Training

Goal

Implement a plan for compliance with responsible conduct of research (RCR) instruction requirements that meets federal funding agencies’ compliance requirements and provides the resources needed to support broader RCR instruction at the University. Responsible conduct of research is defined 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. The information contained on this website is a guide for faculty to determine the specific individual development plan for the student/trainee and submitted to the funding agency.

Grant Application Requirements

NSF. Since January 4, 2010, NSF requires Responsible Conduct of Research Training for all undergraduate, graduate or postdoctoral scholars working on NSF funded projects. The University requires all research personnel, including principal investigators, on NSF funded projects to complete the one-time RCR training.

NIH. NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, or dissertation research grant must receive instruction in responsible conduct of research. NIH has published different requirements for institutional applications and individual applications. Principals Investigators (PI) must include an RCR section in their grant applications.

NIFA. Since February 1, 2013, NIFA requires program directors, faculty, undergraduate students, graduate students, postdoctoral researchers and any staff participating in the research project receive appropriate training and oversight in the responsible and ethical conduct of research.  The University requires all research personnel, including principal investigators, on NIFA funded projects to complete the one-time RCR training.

Basic Principles

The following principles are based on several key concepts about responsible conduct of research and best practices that have evolved over the past two decades’ 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 scientist’s 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.

Instruction in the responsible conduct of research (RCR) consists of (but is not limited to) the following core content areas:

• Mentor/Trainee Responsibilities
• Data Acquisition, Management, Sharing and Ownership
• Publication Practices and Responsible Authorship
• Peer Review
• Collaborative Science
• Research Ethics and the Role of the Scientist
• Research Misconduct
• Conflict of Interest and Conflict of Commitment
• Human Subjects
• Animal Welfare
• Safe Laboratory Practices

Template for NIH Instruction in the Responsible Conduct of Research

Please adapt this template to your particular circumstances.

This section is limited to 1 page for individual award applications for Fellowships (F) and Career Development (K), and to 3 pages for Institutional Training (T) award applications. Renewal applications must describe any changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current RCR instruction. 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.

Introduction

University of Nevada, Reno (UNR), in compliance with the requirements of the National Institutes of Health (NIH) and the National Science Foundation (NSF), is committed to training relevant personnel in the Responsible Conduct of Research (RCR) who are funded by these agencies to conduct research. The University believes that RCR training is an essential component of baccalaureate and graduate education for those pursuing research opportunities. Because RCR is most effective in the scope of daily activities, the plan for RCR training must be tailored to meet the specific needs of the covered participants. UNR has several options for providing educational opportunities to undergraduate and graduate students and faculty and staff regarding RCR. All such opportunities are designed to be in full compliance with the policy requirements for RCR education promulgated by NIH in NOT-OD-10-019, issued November 24, 2009.

Format

University of Nevada, Reno (UNR) provides a comprehensive RCR training plan which includes both interdisciplinary general and program-specific RCR content. The phased program described below is intended to provide quality training experiences while offering flexibility for the learner.

Basic training

Those covered individuals are required to complete an online RCR course provided by the online Collaborative Institutional Training Initiative (CITI). The online RCR course consists of 13 modules with an anticipated completion time of 4 hours. This requirement must be completed within the first 12 months of support/employment on the award (or earlier, at the discretion of the PI).

Advanced training

Trainees are also required to engage in an additional eight (8) contact hours of didactic and small-group discussion-based RCR training. This may include a variety of activities determined by the PI to be effective and engaging. The contact hours will include more than one topic area. Custom-designed workshops, forums, and classes, or existing classes and seminars offered by the college or department, and/or participation in external offerings may all be included. Plans may include encouragement to attend some of the RCR programs offered through the Vice President for Research and Innovation office, such as Research Integrity Brownbag discussions, RCR Workshops, and Ethics Workshops. For an existing course or program to be suitable for fulfilling one of the training requirements, the PI must document that relevant RCR topics are covered in the trainee’s individual development plan.

Subject Matter

Topics covered include, but are not limited to: conflict of interest – personal, professional, and financial; policies regarding human subjects, live vertebrate animal subjects 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. Online CITI training in RCR offers modules by discipline type: biomedical, social and behavioral sciences, physical sciences and humanities. Instructional material is not mandated but rather chosen by departmental faculty focusing on discipline specific topics that are meaningful to the discipline and the participant. The ORC provides resources (e.g. training for faculty, consultation and advice, teaching resources) to support the RCR training program and its implementation by the PI.

Faculty Participation

All live lectures and small group discussions are taught by University faculty and staff with extensive experience in the subject matter. Instructors leading journal club sessions also stimulate informal discussions involving RCR topics. Additional RCR discussion also occurs throughout the applicant’s training within the institution in the course of interaction with mentors and research meetings.

Duration of Instruction

Instruction consists of at least XX hours, delivered as XX weeks of live lectures and group discussions. Additional face-to-face RCR discussions with faculty and mentor(s) are on- going. The basic training consists of an online course that takes approximately 4 hours to complete. The advanced training portion of the training program consists of 8 contact hours.

Frequency of Instruction

Frequency of instruction depends upon the educational experience and length of time that the trainees/fellow/scholar/participant will be involved on the NIH grant and on the career stage of the covered individuals. Trainees must participate in all RCR programs at their earliest opportunity. Interactive discussions regarding RCR occur throughout the program facilitated by the faculty mentor(s).

How Participation in RCR Individual Development Plan is Monitored

CITI training compliance is administered under the University’s Office of the Vice President for Research and Innovation, Research Integrity. Additionally, activities are monitored in several ways: signed and dated attendance rosters, online class registration, Webcampus graded quiz/test and a final grade of Satisfactory (“S”) or Unsatisfactory (“U”) after each lecture/small group discussion or module from the faculty member using Webcampus. Trainees are expected to be actively involved in all discussions and activities. Because research is being done in a multitude of subject areas, having input from all trainees is essential to having a discussion that sees a situation from multiple viewpoints. PIs are responsible for implementing and documenting achievement of the participant’s plan.

This page contains links to 3rd party online content; if you experience any issues accessing this content, please contact Research Integrity.

Investigators working on projects funded by the Public Health Service (e.g., NIH, CDC, SAMHSA, FDA, HRSA, IHS, etc.), agencies that have adopted PHS requirements, and the Department of Energy are required to complete conflict of interest (COI) training prior to the expenditure of funds on the award and at least every four years thereafter.

For this purpose, the definition of “Investigator” includes the Principal Investigator and any other person, regardless of title or position, who is responsible for the purpose, design, conduct or reporting of the project. In some instances, the definition may be expanded to include anyone who participates in the purpose, design, conduct or reporting of the project.

Additionally, all persons included in a COI Management Plan must complete COI training.

To meet this training requirement, the University of Nevada, Reno utilizes the online “Conflict of Interest” course through CITI Program. This course includes four modules, all of which must be completed. Although some of the modules are geared toward PHS researchers, they include helpful information that is applicable to all conflict of interest situations.

Sponsored Projects will not complete the set-up of an award until all required persons have completed their COI training. If you have questions, please contact Michele Dondanville at mdondanville@unr.edu.

Since January 4, 2010, National Science Foundation (NSF) requires Responsible Conduct of Research Training for all undergraduate, graduates or postdoctoral scholars working on NSF funded projects. The university requires all research personnel, including principal investigators, on NSF funded projects to complete the one-time RCR training.

Research Integrity director and staff

• Ethical Research Oversight Course offered on the PRIM&R website. Does not expire.
• New personnel will also complete an in-office human research protection training “boot camp” as determined by the Research Integrity director. Training will be customized to reflect the knowledge and experience of the individual employee and may include review/discussion of applicable federal regulations, Research Integrity (IRB) Policy Manual, the OHRP Guidebook, guidance documents, and any other materials identified by the Research Integrity director. New personnel will also attend PRIM&R IRB 101 as funding allows.

IRB Members

• Ethical Research Oversight Course offered on the PRIM&R website. Does not expire.
• Additional training is offered at each IRB meeting; if not in attendance, self-study of attached power point slides in IRBNet agenda documents is expected.
• Orientation is required for new IRB members before they may participate as voting members of an IRB.

All protocols must be submitted through IRBNet.  View  step-by-step guides to setting-up and navigating IRBNet