Responsible Conduct of Research Lauren Solberg CRC Research Skills Workshop January 18, 2008.

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: [email protected] Campus Phone: 6-0399