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

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 July 20, 2018: Changes for Continuing Review -- Transitioning to "2018 Requirements"

  As on July 19, 2018, IRBs are allowed to remove the requirement for continuing review for research eligible for expedited review. Some other research is also eligible, but research involving the FDA, VA, or DOD is ineligible.

This is a new provision of the "2018 Requirements" for the Federal Policy for the Protection of Human Subjects.

See our guidance document for more details.

• 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”:  https://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: https://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

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