Responsible Conduct of Research (RCR) Workshop

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Responsible Conduct of Research (RCR)
Workshop

Office of the Vice Chancellor for Research

March 4, 2013








http://www.cuny.edu/research/
compliance.html


RCR Training


CUNY RCR training requirements for students and
postdoctoral researchers:


CITI on
-
line modules in RCR


RCR workshops


Individual training by faculty (Faculty Advisor)


http://www.cuny.edu/research/compliance/Responsible
-
Conduct
-
of
-
Research/RCR_Training_Policy_8_22_12.
pdf


Additional RCR Resources


Miguel
Roig
,
Avoiding plagiarism, self
-
plagiarism,
and other questionable writing practices: a guide to
ethical writing

https://ori.hhs.gov/images/ddblock/
plagiarism.pdf



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


http://www.cuny.edu/research/compliance/Responsible
-
Conduct
-
of
-
Research/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.

Examples of Fabrication


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
.


Example of Falsification


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


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


Example of Plagiarism

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
:


HRPP
(human research protection program 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: Fabrication

Scenario 1: Fabrication


How should Dr.
deStreamroller

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

Dealing with Suspicions of
Misconduct: Falsification

Scenario 2: Falsification


Was Eric justified in removing the data points?


Are
there legitimate ways to handle or exclude
outliers?



RCR Scenarios

Scenario 3

Dealing with Suspicions of
Misconduct: Plagiarism

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?



Conflict of Interest


Financial Conflict of Interest


CUNY policy, procedures and disclosure forms
at
http://www.cuny.edu/research/compliance/
conflictofinter
estpolicy.html



CUNY Conflicts Committee


Conflict of Commitment


Relationships with individuals or entities


Use of resources


Honor time commitments made

Protection of Human Subjects


CUNY Human Research Protection Program (HRPP)


http://www.cuny.edu/research/compliance/human
-
subjects
-
research
-
1.
html


College specific HRPP Coordinator


4 University Integrated (UI) Institutional Review Boards (IRB)


1 Expedited Review Panel


HRPP / IRB review is required when:


Activity involves research (systematic investigation for
generalizable knowledge); and


Activity involves human subjects (living individual about whom
data is collected through intervention or interaction; or private
identifiable information is collected); and


CUNY is engaged

Animal Welfare


Humane treatment of animals used in research and
educational activities


College specific Institutional Animal Care and Use
Committee


College specific animal facilities, veterinarian and
staff

Biosafety


Environmental Health, Safety & Risk Management


Policies and procedures regarding laboratory safety,
hazardous materials, health safety &
radiation safety
http://www.cuny.edu/about/administration/offices/
ehsrm
.html



Responsible for training, oversight and audits


College specific Institutional Biosafety Committees
(IBC)


Recombinant DNA & gene therapy research


Risk group 2 or higher infectious agent use


Use of transgenic animals

Export Control


CUNY policy, procedures, guidance & forms


http://www.cuny.edu/research/compliance/Export
-
Control.html



College specific Export Control Administrators


Controls


State, Commerce & Treasury Controls


Hardware, software, materials, equipment, technology &
technological data that have
civilian and inherent military or
defense application


Defense
articles and activities
designed or modified for defense or
military application without civil equivalent


Restricted transactions; for our purposes, those with Cuba, Iran,
Syria or Sudan

Export Control


Requirements


Prior authorization or license may be required


Exceptions for fundamental research activities


No publication or citizenship restrictions accepted

Mentor / Trainee Responsibilities


Proactively 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 contributions to the research


Assumed responsibility for data collection & analysis


Participated in drafting the publication


Approved the final publication


Improper practice


Honorary authorship


Duplicate publication

Data Management


Data Ownership


Funding agency


grants vs. contracts


Institutional policy


CUNY Intellectual Property Policy
:
http://www.cuny.edu/about/administration/offices/la/intellectual
_property_9.20.11.
pdf



Data Source


Data Collection


Methods are appropriate for type of research


Data recorded such that it can be validated


Appropriate authorization



human subjects; animal subjects; hazardous material & 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 &/or institutional
practice


Data Sharing


Data transfer from CUNY requires a data transfer
agreement

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 &
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


Contact research compliance staff prior to signing these


Ensure that your collaboration is documented in a formal
Agreement


Examples include: Memorandum of Understanding;
Memorandum of Agreement; Material Transfer
Agreement; Data Transfer Agreement


Compliance


Management plan should address how compliance with
regulatory & institutional requirements will be ensured

RCR Scenarios

Scenario 4

Conflict of Interest

Scenario
4
: Conflict of Interest


Can a professor require his student to work for his
company?


What are the consequences of this?


Can a company operate out of University property?



RCR Scenarios

Scenario 5

Human Subjects Research

Scenario 5: 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?



RCR Scenarios

Scenario 6

Authorship

Scenario 6: Authorship

May a Professor submit a paper without a co
-
author
postdoc, student, or colleague having seen it?



RCR Scenarios

Scenario 7

Data Management

Scenario 7: Data Management


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 8

Collaborative Research

Scenario 8: Collaborative Research


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?