Transcript Slide 1

Responsible
Conduct of
Research (RCR)
David R. Clark ([email protected])
Research Compliance Officer
(335-1585)
www.research-compliance.wsu.edu
Research Compliance Office 05/04/06
Responsible Conduct
of Research (RCR)
I.
Introduction
II.
Core Instructional Topics
1.
2.
3.
4.
5.
6.
7.
8.
9.
III.
Data Acquisition, Management,
Sharing, and Ownership
Conflict of Interest and Commitment
Human Subjects
Animal Subjects
Research Misconduct
Publication Practices and
Responsible Authorship
Mentor/Trainee Responsibilities
Peer Review
Collaborative Science
Conclusion
I. Introduction
The material presented here
(sometimes verbatim) is
primarily summarized from
“Introduction to the Responsible
Conduct of Research”. This
book can be downloaded at
http://ori.hhs.gov/documents/rcr
intro.pdf
Additional information can be
found at the U.S. Dept of Health
and Human Services (DHHS)
Office of Research Integrity
(ORI) website http://ori.hhs.gov/
Why discuss responsible conduct of
research?
• Research responsibilities are
complex and must be discussed
in order to be understood
• Research responsibilities are
found in many different sources
 Professional codes
 Government regulations
 Institutional policies and
procedures
 Personal convictions
Why discuss responsible conduct of
research?
• Establish an environment that fosters open
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communication
Develop a common foundation
Promote best practices
Share ideas
Increase understanding
Establish a culture of concern
• Seek to overcome the lack of a perceived need for
guidance on the responsible conduct of research
II. RCR Core Instructional Areas
ORI supports programs designed to promote education and training
in the responsible conduct of research (RCR) that covers the
following nine instructional areas:
1.
2.
3.
4.
5.
6.
Data Acquisition, Management, Sharing and Ownership
Conflict of Interest and Commitment
Human Subjects
Animal Welfare
Research Misconduct
Publication Practices and
Responsible Authorship
7. Mentor / Trainee Responsibilities
8. Peer Review
9. Collaborative Science
1. Data Acquisition, Management,
Sharing, and Ownership
• Data are integral to the research
process.
• Data management practices are
complex (including collection,
management, sharing, and
ownership) and should be
discussed before data are
collected.
• The integrity of data is of
paramount importance and
requires careful planning.
Data Acquisition (Collection)
Considerations regarding data
acquisition include:
• Appropriate methods
• Attention to detail
• Authorizations
 Human subjects
(IRB http://www.irb.wsu.edu/)
 Animal subjects
(IACUC http://www.iacuc.wsu.edu/)
 Biological agents
(IBC http://www.bio-safety.wsu.edu/)
 Radioactive materials
(RSC http://www.rso.wsu.edu/)
 Hazardous Materials
(EH&S http://www.ehs.wsu.edu/)
 Copyrighted or patented processes or
materials
Data Management (Protection)
Data must be protected for later use (confirmation,
establish priority, or be reanalyzed by others):
• Data Storage: Lab notebooks in a safe place;
computer files backed up; samples saved so as not
to degrade
• Confidentiality: Some data may be subject to
privacy restrictions (human subjects or
confidential business information)
• Retention: In general data must be retained for 3
years after the completion of the research.
Data Sharing
Although there is general agreement that
research data must be shared there are often
difficult questions that must be addressed:
•Preliminary data:
generally should not be
released
•Confirmed or validated data: keeping data
confidential until publication is widely accepted
•Published data: Once published there is an
expectation that all the information about that
experiment (including final data) should be
freely available
Data Ownership
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In general for government funding (state or
federal):
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Grants: researchers perform research and
submit reports, but control of the data remains
with the institution that received the funds
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Contracts: require the researcher to deliver a
product or service which is then owned or
controlled by the government
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Support for research institutions is awarded to
the research institution, not to individual
researchers
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In general WSU owns the data
Who owns research data?
2. Conflict of Interest and Commitment
a. Financial conflicts
b. Conflicts of commitment
Conflicts of interest are to be expected
in the complex world of research with
many competing demands and
interests. Conflicts of interest or
commitment are not necessarily
good or bad – what is important is
how they are acted on.
Whose interest comes first?
Financial Conflict of Interest
• Financial Conflicts
• Potential financial conflicts are not inherently wrong.
Researchers should:
 report significant ($10,000 per year, or equity interest
>5%) financial conflicts before any research is undertaken
 Manage, reduce, or eliminate significant fianncial
conflicts. This is generally accomplished by disclosure to
the WSU Conflict of Interest Committee.
• WSU Policy
http://www.ogrd.wsu.edu/policies_guidelines.asp
(Document #3, Conflict of interest policy)
Conflicts of Commitment
Conflicts of commitment occur from the competing
demands on a researcher’s time and loyalties:
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Working on more than one funded project
Preparing proposals for new projects
Teaching and advising students
Attending professional meetings
Serving as a peer reviewer
Serving on advisory boards
Working as a paid consultant, officer, or
employee in a private company
Concerns include allocation of time; relationships
with students; use of resources; disclosure of
affiliations; and representing outside entities
3. Human Subjects
IRB (Institutional Review Board)
Human Subjects
Research involving humans has many benefits for society
and is often a necessary component of research. Research
involving human subjects has many specific requirements
•IRB review and approval
Risks to subjects are minimized
Informed consent
Belmont principles (respect for
persons, beneficence, justice)
Education/Training
http://www.irb.wsu.edu/
4.
Animal Welfare
IACUC (Institutional Animal Care
and Use Committee)
4. Animal Welfare
The use of animals in research requires
careful planning and Institutional
approval.
• IACUC review and approval
 Reviewing animal use protocols
 Review WSU’s animal care program
 Inspect animal facilities
 Submit reports
 Education/training
http://www.iacuc.wsu.edu/
http://campusvet.wsu.edu/
Animal Welfare
• The IACUC (and the OCV) are concerned with many
principles
 The humane use of animals
in research
 Justifying the use of animals
 The 3 Rs (replacement, reduction,
refinement)
 Minimizing any pain or suffering
 Minimizing the number of animals
• The WSU has accreditation form the Association for
Assessment and Accreditation of Laboratory Animal Care
(AAALAC)
5. Research Misconduct
• Research misconduct is serious
and has received considerable
public attention.
• Researchers who act dishonestly
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When research misconduct becomes public
Waste public funds
Harm the research record
Distort the research process
Undermine public trust
May adversely impact public
health and safety
Research Misconduct
Research misconduct is
defined as fabrication,
falsification, or plagiarism in
proposing, performing, or
reviewing research, or in
reporting results.
 Fabrication is making up data or results
and recording or reporting them
 Falsification is 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 is the appropriation of
another person’s ideas, processes,
results, or words without giving them
appropriate credit
From: io.uwinnipeg.ca (Chronicle of Higher Ed)
Research Misconduct
Research misconduct
does not include honest
errors, differences of
opinion, or honest
differences in
interpretations or
judgments of data.
Research Misconduct
• Possible research misconduct should be reported
to the Vice Provost for Research. The WSU policy
can be found at
http://officeofresearch.wsu.edu/faculty_resources/policies.h
tml
• Laws and policies are meant to protect both the
individuals that make complaints and the
individual who is accused of misconduct.
• Inquiries and investigations are handled with
extreme confidentiality.
6. Publication Practices and
Responsible Authorship
• Researchers typically share the
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results of their activities with
colleagues and the public
through publication.
Results of publication in research
should meet some minimum
standards:
 A full and fair description of the
work,
 An accurate report of the
results,
 An honest and open
assessment of the findings.
Responsible Publications
• Elements of a responsible publication
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Abstracts
Methods
Results
Discussion
Notes, bibliography,
and acknowledgements
Responsible Publications
• Practices that should be avoided
 Honorary authorship
 Practices that put quantity above quality
• Salami (sometimes called bologna or trivial
publications). The practice of dividing one significant
piece of research into a number of small experiments
(least publishable units or LPUs).
• Duplicate publications
 Premature public statements
Responsible Authorship
• The names on a paper let
others know who
conducted the research
and should get credit for
the work
• The authors listed on
papers should fairly and
accurately represent the
person(s) responsible for
the work
Responsible Authorship
• Contribution:
Authorship is generally limited to
individuals who make significant contributions to
the work. A high standard (International Committee of Medical
Journal Editors) recommends limiting authorship to persons who
contribute to the conception and design or data collection and
interpretation, and assist in drafting and finalizing the manuscript.
• Importance: Authors are usually listed in order of
importance.
The designation first or last author usually carries
special weight (most significant contribution).
• Corresponding or primary author: This is an
important responsibility as these authors will act
on behalf of their colleagues.
7. Mentor / Trainee
Responsibilities
• Successful, experienced,
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established, and/or senior
researchers often assume the
added role of mentor while
conducting investigations.
The mentor/trainee relationship is
complex and may harbor potential
conflicts (who gets credit? Who
owns the results? When does the
trainee become independent?).
Mentor / Trainee
•Basic Responsibilities:
The mentor/trainee
relationship begins when an experienced and an
inexperienced research agree to work together.
Each brings something to the arrangement and each
expects to get something out of the arrangement.
 Trainees need to know: How much time mentor expects
them to work on mentors research; criteria to judge performance;
how responsibilities are divided or shared, SOPs, authorship.
 Mentors need to know that a trainee will:
do
assigned work conscientiously, respect the authority of others in the
research; follow SOPs, protocols, procedures; live by authorship
and ownership agreements.
Mentor / Trainee
• Research Environment:
Mentors tend to establish the research
environment. Some may emphasize competition
and others may emphasize cooperation. No matter
what their style mentors should:
 Provide equal treatment
 Maintain a professional atmosphere
 Train and educate in the responsible conduct of
research
Mentor / Trainee
• Supervision and review:
Mentors assume
responsibility to properly and appropriately train.
 Assure proper instruction in research methods
 Foster intellectual development
 Impart an understanding of responsible research
practices
 Routinely check and “coach” to make sure the
trainee develops into a responsible researcher
Mentor / Trainee
 Transition to independent researcher:
The ultimate goal of research training is
to produce successful, independent
researchers. The mentors final responsibility of the
mentor is to help the trainee become firmly
established as independent researchers.
History has repeatedly shown that experienced
researchers often do not give over control to the
next generation easily.
8. Peer Review
Benefit of peer review?
Peer review (the evaluation by
colleagues with similar
knowledge and experience) is an
essential component of research
and the self-regulation of
professionals.
•Grant reviews
•Manuscript reviews
•Personnel reviews
•Literature reviews and expert
testimony
Peer Review
Regardless of the type of peer review it must:
• Meet the deadline: Be timely.
• Assess quality: Be thorough with respect to
methods, calculations, conclusions, literature
cited.
• Judge importance: Is the research important?
Does it contribute in a significant way?
8. Peer Review
• Preserve confidentiality:
Peer review occurs
with the understanding that the information
will not be used or shared with anyone else.
It is not permissible to do any of the following (without
permission)
 Ask a student or anyone else to do the review assigned to
you
 Use an idea or information contained in a grant or
unpublished manuscript
 Discuss a grant proposal or manuscript with colleagues
 Retain a copy of the reviewed materials
 Discuss hiring decisions with colleagues not on the
committee or providing a reference.
9. Collaborative
Science
• Researchers collaborate
with colleagues who have
expertise and/or resources
to contribute to a project.
• Federal agencies and
universities seek to foster
interdisciplinary science.
• Any project with more than
one person working on it
requires collaboration –
working together.
Collaboration or competition?
Collaborative Science
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Collaboration can offer many
benefits and advantages,
however, there are added
responsibilities:
Increasingly complex roles and relationships
More complex management requirements
Common, but not necessarily identical interests
Cultural differences
Collaborative Science
Roles and relationships:
Effective collaboration
begins with a clear
understanding of roles and
relationships, which should
begin the day the
collaboration is established.
• Goals and anticipated outcomes
• Roles of each partner
• Data collection, storage, sharing
• Agreeing to changes in research
design
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Who will draft publications
Criteria to rank authors
Authority to speak publicly
Intellectual property rights and
ownership
How the collaboration can be
changed
When the collaboration will end
Collaborative Science
Effective management must include:
• Financial management: Responsibility for
ensuring that federal funds (project funds) are
expended in accordance with federal rules (A-21 and
A-110).
•Training and supervision: All research staff and project personnel
should be properly trained and supervised.
•Formal agreements: Some aspects of collaboration must be worked out
with formal agreements in advance (who owns materials; uses/restrictions on the
materials, acknowledgements of the source).
•Compliance: When a research institution is involved in a collaboration
responsibility for compliance can extend to other institutions (as well as
compliance responsibilities at their own institution).
Collaborative Science
• Research interests:
Collaborative projects
encourage researchers to pursue interdisciplinary
research, however, most researchers have devoted their
career to one field of research and spend their time
talking to colleagues with similar interests. This may
cause tension or competing goals in a collaborative project.
• Cultural difference:
Not only geographic differences, but differences
resulting from the research field. Researchers from different fields may bring
different practices or expectations to a project. Such differences may include
potential conflict of interest, ownership and intellectual property, collecting
data, publishing results, etc.
When in doubt, it is advisable to follow the more stringent
course of action (the highest standard of conduct).
III. Conclusion
NIH
WSU RSO
IACUC
Responsible conduct
of research
IBC
WSU EHS
DOT/FAA
DHHS/OHRP
Researcher
DHHS/ORI
WSU
IRB
Policy/Procedure
WSU BSO
Collaborative
obligations
FDA
USDA/APHIS
Assistance and Resources
• Research Compliance Officer
•
•
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David Clark, Phone 335-1585, [email protected]
IACUC Coordinator
Rebecca Van Wyck, Phone 335-9661, [email protected]
IRB & IBC & COI Coordinator
Malathi Jandhyala, Phone 335-9661, [email protected]
Biological Safety Officer
Lorraine McConnell, Phone 335-9661, [email protected]
Research Compliance Office
website: http://www.research-compliance.wsu.edu/
forms (IACUC, IBC, IRB): http://www.ogrd.wsu.edu/forms.asp
Vice Provost for Research
WSU RCR Education website: https://myresearch.wsu.edu/
Responsible
Conduct
of
Research