The American Medical Informatics Association is asking the Trump Administration to implement revisions to the Common Rule, which protects human research subjects.
The revisions were finalized in January and then subjected to a regulatory freeze for review that was to have lasted for 40 days.
Now, 150 days later, there has been no communication from the Department of Health and Human Services on the current or future status of Common Rule updates, AMIA notes in a letter to HHS and the Office of Management and Budget.
The final rule supports provisions to enhance modern research using the latest informatics tools and methods while protecting the privacy and autonomy of research participants, according to the association.
AMIA is asking that HHS keep the rule’s effective date of Jan. 19, 2017, but move the compliance date to June 19, 2018, to give researchers time to harmonize old and new provisions.
“Over the last several years, a paradigm shift has occurred in the nature, scope and frequency of research involving human subjects, their biospecimens and their data,” AMIA says in its letter to HHS. “Combined with rapid adoption of electronic health records by care providers and dramatic improvements in computing technology, we believe the final revisions to the Common Rule are necessary to improve discovery of new health insights and advance healthcare transformation.”
The letter, available here, reminds federal officials of important provisions in final revisions to the Common Rule:
* Makes changes to consent by requiring that the most important information about a study be explained in a way a reasonable person could understand.
* Enables researchers to seek broad consent that will improve availability of biospecimens and patient-reported data including from mobile apps and other devices.
* Enables more secondary research of EHR data by exempting low-risk studies conducted by HIPAA covered entities.
* Clarifies that certain public health surveillance activities are outside the scope of the Common Rule so the spread of disease can be more easily monitored.
* Eliminates the need for continuing review of many studies to reduce administrative burden.
* Provides a new option meant to help screening of potential participants so patients who qualify for new treatments are more likely to learn from them.
“We live in an age of ubiquitous data,” says Doug Fridsma, MD, president and CEO at AMIA. “Patients expect researchers to leverage their data for improved care in responsible ways. The updated Common Rule enables and encourages better transparency so that new discoveries are possible.”
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