Responsible Conduct of Research

Research, scholarship, professional and creative activities conducted at American University are to be done according to the highest ethical and professional standards. A framework for imparting the “best practices” associated with ethical and professional standards, and increasingly regarded as a critical component of scholarly and career development, is training in the Responsible Conduct of Research (RCR). The initial National Institutes of Health (NIH) policy on RCR was published in 1989. RCR training was mandated for graduate students and postdoctoral fellows and faculty funded by the NIH training grants and career awards. New standards for RCR training were issued by the NIH on January 24, 2010. RCR training is required for NIH Institutional Research Training Grant Awards, Individual Fellowship Awards, Career Development Awards (Institutional and Individual), Research Education Grants, Dissertation Research Grant Awards, and other grant awards with a training component as noted in the funding opportunity announcement (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html) and must meet more specific guidelines. As of January 4, 2010, RCR training is also required for undergraduates, graduate students, and postdoctoral fellows funded by the National Science Foundation (NSF) (http://edocket.access.gpo.gov/2009/E9-19930.htm). Beyond these regulations, RCR training is strongly encouraged for all faculty, staff, and students engaged in scholarly work, regardless of funding source or field of study.

RCR training usually includes the following topics.

  • Research Misconduct (falsification, fabrication, plagiarism)
  • Conflict of Interest and Conflict of Commitment
  • Authorship and Publication
  • Data Management and Data Ownership
  • Mentor and Traineeship Responsibilities
  • Peer Review
  • Collaborative Research
  • Protection of Human Subjects
  • Welfare of Laboratory Animals

Other topics frequently considered in RCR training include ethical deliberation, whistle blowing, lab management, environmental and lab safety, intellectual property, national security and export control, research in international and intercultural environment, public diplomacy / policy.

RCR Training at AU

AU is in the process of developing resources for RCR training, including an on-line course developed by the Collaborative Institutional Training Initiative (CITI). The CITI on-line course can be accessed at https://www.citiprogram.org/Default.asp? Be sure to affiliate with American University during registration. Do not select “Human Subjects Research” modules from the “Select Curriculum” screen unless directed by your faculty advisor or the Institutional Review Board (IRB).

Regulations

NIH RCR Training Requirements

Training grant and career award applicants are required to include a plan for their training in RCR. It is important to review the specific terms of the award announcement to determine what is required as this may vary with the type and level of award. However, NIH recently released a notice outlining new standards for RCR training and these requirements are effective January 25, 2010. Note that training plans must address in full the five instructional components: format, faculty participation, subject matter, duration, and frequency of instruction, and that on-line training alone is not considered sufficient.

Here is summary of the new requirements:

  • Effective January 25, 2010 for new and renewal apps and January 1, 2011 for continuations
  • Covers a broad range of training and career development awards

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.

  • Provides definition and six “basic principles” of RCR that refer to value of training and importance of faculty participation
  • RCR to be evaluated on the criteria of 5 “Instructional Components”: Format, Subject Matter, Faculty Participation, Duration, and Frequency
    • Format: On-line alone is not acceptable; “substantial” face-to-face discussion required; combination of didactic and small-group discussion is highly encouraged
    • Subject Matter: 9 topics to be covered
    • Faculty Participation: Training faculty and sponsors/mentors are highly encouraged to contribute to formal and informal instruction; senior fellows and awardees may fulfill their requirement by participating as lecturers or discussion leaders; rotation of faculty is suggested
    • Duration of Instruction: “Substantive contact hours” is required – minimum of eight contact hours; semester long courses preferred over single day workshops
    • Frequency of Instruction: Tailor RCR training to each career stage; must be taken once at each stage and at a frequency of no less than once every four years. Instruction beginning in graduate school is highly encouraged
  • There are special considerations by type of award
    • Institutional programs (T’s, K12, K30) are encouraged to provide training for all individuals associated with the program regardless of their source of support
    • On-line training may be appropriate for short-term programs (i.e., those lasting less than 6 months)
    • Individual awardees are encouraged to tailor their programs to their own needs (going beyond formal instruction…individualized plan to supplement institutional RCR program)
  • Applications must include detailed plan covering above 5 criteria
  • Peer Review: Plans for, and past record of, instruction in RCR will be rated as ACCEPTABLE or UNACCEPTABLE. Results of the review will be reported as an administrative note in summary panel with explanation. Applications with unacceptable plans will not be funded until plan is revised.
  • Reporting Requirements
    • Continuation applications must describe RCR instruction in terms of 5 instructional components.
    • Reporting requirements are slightly different for each type of award
  • Compliance: It is expected that course attendance is monitored and that a certificate or documentation of participation is available upon course completion. NIH expects the institution to maintain records sufficient to demonstrate that NIH-supported trainees, fellows, and scholars have received the required instruction.

NSF RCR Training Requirements

Starting with new applications after January 4, 2010, all undergraduates, graduates, and postdoctoral fellows funded by NSF awards are required to complete RCR training. The requirement can be fulfilled by completing an on-line RCR course available through the Collaborative Institutional Training Initiative (CITI). The course can be accessed at https://www.citiprogram.org/Default.asp? Be sure to affiliate with American University during registration. Do not select “Human Subjects Research” modules from the “Select Curriculum” screen unless directed by your faculty advisor or the Institutional Review Board (IRB).

Below is a summary of the elements of the NSF RCR training requirements.

Requirements effective January 4, 2010

  • At the time of proposal submission, institution must certify that the institution has a plan to provide appropriate training and oversight in RCR to undergraduates, graduate students, and postdoctoral researchers supported by NSF.
  • Training plans are not required to be included in the submission to NSF (but are subject to review upon request by NSF).
  • An institution must designate one or more persons to oversee compliance with the RCR training requirement.

Institutions are responsible for verifying that undergraduate students, graduate students, and postdoctoral researchers supported by NSF to conduct research have received training in the responsible and ethical conduct of research.