National Institutes of Health (NIH) Responsible Conduct of Research

The National Institutes of Health (NIH) has established a training requirement in the Responsible Conduct of Research (RCR) for individuals receiving support through NIH Institutional Research Training Grants, Individual Fellowship Awards, Career Development Awards (Institutional and Individual), Research Education Grants, Dissertation Research Grants, and any other program that requires such training as identified in the NIH Funding Opportunity Announcement. 

The programs affected include:

Instructional Components

NIH has outlined the instructional components, which include format, subject matter, faculty participation, duration, and frequency needed to satisfy this requirement. 

Format

The NIH training requirement states that online instruction alone is not sufficient to satisfy the training requirement. NIH expects significant face-to-face interaction and discussion to occur among trainees, fellows, scholars, and/or participants.  However, for participants supported by short-term programs lasting six or fewer month’s online instruction is acceptable.

Subject Matter

NIH has recommended areas of instruction including, but not limited to, conflict of interest human subjects, mentor/mentee responsibilities, collaborative research, peer review, research misconduct, responsible authorship and publication, and data management sharing and ownership.

Faculty participation

Training faculty and sponsors/mentors are highly encouraged to contribute in formal and informal instruction.

Duration

NIH recommends at least 8 hours contact hours between the trainers, fellows, scholars, participants and participating faculty.  NIH prefers semester-long seminar series or programs in which the topics are covered in significant depth. 

Frequency: Instruction is required at each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty) at a frequency no less than once every four years.

The University has established the following option for assisting faculty in meeting the formal instruction component of the NIH requirement:

Face-to-Face instruction (> 6 months)

Principal Investigator(s) will be responsible for assuring that all trainees, fellows, participants, and scholars who are supported longer than six months by their NIH projects, including subawards, complete Responsible Conduct of Research face-to-face instruction. All trainees, fellows, participants, and scholars who are supported longer than six months by their NIH projects, including sub-awards, must complete 8 hours of in-person RCR training within 12 months of receiving NIH support

Courses that satisfy the graduate school's Scholarly Ethics and Integrity requirement can be used to satisfy the NIH's in-person Responsible Conduct of Research (RCR) training requirement. Students enrolled or planning to enroll in such courses should contact the Research Integrity and Consultation Program at integrity@vt.edu to confirm that the course content satisfies that NIH's in-person RCR training requirement. Additionally, faculty teaching courses that satisfy the graduate school’s Scholarly Ethics and Integrity requirement are encouraged to contact the Research Integrity and Consultation Program at integrity@vt.edu to ensure that all students who successfully complete their courses receive the NIH in-person training hours that they have earned.  

The Division of Scholarly Integrity and Research Compliance also offers Investigator Series courses. The SIRC Investigator Series provides in-person RCR training hours that count towards the NIH’s in-person Responsible Conduct of Research (RCR) training requirement. . Investigator Series seminars and workshops are open to all Virginia Tech students, faculty, and staff. Researchers interested in attending Investigator Series events can find information about upcoming Investigator Series Events on the Seminars webpage.

On-line instruction (< 6 months)

Principal Investigator(s) will be responsible for assuring that all trainees, fellows, participants, and scholars who are supported by their NIH projects, including subawards, submitted (and subsequently awarded) after January 25, 2010, complete Responsible Conduct of Research training.  All such participants supported less than six months must complete online training in Responsible Conduct of Research no later than 30 days following initial participation on the project, including individuals added to a project in progress.  This requirement will be expanded to all continuation (Type 5) applications with deadlines on or after January 1, 2011.

Instructions for Virginia Tech CITI Learners

Individuals can access an on-line course created and maintained by the Collaborative Institutional Training Initiative (CITI), a nationally-recognized source for research-related training.

Learners are required to complete a basic set of required modules within a specialty area, including case studies, which are appropriate to the nature of his or her role in the sponsored research.  The specialty areas include:

• Biomedical Responsible Conduct of Research
  
  
• Social and Behavioral Responsible Conduct of Research
  
  
• Physical Science Responsible Conduct of Research
   
  
• Humanities Responsible Conduct of Research
  
  
• Responsible Conduct of Research for Engineers

The basic modules within these specialty areas review the following issues concerning ethical research:

• Introduction to Responsible Conduct of Research
  
  
• Research Misconduct
  
  
• Conflicts of Interest and Commitment
  
  
• Publication Practices and Responsible Authorship
  
  
• Data Acquisition, Management, Sharing and Ownership
  
  
• Mentor/Trainee Responsibilities
  
  
• Peer Review
  
  
• Collaborative Research
  
  
• Human Subjects
  
  
• Animal Subjects  (optional)

The minimum "passing" aggregate score for the collection of Responsible Research Conduct modules is 80%, which is required in order to satisfy the NIH requirement described above.

The Manager of Research Education and Development in the Office of the Vice President for Research will coordinate access to the training materials, as well as the tracking mechanism for compliance with this requirement.  Tracking will include identification of required participants, collection of training data, and reporting results of participants to PIs, the Authorized Organizational Representative, and the Research Integrity Officer.  After the learners complete and pass the appropriate module, they will be able to print a completion report.

Failure to comply with this policy by any required participants within the specified time frame may result in freezing the account of the project supporting these personnel.

Please note that this plan is subject to revision as NIH requirements change. 

The requirement applies to all trainees, fellows, participants, and scholars who are supported on identified NIH projects submitted (and subsequently awarded) after January 25, 2010, including competitive renewals.  This requirement will be expanded to all continuation (Type 5) applications with deadlines on or after January 1, 2011.

• NIH Notice Number: NOT-OD-10-019, November 24, 2009