Responsible Conduct of Research
Lauren Solberg
CRC Research Skills Workshop
January 18, 2008
Office of Research Integrity (ORI)




http://ori.dhhs.gov
Oversees PHS research integrity activities
on behalf of Secretary for HHS
1 exception – FDA oversees their own
regulatory research activities
2000 – PHS initiated requirement that all
PHS-funded research staff undergo RCR
education
ORI Emphasis on RCR









Data Acquisition, Management, Sharing and
Ownership
Conflict of Interest and Commitment
Human Subjects
Animal Welfare
Research Misconduct
Publication Practices and Responsible Authorship
Mentor / Trainee Responsibilities
Peer Review
Collaborative Science
Research Misconduct



As defined by Office of Research Integrity
Fabrication, falsification, plagiarism, or
other practices that seriously deviate from
those that are commonly accepted in the
scientific community for proposing,
conducting, or reporting research
Not honest error or honest differences in
opinion
Research Misconduct Statistics



Reported in December 2007 ORI
newsletter
Between 1992 and 2001, 248 different
research institutions reported instances of
research misconduct
145 (58%) reported misconduct in only 1
year of the 10-year period
Fabrication

Intentionally creating records that do not exist and
for which there is no truth with the intent to
mislead or deceive



Interviewer completing a questionnaire for a fictitious
subject that was never interviewed
Preparing records for follow-up calls or contacts to
subjects who were really lost to follow-up
Creating notes for a subject visit that never took place
Eric Poehlman, PhD




UVM College of Medicine – fabricated data in 17
grant applications for federal funding as well as in
journal articles
Barred for life from receiving any federal funds for
research – plead guilty to fraud –sentenced in
6/06 to a year and one day in prison
Letters of retraction published
Also see NY Times article “An Unwelcome
Discovery” (10/22/06)
Research Staff –
Held to the Same Standard



Jessica Grol, Research Project Coordinator
at University of Pittsburgh – 11/05
Fabricated study research records for 15
subjects, including interview data –
research funded by NIH
For 3 years – debarred from contracting or
subcontracting w/ any US Gov’t agency
Falsification


Alteration of data collected in the conduct of
scientific investigation
Omission/deletion/suppression of conflicting data
without scientific justification


Back-dating interviews to fit within the timeline provided in
protocol
Changing a subject’s age in data records by an
unimportant amount to fit enrollment criteria
Craig Gelband, Ph.D.




Published in 11/03 Federal Register
Falsified data in different manuscripts or
publications citing NIH support and NIH
grant applications
10-year Voluntary Exclusion Agreement
2 papers retracted, 1 paper withdrawn,
figures retracted from 3 papers
Joy Bryant and Diana Layman




Published in 7/07 Federal Register
Phlebotomists at University of Oklahoma Health
Sciences Center
Falsified research in study by substituting their
own blood for the 10-15 blood samples of child
study participants as required by the protocol
Entered into Voluntary Exclusion Agreement for 3
years
Kristin Roovers, Ph.D.




Published in Federal Register in 7/07
University of Pennsylvania researcher
Falsified data by duplicating and reusing
data to misrepresent results as data from
different experiments
ORI Action: For 5 years – cannot contract
or subcontract w/ U.S. government agency
or serve in any advisory capacity to PHS
Andrew Friedman, MD





Brigham and Women’s Hospital physician
Between 1992 and 1995, altered and fabricated
data in permanent medical records
Also falsified and fabricated research data in 80%
of his publications (retractions published)
1996 - 3 year Voluntary Exclusion Agreement; for
2 years following 3-year period, employer must
submit a plan detailing how he will be supervised
for any PHS proposals
Now researcher at Ortho-Mcneil Pharmaceutical
Plagiarism


Intentional use of someone else’s words,
thoughts, or ideas, as though they are your
own
Also includes “self-plagiarism” – author
using his/her own published material in
another work without citation
Ralph Highshaw, MD



Urology Fellow from MD Anderson Cancer
Center
Plagiarized 9 pages of a 21-page article on
prevention of urologic cancer – 1/06
For next 3 years – required to certify in all
work that all contributors are properly cited
– and institution must certify that all work is
original, valid, and accurately reported
Ali Sultan, MD, PhD




From Harvard School of Public Health
Plagiarized text and figures from emails from his
post-doctoral student
Also falsified results of research, and fabricated
parts of emails from the student to falsely
implicate the student
For 3 years – debarred from contracting or
subcontracting w/ any US Gov’t agency
Categories of Research Misconduct at
Vanderbilt





Falsification, fabrication, or theft of data or
samples
Plagiarism
Unauthorized use of privileged information
Abuse of authorship
Significant failure to comply with federal,
state, or University rules regarding
research
If Scientific Misconduct is Reported…




See Vanderbilt’s Internal Policy on
Scientific Misconduct in Faculty Manual
Dean may conduct initial inquiry to
determine if formal investigation warranted
Formal investigation will follow if major
discipline anticipated
If minor disciplinary action anticipated,
Dean will take final action after initial inquiry
Finding of Misconduct



By federal regulation, if further investigation
is warranted, University must notify ORI
Research may be suspended (during
investigation and if finding)
Other results include reprimand, retraction
or correction of publications, special
monitoring of future work, probation or
suspension, termination of employment
Reminder


Inappropriate acts that do not qualify as
fabrication or falsification of data or plagiarism are
still punishable
Misconduct such as:
Breach of human subject confidentiality
 Forgery of physician’s signature on medical order
 Protocol deviation
 Failure to report adverse event
Will be forwarded to appropriate agency
(usually OHRP or FDA)

Authorship and Publication
International Committee of Medical
Journal Editors (ICMJE)


Group that established publication
guidelines for medical journals
Uniform Requirements provide good rules
of thumb (or required rules) for
understanding authorship – last revision in
2005
Authorship: Why does it matter?


Publications = promotions, tenure, salary
Represent ownership of new ideas
What is an Author?

Someone who has made substantive
intellectual contributions to a published
study
Basis for Authorship
Authorship should be based on:



Substantial contributions to conception and
design, or acquisition of data, or analysis and
interpretation of data
Drafting the article or revising it critically for
important intellectual content; AND
Final approval of the version to published
Maintaining Fairness


All persons designated as authors should
qualify for authorship
All persons who qualify for authorship
should be designated as authors
No Basis for Authorship



Acquisition of funding
Collection of data
Supervision of the research group
Consider…




Who developed the concept of the paper?
Who conducted the actual research?
Who wrote and/or edited the draft?
Who calculated the statistics?
Should these people be listed as authors?
Order of Authors



Consider how much work each person did
in writing and editing the draft, and
contributing to study design
How important is the paper?
Discuss order with co-authors
Acknowledgements

Contributors who do not meet criteria for
authorship should be listed in
acknowledgements section (if permitted)




Person providing technical help
Person providing writing assistance
Department Chair who provided only general support
Readers may infer endorsement of the data and
conclusions – all persons should give written
permission to be acknowledged
APA Ethical Practices Re: Authorship



Take responsibility and credit only for work that
a researcher actually performed or to which
he/she substantially contributed
Appropriately acknowledge those who made
minor contributions to research or written
publication
Mere possession of institutional position does
not justify authorship, i.e. dept. chair
Student Authorship
Decide early on how authorship decisions
will be made
 Except under exceptional circumstances,
student should be listed as first author on
publication based on dissertation

How to Avoid Authorship Disputes




Discuss expectations early on in the project
Accept an individual’s request not to be an
author
Refer to professional society’s ethical code
Check specific journal requirements
Publication Practices




Generally submit to only one journal at a
time
Confirm whether giving copyright to journal
Disclose all potential conflicts of interest as
required
Remember to obtain necessary informed
consent (or release) from any individual
who may be identifiable in the publication
Clinical Trial Registry



ICMJE journals require registration of clinical trials
in a registry
If no registration, journals will not consider study
for publication
Clinical trial = any research project that
prospectively assigns human subjects to
intervention or concurrent comparison or control
groups to study the cause-and-effect relationship
between a medical intervention and a health
outcome
Editorial Decisions




Accept (“in press”)
Accept with revisions
Revise and resubmit
Reject
Summary





Research Misconduct
Responsible Authorship
Publication Practices
Remember – ethics and common sense
often dictate – but check written
requirements as well
If you’re unsure – ask!
Contact Information


Email: lauren.b.solberg@vanderbilt.edu
Campus Phone: 6-0399