The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). Research at most institutions is subject to HHS regulations at 45 CFR 46, also known as the “Common Rule”.Go to Office for Human Research Protections (OHRP)
Check out OHRP's educational materials on some of the new provisions and changes in the revised Common Rule. Find videos and a set of commonly asked Q&As for quick reference. More resources are being developed and will be posted by HHS/OHRP regularly.
The U.S. Food & Drug Administration (FDA) is another agencies providing oversight for clinical investigations that may be regulated by the FDA. This includes, but is not limited to, research investigating drugs, devices, or other products regulated by the FDA. As the definition of what is covered by the FDA evolves, it is important to determine whether your study may be subject to FDA regulations. At most institutions, research may be subject to Food and Drug Administration (FDA) regulations at 21 CFR 50 and 21 CFR 56. Go to U.S. Food & Drug Administration (FDA)
To honor its commitment to the VA Eastern Colorado Health Care System (VA ECHCS), COMIRB abides by the Department of Veterans Affairs policies for human research protection, including the regulations at 38 CFR 16, and the VHA Handbook 1200.05. The VA ECHCS Research Office website can be found here.
The full list of COMIRB announcements can be found here.
The PM&R Delegation of Authority Log (DoA) is a required document for all PM&R research studies. Principal Investigators must outline the scope of each individual’s work on the respective study, and the DoA serves as a consolidated, easily accessible list of these responsibilities. When you have a new study starting, please make sure you complete the PM&R Study Staff Training and Delegation of Duty Log to be included with your study records. See the template and corresponding SOP below for more information.
The PM&R Study Staff Training Record internally tracks the mandatory training of non-key study personnel. Training records for key personnel such as the Principal Investigator, Co-Investigators, and the Primary Contact are maintained by COMIRB. You may use this form in place of adding research assistants and non-key personnel to your COMIRB application. Please see the template and SOP below to learn more about when and how to use this tracking mechanism.
The transfer or sharing of data and/or materials with individuals or institutions outside of the University of Colorado Anschutz Medical Campus is subject to review by the HIPAA Privacy Official. To learn more about the HIPAA regulations pertaining to Protected Health Information (PHI), click here.
To initiate a Data Use Agreement (DUA), use the DUA Portal.
If a DUA is initiated by another institution, please complete the DUA portal request.
Contact: ClinicalResearchSupportCenter@ucdenver.edu (303) 724-1111
Working with foreign national collaborators, institutions, or students may fall under the purview of various federal export control laws. Learn more about Export Controls
Export Control Decision Tree (courtesy of The Office of Regulatory Compliance)
More information will be posted soon!
Both COMIRB and the Clinical Research Support Center have several guidance tools available to help with your IRB submissions. While the PM&R RISE (Research Innovation Services Enterprise) is available for questions and guidance, we highly suggest utilizing these resources.
A good place to begin is the COMIRB Submission Guidance Page. This has preliminary instructions on each submission type, offers tools to help decide what level of review your project will need, and provides a checklist for documents required for each review level.
Attending a COMIRB Office Hours session is also greatly advised. Office hours sessions are useful for determining levels of review, what documents may be needed, and how to fill out application forms. To make the most out of your office hour session, we suggest going through COMIRB’s guidance and preparing your forms (and questions) in advance. COMIRB hosts their forms and templates on their COMIRB Forms Page. Check this page often as forms are often updated.
For additional regulatory assistance, PM&R Faculty and Staff may consult with our Regulatory Core.
You may email Meredith.Mealer@ucdenver.edu with questions or to set up an appointment.
NEW! Spanish Resources on Protections for Research Participants
OHRP has expanded the Spanish language materials available on its public outreach website, About Research Participation, https://hhs.gov/about-research-participation. From the main page, users can choose to view the site in English or Spanish. The Spanish pages include short videos about participating in research and a printable list of questions that potential volunteers can ask researchers. New to the site is a series of infographics to help Spanish-speaking members of the public understand the protections that exist for research participants. You can view the infographics at: https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/protegiendo-a-los-voluntarios-que-participan-en-investigaciones/index.html
Trial coordinators and research staff can use these materials to facilitate and improve the informed consent process. We hope the availability of these materials in Spanish will be a valuable resource for the research community as well as the general public. Please consider sharing this information with other human research protection professionals!
(Affiliating with new institutions to complete courses or transfer credits)
According to their website, “The Colorado Clinical & Translational Sciences Institute (CCTSI) is the academic home to help transform the clinical and translational research and training efforts at the University of Colorado Anschutz Medical Campus and affiliated institutions. The CCTSI was created in 2008 with funding from the Clinical and Translational Science Award (CTSA) initiative of the National Institutes of Health (NIH)”.
NIH offers funding for many types of grants, contracts, and even programs that help repay loans for researchers. Learn about these programs, as well as about NIH's budget process, grant funding strategies, and policies, and more.
The Department of PM&R periodically accepts proposals for research pilot projects. The deadlines will be announced during faculty meetings and through email.
The objective of this opportunity is to enhance the value and effectiveness of pilot research conducted within the Department to accomplish four objectives:
Proposals will be accepted from any PM&R faculty member (regular track or research series).
CUPMR.Research@ucdenver.edu by 6pm MST.
Stay tuned for information
Stay tuned for information