NIH National REACT
According to their website, REACT is "a national resource of expertise, skills, and tools for medical rehabilitation researchers to catalyze high-impact, interdisciplinary clinical trials." This NIH resource funds pilot studies and provides education, collaboration/data sharing, consult services, and access to core facilities.
To learn more about REACT and access these valuable resources, visit their web page 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.
Template | SOP
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.
Template | SOP
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.
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.
Contact(s): Lori.Hopper@ucdenver.edu and Christine.Ahearn@ucdenver.edu
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
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. 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.