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Grants

Policy on Responsible Conduct of Research for Federally Funded Research

To promote objectivity in research and foster compliance with federal regulations, it is the policy of Illinois Wesleyan University to ensure that all faculty and students engaged in federally funded research are compliant in the following Responsible Conduct of Research Policy. This policy fulfills the requirements of grantee institutions as set forth in the National Institutes of Health guidelines1 and The National Science Foundation’s policies2. Faculty and staff supported by federal funding to conduct research or supervise student researchers (paid or volunteer) are responsible for ensuring that all work is done in compliance with the IWU Responsible Conduct of Research Policy and governmental regulations.

Contents
  1. Regulations for RCR Applicable to NSF
  2. Regulations for RCR Applicable to NIH
  3. Required RCR Topics & Training Plan
    1. Financial Conflict of Interest
    2. Protection of Human Research Subjects
    3. Research with Vertebrate Animals
    4. Research Misconduct
  4. Additional Resources

 

  1.  Regulations for Responsible Conduct of Research Applicable to National Science Foundation: Pursuant to the America COMPETES Act, Section 7009, August 20, 2009, “The Institution receiving NSF grant funds in which undergraduate, graduate students or post docs are listed as research personnel must provide RCR training to those individuals.”  The NSF adopted a certification requirement that became effective 1/4/2010. It reads, “The Institution certifies at time of application that it has a plan in place to provide appropriate training and oversight on the Responsible Conduct of Research to NSF-supported undergrads, grad students and postdoctoral researchers; has designated an individual to oversee compliance; and is able to verify the delivery of the training.” NSF may request this plan at any time and may audit compliance.
    1. Background: The responsible and ethical conduct of research (RCR) is critical for excellence, as well as
      public trust, in science and engineering. Consequently, education in RCR is considered essential in the
      preparation of future scientists and engineers. Section 7009 of the America Creating Opportunities to
      Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act (42 U.S.C.
      1862o–1 requires that ‘‘each institution that applies for financial assistance from the Foundation for
      science and engineering research or education describe in its grant proposal a plan to provide
      appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project.”
    2. Institutional Responsibilities
      1. An institution must have a plan in place 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. As noted in GPG Chapter II.C.1e, institutional certification to this effect is required for each proposal.
      2. While training plans are not required to be included in proposals submitted to NSF, institutions
        are advised that they are subject to review, upon request.
      3. An institution must designate one or more persons to oversee compliance with the RCR training
        requirement.
      4. Institutions are responsible for verifying that undergraduate students, graduate students, and
        postdoctoral researchers supported by NSF to conduct research have received training in the
        responsible and ethical conduct of research.
  2. Regulations for Responsible Conduct of Research Application to National Institutes of Health
    1. Background: Nov. 24, 2009 NIH published “An Update on the Requirements for Instruction in
      Responsible Conduct in Research” NIH requires that any and all trainees, fellows, participants, and
      scholars receiving support through NIH training, career development, research education, dissertation
      grant or award must receive RCR training. 
    2. Institutional Responsibility: Training must occur no less than every four years for faculty. 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. Plans to meet the RCR requirement must now be included in most NIH proposal applications. That plan requires information on format, subject matter, faculty participation, duration and frequency. The GFR Office will assist the PI to ensure all requirements are met by the training plan. At the time the External Grant Proposal Review form is submitted for approval, the PI must sign to indicate agreement to include a training plan regarding RCR in the proposal and implement it with participating faculty and/or students.
  3. Required RCR Topics and Training Plan: Faculty PI’s have the primary responsibility for training
    student researchers. At the time the External Grant Proposal Review form is submitted for approval, the PI must sign to indicate agreement to include training to participating students in appropriate RCR. The GFR Office will provide compliance oversight and record retention, with guidance from the Provost when necessary. 

    All Federally Funded Research Awards:
    • RCR training appropriate to the research and discipline is required for all students receiving
      wages (stipend or work study), working as volunteers, or receiving academic credit for
      participating in funded research. Completion of training is required within the semester or
      summer that the student begins work on the funded research.
      • Completion of student researcher training plan:
        • Online modules: FCOI, Human Subjects, Animal Subjects, Research Misconduct,
          others as research dictates via National Ethics Center, www.nationalethicscenter.org using IWU Grants group log in. 
      • Login and password for accessing the online account is located on the student
        researcher training plan form, which contains PI Certification (signature) that student
        has received RCR training appropriate to the research, discipline and level of
        involvement for each student and has completed the Financial Conflict of Interest for
        Federally Funded Grants policy and the FCOI Disclosure Form.
    • PI’s are required to maintain a current listing of students participating in research. GFR Office
      will maintain records of completed training in each grant’s respective file.
    All Federally Funded Research Awards:

    NIH Awards:

    Certain topics are required (in bold) and the additional topics are encouraged and have been incorporated into acceptable plans of instruction:
      • Conflict of interest – personal, professional and financial
      • Policies regarding human subjects*, live vertebrate animals* in research and safe laboratory
        practices
      • Mentor-mentee responsibilities and relationships
      • Collaborative research, including collaborations with industry
      • Peer review
      • Data acquisition and laboratory tools; management, sharing and ownership
      • Research misconduct and policies for handling misconduct
      • Responsible authorship and publication
      • The scientist as a responsible member of society, contemporary ethical issues in biomedical
        research, and the environmental and societal impacts of scientific research.

*When applicable to research

    1. Financial Conflict of Interest: Faculty and Students conducting research under NIH supported
      projects must complete the online tutorial in Financial Conflict of Interest.

      Once completed, each participant should send a copy of their certificate to the PI/PD, who will
      file it with grant documents in the shared digital grants folder.

      In addition to Illinois Wesleyan University’s Conflict of Interest Policy, PI/PD’s and students
      working on federally-funded research must also be educated on the Financial Conflict of Interest
      for Federally Funded Grants policy in Faculty Grants Manual and sign the FCOI Disclosure Form
      on an annual basis or when indicated by a change in circumstance. The regulation covers all
      financial interests that have monetary value, whether or not the value is readily ascertainable.
      Please see the Financial Conflict of Interest for Federally Funded Grants Policy in the Faculty
      Grants Manual. The PI/PD will maintain signed forms and supporting documentation in each
      shared digital grants folder.

      The education requirement does not apply to awards that do not involve human subjects. But it
      is important for all investigators, even those working with tissues or specimens derived from human sources to understand when proposed research triggers regulatory and policy requirements. Research using human specimens, tissues, or data that are unidentifiable may not be considered human subjects research. NIH provides Guidance on Research Involving Coded Private Information or Biological Specimens to assist in determining. Investigators who conduct studies with human specimens, tissues, or data that are determined not to involve human subjects are not required to receive the required education.

      Grantees must certify that an education program in the protection of human subjects has been
      completed (when required). NIH’s Office of Extramural Research provides the online tutorial
      PHRP – Protecting Human Research Participants, which provides a certificate upon completion.
      Once completed, each participant should send a copy of their certificate of completion to their
      PI/PD, who will file it with grant documents in the shared digital grants folder.

    2. Research with Vertebrate Animals: In addition to following the IWU Faculty Handbook’s Policy for
      the Humane Care and Use of Laboratory Animals, PI’s conducting NIH funded research with
      vertebrate animals must follow the PHS Policy on Humane Care and Use of Laboratory Animals,
      2002 and the Guide for the Care and Use of Laboratory Animals, 8th Edition. An online tutorial
      PHS Policy on Humane Care and Use of Laboratory Animals by the Office of Animal Laboratory
      Welfare (OLAW) must be completed by researchers (faculty and student) prior to the
      expenditure of any grant funds. Once completed, each participant should send a copy of their
      certificate of completion to their PI/PD, who will file it with grant documents in the shared
      digital grants folder.

    3. Research Misconduct: Illinois Wesleyan University seeks to prevent any instance of research
      misconduct and take seriously the need to investigate possible instances, while protecting the
      positions and reputations of those who file complaints in good faith, any witnesses and those
      asked to serve on committees so that any necessary investigations can proceed without fear or
      favor.

      Research Misconduct is defined as: “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.

      Cases of alleged research misconduct will be handled in the manner outlined in the IWU Faculty
      Handbook; Policy Statements on Research, Process for Disclosure, Process for Adjudication of
      Complaints Stemming from Disclosure, Disciplinary Actions and the IWU Whistleblower Policy
  1. Additional Resources
    PI's may utilize resources available on NIH’s Office of Extramural Research Financial Conflict of Interest
    web page and Protecting Human Research Participants (PHRP) to satisfy some of the training
    requirements. However, IWU’s GFR Office will also provide additional training regarding Investigator’s responsibilities for disclosure of Significant Financial Interests and of the IWU policy on financial
    conflicts of interests for federally funded research. This training will occur with PI’s prior to expenditure
    of any funds.

    Office of Research Integrity (ORI) of the DHHS has RCR resources from different disciplines, appropriate to different levels of student involvement. Also check the ORI Introduction to the Responsible Conduct of Research for appropriate material.

    Tools and Resources for National Science Foundation (NSF) requirements for Responsible Conduct of Research (RCR) is a searchable resource database for articles, training and more information by disciple, audience and topic area.

1 http://www.grants.nih.gov/grants/policy
2 https://www.nsf.gov/pubs/policydocs/pappg17_1/index.jsp