Revised Common Rule

Human Subject Research

The revised Common Rule applying to research supported by DHHS and many other federal agencies (excluding FDA and DOJ), went into effect on January 21, 2019. This site provides an overview of the major changes and how the DU IRB implemented them.

Major Regulatory Changes

  • Exemptions

    Categories have been updated, mostly to expand the type of research qualifying for exemption. New categories have also been added.

  • Expedited Continuing Review

    Continuing review is no longer required for research approved through expedited review. 

  • Informed Consent

    Consent forms are now required to include a "Key Elements" section and new elements of informed consent are required in some circumstances. DU IRB consent form templates have been updated to reflect the regulatory changes.

  • Single IRB of Record

    Beginning January 20, 2020, federally-funded multi-site/collaborative research projects occurring in the U.S. will be required to use a single IRB review process.

Minor Regulatory Changes

  • Human Subjects Research

    The definition of what qualifies as human subjects research has been updated to include identifiable biospecimens and to specifically exclude particular types of non-research activities.

  • Waiver of Informed Consent

    In order to approve a waiver of informed consent, in addition to previously existing waiver criteria, the IRB must now also determine if the research involves using identifiable private information or identifiable biospecimens and whether the research could not practicably be carried out without using such information or biospecimens in an identifiable format.

  • Clinical Trial Consent Form

    For each clinical trial supported by a federal department or agency, one IRB-approved informed consent form used to enroll subjects has to be posted by the PI on ClinicalTrials.gov that will be established as a repository for such forms. The form must be posted on ClinicalTrials.gov website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject.

Implementation of Regulatory Changes

  • IRB form updates have been released and posted.
  • Informed consent templates have been revised.
  • IRB Policies & Procedures were updated.
  • The DU IRB did not implement Broad Consent or Exempt categories 7 & 8.

New Studies approved January 21, 2019 and later:

  • Studies approved after January 21, 2019 were approved in compliance with the New Common Rule.
  • Expedited and Exempt review projects were issued a Next Report Due date. Faculty and staff investigators were issued a two-year review period and student investigators were issued a one-year review period.
  • The DU IRB will serve as a single IRB in limited circumstances. Consult with IRB staff prior to submitting an application in these cases.

Studies approved before January 21, 2019:

  • Existing exempt studies will remain unchanged unless an amendment submission requires a re-categorization.
  • Studies approved via Expedited or Full Board review were evaluated at the time of continuing review to determine if they were eligible for reclassification.
  • Federally funded studies approved via Expedited review were issued expiration dates; non-federally funded studies approved via Expedited review were issued a Next Report Due date. Faculty and staff investigators were issued two-year review periods and student investigators were issued a one-year review period.
  • Studies granted an Exempt status were issued a Next Report Due date. Faculty and staff investigators were issued a two-year review period and student investigators were issued a one-year review period.
  • At the end of the designated review period, PI are requested to provide the IRB with a status report of their project. Notices are sent prior to the assigned Next Report Due date and investigators are requested to submit a Project Status Report for ongoing projects or a Final Report for studies that have been completed.