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Responsibilities and Ethics in the
     Conduct of Research
                 January 14, 2013

                  RESOURCES at:
   http://graduateschool.nd.edu/ethics-resources
On the index card at your seat:
• Please jot down a description of an unethical
  situation in your professional life in which you
  wanted to act on behalf of your values but
  didn't know what to do
• If you can't think of one, jot down a
  description of a situation you have heard
  about with respect to research and reflect on
  how you may have acted if it had happened to
  you.
Welcoming Remarks
Chris Maziar
      Acting Dean of the Graduate School
      Vice President & Senior Associate Provost
      Professor of Electrical Engineering
Bob Bernhard
      Vice President for Research
      Professor of Aerospace & Mechanical
      Engineering
Recognizing and Approaching
     Ethical Problems
      Jessica McManus Warnell
     Mendoza College of Business
         jmcmanus@nd.edu
Consider this scenario
• After a busy day, you are having dinner with a
  fellow graduate student from your program. You
  discuss your research and end up spending the
  next few hours brainstorming together different
  ideas. The next day, you sit down to work on a
  description for your next research project and
  decide one of the ideas that came up last night
  has merit and is worth pursuing.

• Can you simply take the topic and pursue it on
  your own?
Today’s goal:
• Discuss how we can approach this type of
  dilemma with principled analyses and
  strategies for effective resolution
Decision Model for
                 Resolving Ethical Issues
AWARENESS/                              KNOWLEDGE/                   ACTION/
  SENSITIVITY                           JUDGMENT                     BEHAVIOR

1.   Get the facts (unbiased, fair, accurate)

2.   Understand the issues involved, including relevant principles and obligations,
     and how they may conflict (classification & assessment)

3.   Identify stakeholders and how they will be affected (perspective-taking)

4.   Explore alternatives and their consequences (moral imagination)

5.   Consider universalizability and make a principled decision
The Case of the Good Idea
1)   Get the facts
         Who, what, when, how
2)   Understand the issues, relevant principles and obligations, and how they
     may conflict
         Dishonesty, integrity, justice, veracity, fidelity, loyalty, justice
3)   Identify stakeholders and how they will be affected
         Advisor, friend, work group, university, academic community
4)   Explore alternatives and their consequences
         Use the idea – go for it!
         Use the idea – with attribution
         Moral imagination – a better resolution?
5)   Consider universalizability and make a principled decision
         Is this decision precedential? Universalizable?
Table Talk
• Share the dilemmas that you jotted down with
  your table.

• Select one and work through how you would
  apply the decision model to this dilemma

• Are there any steps that are particularly
  difficult?
Decision Model for
                 Resolving Ethical Issues
AWARENESS/                              KNOWLEDGE/                   ACTION/
  SENSITIVITY                           JUDGMENT                     BEHAVIOR

1.   Get the facts (unbiased, fair, accurate)

2.   Understand the issues involved, including relevant principles and obligations,
     and how they may conflict (classification & assessment)

3.   Identify stakeholders and how they will be affected (perspective-taking)

4.   Explore alternatives and their consequences (moral imagination)

5.   Consider universalizability and make a principled decision
Pay attention to post-decision making
After one determines the appropriate course of
  action, how, specifically, does he/she act on it
  within a given context?
Why do we overestimate our ability to act
  ethically, and act unethically without meaning
  to? How can we address “ethical fading”?
Ethics is a habit
• “Living an ethical life is something you do. It is not simply
  a theory or a certain understanding. Ethics should be
  viewed as a practical activity that has a tactical
  dimension, and as such, requires practice, much like
  playing a sport or instrument….

• Becoming an ethical leader requires paying attention to
  the small decisions made every day. A pattern of ethical
  decision making becomes a habit, and good habits
  become virtues. In turn, virtues add up to character.”
                     - Rev. John Jenkins, “The Ethics of Leadership”
Possible next steps
Identify your purpose – why am I doing what I’m doing?
  and acknowledge choice

Engage with curriculum in conceptual foundations of
  ethics, and, critically, in application of ethics to our
  chosen field of study

Acknowledge challenges, reasons and rationalizations,
  and “blind spots”

Be explicit – acknowledge, discuss, practice, model ethics
Resources
• Mendoza College of Business Ask More of
  Business Framework
• Giving Voice to Values Program
• Blind Spots resources page
• Blurb about 4 component model
Mentoring

              Jennifer Tank (Biology)
            Jessica Collett (Sociology)
Ed Maginn (Chemical and Biomolecular Engineering)
                Erin Drew (English)
Importance of Mentoring
Expectations for “graduate success” vary across departments
    – Be as detailed as you can in your dialogue
    – (e.g. hours, access to advisor, synergy vs. independence).

Importance of communication and establishing expectations
   • “failure to thrive” is often due in part to a lack of communication

Recognize not all faculty are naturally the best mentors
   • “manage” your advisor to get the mentoring you need
   • Exchange information with peers as a litmus test on progress

Take-home: You must be self-motivated!
   • Products (publications, presentations etc.) = next job and your future!
   • U of M resources are excellent guides for TWO-way communication and
      effective student-mentor relationships
Supporting findings from research
            on mentoring
• All students experience uncertainty – at one time
  or another – in graduate school
• All students want mentoring
   – However, its frequency and form vary across
     disciplines and gender lines
• Few faculty are explicitly trained in mentoring
   – The limits of observation (for students)
   – The problems with assumptions (for everyone)
Table Talk
• Have you had this discussion with your
  advisor?

• Describe the culture of expectations in your
  department or program

• Does your advisor know your goals and do you
  know your advisor’s goals?
Comments from table and panel
But what if I don’t work in lab..
• In some disciplines, students work alone, but
  we are still responsible to our adviser/dept for
  producing work in a timely fashion
Some questions to ask your DGS and adviser:
  -When do you expect me to begin presenting or publishing
  work?
  -How frequently should I turn in drafts/chapters to you?
  -What can I do to help you as you read and respond to my
  work? (How rough is too rough? Stick to deadlines? Etc.)
Table Talk
• Can you describe the student’s goal for this
  conversation? Did he get what he wanted?

• How do you think the advisor felt? Why?
Comments from table and panel
Table Talk
• Describe whether your perception of the
  interaction has changed

• How do you think your
  gender/race/nationality could influence your
  interactions with your advisor
Comments from table and panel
Possible next steps
Read U of M guides (from mentor and advisee
  perspective) (on the workshop resource page)

Have a conversation with your mentor.

Talk to your peers about the expectations in your
  discipline and in your program


    The key is communicating, understanding and
          respecting needs and expectations.
Resources
Great place to start…

University of Michigan resources on mentoring
   Note: also posted on Notre Dame resource page

• How to Get the Mentoring You Want: A Guide for Graduate
  Students at a Diverse University
   – http://www.rackham.umich.edu/downloads/publications/
     mentoring.pdf

• How to Mentor Graduate Students: A Guide for Faculty at a
  Diverse University
   – http://www.rackham.umich.edu/downloads/publications/
     Fmentoring.pdf
BREAK


We will resume at 10:25
Conflict of Interest and
Conflict of Commitment

       Liz Rulli, Office of Research
Jeff Kantor, Chemical and Biomolecular
                Engineering
Conflict of Interest
Dictionary Definition:

A conflict between the private interests and the
official responsibilities of a person in a position
of trust.

                         ‐www.merriam‐webster.com/dictionary
Conflict of Interest
University Policy Definition:
An actual Conflict of Interest arises in a situation where financial or other
personal or professional considerations compromise an individual’s
objectivity, professional judgment, professional integrity, and/or ability to
perform his or her professional responsibilities to the University.

Perceived or potential Conflicts of Interest can be said to exist in situations
where an individual member of the University community (Member), a
member of the individual’s family (Family), or a close personal relation (Close
Relation) has financial interests, personal relationships, or professional
associations with an individual, individuals, or outside organization, such
that his or her activities within the University could appear to be influenced
by that interest or relationship.
Conflict of Interest
Federal Funding Agency Requirements:
Federal Conflict of Interest Policy focuses around ensuring
objectivity in research. If you have a significant financial
interest that is related to your role at the university that
could potentially impact the design, conduct or reporting
of research, that significant financial interest is
considered a financial conflict of interest.
You must disclose the interest/potential conflict before
proposals are submitted. If the interest rises to the level
of a financial conflict of interest it must be managed or
eliminated before conducting the work.
Conflict of Commitment
ND Faculty Policy
 A conflict of commitment refers to a situation
 in which a faculty member engages in an
 activity, whether paid or unpaid, that
 compromises his or her professional
 obligations to the University.
How is a COC Different from a COI?
• A conflict of interest may not involve a
  significant commitment of one's time
  – doing business with the university
  – in personnel decisions


• A conflict of commitment can occur when
  there is no conflict of interest
  – excessive involvement with outside organizations.
Table Talk

  Discuss any conflicts of interest
that you identify from the scenario
Conflict of Commitment Reactions

         Table Reports
Table Talk

   Discuss any conflicts of
commitment that you identify
      from the scenario
Conflict of Commitment Reactions

         Table Reports
Graduate Students Need to Know
1. Funding agency focus on ensuring objectivity
   in research
2. Disclosure and management is key
3. Protections in place for students and
   processes in place for oversight
4. Students may be “covered researchers”
Graduate Students Need to Know
1 You need to be aware of your obligations to
  the agencies that are supporting your work.
2 Disclose significant outside involvements to
  your advisor . (Guideline: 1 day per month)
3 Do not let personal obligations interfere with
  University commitments.
4 Cooperate with effort reporting.
Areas of Special Concern for Students
• You are identified as a “covered researcher”
• You are informally aware that your advisor has an
  outside activity but you haven’t discussed any
  possible implications for you
• It is unclear whether your intellectual
  contributions for some activities are being
  exploited for private interests
• You are involved in activities where relationships
  are unclear (financial, evaluative, data ownership,
  who you are working for)
Areas of Special Concern for Students
• Excessive coursework that conflicts with major
  area of interest, or with research funding.
• Use of university resources for private purposes.
• Engagement with outside activities that
  compromise progress towards your degree.
• Financial aid from other sources that require a
  time commitment.
• Outside employment.
• Outside consulting.
Resources
• University Conflict of Interest Policy
    – http://conflictpolicy.nd.edu/
• University Conflict of Commitment Policy
    – http://policy.nd.edu/policy_files/ConflictofCommitmentPolicy.pdf
• NIH Financial Conflict of Interest Page
    – http://grants.nih.gov/grants/policy/coi/
•   NIH Financial Conflict of Interest FAQ’s
    – http://grants.nih.gov/grants/policy/coi/coi_faqs.htm
• NSF Financial Conflict of Interest Policy
    – http://www.nsf.gov/pubs/manuals/gpm05_131/gpm5.jsp#510
• Other Agencies Adopting PHS/NIH COI Guidelines
    – http://sites.nationalacademies.org/PGA/fdp/PGA_070596
• CITI COI Training Module
    – https://www.citiprogram.org/default.asp?language=english
Avoiding
Plagiarism

Susan D. Blum
Department of Anthropology

John Lubker
The Graduate School

The University of Notre Dame
Avoiding plagiarism
    What Is Plagiarism?


  Why do we have such a
        concept?


        Table Talk



      Complications
http://gamezblog.com/wp-content/uploads/2011/02/Plagiarism.gif
http://www.csmonitor.com/Books/2010/1208/4-recent-cases-of-plagiarism-charges-in-the-headlines/Michel-Houellebecq-and-La-carte-and-le-territoire
http://ecx.images-amazon.com/images/I/51zEVTDUlnL._SL500_AA300_.jpg
Avoiding plagiarism
   What Is Plagiarism?


  Why do we have such a
        concept?


        Table Talk



      Complications
What is plagiarism?
“The uncredited use (both intentional and unintentional)
   of somebody else‟s words or ideas.”
     From The OWL at Purdue, http://owl.english.purdue.edu/owl/resource/589/01/. Accessed August 20, 2009.



Originally from a Latin term, plagiarius, meaning “kidnapping”


     Oxford English Dictionary
The important thing….
Give credit!
“Plagiarism 1”
Unintentional or inadvertent

   Comes from ignorance or imperfect mastery of complicated
   rules


      Often results in
        Omitting quotation marks from properly used quoted material
        Omitting attribution from properly used quoted or
        paraphrased material
                                 http://operachic.typepad.com/photos/uncategorized/2008/02/14/jobs_perplexed.jpg
“Plagiarism 2”
Deliberate or intentional

Comes from an attempt to circumvent guidelines

    Often results in:
       Importation of improper amount of someone else‟s
       material
          Sentences
          Paragraphs
       Use of someone else‟s paper (classmate, fraternity
       brother, website)
“Plagiarism”
Statistics

66% (60 – 80 %) of students in college and high school
admit they have copied material
without attributing it to its source.
Donald L. McCabe, Linda Klebe Treviño, and Kenneth D. Butterfield, “Cheating in Academic Institutions: A Decade of Research.” Ethics and Behavior
11, no. 3 (2001): 219-232.

Also Character Counts (Josephson Institute). Charactercounts.org.
Avoiding plagiarism
    What Is Plagiarism?


  Why do we have such a
        concept?


        Table Talk



      Complications
Why do we have such a
       concept?
Economic

Moral

Legal / Professional / Ethical

Pedagogical / Educational
Why?

Economic:
   Copyright
   Making a living from writing
   Professional advancement
   from credit for ideas




                                  http://uechi.typepad.com/.a/6a00d8341d471653ef011168420948970c-320wi
Why?
               Moral: Idea of author and individual
                 We own our own words and ideas
                 People are creative and have important original
                 contributions to make


                    ??                                                                                                                ??




http://www.livius.org/a/1/greeks/homer.JPG                                                                    http://www.sllib.org/Pages/Digital%20Library/Shakespeare.jpg
                                             http://famouspoetsandpoems.com/pictures/william_wordsworth.jpg
Why?


“Legal” / professional / ethical within

   an academic framework:

 Academic “guild”

 Footnotes
       Indicate sources, evidence, due diligence
       Permit others to trace influence
  Students as apprentices
                                          http://cdn-write.demandstudios.com/upload//1000/100/90/1/61191.jpg
Why?

Pedagogical / Educational: Intended to support learning,
which assumes a need for originality and engagement




                                        http://www.bendlearningcenter.com/art/college_students.jpg
Avoiding plagiarism
    What Is Plagiarism?


  Why do we have such a
        concept?


       Table Talk



      Complications
Table Talk 1a
Do you need to acknowledge…..

      information you copy directly from a book?
Table Talk 1b
Do you need to acknowledge…..

      information you quote from an online article?
Table Talk 1c
Do you need to acknowledge…..

      information you summarize from a popular

            magazine?
Table Talk 1d
Do you need to acknowledge…..

      concepts you learned from a class text?
Table Talk 2a
[original text]
Abraham Lincoln, William Henry Seward, Salmon Chase, and Edward
Bates were members of a restless generation of Americans, destined
to leave behind the eighteenth-century world of their fathers. Bates,
the oldest, was born when George Washington was still president;
Seward and Chase during Jefferson’s administration; Lincoln shortly
before James Madison took over. Thousands of miles separate their
birthplaces in Virginia, New York, New Hampshire, and Kentucky.
Nonetheless, social and economic forces shaped their paths with
marked similarities.
       Doris Kearns Goodwin, Team of Rivals: The Political Genius of Abraham
       Lincoln (New York: Simon and Schuster, 2005), p. 28.

        Is this paraphrase acceptable?
Abraham Lincoln, William Henry Seward, Salmon Chase, and Edward
Bates were men of an impatient generation of Americans, fated to
escape the eighteenth-century world of their forebears.
Only a few words were substituted.

The structure is identical to the original.

The source was not cited.

This would be considered plagiarism.
Table Talk 2a
[original text]
Abraham Lincoln, William Henry Seward, Salmon Chase, and
Edward Bates were members of a restless generation of Americans,
destined to leave behind the eighteenth-century world of their
fathers. Bates, the oldest, was born when George Washington was
still president; Seward and Chase during Jefferson’s administration;
Lincoln shortly before James Madison took over. Thousands of miles
separate their birthplaces in Virginia, New York, New Hampshire, and
Kentucky. Nonetheless, social and economic forces shaped their
paths with marked similarities.
       Doris Kearns Goodwin, Team of Rivals: The Political Genius of Abraham
       Lincoln (New York: Simon and Schuster, 2005), p. 28.

        Is this paraphrase acceptable?
Abraham Lincoln, William Henry Seward, Salmon Chase, and
Edward Bates were men of an impatient generation of Americans,
fated to escape the eighteenth-century world of their forebears.
Table Talk 2b
[original text]

Abraham Lincoln, William Henry Seward, Salmon Chase, and Edward
Bates were members of a restless generation of Americans, destined
to leave behind the eighteenth-century world of their fathers. Bates,
the oldest, was born when George Washington was still president;
Seward and Chase during Jefferson’s administration; Lincoln shortly
before James Madison took over. Thousands of miles separate their
birthplaces in Virginia, New York, New Hampshire, and Kentucky.
Nonetheless, social and economic forces shaped their paths with
marked similarities.
        Doris Kearns Goodwin, Team of Rivals: The Political Genius of Abraham
        Lincoln (New York: Simon and Schuster, 2005), p. 28.

         Is this paraphrase acceptable?

Nineteenth-century political leaders such as Abraham Lincoln and his
erstwhile rivals Seward, Chase, and Bates, despite differences in age
and origin, shared many aspects of their trajectory (Goodwin 2005: 28).
The writer (paraphraser) used her own words.

The source was cited.

This is acceptable.
Table Talk 2b
[original text]

Abraham Lincoln, William Henry Seward, Salmon Chase, and Edward
Bates were members of a restless generation of Americans, destined
to leave behind the eighteenth-century world of their fathers. Bates,
the oldest, was born when George Washington was still president;
Seward and Chase during Jefferson’s administration; Lincoln shortly
before James Madison took over. Thousands of miles separate their
birthplaces in Virginia, New York, New Hampshire, and Kentucky.
Nonetheless, social and economic forces shaped their paths with
marked similarities.
        Doris Kearns Goodwin, Team of Rivals: The Political Genius of Abraham
        Lincoln (New York: Simon and Schuster, 2005), p. 28.

         Is this paraphrase acceptable?

Nineteenth-century political leaders such as Abraham Lincoln and his
erstwhile rivals Seward, Chase, and Bates, despite differences in age
and origin, shared many aspects of their trajectory (Goodwin 2005: 28).
Table Talk 2c
[original text]

Abraham Lincoln, William Henry Seward, Salmon Chase, and Edward
Bates were members of a restless generation of Americans, destined to
leave behind the eighteenth-century world of their fathers. Bates, the
oldest, was born when George Washington was still president; Seward
and Chase during Jefferson’s administration; Lincoln shortly before
James Madison took over. Thousands of miles separate their birthplaces
in Virginia, New York, New Hampshire, and Kentucky. Nonetheless, social
and economic forces shaped their paths with marked similarities.
        Doris Kearns Goodwin, Team of Rivals: The Political Genius of Abraham Lincoln
        (New York: Simon and Schuster, 2005), p. 28.

         Is this paraphrase with quotation acceptable?

Nineteenth-century political leaders such as Abraham Lincoln and his
erstwhile rivals Seward, Chase, and Bates, despite differences in age and
origin, shared many aspects of their trajectory, and were “members of a
restless generation of Americans, destined to leave behind the
eighteenth-century world of their fathers” (Goodwin 2005: 28).
The original information is accurately conveyed.

The ideas in the passage are credited.

The distinction between the original author’s and
the paraphraser’s words is clearly indicated by the
use of quotation marks and page number.

This is acceptable.
Table Talk 2c
[original text]

Abraham Lincoln, William Henry Seward, Salmon Chase, and Edward
Bates were members of a restless generation of Americans, destined to
leave behind the eighteenth-century world of their fathers. Bates, the
oldest, was born when George Washington was still president; Seward
and Chase during Jefferson’s administration; Lincoln shortly before
James Madison took over. Thousands of miles separate their birthplaces
in Virginia, New York, New Hampshire, and Kentucky. Nonetheless, social
and economic forces shaped their paths with marked similarities.
        Doris Kearns Goodwin, Team of Rivals: The Political Genius of Abraham Lincoln
        (New York: Simon and Schuster, 2005), p. 28.

         Is this paraphrase with quotation acceptable?

Nineteenth-century political leaders such as Abraham Lincoln and his
erstwhile rivals Seward, Chase, and Bates, despite differences in age and
origin, shared many aspects of their trajectory, and were “members of a
restless generation of Americans, destined to leave behind the
eighteenth-century world of their fathers” (Goodwin 2005: 28).
Important things to
        remember
Any exact phrase from the original must be put in
quotation marks and the source indicated.

Paraphrasing must not be a simple substitution of a
few words but must be in your own words.
   A hint: Read over the original and then without
   looking at it summarize it in your own words.

Any time you use words (quotations) or ideas
(paraphrases) from a source, you must provide
information about the source.
Avoiding plagiarism
       What Is Plagiarism?




 Why do we have such a concept?




           Table Talk




        Complications
Paradoxes, Peculiarities,
     Complications
Unnamed authors (especially in the past; folklore)
Impossibility of naming every influence
Inconsistency across
    Time
    Place (relevant for international students)
    Discipline
    Individual

Nature of learning as having been influenced
Genres, which derive from conventions, not originality
“Common knowledge”
“Self-plagiarism”: double-counting
“Common knowledge”
“Self-plagiarism”
Double credit
   Turning in the same material twice

Republishing the same material twice (or more)
without acknowledging the previous source
Some subtleties
Plagiarism is not the same thing as….

       copyright infringement

       academic fraud

       examination cheating

       stealing data

       fabricating data or quotations
When in doubt….

Give Credit!




       http://psuprssa.files.wordpress.com/2012/02/422701_339872559385800_286997421339981_1019238_956035530_n.jpg
University of Notre Dame
 Graduate School Policy

         John Lubker
  Associate Dean of Students
Graduate School Policy
Violation of integrity in research/scholarship

  Plagiarism; fabrication or falsification in proposing,
  performing, or reporting research; or other
  misrepresentation in proposing, conducting,
  reporting, or reviewing research.

  Misconduct includes practices that materially and
  adversely affect the integrity of scholarship and
  research.
Graduate School Policy
Plagiarism
  A person’s words and ideas are his or her own; they
  belong to the individual and should be considered
  the individual’s property. Those who appropriate the
  words and/or ideas of another, and who attempt to
  present them as their own without proper
  acknowledgement of the source, whether
  intentional or not, are committing plagiarism or
  intellectual theft.
Graduate School Policy
Plagiarism
  Any representation of the work of another that is
  not properly referenced is considered to be
  plagiarism. Ignorance of what constitutes plagiarism
  is not a defense to an allegation of a violation of the
  academic integrity policy. It is the responsibility of
  students to familiarize themselves with this
  definition of plagiarism and to learn proper citation
  techniques.
Graduate School Policy
Violations of Academic Integrity
  Handled at dept level
     Found innocent
     Found guilty
  Appeals to the dean of the Grad School
What do I do now?
Understand your rights and responsibilities
 http://graduateschool.nd.edu/
     Academic Code – “Academic Integrity”
     Bulletin of Information – “Academic
     Integrity”

Guidance with properly referencing your work
  Writing Center
  English for Academic Purposes
Creations and Data: rights and
         responsibilities

                Patrick J. Flynn
Professor of Computer Science and Engineering
Setting the stage: questions
• If you create (discover, author, compose) something
  wonderful as a result of research conducted here at ND
   – “Researcher” versus “owner”
   – Who owns it? What does “ownership” mean?
• If you collect some great data sets as part of your research
  here at ND, what can be done with the data?
   – Can you take it to your next job?
   – Can you give it to other researchers if they ask you?
• Why do these questions matter?
Creations and matching IP concept

• Authorship (copyright)
• Composition (copyright, trademark)
• Invention (patent, trade secret)

• Distinctions later
Creator
• Policy does not influence your status as a creator
• But you still need to be able to prove your role as the
  “originator”
   – Keep good records of your work (lab notebook, etc.): process, date
     stamp, data collection
• Disclosure of creation
   – Any publication is a disclosure (if contemplating patent, you have one
     year after disclosure to file)
• Collaborative creations: assign credit by consensus, if possible
Owner
• Not necessarily the same as creator
• Right to commercialize
• University owns inventions created by
   – faculty (if invented in course of their Univ. duties)
   – graduate students (in most cases)
• Authorship (books, compositions): more complex
• Sponsor of research may also have certain rights (negotiated as
  part of sponsorship agreement)
• The OVPR and the Tech Transfer Office should rule on ownership
  questions – do not rule on this yourself!
Research Data: ownership and rights

• The University owns the data you collect
   – Controls whom else, at ND or outside ND, can get it
   – Controls whether you can continue to use it



• Some data has special issues that essentially mandate active central
  management and/or involvement
   – Human subjects (IRB approval process)
   – Animals (IACUC approval process)
   – Export controls (ITAR review)
Take-home points
•   Be creative!
•   Understand the university context
•   Live with the restrictions – they are not burdensome
•   Understand your obligations
•   Take advantage of opportunities for innovation if the
    circumstances are right
Intellectual Property

              Richard Cox
Director, Office of Technology Transfer
Intellectual Property
• What is it?

• What should a first year graduate student
  know about or care about Intellectual
  Property (IP)?
4 basic types of intellectual property
• Patents
   – Covers things (manufactured articles, compositions of matter) & ways
      to make things (methods, processes)
   – 20 year life
• Copyrights
   – Covers expression of ideas (writings, paintings, music, performances)
   – Life of author + 70 years
• Trademarks/service marks
   – Covers origin of goods & distinguishes from competitors
   – Unlimited life if maintained
• Trade Secrets
   – Covers information
   – Unlimited life if secrecy of information is maintained
Notre Dame IP policy
• ND’s IP policy “governs the protection and administration of
  intellectual property developed in support of the University’s
  mission.”
• “It is the policy of the University of Notre Dame, subject to
  the exceptions contained herein, that the University claims
  the exclusive right to all intellectual property arising from
  University Research. “
• “University Research” means any research or development
  activity which is undertaken in connection with an externally
  funded project, or which is related to duties and
  responsibilities for which a person is compensated by the
  University, or which is conducted with substantial use of
  University facilities, or resources.
Notre Dame IP policy (cont.)
• “Creators of intellectual property have an obligation to
  disclose intellectual property in the manner prescribed within
  this policy, to assign intellectual property rights to the
  University, and to assist the University in legally protecting the
  intellectual property. The University and the creator share in
  any royalty income resulting from the intellectual property as
  described in this policy.”
• Applies “to all faculty, staff, students, and others who make
  use of University facilities, equipment, or other resources or
  who receive funds from the University in the form of salary,
  wages, stipend, or other support, but not including
  undergraduate student financial aid.”
Notre Dame IP policy (cont.)
• ND normally waives rights to student-created IP “where
  the use of University facilities, equipment, or other
  resources has been properly authorized, except when:
   – faculty or staff involvement is substantial,
   – the work is part of a larger University work or specifically
     commissioned by the University,
   – the use of facilities, equipment, or other resources is
     substantially in excess of the norm for educational
     purposes, or
   – the intellectual property resulted from the student’s
     employment with the University.”

• http://policy.nd.edu/policy_files/IntellectualPropertyPolicy.pdf
University IP checklist
• Designed to help determine
  creator’s reporting obligations
     • Employment status
     • Commissioned work or
       otherwise funded by ND
     • Use of ND resources
     • Contribution by other ND
       personnel
• Assistive, not determinative
• If in doubt, best to ask
 Office of Technology Transfer
   phone: (574) 631-4551
   email: ott@nd.edu
   web:   http://ott.nd.edu
Copyright Basics

 Marsha Stevenson
 Hesburgh Library
• Copyright is a form of protection grounded in the U.S.
  Constitution; Article 1, Section 8 empowers Congress to
  “Promote the Progress of Science and Useful Arts, by
  securing for limited Times to Authors and Inventors the
  exclusive Right to their respective Writings and
  Discoveries”.


• Copyright protection is provided for by law (title 17, US
  Code). It applies to original works of authorship fixed in
  a tangible medium of expression. Both published and
  unpublished works are protected.

• A form of Intellectual property
Works eligible for copyright protection

Literary works including translations
Musical works with accompanying words
Dramatic works with accompanying music
Pictorial, graphical, and sculptural works
Motion pictures and other audiovisual works
Choreographic works
Sound and digital recordings
Architectural works
Software
Technical manuals
Who can be an author?

A writer
A musician or artist
A photographer
A student or professor
A company or organization
An unknown entity


      But who controls the rights????
What are the exclusive rights given to an author ?

To prepare derivative works based upon the work; Only the owner of
copyright in a work has the right to prepare, or to authorize someone else
to create, a new version of that work.

To reproduce the work

To distribute copies of the work to the public

To perform the work publicly

To display the copyrighted work publicly

To perform the work publicly by means of a digital audio transmission
Works you can use without permission

Works you create yourself

Work not protected by federal law

Works in the Public Domain

Works governed by Creative Commons License

Works which would be considered Fair Use
Works in Favor                      Works Against


Teaching-Research- Scholarship      Commercial Activity
Nonprofit educational institution   Profiting from use
Criticism-Comment                   Entertainment
News reporting                      Bad faith behavior
Transformative use                  Denying credit to original author
Restricted access
Parody
Table Talk
• Discuss your reactions to this scenario
• Do you know who owns the data?
• How would you resolve this conflict?
Possible Next Steps
• Questions about ownership rights in IP or need to disclose new IP?
   – contact the Office of Technology Transfer
       • Phone:     (574) 631-4551
       • Email:     ott@nd.edu
       • Web:       http://ott.nd.edu

 • Questions about Copyright issues?
    – contact Linda Sharp
        • Phone:     (574) 631-6818
        • Email:     sharp.1@nd.edu
Lunch and Keynote Speaker
Allegra Goodman
Research Misconduct

               Darren Davis
     Department of Political Science
Office of the Vice President for Research
Federal Regulations in University Research



               Research
              Misconduct
                (F-F-P)


        Human             Animal
       Subjects          Welfare
      Regulations       Regulations
Federal Laws on Research Misconduct
• Public concern over research misconduct initially arose in the
  early 1980‟s.
          William Summerlin (1974)
          Vijay Soman & Philip Felig (1978)
          John Darsee (1981)
          Stephan Breunig (1983)


• At the time, research institutions sometimes ignored or covered
  up potential misconduct problems rather than investigate them.


• In December 2000 the Office of Science and Technology Policy
  adopted a federal policy on research misconduct.
• Department of Health and Human Services (DHHS) enacted
  regulation effective 6/15/05

      “Public Health Service Policies on Research Misconduct”

      Implements legislative and policy changes applicable to research
       misconduct that occurred over last several years.

      Covers any entity that applies for a research, research-training or
       research-related grant or cooperative agreement with the Public Health
       Service (PHS)
Purpose of Research Misconduct Policies
 • Establish definitions for research misconduct



 • Outline procedures for reporting and investigating
   misconduct

 • Provide protection for whistleblowers and persons
   accused of misconduct
Research Misconduct Defined
• What is it?:
  The Department of Health and Human Services defines
  research misconduct as:

   Fabrication, falsification, or plagiarism in proposing,
   performing, or reviewing research results.

          Fabrication: making up results and recording or reporting them
          Falsification: manipulation of research materials, equipment,
          or processes, or changing or omitting results such that the
          research is not accurately represented in the record.
          Plagiarism: the appropriation of another’s ideas, processes,
          results, or words without giving proper credit.
Criteria for Research Misconduct
• Represents a significant departure from accepted
  practices

• Has been committed intentionally, or knowingly, or
  recklessly; and

• Can be proven by a preponderance of evidence

• What is NOT MISCONDUCT: honest, unintentional error
Research Misconduct and Integrity
• 1. Falsifying or „cooking‟ research data
• 2. Ignoring major aspects of human-subject requirements
• 3. Not properly disclosing involvement in firms whose products are based
  on one„s own research
• 4. Relationships with students, research subjects or clients that may be
  interpreted as questionable
• 5. Using another‟s ideas without obtaining permission or giving due credit
  (plagiarism)
• 6. Unauthorized use of confidential information in connection with one‟s
  own research
• 7. Failing to present data that contradict one‟s own previous research
• 8. Circumventing certain minor aspects of human-subject
  requirements
Misconduct and Integrity (continued)
•    9. Overlooking others‟ use of flawed data or questionable interpretation
    of data
•   10. Changing the design, methodology or results of a study in response
    to pressure from a funding source (falsification)
•   11. Publishing the same data or results in two or more publications
•   12. Inappropriately assigning authorship credit
•   13. Withholding details of methodology or results in papers or proposals
•   14. Using inadequate or inappropriate research designs
•   15. Dropping observations or data points from analyses based on a gut
    feeling that they were inaccurate
•   16. Inadequate record keeping related to research projects
Why does research misconduct happen?

 •   Publish or Perish Pressure
 •   Desire to “get ahead”
 •   Personal problems
 •   Character issues
 •   Cultural Differences
Consequences
                (if misconduct is substantiated)

• Withdrawal or correction of all pending and published papers and
  abstracts affected by the misconduct
• Reprimand, removal from project, rank and salary reduction, dismissal
• Restitution of funds to the granting agency
• Ineligibility to apply for Federal grants for years
• I.E. the end of your research career!
Mentor Responsibilities
• Mentors have the responsibility to ensure that all trainees (post-docs,
  grad students, undergrads) are aware of the responsible conduct of
  research

       Define the Relationship
         - Role of Trainee
         - Publication/Authorship
         - Serving as PI or Co-PI

• Obligation to report

       Good faith report
Research on Research Misconduct
   Admission rates of data fabrication,
  falsification and alteration in non-self
                  reports.




Fanelli D (2009) How Many Scientists Fabricate and Falsify
Research? A Systematic Review and Meta-Analysis of Survey Data.
PLoS ONE 4(5): e5738. doi:10.1371/journal.pone.0005738
http://www.plosone.org/article/info:doi/10.1371/journal.pone.000
5738
What can someone concerned about
     potential Research Misconduct do?
• Talk to someone else (confidentiality will be protected)

       Vice President for Research
       Responsible Academic Officer
         -The Chair, Dean or Director of the Department, School, Institute or
         Center where the Respondent is a member
       Director of Research Compliance
       Office of General Counsel

• Try to resolve the concern informally
• If informal resolution fails, an Inquiry and Investigation may follow
“The Lab”

        http://ori.hhs.gov/thelab

Please check your nametag for your room assignment.
                BR stays in Ballroom
        NDR moves to the Notre Dame Room
“The Lab”
                    Key Learning Points
• As a scientist, review any article on which you‟re listed as a co-author

• If you suspect research misconduct, seek advice from those you
  respect and talk to the research integrity officer

• Don‟t confront someone you suspect of falsifying data; your action
  could tip off the person and hinder any further investigation

• Report any instances of retaliation to the research integrity officer
   • Bob Bernhard, Vice President for Research
Publication and Peer Review

             Prashant Kamat (Radiation Lab)
         Eric Lease Morgan (Hesburgh Libraries)
Joan Brennecke (Chemical and Biomolecular Engineering)
Scientific Knowledge
 Scientific Knowledge

The object of research is to extend human
knowledge beyond what is already known.

But an individual’s knowledge enters the
domain of science only after it is presented to
others in such a fashion that they can
independently judge its validity

                (NAP, “On Being a Scientist” 1995)
Sharing Scientific Knowledge
  Sharing
          Scientific Knowledge
    “Science is a shared knowledge based
    on a common understanding of some
    aspect of the physical or social world”
                      (NAP, “On Being a Scientist” 1995)

Presentations
   - Social conventions play an important role in establishing
   the reliability of scientific knowledge

Publications in peer reviewed journals
  - Research results are privileged until they are published

Thesis
Why Publish?
              Why Publish?
• “A paper is an organized description of
  hypotheses, data and conclusions, intended
  to instruct the reader. If your research does not
  generate papers, it might just as well not have
  been done” (G. Whitesides, Adv. Mater., 2004,
  16, 1375)
• “if it wasn’t published, it wasn’t done” - in
  E.H. Miller 1993
Scientific Publication is a Team Effort




                    Journal




Authors                                 Reviewer




    ACS Journals:http://pubs.acs.org/about.html
Authorship                Authorship
                                                                       Great Manuscript!
• The list of authors establishes accountability as                     But LAB CHIEF
  well as credit.                                                      always gets listed
                                                                       as FIRST author!
• Policies at most scientific journals state that a
  person should be listed as the author of a paper
  only if that person made a direct and substantial
  intellectual contribution to the design of the
  research, the interpretation of the data, or the
  drafting of the paper.

• The acknowledgments section can be used to
  thank those who indirectly contributed to the
  work.

Including “honorary,” “guest,” or “gift” authors dilutes
the credit due the people who actually did the work,
inflates the credentials of the added authors, and
                                                                        Responsible authorship?
makes the proper attribution of credit more difficult.
                     (“On Being a Scientist” , NAP)        (From ORI
                                                           http://ori.dhhs.gov/educ ation/products/RCR
                                                           intro/c02/0c2.html )
Author Responsibilities
          Author Responsibilities
  – Preparation and Submission of Manuscripts:

Follow General Rules:
   –   Ensure work is new and original research
   –   All Authors are aware of submission and agree with content
       and support submission
   –   Agree that the manuscript can be examined by anonymous
       reviewers.
   –   Provide copies of related work submitted or published
       elsewhere
   –   Obtain copyright permission if figures/tables need to be
       reproduced
   –   Include proper affiliation
What is publishable .
           What is publishable?
  Journals like to publish papers that are going to be
  widely read and useful to the readers


• Papers that report “original and significant” findings that are
  likely to be of interest to a broad spectrum of its readers

• Papers that are well organized and well written, with clear
  statements regarding how the findings relate to and advance the
  understanding/development of the subject

• Papers that are concise and yet complete in their presentation
  of the findings
What is not acceptable
       What is not acceptable
• Papers that are routine extensions of previous reports
  and that do not appreciably advance fundamental
  understanding or knowledge in the area

• Incremental / fragmentary reports of research results

• Verbose, poorly organized, papers cluttered with
  unnecessary or poor quality illustrations

• Violations of ethical guidelines, including plagiarism of
  any type or degree (of others or of oneself) and
  questionable research practices (QRP)
Table Talk
• What key points to check before submitting
  your manuscript for publication?
• What criterion one needs to follow to
  reproduce a figure or table from the published
  paper?
• Discuss the importance of adding institute
  affiliation and acknowledgment section in the
  manuscript.
Where to Publish
• It goes almost without saying, you will want to
  publish in peer-reviewed journals, but within
  that category, you may want to distinguish
  between:
  – Top tier vs. lower tier
  – Society vs. general audience journals
  – Theoretical vs. empirical journals
Open Access Journals
• “Open access journals” are serial publications
  whose content is free – at no financial cost –
  for the reader to read.
• Issues surrounding copyrights, dissemination,
  and content re-use are advantages of open
  access publications.
• Shifting costs, reputation, and the digital-only
  nature of open access can be disadvantages.
Definitions:
  Plagiarismto worry about
     Issues and Self-Plagiarism
• Plagiarism: using the ideas or words of another
  person without giving appropriate credit (Nat. Acad.
  Press document)

• Self-Plagiarism: The verbatim copying or reuse of
  one’s own research (IEEE Policy statement)

  Both types of plagiarism are considered to be
  unacceptable practice in scientific literature
ACS Publication Policy
Plagiarism statement for Ethical Guidelines
January 2009

B. 9. It is the responsibility of the author to ensure that the submitted manuscript
is original and shall not contain plagiarized material. Plagiarism is passing off
another person’s work as one’s own, i.e., reusing text, results, or creative
expression without explicitly acknowledging or referencing the original
author or publication.

Authors should be aware this includes self-plagiarism, defined as the reuse of
significant portions of the author’s own published work or works, without
attribution to the original source. Examples of plagiarism include verbatim
copying of published articles; verbatim copying of elements of published articles
(e.g., figures, illustrations, tables); verbatim copying of elements of published
articles with crediting, but not clearly differentiating original work from previously
published work; and self-plagiarism.

It is the responsibility of the author to obtain proper permission and to
appropriately cite or quote the material not original to the author. In this context,
“quote” is defined as reusing other works with proper acknowledgement.
Appropriate citation applies whether the material was written by another author or
the author him or herself.
What is Self-Plagiarism?
• How you describe your research is also part of
  the creative process
• Your WORDS matter, not just your results
• Even things that may seem mundane to you
  (e.g., experimental description) need to be
  original
• Verbatim sentences need to be put in
  quotations marks
Tools to Catch Self-Plagiarism
• Show Ithenticate Example
Other Types of Ethical Violations
  Other things to worry about
• Duplicate publication/submission of research
  findings; failure to inform the editor of related papers
  that the author has under consideration or “in press”

• Unrevealed conflicts of interest that could affect the
  interpretation of the findings

• Misrepresentation of research findings - use of
  selective or fraudulent data to support a hypothesis
  or claim
Table Talk
• Is it OK to post a copy of a presentation on
  your website that includes figures from one of
  your published papers?
• What should you do if you read a research
  paper that presents results as new and you
  realize that you have seen the same results by
  those authors in another paper?
What do I do now?
- Publish original and significant findings
- Choose appropriate journal for the material
- Take care to avoid all forms of self-plagiarism
Resources
• ACS Ethical Guidelines to Publication of Chemical Research –
  http://pubs.acs.org/userimages/ContentEditor/1218054468605/ethics.pdf
• Journal Citation Reports – http://eresources.library.nd.edu/databases/jcr
• Thorough introduction to open access publishing - http://bit.ly/oa-
  overview
• Whitesides, G. M. Whitesides' group: Writing a paper. Adv. Mater. 2004,
  16, 1375-1377.
• ON BEING A SCIENTIST, RESPONSIBLE CONDUCT IN RESEARCH, NATIONAL
  ACADEMY PRESS, 1995
  (http://www.nap.edu/openbook.php?record_id=4917&page=R1 ) Kamat,
  P. V.; Schatz, G. C. Getting your Submission Right and Avoiding Rejection. J.
  Phys. Chem. Lett. 2012, 3, 3088-3089.
• Publishing your research 101 Video clips
  http://pubs.acs.org/page/publish-research/index.html
BREAK

            We will resume at 3:45
   Animal research session is in the Ballroom
Human Subjects session is in the Notre Dame Room
Animal Research and
   Laboratory Safety

              Mark Suckow
 Assistant Vice President for Research
Director, Freimann Animal Care Facility
Numbers in Perspective
                      10000

                                                                                                                                    9,031
                             9000
Millions of animals killed




                             8000


                             7000


                             6000


                             5000


                             4000


                             3000


                             2000


                             1000
                                                                       365
                                    1     26           150                             27             38              105
                                0
         Research exc. Mice, rats and birds rats and birds
                        Research inc. Mice,          Hunting Killed by Automobiles
                                                                                Ducks for food sheep, calves for Pigs for food Chickens for food
                                                                                        cattle,                  food
René Descartes
Animals are just
 machines and thus
 incapable of
 thinking




                     Philosopher & Mathematician
                     (1596-1650)
Jeremy Bentham
“But a full-grown horse or
dog is beyond comparison a
more rational, as well as a
more conversable animal,
than an infant of a day, or a
week, or even a month, old.
But suppose the case were
otherwise, what would it
avail? The question is not,
can they reason? Nor, can
they talk, but can they                                Founder of Modern Utilitarianism
   suffer?”                                                         1748-1832



             Utilitarianism: If the good outcome exceeds the cost,
             then an act is acceptable
The Importance of
          Animals in Biomedical Research


Most of our children have not even heard
 of, much less know anything about, many
 of the diseases our ancestors experienced
 first-hand. Why? They have either been
 eradicated or can be controlled due to
 findings from research using animals.
A Brief History
• FDR 1935, Social Security Act:
  $2 million/year for disease research
• Surging economy post WW II
• Taxpayer funding for health-related
  research
• Explosive increase in biomedical
  research
Post WWII lab animal care
• Housing - homes, basements, barns...
• Food - leftover table scraps
• Caging - wooden, wire
• Bedding - dirty, vermin
• Ventilation/temperature
  - no control
• Care - variable
Problems


• Animal health concerns

• Surgery and procedure sites

• Inability to repeat research results
Imperatives for Animal Use
Nuremberg Code 1949
• Any experiment on humans “should be
  designed and based on the results of animal
  experimentation”
The Declaration of Helsinki 1964
• Medical research on human subjects “should
  be based on adequately performed laboratory
  and animal experimentation”
Animal Care Panel
        1950

• Veterinarians

• In 1967, name changed to:
  American Association for Laboratory Animal
  Science (AALAS)
Guide for the Care and Use
        of Laboratory Animals

• 1963 first Guide
   by Animal Care Panel
• Revisions: „65, „68, „72,
 „78, „85, ‟96, and 2011
Guide for the Care and Use of
         Laboratory Animals


• Basis for PHS evaluation of animal care
  and use program. Failure to follow the Guide
  can result in loss of funding to the institution


• Also used by accrediting agency
  (AAALAC).

• Government publication
The Guide for the Care and Use of
       Laboratory Animals

• Outlines and provides references for:
  – Veterinary care
  – Euthanasia
  – Housing and environment
  – Personnel qualifications
  – Sanitation
  – Surgical and post-operative care
  – Facility construction
The Animal Welfare Act (AWA)

• Passed in 1966

• “Pepper” the stolen
  Dalmation, Sports Illustrated

• Life Magazine feature
Laboratory Animal Welfare Act
 •   Passed in 1965; 1966 - Public Law 89-544

 •   Unannounced USDA Inspections at least annually

 •   failure to follow the law can result in fines or jail

 •   Principal purposes:
      – Regulate research use of dogs, cats, rabbits, hamsters, guinea
         pigs, and nonhuman primates
      – Establish standards for housing, transportation, and “adequate
         veterinary care” provided by or under direction of a veterinarian
Institutional Animal Care and Use
           Committee (IACUC)
• Mandated by
  USDA, PHS, NSF, accrediting and
  funding agencies

• Designates “Institutional Official (Dr.
  Robert Bernhard)

• Charged with reviewing and oversight
  of animal care and use
The IACUC Assures
• Animals are used only when justified; minimum number used;
  alternative replacements have been ruled out.

• If procedures that might potentially cause pain are to be
  used, adequate pain-relieving medicine is used.

•    That personnel working with animals are properly trained
    and protected.

• Veterinary care is provided

• Animals are housed safely in clean conditions, with fresh food
  and water.
Who serves on the IACUC?
• PHS: at least five members
  – Chair (Dr. Jeff Scorey)

  – Veterinarian (Dr. Mark Suckow)

  – Scientist (multiple members)

  – Non-scientist (Valerie Schroeder)

  – Community member (Dr. Prentiss Jones)
What does the IACUC do?
• Review animal care and use protocols

• Ensure training of personnel

• Review occupational health related to
  animal exposure

• Inspect animal housing and use areas

• Meets monthly
First Step: The IACUC Protocol
• Before any research or teaching using
  vertebrates or tissues from
  vertebrates, including field research.

• Form available at Office of Research
  website (http://or.nd.edu/forms/forms-
  list/)

• Contact Tracey Poston, Director of
  Research Compliance (1-1461)
IACUC Protocol
• Species, type of animal

• Number to be used (with justification)

• Lay description of project and goals

• Description of animal use procedures
  and how they connect
IACUC Protocol
 Alternatives
  ◦ The Principles of Humane
   Experimental Technique - 1959
  ◦ Replacement
  ◦ Reduction
  ◦ Refinement

 Assurance that project does not unnecessarily
  duplicate previous work.
IACUC Protocol – Some Specifics
• Justify any exceptions to standards
  – -housing, bedding, light, etc.
  – -use of non-pharmaceutical grade drugs

• Describe likely phenotypes or clinical
  outcomes

• State specific endpoints

• Describe methods to eliminate or minimize
  any pain or distress
Additional Specifics
• Describe any hazards and steps to
  mitigate risk
  – Biohazards
  – Chemical
  – Radioisotopes


• Carefully describe who performs
  procedures and qualifications
AVMA Guidelines on Euthanasia

• Basis for most IACUC determinations of
  humane or acceptable euthanasia

• Justification required if method is not
  recommended

• Most recent edition published
  in June 2007
IACUC Protocol Review

• Does the research address an important question?

• Does the research require the use of animals?

• Is the research necessary, in that it does not needlessly
  repeat previous work?

• Is the experience of each animal in the study adequately
  described and justified?
IACUC Protocol Review
• Reviewed by entire committee

• Approve; approve with modifications;
  withhold approval

• Decisions cannot be overruled

• Typically 1 -2 months for approval
Protocol Amendments

• Any change to protocol:
  personnel, species, number, procedur
  es/methods, etc.

• Form available at Office of Research
  website
  (http://or.nd.edu/forms/forms-list/)
Training
• Required and key to success!

• Basic on-line training for all
  – Valerie Schroeder, RVT (1-6087)

• Specialized on-line training

• Hand-on training
Occupational Health for Animal Users
• Anyone handling animals or entering
  facility

• Risk-based assessment

• Allergy

• Vaccinations

• Contact Jenna Leevy at RMS (1-5037)
Where do you fit in?
• Do not begin any studies before protocol
  approval

• Training and occupational health

• Report any animal-related concerns to
  IACUC

• Handle animals with care and
  compassion
Where is Animal Research Done at
             Notre Dame
• Freimann Life Science Center
   – -Dr. Mark Suckow, DVM, Director (1-6085)
   – -Main site on campus; administrative center
   – -35,000 sf

• Raclin-Carmichael Hall

• Some laboratories

• UNDERC (mostly field studies)

• Other field sites
Freimann Life Science Center
• All animals ordered through FLSC
  (contact: Kay Stewart, 1-6085).

• Highly skilled technical staff

• Access is controlled

• Several procedure rooms, but clean up
  your mess!
Why Should We Do Any of This?
• USDA Regs are part of Public Law

• Freedom of Information Act 1966
• If taxpayer $$ are used, public can access information
• USDA inspection reports on the web (off and now on again…)

• Negative Outcomes
   – -Loss of funding
   – -Loss of ability to do animal research
   – -Public perception of Notre Dame



• It‟s in the interest of the animals!
General Rules for Working with Animals
• The use of any animal or animal tissue is a privilege, not a right.

• Animals feel pain and distress just as humans do.

• Experiment should be done with the lease possible infliction of
  pain, suffering, and distress.

• The Principal Investigator is required to determine that there is not an
  alternative technique to animal use.

• ANY experiment involving animals or animal tissues must be approved by
  the IACUC.
Laboratory Safety
• YOU are responsible for your safety

• Integrated Laboratory Safety Plan

• Follow all rules, take all precautions – no
  short cuts!

• Questions/Concerns: call RMS at 1-5037
It all comes down to personal
           integrity!
Questions?
Research on Human Subjects

              Darcia Narvaez
    Chair, Institutional Review Board
      Department of Psychology
Evolution of Institutional Review Boards (IRBs)
 1974 National Research Act, established the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research.

Charged with identifying the basic ethical principles that should underlie the conduct of
biomedical and behavioral research involving human subjects and to develop guidelines
which should be followed to assure that such research is conducted in accordance with
those principles.

 The National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research prepared the Belmont Report in 1979. The Belmont Report attempts to
summarize the basic ethical principles identified by the Commission in the course of its
deliberations.


 In 1981, the Department of Health and Human Services (DHHS) and the Food and Drug
Administration (FDA) issued regulations based on the Belmont Report.

DHHS issued Code of Federal Regulations (CFR) Title 45 (public welfare), Part 46 (protection
of human subjects). The FDA issued CFR Title 21 (food and drugs), Parts 50 (protection of
human subjects) and 56 (Institutional Review Boards).
The Common Rule
The “Common Rule” is the set of regulations which were developed to
ensure compliance with the principles of the Belmont Report. The
regulations fall under the Department of Health and Human Services.
These regulations have been adopted by many other federal
departments which regulate human research.


There are many other regulations with which the University of Notre
Dame are required to comply, such as the Food and Drug
Administration, but these are all in addition to the “Common Rule”.
Basic Principles of
     the Belmont Report

1.    Respect for Persons

2.    Beneficence

3.    Justice
Respect for Persons

• Treat individuals as autonomous agents

• Do not use people as a means to an end

• Allow people to choose for themselves

• Provide extra protections to those with diminished autonomy
  (i.e., Prisoners, Children, Cognitively Impaired, etc.)
Beneficence

• The two general rules formulated from the principle of beneficence
  are:

           First, do no harm

           Second, maximize possible benefits and minimize risks
Justice

• Treat people fairly

• Fair sharing of burdens and benefits of the research

    An injustice occurs when:

      1.   benefits to which a person is entitled are denied without
           good reason, or

      2.   when burdens are imposed unduly.
What Is Research?
                 45 CFR 46.102(d)

• Research means a systematic investigation, including research
  development, testing and evaluation, designed to develop or
  contribute to generalizable knowledge. Activities which meet this
  definition constitute research for purposes of this policy, whether or
  not they are conducted or supported under a program which is
  considered research for other purposes. For example, some
  demonstration and service programs may include research activities.
What Are Human Subjects?
        45 CFR 46.102(f)
•   Human subject means a living individual about whom an investigator
    (whether professional or student) conducting research obtains

     – Data through intervention or interaction with the individual, or

     – Identifiable private information.
IRB Review of Research
• All research projects are categorized into one of three categories for
  the IRB review process. Each category is different in the level of
  scrutiny and submission procedures. The IRB is responsible for
  making the final decision of which category a research project falls
  under.

               Full

               Expedited

               Exempt

               Research Not Involving Human Subjects
The IRB has the authority to:

• Approve

• Require modifications prior to approval


• Table


• Disapprove all research activities including proposed
  changes in previously approved human subject
  research.
The policy of the University of Notre Dame, and most other colleges and
universities in the U.S., mandates that all human subject research be
reviewed and approved, regardless of funding.

Structure of University of Notre Dame’s IRB
Federal guidelines partially define IRB membership:

       Community representative unaffiliated with the university
       Non-scientist
       Diverse
Membership (9 appointed members)

       Professional
       Volunteer
       Methodological diversity (quantitative and qualitative)
       Disciplinary diversity
       Centers and Institutes represented (Kroc, ACE, ISLA, CSR)
Human subject research at Notre Dame:

  •   Surveys and interviews (international, national, local, and elite)

  •   Community based research

  •   Laboratory experiments

  •   Ethnographic research

  •   DNA Research

  •   Internet based research – forums and chat rooms
Challenges faced by Notre Dame’s IRB:
• Student Research (Undergraduate and Graduate)
        Lack of familiarity with issues in human subject research
        Training in methodology and research ethics
        Personal security
        Data security
• International Research
          Vulnerable populations
          High risk areas
          Ethical issues
          Student involvement
          Research may begin before approval of research
• Biased perceptions of the IRB
• Lack of knowledge of human subject research and IRB processes
• Non-Social Science researchers venturing into human subject research

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2012 Ethics Workshop Presentation

  • 1. Responsibilities and Ethics in the Conduct of Research January 14, 2013 RESOURCES at: http://graduateschool.nd.edu/ethics-resources
  • 2. On the index card at your seat: • Please jot down a description of an unethical situation in your professional life in which you wanted to act on behalf of your values but didn't know what to do • If you can't think of one, jot down a description of a situation you have heard about with respect to research and reflect on how you may have acted if it had happened to you.
  • 3. Welcoming Remarks Chris Maziar Acting Dean of the Graduate School Vice President & Senior Associate Provost Professor of Electrical Engineering Bob Bernhard Vice President for Research Professor of Aerospace & Mechanical Engineering
  • 4. Recognizing and Approaching Ethical Problems Jessica McManus Warnell Mendoza College of Business jmcmanus@nd.edu
  • 5. Consider this scenario • After a busy day, you are having dinner with a fellow graduate student from your program. You discuss your research and end up spending the next few hours brainstorming together different ideas. The next day, you sit down to work on a description for your next research project and decide one of the ideas that came up last night has merit and is worth pursuing. • Can you simply take the topic and pursue it on your own?
  • 6. Today’s goal: • Discuss how we can approach this type of dilemma with principled analyses and strategies for effective resolution
  • 7. Decision Model for Resolving Ethical Issues AWARENESS/ KNOWLEDGE/ ACTION/ SENSITIVITY JUDGMENT BEHAVIOR 1. Get the facts (unbiased, fair, accurate) 2. Understand the issues involved, including relevant principles and obligations, and how they may conflict (classification & assessment) 3. Identify stakeholders and how they will be affected (perspective-taking) 4. Explore alternatives and their consequences (moral imagination) 5. Consider universalizability and make a principled decision
  • 8. The Case of the Good Idea 1) Get the facts Who, what, when, how 2) Understand the issues, relevant principles and obligations, and how they may conflict Dishonesty, integrity, justice, veracity, fidelity, loyalty, justice 3) Identify stakeholders and how they will be affected Advisor, friend, work group, university, academic community 4) Explore alternatives and their consequences Use the idea – go for it! Use the idea – with attribution Moral imagination – a better resolution? 5) Consider universalizability and make a principled decision Is this decision precedential? Universalizable?
  • 9. Table Talk • Share the dilemmas that you jotted down with your table. • Select one and work through how you would apply the decision model to this dilemma • Are there any steps that are particularly difficult?
  • 10. Decision Model for Resolving Ethical Issues AWARENESS/ KNOWLEDGE/ ACTION/ SENSITIVITY JUDGMENT BEHAVIOR 1. Get the facts (unbiased, fair, accurate) 2. Understand the issues involved, including relevant principles and obligations, and how they may conflict (classification & assessment) 3. Identify stakeholders and how they will be affected (perspective-taking) 4. Explore alternatives and their consequences (moral imagination) 5. Consider universalizability and make a principled decision
  • 11. Pay attention to post-decision making After one determines the appropriate course of action, how, specifically, does he/she act on it within a given context? Why do we overestimate our ability to act ethically, and act unethically without meaning to? How can we address “ethical fading”?
  • 12. Ethics is a habit • “Living an ethical life is something you do. It is not simply a theory or a certain understanding. Ethics should be viewed as a practical activity that has a tactical dimension, and as such, requires practice, much like playing a sport or instrument…. • Becoming an ethical leader requires paying attention to the small decisions made every day. A pattern of ethical decision making becomes a habit, and good habits become virtues. In turn, virtues add up to character.” - Rev. John Jenkins, “The Ethics of Leadership”
  • 13. Possible next steps Identify your purpose – why am I doing what I’m doing? and acknowledge choice Engage with curriculum in conceptual foundations of ethics, and, critically, in application of ethics to our chosen field of study Acknowledge challenges, reasons and rationalizations, and “blind spots” Be explicit – acknowledge, discuss, practice, model ethics
  • 14. Resources • Mendoza College of Business Ask More of Business Framework • Giving Voice to Values Program • Blind Spots resources page • Blurb about 4 component model
  • 15. Mentoring Jennifer Tank (Biology) Jessica Collett (Sociology) Ed Maginn (Chemical and Biomolecular Engineering) Erin Drew (English)
  • 16. Importance of Mentoring Expectations for “graduate success” vary across departments – Be as detailed as you can in your dialogue – (e.g. hours, access to advisor, synergy vs. independence). Importance of communication and establishing expectations • “failure to thrive” is often due in part to a lack of communication Recognize not all faculty are naturally the best mentors • “manage” your advisor to get the mentoring you need • Exchange information with peers as a litmus test on progress Take-home: You must be self-motivated! • Products (publications, presentations etc.) = next job and your future! • U of M resources are excellent guides for TWO-way communication and effective student-mentor relationships
  • 17. Supporting findings from research on mentoring • All students experience uncertainty – at one time or another – in graduate school • All students want mentoring – However, its frequency and form vary across disciplines and gender lines • Few faculty are explicitly trained in mentoring – The limits of observation (for students) – The problems with assumptions (for everyone)
  • 18.
  • 19. Table Talk • Have you had this discussion with your advisor? • Describe the culture of expectations in your department or program • Does your advisor know your goals and do you know your advisor’s goals?
  • 20. Comments from table and panel
  • 21. But what if I don’t work in lab.. • In some disciplines, students work alone, but we are still responsible to our adviser/dept for producing work in a timely fashion Some questions to ask your DGS and adviser: -When do you expect me to begin presenting or publishing work? -How frequently should I turn in drafts/chapters to you? -What can I do to help you as you read and respond to my work? (How rough is too rough? Stick to deadlines? Etc.)
  • 22.
  • 23. Table Talk • Can you describe the student’s goal for this conversation? Did he get what he wanted? • How do you think the advisor felt? Why?
  • 24. Comments from table and panel
  • 25.
  • 26. Table Talk • Describe whether your perception of the interaction has changed • How do you think your gender/race/nationality could influence your interactions with your advisor
  • 27. Comments from table and panel
  • 28. Possible next steps Read U of M guides (from mentor and advisee perspective) (on the workshop resource page) Have a conversation with your mentor. Talk to your peers about the expectations in your discipline and in your program The key is communicating, understanding and respecting needs and expectations.
  • 29. Resources Great place to start… University of Michigan resources on mentoring Note: also posted on Notre Dame resource page • How to Get the Mentoring You Want: A Guide for Graduate Students at a Diverse University – http://www.rackham.umich.edu/downloads/publications/ mentoring.pdf • How to Mentor Graduate Students: A Guide for Faculty at a Diverse University – http://www.rackham.umich.edu/downloads/publications/ Fmentoring.pdf
  • 31. Conflict of Interest and Conflict of Commitment Liz Rulli, Office of Research Jeff Kantor, Chemical and Biomolecular Engineering
  • 32. Conflict of Interest Dictionary Definition: A conflict between the private interests and the official responsibilities of a person in a position of trust. ‐www.merriam‐webster.com/dictionary
  • 33. Conflict of Interest University Policy Definition: An actual Conflict of Interest arises in a situation where financial or other personal or professional considerations compromise an individual’s objectivity, professional judgment, professional integrity, and/or ability to perform his or her professional responsibilities to the University. Perceived or potential Conflicts of Interest can be said to exist in situations where an individual member of the University community (Member), a member of the individual’s family (Family), or a close personal relation (Close Relation) has financial interests, personal relationships, or professional associations with an individual, individuals, or outside organization, such that his or her activities within the University could appear to be influenced by that interest or relationship.
  • 34. Conflict of Interest Federal Funding Agency Requirements: Federal Conflict of Interest Policy focuses around ensuring objectivity in research. If you have a significant financial interest that is related to your role at the university that could potentially impact the design, conduct or reporting of research, that significant financial interest is considered a financial conflict of interest. You must disclose the interest/potential conflict before proposals are submitted. If the interest rises to the level of a financial conflict of interest it must be managed or eliminated before conducting the work.
  • 35. Conflict of Commitment ND Faculty Policy A conflict of commitment refers to a situation in which a faculty member engages in an activity, whether paid or unpaid, that compromises his or her professional obligations to the University.
  • 36. How is a COC Different from a COI? • A conflict of interest may not involve a significant commitment of one's time – doing business with the university – in personnel decisions • A conflict of commitment can occur when there is no conflict of interest – excessive involvement with outside organizations.
  • 37.
  • 38. Table Talk Discuss any conflicts of interest that you identify from the scenario
  • 39. Conflict of Commitment Reactions Table Reports
  • 40. Table Talk Discuss any conflicts of commitment that you identify from the scenario
  • 41. Conflict of Commitment Reactions Table Reports
  • 42. Graduate Students Need to Know 1. Funding agency focus on ensuring objectivity in research 2. Disclosure and management is key 3. Protections in place for students and processes in place for oversight 4. Students may be “covered researchers”
  • 43. Graduate Students Need to Know 1 You need to be aware of your obligations to the agencies that are supporting your work. 2 Disclose significant outside involvements to your advisor . (Guideline: 1 day per month) 3 Do not let personal obligations interfere with University commitments. 4 Cooperate with effort reporting.
  • 44. Areas of Special Concern for Students • You are identified as a “covered researcher” • You are informally aware that your advisor has an outside activity but you haven’t discussed any possible implications for you • It is unclear whether your intellectual contributions for some activities are being exploited for private interests • You are involved in activities where relationships are unclear (financial, evaluative, data ownership, who you are working for)
  • 45. Areas of Special Concern for Students • Excessive coursework that conflicts with major area of interest, or with research funding. • Use of university resources for private purposes. • Engagement with outside activities that compromise progress towards your degree. • Financial aid from other sources that require a time commitment. • Outside employment. • Outside consulting.
  • 46. Resources • University Conflict of Interest Policy – http://conflictpolicy.nd.edu/ • University Conflict of Commitment Policy – http://policy.nd.edu/policy_files/ConflictofCommitmentPolicy.pdf • NIH Financial Conflict of Interest Page – http://grants.nih.gov/grants/policy/coi/ • NIH Financial Conflict of Interest FAQ’s – http://grants.nih.gov/grants/policy/coi/coi_faqs.htm • NSF Financial Conflict of Interest Policy – http://www.nsf.gov/pubs/manuals/gpm05_131/gpm5.jsp#510 • Other Agencies Adopting PHS/NIH COI Guidelines – http://sites.nationalacademies.org/PGA/fdp/PGA_070596 • CITI COI Training Module – https://www.citiprogram.org/default.asp?language=english
  • 47. Avoiding Plagiarism Susan D. Blum Department of Anthropology John Lubker The Graduate School The University of Notre Dame
  • 48. Avoiding plagiarism What Is Plagiarism? Why do we have such a concept? Table Talk Complications
  • 52. Avoiding plagiarism What Is Plagiarism? Why do we have such a concept? Table Talk Complications
  • 53. What is plagiarism? “The uncredited use (both intentional and unintentional) of somebody else‟s words or ideas.” From The OWL at Purdue, http://owl.english.purdue.edu/owl/resource/589/01/. Accessed August 20, 2009. Originally from a Latin term, plagiarius, meaning “kidnapping” Oxford English Dictionary
  • 55. “Plagiarism 1” Unintentional or inadvertent Comes from ignorance or imperfect mastery of complicated rules Often results in Omitting quotation marks from properly used quoted material Omitting attribution from properly used quoted or paraphrased material http://operachic.typepad.com/photos/uncategorized/2008/02/14/jobs_perplexed.jpg
  • 56. “Plagiarism 2” Deliberate or intentional Comes from an attempt to circumvent guidelines Often results in: Importation of improper amount of someone else‟s material Sentences Paragraphs Use of someone else‟s paper (classmate, fraternity brother, website)
  • 57. “Plagiarism” Statistics 66% (60 – 80 %) of students in college and high school admit they have copied material without attributing it to its source. Donald L. McCabe, Linda Klebe Treviño, and Kenneth D. Butterfield, “Cheating in Academic Institutions: A Decade of Research.” Ethics and Behavior 11, no. 3 (2001): 219-232. Also Character Counts (Josephson Institute). Charactercounts.org.
  • 58. Avoiding plagiarism What Is Plagiarism? Why do we have such a concept? Table Talk Complications
  • 59. Why do we have such a concept? Economic Moral Legal / Professional / Ethical Pedagogical / Educational
  • 60. Why? Economic: Copyright Making a living from writing Professional advancement from credit for ideas http://uechi.typepad.com/.a/6a00d8341d471653ef011168420948970c-320wi
  • 61. Why? Moral: Idea of author and individual We own our own words and ideas People are creative and have important original contributions to make ?? ?? http://www.livius.org/a/1/greeks/homer.JPG http://www.sllib.org/Pages/Digital%20Library/Shakespeare.jpg http://famouspoetsandpoems.com/pictures/william_wordsworth.jpg
  • 62. Why? “Legal” / professional / ethical within an academic framework: Academic “guild” Footnotes Indicate sources, evidence, due diligence Permit others to trace influence Students as apprentices http://cdn-write.demandstudios.com/upload//1000/100/90/1/61191.jpg
  • 63. Why? Pedagogical / Educational: Intended to support learning, which assumes a need for originality and engagement http://www.bendlearningcenter.com/art/college_students.jpg
  • 64. Avoiding plagiarism What Is Plagiarism? Why do we have such a concept? Table Talk Complications
  • 65. Table Talk 1a Do you need to acknowledge….. information you copy directly from a book?
  • 66. Table Talk 1b Do you need to acknowledge….. information you quote from an online article?
  • 67. Table Talk 1c Do you need to acknowledge….. information you summarize from a popular magazine?
  • 68. Table Talk 1d Do you need to acknowledge….. concepts you learned from a class text?
  • 69. Table Talk 2a [original text] Abraham Lincoln, William Henry Seward, Salmon Chase, and Edward Bates were members of a restless generation of Americans, destined to leave behind the eighteenth-century world of their fathers. Bates, the oldest, was born when George Washington was still president; Seward and Chase during Jefferson’s administration; Lincoln shortly before James Madison took over. Thousands of miles separate their birthplaces in Virginia, New York, New Hampshire, and Kentucky. Nonetheless, social and economic forces shaped their paths with marked similarities. Doris Kearns Goodwin, Team of Rivals: The Political Genius of Abraham Lincoln (New York: Simon and Schuster, 2005), p. 28. Is this paraphrase acceptable? Abraham Lincoln, William Henry Seward, Salmon Chase, and Edward Bates were men of an impatient generation of Americans, fated to escape the eighteenth-century world of their forebears.
  • 70. Only a few words were substituted. The structure is identical to the original. The source was not cited. This would be considered plagiarism.
  • 71. Table Talk 2a [original text] Abraham Lincoln, William Henry Seward, Salmon Chase, and Edward Bates were members of a restless generation of Americans, destined to leave behind the eighteenth-century world of their fathers. Bates, the oldest, was born when George Washington was still president; Seward and Chase during Jefferson’s administration; Lincoln shortly before James Madison took over. Thousands of miles separate their birthplaces in Virginia, New York, New Hampshire, and Kentucky. Nonetheless, social and economic forces shaped their paths with marked similarities. Doris Kearns Goodwin, Team of Rivals: The Political Genius of Abraham Lincoln (New York: Simon and Schuster, 2005), p. 28. Is this paraphrase acceptable? Abraham Lincoln, William Henry Seward, Salmon Chase, and Edward Bates were men of an impatient generation of Americans, fated to escape the eighteenth-century world of their forebears.
  • 72. Table Talk 2b [original text] Abraham Lincoln, William Henry Seward, Salmon Chase, and Edward Bates were members of a restless generation of Americans, destined to leave behind the eighteenth-century world of their fathers. Bates, the oldest, was born when George Washington was still president; Seward and Chase during Jefferson’s administration; Lincoln shortly before James Madison took over. Thousands of miles separate their birthplaces in Virginia, New York, New Hampshire, and Kentucky. Nonetheless, social and economic forces shaped their paths with marked similarities. Doris Kearns Goodwin, Team of Rivals: The Political Genius of Abraham Lincoln (New York: Simon and Schuster, 2005), p. 28. Is this paraphrase acceptable? Nineteenth-century political leaders such as Abraham Lincoln and his erstwhile rivals Seward, Chase, and Bates, despite differences in age and origin, shared many aspects of their trajectory (Goodwin 2005: 28).
  • 73. The writer (paraphraser) used her own words. The source was cited. This is acceptable.
  • 74. Table Talk 2b [original text] Abraham Lincoln, William Henry Seward, Salmon Chase, and Edward Bates were members of a restless generation of Americans, destined to leave behind the eighteenth-century world of their fathers. Bates, the oldest, was born when George Washington was still president; Seward and Chase during Jefferson’s administration; Lincoln shortly before James Madison took over. Thousands of miles separate their birthplaces in Virginia, New York, New Hampshire, and Kentucky. Nonetheless, social and economic forces shaped their paths with marked similarities. Doris Kearns Goodwin, Team of Rivals: The Political Genius of Abraham Lincoln (New York: Simon and Schuster, 2005), p. 28. Is this paraphrase acceptable? Nineteenth-century political leaders such as Abraham Lincoln and his erstwhile rivals Seward, Chase, and Bates, despite differences in age and origin, shared many aspects of their trajectory (Goodwin 2005: 28).
  • 75. Table Talk 2c [original text] Abraham Lincoln, William Henry Seward, Salmon Chase, and Edward Bates were members of a restless generation of Americans, destined to leave behind the eighteenth-century world of their fathers. Bates, the oldest, was born when George Washington was still president; Seward and Chase during Jefferson’s administration; Lincoln shortly before James Madison took over. Thousands of miles separate their birthplaces in Virginia, New York, New Hampshire, and Kentucky. Nonetheless, social and economic forces shaped their paths with marked similarities. Doris Kearns Goodwin, Team of Rivals: The Political Genius of Abraham Lincoln (New York: Simon and Schuster, 2005), p. 28. Is this paraphrase with quotation acceptable? Nineteenth-century political leaders such as Abraham Lincoln and his erstwhile rivals Seward, Chase, and Bates, despite differences in age and origin, shared many aspects of their trajectory, and were “members of a restless generation of Americans, destined to leave behind the eighteenth-century world of their fathers” (Goodwin 2005: 28).
  • 76. The original information is accurately conveyed. The ideas in the passage are credited. The distinction between the original author’s and the paraphraser’s words is clearly indicated by the use of quotation marks and page number. This is acceptable.
  • 77. Table Talk 2c [original text] Abraham Lincoln, William Henry Seward, Salmon Chase, and Edward Bates were members of a restless generation of Americans, destined to leave behind the eighteenth-century world of their fathers. Bates, the oldest, was born when George Washington was still president; Seward and Chase during Jefferson’s administration; Lincoln shortly before James Madison took over. Thousands of miles separate their birthplaces in Virginia, New York, New Hampshire, and Kentucky. Nonetheless, social and economic forces shaped their paths with marked similarities. Doris Kearns Goodwin, Team of Rivals: The Political Genius of Abraham Lincoln (New York: Simon and Schuster, 2005), p. 28. Is this paraphrase with quotation acceptable? Nineteenth-century political leaders such as Abraham Lincoln and his erstwhile rivals Seward, Chase, and Bates, despite differences in age and origin, shared many aspects of their trajectory, and were “members of a restless generation of Americans, destined to leave behind the eighteenth-century world of their fathers” (Goodwin 2005: 28).
  • 78. Important things to remember Any exact phrase from the original must be put in quotation marks and the source indicated. Paraphrasing must not be a simple substitution of a few words but must be in your own words. A hint: Read over the original and then without looking at it summarize it in your own words. Any time you use words (quotations) or ideas (paraphrases) from a source, you must provide information about the source.
  • 79. Avoiding plagiarism What Is Plagiarism? Why do we have such a concept? Table Talk Complications
  • 80. Paradoxes, Peculiarities, Complications Unnamed authors (especially in the past; folklore) Impossibility of naming every influence Inconsistency across Time Place (relevant for international students) Discipline Individual Nature of learning as having been influenced Genres, which derive from conventions, not originality “Common knowledge” “Self-plagiarism”: double-counting
  • 82. “Self-plagiarism” Double credit Turning in the same material twice Republishing the same material twice (or more) without acknowledging the previous source
  • 83. Some subtleties Plagiarism is not the same thing as…. copyright infringement academic fraud examination cheating stealing data fabricating data or quotations
  • 84. When in doubt…. Give Credit! http://psuprssa.files.wordpress.com/2012/02/422701_339872559385800_286997421339981_1019238_956035530_n.jpg
  • 85. University of Notre Dame Graduate School Policy John Lubker Associate Dean of Students
  • 86. Graduate School Policy Violation of integrity in research/scholarship Plagiarism; fabrication or falsification in proposing, performing, or reporting research; or other misrepresentation in proposing, conducting, reporting, or reviewing research. Misconduct includes practices that materially and adversely affect the integrity of scholarship and research.
  • 87. Graduate School Policy Plagiarism A person’s words and ideas are his or her own; they belong to the individual and should be considered the individual’s property. Those who appropriate the words and/or ideas of another, and who attempt to present them as their own without proper acknowledgement of the source, whether intentional or not, are committing plagiarism or intellectual theft.
  • 88. Graduate School Policy Plagiarism Any representation of the work of another that is not properly referenced is considered to be plagiarism. Ignorance of what constitutes plagiarism is not a defense to an allegation of a violation of the academic integrity policy. It is the responsibility of students to familiarize themselves with this definition of plagiarism and to learn proper citation techniques.
  • 89. Graduate School Policy Violations of Academic Integrity Handled at dept level Found innocent Found guilty Appeals to the dean of the Grad School
  • 90. What do I do now? Understand your rights and responsibilities http://graduateschool.nd.edu/ Academic Code – “Academic Integrity” Bulletin of Information – “Academic Integrity” Guidance with properly referencing your work Writing Center English for Academic Purposes
  • 91. Creations and Data: rights and responsibilities Patrick J. Flynn Professor of Computer Science and Engineering
  • 92. Setting the stage: questions • If you create (discover, author, compose) something wonderful as a result of research conducted here at ND – “Researcher” versus “owner” – Who owns it? What does “ownership” mean? • If you collect some great data sets as part of your research here at ND, what can be done with the data? – Can you take it to your next job? – Can you give it to other researchers if they ask you? • Why do these questions matter?
  • 93. Creations and matching IP concept • Authorship (copyright) • Composition (copyright, trademark) • Invention (patent, trade secret) • Distinctions later
  • 94. Creator • Policy does not influence your status as a creator • But you still need to be able to prove your role as the “originator” – Keep good records of your work (lab notebook, etc.): process, date stamp, data collection • Disclosure of creation – Any publication is a disclosure (if contemplating patent, you have one year after disclosure to file) • Collaborative creations: assign credit by consensus, if possible
  • 95. Owner • Not necessarily the same as creator • Right to commercialize • University owns inventions created by – faculty (if invented in course of their Univ. duties) – graduate students (in most cases) • Authorship (books, compositions): more complex • Sponsor of research may also have certain rights (negotiated as part of sponsorship agreement) • The OVPR and the Tech Transfer Office should rule on ownership questions – do not rule on this yourself!
  • 96. Research Data: ownership and rights • The University owns the data you collect – Controls whom else, at ND or outside ND, can get it – Controls whether you can continue to use it • Some data has special issues that essentially mandate active central management and/or involvement – Human subjects (IRB approval process) – Animals (IACUC approval process) – Export controls (ITAR review)
  • 97. Take-home points • Be creative! • Understand the university context • Live with the restrictions – they are not burdensome • Understand your obligations • Take advantage of opportunities for innovation if the circumstances are right
  • 98. Intellectual Property Richard Cox Director, Office of Technology Transfer
  • 99. Intellectual Property • What is it? • What should a first year graduate student know about or care about Intellectual Property (IP)?
  • 100. 4 basic types of intellectual property • Patents – Covers things (manufactured articles, compositions of matter) & ways to make things (methods, processes) – 20 year life • Copyrights – Covers expression of ideas (writings, paintings, music, performances) – Life of author + 70 years • Trademarks/service marks – Covers origin of goods & distinguishes from competitors – Unlimited life if maintained • Trade Secrets – Covers information – Unlimited life if secrecy of information is maintained
  • 101. Notre Dame IP policy • ND’s IP policy “governs the protection and administration of intellectual property developed in support of the University’s mission.” • “It is the policy of the University of Notre Dame, subject to the exceptions contained herein, that the University claims the exclusive right to all intellectual property arising from University Research. “ • “University Research” means any research or development activity which is undertaken in connection with an externally funded project, or which is related to duties and responsibilities for which a person is compensated by the University, or which is conducted with substantial use of University facilities, or resources.
  • 102. Notre Dame IP policy (cont.) • “Creators of intellectual property have an obligation to disclose intellectual property in the manner prescribed within this policy, to assign intellectual property rights to the University, and to assist the University in legally protecting the intellectual property. The University and the creator share in any royalty income resulting from the intellectual property as described in this policy.” • Applies “to all faculty, staff, students, and others who make use of University facilities, equipment, or other resources or who receive funds from the University in the form of salary, wages, stipend, or other support, but not including undergraduate student financial aid.”
  • 103. Notre Dame IP policy (cont.) • ND normally waives rights to student-created IP “where the use of University facilities, equipment, or other resources has been properly authorized, except when: – faculty or staff involvement is substantial, – the work is part of a larger University work or specifically commissioned by the University, – the use of facilities, equipment, or other resources is substantially in excess of the norm for educational purposes, or – the intellectual property resulted from the student’s employment with the University.” • http://policy.nd.edu/policy_files/IntellectualPropertyPolicy.pdf
  • 104. University IP checklist • Designed to help determine creator’s reporting obligations • Employment status • Commissioned work or otherwise funded by ND • Use of ND resources • Contribution by other ND personnel • Assistive, not determinative • If in doubt, best to ask Office of Technology Transfer phone: (574) 631-4551 email: ott@nd.edu web: http://ott.nd.edu
  • 105. Copyright Basics Marsha Stevenson Hesburgh Library
  • 106. • Copyright is a form of protection grounded in the U.S. Constitution; Article 1, Section 8 empowers Congress to “Promote the Progress of Science and Useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries”. • Copyright protection is provided for by law (title 17, US Code). It applies to original works of authorship fixed in a tangible medium of expression. Both published and unpublished works are protected. • A form of Intellectual property
  • 107. Works eligible for copyright protection Literary works including translations Musical works with accompanying words Dramatic works with accompanying music Pictorial, graphical, and sculptural works Motion pictures and other audiovisual works Choreographic works Sound and digital recordings Architectural works Software Technical manuals
  • 108. Who can be an author? A writer A musician or artist A photographer A student or professor A company or organization An unknown entity But who controls the rights????
  • 109. What are the exclusive rights given to an author ? To prepare derivative works based upon the work; Only the owner of copyright in a work has the right to prepare, or to authorize someone else to create, a new version of that work. To reproduce the work To distribute copies of the work to the public To perform the work publicly To display the copyrighted work publicly To perform the work publicly by means of a digital audio transmission
  • 110. Works you can use without permission Works you create yourself Work not protected by federal law Works in the Public Domain Works governed by Creative Commons License Works which would be considered Fair Use
  • 111. Works in Favor Works Against Teaching-Research- Scholarship Commercial Activity Nonprofit educational institution Profiting from use Criticism-Comment Entertainment News reporting Bad faith behavior Transformative use Denying credit to original author Restricted access Parody
  • 112. Table Talk • Discuss your reactions to this scenario • Do you know who owns the data? • How would you resolve this conflict?
  • 113. Possible Next Steps • Questions about ownership rights in IP or need to disclose new IP? – contact the Office of Technology Transfer • Phone: (574) 631-4551 • Email: ott@nd.edu • Web: http://ott.nd.edu • Questions about Copyright issues? – contact Linda Sharp • Phone: (574) 631-6818 • Email: sharp.1@nd.edu
  • 114.
  • 115. Lunch and Keynote Speaker
  • 117. Research Misconduct Darren Davis Department of Political Science Office of the Vice President for Research
  • 118. Federal Regulations in University Research Research Misconduct (F-F-P) Human Animal Subjects Welfare Regulations Regulations
  • 119. Federal Laws on Research Misconduct • Public concern over research misconduct initially arose in the early 1980‟s.  William Summerlin (1974)  Vijay Soman & Philip Felig (1978)  John Darsee (1981)  Stephan Breunig (1983) • At the time, research institutions sometimes ignored or covered up potential misconduct problems rather than investigate them. • In December 2000 the Office of Science and Technology Policy adopted a federal policy on research misconduct.
  • 120. • Department of Health and Human Services (DHHS) enacted regulation effective 6/15/05  “Public Health Service Policies on Research Misconduct”  Implements legislative and policy changes applicable to research misconduct that occurred over last several years.  Covers any entity that applies for a research, research-training or research-related grant or cooperative agreement with the Public Health Service (PHS)
  • 121. Purpose of Research Misconduct Policies • Establish definitions for research misconduct • Outline procedures for reporting and investigating misconduct • Provide protection for whistleblowers and persons accused of misconduct
  • 122. Research Misconduct Defined • What is it?: The Department of Health and Human Services defines research misconduct as: Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research results.  Fabrication: making up results and recording or reporting them  Falsification: manipulation of research materials, equipment, or processes, or changing or omitting results such that the research is not accurately represented in the record.  Plagiarism: the appropriation of another’s ideas, processes, results, or words without giving proper credit.
  • 123. Criteria for Research Misconduct • Represents a significant departure from accepted practices • Has been committed intentionally, or knowingly, or recklessly; and • Can be proven by a preponderance of evidence • What is NOT MISCONDUCT: honest, unintentional error
  • 124. Research Misconduct and Integrity • 1. Falsifying or „cooking‟ research data • 2. Ignoring major aspects of human-subject requirements • 3. Not properly disclosing involvement in firms whose products are based on one„s own research • 4. Relationships with students, research subjects or clients that may be interpreted as questionable • 5. Using another‟s ideas without obtaining permission or giving due credit (plagiarism) • 6. Unauthorized use of confidential information in connection with one‟s own research • 7. Failing to present data that contradict one‟s own previous research • 8. Circumventing certain minor aspects of human-subject requirements
  • 125. Misconduct and Integrity (continued) • 9. Overlooking others‟ use of flawed data or questionable interpretation of data • 10. Changing the design, methodology or results of a study in response to pressure from a funding source (falsification) • 11. Publishing the same data or results in two or more publications • 12. Inappropriately assigning authorship credit • 13. Withholding details of methodology or results in papers or proposals • 14. Using inadequate or inappropriate research designs • 15. Dropping observations or data points from analyses based on a gut feeling that they were inaccurate • 16. Inadequate record keeping related to research projects
  • 126. Why does research misconduct happen? • Publish or Perish Pressure • Desire to “get ahead” • Personal problems • Character issues • Cultural Differences
  • 127. Consequences (if misconduct is substantiated) • Withdrawal or correction of all pending and published papers and abstracts affected by the misconduct • Reprimand, removal from project, rank and salary reduction, dismissal • Restitution of funds to the granting agency • Ineligibility to apply for Federal grants for years • I.E. the end of your research career!
  • 128. Mentor Responsibilities • Mentors have the responsibility to ensure that all trainees (post-docs, grad students, undergrads) are aware of the responsible conduct of research  Define the Relationship - Role of Trainee - Publication/Authorship - Serving as PI or Co-PI • Obligation to report  Good faith report
  • 129. Research on Research Misconduct Admission rates of data fabrication, falsification and alteration in non-self reports. Fanelli D (2009) How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta-Analysis of Survey Data. PLoS ONE 4(5): e5738. doi:10.1371/journal.pone.0005738 http://www.plosone.org/article/info:doi/10.1371/journal.pone.000 5738
  • 130. What can someone concerned about potential Research Misconduct do? • Talk to someone else (confidentiality will be protected)  Vice President for Research  Responsible Academic Officer -The Chair, Dean or Director of the Department, School, Institute or Center where the Respondent is a member  Director of Research Compliance  Office of General Counsel • Try to resolve the concern informally • If informal resolution fails, an Inquiry and Investigation may follow
  • 131. “The Lab” http://ori.hhs.gov/thelab Please check your nametag for your room assignment. BR stays in Ballroom NDR moves to the Notre Dame Room
  • 132. “The Lab” Key Learning Points • As a scientist, review any article on which you‟re listed as a co-author • If you suspect research misconduct, seek advice from those you respect and talk to the research integrity officer • Don‟t confront someone you suspect of falsifying data; your action could tip off the person and hinder any further investigation • Report any instances of retaliation to the research integrity officer • Bob Bernhard, Vice President for Research
  • 133. Publication and Peer Review Prashant Kamat (Radiation Lab) Eric Lease Morgan (Hesburgh Libraries) Joan Brennecke (Chemical and Biomolecular Engineering)
  • 134. Scientific Knowledge Scientific Knowledge The object of research is to extend human knowledge beyond what is already known. But an individual’s knowledge enters the domain of science only after it is presented to others in such a fashion that they can independently judge its validity (NAP, “On Being a Scientist” 1995)
  • 135. Sharing Scientific Knowledge Sharing Scientific Knowledge “Science is a shared knowledge based on a common understanding of some aspect of the physical or social world” (NAP, “On Being a Scientist” 1995) Presentations - Social conventions play an important role in establishing the reliability of scientific knowledge Publications in peer reviewed journals - Research results are privileged until they are published Thesis
  • 136. Why Publish? Why Publish? • “A paper is an organized description of hypotheses, data and conclusions, intended to instruct the reader. If your research does not generate papers, it might just as well not have been done” (G. Whitesides, Adv. Mater., 2004, 16, 1375) • “if it wasn’t published, it wasn’t done” - in E.H. Miller 1993
  • 137. Scientific Publication is a Team Effort Journal Authors Reviewer ACS Journals:http://pubs.acs.org/about.html
  • 138. Authorship Authorship Great Manuscript! • The list of authors establishes accountability as But LAB CHIEF well as credit. always gets listed as FIRST author! • Policies at most scientific journals state that a person should be listed as the author of a paper only if that person made a direct and substantial intellectual contribution to the design of the research, the interpretation of the data, or the drafting of the paper. • The acknowledgments section can be used to thank those who indirectly contributed to the work. Including “honorary,” “guest,” or “gift” authors dilutes the credit due the people who actually did the work, inflates the credentials of the added authors, and Responsible authorship? makes the proper attribution of credit more difficult. (“On Being a Scientist” , NAP) (From ORI http://ori.dhhs.gov/educ ation/products/RCR intro/c02/0c2.html )
  • 139. Author Responsibilities Author Responsibilities – Preparation and Submission of Manuscripts: Follow General Rules: – Ensure work is new and original research – All Authors are aware of submission and agree with content and support submission – Agree that the manuscript can be examined by anonymous reviewers. – Provide copies of related work submitted or published elsewhere – Obtain copyright permission if figures/tables need to be reproduced – Include proper affiliation
  • 140. What is publishable . What is publishable? Journals like to publish papers that are going to be widely read and useful to the readers • Papers that report “original and significant” findings that are likely to be of interest to a broad spectrum of its readers • Papers that are well organized and well written, with clear statements regarding how the findings relate to and advance the understanding/development of the subject • Papers that are concise and yet complete in their presentation of the findings
  • 141. What is not acceptable What is not acceptable • Papers that are routine extensions of previous reports and that do not appreciably advance fundamental understanding or knowledge in the area • Incremental / fragmentary reports of research results • Verbose, poorly organized, papers cluttered with unnecessary or poor quality illustrations • Violations of ethical guidelines, including plagiarism of any type or degree (of others or of oneself) and questionable research practices (QRP)
  • 142. Table Talk • What key points to check before submitting your manuscript for publication? • What criterion one needs to follow to reproduce a figure or table from the published paper? • Discuss the importance of adding institute affiliation and acknowledgment section in the manuscript.
  • 143. Where to Publish • It goes almost without saying, you will want to publish in peer-reviewed journals, but within that category, you may want to distinguish between: – Top tier vs. lower tier – Society vs. general audience journals – Theoretical vs. empirical journals
  • 144. Open Access Journals • “Open access journals” are serial publications whose content is free – at no financial cost – for the reader to read. • Issues surrounding copyrights, dissemination, and content re-use are advantages of open access publications. • Shifting costs, reputation, and the digital-only nature of open access can be disadvantages.
  • 145. Definitions: Plagiarismto worry about Issues and Self-Plagiarism • Plagiarism: using the ideas or words of another person without giving appropriate credit (Nat. Acad. Press document) • Self-Plagiarism: The verbatim copying or reuse of one’s own research (IEEE Policy statement) Both types of plagiarism are considered to be unacceptable practice in scientific literature
  • 146. ACS Publication Policy Plagiarism statement for Ethical Guidelines January 2009 B. 9. It is the responsibility of the author to ensure that the submitted manuscript is original and shall not contain plagiarized material. Plagiarism is passing off another person’s work as one’s own, i.e., reusing text, results, or creative expression without explicitly acknowledging or referencing the original author or publication. Authors should be aware this includes self-plagiarism, defined as the reuse of significant portions of the author’s own published work or works, without attribution to the original source. Examples of plagiarism include verbatim copying of published articles; verbatim copying of elements of published articles (e.g., figures, illustrations, tables); verbatim copying of elements of published articles with crediting, but not clearly differentiating original work from previously published work; and self-plagiarism. It is the responsibility of the author to obtain proper permission and to appropriately cite or quote the material not original to the author. In this context, “quote” is defined as reusing other works with proper acknowledgement. Appropriate citation applies whether the material was written by another author or the author him or herself.
  • 147. What is Self-Plagiarism? • How you describe your research is also part of the creative process • Your WORDS matter, not just your results • Even things that may seem mundane to you (e.g., experimental description) need to be original • Verbatim sentences need to be put in quotations marks
  • 148. Tools to Catch Self-Plagiarism • Show Ithenticate Example
  • 149. Other Types of Ethical Violations Other things to worry about • Duplicate publication/submission of research findings; failure to inform the editor of related papers that the author has under consideration or “in press” • Unrevealed conflicts of interest that could affect the interpretation of the findings • Misrepresentation of research findings - use of selective or fraudulent data to support a hypothesis or claim
  • 150. Table Talk • Is it OK to post a copy of a presentation on your website that includes figures from one of your published papers? • What should you do if you read a research paper that presents results as new and you realize that you have seen the same results by those authors in another paper?
  • 151. What do I do now? - Publish original and significant findings - Choose appropriate journal for the material - Take care to avoid all forms of self-plagiarism
  • 152. Resources • ACS Ethical Guidelines to Publication of Chemical Research – http://pubs.acs.org/userimages/ContentEditor/1218054468605/ethics.pdf • Journal Citation Reports – http://eresources.library.nd.edu/databases/jcr • Thorough introduction to open access publishing - http://bit.ly/oa- overview • Whitesides, G. M. Whitesides' group: Writing a paper. Adv. Mater. 2004, 16, 1375-1377. • ON BEING A SCIENTIST, RESPONSIBLE CONDUCT IN RESEARCH, NATIONAL ACADEMY PRESS, 1995 (http://www.nap.edu/openbook.php?record_id=4917&page=R1 ) Kamat, P. V.; Schatz, G. C. Getting your Submission Right and Avoiding Rejection. J. Phys. Chem. Lett. 2012, 3, 3088-3089. • Publishing your research 101 Video clips http://pubs.acs.org/page/publish-research/index.html
  • 153. BREAK We will resume at 3:45 Animal research session is in the Ballroom Human Subjects session is in the Notre Dame Room
  • 154. Animal Research and Laboratory Safety Mark Suckow Assistant Vice President for Research Director, Freimann Animal Care Facility
  • 155. Numbers in Perspective 10000 9,031 9000 Millions of animals killed 8000 7000 6000 5000 4000 3000 2000 1000 365 1 26 150 27 38 105 0 Research exc. Mice, rats and birds rats and birds Research inc. Mice, Hunting Killed by Automobiles Ducks for food sheep, calves for Pigs for food Chickens for food cattle, food
  • 156. René Descartes Animals are just machines and thus incapable of thinking Philosopher & Mathematician (1596-1650)
  • 157. Jeremy Bentham “But a full-grown horse or dog is beyond comparison a more rational, as well as a more conversable animal, than an infant of a day, or a week, or even a month, old. But suppose the case were otherwise, what would it avail? The question is not, can they reason? Nor, can they talk, but can they Founder of Modern Utilitarianism suffer?” 1748-1832 Utilitarianism: If the good outcome exceeds the cost, then an act is acceptable
  • 158. The Importance of Animals in Biomedical Research Most of our children have not even heard of, much less know anything about, many of the diseases our ancestors experienced first-hand. Why? They have either been eradicated or can be controlled due to findings from research using animals.
  • 159. A Brief History • FDR 1935, Social Security Act: $2 million/year for disease research • Surging economy post WW II • Taxpayer funding for health-related research • Explosive increase in biomedical research
  • 160. Post WWII lab animal care • Housing - homes, basements, barns... • Food - leftover table scraps • Caging - wooden, wire • Bedding - dirty, vermin • Ventilation/temperature - no control • Care - variable
  • 161. Problems • Animal health concerns • Surgery and procedure sites • Inability to repeat research results
  • 162. Imperatives for Animal Use Nuremberg Code 1949 • Any experiment on humans “should be designed and based on the results of animal experimentation” The Declaration of Helsinki 1964 • Medical research on human subjects “should be based on adequately performed laboratory and animal experimentation”
  • 163. Animal Care Panel 1950 • Veterinarians • In 1967, name changed to: American Association for Laboratory Animal Science (AALAS)
  • 164. Guide for the Care and Use of Laboratory Animals • 1963 first Guide by Animal Care Panel • Revisions: „65, „68, „72, „78, „85, ‟96, and 2011
  • 165. Guide for the Care and Use of Laboratory Animals • Basis for PHS evaluation of animal care and use program. Failure to follow the Guide can result in loss of funding to the institution • Also used by accrediting agency (AAALAC). • Government publication
  • 166. The Guide for the Care and Use of Laboratory Animals • Outlines and provides references for: – Veterinary care – Euthanasia – Housing and environment – Personnel qualifications – Sanitation – Surgical and post-operative care – Facility construction
  • 167. The Animal Welfare Act (AWA) • Passed in 1966 • “Pepper” the stolen Dalmation, Sports Illustrated • Life Magazine feature
  • 168.
  • 169.
  • 170. Laboratory Animal Welfare Act • Passed in 1965; 1966 - Public Law 89-544 • Unannounced USDA Inspections at least annually • failure to follow the law can result in fines or jail • Principal purposes: – Regulate research use of dogs, cats, rabbits, hamsters, guinea pigs, and nonhuman primates – Establish standards for housing, transportation, and “adequate veterinary care” provided by or under direction of a veterinarian
  • 171. Institutional Animal Care and Use Committee (IACUC) • Mandated by USDA, PHS, NSF, accrediting and funding agencies • Designates “Institutional Official (Dr. Robert Bernhard) • Charged with reviewing and oversight of animal care and use
  • 172. The IACUC Assures • Animals are used only when justified; minimum number used; alternative replacements have been ruled out. • If procedures that might potentially cause pain are to be used, adequate pain-relieving medicine is used. • That personnel working with animals are properly trained and protected. • Veterinary care is provided • Animals are housed safely in clean conditions, with fresh food and water.
  • 173. Who serves on the IACUC? • PHS: at least five members – Chair (Dr. Jeff Scorey) – Veterinarian (Dr. Mark Suckow) – Scientist (multiple members) – Non-scientist (Valerie Schroeder) – Community member (Dr. Prentiss Jones)
  • 174. What does the IACUC do? • Review animal care and use protocols • Ensure training of personnel • Review occupational health related to animal exposure • Inspect animal housing and use areas • Meets monthly
  • 175. First Step: The IACUC Protocol • Before any research or teaching using vertebrates or tissues from vertebrates, including field research. • Form available at Office of Research website (http://or.nd.edu/forms/forms- list/) • Contact Tracey Poston, Director of Research Compliance (1-1461)
  • 176. IACUC Protocol • Species, type of animal • Number to be used (with justification) • Lay description of project and goals • Description of animal use procedures and how they connect
  • 177. IACUC Protocol  Alternatives ◦ The Principles of Humane Experimental Technique - 1959 ◦ Replacement ◦ Reduction ◦ Refinement  Assurance that project does not unnecessarily duplicate previous work.
  • 178. IACUC Protocol – Some Specifics • Justify any exceptions to standards – -housing, bedding, light, etc. – -use of non-pharmaceutical grade drugs • Describe likely phenotypes or clinical outcomes • State specific endpoints • Describe methods to eliminate or minimize any pain or distress
  • 179. Additional Specifics • Describe any hazards and steps to mitigate risk – Biohazards – Chemical – Radioisotopes • Carefully describe who performs procedures and qualifications
  • 180. AVMA Guidelines on Euthanasia • Basis for most IACUC determinations of humane or acceptable euthanasia • Justification required if method is not recommended • Most recent edition published in June 2007
  • 181. IACUC Protocol Review • Does the research address an important question? • Does the research require the use of animals? • Is the research necessary, in that it does not needlessly repeat previous work? • Is the experience of each animal in the study adequately described and justified?
  • 182. IACUC Protocol Review • Reviewed by entire committee • Approve; approve with modifications; withhold approval • Decisions cannot be overruled • Typically 1 -2 months for approval
  • 183. Protocol Amendments • Any change to protocol: personnel, species, number, procedur es/methods, etc. • Form available at Office of Research website (http://or.nd.edu/forms/forms-list/)
  • 184. Training • Required and key to success! • Basic on-line training for all – Valerie Schroeder, RVT (1-6087) • Specialized on-line training • Hand-on training
  • 185. Occupational Health for Animal Users • Anyone handling animals or entering facility • Risk-based assessment • Allergy • Vaccinations • Contact Jenna Leevy at RMS (1-5037)
  • 186. Where do you fit in? • Do not begin any studies before protocol approval • Training and occupational health • Report any animal-related concerns to IACUC • Handle animals with care and compassion
  • 187. Where is Animal Research Done at Notre Dame • Freimann Life Science Center – -Dr. Mark Suckow, DVM, Director (1-6085) – -Main site on campus; administrative center – -35,000 sf • Raclin-Carmichael Hall • Some laboratories • UNDERC (mostly field studies) • Other field sites
  • 188. Freimann Life Science Center • All animals ordered through FLSC (contact: Kay Stewart, 1-6085). • Highly skilled technical staff • Access is controlled • Several procedure rooms, but clean up your mess!
  • 189. Why Should We Do Any of This? • USDA Regs are part of Public Law • Freedom of Information Act 1966 • If taxpayer $$ are used, public can access information • USDA inspection reports on the web (off and now on again…) • Negative Outcomes – -Loss of funding – -Loss of ability to do animal research – -Public perception of Notre Dame • It‟s in the interest of the animals!
  • 190. General Rules for Working with Animals • The use of any animal or animal tissue is a privilege, not a right. • Animals feel pain and distress just as humans do. • Experiment should be done with the lease possible infliction of pain, suffering, and distress. • The Principal Investigator is required to determine that there is not an alternative technique to animal use. • ANY experiment involving animals or animal tissues must be approved by the IACUC.
  • 191. Laboratory Safety • YOU are responsible for your safety • Integrated Laboratory Safety Plan • Follow all rules, take all precautions – no short cuts! • Questions/Concerns: call RMS at 1-5037
  • 192. It all comes down to personal integrity!
  • 194. Research on Human Subjects Darcia Narvaez Chair, Institutional Review Board Department of Psychology
  • 195. Evolution of Institutional Review Boards (IRBs)  1974 National Research Act, established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Charged with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.  The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research prepared the Belmont Report in 1979. The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations.  In 1981, the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) issued regulations based on the Belmont Report. DHHS issued Code of Federal Regulations (CFR) Title 45 (public welfare), Part 46 (protection of human subjects). The FDA issued CFR Title 21 (food and drugs), Parts 50 (protection of human subjects) and 56 (Institutional Review Boards).
  • 196. The Common Rule The “Common Rule” is the set of regulations which were developed to ensure compliance with the principles of the Belmont Report. The regulations fall under the Department of Health and Human Services. These regulations have been adopted by many other federal departments which regulate human research. There are many other regulations with which the University of Notre Dame are required to comply, such as the Food and Drug Administration, but these are all in addition to the “Common Rule”.
  • 197. Basic Principles of the Belmont Report 1. Respect for Persons 2. Beneficence 3. Justice
  • 198. Respect for Persons • Treat individuals as autonomous agents • Do not use people as a means to an end • Allow people to choose for themselves • Provide extra protections to those with diminished autonomy (i.e., Prisoners, Children, Cognitively Impaired, etc.)
  • 199. Beneficence • The two general rules formulated from the principle of beneficence are:  First, do no harm  Second, maximize possible benefits and minimize risks
  • 200. Justice • Treat people fairly • Fair sharing of burdens and benefits of the research  An injustice occurs when: 1. benefits to which a person is entitled are denied without good reason, or 2. when burdens are imposed unduly.
  • 201. What Is Research? 45 CFR 46.102(d) • Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
  • 202. What Are Human Subjects? 45 CFR 46.102(f) • Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains – Data through intervention or interaction with the individual, or – Identifiable private information.
  • 203. IRB Review of Research • All research projects are categorized into one of three categories for the IRB review process. Each category is different in the level of scrutiny and submission procedures. The IRB is responsible for making the final decision of which category a research project falls under.  Full  Expedited  Exempt  Research Not Involving Human Subjects
  • 204. The IRB has the authority to: • Approve • Require modifications prior to approval • Table • Disapprove all research activities including proposed changes in previously approved human subject research.
  • 205. The policy of the University of Notre Dame, and most other colleges and universities in the U.S., mandates that all human subject research be reviewed and approved, regardless of funding. Structure of University of Notre Dame’s IRB Federal guidelines partially define IRB membership:  Community representative unaffiliated with the university  Non-scientist  Diverse Membership (9 appointed members)  Professional  Volunteer  Methodological diversity (quantitative and qualitative)  Disciplinary diversity  Centers and Institutes represented (Kroc, ACE, ISLA, CSR)
  • 206. Human subject research at Notre Dame: • Surveys and interviews (international, national, local, and elite) • Community based research • Laboratory experiments • Ethnographic research • DNA Research • Internet based research – forums and chat rooms
  • 207. Challenges faced by Notre Dame’s IRB: • Student Research (Undergraduate and Graduate)  Lack of familiarity with issues in human subject research  Training in methodology and research ethics  Personal security  Data security • International Research  Vulnerable populations  High risk areas  Ethical issues  Student involvement  Research may begin before approval of research • Biased perceptions of the IRB • Lack of knowledge of human subject research and IRB processes • Non-Social Science researchers venturing into human subject research

Editor's Notes

  1. Chris and Bob – here are the points we want you to make:Emphasis on the importance of RCR/Ethics across disciplinesFocus on practical ethics and rcr components Situations that you will likely encounter in your graduate career We want you to be able to recognize these Provide you with resources to help if/when they happen to youPromote lunch time speakerEncourage full participation throughout the dayMorning through lunch – all studentsAll day – all students potentially on funded research
  2. As an undergraduate – primary issue involves plagiarism of external sourcesGraduate work– introduces the issue of inappropriate use of peer work
  3. 5-7 minutes for discussion; Introduce these discussion points then display next slide with framework
  4. 5-7 minutes – ask for volunteers
  5. Awareness & Analysis: Traditional focus of most ethics classes (corporate or academic); necessary precursorsAction: GVV begins with: “What if you were going to act on your values? What would you do and say?”and then focuses on the tools for doing so; critical next stepNote my article on GVV as resource for leadership and effectiveness development for emerging professionalsResearch tells us we are more likely to make ethical decisions if we anticipate them, practice them, voice them in front if peers; those who successfully displayed moral courage have the experience in common of having voiced values in front of peers and explicitly considered decision-making prior when stakes weren't as high;It’s about anticipating common reasons and rationalizations for unethical behavior, developing strategies for confronting them, practicing these strategies with dilemmas relevant to our professional activities (“scripting”) and engaging in peer discussions (“peer coaching”). Ethical fading = allowing the ethical dimensions of a situation to fade to the background – “rationalizations” – for perceived “practical” considerations (financial, immediate, etc.)There has been a series of articles circulating in the business/psychology domains accusing authors of manipulating results etc. It is a big deal, with thoughts it may lead to revocation of tenure.In terms of Blind Spots, the main idea is we are all vulnerable to making unethical choices. We need to recognize, look where ethical fading may occur, look at reward systems for institutions and decide whether it fits with ours and look at situations where we allow motivated blindness to occur (where we are motivated not to see the unethical behavior of others and hence don't give voice to values).
  6. Consistent with Aristotelian ethics of virtue and character
  7. Student is “caught up” in dual relationship with faculty mentor– as mentor and as bossWork for company vs. work to complete degree (time and effort)Intellectual property – data and ownershipSupervised and evaluated by same person in two different rolesPaid for only one activity, with future job offer as incentive
  8. The researcher’s *intent* is key to whether or not a particular project falls within this definition of research.