Responsible Conduct of Research (RCR)
Responsible conduct of research (RCR) is defined as “the practice of scientific investigation with integrity.” RCR includes most of the professional activities that comprise a research career and encompasses the following nine areas:
- Collaborative Science
- Conflict of Interest and Commitments
- Data Acquisition
- Human Research Protections
- Lab Animal Welfare
- Mentoring
- Peer Review
- Publication Practices and Responsible Authorship
- Research Misconduct
The basic principles of RCR are:
1. 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 funding decisions.
2. Active involved in the issues of Responsible Conduct of Research should occur throughout a scientist's career. Instruction instruction in RCR should therefore be appropriate to the career stage of the individuals receiving training.
3. Individuals supported by individual funding opportunities such as fellowships and career development awards are encouraged to assume individual and personal responsibility for their instruction in responsible conduct of research.
4. 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.
5. Instruction should include face-to-face discussions by course participants and faculty; i.e., on-line instruction may be a component of instruction in responsible conduct of research; however this is not sufficient to meet the NIH requirement for such instruction, except in special or unusual circumstances.
6. Instruction in responsible conduct of research must be carefully evaluated in all NIH grant applications for which it is a required component.
The guidance provided below is directed at formal instruction:
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:
- 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.
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. 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.
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. 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.
Resources
RCR – Research Misconduct, developed by Columbia University