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    Responsible Conduct of Research

    The information on this page is taken from the NIH website.

    A. Instructional Components

    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 (see below), 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:
      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
      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.

    1. 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. Training faculty may contribute to formal instruction in responsible conduct of research as discussion leaders, speakers, lecturers, and/or course directors. Rotation of training faculty as course directors, instructors, and/or discussion leaders may be a useful way to achieve the ideal of full faculty participation in formal responsible conduct of research courses over a period of time.

    2. 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.

    3. 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. It is highly encouraged that initial instruction during predoctoral training occurs as early as possible in graduate school. Individuals at the early career investigator level (including mentored K awardees and K12 scholars) must receive instruction in responsible conduct of research at least once during this career stage. Senior fellows and career award recipients (including F33, K02, K05, and K24 awardees) may fulfill the requirement for instruction in responsible conduct of research by participating as lecturers and discussion leaders. To meet the above requirements, instruction in responsible conduct of research may take place, in appropriate circumstances, in a year when the trainee, fellow or career award recipient is not actually supported by an NIH grant. This instruction can be documented as described below.

    B. Special Considerations by Type of Award

    Institutional training and institutional career development programs (for example, T15, T32, T34, T90/R90, TL1, K12, or K30 programs):  Institutional programs are encouraged to provide instruction in responsible conduct of research for all individuals associated with the program of training regardless of their source of support.

    Short-term training and research education programs (for example, T35 and R25 programs lasting six or fewer months, short-term trainees supported on T15, T32 and T34 programs, and short-term participants in R25 programs):  The duration of RCR instruction within short-term institutional programs should be appropriate for the total duration of the program and should be justified in the application and is an instance where on-line instruction could be appropriate. Such programs may also use innovative strategies to incorporate instruction in responsible conduct of research and to relate instruction in responsible conduct of research to the scientific focus of the short-term program.

    Individual awards:  In keeping with the individual nature of these programs, fellows and scholars, along with their institutions and sponsors/mentors, are encouraged to tailor instruction in responsible conduct of research to the needs of the individual. Thus, instruction may go beyond formal institutional courses and provide opportunities for the individual to develop their own scholarly understanding of the ethical issues associated with their research activities and their impact on society. An individualized plan would be appropriate in the rare instances where an institution does not have an established formal mechanism for such instruction.

    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.

    Last modified: 02/12/2013 05:12:33

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