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Research Resources


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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)

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.

  • Posted January 17, 2018: New Rule Delay
    The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149). Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018.

    The IFR delays the effective date and general compliance date to July 19, 2018, providing regulated entities additional time to prepare to implement these revisions.

    The IFR has been put on public display by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2018/01/22/2018-00997/federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-for.

    Until July 19, 2018, regulated entities will be required to comply with the pre-2018 Common Rule as published in the 2016 edition of the Code of Federal Regulations (i.e., the Federal Policy for the Protection of Human Subjects, originally published on June 18, 1991, and subsequently amended on June 23, 2005) that can be accessed at: https://www.gpo.gov/fdsys/pkg/CFR-2016-title45-vol1/pdf/CFR-2016-title45-vol1-part46.pdf . This means that before July 19, 2018, institutions may only begin implementing provisions of the revised Common Rule that do not conflict with the pre-2018 Common Rule. An example of a revised provision that does not conflict with the pre-2018 rule is one that addresses new elements of informed consent (revised rule at §__.116(b)(9), (c)(7)-(9)). It is permissible to incorporate these new elements of consent now because the pre-2018 rule does not prohibit including these elements in informed consent.

    An example of a revised provision that conflicts with the pre-2018 rule, and thus could not be implemented prior to July 19, 2018, is the provision eliminating the requirement for continuing review in certain circumstances (as described in the revised rule at §__.109(f)). Because the pre-2018 regulations require continuing review at least annually for all ongoing non-exempt human subjects research, halting continuing review for such research before that date would be considered non-compliance.

    The IFR does not delay the compliance date for the cooperative research provision of the revised Common Rule (found at §__114(b)), which remains January 20, 2020.

    Federal departments and agencies listed in the IFR are also in the process of developing a notice of proposed rulemaking (NPRM) seeking public comment on a proposal for further delay in the required implementation of the revised Common Rule (for example, until January 21, 2019). If such an NPRM is published, after consideration of the public comments, the federal departments and agencies will determine whether a final rule to further delay the revised Common Rule will be issued.

  • 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

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.

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

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.

Research Education


OHRP Resources - Participation in Research

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 re​search protection professionals!


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 your menu does not have this affiliation, 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

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:

 


Institutional Awards

PM&R Research Pilot Competition Call For Proposals: Applications due May 31, 2018

Download the RFP

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:

  • 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).

Applications are due May 31, 2018 to CUPMR.Research@ucdenver.edu by 6pm MST.

 


New RFPs/RFAs

Stay tuned for information

 


Foundations

Stay tuned for information

 


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

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.

REDCap Intake Form

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.​​