Transcript Copyright Policy at FSU

Non-Financial
Compliance Overview
CReATE
Presented by: Amber L. Pursley, Grants Compliance Analyst
Topics 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
Intellectual Property 101
Office of Intellectual
Property Development and
Commercialization
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
Patents
 Form of protection for inventions
 Invention = a solution to a specific
technological problem if it is novel, useful,
and not obvious
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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
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intellectual works, both published and unpublished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
Trademark
 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
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
Importance 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
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
More Help
 www.techtransfer.fsu.edu
 http://www.research.fsu.edu/techtransfer/faculty
staff.html
 http://www.research.fsu.edu/techtransfer/resour
ces.html
 Also:
 Campus-wide IP seminars (Fall & Spring)
 Department/program presentations
 Individual consultation
Responsible Use and
Welfare of 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
DNA
Homology
With Man
Why Use Animals?
Chimpanzee – 98.7%
Mouse – 85%
Yeast – 46%
Banana – 50%
Fruit Fly –
60%
Outside 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)
Animal Welfare Act (1966)
 Administered by the USDA
 Covers warm-blooded animals such as dogs, cats,
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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
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
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
Health Research Extension Act
 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)
Office of Laboratory Animal
Welfare
 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
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
Other Regulations
 USDA Animal Care Policies
 NIH & CDC Biosafety & Hazardous Agents
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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
Institutional Animal Care & Use
Committee (IACUC)
 Responsible for animal use protocol review
 Responsible for animal research program review
 Responsible for the development and review of institutional
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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
IACUC 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
Researcher Responsibilities and
Obligations
 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
Research Team Responsibilities
IACUC Protocol
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Know the animal protocol
Refer to the protocol often
Make no deviations from the protocol
Make sure everyone in the lab has read the
protocol and knows where it is located
 There is no such thing as a pilot study that
does not need IACUC approval
Review Prior to Release of Funds
 SRS submits the following to Laboratory
Animal Resources (LAR):
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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
Forms
Animal Care and Use Forms
Remember…
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
Protecting Human
Research Subjects
Human Subjects
Committee
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
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
U.S. Government-Funded Syphilis Study in
African American Men (1932-1972) – “Tuskegee”
 400 Syphilitic men and 200 control group recruited in
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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
Definitions
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
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
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
Federal Regulation Requirements
(The Common Rule)
 Review of research by an IRB
 Institutional assurance of compliance
 Informed consent of subjects
IRB 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
Types of IRB Review
 Full Committee – vulnerable
populations, greater than minimal risk
 Expedited/Exempt – no more than
minimal risks, criteria described in
regulations
Voting 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
Documents Required for IRB Review
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Completed IRB application
Protocol
Proposed informed consent document(s)
Grant application
Copies of surveys, questionnaires, or videotapes
Advertisement/recruitment flyers
Continuing Review
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Application (Request for Renewal)
Progress report
Adverse events
Current approved informed consent document
Amendments or changes to protocol requests
IRB 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
IRB 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
Institutional Responsibilities (FSU)
 Full legal responsibility pursuant to Assurance
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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
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
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
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
Human Subjects Website
Human 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
Contact
Office of Research
Human Subjects Committee
Physical Address
2010 Levy Avenue
Building B, Suite 276
Tallahassee, FL 32310
Mailing Address
Florida State University
Human Subjects Committee
Tallahassee, FL 32306-2742
Campus Mail Code: 2742
Phone: (850) 644-8673
Fax: (850) 644-4392
http://www.research.fsu.edu/humansubjects/
FSU Department of
Environmental Health
& Safety
Research 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
Miscellaneous
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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
Contact
www.safety.fsu.edu
(850) 644-6895
Federal Requirements for
Working with 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
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
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
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environment (not intentionally introduced)
Nonviable agents or fixed tissues
Certain vaccine strains
Attenuated strains or forms of agents or toxins (must
apply for an exclusion)
Toxins below the aggregate limits
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
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
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
Security 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
Restricted Person
 Indicted of a crime punishable by imprisonment
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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
Unauthorized 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
Authorized/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
Penalties 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
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
Contact
Jane Mostoller, Associate General Counsel, Office Of Research
E-mail:
Phone:
Fax:
Address:
Mail Code:
[email protected]
(850) 644-0284
(850) 644-4392
2010 Levy Avenue
Building B, Suite 276
Tallahassee, FL 32310
2742
Tom Jacobson, Director, Environmental Health and Safety
E-mail:
Phone:
Fax:
Address:
Mail Code:
Website:
[email protected]
(850) 644-7687
(850) 644-8842
1200 Carothers Hall
Tallahassee, FL 32306
4481
http://www.safety.fsu.edu
Classified Research –
EAR, ITAR and
OFAC
Classified Research – Executive Order
12958 (1995)
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 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
Classified Research
 Export Administration Regulations
(EAR)
 International Traffic in Arms
Regulations (ITAR)
 Office of Foreign Assets Control
(OFAC)
Export Administration Regulations (EAR)
 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
International Traffic In Arms Regulations
(ITAR)
 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
Exemptions
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
**University research is NOT considered
fundamental research if…
 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
Deemed 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)
Foreign 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
Bottom Line
 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
Council on Governmental Relations
(COGR)
 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
Foreign 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:
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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)
Penalties
The consequences can be
severe, ranging from loss of
research contracts, to monetary
penalties, to jail time for the
individual violating these
regulations
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
Remember…
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
Contact
Jane Mostoller, Associate General Counsel,
Office of Research
E-mail:
Phone:
Fax:
Location:
Mail Code:
[email protected]
(850) 644-0284
(850) 644-4392
2010 Levy Avenue
Building B, Suite 276
Tallahassee, FL 32310
2742
Website:
http://www.research.fsu.edu/researchcompliance/index.html
Questions?