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
Presenters
Leslie 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
AGENDA
1:00 - 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
AGENDA
2:50 - 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
•
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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/fh
400.html#430.00
Research Misconduct Definition
Plagiarism:
“the appropriation of another person's
ideas, processes, results, or words
without giving appropriate credit. “
Research MisconductDefinition
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
•
•
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•
What is Technology Transfer
What is Intellectual Property (IP)
How we Protect and License IP
Student Issues
When to Contact our Office (TTO)
Land Grant Institution
Our mission is to
create and distribute
knowledge.
MSU Engages in Technology
Transfer
• Education and Employment of
Students
• Publications
• Patenting/Licensing
Benefits of Technology
Transfer
 Transfer MSU Creations for Public Benefit
 Foster Relationships with Industry
 Promote Local Economic Growth
 Reward, Retain, Recruit and Serve Faculty
 Recognition of MSU and Faculty
 Royalties to MSU and Inventors
MSU
Research
Expenditur
es
Mill $
Licenses
/
Options
Types of Intellectual
Property (IP)
•
•
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•
Know How
Copyright
Trademark
Trade Secrets
Plant Variety Protection (PVP)
Patent (presentation focus)
Patent
“…the right to exclude others from
making, using, or selling the
invention throughout the United
States”
Patenting Requirements
Novel
Useful
Non-Obvious
What is Patentable?
•
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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
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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)
994-7868
tto@montana.edu
website http://tto.montana.edu
Protecting People Who
Participate In Research
Mark Quinn
Who is a research participant?
• Anybody we gather information about
• Information comes from
– experiments
– observations (sometimes)
– medical records review
– surveys
CODE OF FEDERAL REGULATIONS
TITLE 45-PUBLIC WELFARE
PART 46-PROTECTION OF HUMAN SUBJECTS
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•
•
Informed consent
Training to protect participants (CITI)
Training to protect privacy
All research on people must have IRB
approval
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 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 University
MSU 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 1966
USDA/APHIS
Major updates 1985
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Personnel Training
Adequate veterinary care
Establish IACUC
Consider alternatives
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”
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 Official
Dr. Tom McCoy
IACUC Chair
Dr. Mike Babcock
Attending
Veterinarian
Dr. Chris O’Rourke
IACUC Responsibilities
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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
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•
•
•
•
•
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/intellectualprope
rty/cprtindx.htm
• University of Texas Copyright guidance
Theses
STATEMENT 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
www.citiprogram.org
Sandy Sward
Montana State
University
Questions?