Guidance for Responsible Conduct of Research (RCR) Training Requirements

Purpose

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. 

For complete requirements, applicants should review official policies NOT-OD-10-019  and NOT-OD-22-055 .

NIMH-specific RCR information

NIMH requires successful completion RCR instruction during Year 01 of NIMH-supported research training and career development awards (i.e. NRSAs, mentored Ks), including the R36 and R25. Instructional details must be reported in the Research Performance Progress Report (RPPR). This requirement is fulfilled if the fellow/trainee provides documentation that acceptable instruction has been completed within the last four years and during the current career stage (e.g. if a postdoctoral fellow, during the postdoctoral period).

Instructional component recommendations

Format of Instruction: Describe the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable). Discussion-based instruction should not exclusively employ video conferencing unless there are unusual or well-justified circumstances.

Subject matter: While there are no specific curricular requirements for instruction in responsible conduct of research, the following topics (non-bold text) have been incorporated into most acceptable plans for such instruction, cited in NOT-OD-10-019 . Developments in the conduct of research and a growing understanding of the impact of the broader research environment have led to a recognition that additional topics merit inclusion in discussions of the responsible conduct of research. For context, those additional subjects among the list of topics traditionally included in most acceptable plans for RCR instruction, cited (bold text) in NOT-OD-22-055  and appearing below:

• Conflict of interest– personal, professional, and financial – and conflict of commitment, in allocating time, effort, or other research resources
• Policies regarding human subjects, live vertebrate animal subjects in research, and 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; 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

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 during laboratory interactions and in other informal situations throughout the year.

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.

Frequency of Instruction: Instruction must be undertaken at least once during each career stage, and at a frequency of no less than once every four years.

Additional RCR advice for applicants

• Online training is not considered sufficient for RCR training though it can serve as a valuable supplement to face-to-face instruction. A plan that employs only online coursework for instruction in RCR will not be considered acceptable, except in special instances of short-term career development programs, or unusual and well-justified circumstances.
• Discussion-based instruction and face-to-face interaction is expected to remain a key feature of RCR training. However, it is recognized that video conferencing allows for effective “face-to-face” discussions, provided that virtual options are utilized in a way that fosters discussion, active learning, engagement, and interaction. RCR plans that that only include video conference-based training will not be considered acceptable, except in the circumstances described in NOT-OD-10-019 .
• It is helpful to use the above categories (format, subject matter, faculty participation, duration, and frequency) as a framework for describing the proposed training.
• Applicants are encouraged to tailor RCR instruction to the needs of the individual and to include instruction beyond formal institutional courses. RCR training should provide opportunities to develop the trainee’s own scholarly understanding of the ethical issues associated with their research activities and its impact on society.

For complete requirements, applicants should review official policiesNOT-OD-10-019  and NOT-OD-22-055 .