on the Commerce Control List to foreign countries without an appropriate export license

EAR also cover the transfer of dual use commercial goods, which are those that have both a legitimate civilian and military use

Export Administration Regulations (EAR)Export Administration Regulations (EAR)

Page 75: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

The Department of State implements ITAR, which regulate the export of items on the Munitions Control List, and technical information about them

Because technologies for space science are similar to those for military space applications, space scientists have encountered problems with exchange of items and information, and collaborations with foreign colleagues, students and faculty

International Traffic In Arms Regulations (ITAR) International Traffic In Arms Regulations (ITAR)

Page 76: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Both EAR and ITAR possess exemptions for “fundamental research”

Both clarify the definition of fundamental research as “basic and applied research in science and engineering where the resulting information is ordinarily published and shared broadly within the scientific community”

This is distinguished from research, the results of which are restricted for proprietary reasons or specific U.S. Government access and dissemination controls

ExemptionsExemptions

Page 77: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

The university or its researchers accept restrictions on publication of scientific and technical information resulting from the project or activity, OR

The research is funded by the U.S. government and the government has instituted specific access and dissemination controls protecting information resulting from the research

**University research is NOT considered fundamental research if…

**University research is NOT considered fundamental research if…

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Deemed ExportDeemed Export

A transfer of information about controlled technologies to foreign nationals in the U.S. is “deemed” to be an export to foreign national’s home country

A license is required and other access restrictions are imposed

Example: If a company hires a foreign person who will be exposed to data controlled by EAR or ITAR, the business must obtain an export license (unless another exemption applies)

Page 79: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Foreign National/PersonForeign National/Person Not a U.S. citizen

Not a permanent resident alien (i.e., green card holder)

Not granted asylum status

Defines virtually all of our foreign students and many of our visiting scientists

Page 80: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

Export controls have the potential to harm the quality of university research, undermine publication rights, and prohibit international collaboration if the research is subject to EAR/ITAR, is not published or otherwise placed in the public domain, and does not qualify for the fundamental research exclusion

Universities should strive for maximum openness among agencies – governmental or private – that place any kind of restriction upon access to information of a scholarly character

Bottom LineBottom Line

Page 81: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

COGR has compiled a list of materials and resources on export control issues and is engaged in ongoing discussions with federal agencies about these issues

See COGR website at www.cogr.edu

Any FSU employee can request access to “members only” information from this website

Council on Governmental Relations (COGR)Council on Governmental Relations (COGR)

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Foreign Asset ControlForeign Asset Control Oversight by the Department of Treasury Office of

Foreign Assets Control (OFAC)

OFAC administers and enforces economic and trade sanctions against hostile targets to further U.S. foreign policy and national security objectives

Hostile targets include: Foreign governments (e.g., Iran, Sudan, Cuba) Individuals (e.g., terrorists, narcotics traffickers) Entities (e.g., drug front companies, charities linked

to terrorist groups) Practices (e.g., trade in non-certified rough

diamonds, proliferation of WMD)

Page 83: Non-Financial Compliance Overview CReATE Presented by: Amber L. Pursley, Grants Compliance Analyst

The consequences can be severe, ranging from loss of research contracts, to monetary penalties, to jail time for the individual violating these regulations

Penalties

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Advice Visit the Office of Research, Research Compliance website at

http://www.research.fsu.edu/researchcompliance/exportcontrols.html for detailed information regarding the federal regulations and FSU’s requirements

Prior to commencing any research, determine whether the research is impacted by the controls or requirements contained within export regulations

Make export determinations far enough in advance to obtain an authorization, should one be required, particularly when transferring scientific equipment, research materials, or confidential information to researchers in other countries or accepting confidential information from private companies

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If FSU accepts research subject to certain restrictions or controls, the Vice President for Research must approve the project and the resultant federal compliance responsibilities

Remember…

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Contact Jane Mostoller, Associate General Counsel,

Office of Research

E-mail: [email protected]: (850) 644-0284Fax: (850) 644-4392Location: 2010 Levy Avenue

Building B, Suite 276Tallahassee, FL 32310

Mail Code: 2742

Website: http://www.research.fsu.edu/researchcompliance/index.html

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Questions?Questions?