How many regulations impact the
conduct of research?
Why do we care about conducting
ethical research?

First and foremost, it is the right thing to do!

As an institution of higher learning, we strive
daily to nurture and strengthen our
relationship with the community. A headline
or news item on TV or radio can shatter that
trust in a matter of seconds

As funded researchers, we must be
accountable stewards of those funds and
conduct ourselves in an integrity driven
manner

Institution Driven
◦ Position
◦ Role
◦ Employment Location

Facility Driven
◦ Hospitals
◦ Center for Predictive Medicine
◦ Private Practice

Activity Driven
◦ Animals
◦ Humans
◦ Chemicals / Hazardous Materials / Equipment

Data Driven
◦ Protected Health Information
◦ Confidential / Sensitive Data

Sponsor Driven
◦ Training
◦ Reporting
◦ Purchasing / Spending
Human
Subjects
Research
Misconduct
Social
Responsibility
in Science
HIPAA
Responsible
Conduct of
Research
Animal
Subjects
Biological and
Environmental
Safety
Professional
Standards
Fiscal
Responsibility
Conflicts of
Interest
Human
Subjects
Research
Misconduct
Social
Responsibility
in Science
HIPAA
Responsible
Conduct of
Research
Animal
Subjects
Biological and
Environmental
Safety
Professional
Standards
Fiscal
Responsibility
Conflicts of
Interest
Conflict of Interest is not
a “four letter word”…
but even in the best of
times it can be confusing
to navigate

Why do we care????
◦ It helps to assure the public that the research
community is acting in conformity with the spirit
and guidelines of the University of Louisville
Policy and with the public good in mind
◦ Newspaper Headlines
◦ Governmental Agency Reports
◦ Scientific Journals
◦ Funding Agencies

University of Louisville supports technology
transfer
 to patent and license,
 to participate in the establishment of industry
partnerships,
 to accept company-sponsored research funding,
and
 to consult.

Federal government has mandated that
universities seek to commercialize the
results of federally supported research for
the public good

Conflict of Financial Interest
◦ A researcher has a responsibility to respect the well being of the
University

Conflict of Research Integrity
◦ Researchers should maintain the highest level of scientific integrity in
the conduct of research. The complete, objective, and timely
distribution of new findings through publications and presentations,
is essential for research integrity.

Conflict of Educational Mission
◦ Students and post-doctoral fellows must be assured of an
educationally appropriate training program

Conflict of Commitment
◦ The workforce owes its primary commitment and allegiance to the
University







The University has established policies that define potential conflicts
and provide guidelines and procedures for limiting and managing
them.
Annual disclosure requirement remains in effect
Thresholds for disclosure have been lowered
Training is required
External Interests must be reviewed across the aggregate relationship
Relationships with non-profits are no longer exempt from disclosure
Directly sponsored or directly reimbursed travel must be disclosed
Human
Subjects
Research
Misconduct
Social
Responsibility
in Science
HIPAA
Responsible
Conduct of
Research
Animal
Subjects
Biological and
Environmental
Safety
Professional
Standards
Fiscal
Responsibility
Conflicts of
Interest

Financial Stewardship

Institutional and Sponsor Requirements

Training required
Human
Subjects
Research
Misconduct
Social
Responsibility
in Science
HIPAA
Responsible
Conduct of
Research
Animal
Subjects
Biological and
Environmental
Safety
Professional
Standards
Fiscal
Responsibility
Conflicts of
Interest

Authorship and Publication

Collaboration

Data Management and Stewardship

Mentor / Mentee Relationships

Peer Review


Original work in which the author has made a new
and significant intellectual contribution to others
Be Careful!
◦ Taking Credit=Responsibility for Accuracy

Avoid Dilution
◦ Only include those who significantly contributed
◦ Laboratory, financial or technical assistance (i.e.) may be
acknowledged with consent

Author Order
◦ Responsibility of Principals and determined early!
◦ Become familiar with order of authorship in your discipline

Nativio, D.G. (Sep2000 ) Authorship. Journal of the American Academy of Nurse Practitioners. (V12, I 9, p351). Retrieved August 3, 2009 from
http://web.ebscohost.com/ehost/pdf?vid=6&hid=9&sid=80c85c3f-550d-4411-af19-666faaec0dd1%40sessionmgr11

All authors should review final before submission

Be prepared to produce original data


Be prepared to produce breakdown of
contributions
Nativio, D.G. (Sep2000 ) Authorship. Journal of the American Academy of Nurse Practitioners. (V12, I 9, p351). Retrieved August 3, 2009 from
http://web.ebscohost.com/ehost/pdf?vid=6&hid=9&sid=80c85c3f-550d-4411-af19-666faaec0dd1%40sessionmgr11



Basis of collaborative arrangement is
“contractual”
Look ahead, plan ahead, anticipate
Be direct and honest about possible
problems, misunderstandings

In shared research all must adhere to ethical
standards.

Confidentiality when promised or
appropriate should be maintained.

Design and conduct research with honesty
and integrity.

Original data must be recorded, preserved,
made accessible to University.

What the Mentor can do!
◦
◦
◦
◦
◦
◦
Serve as a Positive Role Model
Be Available
Continually Evaluate Progress and Performance
Serve as Career Coach
Engage Beyond Current Projects
Encourage Relationships
◦
University of Louisville Graduate School Graduate Council. (1998-1999) Mentor and Graduate Student Strategies for Success.
Retrieved August 3, 2009 from https://graduate.louisville.edu/pubs/mentor-and-graduate-student-strategies-for-success.html

What the Mentee can do!
◦ Keep in Touch
 Problems
◦ Contribute Knowledge
 Good mentors know mentees will surpass them
◦ Seek Advice from Others
 From best prepared
◦ Change the relationship if necessary
 Not all are successful
◦
University of Louisville Graduate School Graduate Council. (1998-1999) Mentor and Graduate Student Strategies for Success.
Retrieved August 3, 2009 from https://graduate.louisville.edu/pubs/mentor-and-graduate-student-strategies-for-success.html

Reviewers shall provide reviews that are thorough

Reviewers shall provide reviews that are unbiased

Reviews should be done in a timely fashion

Expert reviews and the materials being evaluated
shall remain confidential
Human
Subjects
Research
Misconduct
Social
Responsibility
in Science
HIPAA
Responsible
Conduct of
Research
Animal
Subjects
Biological and
Environmental
Safety
Professional
Standards
Fiscal
Responsibility
Conflicts of
Interest
Why do we care about conducting socially
responsible (ethical) research?

Ethical questions arise because of social
responsibilities to others in the community and
because behavior is capable of influencing the
welfare of others





Research with Vulnerable Populations
International Research
Research on Controversial Issues
Dual Use Technologies
Genetic manipulation of plants,
organisms, people

Valid research design

Competent research personnel


Consequences / Impacts have been identified
and addressed as needed
Design, Performance and reporting of the
research is free from bias
Human
Subjects
Research
Misconduct
Social
Responsibility
in Science
HIPAA
Responsible
Conduct of
Research
Animal
Subjects
Biological and
Environmental
Safety
Professional
Standards
Fiscal
Responsibility
Conflicts of
Interest

Research Misconduct means fabrication,
falsification, or plagiarism in proposing,
performing or reviewing research, or in
reporting research results

Making up data or results and recording or
reporting them
It would have taken me
forever to actually
perform all of those
tests.

Altering raw data for reporting purposes
22% 98%
12% 100%
Sample size: 16
Sample size: 900

Reporting others’ data,
ideas, processes, results,
or words without giving
credit by acknowledging
the source

Allegations of Research Misconduct
◦ Consult with Research Integrity Ombudsperson




Barbara Speck (Nursing)
Richard Stremel (Physiology)
Eleanor Lederer (Renal Medicine)
Douglas Darling (Dentistry)
◦ Consult with Research Integrity
 Allison Ratterman – 852-2453

While not meeting the federal definition of research misconduct, the
following behaviors are examples of unethical research practices:
◦ Forging a practitioner's signature on medical orders;
◦ Breaching human subject confidentiality;
◦ Failing to obtain IRB and/or FDA approval for changes implemented in an
approved protocol.
◦ Serious deviation from accepted practices in proposing or carrying out
research, improper manipulation of experiments to obtain biased results,
deceptive statistical or analytical manipulations, or improper reporting of
results.
◦ Improper use of information gained by privileged access, such as
information obtained through service on peer review panels and editorial
boards.
◦ Deliberately sabotaging or physically damaging the laboratory research set
up, equipment, or records.

Allegations of Research Misconduct Process
◦ Allegation Referral Form
 Dr. Ratterman will work with you to complete
the form
◦ Research Integrity Ombudsperson performs
Preliminary Assessment
◦ Depending on outcome of assessment, inquiry may
be opened

Allegations of Research Misconduct Process
◦ Inquiry determines whether alleged actions meet
regulatory criteria of research misconduct or
unacceptable research practices
 If yes, investigation opened
 If no, recommendation made for resolution of any identified
issues
◦ Investigation determines if misconduct occurred, by
whom and to what extent
◦ Deciding Official determines institutional action
required



Plan, then act
When in doubt, ask
Make use of available
resources both inside your
unit, your institution and
beyond…

Faculty and Administrators

Research Integrity Program

Professional Societies

Colleagues
Questions????
If you have questions about anything included in this
presentation, please feel free to contact:
Allison Griffin Ratterman, Ph.D.
Research Integrity Program
Office of the Executive Vice President for Research
akgrif01@louisville.edu
ori@louisville.edu
502-852-2454
research.louisville.edu/researchintegrity
Sources used for this presentation include:
http://louisville.edu/research/humansubjects/investigator-research-team-information
www.asiaplanet.net
http://web.missouri.edu/~bondesonw/Laud.html
www.kwintessential.co.uk/resources/global-etiquette
“Culture and Global Business Research” road.uww.edu/.../Marketing%20Research%20Spring
“Responsible Conduct of Research” presentation by Allison Griffin Ratterman PhD
“The Research Integrity Program” presentation by Laura Engel
Screen Beans Art : © A Bit Better Corporation, used under licensed permission
Clip art provided by Microsoft “Clip art on Office Online” at : http://office.microsoft.com/enus/clipart/download.aspx
“Ethical Concerns in Research: What is all the fuss about?” The Research Integrity Program, University of Louisville,
Presentation by Allison Griffin Ratterman Ph. D.
http://louisville.edu/research/humansubjects/investigator-research-team-information