XI. Responsible Conduct in Research
Responsible conduct in research is an imperative for Lesley
University's faculty and students. With or without federal mandate
the institution would embrace the opportunity to augment
educational programming with this very important aspect of
research.
THE NIH: According to the NIH's notice "Update
on the Requirement for Instruction in the Responsible Conduct in
Research" Notice Number: NOT-OD-10-019, dated 11/24/09, upon award
of any NIH Institutional Research Training Grants, Individual
Fellowship Awards, Career Development Awards, Research Education
Grants, Dissertation Research Grants or other grant programs with a
training component that requires instruction in responsible conduct
in research as noted in the Funding Opportunity Announcement, a
formal training program which includes at least 8 hours of contact
hours (face to face engagement) between faculty and trainees is
required. This training program should be provided throughout the
trainees' scientific career and should occur as an undergraduate,
graduate, and post-doc student, as well as during Career Awards and
other milestones in a scientist's career.
THE NSF: Pursuant to the 2007 America COMPETES
Act, the National Science Foundation (NSF) has adopted a new
certification requirement that becomes effective January 4, 2010.
The new NSF Grant Proposal Guide states: "When submitting a
proposal to NSF, the Authorized Organizational Representative is
required to complete a certification that the institution has a
plan to provide appropriate training and oversight in the
responsible and ethical conduct of research to undergraduates,
graduate students, and postdoctoral researchers who will be
supported by NSF to conduct research." The plan must also include a
system to verify that the training has occurred. The plan does not
have to be submitted with proposals, but NSF could request it at
any time- and NSF could audit compliance. Currently, institutions
are free to develop their own plans. For more information, visit the Officeof the Provost website.
To assist faculty in the development of a training program,
Lesley University uses the NIH online training certificate program.
The modules included in the NIH online training can be used to
guide and augment responsible conduct in research training in
addition to face-to-face didactic interactions with students.
Adequate training includes the following components:
a. Conflict of interest: personal, professional, and
financial
b. Policies regarding human subjects, live vertebrate animals 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
(please see LU's policy)
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
It is incumbent upon the Principal Investigator of an NIH and/or
NSF award requiring responsible conduct in research training to
prepare, administer and document the training provided to students
involved in research.
1. Faculty Principal Investigators (PIs) have the primary
responsibility for training the students involved in their
NSF-funded research. The Preliminary Grant Approval Form requires a
signature from any PI who submits an NSF proposal that requests
funding for undergraduate students. This signature indicates that
the PI agrees to participate in appropriate RCR training.
2. Responsible Conduct of Research (RCR) training will be
required for all undergraduate receiving wages (or working as
volunteers) or receiving academic credit for participating in
NSF-funded research. Training must be completed within the semester
or summer that the undergraduate begins work on the NSF-funded
research. RCR training will be documented on a form developed for
that purpose, signed by both the PI and the undergraduate. This RCR
form will be maintained by the Institutional Review Board (IRB)
until the IRB learns that documentation is no longer needed. RCR
training will include the following components:
a) Each student must successfully complete the appropriate NationalInstitute of Health module of RCR training. The National
Institute of Health computer based training option is
available 24 hours a day at no cost. Upon completion of the self-guidedstudy and test a certificate can be printed.
This requirement can be waived by the Associate Dean for
students who have successfully completed an RCR workshop at Lesley
or another institution designed to satisfy NSF's training
requirement or other comparable training; the Associate Dean will
specify what constitutes appropriate documentation in these cases.
Successful completion should be documented by completing the RCRT
Form and attaching a certificate generated by the online training
program or by other documentation acceptable to the Associate
Dean.
b) PIs will certify on the RCRT form that the student has
received RCR training appropriate to the search and discipline.
3. The Finance or Grants Officer will notify the IRB when the
University receives a grant from the National Science Foundation,
providing the name of the PI and the NSF grant number. PIs give the
Associate Dean periodic updates listing the students participating
in the research. The Dean of Faculty will facilitate this process
by sending reminder emails to all faculty who are PIs on NSF grants
at the beginning of each semester and before summer research
begins.
4. The Lesley University academic deans may amend this plan at
any time after consultation with the Associate Provost and/or Dean
of Faculty. Details of any amended plan will be sent to all faculty
with NSF grants, the Grants Officer, the Associate Dean, and the
Finance Office and will be posted on the Provost's website. At a
minimum, the plan will be reviewed and updated annually, no later
than July 1 of each year (beginning July 1, 2010).
5. The Associate Dean in consultation with the Dean of Faculty
and the Associate Provost will make decisions on a case-by-case
basis about students whose only participation in NSF funded
research falls into one of the following situations:
- the active NSF grant funds equipment used in courses to provide
research training
- the active NSF grant funds research that is incorporated into
the research training provided to students in a course
To access the training module, please complete the RCR training
form and follow the RCR training form and follow the instructions
for your RCR training.
RESPONSIBLE CONDUCT OF RESEARCH TRAINING
POLICY
BASIC PRINCIPLES:
Lesley University is committed to the ethical conduct of
research and is in compliance with Section 7009 of the America
Creating Opportunities to Meaningfully Promote Excellence in
Technology, Education and Science (America COMPETES) Act which
requires that an institutional plan be in place to provide
appropriate training and oversight in the responsible and ethical
conduct of research to undergraduate students, graduate students,
and postdoctoral researchers participating in National Science
Foundation (NSF) funded research projects.
APPLICATION:
The Principal Investigator (PI) will be responsible for
providing appropriate RCR training to undergraduate and graduate
students and post doctoral employees who are working on the PI's
NSF-funded projects. At this point, only those students and post
docs who are part of a NSF-funded project are required to undergo
RCR training.
Principal Investigators will be trained on the RCR policy by the
Institutional Review Board (IRB).
DEFINITIONS:
Principal Investigator can also be known as the co-investigator
(for collaborative grants) or the project director and is the
faculty member or administrator responsible for directing the work
of the NSF grant project at Lesley University.
Educational training can be offered as various activities such
as lectures, workshops, online courses, discussion groups, or any
other educational activity approved and tracked by the IRB.
The core instructional areas (modules) of the Responsible
Conduct of Research as indicated by the U.S. Office of Research
Integrity are:
- Data Acquisition, Management, Sharing, and Ownership: Accepted
practices for acquiring and maintaining research data. Proper
methods for record keeping and electronic data collection and
storage in scientific research. Includes defining what constitutes
data; keeping data notebooks or electronic files; data privacy and
confidentiality; data selection, retention, sharing, ownership, and
analysis; data as legal documents and intellectual property,
including copyright laws*.
* See "PHS Policy on Instruction in the Responsible Conduct of
Research": http://ori.dhhs.gov/policies/RCR_Policy.shtml
- Conflicts of Interest and Commitment: The definition of
conficts of interest and how to handle conflicts of interest. Types
of conflicts encountered by researchers and institutions. Includes
topics such as conflicts associated with collaborators,
publication, financial conflicts, obligations to other
constituencies, and other types of conflicts.
- Human Subjects: Issues important in conducting research
involving human subjects. Includes topics such as the definition of
human subjects research, ethical principles for conducting human
subjects research, informed consent, confidentiality, and privacy
of data and patient records, risks and benefits, preparation of a
research protocol, institutional review boards, adherence to study
protocol, proper conduct of the study, and special protections for
targeted populations, e.g., children, minorities, and the
elderly.
- Animal Welfare: Issues important to conducting research
involving animals. Includes topics such as definition of research
involving animals, ethical principles for conducting research on
animals, Federal regulations governing animal research,
institutional animal care and use committees, and treatment of
animals.
- Research Misconduct: (fabrication or falsification of data
including image manipulation, plagiarism). The meaning of research
misconduct and the regulations, policies, and guidelines that
govern research misconduct in PHS-funded institutions. Includes
topics such as fabrication, falsification, and plagiarism; error
vs. intentional misconduct; institutional misconduct policies;
identifying misconduct; procedures for reporting misconduct;
protection of whistleblowers; and outcomes of investigations,
including institutional and Federal actions.
- Publication Practices and Responsible Authorship: The purpose
and importance of scientific publication, and the responsibilities
of the authors. Includes topics such as collaborative work and
assigning appropriate credit, acknowledgements, appropriate
citations, repetitive publications, fragmentary publication,
sufficient description of methods, corrections and retractions,
conventions for deciding upon authors, author responsibilities, and
the pressure to publish.
- Mentor/Trainee Responsibilities: the responsibilities of
mentors and trainees in pre- and postdoctoral research programs.
Includes the role of a mentor, responsibilities of a mentor,
conflicts between mentor and trainee, collaboration and
competition, selection of a mentor, and abusing the mentor/trainee
relationship
- Peer Review: The purpose of peer review is to determine the
merit for research funding and publications. It includes topics
such as, the definition of peer review, impartiality, how peer
review works, editorial boards and ad hoc reviewers,
responsibilities of the reviewers, privileged information and
confidentiality.
- Collaborative Science: A number of research issues may arise
when scientists collaborate. As a result, this approach to science
includes topics such as setting ground rules early in the
collaboration, avoiding authorship disputes, and sharing materials
and information with internal and external science partners.
Only those instructional areas applicable to the grant funded
research project are required to be covered. For example, a
chemistry project might not involve the use of human subjects; the
human subjects module would therefore not be required as part of
the training.
ADMINISTRATION:
Dissemination and administration of these regulations will be
the responsibility of the Associate Provost. The IRB will provide
support in developing and offering training and resources to the
Principal Investigators; track who has been trained; monitor the
regulations; assess the program; make recommendations; and keep
current on federal regulations pertaining to this policy.
RESEARCHER MENTORING PLAN
In order to provide the fullest orientation to research grant
processes and procedures, and to enhance the understanding and
collaboration of all those working on sponsored research, Lesley
University has implemented a Mentoring Plan. Mentoring is required
in the preparation for new faculty ad students, undergraduate,
graduate or post-doctoral, who take part in grant-funded research
projects.
The Mentoring Plan includes the following elements:
- A senior faculty is identified by the Dean of Faculty to serve
as a "Mentor Sponsor" who has responsibility for maintaining
contact with the mentee, providing institutional knowledge, and
acting as the primary resource for any problems or questions that
arise during the research project.
- Mentees and mentors meet before the beginning of a grant
process that involves the mentee. The meeting serves to review key
elements of the Mentoring Plan, to build a community of
researchers, and to present a panel of experienced Lesley
researchers sharing their work.
- Four additional meetings are scheduled within the first
semester a student or post-doc is involved with the project to
cover important information about sponsored research processes.
These sessions are held in 2 1/2 hour blocks, throughout the
semester, and are facilitated by appropriate faculty or research
office personnel. Topics include:
- Preparation of grant proposals and publications. This will
include the review of successful proposals and their publications,
as well as guidelines for turning research questions into
successful proposals.
- Collaborating with researchers from diverse backgrounds and
disciplines. Conversations about intercultural communication and
respect for differences will shape this topic.
- Responsible professional and ethical practices. Based in the
federal guidelines for research with human subjects, this
conversation will center on criteria for ethical practices in
research.
- Guidelines for effective teaching skills. Theory-based practice
based in empirical research relies on connections between research
and practice. This meeting will include strategies for informing
teaching through research.
- Feedback Process: At the end of the semester, an evaluation is
sent to each mentor sponsor and mentee, to gather feedback about
their experience and learning. This evaluation is used to make any
changes in the Mentoring Plan for the next semester.
Download the Responsible Conduct of Research Training Form forStudents and Post-Docs form [PDF].