NIH requires RCR education for 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. NIH applications require a plan for instruction in responsible conduct of research (This applies to NIH F, K, T, or Dissertation Awards 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).
The NIH updated requirements in the instruction of the responsible conduct of research (RCR). These changes go into effect for the 2022-2023 academic year. New/Renewal applications must incorporate these changes beginning with the September 25th deadline.
NIH requires that all trainees, fellows, participants, and scholars receiving funding through any NIH training, an individual career development award, an institutional career development award, a research education grant, and/or a dissertation research grant, must receive instruction in responsible conduct of research (RCR) education. Unlike the NSF requirement, the NIH requires that all eligible researchers complete an interactive program of RCR education of at least 8 hours.
Summary of NIH RCR changes:
Format:
- Inclusion of video conferencing is now recognized as an effective tool for “face-to-face” discussions. Video conferencing must foster “discussion, active learning, engagement, and interaction among the participants”
- Video conferencing cannot be the sole means for meeting the RCR education requirement
Frequency & Timing:
- Same recommendations remain to undertake RCR education at least once during each career stage, and at a frequency of no less than once every four years. With a consideration to alter the approach for those who have been exposed to the full range of topics traditionally included in RCR. “Optimize the timing and delivery” of RCR instruction, including discipline-specific training for advanced career stages (e.g. advanced graduate students, postdocs, etc.).
Subject Matter:
- NIH now requires 11 subject areas. The original nine subjects remain; some of these have been supplemented. This includes the separation of one subject into two areas.
- Expanded topics to cover with new topics in bold.
- 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 (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
Implementation
The Principle Investigators are responsible for:
- Identifying individuals who are participating in the research project and ensuring that they comply with NIH RCR requirement
- Providing and resourcing project/discipline mentoring and appropriate oversight in the ethical and responsible conduct of research for all personnel participating in the research project; and
- Maintaining records to document that each person has completed the of the RCR education.