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:
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.
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