1. Which NIH programs must follow the RCR training requirements?
NIH requirements for RCR training are detailed in NIH notice NOT-OD-10-019. These requirements apply to the following programs: 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.
2. Are there specific requirements for the content of RCR training?
The 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. Formal RCR instruction must adhere to the following guidelines.
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, 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:
- 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
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 Resources.
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. The R4I@UF Case of the Month discussions are designed to provide additional opportunities for mentors to participate in RCR instruction in an ongoing manner.
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 scientist’s career: at the undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels. Instruction must be undertaken at least once during each career stage, and at a frequency of no less than once every four years. The R4I@UF Case of the Month discussions are designed to provide additional opportunities for mentors to participate in RCR instruction in an ongoing manner.
3. Where can I find more information about NIH RCR training requirements?
The NIH Research Training website includes additional information about RCR training, and links to the Office of Research Integrity, links to instructional materials, and examples of programs that have been regarded as good models for instruction in responsible conduct of research.
4. What are the new NIH requirements for training in rigor and reproducibility in research?
NIH requirements for rigor & reproducibility training are detailed in NIH notices NOT-OD-20-033 and NOT-OD-090, and summarized below. Recommended plans for training in rigor & reproducibility for NIH applications will be available by May 2020.
| Type of Application | Changes |
|---|---|
| Institutional Research Training (T) and Institutional Career Development (K) | The Program Plan section of the application will be expected to include a description of how the program and faculty will provide training in rigorous research design and relevant data science and quantitative approaches. There is a new requirement to include a Plan for Instruction in Methods for Enhancing Reproducibility attachment. |
| Individual Fellowships (F) | In describing their training goals and objectives in the Program Plan attachment, fellowship candidates will be expected to address, as applicable, any new research skills they plan to acquire in the areas of rigorous research design, experimental methods, quantitative approaches, and data analysis and interpretation. In the Research Strategy section of the Program Plan attachment, fellowship candidates will be expected to describe (a) the strengths and weaknesses in the rigor of the prior research that serves as the key support for the proposed project, (b) plans to address any weaknesses in the rigor of the prior research, (c) how the experimental objectives proposed will achieve robust and unbiased results, and (d) how relevant biological variables are factored into research designs and analyses. If applicable, fellowship candidates will be required to include the Authentication of Key Biological and/or Chemical Resources attachment. |
| Individual Career Development (K) | In describing their career development plans in the Program Plan attachment, candidates for career development awards will be expected to address, as applicable, any new research skills they plan to acquire in the areas of rigorous research design, experimental methods, quantitative approaches, and data analysis and interpretation. |