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)
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.
As on July 19, 2018, IRBs are allowed to remove the requirement for continuing review for research eligible for expedited review. Some other research is also eligible, but research involving the FDA, VA, or DOD is ineligible.
This is a new provision of the "2018 Requirements" for the Federal Policy for the Protection of Human Subjects.
See our guidance document for more details.
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 template provided by The Office of Regulatory Compliance.
If a DUA is initiated by another institution, please complete the Summary Sheet (page 1) of the template and submit the documents for review by the HIPAA Privacy Official.
The Office of Regulatory Compliance oversees the regulation of Material Transfer Agreements. Click here for information and instructions on MTA requests and reviews.
Submission Portal: https://forms.ucdenver.edu/secure/rss_ra_ogc_ra
Working with foreign national collaborators, institutions, or students may fall under the purview of various federal export control laws. To learn more about Export Controls, click here.
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. Additional guidance documents may be found here.
For additional regulatory assistance, PM&R Faculty and Staff may consult with our Regulatory Core. You may email Meredith.Mealer@ucdenver.edu or Kathryn.Cochran@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)
CITI Program has created the resources below to help the research community understand the revisions to the Common Rule issued on 19 January 2017 and set to take effect in January 2018. They were developed with the assistance of expert authors and peer reviewers. [CITI] will continue to add resources throughout the year so be sure to check back often. [CITI] will also be updating CITI Program courses to reflect the revisions by January 2018. Click here to access CITI Program’s Final Rule Resources.
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 is accepting proposals for research pilot projects. 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).
Applications are due May 31, 2018 to CUPMR.Research@ucdenver.edu by 6pm MST.
Stay tuned for information
Stay tuned for information
Is your project considered research? Do you need help with this determination? Use some of our tools below to distinguish what is considered research, quality improvement, program evaluation, or other not human subjects research categories.
The University of Colorado Denver, Colorado Multiple Institutional Review Board (COMIRB), Policies and Procedures for the Protection of Human Subjects, does not require submission of QI, PE and NHSR for review and concurrence and delegates this responsibility to departments and investigators. The Department of PM&R has put together a committee to conduct internal reviews of PM&R studies believed to be considered “not human subjects research”.
Faculty and staff will submit all QI, PE and NHSR to the committee for review and approval. The committee will provide a departmental letter to satisfy review requirements requested by journals, conference presentations and/or institutional quality assurance reviews. The Committee will be comprised of the Research Integrity Officer, Director of Research and a research administrator. More details can be found in the SOP located here.
Please use our REDCap Intake Form to submit your proposal for review by the Dept. PM&R QI/PE/NHSR committee. For a template with guidance on how to submit, click here.
Any questions should be directed to Dr. Meredith Mealer at Meredith.Mealer@ucdenver.edu.