NIH Requirement for Instruction in the Responsible Conduct of Research

NIH Training Requirement

The National Institutes of Health: Update on the Requirement for Instruction in the Responsible Conduct of Research (NIH) require that all trainees, fellows, participants, and scholars that are recipients of the following award types complete responsible conduct of research training:

• Any NIH Training
• Institutional Research Training Grants
• Individual Fellowship Awards
• Career Development Awards (individual or institutional)
• Research Education Grants
• Dissertation Research Grants
• Certain other programs with a training requirement.

The following programs are required to adhere to the NIH Responsible Conduct of Research training requirements: 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. This information can be found at NOT-OD-22-055.

All University of Minnesota NIH applicants must complete the RCR Core Training through CITI Program. They must also seek opportunities for formal and informal training that is in-person, ongoing, relevant to their own disciplines and appropriate to their career stage. Applicants are required to provide detailed descriptions of these activities as part of their applications for funding and reports. This is the responsibility of the applicant.

The RCR Core Curriculum offered by the University of Minnesota through CITI Program includes the following topics:

• Introduction to RCR: overview of responsible conduct of research
• Authorship
• Collaborative Research
• Conflicts of Interest and Commitment
• Data Management
• Financial Responsibility
• Mentoring
• Peer Review
• Plagiarism
• Research Misconduct
• Export Controls and Economic Sanctions
• Financial Responsibility & Other Research Areas
• Technology and Commercialization at the University of Minnesota.

The NIH expects the following topics to be incorporated into acceptable training plans:

• Conflict of interest – personal, professional, and financial
• Conflict of commitment in allocating time, effort, or other research resources
• Policies regarding human subjects and live vertebrate animal subjects in research
• Safe laboratory practices
• Mentor/mentee responsibilities and relationships
• Safe research environments (e.g., those that promote inclusion and are free of sexual, racial, ethnic, disability and other forms of discriminatory harassment)
• Collaborative research, including collaborations with industry and investigators and institutions in other countries
• Peer review, including the responsibility for maintaining confidentiality and security in peer review
• Data acquisition and analysis
• Use of laboratory tools (e.g., tools for analyzing data and creating or working with digital images)
• Recordkeeping practices, including methods such as electronic laboratory notebooks
• Secure and ethical data use
• Data confidentiality, 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.

It is the responsibility of the PI of the grant to determine how they deliver any additional education hours to their team to meet the NIH Requirements for the eight total hours of training, which cannot all be through the online CITI program course, covering any of the relevant RCR topics. This may be through seminars, face-to-face meetings, additional coursework, workshops, etc. Additional opportunities may be made available through the Research and Innovation Office and will be communicated if they are made available.

The NIH expects that discussion-based instruction in RCR is the key component of training researchers. It is okay to utilize online discussion, but it is expected that other methods besides an asynchronous class and online meetings will be included (i.e. a face-to-face session) as part of the complete RCR education. The NIH does not consider a training plan that includes only the CITI Program education and video conferencing as acceptable except for short-term research training and research education programs.

Frequency and Timing: Existing policy and guidance call for RCR instruction to be undertaken at least once during each career stage, and at a frequency of no less than once every four years. As institutions consider how to optimize the timing and delivery of instruction in the responsible conduct of research, they are encouraged to bear in mind the value of ongoing and discipline-specific training as individuals progress in their research careers. For example, while broad-based instruction in the responsible conduct of research is often appropriate early in graduate school; a more tailored, discipline-specific approach may better fit the needs of advanced graduate students and those who have transitioned to postdoctoral status. If advanced students and postdoctorates have been exposed to the full range of topics traditionally included in RCR instruction early in their scientific training, it may make sense for their ongoing and/or subsequent RCR training to focus on subjects most relevant to their fields, and institutions may wish to consider this approach, where applicable.

It is the responsibility of the researcher to complete RCR instruction at least one time during each career stage and at a frequency of no less than every four years. Additional opportunities for RCR education are offered throughout the University, and Research Integrity and Compliance (RIC) can help you find opportunities. There is also an RCR Refresher course, Communicating with the Public course, Presentation of Research Findings Course, Reproducibility of Research Results Course, and a Research, Ethics, and Society Course available through CITI Program that can be utilized as part of the continuing education requirements.

Guidance on Writing Training Descriptions

The following is suggested wording that is strongly encouraged in constructing training descriptions for NIH grant proposals to describe the University of Minnesota RCR curriculum on applications for training-related funding from NIH.

Wording (may be copied, pasted, and adjusted for proposal use):

[All members of the University of Minnesota community are expected to exemplify the highest standards of integrity and ethics. Per Board of Regents Policy: Submitting and Accepting Sponsored Projects (PDF) Subd. 2(c) “…Principal Investigators (PI) must complete training required by Sponsors and the University.” Per Administrative Policy: Responsible Conduct of Research Education,“ Faculty, staff, and students who serve in various capacities on research and scholarship projects are required to complete training that is appropriate for the role they will serve on the project and meets sponsor regulations. Sponsor regulations, University policies, and the supervisors of staff and students will determine the appropriate level of training.” The University of Minnesota requires all individuals supported by NIH training-related funding to take Responsible Conduct of Research (RCR) Core curriculum.

The RCR Core curriculum is an online course through CITI Program that includes the following:

• Introduction to RCR: overview of responsible conduct of research
• Authorship
• Collaborative Research
• Conflicts of Interest and Commitment
• Data Management
• Financial Responsibility
• Mentoring
• Peer Review
• Plagiarism
• Research Misconduct
• Export Controls and Economic Sanctions
• Financial Responsibility & Other Research Areas
• Technology and Commercialization at the University of Minnesota.

Per NIH RCR training related requirements, in addition to the RCR Core, I have had or will participate in the following in-person training (prior to the end of the project year).  [Identify additional training taken or planned, which should include the Sexual Harassment Training, lab-specific trainings, and trainings related to human subjects research, research with animals, and/or research with biological or chemical agents. Also include description of the additional in-person, college, department, or discipline-specific responsible conduct of research instruction in which was completed over the last year. The total should be at least eight hours per year of RCR education.]

Notification

Reports will be generated daily to identify the students, postdocs, and staff who are being paid from these sponsored projects, based on University payroll records for the appropriate employee categories. An automated email will be sent to the individuals who have not yet completed the required training, based on this report. A copy of the email will also be sent to the PI on the project and to the Resource Responsibility Center (RRC) Manager assigned to the unit. The email will contain information about the requirement, the options and deadline for completing it, and the consequences for failure to do so.

Oversight and tracking of requirement

Oversight and tracking of this responsible and ethical conduct of research training requirement is a responsibility shared between PIs, departments, and RIO/RIC. Completion of for-credit courses and the CITI RCR curriculum will be tracked electronically. If students complete non-credit seminars or activities, the coordinating department or program must submit a list of participants to RIC, or the individual student must submit a Completion Form to RIC. All data entry of completed courses or activities is done by RIC staff.

Failure to complete training

If the requirement has not been met at the 30-day deadline of completing training after receiving sponsored funds or within 30 days of becoming a PI or researcher, a final reminder email will be sent to the student, PI, RRC Manager, and to the Associate Dean for Research or equivalent for the collegiate unit. If the training is not completed after this final reminder, RIC will remove the individual's salary and fringe benefits charged to the project to a departmental non-sponsored default account until the requirement has been met for personnel being paid through sponsored funds.