Following a year-long delay, the federal government has made available an interim final rule for the Common Rule that governs the processes of conducting medical research, including protection for human subjects involved in research.
The rule is promulgated by the Department of Health and Human Services and 15 other federal departments and agencies. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay and ambiguity for investigators.
Provisions of the recently released interim rule contain provisions the use of data in electronic health records and other patient information that helps identify patients suitable for research programs. For all participating departments and agencies, the Common Rule outlines the basic provisions for institutional review boards, informed consent and assurances of compliance regarding human subject research.
The interim final rule was originally planned to come out in January 2017, but it and many other initiatives that originated during the Obama administration were subject to a freeze expected to last 40 days, while they were reviewed. But the Common Rule freeze stayed in effect all year, only being resolved with the release of the interim final rule.
Delays in finalizing the interim rule have been frustrating to the nation’s medical informatics community, as electronic health records research also has been delayed, says Jeff Smith, vice president of public policy at the American Medical Information Association. Data in EHRs, Smith notes, can help informaticists and clinicians assess the best tools and processes.
For example, a physician specializing in knee replacement procedures might use several different types of replacement devices depending on factors related to the patients, but analytics can pinpoint which replacements work best for particular types of patients.
A core goal for the rule is to remove bureaucratic constraints and other unnecessary restrictions to research and to better facilitate research under the Common Rule. “If you could grade regulation on a one to 10 scale, the Common Rule would be right up there on complexity and current processes have made it even more complex. The Common Rule is like HIPAA for the clinical research community,” Smith says.
New requirements in the 2018 interim final rule, according to AMIA, include:
- Requiring the most important information in a study to be explained clearly and concisely in a manner that a “reasonable person” could understand.
- Permitting 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.
- Enabling more secondary uses of EHR data for research 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, for example.
- Clarifying 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.
- Eliminating the need for continuing review for many studies to reduce administrative burden.
- Providing a new option meant to help screening of potential participants so patients who qualify for new treatments are more likely to learn about them.
Federal officials have delayed implementation until July to allow public input on next steps. The hope is that the final rule will be in force sometime in 2019, according to Smith. “There are still a lot of unknowns regarding the administration’s intentions to fully implement this rule in a reasonable timeframe.” Smith believes a further delay of the rules effective date to early 2019 would be reasonable.
The interim final rule is available here.
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