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The following statement was released today by Douglas B. Fridsma, MD, PhD, FACP, FACMI, President and CEO, AMIA, in regards to the Common Rule interim final rule:

AMIA is pleased to see the interim final rule. The six month compliance delay is a necessary step towards getting this critical research rule back on track after languishing for a full year.

While the additional time will allow federal officials and the clinical research community to develop a coordinated implementation strategy and much-needed guidance, it will be important that Common Rule provisions meant to improve the availability of data for secondary research, while strengthening protections for research participants proceed in a timely fashion.

  • Specifically, the 2018 Requirements established in the January 2017 final rule:
  • Makes important changes to consent by requiring the most important information regarding a study to be explained clearly and concisely, and in a way that a “reasonable person” could understand;
  • Permits researchers to seek broad consent, which will greatly improve the availability of biospecimens and patient-reported data (including real-time data from mobile applications and devices) for secondary research;
  • Enables more secondary research of EHR data by exempting certain low-risk studies conducted by HIPAA covered entities. Such research could include observational studies meant to find patterns in patient records to improve how joint replacements are performed.
  • Clarifies that certain public health surveillance activities are explicitly outside the scope of the Common Rule, so that the spread of disease can be more easily monitored;
  • Eliminates the need for continuing review for many studies, reducing administrative burden; and
  • Provides a new option meant to help screening of potential participants, so patients who qualify for new treatments are more likely to learn about them.

We look forward to closer review of the IFR, and we will monitor with anticipation the forthcoming proposed rule.