2012 Ethics Workshop Presentation

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 MaziarActing Dean of the Graduate SchoolVice President & Senior Associate ProvostProfessor of Electrical Engineering

Bob BernhardVice President for ResearchProfessor of Aerospace & Mechanical

Engineering

Recognizing and Approaching Ethical Problems

Jessica McManus WarnellMendoza 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 Idea1) 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”

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

Possible next steps

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 MentoringExpectations 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?

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

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.

Possible next steps

ResourcesGreat 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

We will resume at 10:25

Conflict of Interest and Conflict of Commitment

Liz Rulli, Office of ResearchJeff 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 InterestFederal 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 PolicyA 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

Table Reports

Conflict of Commitment Reactions

Table Talk

Discuss any conflicts of commitment that you identify

from the scenario

Table Reports

Conflict of Commitment Reactions

Graduate Students Need to Know

1. Funding agency focus on ensuring objectivity in research

2. Disclosure and management is key3. Protections in place for students and

processes in place for oversight4. 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

AvoidingPlagiarism

Susan D. BlumDepartment of Anthropology

John LubkerThe Graduate School

The University of Notre Dame

Avoiding plagiarismWhat 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

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 inOmitting quotation marks from properly used quoted materialOmitting 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

SentencesParagraphs

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.

Table Talk

Complications

Economic

Legal / Professional / Ethical

Pedagogical / Educational

Economic: CopyrightMaking a living from writingProfessional 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 ideasPeople are creative and have important original contributions to make

http://www.sllib.org/Pages/Digital%20Library/Shakespeare.jpghttp://www.livius.org/a/1/greeks/homer.JPG

http://famouspoetsandpoems.com/pictures/william_wordsworth.jpg

“Legal” / professional / ethical within

an academic framework:

Academic “guild”

FootnotesIndicate sources, evidence, due diligencePermit others to trace influence

Students as apprenticeshttp://cdn-write.demandstudios.com/upload//1000/100/90/1/61191.jpg

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

http://www.bendlearningcenter.com/art/college_students.jpg

Table Talk

Complications

Table Talk 1a

Do you need to acknowledge…..

information you copy directly from a book?

Table Talk 1b

information you quote from an online article?

Table Talk 1c

information you summarize from a popular

magazine?

Table Talk 1d

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 men of an impatient generation of Americans, fated to escape the eighteenth-century world of their forebears.

Table Talk 2b[original text]

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]

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]

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]

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?

Table Talk

Complications

Paradoxes, Peculiarities, Complications

Unnamed authors (especially in the past; folklore)

Impossibility of naming every influence

Inconsistency acrossTime

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 creditTurning 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 LubkerAssociate 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.

PlagiarismA 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.

PlagiarismAny 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.

Violations of Academic IntegrityHandled 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 workWriting CenterEnglish for Academic Purposes

Creations and Data: rights and responsibilities

Patrick J. FlynnProfessor 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 CoxDirector, 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 Transferphone: (574) 631-4551email: ott@nd.edu web: http://ott.nd.edu

Copyright Basics

Marsha StevensonHesburgh 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 wordsDramatic works with accompanying musicPictorial, graphical, and sculptural worksMotion pictures and other audiovisual worksChoreographic worksSound and digital recordingsArchitectural worksSoftware Technical manuals

Who can be an author?

A writerA musician or artistA photographerA student or professorA company or organizationAn 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 ActivityNonprofit educational institution Profiting from useCriticism-Comment EntertainmentNews reporting Bad faith behaviorTransformative use Denying credit to original authorRestricted accessParody

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

Research Misconduct

(F-F-P)

AnimalWelfare

Regulations

Human Subjects

Regulations

Federal Regulations in University Research

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.0005738http://www.plosone.org/article/info:doi/10.1371/journal.pone.0005738

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

Sharing Scientific Knowledge

Why Publish?

Authorship

Author Responsibilities

What is publishable?

What is not acceptable

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.

Issues to worry about

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 things to worry about

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

We will resume at 3:45Animal 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

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Numbers in Perspective

René Descartes

Animals are just machines and thus incapable of thinking

Philosopher & Mathematician(1596-1650)

Jeremy Bentham“But a full-grown horse

ordog is beyond

comparison amore rational, as well as

amore conversable

animal,than an infant of a day,

or aweek, or even a month,

old.But suppose the case

wereotherwise, what would itavail? The question is

not,can they reason? Nor,

canthey talk, but can they

suffer?”

Founder of Modern Utilitarianism1748-1832

Utilitarianism: If the good outcome exceeds the cost,then an act is acceptable

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.

The Importance ofAnimals in Biomedical Research

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 Panel1950

• 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

• 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

Institutional Animal Care and Use Committee (IACUC)

• 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.

The IACUC Assures

• 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)

Who serves on the IACUC?

• 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

What does the IACUC do?

• 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)

First Step: The 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

• 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

IACUC Protocol – Some Specifics

• Describe any hazards and steps to mitigate risk– Biohazards– Chemical– Radioisotopes

• Carefully describe who performs procedures and qualifications

Additional Specifics

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?

• Reviewed by entire committee

• Approve; approve with modifications; withhold approval

• Decisions cannot be overruled

• Typically 1 -2 months for approval

IACUC Protocol Review

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

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

Protocol Amendments

• Required and key to success!

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

• Specialized on-line training

• Hand-on training

Training

• Anyone handling animals or entering facility

• Risk-based assessment

• Allergy

• Vaccinations

• Contact Jenna Leevy at RMS (1-5037)

Occupational Health for Animal Users

• 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 do you fit in?

• 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

Where is Animal Research Done at Notre Dame

• 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!

Freimann Life Science Center

• 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!

Why Should We Do Any of This?

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.

• 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

Laboratory Safety

It all comes down to personal integrity!

Questions?

Research on Human Subjects

Darcia NarvaezChair, 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” 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”.

The Common Rule

1. Respect for Persons

2. Beneficence

3. Justice

Basic Principles of the Belmont Report

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.

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:

• Laboratory experiments

• Community based research

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

• Ethnographic research

• DNA Research

• Internet based research – forums and chat rooms

Challenges faced by Notre Dame’s IRB:

• Biased perceptions of the IRB

• Non-Social Science researchers venturing into human subject research

• International Research Vulnerable populations High risk areas Ethical issues Student involvement Research may begin before approval of research

• Student Research (Undergraduate and Graduate) Lack of familiarity with issues in human subject research Training in methodology and research ethics Personal security Data security

• Lack of knowledge of human subject research and IRB processes

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