Administrative
Responsibilities/Issues:
Science
is systematic, exact and built on a foundation of trust
and honesty. It is knowledge gleaned from study, experimentation
and observation. For science to provide an understanding
of nature, the utmost integrity must be woven into this
experimentation and the interpretation of its results.
Assurance of the responsible conduct of research lies
not only with the investigator but with all involved in
the conduct and administration of sponsored research activities.
While administrative staff may not have significant control
over some components of research, a basic knowledge of
what constitutes "responsible research" can lay the groundwork
for overall compliance.
- Environmental
health and safety:
In these days of uncertainty, everyone involved in
research should be aware of the policies and procedures
for day-to-day laboratory safety, and in the event
of a large scale emergency. Often, both faculty and
staff turn to their administrative staff for direction
in these situations. Administrators need to be aware
of the policies and procedures for emergency response,
fire, industrial accidents, biosafety hazards and
pest control. Information to assist administrators
on any of these issues can be found on the Environmental
Health and Safety website (http://www.safety.rochester.edu)
and in Section 2. Administrators
should strive to act proactively with regard to environmental
health and safety as opposed to reactively.
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Use and protection of human subjects:
Protecting human subjects is not usually a task found
in the job description of a research administrator.
However, a knowledgeable administrator can be of considerable
assistance to an investigator proposing the use of
human subjects, and to a study coordinator. Helpful
information on how to submit a proposal to the University
of Rochester’s Office for the Human Subject Protection,
RSRB forms and guidelines, HSPP educational information
and regulations and references can be found on their
website (http://www.urmc.rochester.edu/rsrb).
Administrators should become familiar with the information
found on this site and encourage their investigators
to review this information before drafting their protocol
and consent forms.
Maintaining
compliance is difficult given the volume of
regulations, guidelines, policies and ever increasing
demands on the investigator’s time. It is important
to remember that subjects cannot be enrolled
without an active RSRB approval. Administrators
may find it helpful to create a database of
approval numbers and expiration dates for their
investigators. Every investigator would appreciate
a helpful reminder to keep their RSRB approvals
active. Additional information on the regulations
that govern the use of human subjects in research
can be found on the website of the Office for
Human Research Protections (OHRP) at the following
url: http://www.hhs.gov/ohrp
.
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Use and protection of animals:
Scientists conduct research on animals because the
risk to humans is too high. Although some members
of society question whether this decision is an ethical
one, the majority accept the necessity of animal research
but insist that it be conducted in a humane manner.
Administrators should stress the importance of the
humane treatment of animals to all of their investigators.
An approval by the University Committee on Animal
Resources is required before research using animals
can commence. Information on how to submit studies
to UCAR for approval can be found on their website
(http://www.urmc.rochester.edu/ucar).
Annual reports to UCAR are required to continue research
using animals. Administrators may want to consider
developing a data base to track the UCAR approval
numbers and their expiration date for their investigators.
Every investigator would appreciate a helpful reminder
to keep their UCAR approvals active. Administrators
should ensure that anyone working with animals have
successfully completed the training required by the
University Committee on Animal Resources.
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Conflicts of interest:
Conflict of interest is a term that encompasses a
wide spectrum of behaviors or actions involving personal
gain or financial interest. A conflict of interest
exists when an individual exploits, or appears to
exploit their position for personal gain or for the
profit of a family member. The University of Rochester
conflict of interest policy (http://www.rochester.edu/ORPA/policies/)
prohibits activities that create even the appearance
of a conflict of interest. Full disclosure is the
only means to address conflict of interest, whether
real or perceived. Administrators must ensure that
all investigators (please see the definition in the
Faculty Policy on Conflict of Commitment and Interest)
complete and sign an annual conflict of interest disclosure
form (http://www.rochester.edu/ORPA/policies/),
that their departmental chair or center director reviews
all completed forms and that disclosures of conflict
are disclosed to the Dean’s office. Administrators
should be prepared to assist in the development of
a plan to manage the disclosed conflict.
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Publication:
The publication of experimental work accomplishes
several things. It reports new scientific findings;
allows for the evaluation of results; credits other
scientists and enables others to extend or repeat
work; attributes credit for the work to the authors
and even more importantly, establishes who accepts
responsibility for the work. Publishing helps scientists
win grants, promotions, tenure, higher compensation
and professional prestige. A common saying in science,
“publish or perish” can be all too true. Scientists
often feel pressured to publish. Science benefits
society only insofar as its findings are made public.
The
duties and responsibilities of authorship are not
to be taken lightly. Determination of authorship is
an important issue. In general, authors must contribute
to the published work in some way. Defining the responsibilities
of authorship can present a problem. If a published
work contains an honest mistake the result of which
is a significant impact on the paper’s scientific
message and the mistake is attributed to one author,
are all authors responsible for the mistake as well?
Administrators should encourage authors to read and
understand the “instructions to authors” provided
by scientific journals to ensure that those applicable
sponsors are acknowledged on published works, including
posters and abstracts. Proper identification of authorship
is particularly important because authorship can play
a critical role in identifying scientific participants
on projects, invention disclosures and subsequent
royalty payments, and scientific and fiscal accountability
during the life of the project and for audit issues.
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Data and Intellectual property:
The determination of ownership of research data begins
with one question: Who collected the data? However,
equally important is a second question: Under whose
intellectual direction and guidance were the data
collected? A third question that must be asked is:
Is there a valid obligation to assign the rights of
the data to another? When PHS awards a grant to the
University, all data collected as part of that grant
belongs to the University. Grants may be transferred
from one institution to another in the event that
the Principal Investigator relocates, but this transfer
must be approved by the original grantee institution
as well as the sponsor. Laboratory personnel, including
trainees should never be allowed to take their original
data notebooks with them when they leave the institution
to begin a new career. The removal of copies may be
permitted to allow the trainee to prepare papers or
manuscripts but always only with the permission of
the principal investigator. The University of Rochester
has specific policies regarding access to and retention
of research data and the freedom of information act.
(http://www.rochester.edu/ORPA/policies/recgrid.html)
A
copyright exists the instant the author’s words/actions
are rendered into some tangible form. The owner
of a copyright (the author) has exclusive rights
over reproduction, distribution, sale and public
performance of the work. Co-authors own the copyright
on their portion of the work. Current copyright
law states that “fair use” of copyrighted material
will not constitute an act of infringement. The
definition of “fair use” states that the copying
and use of copyrighted material must be of a personal,
nonprofit nature ( ie: criticism, news reporting,
teaching, research or scholarship). Any questions
regarding “fair use” should be directed to the University’s
Office of Counsel.
A
patent is a grant to an applicant for a specific
and limited period of time during which the
grantee has a legal right to exclude others
from making, using or selling his or her claimed
invention in exchange for the grantee’s provision
of a full disclosure as to how the invention
may be made, used or functions. In short, it
is a reward for disclosing something of social
value to the public. A patent is governed by
explicit law. The point in time to file a patent
is as soon as the inventor is able to provide
the full and complete disclosure. The University
of Rochester’s Office(s) for Technology Transfer
(medical
center - http://www.urmc.rochester.edu/techtransfer/ ,
or campus - http://www.rochester.edu/ott/)
are responsible for the management of intellectual
property resources at the University of Rochester.
Principal Investigators should be encouraged
to contact the Office of Technology Transfer
as early as possible if they believe they
have intellectual property that could be
patented and/or commercialized.
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Error, negligence or misconduct:
Even the most responsible scientist can make an honest
mistake. When such errors are discovered, they should
be acknowledged in the same journal in which the mistaken
information was originally published. Mistakes made
through negligent work are a different story. If scientists
cut corners for whatever reason, they are placing
their reputation and the public’s confidence in science
at risk. Beyond honest errors and errors caused through
negligence are another category of errors, those that
involve deception. These acts of scientific misconduct
undermine progress and the entire set of values on
which science rests.
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Response to violations of ethical standards:
Encountering or witnessing a violation of the ethical
standards of the research community can be one of
the most difficult situations one can face. In this
situation it is easy to find an excuse to do nothing,
but someone who has witnessed this type of misconduct
has an unmistakable responsibility to act. The federal
government requires that all research institutions
that receive public funds for research have a policy
in place to deal with allegations of unethical research
(http://www.rochester.edu/ORPA/policies/).
In addition, these same funding agencies enforce their
own laws and regulations that deal with misconduct
in science (http://www.rochester.edu/ORPA/Regulations/debarmen.htm).
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Collaborative research:
Collaborative research presents several advantages.
By combining unique expertise, resources and technology,
investigators are empowered to tackle problems that
are not conducive to a singular experimental approach.
Collaborative research can occur between researchers
in different departments at the same institution,
between researchers located at different institutions,
and between industry and the University. While almost
always a positive approach, collaborative research
also comes with its share of challenges. The rules
of engagement involving collaborative arrangements
must always be clearly stated and understood. Departmental
research administrators can assist their investigators
by stressing the importance of formalizing research
collaborations in writing whenever possible.
Much
of what is called collaborative research is interdisciplinary
and often interdepartmental. Unfortunately, collaborations
may be viewed and misconstrued as undermining the
traditional departmental infrastructure. This perception
can be somewhat alleviated by insuring that University
signoff procedures are followed for grant submissions.
These signoff procedures insure that all departments
have reviewed and agreed to the collaborative research
as well as the financial considerations.
Collaborative research between different institutions
must begin with an understanding, on the part
of both the researchers and the institutions,
of the responsibilities on each side of the collaboration.
This understanding should be documented by a formal
letter acknowledging the collaboration and providing
assurance that the subcontractor will follow all
appropriate policies and regulations. The Office
of Research and Project Administration will provide
such a letter during the required proposal signoff
process.
When
collaborative research occurs between industry
and the University, concerns arise regarding
the sharing of research resources, restrictions
on public disclosure and publication of the
research. For these types of collaborations,
a formal collaborative agreement should be utilized.
The types of issues that should be addressed
in this type of agreement include: the goals
of the research, the responsibilities of the
collaborating parties, a timeline for completion
of the stated goals, statements regarding accountability
and authorship as well as ownership of data.
The Office of Research and Project Administration
can assist in the development of these agreements
and is responsible for the negotiation of these
agreements.
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Mentoring:
The word mentor means a loyal and trusted friend,
enlightened advisor and teacher. In the research environment,
a mentor is someone who is responsible for the guidance
and academic, technical and ethical development of
a trainee. Mentoring is more than just advising. Mentors
inform, instruct and provide an example for their
trainees. The actions and activities of mentors affect
the attitude of their trainees to such degree that
trainees often assume the traits and values of their
mentors.
The mentor is responsible for providing trainees with
all relevant rules, regulations and guidelines that
may apply to the conduct of research. Administrators
can assist mentors by helping them keep abreast of
changes in these rules, regulations and guidelines
as they occur. Students, post-docs and even laboratory
technical staff can be mentored. Administrators should
introduce themselves to those being mentored to allow
the mentee to understand there is someone other than
their mentor they can go for guidance and information.
- Training
in the Ethical Conduct of Research:
The University of Rochester requires that graduate
students and postdoctoral fellows attend the “Ethics
in Research” course offered each fall. This class
is offered at no cost. Administrative and technical
staff are invited to attend these classes as well.
Information on the course can be found at the following
url: http://www.urmc.rochester.edu/neuroscigrad/courses.html#1501.
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