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An update on the requirement for instruction in the Responsible Conduct of Research was issued by NIH on November 24, 2009 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html). In it, NIH reiterated that 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 NIH funding decisions. We are reminded that active involvement in the issues of responsible conduct of research should occur throughout a scientist’s career and that 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.

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. This policy will take effect with all new and renewal applications submitted on or after January 25, 2010, and for all continuation (Type 5) applications with deadlines on or after January 1, 2011. This Notice applies 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. This policy also applies to any other NIH-funded programs supporting research training, career development, or research education that require instruction in responsible conduct of research as stated in the relevant funding opportunity announcements.

NIH recognizes that instruction in responsible conduct of research occurs formally and informally occurs throughout the research training experience. They do, however, provide the following guidance for formal instruction in responsible conduct of research:

  • 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 (see update).
  • 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:
    1. Conflict of interest – personal, professional, and financial
    2. Policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices
    3. Mentor/mentee responsibilities and relationships
    4. Collaborative research including collaborations with industry
    5. Peer review
    6. Data acquisition and laboratory tools; management, sharing and ownership
    7. Research misconduct and policies for handling misconduct
    8. Responsible authorship and publication
    9. The scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research
  • 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: Reflection on responsible conduct of research should recur throughout a scientist’s career: at the undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels. Institutional training programs and individual fellows/scholars are strongly encouraged to consider how to optimize instruction in responsible conduct of research for the particular career stage(s) of the individual(s) involved. Instruction must be undertaken at least once during each career stage, and at a frequency of no less than once every four years.

Institutional applications (both new and renewals) must include a plan for instruction in responsible conduct of research and describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction in responsible conduct of research. 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. In addition to addressing the five instructional components, the plan must describe how participation in instruction in responsible conduct of research will be monitored.

Individual new applications must include a section on instruction in responsible conduct of research, appropriate to the career stage of the applicant (instruction for applicants in the early stages of their careers; participation as course directors, lecturers, or discussion leaders for applicants in middle or senior stages of their careers), as part of the Research Training Plan or Candidate Information and Career Development Plan. This section will document prior participation or instruction in responsible conduct of research during the applicant’s current career stage (including the date instruction was last completed) and propose plans to either receive instruction in responsible conduct of research or participate as a course lecturer, etc., depending on the applicant’s career stage. The role of the sponsor/mentor in instruction in responsible conduct of research must be described. Where applicable, renewal applications must describe instruction in responsible conduct of research activities undertaken during the past project period as well as future plans in order to meet the frequency requirement as outlined in Instructional Components. Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process or not reviewed.

There are reporting requirements on RCR instruction AND participation for each award mechanism (see update).

Compliance: NIH policy requires participation in and successful completion of instruction in responsible conduct of research by individuals supported by any NIH training/research education/fellowship/career award. It is expected that course attendance is monitored and that a certificate or documentation of participation is available upon course completion. NIH does not require certification of compliance or submission of documentation, but expects institutions to maintain records sufficient to demonstrate that NIH-supported trainees, fellows, and scholars have received the required instruction.