Montana State University

Responsible Conduct of Research (RCR) Training - August 2010

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

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

Provides good foundation for students Required 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 hours

PresentersLeslie Schmidt, Asst VP for Research

Pam 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 Programs

AGENDA1:00 - 1:05 p.m. Welcome & Introduction

Leslie 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. – Break

AGENDA2:50 - 3:20 p.m.  Conflict of Interest

Pam 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

Responsible Conduct of

Research/Research Misconduct

Carl Fox

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.

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

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

Components of RCR• Research Misconduct• Human and Animal Welfare and Laboratory Safety• Conflict of Interest• Data Acquisition, Security, Management,

Ownership, Export Controls• Responsible Authorship and Publication• Peer Review• Collaborative Research• Mentor/Mentee Responsibilities and Relationships• Societal Responsibilities

Case Studies

Overwhelmed

Preliminary Data

Authorship

Ethics and Pressure

Montana State University

Questions?

Research Misconduct Policy

Pam Merrell

Research Misconduct Regulation

• Federal 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

Research Misconduct -Definition

Plagiarism:

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

Research Misconduct-Definition

Fabrication:

“making up data or results and recording or reporting them.”

Research Misconduct - Definition

Falsification:

“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.”

Research Misconduct - NOT

Authorship Disputes

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

Reporting Research Misconduct

• Report to Dept. Head or Dean• They report to VP Research• Directly to VP Research

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 specific

Research Misconduct Allegation—Process

Inquiry– VP Appointed inquirer– Written Determination—whether full

investigation is warranted– If warranted report to funding agency

Research Misconduct Allegation - Process

Investigation– Detailed procedures from appointing

investigator to final report including:• Securing research data, documents, etc. related to

allegations• MUST find: significant departure from accepted practices;

committed intentionally, knowingly, or recklessly; and proven by a preponderance of the evidence

• Confidentiality• Restoration of reputations

Research Misconduct Allegation—Process

Discipline– Students, Student Code of Conduct Violations– Employees, Breach of Employment Contract– Federal Sponsors may impose sanctions

• Debarment from Federal Research

Loss of Research Career– Hauser at Harvard—Monkey Reactions or NOT– Historian –Guns in American History

Montana State University

Questions?

Technology Transfer

Rebecca W. Mahurin, Ph.D., Director

Nick Zelver, Associate Director

MSU Technology Transfer Office (TTO)

Purpose of Presentation

• What is Technology Transfer• What is Intellectual Property (IP)• How we Protect and License IP • Student Issues• When to Contact our Office (TTO)

Our mission is to

create and distribute knowledge.

Land Grant Institution

MSU Engages in Technology Transfer

• Education and Employment of Students

• Publications• Patenting/Licensing

Benefits of Technology Transfer

Transfer MSU Creations for Public BenefitFoster Relationships with IndustryPromote Local Economic Growth Reward, Retain, Recruit and Serve FacultyRecognition of MSU and FacultyRoyalties to MSU and Inventors

MSU Research ExpendituresMill $Licenses / Options

Types of Intellectual Property (IP)

• Know How• Copyright• Trademark• Trade Secrets• Plant Variety Protection (PVP)• Patent (presentation focus)

“…the right to exclude others from making, using, or selling the

invention throughout the United States”

Patent

Patenting Requirements

NovelUseful

Non-Obvious

What is Patentable?• Processes• Machines• Compositions of Matter• Improvements on the Above• Asexually Reproduced Plants• Plants & Microorganisms Which Have Been

Genetically Altered• Software

Patent Costs

• U.S. ~ $30,000 or More

• Foreign ~ $100,000 or More

• MSU TTO Seeks Licensee Commitment before Incurring Patent Costs

When to File a Patent• U.S. – Must File Within One Year of

Public Disclosure or Before Disclosure

• Foreign – Complete Novelty Is Required & Cannot Have Been Publicly Disclosed

Public Disclosure Examples

• Publication (including enabling abstract)

• Seminars/Conferences• Sale or Distribution of Product• Electronic Disclosure

Protecting Intellectual Property

• Patent• Laboratory Notebook• Confidential Disclosure Agreements• Material Transfer Agreements• Research Agreements

Laboratory Notebook

• Evidence in Patent Disputes• Establishes Dates of Conception and

Reduction to Practice• Use Best Practices and Date Entries• Notebooks Are MSU Property Under

the Management of the PI

Confidential Disclosure or Non-Disclosure Agreements

• Recipient Agrees in Writing Not to Disclose

• Allows Disclosure Without Barring Patentability

• Example NDA on TTO Website• Must Be Reviewed and Signed by TTO

Material Transfer Agreements

• Allows Sharing of Proprietary Materials without Barring Patentability

• Materials Typically Must Be Destroyed or Returned After Use

• Example MTA on TTO Website• Must Be Reviewed and Signed by TTO

Sponsored Research Agreements

• If There is an Invention MSU Files Patent and Retains Ownership

• Company Has Option to License• University Can Publish Results

Testing Agreements

• Recognizes that University is Testing Company’s Proprietary Material

• Testing Services Are Not Expected to Develop MSU Intellectual Property

• Agreement Must be Reviewed by TTO to Ensure No MSU Intellectual Property is Involved

Where to Start:MSU Invention Disclosure

• Not a Public Disclosure • Starts Process for TTO Market Evaluation ,

IP Protection, and Potential Patenting• What is the Invention, Who Are the

Inventors, Who Funded the Work• Provide Time for TTO to Process• Disclosure Form Available On TTO

Website

Sharing In Rewards

Revenue Sharing With Faculty & Students

Patent Ownership

Regents Policies

• Ownership of IP• Students & IP• Co-Inventorship• Rewards

Student Projects

• MFA (Film Making)

• Fellowships• Capstone Projects/Company Participation

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)

994-7868tto@montana.edu

website http://tto.montana.edu

Mark Quinn

Protecting People Who Participate In ResearchProtecting People Who Participate In Research

Who is a research participant?

Who is a research participant?

• Anybody we gather information about

• Information comes from– experiments– observations (sometimes)– medical records review– surveys

• Informed consent• Training 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 SUBJECTS

Informed ConsentInformed 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 participate

What is an IRB?Institutional Review Board

• At least 5 members, not all men, not all women

• Not all members of one profession• Experts appropriate to the research• At least one scientist, one non-scientist• At least one member from outside the

institution

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.

SUMMARY

• Research involving people– Helps make better programs or treatments– Only done with permission of participants– Rules to make it as safe as possible– Must be approved by an IRB

Montana State UniversityMSU IRB - http://www2.montana.edu/irb

– Types of protocols• Exempt• Expedited• Full board review

What you need to do:1. Complete IRB protocol application form

2. Complete online CITI training w/ certificate

3. Submit for review

Montana State University

Questions?

Institutional Animal Care and Use Committee (IACUC)

Regulatory Oversight of Animal Research

Animal Welfare Act 1966USDA/APHIS

Major updates 1985• Personnel Training• Adequate veterinary care• Establish IACUC• Consider alternatives

Regulatory OversightPublic Health Service Policy (1985)

DHHS; OLAWIncludes NIH, CDC, FDA fundingInstitutional OfficialAssurance statement

• Training• Adequate vet care• IACUC• Institutional “promise”

AAALAC Accreditation

• Association for the Assessment and Accreditation of Laboratory Animal Care

• Voluntary, external review program• Above and beyond the required

regulations• External review performed every three

years

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 research

IACUC Responsibilities

Assure that animal research is performed to the highest standards

Protect both the individual investigator and the institution

Institutional OfficialDr. Tom McCoy

IACUC ChairDr. Mike Babcock

Attending VeterinarianDr. Chris O’Rourke

IACUC Responsibilities

• Protocol review• Semi-annual program review• Semi-annual facility inspections• Investigate animal concerns• Suspend animal activities if necessary• Formal reporting and program

recommendations to the Institutional Official (IO)

Current Issues in Animal Research

Humane Society of United States

PETA

Montana State University

Questions?

CONFLICTS OF INTEREST

Pam Merrell

Conflict of Interest

• MSU Policy and Federal Regulations:– Prohibit real or apparent conflicts of

interest related to award– Prohibit acceptance of gratuities, favors, or

anything of monetary value from contractors, or parties to subagreements

Research Disclosures• Investigators must disclose “Significant

Financial Interests”– That would reasonably appear to be affected

by research– Interests in entities whose financial interests

would reasonably appear to be affected by the research

– “Investigator” broadly defined• NIH requires reporting to Agency

Significant Financial Interests

• Anything of “monetary value” of $10,000 or more or 5% or more interest in an entity– Interest of immediate family aggregated

• Does NOT include:– Salary, royalties from MSU– Income from seminars, etc. sponsored by public or

nonprofits– Income from advisory committees or review

panels of public or nonprofit entities

When Disclosed

– Proposals - 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 acquired

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    

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.

BOR §407 DISCLOSURES

Inventor Disclosures

– Inventor 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.

SCENARIO 1• Researcher’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?

SCENARIO 2• Researcher’s “partner” (HINT:

consensual romantic relationship) applies for a job supervised by researcher in NIH sponsored research– Potential COI?– Disclose?– Disclose to NIH?– Manage?

SCENARIO 3• MSU 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?

SCENARIO 4• Researcher 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?

SCENARIO 5• Noseall—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 income– Disclose?– Manage?

SCENARIO 6• Researcher 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?

Export Control Basics

Pam Merrell & Adam Edelman

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.

Export Controls

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

• MORE than you would think

Export Control

• What is controlled:– ITAR—Inherently military items AND related technical

information (RESEARCH) • Examples at MSU—satellite, radar, laser research

– EAR—Dual Use Items AND related technical information (RESEARCH) • Examples at MSU—brucellosis bacteria, ecoli

research– Commerce with “DREADED” countries and individuals

Export Controls• How 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 States

Export Controls

• Methods of disclosure include – Fax– Telephone discussions– E-mail communications– Computer data disclosure– Face-to-face discussions– Training sessions– Tours which involve visual inspections

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

attendance

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)

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.”

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 data

MSU Export Control Policy• Policy: “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.

Technology Control Plan• Personnel Security• Physical Security• IT Security• Travel Security• Training• Audit or Assessment

Export Controls• Triggers to Consider Export Control Issues

– Sending any items abroad– Travelling abroad carrying information—e.g., with

a laptop– Grants which restrict publication or have security

restrictions– Transactions with foreign countries—e.g.,

Material Transfer Agreements, transferring research equipment to foreign countries, subgrant to a person in a foreign country

Export Controls

The Reese Roth Case– Professor Emeritus U Tennessee– ITAR controlled subcontract

Information Security

• Why Are We Concerned?– Types of Data– Threats

Information Security

• Appropriate Data Storage– Properly Managed Servers– Portable Devices - Maybe– Encryption

Information Security

• Appropriate Data Sharing– Properly Managed Servers– Email - No

Information Security

• General Security Best Practices– Safe Email and Web Usage– Appropriate Desktop Management– Proper Account Management

Information Security Resources

• Enterprise Security Group: itsecurity@montana.edu

• IT Center Help Desk: 994-1777; helpdesk@montana.edu

• Safe Computing Web Site: http://www.montana.edu/itcenter/safecomputing

• Data Stewardship Policy & Guidelines: http://www2.montana.edu/policy/itc/data_stewardship.htm

Montana State University

Questions?

Copyright, Plagiarism, and Responsible Authorship

Tamara Miller

Plagiarism• The 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

Plagiarism

410.00 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 Code

Avoiding Plagiarism• Cite your sources• Cite your sources• Cite your sources• Defining and Avoiding Plagiarism:

The Writing Program Administrators Statement on Best Practices

• (http://www.wpacouncil.org/node/9)

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.

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.

Copyright• Copyright 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.

Copyright

“Someone owns just about everything

Fair use lets you use their things

- But not as much as you'd like to

Sometimes you have to ask for permission

Sometimes you are the owner - think about that!” --- Georgia Harper, University of Texas

Fair Use• Section 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 needed

Fair Use Factors

– The purpose and character of the use, including whether such use

is of commercial nature or is for nonprofit educational purposes

– The 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

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.htm

• University of Texas Copyright guidance

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.

Creative Commons• You 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.

Montana State University

Questions?

CITI demo –handout

Sandy Sward

www.citiprogram.org

Montana State University

Questions?