The Colorado Multiple Institutional Review Board requires that all trainees and personnel involved in research must complete the Collaborative Institutional Training Initiative (CITI) Basic Course in the Protection of Human Research Subjects and the CITI HIPAA Course. In order to maintain current competence in these important skills, we are also required to complete CITI refresher courses on an every three year basis. I completed the initial training and I am up to date with all of the refresher courses in Ethical Conduct of Research Involving Human Subjects. All trainees and personnel that are supported by this award are also current with this training in the responsible conduct of research and their HIPAA training. COMIRB recently added a requirement that all Principal Investigators complete Good Clinical Practice training through CITI, in addition to the Human Subject Protection training.
I guarantee that all personnel under my supervision will continue to conduct research in a responsible manner, as defined as the practice of scientific investigation with integrity. All of our research trainees, collaborators, and personnel will apply established professional norms and ethical principles in the performance of all activities related to scientific research. The ethical conduct of research is integrated into all aspects of our research group activities. All designated personnel will be required to participate in didactic courses covering the concepts inherent to the ethical conduct of research with human participants, issues of scientific integrity, and ethical theories and principles. These courses have been specifically designed to meet all requirements for the NIH guidelines for trainees and are listed below:
A certificate will be awarded to participants who attend at least eight hours of training within 4 years. The goals of each session are to stimulate on-going discussions and problem solving within labs and research groups and to facilitate subsequent small group discussions. This curriculum is also repeated once per year over the course of a week as a "make-up" to allow those who missed sessions during the year another opportunity to attend. An RCR website is also being developed which will include the key components of this curriculum as a resource for other faculty who prefer to develop their own RCR course using this framework as a starting point.
The Colorado Clinical and Translational Sciences Institute’s Education, Training, and Career Development program and Regulatory core in conjunction with the CU-D Graduate School have developed an additional interactive and innovative campus-wide RCR Curriculum. The goal of this additional RCR program is to make RCR training more easily accessible to all clinical and translational investigators. The curriculum consists of nine one hour sessions, given once per month that also follows the curricular requirements of NOT-OD-10-019. These sessions are open to all faculty, students and trainees across the spectrum of research and are free to all participants. Using videos, mock grant review committees, and interactive discussions, these classes are designed to provide the basic framework and tools to maintain exemplary responsible conduct of research. These sessions are taught by a rotating group of faculty involved in the various training programs on campus. A certificate will be awarded to participants who complete the nine classes within 4 years. The goals of each session are to stimulate on-going discussions and problem solving within labs and research groups and to facilitate subsequent small group discussions. This curriculum is also offered as a one-day (8 hour) seminar and will be made available once per year. A RCR website is also being developed which will include the key components of this curriculum as a resource for other faculty who prefer to develop their own RCR course using this framework as a starting point.
Together, these didactic courses and seminars, combined with weekly lab meetings will allow for substantial face-to-face and small-group discussions among the personnel involved in this proposal. Finally, one of the most important aspects of clinical training involves teaching by example. As such, I try to serve as a role model to clinicians-in-training by showing respect and compassion for patients, collegiality with other care providers, and dedication to providing quality patient care. Needless to say, these same principals are extended within the clinical research environment.
Last updated: 2/5/2016.