staying on the right road with responsible conduct...dual comp staying on the right road with... dr....

DualComp

Staying on the right road with...

Dr. M. J. Soileau Dr. Stephen M. KueblerVP for Research Interim Asst. VP for Research

[email protected] [email protected] x3-2990

Office of Research Millican Hall, Suite 243 www.research.ucf.edu

Responsible Conduct

•Professional misconduct We expect the highest level of professionalismfrom ourselves and our peers.

•Violating federal rules Jeopardizes UCF access to federal funds.

•Misusing state resources Could bring even more state regulations!

What are the issues and why should you care?

Ask yourself the following:•What is your career worth to you?

There can be criminal liability!•How could it impact your students' careers?•How could it impact your colleagues' careers?•How could it impact your institution?

So what's this all about?

It's about MJ's Mantra!...

True or False?It's my work, so it's ok to copy it.

Anything I create while working at UCF is my intellectual property (IP).

I can work up to one day per week for myself.

I need IRB approval for all projects involving data gathered on human subjects.

I can take this equipment home because I am using it for work.

We love to give quizzes, so let's take one!

AnswerFalse. This is self‐plagiarism, and the publisher owns the copyright.

False. UCF owns all IP we create connected to our area of employment.*

False. Outside activity is permitted only if it does not create COI/COC.

True, even if you got consent from the human subjects themselves!

False... but True if you obtain authorization.

*There are exceptions. We'll talk more about books, course notes, and other creative works in a bit...

MJ, are you making up these rules?!?!

But think of me as the "Bodhisattva of Responsible Conduct"...

... because all fun aside, this stuff is getting serious!

No, I am just the messenger!

Federal law/regulations

• "Responsibility of Applicants for Promoting Objectivity inResearch" (42 CFR 50.602, 50.603, & 50.604)

• "Financial Disclosure by Clinical Investigators"(21 CFR 54.1‐3 & 54.4‐6, FDA)

•Dept. of Health and Human Services (DHHS)National Science Foundation (NSF)National Institute of Health (NIH)

• "Federal Educational Rights and Protections Act" (FERPA)

•Occupational Safety and Health Administration (OSHA)

• Environmental Protection Agency (EPA)

Rules for Responsible Conduct come from...


State law/regulations


• FL Department of Environmental Protectionhttp://www.dep.state.fl.us

• Bureau of Radiation Control, FL Department of HealthWe must register lasers/X‐ray sources with the state.

http://www.myfloridaeh.com/radiation



County regulations


• Building codes• Sometimes lower‐tier rules are actually more stringent!



County regulations

City codes


• Building fire codes• And codes for counties and cities of our satellite campuses



County regulations

City codes

State University System (BOG)


•Use of E&G funds (Education and General)•Use and stewardship of state property(e.g., lab eqpt., computers, vehicles)



County regulations

City codes

State University System (BOG)

UCF/BOT regulations & policiesCollective Bargaining Agreement


• Intellectual property•Hiring practices

Follow the path ofResponsible Conduct...

• Probably not and do well with teaching and research...

• There are simply too many details to be an authority!

• ... and the rules keep changing!(e.g., DHHS rules on COI are new.)

Can you keep trackof all this?

So follow the Mantra:1. Know the issues of RC.2. Compliance is your responsibility.3. Contact ORC for help!

Ethics in Authorship

• Who is an author?‐ Include all people who contributed, but do not includethose who did not.

• All authors are responsible for the entire content.‐ All authors must consent to publication.

• Do not re‐publish the same work.

• Do not post PDFs of your published articles or distribute electronically, unless permitted.

"The action or practice of taking someone else's work, idea, etc., and passing it off as one's own; literary theft."(Oxford English Dictionary, online, 2013)

•Applies to papers, proposals,presentations, reports, webpages,...

•NSF, NIH, etc. are increasingscrutiny.

Plagiarism

"The action or practice of taking someone else's work, idea, etc., and passing it off as one's own; literary theft."(Oxford English Dictionary, online, 2013)

•Applies to papers, proposals,presentations, reports, webpages,...

•NSF, NIH, etc. are increasingscrutiny.

• Incidents at UCF have put us under the magnifying glass.

Plagiarism

• Changing a few words is not enough!

• Cite properly:‐ Use quotes.‐ Cite images & figures in the caption.‐ Copy/paste from your own work is self‐plagiarism. Cite & use quotes.

• A ruling of plagiarism can:‐ Bar you from federal funding;‐ Ruin your career;‐ Cause UCF to lose federal funding;‐ Ruin the reputation of UCF;‐ Tarnish the reputation of studentswho work(ed) with you.

• If your name is on it...... YOU and UCF are responsible.... not students, postdocs, or co‐PIs.

Plagiarism

• iThenticate is a rapid system for checkingproposals.

• Use is mandatory for all proposals from UCF.

• It is used by NSF, NIH, etc.

• It can can keep you out of trouble by catchingplagiarism in content provided by collaborators,post‐docs, etc!

• The results of a scan are not seen by anyone but you.

• It does not put your IP at risk:

‐ Submitted works cannot be viewed by public or the iThenticate company.

‐ User license does not grant the iThenticate company rights to the user's IP or proprietary data.

Protecting yourself and UCF from Plagiarism

www.rcr.ucf.edu/ithenticate.htmlwww.ithenticate.com

iThenticate protects you and UCF against unintentional plagiarism.

Falsifying and Misrepresenting Data

V. NinovFaked discovery of elements 116 & 118.

J. H. SchönFraud in organic electronics.

Photos from Nature, 420, 728 (2002) andChung Sung‐Jun/Getty Images.

H. Woo‐SukFaked results in stem cell research.

Where arethese researchers

now?

IRB = Institutional Review BoardIACUC = Institutional Animal Care and Use Committee

IRB and IACUC Consent

www.research.ucf.edu/Research/IACUC_ARPO.html www.research.ucf.edu/Compliance/irb.html

Governing documents•National Research Act (1974)•Title 45 CFR Pt. 46 (1974)Revised through 21 CFR 50, 21 CFR 56 (1981)

•“The Common Rule” (1991)Policy applying to 17 Federal agencies/offices

•Animal Welfare Act & Public Health Service

IRB = Institutional Review BoardIACUC = Institutional Animal Care and Use Committee

www.research.ucf.edu/Research/IACUC_ARPO.html www.research.ucf.edu/Compliance/irb.html

Purpose•Ensure ethics in research involving human (IRB) and animal (IACUC) subjects

• IRB/IACUC reviews and provides oversight for ensuring ethical protocols.

1. IRB (IACUC) consent is required for all research involving human (animal) subjects.

2. Seek approval, even if you don't think it's needed:‐ You may not be able to publish data if approval was not obtained.

‐ You can't get approval "after the fact"!3. Let IRB be the one to tell you it is exempt.

IRB and IACUC Consent

•Train students/workers properly.•Comply with all EH&S regulations (UCF Policy 3‐122 )‐ Keep training up to date; post your emergency plan.‐Maintain PPE, lab eqpt., & chemical inventory.‐ Safely maintain flammables, chemicals, & biologicals.

•Register Class III/IV lasers and X‐ray sources.‐ Failure to register is a misdemeanor.‐ www.myfloridaeh.com/radiation(FL Stat. 501.122).

•Disclose chemical/bio/laserhazards on PTF.

Facility Safety

You could be criminally liable if:‐Workers are not properly trained;‐ Lab not properly equipped;‐ Safety regs not followed; and‐ Risks are not documented.

NIH,NSF, DOD, & DOE attach Safety/EH&S Policies to grants.‐ If they are not followed, it could jeopardize that grant & all others at the institution.

Sheri Sangji died 16 Jan. 2009from burns resulting from a

chemistry experiment at UCLA.(Photo from Naveen Sangji/ACS)

UCLA Prof. Patrick Harran faces felony charges for occupational safety

violations that resultedin Sangji's death.

(Photo from Patrick Harran/ACS)

Conflict of Interest & CommitmentGoverning documents• Federal law and agency regulations• FL Statutes (FL Code of Ethics, Title X, Ch. 112, Pt. III)• SUS Regulations•UCF Regulations•Collective Bargaining Agreement (CBA)

Ima Prof, Ph.D.Office Hours

Mon 2 ‐ 4 pmTues 9 ‐ 10 amFri 4 ‐ 5 pm

Outside Activity is• "Any private practice, private consulting, additional teaching or research, or other activity, whether compensated or uncompensated, which is not part of the employee's assigned duties and for which the University provides no compensation."

(CBA Art. 19.2)

• Permitted within limits because it advances faculty and institutional competance and reputation.

(CBA Art. 19.1)

Effort reports must reflect ALL outside activities. More on this later...

Conflicts of Interest and Commitment are Prohibited.

Conflict of Interest (COI) is

" (1) any conflict between the private interests of the employee and the public interests of the University, the Board of Governors, or the State of Florida, including conflicts of interest specified under Florida Statutes; or

(2) any activity which interferes with the full performance of the employee's professional or institutional responsibilities or obligations. " (Art. 19.2 of CBA)

Conflict of Commitment (COC) means

" (1) outside activities that involve frequent or prolonged absences from the University on non‐University business; or

(2) outside activities that engage a substantial portion of the time an employee is expected to spend on assigned duties or University‐related activities. " (Art. 19.2 of CBA)

You cannot be the arbiter ofyour own COI.

Significant Financial Interest (SFI)•You must disclose SFI if it:‐ relates to your "institutional responsibilities" and‐ exceeds $5k (or a 5%‐interest) in one year.

Conflict of Interest & Commitment

Examples•Choosing a textbook you wrote•Consulting fees or honoraria•Using services/products from a company inwhich you have an interest for research (funded or unfunded)

•Applies to anyone involved in design, conduct, or reporting of research(CFR 42 Pt. 50.602/603/604, CFR 21 Pt. 54.1‐6 and Pt. 54.4‐6)

•Material interests include stocks, stock options, ownership interests.• IP rights (e.g., patents, copyrights, royalties)

NIH changed this amount only last year...The rules keep changing!...

So disclose and let ORC help!

All outside activity and potential COI must be reported

•Complete form AA21 annually.http://www.coi.ucf.edu/reporting.html

•Update within 30 days of a change.(FL Stat. 112.313, CBA Art. 19, UCF Regs. 2.032 & 3.018, UCF Policy 4‐504).

Reporting and managing Conflict of Interest (COI)

Milton ChangFounder of Incubic & NewFocusCEO of Newport & JDS‐Uniphase

"If there is no

conflict, there is

no interest."

COI can be managed!

•Contact ORC to develop a COI‐management plan.

•Obtain approval from your supervisor to use UCF resources for outside activity, including:‐ Your time ‐ UCF services (e.g., secretarial/staff)‐ Equipment (e.g., vehicles, computers)‐ Facilities (e.g., lecture halls, labs)

No University Affiliation

•Make clear to your sponsor that you do not represent UCF during outside activity.

Political office•Cannot use UCF resources or position to seek office(FL Statute 104.31, UCF Policy 4‐504 UCF Reg. 4.010)

Employing students•You cannot employ students for whom you have evaluative responsibility, for outside activity. (UCF Reg. 3.108)

•Student‐time COI can be managed through‐ Contracts to UCF‐ Separate supervision

And what's the good news?...•Once you disclose and receive approval, you are off the hook. So...

Conflict of Interest & Commitment

Disclose !

Disclose !

Effort CertificationWe certify effort each semester•Certify %‐effort for you and your employees/students.•%‐effort must be consistent with assignments to avoid COI/COC.• Justify any differences that result; charges may have to be transferred.•Consult with your supervisor and ORC for help.

Max 0.85 FTE chargeable to federal grants in summer•This avoids potential COI found nationwide by federal audits.•There is a work‐around:

You can be paid the remaining 0.15 in summer from E&G if you pay 0.15 of your salary in spring/fall from your C&G.

•Consult your supervisor and/or contact ORC.

It's a pain! We try to make the process as easy as possible...But until the rules change... we must all comply!

The 0.85 FTE rule is a direct result of NSF audit findings nationwide...... so please, follow the rules to help avoid more restrictions!

Intellectual Property (IP) and WorksGoverning documents

•U.S. Constitution (Art. 1, Sect. 8)“Congress shall have the power to... promote theprogress of science and useful arts, by securing for limitedtimes to authors and inventors the exclusive right to theirrespective writings and discoveries. ”

•Patent and Trademark Act Amendments of 1980 (Bayh‐Dole Act).“Universities and small businesses may elect to retain title toinnovations developed under federally‐funded research programs. ”

•Florida Statutes‐ University offices of sponsored research (1004.22)‐ Universities; powers, patents, copyrights, & trademarks (1004.23)

•University Regulations‐ Patents, Trademarks and Trade Secrets (Reg. 2.029)‐ Copyrights and Works (Reg. 2.033)‐ Sponsored Research (Reg. 2.027)

•Collective Bargaining Agreement (Art. 18)

Types of IP

1. Patent Right to exclude others from making, using, selling, or importing an invention

2. Copyright Right to prevent others from copying, distributing, selling, performing, or publically displaying the copyrighted work and its derivatives

3. Trademark Right to prevent others from using a source “mark” in relation to goods or services in a manner that is likely to confuse consumers as to the source

4. Trade Secret Rights in a secret idea having commercial value

Intellectual Property (IP) and Works

Rights to Inventions•UCF owns IP made in your Area of Employment (AOE).‐ AOE = The field in which UCF supports you to teach, research, or give service.

‐ Even if done on your own time... with or without UCF support‐ Inventor(s) share in the proceeds from commercialization.

•You own IP created without UCF support and outside your AOE.‐ i.e., IP arising from authorized Outside Activity and outside your AOE.

Rights to Works•You own rights to scholarly or artistic Works you create for disseminating results of academic research or scholarly study, including books, articles, or artistic expressions; however…

•UCF holds rights in Copyright to all of your other Works as Works for Hire.‐ Creator(s) shall share in the proceeds from commercialization of works.

Intellectual Property (IP) and Works

Disclose all of your Inventions and Works to the ORC.Let us help you commercialize your ideas!

USF v. Petr Taborsky (1989)

1. Progress Technologies Corporation (PTC) contracted USF inAug 1987 for research related to wastewater treatment, protectedby confidentiality agreements signed by all participants, includingTaborsky, an undergraduate research assistant.

2. Taborsky left USF taking his lab notebooks with him.He refused to respond to repeated requests to return the notebooks.

3. In Jan. 1990 a jury convicted Taborsky of second degree grand theft (FL stat. 812.014(2)(b)) and theft of trade secrets (FL stat. 812.081(2)).

4. Taborsky was sentenced to 1 year of house arrest, 15 years probation, and 500 hours of community service. As a condition of probation, the judge prohibited Taborsky from using the stolen research for any purpose.

5. Taborsky then obtained a patent related to research he stole from USF.

6. The criminal court ruled Taborsky willfully violated probation.He was sentenced to 3.5 years prison, suspended, and 15 years probation.The court further directed Taborsky to assign his patent to USF as restitution.

Getting into trouble with IP

Getting into trouble with IP

Export Compliance: What is it?International Traffic in Arms Regulations (ITAR)ITAR prohibits export of USML‐listed “defense articles” (including “know‐how” related to articles) or performance of “defense services” (including training) that are inherently military in character, or specially designed, modified or engineered for military applications.

U.S. Munitions List (USML)The USML enumerates technologies and data that are ITAR restricted.

Export Administration Regulations (EAR)EAR restricts "export" of technical data associated with commercial/military "dual‐use" items on the Commerce Control List (CCL).

Deemed ExportThis rule states that the transfer, release or disclosure to foreign persons in the United States of technical data about controlled commodities is deemed to be an export to the home country of the foreign person.

Export Compliance: What's on the USML?

http://www.research.ucf.edu/ExportControl/itar.html#usml

Category DescriptionI Firearms, Close Assault Weapons and Combat ShotgunsII Guns and ArmamentIII Ammunition / OrdinanceIV Launch Vehicles, Guided Missiles, Ballistic Missiles, Rockets, Torpedoes, Bombs and MinesV Explosives and Energetic Materials, Propellants, Incendiary Agents and Their ConstituentsVI Vessels of War and Special Naval EquipmentVII Tanks and Military VehiclesVIII Aircraft and Associated EquipmentIX Military Training Equipment and TrainingX Protective Personnel Equipment and SheltersXI Military ElectronicsXII Fire Control, Range Finder, Optical and Guidance and Control EquipmentXIII Auxiliary Military EquipmentXIV Toxicological, Chemical, Biological Agents, and Associated EquipmentXV Spacecraft Systems and Associated EquipmentXVI Nuclear Weapons, Design and Testing Related ItemsXVII Classified Articles, Technical Data and Defense Services Not Otherwise EnumeratedXVIII Direct Energy WeaponsXIX ReservedXX Submersible Vessels, Oceanographic and Associated EquipmentXXI Miscellaneous Items

Export Compliance: What's on the CCL?Category Description

0 Nuclear Materials, Facilities & Equipment (Miscellaneous Items)1 Materials, Chemicals, Microorganisms and Toxins2 Materials Processing3 Electronics Design, Development and Production4 Computers

5 (Pt. 1) Telecommunications5 (Pt. 2) Information Security

6 Sensors and Lasers7 Navigation and Avionics8 Marine9 Propulsion Systems, Space Vehicles and Related Equipment

http://www.research.ucf.edu/ExportControl/pdf/ccl_index[1].pdf

If your work is even remotely connected to USML/CCL fields,contact ORC so we can help you remain Export Compliant.

We might even be able to match you withnew funding opportunities!

Export ComplianceCheck the country involved on your projects• Export of data, materials, devices, processes and “know‐how” related to certain technologies is restricted by federal law.

• Foreign nationals (including students!) require federal license to work on ITAR projects. Different approval is required for proprietary EAR projects.

• Contact ORC before attempting to host or collaborate with folks from embargoed and proscribed countries and institutions. See the "Entity List":

http://www.bis.doc.gov/policiesandregulations/ear/744_supp4.pdf

• Technology Control Plans can be constructed to conduct ITAR research in labs where foreign nationals also work.

Visiting Scholars/J1‐Visas• Sponsoring a visa for people coming from an embargoed country or “Entity List” institution requires additional compliance measures. Check with ORC!

ITAR/EAR violations can result in criminal and civil penalties and jeopardize UCF's ability to obtain federal contracts, particularly from DoD.

Contact ORC for help with the above!

• Lock doors and control access to sensitive areas or where expensive equipment is maintained.

• Scales and other lab equipment are prized fordrug manufacture and trade.

• Stolen lab equipment is easily sold on eBay, etc.

Talk to your unit head and aboutmaking your spaces secure.

• ITAR projects can require special controls.

Contact Facility Security Officer Dela Williamsx2‐1123 [email protected]

http://security.research.ucf.edu/index.html

Facility Security

Meth‐lab items seized fromUCF students' Campus Crossing Apartment

(Orange Co. Sheriff's Office)

• Asymmetry in power results when one person isin an evaluative role relative to another.‐ Teacher to Student‐ Employee to Supervisor‐ Faculty to Faculty

Personal Relationships

It is not possible to have a consenting relationship wheneverthere is or could be an asymmetry in power.

• Evaluative structure is highly fluid at a university.‐ Faculty, staff, and students change departments.‐ Students become employees.‐ Faculty move onto evaluative committees

(TIP, RIA, Pomotion & Tenure, etc.).

• You cannot assume that there will never be an asymmetry in power.

The take-home message is"MJ's Mantra"!

1. Know the issues of RC.2. Compliance is your

responsibility.3. Let ORC help you!

ORC is here to help...

It's one ofthe things your

overhead pays for!

Thanks for listening!

Thanks to these folks for helping us put together this presentation!

• Barb Abney Director of Public Relations, ORC

• Douglas Backman Director of Compliance, ORC

• Thomas Briggs Director, EH&S

• Cristina Caamaño Asst. Dir., Research Program Services

• Sophia Dziegielewski IRB Chair

• Michael Miller Asst. Director, Export Controls, ORC

• Tom O'Neal Assoc. VP for Research, ORC

• Svetlana Shtrom Dir., Technol. Commercialization, ORC

• Jo Smith Dir., Outreach/Development/C&G, ORC

• Pallavoor "Vaidy" Vaidyanthan Asst. VP for Research, ORC

• Dela Williams Facility Security Officer, ORC

staying on the right road with responsible conduct...dual comp staying on the right road with... dr....

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