May 11, 2010  2-4 PM
Debra Schaller-Demers, MSOM
Director, Research Outreach and Compliance
Memorial Sloan-Kettering Cancer Center
Tri-Institutional Collaboration Network (TCN) at The Rockefeller University
Instructions:
In the time allotted, find someone in the
group that fits each of these categories
and write his/her name in the space
provided.
You can only use someone once!
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Welcome and Introductions
Gathering: Find a Research Administrator Who…
Agenda Review and Group Guidelines
Brainstorm: What is RCR?
Recognized Core Topics
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Microlab: Why is it important for me to know about RCR?
Notorious Cases
Closer Look at:
Conflict of Interest
Financial Management
Mentor-Trainee Responsibilities
Collaborative Research and Data Management
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Policies, Procedures, Guidelines
Institutional – Organizational
Code of Ethics / Behavior
Various Integrity/Compliance Policies
ORI – Office of Research Integrity
NIH and NSF
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Closing: Words of Encouragement
Responsible Conduct of Research
 Nine Core areas as defined by ORI, DHHS:
1. Data Acquisition, Management, Sharing and
Ownership
2. Conflict of Interest and Commitment
3. Human Subjects
4. Animal Welfare
5. Research Misconduct
6. Publication Practices and Responsible Authorship
7. Mentor / Trainee Responsibilities
8. Peer Review
9. Collaborative Science
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The integrity of research depends on the
integrity of the data. Because data provide
factual basis for scientific work, the integrity
of research depends on integrity in all
aspects of the collection, use, retention,
and sharing of data.
You say conflict like it’s a bad thing…
COI - where two or more competing interests create the perception or
the reality of an increased risk of bias or poor judgment.
 Conflict of commitment (or effort) involves situations where
demands from separate entities jeopardize the duties and
responsibilities associated with one of more of those entities (e.g.,
outside consulting activities interfering with duties of one's primary
employment).
 Conflict of conscience created by having to maintain objectivity in
the face of your convictions, which go against the grain of something
you must act on or evaluate.
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Conflicts encountered in science are not inherently bad. Indeed, they
are to be expected. It's how they are handled that can lead to
untoward, inappropriate, or bad outcomes.
Belmont Report:
1. Respect for persons - incorporates at least two ethical
convictions: first, that individuals should be treated as
autonomous agents, and second, that persons with
diminished autonomy are entitled to protection.
2. Beneficence - Two general rules have been formulated as
complementary expressions of beneficent actions in this
sense: (1) do no harm and (2) maximize possible benefits and
minimize possible risks.
3. Justice - An injustice occurs when some benefit to which a
person is entitled is denied without good reason or when
some burden is imposed unduly.
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
A general principle proposed by Russell and Burch (1959) serves
as guidance for researchers in ensuring that their research
entails procedures that will cause the least pain and/or distress
to the least amount of animals. This principle (3 Rs) consists of
three specific strategies for minimizing the pain and distress to
animal subjects:
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Replacement: When possible, conscious animals should be
replaced with insentient material in research, and higher
animals should be replaced with lower ones.
Reduction: Where it is without a loss of significance or
precision, fewer animals should be used.
Refinement: Procedures should be designed so as to
minimize the incidence and severity of harm to the animal
subjects.
Research misconduct is essentially defined as “FFP”:
"fabrication, falsification, or plagiarism in proposing,
performing, or reviewing research, or in reporting research
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 appropriate credit.
Research misconduct does not include
honest error or differences of opinion.
Attribution of credit and responsibility is central to the
structure of science. Authorship is the most visible form of
credit, but credit in publications is also given in the form
of acknowledgments or appropriate reference citations.
Because credit for publication is so important to disputes
and allegations of research misconduct, it is worth
considering why credit is more than a matter of personal
gratification. The framework of science depends in part on
the ability of institutions, policy makers, and the public to
identify who is responsible for the work and its
interpretation.
Other considerations:
Duplicative Publication, Retractions, Ghostwriting
Mentoring the next generation of scientists is a responsibility for
current scientists. A mentor has experience with the challenges
that will be faced by a trainee, the ability to communicate that
experience, and a willingness to do so. A mentor assists the
trainee in understanding and adhering to the standards of
conduct within their profession. In this way, mentoring of new
researchers by senior investigators passes on the informal and
possibly unwritten standards from one generation of scientists
to the next.
It’s all about modeling behaviors…
RCR in real-life situations
What responsibilities does the “mentee” have?
Much of academic inquiry is relatively specialized,
peers with similar expertise are in the best position to
judge one another's work. This mechanism was
largely designed to evaluate the relative quality of
research. However, with appropriate feedback, it can
also be a valuable tool to improve a manuscript, a
grant application, or the focus of an academic career.
Despite these advantages, the process of peer review
is hampered by both perceived and real limitations.
Fear of bias, conflicts, stealing ideas
The nature of collaborations is so variable that it is
difficult to identify a comprehensive set of ethical
principles; however, responsible collaborations are
defined by openness, communication, and TRUST.
Dispute Resolution
There can be many possible ways to solve a problem
Winning is not getting what you think you want,
but getting what you actually need!
Although not directly involved in the research,
administrative staff play an important part in
promoting the integrity of the research
enterprise. Frequently, administrators
encounter ethical decisions in an environment
of competing obligations and responsibilities.
Microlab Activity…
small group sharing
In order to function effectively and make
appropriate ethical decisions, administrative staff
need to develop the skills to be able to:
 identify when situations present ethical
conflicts
 reason among possible courses of action
 effectively implement their best solution
to the problem.
… there are consequences for every decision we make!
“The successful conduct of research in a free society depends
on trust between the scientific enterprise and the public,
trust in the integrity of the discovery process, and
especially trust in the safety of patients and healthy
volunteers who participate in the process. In recent years,
this essential trust has been shaken by a number of highly
publicized events: tragic deaths of patients enrolled in
clinical trials, high-profile allegations of financial conflicts
of interest, and scientific misconduct by a few
investigators.”
From: Cohen, J. J. and Siegel, E. K. (2005, September 21). Academic medical
centers and medical research. JAMA. Volume 294, No. 11
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Gelsinger and Roche – human subject tragedy
Eric Poehlman – PI sentenced to federal prison
Anne Butkovitz Study Coordinator charged with falsifying
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Jessica Lee Grol
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case report forms, after documenting follow-up phone calls and
information on serious adverse events without actually contacting
parents of children enrolled in a vaccine trial. Sentenced to one year
of probation, fined $1,000 and permanently debarred from working
on FDA studies.
Research Study Coordinator engaged in
scientific misconduct by fabricating study research records for 15
subjects, including the patient interview data, the forms tracking
data, and the medical record extraction data in a study on the
management of cerebral aneurysms.
Think about it… how many people knew and what did they do?
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A Closer Look at:
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Conflict of Interest
Financial Management
Mentor-Trainee Responsibilities
Collaborative Research and Data Management
From the Research Administrator’s POV
http://ori.dhhs.gov/education/products/rcradmin/index.html
Modules developed for the Office of Research Integrity (ORI) by
Stephen Erickson, PhD and Karen Muskavitch, PhD
Boston College
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Administrative staff need to be able to identify real and potential conflicts of
interest. Research administrators are entrusted by the institution to
administer sponsored projects and contracts. This does not mean that each
administrator must "police" awards or financial relationships. However,
administrators should be able to identify situations in which a conflict of
interest has arisen, or if a potential conflict could arise, or if there is a good
possibility that others will perceive the existence of a conflict of interest. To
do this, one must be familiar with your institution’s policies as well as those
of the sponsors.
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Administrators can find themselves in difficult situations with regard to
conflicts of interest involving faculty. Especially when there are long-standing
relationships involved. It is important for administrators to know what to do
and how to do it when they sense that something "just isn't right."
http://ori.dhhs.gov/education/products/rcradmin/index.html
Modules developed for the Office of Research Integrity (ORI) by
Stephen Erickson, PhD and Karen Muskavitch, PhD
Boston College
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Research Administrators often are placed in situations that
require ethical decision-making. Perhaps the Principal
Investigator is not aware of relevant policies and
regulations and /or may be placing his/her personal
interests over those of the Institution. Administrators,
whether in academic departments or in central offices,
need to know about institutional and sponsor rules,
regulations and guidelines. They need to be able to
recognize potential problems and to ask the right
questions. This will lead to resolving problems early in the
process – provided that administrators combine knowledge
with appropriate and ethical decision-making.
http://ori.dhhs.gov/education/products/rcradmin/index.html
Modules developed for the Office of Research Integrity (ORI) by
Stephen Erickson, PhD and Karen Muskavitch, PhD
Boston College
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This is just a sampling of the areas
Research Administrators need to be “expert”
about:
◦ Allowable, Allocable, Reasonable Costs
◦ Cost-Sharing
◦ Time and Effort Reporting
◦ Cost Transfers
http://ori.dhhs.gov/education/products/rcradmin/index.html
Modules developed for the Office of Research Integrity (ORI) by
Stephen Erickson, PhD and Karen Muskavitch, PhD
Boston College
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Research administrators can sometimes find
themselves caught between mentors and trainees.
Finding oneself "in the middle" of situations that
arise within advisor-trainee relationships is not
unique to staff whose job is to administer trainee
programs or services. Therefore, administrative
staff need to both understand these relationships
and think ahead about what role they play.
http://ori.dhhs.gov/education/products/rcradmin/index.html
Modules developed for the Office of Research Integrity (ORI) by
Stephen Erickson, PhD and Karen Muskavitch, PhD
Boston College
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Terms and expectations should be clearly discussed – before (as early
as possible) and ongoing during the research process. Written
agreements are preferable and sometimes, the collaborators'
institutions or funding sponsors will require written agreements
formalizing the research relationship. Likely, administrative staff will
need to be involved. The need for clear communication concerning
the terms of collaborations is increasing as the number of
collaborations increase, and is particularly acute for those that are
interdisciplinary, and/or between academic institutions and private
companies. For interdisciplinary and/or academic-commercial
collaborations, the norms and expectations of the collaborating
parties can be quite disparate and hold a high potential for
misunderstandings, as can multi-national collaborations, where
differing cultural norms come into play.
http://ori.dhhs.gov/education/products/rcradmin/index.html
Modules developed for the Office of Research Integrity (ORI) by
Stephen Erickson, PhD and Karen Muskavitch, PhD
Boston College
 Institutional - Organizational
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Code of Ethics/Conduct
Research Misconduct
Conflicts of Interest
Authorship Guidelines
Data Retention and Access
 ORI – Office of Research Integrity
 NIH – OHRP, OLAW
 NSF
Follow the rules or your heart?