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Revised Common Rule

  1. Home
  2. Academics
  3. Research, Scholarship, and Creative Activity
  4. Institutional Review Board
  5. Revised Common Rule

Research Resources

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T (773) 442-6012

graduatestudies@neiu.edu

Contact Us

The Revised Common Rule is in effect as of January 21, 2019

The revised Federal Policy for the Protection of Human Subjects (45 CFR 46. Subpart A) known as the "Common Rule” went into effect on Jan. 21 of 2019. All studies involving human subjects submitted on or after January 21, 2019 will be reviewed by the IRB in accordance with the requirements of the revised rule.

Review OHRP’s draft guidance on transitioning to the revised Rule to find out how this might affect regulated research with human subjects.

Share and bookmark this page to access OHRP educational resources on the revised Common Rule. 

Summary of Major Changes in the Revised Common Rule

Continuing Review - No longer required for most expedited studies. Furthermore, studies approved by the convened IRB, where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data, will no longer require continuing review.

Exemptions - The Common Rule defines three levels of review for human subjects research: exempt, expedited, and full (board). The revised Common Rule broadens the types of research that can be reviewed at the exempt level, which is the level requiring the least oversight.

Informed Consent - The revised Common Rule requires a new "Key Elements" section and a rearrangement of the content of consent forms to facilitate a potential subject's decision to participate or not. A "broad consent" option has been added for unspecified future use of identifiable data/biospecimens. 

Single IRB-of-Record (sIRB) - Most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB starting Jan. 20, 2020. NIH funded research projects will be required to use a single IRB starting Jan. 25, 2018. See the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research for information about the NIH sIRB policy implementation.

What to Expect

Previously approved studies:

The new regulations will not apply retroactively to existing studies. For approved expedited studies and full review studies, the IRB will evaluate the need for continuing review at the time of the next scheduled continuing review submission.

New studies:

All studies involving human subjects submitted on or after January 21, 2019 will be reviewed by the IRB in accordance with the requirements of the revised rule.

More information will be forthcoming. Feel free to contact us with any questions you may have at irb@neiu.edu or (773) 442-4675. 

QuickLinks

Final Revisions to the Common Rule
NIH Policy on the Use of a Single IRB

Research Resources

  • Research and Creative Activities Assistantship
  • NEH Opportunities
  • Campus Resources for Faculty Research
    • Faculty Research and Creative Activities Symposium
  • Office of Research and Sponsored Projects
    • Responsibilities of a Principal Investigator on a Grant
    • Post-Award Conference
    • Financial Conflict of Interest
    • Finding Funding
    • Proposal Preparation Assistance
    • Grants Administration
    • Guides for Writing Grant Proposals
    • Grant Prospecting for Faculty
    • Grants 101 Training
    • Grant Prospects for Faculty from the National Endowment for the Humanities
  • Institutional Review Board
    • Institutional Review Board Leadership
    • Revised Common Rule
    • Getting Started
    • Resources and Templates for New Research
    • Resources and Templates for Approved Research
    • IRB Policies and SOPs
  • Research Policies
  • Research and Creative Activities Advisory Group
  • Contact Us

CONTACT US

T (773) 442-6012

graduatestudies@neiu.edu

Contact Us

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