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Research Integrity & Education

Revised Common Rule

Overview: Revised common rule

The U.S Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (45 CFR 46 Subpart A), also known as the Common Rule. The revised Common Rule implementation date was January 21, 2019 and was changed to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. 

In many cases, the Common Rule changes will not impact ongoing research. To review some of the key changes of the revised Common Rule, please refer to the PowerPoint program presented at the Town Hall Meetings in January 2019.

Relevant changes

The DU IRB has made changes to relevant policies and procedures in accordance with the New Common Rule.

Key Changes:

1. Revised Definitions
  • Research: A systemic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. 
  • Human Subjects: A living individual about whom an investigator conducts research.
    • Obtains information or biospecimens through interventions or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or 
    • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. 
2. Eliminated continuing review for minimal risk studies

Continuing review is eliminated for studies reviewed via expedited review. However, the IRB can require continuing review for a study if there is cause.

  • Continuing review is also eliminated for full board projects once subject interaction is complete 
  • Amendments and Adverse Event/Reportable Events are still required
  • Investigators will receive reminders about submitting continuing review reports for full board review only
  • Implementation of Post Approval Monitoring Program
3. Expanded Exemption Categories

There are REVISIONS to exemptions:

  • New restrictions have been added to the old exemptions with the exemption of category 6, which has no changes (taste and food quality studies)
  • New uses and restrictions on exemptions for research involving children
  • New exemptions for categories 2, 3, 7, and 8 that require a "limited IRB review."

Additionally, there are NEW exemptions for:

  • Research involving benign behavioral interventions in conjunction with the collection of information from adults
  • Secondary research uses of identifiable private information or identifiable biospecimens
  • Storage or maintenance for secondary research use of private information or identifiable biospecimens
  • Research involving the use of private information or identifiable biospecimens that have been stored or maintained for research use

For more information, please refer to:

  • Exemption Categories Chart per revised Common Rule | Word
  • PowerPoint presented in the Town Hall Meetings (January 2019) | PDF
4. Broad Consent

Broad Consent Template: We have created a new Broad Consent Template that allows the participants the right to make a choice whether to allow for the use of their identifiable information or biospecimens for future research use.

  • Not required for storage and secondary research use of de-identified data or specimens or for use consistent with the original informed consent
  • This consent must be accessible for verification/tracking if the information will be used and must be managed in order to remove if the individual changes their mind about sharing their information or biospecimens.
  • Broad Consent Template| Word

Broad Consent Changes: All consents must provide a "concise and focused presentation of key information" in the beginning of the consent. This includes voluntary participation, summary of research procedures, risks, and benefits. 

New consent elements (if applicable) include:

  • Biospecimens may be used for commercial profit (and whether the subject will share in that profit)
  • Clinically relevant results will be returned (or not)
  • De-identified data or biospecimens may be shared for future research (or not)

 Broad Consent GuidanceWord

5. Single IRB Review (sIRB)

The sIRB requires that all federally-sponsored research with multi-institutional collaborators be reviewed by one designated IRB of record.  Additionally it requires an IRB Authorization Agreement signed by a DU authorized signatory official and other institution. However, this is not required until January 2020.

6. Changes to current exempt and expedited projects

Current Exempt Projects: All exempt projects will be assigned a two-year review period. This review period will appear in IRBNet as "Next Report Due." There will no longer be an expiration date for Exempt Projects but instead will require Post Approval Monitoring. Post Approval Monitoring will occur after the study has been granted exempt status.

Changes to Current EXEMPT Research Projects | Word

Current Expedited Projects: All expedited projects will be assigned a two-year review period. This review period will appear in IRBNet in the "Next Report Due" field. Project expiration dates will be removed in IRBNet administratively by the IRB Office. Additionally, continuing review will no longer be required but instead Post Approval Monitoring will occur after the study has been approved. 

For information on how current exempt and expedited research projects reviewed by the DU IRB are being modified in response to revisions to the human subject research regulations, please refer to the following documents:

Changes to Current EXPEDITED Research Projects | Word

What Do I submit For IRB Review?

IRB Path Revised Common Rule