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Listing of Responsible Conduct of Research (RCR) Courses at UNC-CH and other RCR training opportunities

Background

Public trust in the integrity and ethical behavior of scholars must be maintained if research is to continue to play its proper role in our University and society. It is the policy of the University of North Carolina at Chapel Hill that its research be carried out with the highest standards of integrity and ethical behavior.

— Adapted from the University of North Carolina at Chapel Hill Policy and Procedures on Responding to Allegations of Research Misconduct and the University of North Carolina at Chapel Hill Policy on Research Code of Conduct.

Responsible Conduct of Research (RCR) is broadly defined as the application of best practices in the proposing, performing, or reviewing research, or in reporting research results regardless of the scientific or scholarly discipline. RCR encompasses responsible and ethical conduct of research and of research compliance. The latter is comprised of complying with all applicable laws, regulations and policies governing research, including but not limited to human subjects, use of animals in research, export control, conflict of interest (personal, professional, and financial), and safe laboratory practices as examples. The NIH defines RCR 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.”

Instruction in responsible conduct of research or RCR training has emerged as the vehicle to provide researchers in biomedical, behavioral and clinical sciences across the research career lifespan (undergraduate, graduate, postdoc, staff and faculty) with foundational knowledge on institutional policies, best research practices and in fostering a culture of research integrity.

While there is emphasis on RCR training as meeting requirements associated with institutionsʼ obligations to federal funding agencies (NIH and NSF as examples), RCR training is seen as beneficial to all individuals engaged in research regardless of funding.


Synopsis of Federal Requirements for RCR Training

“The 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.” Through the notice published in 2010, NOT-OD-10-019, the NIH defines the basic principles, policy, instruction components, and other special considerations by award type, applications for individual and institutional awards, reporting requirements and compliance for instruction of RCR.

Among the federal agencies that provide research training support, the NIH has greater compliance requirements. Therefore, those key points will be presented first and are also provided in detail through the link to NOT-OD-10-019 below.


Basic Principles of NIH RCR Training Requirements

The following principles are based on several key concepts about responsible conduct of research and best practices that have evolved over the past two decadesʼ experiences:

  1. Responsible conduct of research is an essential component of research training. Therefore, instruction in responsible conduct of research is an integral part of all research training programs, and its evaluation will impact funding decisions.
  2. Active involvement in the issues of responsible conduct of research should occur throughout a scientistʼs career. Instruction in responsible conduct of research should therefore be appropriate to the career stage of the individuals receiving training.
  3. Individuals supported by individual funding opportunities such as fellowships and career development awards are encouraged to assume individual and personal responsibility for their instruction in responsible conduct of research.
  4. Research faculty of the institution should participate in instruction in responsible conduct of research in ways that allow them to serve as effective role models for their trainees, fellows, and scholars.
  5. Instruction should include face-to-face discussions by course participants and faculty; i.e., on-line instruction may be a component of instruction in responsible conduct of research but is not sufficient to meet the NIH requirement for such instruction, except in special or unusual circumstances.
  6. Instruction in responsible conduct of research must be carefully evaluated in all NIH grant applications for which it is a required component.

Instructional Components of NIH RCR Training Programs

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. 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 the Resources section of NOT-OD-10-019.

  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:
    1. conflict of interest — personal, professional, and financial
    2. policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices
    3. mentor/mentee responsibilities and relationships
    4. collaborative research including collaborations with industry
    5. peer review
    6. data acquisition and laboratory tools; management, sharing and ownership
    7. research misconduct and policies for handling misconduct
    8. responsible authorship and publication
    9. the scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research
  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 scientistʼs career: at the undergraduate, post-baccalaureate, predoctoral, 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 (as an undergraduate student, graduate student, postdoctoral fellow or faculty), 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.

RCR Training to Meet NSF Requirements

The National Science Foundation (NSF) requirement for RCR emerged from implemented Section 7009 of the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act (42 U.S.C. 1862o-1). This section of the Act 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.” This means that the NSF expects institutions to be able to verify that those students (undergraduates and graduates) and postdoctoral researchers who receive NSF funds (support from salary and/or stipends to conduct research on NSF grants) will obtain RCR training. If RCR training has not been completed prior to appointment to an NSF award, RCR training MUST be completed during the first year of appointment to an NSF award OR within the period of support, if that period is shorter than one year. All RCR training that meets the NIH requirements will also meet the NSF requirements. At minimum students (undergraduates and graduates) and postdoctoral researchers who receive NSF funds can meet the NSF requirements by completing the online Collaborative Institutional Training Initiative (CITI) RCR training.

Instructions for Accessing Collaborative Institutional Training Initiative (CITI) RCR training

The CITI homepage can be accessed at https://about.citiprogram.org/en/homepage/ . The blue login button will take you to a page where you can access via Log in through my institution. There you can scroll down until you find University of North Carolina at Chapel Hill. Use your ONYEN to log in. Once logged in you can view courses available to you. You will want to select an RCR course. Your choices are Biomedical Responsible Conduct of Research; Physical Science Responsible Conduct of Research; Responsible Conduct of Research for Engineers; or Social and Behavioral Responsible Conduct of Research. Each has between 9 and 10 modules.

The following are examples of available topics:

  • Authorship (RCR-Basic)
  • Collaborative Research (RCR-Basic)
  • Conflicts of Interest (RCR-Basic)
  • Data Management (RCR-Basic)
  • Mentoring (RCR-Basic)
  • Peer Review (RCR-Basic)
  • Research Involving Human Subjects (RCR-Basic)
  • Using Animal Subjects in Research (RCR-Basic)
  • Research Misconduct (RCR-Basic)

You will need to successfully complete all of the associated modules in the course selected to meet the RCR requirement for the NSF. You can select the course most closely aligned with your research discipline.

It is important to note that CITI also provides online training for human subject research. You might see a course listed as Group 1: Biomedical Research; Group 2: Social and Behavioral Research; or Group 3: Data and Specimens ONLY. These are for Human Subjects Protection training. The Good Clinical Practice (GCP) course and Human Subjects Protection modules are required by the UNC Office of Human Research Ethics for individuals engaged in human subject research. These will not satisfy the RCR training requirements for the NSF.

When you have completed the RCR training you can print a hard copy of the completed Grade Book for your own records. It is not necessary to forward your completed CITI course information to the University. UNC-CH is automatically notified once you have completed the CITI training. Your name will appear in the UNC Research Training database within 48 business hours.

To generate a training completion certificate, go to the UNC Research Training Database.


RCR Courses at UNC-CH that Either Focus on RCR Training or have it as a Component in Their Syllabi

BBSP 902
Seminar in Biological and Biomedical Sciences

0.5-4 Credits

Description

Enrollment in BBSP program required. First Year Group course of small interest-based groups led by faculty advisors. Includes professional skills development in a research community. The First Year Group (FYG) has been developed to help students during their first year in graduate school. The main goals of FYG are:

  • Building skills to flexibly communicate to a variety of audiences using different methods
  • Fostering a sense of belonging and connecting students with the UNC scientific community
  • Advising from faculty and peer mentors to help you decide on rotation labs, classes, PhD programs, and eventually your dissertation lab
  • Training in Responsible Conduct of Research (RCR)
  • Promoting student wellness and principles of diversity, equity, and inclusion

Responsible Conduct of Research (RCR) Sessions: Attendance at each RCR session is mandatory because the NIH requires all trainees to undergo Responsible Conduct of Research training at the beginning of their graduate career. If you miss an RCR session, you will be required to attend the equivalent session the following year. Full participation in each session is expected including reading all assigned articles and participating in the class discussions.

BCB 888
Responsible Conduct of Research

1 Credit, open to 4th year Biochemistry & Biophysics PhD students and offered in the Spring

Description

Classroom-based graduate level course covering critical topics for ethical and responsible conduct of experimental research. There are both classroom lecture, workshop-type discussion components, in addition to assigned outside of class readings. Case studies and hypothetical situations involving the most likely scenarios confronting graduate students will be covered, these topics include mentor and mentee relationships, publication authorship, collaboration, peer review, conflicts of interest, intellectual property, plagiarism, data acquisition and data processing. Restricted to students in good standing as a graduate student at UNC; In the unlikely event that classroom space is limited, preference will be given to graduate students who have previously received external federal funding sources and may require a refresher course in RCR.

BIOC 888
Responsible Conduct of Research

1 Credit open to 4th year Bioinformatics and Computational Biology PhD students and offered in the Spring

Description

Classroom-based graduate level course covering critical topics for ethical and responsible conduct of experimental research. There are both classroom lecture, workshop-type discussion components, in addition to assigned outside of class readings. Case studies and hypothetical situations involving the most likely scenarios confronting graduate students will be covered, these topics include mentor and mentee relationships, publication authorship, collaboration, peer review, conflicts of interest, intellectual property, plagiarism, data acquisition and data processing. Restricted to students in good standing as a graduate student at UNC; In the unlikely event that classroom space is limited, preference will be given to graduate students who have previously received external federal funding sources and may require a refresher course in RCR.

CBPH 895
Responsible Conduct of Research (RCR)

1 Credit Refresher Course on Responsible Conduct of Research offered to 4th year Neuroscience Curriculum and Cell Biology & Physiology PhD students in the Fall

Description

Responsible conduct of research is a classroom-based graduate level course covering critical topics for ethical and responsible conduct of experimental research. There are both classroom lecture, workshop-type discussion components, in addition to assigned outside of class readings. Topics include mentor and mentee relationships, publication authorship, collaboration, peer review, ethical use of human and animal subjects, conflicts of interest, intellectual property, plagiarism, data acquisition, and data processing.

GNET 888
Responsible Conduct of Research

1 Credit

Description

Provides advanced predoctoral students with an understanding of issues relevant to conducting biomedical research as responsible citizens. It fulfills the NIH requirement for continued RCR training. Open to 4th and 5th year students in the Biology, Genetics and Molecular Biology, and Biochemistry PhD programs or by permission of the instructor.

MCRO 721
Refresher Training in the Responsible Conduct of Research

1 Credit open to Microbiology and Immunology PhD students

Description

MCRO 721 is a modular course that meets the requirements of the National Institutes of Health for refresher training in the Responsible Conduct of Research. The course involves a mixture of assigned readings, formal presentations by department faculty who are active in research, and small group discussions. The course grade is based on attendance and participation.

PHRS 801
Foundations for Cross-Disciplinary Training in the Pharmaceutical Sciences

Listing of 1-3 Credits

Description

This is a required course for first year pharmaceutical sciences graduate students. Students participate on cross-discipline teams to discuss topics in three foundational areas essential to their development as pharmaceutical scientists: research ethics, which meets RCR training requirements; leading research articles within five areas of pharmaceutical sciences; and professional development.


Other RCR Training Opportunities at UNC-CH

The UNC Office of Postdoctoral Affairs (UNC OPA) offers biannual RCR training programs (usually in the Spring and in the Fall) tailored to postdoctoral research fellows, postdoctoral research trainees, and postdoctoral research associates. This RCR training meets requirements both for the NIH and NSF.

The RCR programs through the UNC OPA meet NIH requirements for RCR training for individuals supported by T32/T90 institutional training grants and individual NRSAs (F32).

NC TraCS Responsible Conduct of Research offers annually an RCR training course consisting of 3-days during the summer (i.e. July) to all individuals engaged in research and includes students, postdoc, faculty and staff. The course covers all the NIH-required topics for the first phase of responsible conduct of research training. Individuals who have had prior RCR training may volunteer to serve as discussion leaders for the course to document ongoing RCR exposure if needed for training grants. This RCR training meets requirements both for the NIH and NSF.