FDA Common Rule- A Much Needed Update

by | Mar 22, 2018 | News Articles

In a sweeping gesture to better protect human research subjects, sixteen US federal agencies issued a revised Common Rule on January 19, 2017, the first update since 1991.  The final rule, officially known as Federal Policy for the Protection of Human Subjects, aims to modernize and simplify the current system of oversight by reducing administrative burden, delay, and ambiguity in interpreting regulatory requirements.


One of the agencies involved—the Department of Health and Human Services (HHS)—is looking to the revised Common Rule to reflect today’s clinical trial landscape, which is dramatically different than it was back in 1991.  At that time, clinical trials took place largely at universities and medical institutions, but since then, clinical trials have grown in scale, leading to changes such as:

  • An expansion in the number and types of clinical trials, as well as observational studies and cohort studies
  • More diversified types of social and behavioral research
  • Increased use of sophisticated analytic techniques to study human biospecimens
  • Growing use of electronic health data and other digital records to enable large datasets to be rapidly analyzed and combined in novel ways


These are major developments whose time has come, but the implementation date for the new Common Rule seems to be a moving target.


Originally, implementation was scheduled for January 19, 2018, but that date has been pushed forward six months to July 19, 2018, creating a so-called interim Final Rule.  This six month extension provides agencies much needed extra time to prepare for implementation, citing the new rule’s complexity, need for revamping electronic systems to come into compliance, and lack of guidance from the Office for Human Research Protections within HHS.  Yet, even this revised date remains uncertain.  According to the January 22, 2018 Federal Register, “The federal departments and agencies listed in this document are in the process of developing a proposed rule to further delay implementation of the 2018 Requirements.”  As part of this effort, interested parties can submit comments about the new rule until March 19, 2018.


      Five Key Points

What key changes will appear in the revised Common Rule?

  • New requirements regarding the information that must be given to prospective research subjects as part of the informed consent process


  • Allowance for use of broad consent from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens.



  • Establishment of new exempt categories of research based on their risk profile. Under some of the new categories, exempt research would be required to undergo limited IRB review to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.


  • A requirement for US-based institutions engaged in cooperative research to use a single IRB for that portion of the research that takes place within the US, with certain exceptions. This requirement becomes effective three years after publication of the final rule.


  • Removing the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow-up in conjunction with standard clinical care.


It is worth noting that the Common Rule does not expand the federal policy to cover clinical trials that are not federally funded.


Author: Ann Neuer- Medical DeScriptions

[*] Broad consent” refers to seeking prospective consent to unspecified future research, and will be an optional alternative that an investigator may choose instead of having an IRB waive the requirement for informed consent, for example.

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