Responsible Conduct of Research Lauren Solberg CRC Research Skills Workshop January 18, 2008.
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Transcript of 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)
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
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
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
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: [email protected] Campus Phone: 6-0399