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Institutional RCR Plan Information for Proposals

Office of Regulatory Compliance


Institutional RCR Training Plan: Potential Contents for Grant Proposals and Reports

Rationale:

Since the newer requirements for inclusion of training plans in the Responsible Conduct of Research (RCR) were issued by federal funders, the Office of Regulatory Compliance and its satellite offices have been asked for an official institutional version of a plan that could be used, as opposed to each individual grant submission needing to “reinvent the wheel”. The administrative research offices at University of Colorado Denver|AMC desire to assist their researchers by making processes easier and as streamlined as possible, so this repeated inquiry was considered for development.

Caveats:

However, due to the very individual nature of each grant project and its particular participants, it is impossible to write a generic plan that will suffice to fit the many scenarios.

  • Each researcher is: at a different stage of their research career, has a unique background or history of RCR training already completed (especially if they come from a different institution), and has areas of personal need for instruction to meet current project demands.
  • Each department or lab offers its own formal and informal supplemental instruction and topic discussions that help fulfill RCR training.
  • Each of the funding agencies requires differing levels and particulars for meeting its implementation of the America COMPETES Act in this regard.

Results:

With the above in mind, what follows is what our institution currently offers.

The text which follows below and between the lines:

  • may be copied and pasted in its entirety, or (more likely)
  • may be excerpted and inserted within an original text by the grant writer, who selects what is applicable to the person[s] involved in the project.
  • the full one-page text can also be printed as a .pdf or inserted (added) to another .pdf file: RCR Training Plan
    (For NIH: The limit is one page in Arial font size 11 with half-inch margins.)

Also following are:

  • additional suggestions of what can be included in your individual plan to meet certain needs, and
  • resources for RCR instruction to assist faculty in constructing sessions within their department or lab group.

Please contact the Office of Regulatory Compliance​ with any questions or with feedback regarding needed changes as future processing may reveal.


UCD Institutional Offerings and Support for Training in Responsible Conduct of Research (RCR)

The University of Colorado Denver and Anschutz Medical Campuses offer formal instruction in the Responsible Conduct of Research (RCR).

Format

Graduate students, postdocs, faculty and other research scholars have two avenues available to meet federal agency requirements: 1) a semester-long for-credit course (specifically PHCL 7605, IMMU 7606, or TXCL/PHSC 7400), or 2) a series of 9 one-hour face-to-face seminars with online prep materials to read/view and encompassing didactic presentation and live discussion on case studies during delivery.

  • In addition, the University offers researchers free use of the online courses from the Collaborative Institutional Training Initiative (CITI), some are required for any project needing COMIRB approval, but available for any lab or PI to make individual requirements of its involved researchers.
  • Further enabling researchers to meet their training needs, the University offers tuition waivers for all employees, including Postdoctoral Fellows/Trainees, Professional Research Assistants, and all faculty positions.

Subject Matter

The subject matter covered by the above named courses and in the monthly seminar series are:

  1. conflict of interest – personal, professional, and financial
  2. policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices
  3. mentor/mentee responsibilities and relationships
  4. collaborative research including collaborations with industry
  5. peer review
  6. data acquisition and laboratory tools; management, sharing and ownership
  7. research misconduct and policies for handling misconduct
  8. responsible authorship and publication
  9. the scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research

Other applicable required training is dependent upon the project or work assignment of the researcher:

  • Research using animal or human subjects requires additional training through the Clinical Research Support Center (CRSC) involving: animal care and use, HIPAA, biosafety and biosecurity, export compliance, conflict of interest, good clinical and laboratory practices, information privacy and security, disaster planning, among other related topics. This Center consults regarding ethical decisions and research design as well.
  • The Environmental Health and Safety Office (EHS) mandates applicable training in biological safety, chemical waste management, respiratory protection, and radiation and laboratory safety.

Faculty Participation

  • Faculty teach the courses and the seminar series as well as participate in the live discussions.
  • Faculty PIs are encouraged to meet specific needs within their research group by conducting in-house exploration of the intricacies of a topic through discussions, personal research projects, and other avenues of mentoring.

Duration and Frequency of Instruction

Courses = one semester of approximately 17 contact hours, offered no less than once a year

RCR Seminar Series = 9 contact hours, monthly from September through May and repeated in June

  • In accordance with federal agency requirements for recurring instruction, the University requires researchers to repeat full RCR training every four years.
  • The CRSC requires some training regarding human subjects every three years.
  • The UCD shall provide refresher courses or awareness training to workforce members as necessary to ensure adequate continuing knowledge and compliance or when the individual’s job function changes.

Monitoring

  • Course completion and grades are an official institutional record.
  • For the RCR Seminar Series, the Office of Regulatory Compliance provides a Certificate of Attendance for any individual 1-hour session of the series and a Certificate of Completion for completing the 8-hour requirement.
  • UCD maintains documentation of completed training through the Skillport and PeopleSoft systems. PeopleSoft is the system of record for training documentation.

Additional Optional Training Offerings You May Want to Include Depending on the Needs of Individual Researchers:

NIH RCR Online Training http://researchethics.od.nih.gov/

UCD’s CCTSI Education, Training, & Career Development
(see: http://www.ucdenver.edu/research/CCTSI/education-training/Pages/default.aspx

UCD’s ORDE videos:

UCD’s SOM Faculty Affairs Office:

UCD’s HS Library research support services http://hslibrary.ucdenver.edu/research-support/ (including developing Data Management Plans)


Resources for Faculty PIs in Constructing Sessions in RCR Instruction: