Regulatory Agencies
Office for Human Research Protections (OHRP)
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)
Revised Common Rule Educational Resources
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.
Revised Common Rule
U.S. Food & Drug Administration (FDA)
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)
Veterans Health Administration (VHA)
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.
COMIRB
- What is COMIRB?
- According to their website, “The Colorado Multiple Institutional Review Board is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the University of Colorado Denver and its affiliates: Children's Hospital Colorado, Denver Health and Hospital Authority, University of Colorado Hospital, and the VA Eastern Colorado Health Care System.” The COMIRB ensures compliance with the DHHS regulations at 45 CFR 46 (also known as the “Common Rule”), the FDA regulations at 21 CFR 50 and 21 CFR 56, and other applicable institutional policies.
- All research through the Department of Physical Medicine and Rehabilitation must be reviewed and approved by the COMIRB prior to conducting any research procedures.
- To visit the COMIRB website, click here.
COMIRB Timely Announcements
The full list of COMIRB announcements can be found here.
Delegation of Authority
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.
Staff Training Record
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.
Materials Transfer Agreement (MTA) and Data Use Agreement (DUA)
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.
DUAs
To initiate a Data Use Agreement (DUA), use the DUA Portal.
Outside Institution:
If a DUA is initiated by another institution, please complete the
DUA portal request.
Contact(s): Lori.Hopper@ucdenver.edu and Christine.Ahearn@ucdenver.edu
MTAs
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
Contact: ClinicalResearchSupportCenter@ucdenver.edu (303) 724-1111
Export Controls
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)
Social Media
More information will be posted soon!
Webpage Request
IRB Submission Guidance
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.
Research Education
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!
CITI Program
Click here to link to CITI Program.
CITI REGISTRATION INSTRUCTIONS
(Affiliating with new institutions to complete courses or transfer credits)
- To submit to COMIRB, you must be affiliated with University of Colorado Denver in CITI Program. New CITI Program users should visit https://www.citiprogram.org/ and click “Register”.
- New users: upon registering, type “University of Colorado Denver” and follow the prompts to complete registration.
Returning users: On your Main Menu you should see a tab titled 'University of Colorado Denver Courses'. If your menu does not have this affiliation, click “Click here to affiliate with another institution” - Add the required courses to your course list. Click “Add course or update learner group”
- Group 1 Biomedical Investigators or Group 2 Social and Behavioral Research (pick one)
- HIPS for Clinical Investigators
- Group 4 ICH/GCP – meets NIH requirements (select this if you will be the PI on a clinical trial or NHI-funded study)
- Select “No” or “Not at this time” for all other courses listed, unless another institution/sponsor requires them.
- Complete your required training by clicking on the title of the course and following the instructions provided. Course credit transfers will occur automatically if the content is identical between institutions.
Be sure to save a copy of your certificates for your record by clicking “View/Print” under “Completion Reports”.
Colorado Clinical & Translational Sciences Institute (CCTSI)
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)”.
To learn more and the CCSTI and its offerings, visit their website.
NIH Funding
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.
Learn about:
- National Center for Medical Rehabilitation Research (NCMRR)
- Grants (NIH Guide to Grants and Contracts)
- Subscribe to the NIH Grants Guide
- NIH Research Training and Career Development Programs
- Helpful Resources
Institutional Awards
PM&R Research Pilot Competition
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:
- Facilitate interdisciplinary collaboration – This is a special area of emphasis for this call and grants will be scored accordingly. Collaborations can be with those within or outside the Department of PM&R.
- Improve the health outcomes of the rehabilitation population
- Enhance the patient experience of care (including quality, access and reliability)
- Provide departmental researchers the opportunity to collect quality data to leverage future funding
Proposals will be accepted from any PM&R faculty member (regular track or research series).
CUPMR.Research@ucdenver.edu by 6pm MST.
New RFPs/RFAs
Stay tuned for information
Foundations
Stay tuned for information
