Policy: Responsible Conduct of Research (RCR) Training and Education Plan

The university requires individuals in the categories below to successfully complete the Collaborative Institutional Training Initiative (CITI) Basic RCR online training:

• All new faculty members
• All new Post-Doctoral Researchers
• All new Doctoral Students
• All new Master’s Students completing research-based thesis or project work related to their degree
• Training needs to be completed again when early career researchers advance into new roles, as follows:
  • Moving from Master’s Student to Doctoral Student
  • Moving from Doctoral Student to Post-doctoral Researcher
  • Moving from Post-doctoral Researcher to tenure-track Lehigh faculty

When supported by an NSF award (including subawards to Lehigh and collaborative awards), the following categories of personnel must successfully complete the Collaborative Institutional Training Initiative (CITI) RCR Basic course prior to charging their salary to the award:

• All faculty
• Principal investigators
• Co-principal investigators
• Senior/key personnel
• Post-doctoral researchers
• Graduate students
• Undergraduate students

Note: if training was completed per the “Lehigh University Institutional RCR Requirement” section, it does not need to be completed again prior to charging salary to an NSF award.

All trainees, fellows, participants, and scholars receiving support through any NIH training grant, career development award (individual or institutional), research education grant, or dissertation research grant must receive instruction in RCR. The PI is responsible for reviewing award terms and conditions and identifying when RCR training is required (see Responsibilities section below).

The NIH training policy 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.

The NIH training policy also applies to any other NIH-funded programs supporting research training, career development, or research education that require instruction in responsible conduct of research as stated in the relevant funding opportunity announcements.

NIH indicates that eight hours of RCR training is an acceptable standard. Researchers may choose from the following resources to develop an individual training plan that fulfills the RCR requirements and is tailored to the needs of the award and the research team:

1. The RCR Basic Course offered online through the CITI Program provides a total of 4-6 hours of training. This may be used towards a portion, but not all hours, of the required NIH training.
2. The Office of Research Integrity offers workshops on a regular basis.
3. Research Mentoring Training based upon the Center for the Improvement of Mentored Experiences in Research (CIMER) is offered on a regular basis through the Lehigh University ADVANCE Center.
4. Department-sponsored courses that the Office of Research Integrity has confirmed meet at least some RCR requirements.
5. Training developed by the individual Principal Investigator or other RCR experts.

Please note: Lehigh University’s RCR training opportunities regularly evolve. You are encouraged to consider how existing departmental events, seminars, or workshops could be leveraged to incorporate RCR-specific topics to meet the NIH requirements. Please contact the Office of Research Integrity to discuss how your department may partner to develop content.

NIH does not consider RCR training provided exclusively via asynchronous, self-paced online instruction sufficient for meeting the training requirements; rather, NIH-approved RCR training must involve active learning, be discussion-based, and with direct face-to-face engagement among participants and faculty instructors. This face-to-face engagement is expected to primarily be in-person; however, this approach may be supplemented with limited use of videoconferencing.

NIH: RCR training must be completed when changing earlier career state researcher roles at Lehigh (from Master’s student to Doctoral student or from Doctoral student to Post-doctoral Researcher) and at least every four years, regardless of career stage. Renewal training can be completed using the resources as described above.

NSF: the NSF does not require renewal. 

RCR oversight is a shared responsibility of both the PI and the University.

The PI on an applicable NIH award is responsible for:

1. Reviewing the award terms and conditions and identifying when RCR training is required.
2. Identifying and notifying the individuals working on an award who must receive RCR training.
3. Determining the most appropriate format, content and instruction for RCR training, aligned with sponsor requirements and Lehigh University’s RCR Training and Education Plan.
4. Reporting as required under the terms of the specific funding program.
5. Maintaining documentation of completion of RCR training for all applicable personnel.

Colleges/Departments are responsible for:

Developing, implementing and overseeing mechanisms to inform individuals from the populations listed on page 1 in the “Lehigh University RCR Requirement” section when the RCR training requirement applies to them, direct them to appropriate resources to complete the training, and retain records as necessary documenting successful completion. The sample tracking spreadsheet can be adapted by each College/Department for this purpose.

The Office of Research Integrity (ORI) is responsible for: 

1. If necessary, coordinating the University’s response to any RCR-related inquiries from federal research sponsors.
2. Maintaining the University’s Responsible Conduct of Research Training and Education Plan and making it available upon request.
3. Maintaining the University’s access to the online CITI Program, which includes completion records.
4. Providing regular workshops that cover RCR-related topics.
5. Confirming to faculty, College leadership, and research administrators, when department-sponsored courses are eligible for meeting the NIH RCR training requirements.

The Office of Research and Sponsored Programs (ORSP) is responsible for:

1. Issuing the Awards Summary to the PI. The Awards Summary includes confirmation that the PI is responsible for reviewing the award terms and conditions. Terms and conditions can include training requirements.
2. Prior to processing payroll forms for an NSF award or subaward, verifying that all faculty, principal investigators, co-principal investigators, senior personnel, post-doctoral researchers, graduate students, and undergraduate students who are supported by the award have successfully completed the Collaborative Institutional Training Initiative (CITI) RCR Basic Course prior to charging salary to the award.

The Office of the Provost is responsible for:

Informing new faculty in their offer letter of the RCR training requirement.

NSF:
Online training modules and course completion records available through CITI.

NIH:
Documentation of required training completion may occur through eight total hours of:

In-person RCR course attendance, monitoring, and course completion tracking by individual instructors and/or the PI.
Online training modules and course completion records available through CITI.

NIH does not require certification of compliance or submission of documentation demonstrating compliance with RCR requirements, but expects institutions to maintain records sufficient to demonstrate that NIH-supported trainees, fellows, and scholars have received the required instruction.

Upon request, PIs are responsible for providing ORSP or ORI with documentation that the requirements have been satisfied. Researchers are responsible for adhering to the funder/sponsor RCR monitoring, tracking, and reporting requirements in addition to complying with Lehigh University requirements.  

This plan is subject to review upon request by the NIH, NSF, or any other federal agency. 

Individuals who are required to complete RCR training per this policy must do so within the designated timeframe. Failure to complete required training constitutes noncompliance with this policy and may result in administrative consequences, including, but not limited to:

• Limitations on access to sponsored research funds
• Suspended ability to submit sponsored research proposals
• Suspension or restriction of research activities

Individuals found to be noncompliant will be provided an opportunity to remediate the deficiency within a reasonable period. Continued noncompliance may be escalated in accordance with applicable university policies and may be reported to external sponsors, as required. 

Exceptions to RCR training requirements and/or established deadlines may be requested under extenuating circumstances. Requests must be submitted to the Office of Research Integrity and will be reviewed on a case-by-case basis.