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NIH Training Requirement in the 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:

  • D43
  • D7
  • 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
  • T35
  • T36
  • T37
  • T90/R90
  • TL1
  • TU2
  • U2R

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. 

Face-to-face instruction will be offered each spring semester as a course, currently listed as “Responsible Conduct of Research BMVS”.  Students can enroll in this course for credit or they may audit the course.  Sign in for each class is required to obtain a certificate of attendance and completion.  All such participants must complete this course within 12 months of being supported on the NIH project.

Previous courses that meet the instructional components of the NIH requirement may be acceptable with approval from the Research Integrity Officer. Documentation shall include the Instruction Documentation Form below and a course syllabus/outline.  Documentation should be submitted to the Manager of Research Education and Development. 

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 VT 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.

 

For more information:

Technical issues regarding content delivered on the CITI website should be addressed to citisupport@med.miami.edu or to 305-243-7970.

Questions regarding NIH requirements should be addressed to Vicky Ratcliffe, Manager of Research Education and Development, at vratcliffe@vt.edu or 540-231-7964.

Questions regarding this policy should be directed to Dr. Thomas Inzana, Research Integrity Officer, at tinzana@vt.edu or 540-231-5188.