Butler University promotes the responsible conduct of research
through high standards of ethics and accountability in planning,
conducting and reporting research. The responsible conduct of
research is demonstrated through behavior that meets generally
accepted standards. These standards are set forth by state and
federal regulations, institutional policies, professional codes of
conduct and personal convictions. The building blocks of
responsible conduct of research include:
On Aug. 20, 2009, the National Science Foundation
(NSF) published (74 FR
42126) a new requirement for RCR education. For proposals
submitted on or after Jan. 4, 2010 and subsequently awarded,
institutions are responsible for verifying that undergraduate
students, graduate students and post-doctoral researchers supported
by NSF to conduct research have received (RCR) training. At this
time Butler is using the CITI RCR online program to meet
the NSF requirement. See below for information on the CITI
education.
For NSF awards resulting from proposals submitted on or after
Jan. 4, 2010, RCR education needs to be completed by
undergraduates, graduate students and post-doctoral researchers
prior to them receiving any financial support from the
award. It does not need to be completed at the time the
proposal is submitted. If the NSF application requires a
description of the RCR education program at Butler you may use this
standard
language as a guide.
The National Institutes of Health (NIH) also
requires RCR education for certain types of awards [Institutional
Research Training Grants, Individual Fellowship Awards, Career
Development Awards (Institutional and Individual), Research
Education Grants, Dissertation Research Grants and other grant
programs with a training component that requires instruction in
responsible conduct of research]. The recently updated
NIH Policy on Responsible Conduct of Research
Education took effect with all new and renewal
applications submitted on or after Jan. 25, 2010, and for all
continuation (Type 5) applications with deadlines on or after Jan.
1, 2011. The CITI RCR modules may be used to partially satisfy the
NIH requirements.
NIH Policy
NIH requires that all trainees, fellows, participants, and
scholars receiving support through any NIH training, career
development award (individual or institutional), research education
grant, and dissertation research grant must receive instruction in
responsible conduct of research. This policy will take effect with
all new and renewal applications submitted on or after January 25,
2010, and for all continuation (Type 5) applications with deadlines
on or after January 1, 2011. This Notice applies to the following
programs: D43, D71, F05, F30, F31, F32, F33, F34, F37, F38, K01,
K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30,
K99/R00, KL1, KL2, R25, R36, T15, T32, T34, T35, T36, T37, T90/R90,
TL1, TU2, and U2R.This policy also applies to any other NIH-funded
programs supporting research training, career development, or
research education that require instruction in responsible conduct
of research as stated in the relevant funding opportunity
announcements.
Instructional Components
NIH recognizes that instruction in responsible conduct of
research occurs formally and informally in educational settings and
that informal instruction occurs throughout the research training
experience. The guidance provided below is directed at formal
instruction in responsible conduct of research. It reflects the
accumulated experiences and the best practices of the scientific
community over the past two decades. These practices have been
incorporated into many of the best regarded programs of instruction
in responsible conduct of research.
1. Format:Substantial
face-to-face discussions among the participating
trainees/fellows/scholars/participants; a combination of didactic
and small-group discussions (e.g. case studies); and participation
of research training faculty members in instruction in responsible
conduct of research are highly encouraged. While on-line courses
can be a valuable supplement to instruction in responsible conduct
of research, online instruction is not considered adequate as the
sole means of instruction. A plan that employs only online
coursework for instruction in responsible conduct of research will
not be considered acceptable, except in special instances of
short-term training programs (see below), or unusual and
well-justified circumstances.
2. Subject Matter:While there
are no specific curricular requirements for instruction in
responsible conduct of research, the following topics have been
incorporated into most acceptable plans for such instruction:
a. conflict of interest -
personal, professional, and financial
b. policies regarding human
subjects, live vertebrate animal subjects in research, and safe
laboratory practices
c. mentor/mentee
responsibilities and relationships
d. collaborative research
including collaborations with industry
e. peer review
f. data acquisition
and laboratory tools; management, sharing and ownership
g. research misconduct and
policies for handling misconduct
h. responsible authorship and
publication
i. the scientist as a
responsible member of society, contemporary ethical issues in
biomedical research, and the environmental and societal impacts of
scientific research
While courses related to professional ethics, ethical issues in
clinical research, or research involving vertebrate animals may
form a part of instruction in responsible conduct of research, they
generally are not sufficient to cover all of the above topics.
Additional detail regarding subject matter is available under
Resources.
3. Faculty
Participation:Training faculty and sponsors/mentors are highly
encouraged to contribute both to formal and informal instruction in
responsible conduct of research. Informal instruction occurs in the
course of laboratory interactions and in other informal situations
throughout the year. Training faculty may contribute to formal
instruction in responsible conduct of research as discussion
leaders, speakers, lecturers, and/or course directors. Rotation of
training faculty as course directors, instructors, and/or
discussion leaders may be a useful way to achieve the ideal of full
faculty participation in formal responsible conduct of research
courses over a period of time.
4. Duration of
Instruction:Instruction should involve substantive contact hours
between the trainees/fellows/scholars/participants and the
participating faculty. Acceptable programs generally involve at
least eight contact hours. A semester-long series of
seminars/programs may be more effective than a single seminar or
one-day workshop because it is expected that topics will then be
considered in sufficient depth, learning will be better
consolidated, and the subject matter will be synthesized within a
broader conceptual framework.
5. Frequency of
Instruction:Reflection on responsible conduct of research should
recur throughout a scientist's career: at the undergraduate,
post-baccalaureate, pre-doctoral, postdoctoral, and faculty levels.
Institutional training programs and individual fellows/scholars are
strongly encouraged to consider how to optimize instruction in
responsible conduct of research for the particular career stage(s)
of the individual(s) involved. Instruction must be undertaken at
least once during each career stage, and at a frequency of no less
than once every four years. It is highly encouraged that initial
instruction during predoctoral training occurs as early as possible
in graduate school. Individuals at the early career investigator
level (including mentored K awardees and K12 scholars) must receive
instruction in responsible conduct of research at least once during
this career stage. Senior fellows and career award recipients
(including F33, K02, K05, and K24 awardees) may fulfill the
requirement for instruction in responsible conduct of research by
participating as lecturers and discussion leaders. To meet the
above requirements, instruction in responsible conduct of research
may take place, in appropriate circumstances, in a year when the
trainee, fellow or career award recipient is not actually supported
by an NIH grant. This instruction can be documented as described
below.
Special Considerations by Type of Award
Institutional training and institutional career development
programs (for example, T15, T32, T34, T90/R90, TL1, K12, or K30
programs):Institutional programs are encouraged to provide
instruction in responsible conduct of research for all individuals
associated with the program of training regardless of their source
of support.
Short-term training and research education programs (for
example, T35 and R25 programs lasting six or fewer months,
short-term trainees supported on T15, T32 and T34 programs, and
short-term participants in R25 programs):The NIH recognizes that
the duration of an institutional training or research education
program should be considered in the design, implementation, and
review of plans for instruction in responsible conduct of research.
The duration of such instruction within short-term institutional
programs should be appropriate for the total duration of the
program and should be justified in the application. This is an
instance where on-line instruction could be appropriate. Such
programs may also use innovative strategies to incorporate
instruction in responsible conduct of research and to relate
instruction in responsible conduct of research to the scientific
focus of the short-term program.
Individual awards:In keeping with the individual nature of these
programs, fellows and scholars, along with their institutions and
sponsors/mentors, are encouraged to tailor instruction in
responsible conduct of research to the needs of the individual.
Thus, instruction may go beyond formal institutional courses and
provide opportunities for the individual to develop their own
scholarly understanding of the ethical issues associated with their
research activities and their impact on society. An individualized
plan would also be appropriate in the rare instance where an
institution does not have an established formal mechanism for such
instruction.
Application Procedures
1. Institutional
Applications
a. New (Type 1) applications
must include a plan for instruction in responsible conduct of
research. In addition to addressing the five instructional
components, the plan must describe how participation in instruction
in responsible conduct of research will be monitored.
b. Renewal (Type 2) applications
must, in addition, describe changes in formal instruction over the
past project period and plans for the future that address any
weaknesses in the current instruction in responsible conduct of
research. All training faculty who served as course directors,
speakers, lecturers, and/or discussion leaders during the past
project period must be named in the application
2. Individual
Applications
a. New (Type 1) applications
must include a section on instruction in responsible conduct of
research, appropriate to the career stage of the applicant
(instruction for applicants in the early stages of their careers;
participation as course directors, lecturers, or discussion leaders
for applicants in middle or senior stages of their careers), as
part of the Research Training Plan or Candidate Information and
Career Development Plan. This section will document prior
participation or instruction in responsible conduct of research
during the applicant's current career stage (including the date
instruction was last completed) and propose plans to either receive
instruction in responsible conduct of research or participate as a
course lecturer, etc., depending on the applicant's career stage.
Such plans must address the five instructional components outlined
above. The plan may include career stage-appropriate,
individualized instruction or independent scholarly activities that
will enhance the applicant's understanding of ethical issues
related to their specific research activities and the societal
impact of that research. The role of the sponsor/mentor in
instruction in responsible conduct of research must be
described.
b. Where applicable, renewal (Type
2) applications must describe instruction in responsible conduct of
research activities undertaken during the past project period as
well as future plans in order to meet the frequency requirement as
outlined above in Instructional Components.
Applications lacking a plan for instruction in responsible
conduct of research will be considered incomplete and may be
delayed in the review process or not reviewed.
Peer Review
Reviewers will evaluate plans for instruction in responsible
conduct of research as well as the past record of instruction in
responsible conduct of research, where applicable. Reviewers will
specifically address the five Instructional Components (Format,
Subject Matter, Faculty Participation, Duration and Frequency)
taking into account the characteristics of institutional programs
or the unique circumstances outlined for short-term training
programs, individual fellowships, career awards, and research
education programs. The review will be guided ultimately by the
principles set forth at the beginning of this Notice.
The plan for instruction in responsible conduct of research and
the past record of instruction in responsible conduct of research,
where applicable, will be discussed after the overall determination
of merit of the application at large; the review panel's evaluation
of the plan will not be a factor in the determination of the
impact/priority score. Plans and past record will be rated
asACCEPTABLEorUNACCEPTABLE.The results of the review of the plan
for instruction in responsible conduct of research and the past
record of instruction in responsible conduct of research, where
applicable, will be reported as an administrative note in the
summary statement and will explain how the review panel determined
its rating. Regardless of the impact/priority score, applications
with unacceptable plans will not be funded until the applicant
provides an acceptable, revised plan. Institute or Center staff
will apply the principles set forth at the beginning of this Notice
to determine the acceptability of the revised plan.
Reporting Requirements
For Institutional Training, Education, and Institutional Career
Development Awards:
Continuation (Type 5) applications must describe the nature of
the instruction in responsible conduct of research and the extent
of trainee and faculty participation as required in the PHS 2590.
This report must include a description of any enhancements and/or
modifications to the five instructional components from the plan
described in the awarded application. Specific training faculty
members who were contributors to formal instruction in responsible
conduct of research during the last budget period must be
named.
For Individual Fellowships:
Continuation (Type 5) applications must report specifically on
instruction for the fellow in responsible conduct of research. This
report must include subject matter covered, format, frequency and
duration of instruction, or indicate when during a previous or
future budget period instruction in responsible conduct of research
did or will take place. The report should discuss both formal
and/or informal instruction in responsible conduct of research and
should note the extent to which the sponsor or senior fellow
participated in these activities.
For Individual Career Development Awards:
Continuation (Type 5) applications must include a description of
instruction in responsible conduct of research as required in the
PHS 2590. This report should describe instruction, or participation
as a course director, etc. in the case of senior career awardees,
in both formal and informal instruction in responsible conduct of
research in the past budget period, if applicable. If instruction,
or participation as a course director, etc., occurred in a prior
budget period, the PI should note the date of occurrence. Any
activities undertaken to individualize instruction appropriate to
the career stage of the PI should be discussed.
For Dissertation Awards (R36):
Continuation (Type 5) applications must report on instruction in
responsible conduct of research under a separate heading. This
section should describe participation in both formal and informal
instruction in responsible conduct of research in the past budget
period, where applicable. If instruction occurred in a prior budget
period, the PI should note the date when formal instruction was
last completed. Any activities undertaken to individualize
instruction appropriate to the career stage of the PI should be
discussed. The report will describe how the mentor participated in
these activities.
Compliance
NIH policy requires participation in and successful completion
of instruction in responsible conduct of research by individuals
supported by any NIH training/research education/fellowship/career
award. It is expected that course attendance is monitored and that
a certificate or documentation of participation is available upon
course completion. NIH does not require certification of compliance
or submission of documentation, but expects institutions to
maintain records sufficient to demonstrate that NIH-supported
trainees, fellows, and scholars have received the required
instruction.
Resources
The NIH Research Training website (http://grants.nih.gov/training/extramural.htm)
includes additional information on instruction in responsible
conduct of research and links to the Office of Research Integrity
(http://ori.hhs.gov/), links to
instructional materials, and examples of programs that have been
regarded as good models for instruction in responsible conduct of
research (http://bioethics.od.nih.gov/researchethics.html).
The National Academy Press has just published the 3rd. edition of
the classic, On Being a Scientist, and is available online at http://books.nap.edu/catalog.php?record_id=12192.
Program Update
Inquiries
Questions concerning this Notice should be directed to:
Rod Ulane, Ph.D.
NIH Research Training Officer
Director, Division of Scientific Programs
Office of Extramural Programs
National Institutes of Health
Phone: 301-496-3255
Email: ulanere@mail.nih.gov