Montana State University Responsible Conduct of Research RCR

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 ü Provides good foundation for students ü Required by National Institutes of Health (NIH) & National Science Foundation (NSF) ü Additional on-line training available via CITI (Collaborative Institutional Training Initiative) ü Additional coursework available (PHL 491 Research Ethics) this fall ü Principal Investigator (PI) & Student’s responsibility to document & verify that RCR training has been completed ü 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, 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. 1862 o-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 ØOverwhelmed ØPreliminary Data ØAuthorship ØEthics 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: //www 2. 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 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 ü Authorship Disputes ü 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)

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 ü Transfer MSU Creations for Public Benefit ü Foster Relationships with Industry ü Promote Local Economic Growth ü Reward, Retain, Recruit and Serve Faculty ü Recognition of MSU and Faculty ü Royalties to MSU and Inventors

MSU Research Expenditur es Mill $ Licenses / Options

Types of Intellectual Property (IP) • • • 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 ü Novel ü Useful ü Non-Obvious

What is Patentable? • • • Processes Machines Compositions of Matter Improvements on the Above Asexually Reproduced 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 ü Revenue Sharing With Faculty & Students ü 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 • • 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) l The IRB reviews and has authority to approve or disapprove all research activities involving human subjects. l 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: //www 2. 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 • • 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 Mc. Coy IACUC Chair Dr. Mike Babcock Attending Veterinarian Dr. 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 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 $10 K/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: //www 2. 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 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?