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2018 Common Rule Regulations

Changes to the Common Rule, the primary rule governing human subjects research, went into effect on  January 19, 2019. Studies reviewed by the IRB  after  this date fall under the 2018 rule.  
The new rule can be found in its entirety here:  Revised Common Rule . Please note that the U.S. Food and Drug Administration (FDA) and the Department of Justice (DOJ) have not yet signed on to this rule; these changes will not be implemented for studies overseen by these agencies.  

Please note: If your study was approved by the IRB prior to January 19, 2019, these changes do not apply to that study unless it is resubmitted and re-approved under the revised rule.  

  A summary of the primary changes under the new rule include:  

  1. Updated consent form requirements:  
    • Consent forms now require a concise summary of study activities, risks, and benefits presented to research participants at the beginning of the document, prior to the more detailed study information  
    • Additional elements of informed consent are included for applicable studies, including items such as whether a study includes whole genome sequencing, or whether clinically relevant results will be returned to subjects  
    • Updated templates can be found in the ICON library and on the  IRB - Investigator Tools  webpage  
  2. Changes to annual continuing review  
    • For minimal risk, non-FDA-regulated research studies  approved by expedited review AFTER January 21, 2019 , annual continuing review will no longer be required. Full committee review protocols will still require continuing review submission annually, unless in data analysis only or in long term follow-up involving only procedures conducted in routine clinical care  
    • Other follow-on submissions (modifications, unanticipated events, and study closure) are still required.   
  3. Changes to the definition of "Research"  
    • Certain types of activities no longer fall under the definition of research:  
      • Scholarly and journalistic activities that focus directly on the specific individuals about whom the information is collected (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship)  
        • Draft OHRP guidance can be found  here. This determination can be challenging; please consult the IRB office for any questions.  
      • Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority  
      • Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes  
      • Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions  
  4. Changes to the definition of “Human Subject”  
    • The definition of Human Subject now includes not just data, but biospecimens:  
      • "A living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains  information or biospecimens  through intervention or interaction with the individual, and uses, studies, or analyzes the  information or biospecimens ;  OR (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or  identifiable biospecimens .”  
      • Identifiable Biospecimen : a biospecimen for which the identity of the subject is OR may readily be ascertained by the investigator OR associated with the biospecimen.  
  5. Changes to Exempt categories and new requirement for “Limited IRB Review”  
    • The new rule broadens the types of research that qualify as exempt. Several exempt categories have been significantly revised, and there are new subcategories of exemptions (previously not considered exempt) that may undergo “Limited Review” by one IRB member. Many new social/behavioral research studies previously requiring expedited or full review may now be exempt. The exempt categories have been updated  here, and SOPs/checklists/worksheets in the ICON library have been updated. Please note that some exemption categories are not applicable to research involving children, and no exemption categories apply to prisoner subjects.  
    • Two additional exemption categories, both involving broad consent, trackable at an institutional level, are included in the new rule. UH has chosen not to utilize these categories at this time.  
    • The new rule requires that certain clinical trial consent forms be posted on a government website ( The definition of clinical trial now harmonizes with the NIH definition, which is much broader than under the previous rule:
      • Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health related outcomes. 
  7. Changes to categories of vulnerable subjects:  
    • Removed “Pregnant Women”  
    • Replaced “Handicapped” with “Individuals with Impaired Decision-Making Capacity”  
    • Added “Economically or Educationally Disadvantaged Persons”  
Who can I call if I have questions?

The RIO team is standing by to assist you during this time. Please reach out to the following addresses/individuals:  

  • Shehla Barlas,  Research Compliance Analyst, IRB 1  
  • Autumn Waite,  Research Compliance Analyst, IRB 2  
  • Nettie Martinez,   Research Compliance Analyst, IRB 3     
  • Alicia Vargas,   Research Compliance Analyst, Exempt and Expedited Reviews     
  • Kirstin Holzschuh, Executive Director, Research Integrity and Oversight (RIO) Office