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.


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.