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New Common Rule Regulations

Changes to the Common Rule, the primary rule governing human subjects research, go into effect on January 19, 2019. Studies reviewed by the IRB after this date will fall under the new rule.

How does this affect me? The information collected from you, and the process for submission within ICON, remains the same – with two key exceptions:

  • New Informed Consent Templates must be utilized for protocols reviewed after January 19, 2019. These updated templates are located in the ICON library and on our website

 

  • With very few exceptions, protocols approved by expedited or exempt review processes after January 19, 2019 are no longer required to undergo annual continuing review. Your approval letter will not indicate an expiration date unless the IRB specifically determines that annual renewals are needed. You will remain responsible for:
    • Following the approved protocol
    • Submitting modifications to update changes to the protocol and personnel
    • Reporting unanticipated events
    • Closing the protocol in ICON when complete

This does not apply to studies reviewed by a fully convened IRB.

The revised rule primarily affects how the IRB and IRB office review your protocol; it includes new definitions for research and human subject, and provides for new exemption categories. In some cases, a new type of IRB review, called Limited IRB review, is required for exempt protocols.

The new rule can be found in its entirety here: Revised Common Rule. Please note that the U.S. Food and Drug Administration (FDA), the Department of the Interior (DOI), 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 is already approved by the IRB, these changes do not apply to that study. Guidance will be provided soon for a process to transition your study to the new rule, should you request it.

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. Much social behavioral research 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.

  6. Clinicaltrials.gov
    • The new rule requires that certain clinical trial consent forms be posted on a government website (clinicaltrials.gov). 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   
  • Nettie Martinez, Research Compliance Analyst, IRB 2   
  • Danielle Griffin, Research Compliance Specialist, IRB 3   
  • Alicia Vargas, Research Compliance Analyst, Exempt and Expedited Reviews   
  • Kirstin Holzschuh, Executive Director, Research Integrity and Oversight (RIO) Office