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P211: RESPONSIBLE CONDUCT OF RESEARCH (RCR) AND SCHOLARSHIP (RCRS)

Issued by:
Office of the Provost, Office of the Senior Vice President for Health Sciences and Office of the Vice President for Research/Office of Research Compliance
Approved:
December 2016
Updated:
November 2019

I. Policy Statement

The National Institutes of Health (NIH), in NOT-OD-10-019, defines responsible conduct of research "as the practice of scientific investigation with integrity - it involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research". Stony Brook University (SBU) is committed to establishing and maintaining a culture that fosters and values the ethical conduct of research and scholarship. To further this end, SBU requires compliance with federal sponsor training requirements for responsible conduct of research (RCR). Furthermore, SBU requires training in the responsible conduct of research and scholarship (RCRS) across its diverse campus.

II. Federal RCR Guidelines

A. National Institutes of Health (NIH)

NIH Policy: NOT-OD-10-019

NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training grant, career development grant (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research.

Applicable programs include: 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 programs, and any other NIH funded programs supporting research training, career development, or research education that require instruction in RCR per the relevant funding opportunity announcement.

B. National Science Foundation (NSF)

NSF Policy: Section 7009 of America COMPETES Act

NSF requires that all undergraduate students, graduate students, and postdoctoral researchers participating in a research project receive appropriate training and oversight in the responsible conduct of research.

C. United States Department of Agriculture (USDA) - The National Institute of Food and Agriculture (NIFA)

USDA NIFA Policy: 2 CFR Part 422, Sections 2, 3, and 8

USDA requires Principal Investigators, Key Personnel and Investigators to be trained in Responsible Conduct of Research

III. Stony Brook University Guidelines for RCRS

SBU requires that each school/college (academic unit) develop a RCR/RCRS training policy for faculty, research staff, post-docs, research visitors and students involved in research and scholarship (the creation of new knowledge or the creation of novel expressions of knowledge in any form.). These training policies are designated as Complementary Policies (Section IV).

IV. Complementary Policy for RCRS Training

A Complementary Policy defines the academic unit's requirements for completion of RCRS training for their faculty, post-doctoral associates, research staff, graduate students, and undergraduate students involved in research and scholarship (the creation of new knowledge or the creation of novel expressions of knowledge in any form.).

Complementary Policies for each academic unit are available at: https://research.stonybrook.edu/responsible-conduct-research-and-scholarship#complementary-policies-

V. Applicability

  1. All persons subject to Federal RCR Guidelines (Section II); and
  2. All other persons as follows:
    1. Faculty, Post-doctoral Fellows, Research Staff, and Graduate Students as required by their home academic unit's Complementary Policy.
    2. Undergraduate Students
      1. As required by the Vice-Provost for Undergraduate Education; or
      2. As required by an academic unit as part of an educational and/or research program.
    3. Visiting college-level students and visiting scholars who are collaborating on research activities with Stony Brook University faculty, as required by the Complementary Policy of the hosting faculty member's academic unit. For those visitors from another institution, the SBU RCRS training requirement may be waived pending proof of completion of RCRS training at their home institution.

VI. Training Components

There are two training components.

  1. On-line (CITI) Training: RCR modules available through the web-based Collaborative Institutional Training Initiative (CITI).
  2. In Person Training ('IPT'): In general, IPT should promote discussion, foster a climate of ethical conduct of research and scholarly activities, and provide opportunities for training. A successful program includes, as appropriate to the discipline, the following topics:
    • conflict of interest - personal, professional, and financial
    • mentor/mentee responsibilities and relationships
    • collaborative research including collaborations with industry
    • peer review
    • data acquisition and research tools; management, sharing and ownership
    • research misconduct and policies for handling misconduct
    • responsible authorship and publication
    • the scholar as a responsible member of society, contemporary ethical issues and the environmental and societal impacts of research in the discipline
    • policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices

VII. Procedure for Academic Units to Establish Complementary Policy

  1. A Complementary Policy must be developed by the academic unit and submitted to the RCRS Subcommittee for review and approval.
  2. Required in the description of a Complementary Policy are:
    1. Identification of faculty, post-doctoral associates, research staff, graduate students and undergraduate students subject to the on-line training requirements.
    2. Identification of the CITI RCR course(s) to be completed (Biomedical, Social & Behavioral Research, Physical Sciences, Humanities, Engineers)
    3. Identification of faculty, post-doctoral associates, research staff, graduate students and undergraduate students subject to research and scholarship IPT requirements.
    4. Identification of IPT activities/courses.
      1. Academic units should consider formal mechanisms for training, i.e. RCRS coursework/ lecture series/workshops, journal clubs, GRD 500 and similar courses (as available); laboratory rotations; or other curriculum, as well as less formal training opportunities, i.e. faculty meetings; laboratory meetings; faculty/student retreats; departmental research days.
      2. Principal Investigators of federal grants (e.g., NSF, NIH and USDA) with specific RCR requirements will have primary responsibility for ensuring compliance with the applicable agency's RCR training requirements. Exceptions:
        • On grants where a trainee is Principal Investigator, the named faculty mentor retains responsibility for the trainee's compliance with RCR training requirements.
        • On grants where a trainee is Principal Investigator, and there is no named faculty mentor (e.g., K05, K12, K18, KL2 and TU2 programs), the relevant department chair retains responsibility for the trainee's compliance with this RCR training requirement.
    5. Identification of a mechanism for identifying and notifying individuals of their need to renew their IPT training.
    6. Identification of record keeping requirements:
      1. Any activity intended to satisfy the RCR or RCRS training requirement must be supported by appropriate documentation (attendance, topics covered, etc.) either in the central RCRS database (see Section VIII Oversight and Support) or in a departmental database.
      2. Identification of individuals who will be responsible for record keeping of accurate, verifiable information regarding individuals' IPT completion data.

VIII. Oversight and Support

The Office of Research Compliance (ORC) will:

  • Maintain and chair the RCRS Committee and RCRS Subcommittee
    • The RCRS Committee is comprised of a representative from each College/School.
    • A RCRS Subcommittee is a subgroup of the RCRS Committee responsible for reviewing and approving the Complementary Policies
  • Maintain a library of the academic units' Complementary Policies.
  • Maintain an RCRS database, i.e., a tool developed for use by the campus community to help ensure compliance with this policy, allowing designated individuals to enter, monitor, and report training completion data for their academic unit.
  • Conduct or host workshops (upon request) on research involving animal subjects, research involving human subjects, research misconduct, financial conflict of interest, etc., in partial fulfillment of the RCR IPT training requirement.
  • Assist in the development, management and organization of the GRD 500 series across disciplines.
  • Foster collaboration between the disciplines by providing a central repository for sharing of program content (videos/lectures.)
  • Foster collaboration between academic units by hosting an annual workshop meeting for discussion and sharing of RCRS policies and best practices.

Inquiries

Office of Research Compliance (ORC)
Stony Brook University
Stony Brook, New York 11794-3368
Phone (631) 632-9036
Fax: (631) 632-9839

Relevant Standards, Codes, Rules, Regulations, Statutes and Policies


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University Policy Manual @ Stony Brook University