Faculty Resources

Check out the long list of resources available to CU faculty researchers.

Department Resources

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”.

Revised Common Rule Educational Resources

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.

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.

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.

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. 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 here.

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

To submit to COMIRB, you must be affiliated with The University of Colorado Denver in CITI.

"The Collaborative Institutional Training Initiative (CITI Program) is dedicated to serving the training needs of colleges and universities, healthcare institutions, technology and research organizations, and governmental agencies, as they foster integrity and professional advancement of their learners."

Colorado Clinical & Translational Sciences Institute (CCTSI)