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Research Resources


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Regulatory Agencies

Office for Human Research Protections (OHRP)

Federal Drug Administration (FDA)

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.

  • Posted January 4, 2018: Town Hall: The “New Rule,” Federal Policy for the Protection of Human Subjects. COMIRB is hosting a series of town halls to discuss changes necessary to comply with the new rule and to take advantage of flexibility allowed under the New Rule. The New Rule goes into effect January 19, 2018.
    Thursday, January 18, 2:30 – 4:00pm, Ed. 2 North, P28-2102
    Thursday, February 8, 2:30 – 4:00pm, Ed. 2 North, P28-2102
    Tuesday, February 27, 2:30 – 4:00pm, Ed. 2 North, P28-2307
  • Posted December 18, 2017: Full Board and Expedited Study Closures
    InfoEd now offers the submission type "Study Closure." Please select "Study Closure" when closing out an expedited or full board study. For more guidance, please see "Closing a Study" on the COMIRB Submissions Page
  • Posted on November 13, 2017: Simplified Review of Individual Patient Expanded Access IND
    The FDA updated Form 3629 (Individual Patient Expanded Access Investigational New Drug Application) and related guidance documents (e.g., Guidance on Expanded Access to Investigational Drugs for Treatment Use, June 2016) in October, 2017. The updates simplified IRB review requirements for physicians seeking individual patient expanded access to an investigational new drug. Previously, all expanded access protocols required full-board IRB review. The update now allows individual patient expanded access treatment use of an investigational drug to be reviewed by a Chair to obtain Chair’s concurrence before the treatment use begins, in place of obtaining full-board IRB review. The treating physician must request authorization to use this alternative review procedure in Form 3629 (Question 10b).
    COMIRB has developed a new request form and submission process for Individual Patient Expanded Access Investigational New Drug. The new Individual Patient IND Request form and the guidance document can be found in the Forms Library under “Expanded Access/Compassionate Use”: http://www.ucdenver.edu/research/comirb/Pages/forms.aspx
  • Posted on October 20, 2017: Certificates of Confidentiality
    NIH has updated its policy regarding Certificates of Confidentiality in order to implement privacy provisions of the 21st Century Cures Act. Effective October 1, 2017, NIH funded (partially or wholly) research involving human subjects and identifiable data, bio-specimens or genomic data, will automatically be issued a Certificate of Confidentiality as part of the terms and conditions of the award. NIH funded human subjects research that was commenced or ongoing on or after December 13, 2016, has deemed to have been issued a Certificate of Confidentiality. More information is available here: http://www.ucdenver.edu/research/Research%20Administration%20Documents/Certificate-of-Confidentiality.pdf
  • Posted on August 25, 2017: Study Personnel Process Change
    As part of ongoing efforts to increase efficiency and improve turnaround times in the COMIRB Office, the COMIRB will no longer review and approve personnel beyond Principal Investigator, Co-investigators and Primary Contact.
    Effective Monday, September 5, 2017, COMIRB will only review and approve updates or changes to individuals in the roles of: Principal Investigator, Co-investigator, Primary Contact, or Faculty Mentor.
    There is no regulatory requirement for COMIRB to review such changes and the extra work this process has made for study teams and IRB staff will be reduced with this new process.
    For personnel who need administrative access to eRA(InfoEd) for COMIRB submissions, COMIRB communications, or study documents, the PI can:
    1) Assign these individuals as a “Delegate” within eRA(InfoEd) via “My Profile” (click here for instructions), or
    2) Submit a change form allowing access for a specific study.
    This process change does not change the requirement for research personnel to maintain all of the required COI disclosures and CITI education courses as outlined in the COMIRB Policy and Procedures (Section 25.3) and the COMIRB website, This change in process will move the responsibility for oversight and compliance to the Principal Investigator.
    If you have any questions regarding this new process, please contact COMIRB at 4-1055 or COMIRB@ucdenver.edu

Contact COMIRB

Delegation of Authority
Template - links will be available soon
SOP - links will be available soon
Staff Training Record
Template - links will be available soon
SOP - links will be available soon
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 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
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: https://forms.ucdenver.edu/secure/rss_ra_ogc_ra
Contact(s): Crao_Contracts@ucdenver.edu
Export Controls
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)
Social Media
More information will be posted soon
Webpage request
More information will be posted soon

Research Education

CITI Program

Click here to link to CITI Program.

CITI REGISTRATION INSTRUCTIONS

(Affiliating with new institutions to complete courses or transfer credits)

  1. 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”.
  2. 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 yours does not have these affiliations, click “Click here to affiliate with another institution
  3. Add the required courses to your course list. Click “Add course or update learner group
    1. Group 1 Biomedical Investigators or Group 2 Social and Behavioral Research (pick one)
    2. HIPS for Clinical Investigators
    3. Group 4 ICH/GCP – meets NIH requirements (select this if you will be the PI on a clinical trial or NHI-funded study)
    4. Select “No” or “Not at this time” for all other courses listed, unless another institution/sponsor requires them.
  4. 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”.
Final Rule resources from CITI Program

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.

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.

Grants

New RFPs/RFAs

NIH

Foundations

Institutional Awards

QI/PE/NHSR Committee

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.

QI/PE/NHSR Checklist

Click here to access the QI/PE/NHSR Checklist

Coming soon: watch Dr. Mealer’s presentation highlighting the differences between research vs. various not human subject research categories.

Dept. PM&R QI/PE/NHSR Determination Committee

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.