Responsible Conduct of Research Workshop The Office of

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Responsible Conduct of Research
CUNY Policies & Procedures
Vice Chancellor for Research Gillian Small
April 17, 2012
RCR Training
CUNY RCR training requirements for students and
postdoctoral researchers:
• CITI on-line modules in RCR
• RCR workshops
• Individual training by faculty (Principal Investigator)
See: http://www.cuny.edu/research/compliance.html
Additional RCR Resources
• Miguel Roig, Avoiding plagiarism, self-plagiarism,
and other questionable writing practices: a guide
to ethical writing
http://facpub.stjohns.edu/~roigm/plagiarism
• MJ Bebeau, KD Pumple, KMT Muskavitch, SL Borden
and DH Smith, Moral Reasoning in Scientific Research
http://www4.ensp.fiocruz.br/etica/docs/artigos/moralr.pdf
RCR Goals
(in part from MJ Bebeau et.al.)
Rules:
Rules that require appropriate research conduct include
federal rules, funder’s rules and institutional rules
(e.g. attending this workshop!)
Ethics:
Development of ethical sensitivity, critical thinking skills,
and habits that prepare students to effectively resolve
problems as they emerge (more than just cognizance of
the rules)
What are the rules?
Do not engage in Research Misconduct!
The CUNY Research Misconduct policy is based on the 2005
DHHS Final Rule and applies to allegations of:
• Fabrication
• Falsification
• Plagiarism
See: http://www.cuny.edu/research/compliance/Responsible-Conduct-ofResearch/CUNY_Research_Misconduct_Policy-2.pdf
Definitions
Fabrication: making up data or results and recording
or reporting them.
Falsification: manipulating research materials,
equipment, or processes, or changing or omitting
data or results such that the research is not
accurately represented in the research record.
Plagiarism: the appropriation of another person's ideas,
processes, results, or words without giving appropriate
credit.
Fabrication
Examples
• In 1974 Sloan-Kettering Cancer Institute researcher Dr. William
Summerlin colored patches of fur on white mice with a black
marker in an attempt to prove that his new skin graft treatment was
working.
• In 2005, a top obesity researcher at the University of Vermont,
admitted that over the course of 10 years he fabricated data in
17 federal grant applications, resulting in nearly $3 million in
government research funds. He was sentenced to serve a year
and a day in federal prison.
Falsification
Examples
• In October 2011, the ORI found that a postdoctoral fellow
at the University of Michigan Medical School intentionally
falsified data related to 5 Western blot experiments and
switched the labels on 4 cell culture dishes.
• He is debarred from contracting with, or serving in an
advisory capacity for any Public Health Service agency.
Plagiarism
• Appropriating an idea (e.g., an explanation, a theory,
a conclusion, a hypothesis, a metaphor) in whole or
in part, or with superficial modifications without
giving credit to its originator
• Any verbatim text taken from another author must
be enclosed in quotation marks
Note: federal agencies now check submitted grant
proposals for potential plagiarism
*From ORI website: http://ori.dhhs.gov/education/products/plagiarism/
Self-plagiarism
• The publication of what is essentially the same paper
in more than one journal, but without any indication
that the paper has been published elsewhere
• The partitioning of a large study which should have
been reported in a single paper into smaller published
studies
• Copyright infringement
*From ORI website: http://ori.dhhs.gov/education/products/plagiarism/
Plagiarism
Example
• In Nov 2011, the ORI found that a researcher at the University of
Virginia Medical Center plagiarized large amounts of text and an
illustration from other funded research in five publications he
authored.
Outcome: The researcher must submit a retraction letter to one of
the journals, have his research supervised and certified for credibility
with ORI approval for 4 years, and exclude himself from service for
any Public Health Service agency.
Rules….
You must also, as appropriate, learn and follow all
guidelines pertaining to research involving animals,
human subjects, chemical and/or other types of hazards
University Resources
You should be aware of the following committees and/or
positions, some or all of which exist on your campus:
IRB (institutional review board for research involving human subjects)
IACUC (institutional animal care and use committee)
IBC (institutional biosafety committee)
RIO (research integrity officer)
RCR Scenarios
RCR Scenarios
Scenario 1
Dealing with Suspicions of
Misconduct
Scenario 1
Fabrication
How should Dr. deSteamroller respond to this complaint?
How should he deal with:
The student, Nigel?
The postdoc, Dr. Lansing?
The data that have now been called into question?
The institution in which all three individuals work?
The journal in which the possibly fraudulent data were
reported?
RCR Scenarios
Scenario 2
Scenario 2
Falsification
Was Eric justified in removing the data
points?
Are there legitimate ways to handle or exclude
outliers?
RCR Scenarios
Scenario 3
Scenario 3
Plagiarism
When writing a paper, can you copy the
materials and method from a previous paper?
Can you copy the introduction?
Can you self plagiarize?
Responsible Conduct of Research:
An Overview
Farida Lada
University Director for Research Compliance
April 17, 2012
Mentor / Trainee Responsibilities
•
Set expectations
•
Clarify evaluation criteria
•
Clear distribution of responsibilities
•
Standard operating procedures
•
Criteria for establishing authorship & ownership
•
Awareness of and compliance with RCR requirements
Peer Review
• Responsibility
•
•
Assess project for quality
Make judgment regarding importance of research being proposed
• Responsible conduct
•
•
•
•
Timely review
Constructive feedback
Free from personal bias
Maintain confidentiality
Publication Practices & Responsible Authorship
• Authors
•
•
•
•
Made significant contribution to the research
Assumed responsibility for data collection and analysis
Participated in drafting the publication
Approved the final publication
• Improper practices
•
•
Honorary authorship
Duplicate publication
Data Management
• Data Ownership
•
•
Funding agency – grants vs. contracts
Institution
•
•
CUNY IP Policy
(http://www.cuny.edu/about/administration/offices/la.html)
Data source
• Data Collection
•
•
•
Appropriate methods for data collection and analysis
Data recorded such that date and order of data collection can be
validated
Authorization
•
•
•
•
Human & animal subject
Hazardous material and biological agent use
Proprietary data
Copyrighted or patented materials
Data Management
• Data Protection
•
•
•
Proper storage to avoid accidental damage, loss or theft
Confidentiality & privacy agreements honored
Data retention according to contract and/or institutional practice
• Data Sharing
•
•
•
Data transfer from CUNY requires a data transfer agreement
Preliminary data need not be released until validated and
published or publicly announced
Once published, data should be freely available for other
researchers
Conflict of Interest
• Financial Conflict of Interest
•
CUNY Conflict of Interest Policy
•
•
http://www.cuny.edu/research/compliance/conflictofinterestpolicy.html
Sponsor reporting requirements
• Conflict of Commitment
•
•
•
Relationships with individuals or entities
Use of resources
Honor time commitments that are made
Collaborative Research
• Roles & Relationships
•
•
•
Define each collaborator’s role in the project
Ensure common understanding of the research goals
Be familiar with each institution’s intellectual property and
ownership policies
• Financial Management
•
Ensure that all collaborators are in compliance with funding
agency’s financial management rules
• Training & Supervision
•
•
Management plan should address training & supervision of all
research team members
Be familiar with institutional requirements
Collaborative Research
• Formal Agreements
•
•
•
Memorandums of Understanding
Material Transfer Agreement
Data Transfer Agreement
• Compliance
•
Management plan should address how compliance with
regulatory and institutional requirements will be ensured
Biosafety
• Environmental Health, Safety & Risk Management
•
Policies and procedures for lab safety, hazardous materials,
health safety, radiation safety
•
•
http://www.cuny.edu/about/administration/offices/ehsrm/Policies.html
Training, audits and oversight
• Institutional Biosafety Committee
•
•
•
Recombinant DNA & gene therapy research
Risk group 2 or higher infectious agents use
Use of transgenic animals
Export Control
• Controls
•
Commerce Department’s dual use controls
•
•
State Department’s defense-based controls
•
•
Hardware, software, materials, equipment, technology &
technological data that have civilian AND inherent military or defense
application
Defense articles and activities specifically designed or modified for
defense or military application without a civil equivalent
Treasury Department’s economic embargo controls
• Restrict transactions with certain countries
• Cuba, Iran, Syria & Sudan restricted for our purposes
• Requirements
•
•
Prior authorization or license may be required
Exceptions for fundamental research activities
•
No publication or citizenship restrictions accepted by any sponsor
Protection of Human Subjects & Animal Welfare
•
Presentation by Angela Cartmell, Administrator, Office for Protection of
Research Subjects, College of Staten Island
RCR Scenarios
Scenario 4
Scenario 4
Authorship
How would you feel if you were:
Kim?
Ed?
Dr. PCR?
Would the feelings depend upon whether
authorship and author order had been
discussed openly at various times?
Scenario 4
Authorship
May a Professor submit a paper without a
co-author postdoc, student, or colleague
having seen it?
RCR Scenarios
Scenario 5
Scenario 5
What May I Take With Me?
Is it appropriate for a graduate student or
postdoc to ask to take materials with them
when they leave the research group?
At what point should this conversation
take place?
RCR Scenarios
Scenario 6
Scenario 6
Competition and Collaboration
Do you really have an obligation to share
materials immediately under these
circumstances?
Where might you look for advice in this
circumstance?
Are there any other alternatives that could be
explored?
RCR Scenarios
Scenario 7
Scenario 7
Human Subjects Research
What are the appropriate steps to carry out
such a survey?
Can such a survey be made mandatory for
current students?
What options should be made available for
current students who are not interested in
taking this survey?
http://ori.hhs.gov/
Questions?
www.cuny.edu/research
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