The American Medical Informatics Association (AMIA) recently sent a letter to the heads of the Department of Health and Human Services (HHS) and Office of Management and Budget (OMB), seeking information on the Federal Policy for the Protection of Human Subjects, also known as the Common Rule.
Revisions to the rule were finalized in the January 19, 2017, edition of the Federal Register and subsequently subject to a “regulatory freeze” established by the Trump administration. This freeze was meant to last for 40 days; however, more than 150 days later, officials at HHS have not communicated with stakeholders on the current or future status of the Common Rule updates, AMIA officials stated.
AMIA, and others in the research community, have concerns over the rule’s important provisions and implementation timeline.
“The Common Rule provides a framework of protection for human research subjects across the entire federal government, including research conducted or supported by the National Institutes of Health, Centers for Disease Control & Prevention, Department of Veterans’ Affairs, Department of Defense, and other agencies. The Common Rule was first adopted in 1991, and several commenters – including the federal government – acknowledged the pressing need for updates given the changes in 21st century medicine and research, AMIA officials stated.
“The sheer volume of data that can be generated in research, the ease with which it can be shared, and the ways in which it can be used to identify individuals were simply not possible, or even imaginable, when the Common Rule was first adopted,” officials wrote in the notice of proposed rulemaking that initiated the revision process in 2015. AMIA and several other organizations strongly agreed with the federal government’s assessment, and supported numerous provisions meant to bolster modern research, using the latest informatics tools and methods, while protecting the privacy and autonomy of research participants.
In its letter to HHS Secretary Price and OMB Director Mulvaney, AMIA strongly encouraged federal officials to keep the updated rule’s original effective date of January 19, 2018. Additionally, AMIA asked that the rule’s compliance date be moved to June 19, 2018 to give academic and healthcare researchers time to harmonize old and new provisions. The group of informatics experts urged government officials to make an immediate public announcement regarding these recommendations.
“The final revisions to the Common Rule reflect the kind of transparent, deliberate, and constructive process we all seek in government regulation,” AMIA said. “This process, which began more than five years ago and is meant to advance clinical research in the United States for years to come, must be carried through to completion.”
The letter continues, “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. Combined with rapid adoption of electronic health records (EHRs) 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.”
AMIA highlighted several important provisions meant to enable modern research, reduce regulatory burden, and strengthen protections for research participants. Specifically, AMIA said the 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 live in an age of ubiquitous data,” AMIA president and CEO Douglas B. Fridsma, M.D., Ph.D., said in a prepared statement. “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.”
“It is critical that we adopt these changes for the sake of our national research enterprise,” Peter J. Embi, M.D., president and CEO Regenstrief Institute, Inc. “We need to know that important aspects of the finalized Common Rule will proceed as planned. Without such a clear signal, the revised Common Rule’s new benefits will be delayed, leaving in place a 26-year old rule that doesn't serve the needs of research participants or the research community."
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