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Revised Common Rule Implementation

The Common Rule is our primary guidance for human subjects research for definitions, review requirements, and IRB processes.  Changes to the Common Rule – what we will refer to as the revised Common Rule – went into effect on January 21, 2019.

Changes You’ll See to Our IRB Program

Updated Applications

The Exempt and Expedited/Full Board Applications have been updated and are available on the IRB Forms page.  You must use these for all new submissions.  The Exempt protocol has shrunk to 3 pages and includes the updated categories.  The Expedited/Full Board application required some minor edits.

New Protocols

New submissions must follow the Revised Common Rule and use the latest protocol applications from this point forward.  If you submit on an older version, it will be returned to you.

Existing Protocols

Protocols approved under the previous Common Rule will be allowed to continue if no modifications are needed.  We can transition protocols to the revised regulations, but are not required to do so.  We will look at these on a case by case basis to weigh the transition.

Updated Program Guidance

The IRB Program Guide has also been updated to reflect the Revised Common Rule.  We will gradually work on the additional forms and guidance to reflect these changes and as guidance is issued.

CITI Training

CITI has updated there modules to reflect the changes to the Common Rule.  The good news is CITI is simply updating current modules and our module assignments won’t change at this time.  This means the next time you are due for training, you will see the latest content.

Changes to the Common Rule

Overall, the impact on our IRB program and processes is small.  Below is a summary of changes that will affect our program and review of your research.

Exempt Categories

The revised Common Rule is bringing some new exempt categories and revisions to others for a total of 8 categories.  Two, new categories focus on biospecimens.  More details on these are coming…

New and Revised Terms

For the most part, terms are remaining intact.  Most of the updates to terms are provided for clarification or guidance.  Some examples:

  • The term “human subject” replaces “data” with “information and biospecimens”.
  • “Vulnerable” refers to “individuals with impaired decision-making ability”.  This revised meaning is meant to draw focus toward subjects potentially vulnerable to coercion or undue influence in their decision-making ability.

Research that is NOT “Research”

The revised Common Rule contains a more detailed definition of “research”, specifically pointing out certain areas that are NOT “research”.  So what’s not research?

  • Scholarly and journalistic activities focused directly on the specific individuals about whom the information is collected.
  • Public health surveillance conducted, supported, requested, ordered, required, or authorized by a public health authority.
  • Collection and analysis of information or biospecimens for a criminal justice agency authorized by law or court order solely for criminal justice or criminal investigative purposes.
  • Authorized activities in support of intelligence, homeland security, defense or other national security interests.

Clinical Trial

A new definition of “Clinical Trial” is a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.  This new definition is capturing behavioral research that’s never been considered a clinical trial before because it’s looking at a health-related outcome (e.g. school lunch program with interventions).  If your activity fits into this definition and is federally funded, you will have additional registration and reporting requirements to meet.  If your funding comes from the National Institutes of Health (NIH), you have some additional, additional requirements – see NIH-Defined Clinical Trials.

Informed Consent

Some key changes:

  • “Key information” must appear at the beginning to assist a prospective subject in deciding to participate.
  • Electronic consent is allowed but must provide a copy
  • New “broad consent” option for storage, maintenance, and secondary use of biospecimens
  • For “clinical trials”, a requirement to post a copy of an IRB-approved consent form to a federal website.  Currently, NIH uses

Single IRB (Collaborative Review)

NIH currently requires multi-site research to rely on a single IRB of record.  This requirement is coming to all federally funded research in January 2020.