Responsible Conduct of Research
RCR Fundamentals
Introduction
It is now generally accepted that research must be conducted in
accordance with certain ethical and regulatory mandates. In order
to comply with these mandates, each institution has the obligation
to develop policies for the various aspects of research, to train
members of its research community in the areas relevant to their
activities, and to certify compliance with research policies. Taken
together, these policies and their implementation constitute a fabric
that is often called the responsible conduct of research (RCR).
Strong support for the responsible conduct of research is provided
by several guidances that have been issued by agencies of the Federal
government (e.g. http://www.ori.dhhs.gov/html/programs/finalpolicy.asp,
NIH
Policy on Instruction in the Responsible Conduct of Research).
Although the "mandatory aspects of these policies apply only
to research that is supported by Federal funds, it is strongly recommended
that the program apply to all individuals engaged in research at
the institution."
At Penn, we have developed a number of policies and modules which
set forth institutional guidelines and assist in training members
of the research community, including faculty, postdoctoral fellows,
students, and staff. This material has been brought together on
this website, and is organized according to the rubrics listed above.
It is important to be aware that standard practices and normative
behavior varies in different disciplines. Therefore, some of the
policies or recommended practices may not be universal, and discipline-specific
variants are included under some headings.
Training modules
Under each of the thirteen rubrics we have identified those essential
elements, including orientations, policies, and quizzes, that in
the aggregate should constitute an electronic introduction to Responsible
Conduct of Research. These include training materials from Biomedical
Postdoctoral Programs, supplemented with items from websites at
Penn and, in a few instances, from other institutions. Under each
rubric these “fundamental” elements are marked with
.
Penn’s Biomedical Postdoctoral Programs has developed an
excellent online set of training materials. These include short
orientations about subjects such as laboratory notebooks; authorship;
peer review; human subjects; animal research; research misconduct;
and conflict of interest. In addition, there are a set of quizzes
that can be used to 'certify' that a researcher has reviewed the
training materials and has successfully answered a multiple choice
questionnaire about these subjects. These training materials can
be accessed via the website for Biomedical Postdoctoral Programs,
but the user must have a PENNKEY username and password.
Requirement for National Research Service Awards (NSRAs)
NSRA applications (NIH training grants or stand alone awards for
graduate fellowships) require that the applicant institution certify
that awardees will be trained in the elements of Responsible Conduct
of Research. For the convenience of applicants, we provide prototype
language that can be used to respond to that part of the grant application.
Of course, certification implies that the applicant's Department
or School will provide the training program described in the NIH
grant application, and will be able to document that training on
request. The introductory materials, noted above, will likely meet
the basic requirements for certification of electronic training
in the Responsible Conduct of Research.
Stay tuned
It is anticipated that this site will undergo continuous development
as policies, guidelines, and procedures are developed or modified.
Comments, suggestions, and recommendations of new materials to be
incorporated, are welcomed. These should be addressed to Madeline (Lynn) Alexander
(mmga@upenn.edu or 215-573-2874).
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