non-financial compliance overview create presented by: amber l. pursley, grants compliance analyst
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Non-Financial Compliance Overview
Non-Financial Compliance Overview
CReATEPresented 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
Intellectual Property 101Intellectual Property 101
Office of Intellectual Property Development and Commercialization
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
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
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authorship,” including literary, dramatic, musical, artistic, and certain other intellectual works, both published and unpublished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
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
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
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
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
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
Responsible Use and Welfare of Animals in Research
Responsible Use and Welfare of Animals in Research
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
Why Use Animals?Why Use Animals?
Chimpanzee – 98.7%
Mouse – 85%
Fruit Fly – 60%
Yeast – 46%
Banana – 50%
DNA Homology With Man
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)
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
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
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
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
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
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 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
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)
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
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
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
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
Forms
Animal Care and Use Forms
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…
Protecting Human Research Subjects
Protecting Human Research Subjects
Human Subjects Committee
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Human Subjects WebsiteHuman Subjects Website
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
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/
FSU Department of Environmental Health & Safety
FSU Department of Environmental Health & Safety
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
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
ContactContactwww.safety.fsu.edu
(850) 644-6895
Federal Requirements for Working with Select Agents and Toxins
Federal Requirements for Working with Select Agents and Toxins
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
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
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
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
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
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
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
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
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
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
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
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
ContactContactJane Mostoller, Associate General Counsel, Office Of Research
E-mail: jmostoll@mailer.fsu.eduPhone: (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: tjacobso@admin.fsu.eduPhone: (850) 644-7687Fax: (850) 644-8842Address: 1200 Carothers Hall
Tallahassee, FL 32306Mail Code: 4481Website: http://www.safety.fsu.edu
Classified Research – EAR, ITAR and OFAC
Classified Research – EAR, ITAR and OFAC
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)
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
Classified ResearchClassified Research
Export Administration Regulations (EAR)
International Traffic in Arms Regulations (ITAR)
Office of Foreign Assets Control (OFAC)
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)
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)
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
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…
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)
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
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
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)
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)
The consequences can be severe, ranging from loss of research contracts, to monetary penalties, to jail time for the individual violating these regulations
Penalties
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
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…
Contact Jane Mostoller, Associate General Counsel,
Office of Research
E-mail: jmostoll@mailer.fsu.eduPhone: (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
Questions?Questions?
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