Montana State University - PowerPoint Presentation

Slide1

Montana State University

Responsible Conduct of Research (RCR) Training - August 2010

Hosted by: President’s Office, Division of Graduate Education & Vice President for ResearchSlide2

Overview – Why RCR Training?Leslie Schmidt, Asst VP for Research

Provides good foundation for studentsRequired by National Institutes of Health (NIH) & National Science Foundation (NSF)

Additional on-line training available via CITI (Collaborative Institutional Training Initiative)

Additional coursework available (PHL491 Research Ethics) this fall

Principal Investigator (PI) & Student’s responsibility to document & verify that RCR training has been completed

NIH specifically requires a minimum of 8 contact hoursSlide3

Presenters

Leslie Schmidt, Asst VP for ResearchPam Merrell, Legal Counsel

Carl Fox,

Vice Provost

Nick Zelver,

Technology Transfer

Mark Quinn,

Institutional Review Board

Chris O’Rourke,

Animal Resource Center/IACUC

Michael Babcock,

IACUC

Adam Edelman,

Information Technology

Tamara Miller,

Libraries

Sandy Sward,

Office of Sponsored ProgramsSlide4

AGENDA

1:00 - 1:05 p.m. Welcome & IntroductionLeslie Schmidt

1:05 - 1:35 p.m.  Responsible Conduct of Research/Research Misconduct

Carl Fox & Pam Merrell

1:35 - 2:05 p.m. Intellectual Property & Research

Nick Zelver

2:05 - 2:35 p.m.  Human and Animal Welfare in Research and Biosafety

Mark Quinn, Chris O’Rourke & Mike Babcock

2:35 - 2:50 p.m. – BreakSlide5

AGENDA

2:50 - 3:20 p.m.  Conflict of InterestPam Merrell

3:20 - 3:50 p.m. Export Controls and Data Acquisition, Security & Management

Pam Merrell & Adam Edelman

3:50 - 4:20 p.m. Copyright, Plagiarism, and Responsible Authorship

Tamara Miller

4:20 - 4:50 p.m. CITI website demo

Sandy Sward

4:50 - 5:00 p.m. Final Q&A Slide6

Responsible Conduct of Research/Research Misconduct

Carl FoxSlide7

IOM Report 2002

“the responsible conduct of research is not distinct from research; on the contrary, competency in research encompasses the responsible conduct of that research and the capacity for ethical decision making.” From: Institute of Medicine. “Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct.” Washington, D.C., National Research Council of the National Academies, 2002,

p

. 9.Slide8

Definition of RCR

“defined as the practice of scientific investigation with integrity. It involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.” From: NIH

NOT-OD-10-019, November 24, 2009, Update on the Requirement for Instruction in the Responsible Conduct of

Research Slide9

NIH and NSF

NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research.  NIH NOT-OD-10-019, November 24, 2009, Update on the Requirement for Instruction in the Responsible Conduct of Research

NSF  requires that

``each institution that applies for financial assistance from

the Foundation

for science and engineering research or education

describe in

its grant proposal a plan to provide appropriate training

and oversight

in the responsible and ethical conduct of research

to undergraduate

students, graduate students, and postdoctoral

researchers participating

in the proposed research project.

'’

Section

7009 of the America Creating Opportunities

to Meaningfully

Promote Excellence in Technology, Education, and

Science (

COMPETES) Act (42 U.S.C. 1862o-1

Slide10

Components of RCR

Research MisconductHuman and Animal Welfare and Laboratory SafetyConflict of InterestData Acquisition, Security, Management, Ownership, Export Controls

Responsible Authorship and Publication

Peer Review

Collaborative Research

Mentor/Mentee Responsibilities and Relationships

Societal ResponsibilitiesSlide11

Case Studies

OverwhelmedPreliminary DataAuthorship

Ethics and PressureSlide12

Montana State University

Questions?Slide13

Research Misconduct PolicyPam MerrellSlide14

Research Misconduct RegulationFederal funding agencies (Primarily Public Health Service—including NIH) require specific policies and procedures

MSU Research Misconduct Policy: http://www2.montana.edu/policy/faculty_handbook/fh400.html#430.00 Slide15

Research Misconduct -Definition Plagiarism:

“the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. “Slide16

Research Misconduct-DefinitionFabrication: “making up data or results and recording or reporting them.”Slide17

Research Misconduct - DefinitionFalsification:

“manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.”Slide18

Research Misconduct - NOT Authorship Disputes

Research misconduct does not include honest error or differences of opinion. Slide19

Reporting Research MisconductReport to Dept. Head or Dean

They report to VP ResearchDirectly to VP ResearchSlide20

Research Misconduct Allegation - Process

Initial Determination: (1)    meets the definition of research misconduct;(2)    involves either the research, applications for research support, or research records; and,

(3)    allegation sufficiently credible and specificSlide21

Research Misconduct Allegation—ProcessInquiry

VP Appointed inquirerWritten Determination—whether full investigation is warrantedIf warranted report to funding agencySlide22

Research Misconduct Allegation - Process

InvestigationDetailed procedures from appointing investigator to final report including:Securing research data, documents, etc. related to allegationsMUST find: significant departure from accepted practices; committed intentionally, knowingly, or recklessly; and proven by a preponderance of the evidence

Confidentiality

Restoration of reputationsSlide23

Research Misconduct Allegation—ProcessDiscipline

Students, Student Code of Conduct ViolationsEmployees, Breach of Employment ContractFederal Sponsors may impose sanctionsDebarment from Federal Research

Loss of Research Career

Hauser at Harvard—Monkey Reactions or NOT

Historian –Guns in American HistorySlide24

Montana State University

Questions?Slide25

Technology Transfer

Rebecca W. Mahurin, Ph.D., Director

Nick Zelver, Associate Director

MSU Technology Transfer Office (TTO)Slide26

Purpose of PresentationWhat is Technology Transfer

What is Intellectual Property (IP)How we Protect and License IP Student IssuesWhen to Contact our Office (TTO)Slide27

Our mission is to

create and distribute knowledge.Land Grant InstitutionSlide28

MSU Engages in Technology Transfer

Education and Employment of StudentsPublicationsPatenting/LicensingSlide29

Benefits of Technology Transfer

Transfer MSU Creations for Public BenefitFoster Relationships with IndustryPromote Local Economic Growth

Reward, Retain, Recruit and Serve Faculty

Recognition of MSU and Faculty

Royalties to MSU and InventorsSlide30

MSU Research Expenditures

Mill $

Licenses / OptionsSlide31

Types of Intellectual Property (IP)

Know HowCopyrightTrademarkTrade SecretsPlant Variety Protection (PVP)Patent

(presentation focus)Slide32

“…the right to exclude others from making, using, or selling the invention throughout the United States”

PatentSlide33

Patenting Requirements

NovelUsefulNon-ObviousSlide34

What is Patentable?Processes

MachinesCompositions of MatterImprovements on the AboveAsexually Reproduced Plants

Plants & Microorganisms Which Have Been Genetically Altered

SoftwareSlide35

Patent CostsU.S. ~ $30,000 or More

Foreign ~ $100,000 or MoreMSU TTO Seeks Licensee Commitment before Incurring Patent CostsSlide36

When to File a Patent

U.S. – Must File Within One Year of Public Disclosure or Before DisclosureForeign – Complete Novelty Is Required & Cannot Have Been Publicly DisclosedSlide37

Public Disclosure ExamplesPublication (including enabling abstract)

Seminars/ConferencesSale or Distribution of ProductElectronic DisclosureSlide38

Protecting Intellectual PropertyPatent

Laboratory NotebookConfidential Disclosure AgreementsMaterial Transfer AgreementsResearch AgreementsSlide39

Laboratory NotebookEvidence in Patent Disputes

Establishes Dates of Conception and Reduction to PracticeUse Best Practices and Date EntriesNotebooks Are MSU Property Under the Management of the PISlide40

Confidential Disclosure or Non-Disclosure Agreements

Recipient Agrees in Writing Not to DiscloseAllows Disclosure Without Barring PatentabilityExample NDA on TTO WebsiteMust Be Reviewed and Signed by TTOSlide41

Material Transfer AgreementsAllows Sharing of Proprietary Materials without Barring Patentability

Materials Typically Must Be Destroyed or Returned After UseExample MTA on TTO WebsiteMust Be Reviewed and Signed by TTOSlide42

Sponsored Research AgreementsIf There is an Invention MSU Files Patent and Retains Ownership

Company Has Option to License University Can Publish ResultsSlide43

Testing AgreementsRecognizes that University is Testing Company’s Proprietary Material

Testing Services Are Not Expected to Develop MSU Intellectual PropertyAgreement Must be Reviewed by TTO to Ensure No MSU Intellectual Property is Involved Slide44

Where to Start:MSU Invention Disclosure

Not a Public Disclosure Starts Process for TTO Market Evaluation , IP Protection, and Potential PatentingWhat is the Invention, Who Are the Inventors, Who Funded the Work

Provide Time for TTO to Process

Disclosure Form Available On TTO WebsiteSlide45

Sharing In Rewards

Revenue Sharing With Faculty & StudentsPatent OwnershipSlide46

Regents PoliciesOwnership of IPStudents & IPCo-Inventorship

RewardsSlide47

Student ProjectsMFA (Film Making)

FellowshipsCapstone Projects/Company ParticipationSlide48

Questions?

We are here to help. Contact us if you have an IP question, potential invention, etc.

Technology

Transfer Office (TTO)

304

MT

Hall (Third Floor)

994-7868

tto@montana.edu

website http://tto.montana.eduSlide49

Mark Quinn

Protecting People Who Participate In ResearchSlide50

Who is a research participant?

Anybody we gather information aboutInformation comes fromexperiments

observations (sometimes)

medical records review

surveysSlide51

Informed consentTraining to protect participants (CITI)Training to protect privacy

All research on people must have IRB approval

CODE OF FEDERAL REGULATIONS

TITLE 45-PUBLIC WELFARE

PART 46-PROTECTION OF HUMAN SUBJECTSSlide52

Informed Consent

Consent is a PROCESS...

Researcher tells all important information

Participant has chance to ask questions

Researcher answers questions

Participant signs a consent form agreeing to participateSlide53

What is an IRB?Institutional Review Board

At least 5 members, not all men, not all womenNot all members of one professionExperts appropriate to the researchAt least one scientist, one non-scientist

At least one member from outside the institutionSlide54

Institutional

Review Board (IRB)

The IRB reviews and has

authority

to approve or disapprove all research activities involving human subjects

.

The IRB has authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements.Slide55

SUMMARY

Research involving peopleHelps make better programs or treatmentsOnly done with permission of participantsRules to make it as safe as possible

Must be approved by an IRBSlide56

Montana State University

MSU IRB - http://www2.montana.edu/irbTypes of protocolsExemptExpedited

Full board review

What

you

need to do:

Complete IRB protocol application form

Complete online CITI training w/ certificate

Submit for reviewSlide57

Montana State University

Questions?Slide58

Institutional Animal Care and Use Committee (IACUC)Slide59

Regulatory Oversight of Animal Research

Animal Welfare Act 1966USDA/APHIS

Major updates 1985

Personnel Training

Adequate veterinary care

Establish IACUC

Consider alternativesSlide60

Regulatory Oversight

Public Health Service Policy (1985)DHHS; OLAW

Includes NIH, CDC, FDA funding

Institutional Official

Assurance statement

Training

Adequate vet care

IACUC

Institutional “promise”Slide61

AAALAC Accreditation

Association for the Assessment and Accreditation of Laboratory Animal CareVoluntary, external review programAbove and beyond the required regulationsExternal review performed every three yearsSlide62

Research utilizing animals is a

privilege, not a right.

A

single

incident of serious noncompliance with animal welfare regulations can jeopardize the entire institution’s privilege of conducting animal researchSlide63

IACUC Responsibilities

Assure that animal research is performed to the highest standards

Protect both the individual investigator and the institutionSlide64
Slide65

IACUC Responsibilities

Protocol reviewSemi-annual program reviewSemi-annual facility inspectionsInvestigate animal concerns

Suspend animal activities if necessary

Formal reporting and program recommendations to the Institutional Official (IO)Slide66

Current Issues in Animal Research

Humane Society of United States

PETASlide67

Montana State University

Questions?Slide68

CONFLICTS OF INTERESTPam MerrellSlide69

Conflict of InterestMSU Policy and Federal Regulations:

Prohibit real or apparent conflicts of interest related to awardProhibit acceptance of gratuities, favors, or anything of monetary value from contractors, or parties to subagreementsSlide70

Research DisclosuresInvestigators must disclose “Significant Financial Interests”

That would reasonably appear to be affected by researchInterests in entities whose financial interests would reasonably appear to be affected by the research“Investigator” broadly defined

NIH requires reporting to AgencySlide71

Significant Financial InterestsAnything of “monetary value” of $10,000 or more or 5% or more interest in an entity

Interest of immediate family aggregatedDoes NOT include:Salary, royalties from MSUIncome from seminars, etc. sponsored by public or nonprofits

Income from advisory committees or review panels of public or nonprofit entitiesSlide72

When DisclosedProposals -

Disclosure of “Significant Financial Interest” on Proposal clearance form – $10,000 in value or greater than 5% total equity in the sponsor, subcontractor or in the technology

During the research

–

Disclosure to department head, dean and OSP if significant financial interest is acquiredSlide73

Nepotism

Family/Personal/Business relationships in sponsored research.

Whenever PI faces decision potentially benefiting family, partner or business which employs family or partner using sponsored research funds, PI must report. Vice President for Research responsible for managing the potential conflict in accordance with

Personnel Policy and Procedures Manual - Section 400.00

     Slide74

Purchasing

PI must disclose proposed purchase of goods or services from entity in which s/he or an immediate family member has financial interest.  

The purchase should not be completed until the immediate supervisor reviews the matter with the Purchasing Director and obtains his or her approval.Slide75

BOR §407 DISCLOSURES

Inventor DisclosuresInventor or creator interest in certain business entities

.

Before participation as an employee, officer, board member, or owner in an entity which licenses technology from MSU – disclose to TTO

BOR Section 407 Policy.Slide76

SCENARIO 1Researcher’s father owns a Co. and she wants to sub part of her sponsored research work to her father’s Co.

Unique expertise “Immediate family”?Create the appearance of a COI?Disclose?

Manage?Slide77

SCENARIO 2Researcher’s “partner” (HINT: consensual romantic relationship) applies for a job supervised by researcher in NIH sponsored research

Potential COI?Disclose?Disclose to NIH?Manage?Slide78

SCENARIO 3MSU patents Researcher Clever’s invention. Clever’s husband forms company to license invention and commercialize.

Disclose?Potential COI?Violate Montana ethics law?BOR 407 approval?Slide79

SCENARIO 4Researcher Bunion has outside consulting business and he:

Puts link on his MSU staff webpage to his consulting business?Business cards and stationary have his MSU affiliation, address, and phone number?Meets with clients in his office at MSU?

Occasionally uses MSU phone, computer, and internet access?

Advertises MSU expertise? Formal? Informal?Slide80

SCENARIO 5Noseall—Researcher under NIH funded grant and he performs consulting for Co. commercializing IP related to the his research

NIH research results could affect Co.More than $10K/year incomeDisclose?Manage?Slide81

SCENARIO 6Researcher Stone owns geologic imaging patents. Proposal to NSF for research related to technology.

Patented tech is research tool—can he use?Research could invalidate competing technology?Potential COI?Disclose? Manage?Slide82

Export Control BasicsPam Merrell & Adam EdelmanSlide83

Export Controls

US laws that regulate the distribution to foreign nationals and foreign countries of strategically important products, services and information for reasons of foreign policy and national security. Slide84

Export ControlsSo what does this have to do with MSU? We’re not an exporter—Right?

MORE than you would thinkSlide85

Export ControlWhat is controlled:ITAR—Inherently military items AND related technical information (RESEARCH)

Examples at MSU—satellite, radar, laser researchEAR—Dual Use Items AND related technical information (RESEARCH) Examples at MSU—brucellosis bacteria, ecoli researchCommerce with “DREADED” countries and individualsSlide86

Export ControlsHow Controlled

May not be disclosed or provided to foreign persons—whether abroad OR in the U.S.—(Foreign STUDENTS, POST DOCS, EMPLOYEES) without a license from State Department (ITAR—military items) or Commerce Department (EAR Dual Use)Deemed Export—disclosure of controlled information w/out license to a foreign person, in the United StatesSlide87

Export ControlsMethods of disclosure include

FaxTelephone discussionsE-mail communicationsComputer data disclosure

Face-to-face discussions

Training sessions

Tours which involve visual inspectionsSlide88

Export Control

Problematic if research is export controlled:Scientific collaboration with foreign nationals

Using foreign nationals (including students) in research

Sending materials/goods to foreign countries

Making presentations where foreigners may be in attendanceSlide89

EXPORT CONTROL(The Only Good News)

License Requirement Does Not Apply If an Exclusion Applies:

Education and Public Domain Exclusion (ITAR, EAR)

Fundamental Research Exclusion (ITAR, EAR)

Employment Exclusion (ITAR only)Slide90

Fundamental Research Exclusion(The Silver Bullet)

No license is required to disclose to foreign nationals information which is “published

and

which is generally accessible or available to the public [through, for example] fundamental research in science and engineering at universities where the resulting information is

ordinarily published and shared broadly in the scientific community

.”Slide91

Fundamental Research Exclusion (cont.)

Fundamental Research Exclusion is destroyed if the University accepts any contract clause that:

–

Controls the participation of foreign nationals;

– Gives the sponsor a right to

approve

publications resulting from the research; or

– Otherwise operates to restrict participation in research and/or access to and disclosure of research dataSlide92

MSU Export Control PolicyPolicy:

“to claim the benefit of public domain or fundamental research exemptions from federal export regulations whenever possible.”Procedure: institutional decision to accept sponsored research subject to export control regulations.

Technology Control Plan

required.Slide93

Technology Control PlanPersonnel SecurityPhysical Security

IT SecurityTravel SecurityTrainingAudit or AssessmentSlide94

Export ControlsTriggers to Consider Export Control Issues

Sending any items abroadTravelling abroad carrying information—e.g., with a laptopGrants which restrict publication or have security restrictionsTransactions with foreign countries—e.g., Material Transfer Agreements, transferring research equipment to foreign countries, subgrant to a person in a foreign countrySlide95

Export ControlsThe Reese Roth Case

Professor Emeritus U TennesseeITAR controlled subcontractSlide96

Information SecurityWhy Are We Concerned?

Types of DataThreatsSlide97

Information SecurityAppropriate Data StorageProperly Managed Servers

Portable Devices - MaybeEncryptionSlide98

Information SecurityAppropriate Data SharingProperly Managed Servers

Email - NoSlide99

Information SecurityGeneral Security Best PracticesSafe Email and Web Usage

Appropriate Desktop ManagementProper Account ManagementSlide100

Information Security ResourcesEnterprise Security Group

: itsecurity@montana.eduIT Center Help Desk: 994-1777; helpdesk@montana.eduSafe Computing Web Site

: http://www.montana.edu/itcenter/safecomputing

Data Stewardship Policy & Guidelines

: http://www2.montana.edu/policy/itc/data_stewardship.htmSlide101

Montana State University

Questions?Slide102

Copyright, Plagiarism, and Responsible Authorship

Tamara MillerSlide103

PlagiarismThe unauthorized use or close imitation of the language and thoughts of another author and the representation of them as one's own original work. ----

Random House Dictionary, © Random House, Inc. 2010. Directly quoting from a source without acknowledgment Summarizing another's work without acknowledging the source Inadvertent or unintentional misuse or appropriation of another's work Slide104

Plagiarism410.00 ACADEMIC MISCONDUCT

Includes cheating, plagiarism, forgery, falsification, facilitation or aiding academic dishonesty… or tampering with laboratory equipment, experiments, computer programs, or animals without proper authorization … misuse of research data in reporting results ..

.

--- MSU Student Conduct CodeSlide105

Avoiding PlagiarismCite your sources

Cite your sourcesCite your sourcesDefining and Avoiding Plagiarism: The Writing Program Administrators Statement on Best Practices (http://www.wpacouncil.org/node/9

)Slide106

Copyright law

http://www.copyright.gov/Copyright is a form of protection that gives exclusive rights to the authors of “original works of authorship” to reproduce, distribute, perform, display, and creative derivative works.Slide107

What is copyrighted?Copyrightable expression is original authorship, fixed in a tangible medium of expression.

Works do not need to be registered with the US Copyright Office in order to be protected.Works do not need to be published in order to be protected.Slide108

CopyrightCopyright infringement is the unauthorized or prohibited use of works covered by copyright law, in a way that violates one of the copyright owner's exclusive rights, such as the right to reproduce or perform the copyrighted work, or to make derivative works

. Slide109

Copyright“Someone owns just about everything

Fair use lets you use their things - But not as much as you'd like toSometimes you have to ask for permission

Sometimes you are the owner - think about that!”

--- Georgia Harper, University of TexasSlide110

Fair UseSection 107 contains a list of the various purposes for which the reproduction of a particular work may be considered fair, such as criticism, comment, news reporting,

teaching, scholarship, and research. Section 107 also sets out four factors to be considered in determining whether or not a particular use is fair.Fair = Non-infringing and no permission is neededSlide111

Fair Use Factors

The purpose and character of the use, including whether such use is of commercial nature or is for nonprofit educational purposesThe

nature

of the copyrighted work

The

amount

and substantiality of the portion used in relation to the copyrighted work as a whole

The effect of the use upon the potential

market

for, or value of, the copyrighted work Slide112

What can you use?Want to use images? videos? words? songs? designs? layouts? illustrations? diagrams? charts? graphs?

Want to create things with them?You need a crash course in copyright http://www.utsystem.edu/ogc/intellectualproperty/cprtindx.htmUniversity of Texas Copyright guidanceSlide113

ThesesSTATEMENT OF PERMISSION TO USE

In presenting this thesis in partial fulfillment of the requirements for a master’s degree at Montana State University, I agree that the Library shall make it available to borrowers under rules of the Library.If I have indicated my intention to copyright this paper by including a copyright notice page, copying is allowable only for scholarly purposes, consistent with “fair use” as prescribed in the U. S. Copyright Law. Requests for permission for extended quotation from or reproduction of this paper in whole or in parts may be granted only by the copyright holder.Slide114

Creative CommonsYou may wish to license your work

http://creativecommons.org/ With a Creative Commons license, you keep your copyright but allow people to copy and distribute your work provided they give you credit — and only on the conditions you specify.Slide115

Montana State University

Questions?Slide116

CITI demo –handout

Sandy Sward

www.citiprogram.orgSlide117

Montana State University

Questions?