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On June 19, 2018, the federal government published the final rule for the Federal Policy for the Protection of Human Subjects – The Common Rule.
The aim of the Common Rule is to protect individuals who voluntarily participate in research, while also reducing the administrative and regulatory burdens for low-risk research.
A revised Common Rule was due to take effect on January 19, 2018 with an effective compliance date on the same date. However, an interim final rule was published on January 17, 2018 delaying the effective date for six months – The new compliance date was due to be July 19, 2018.
On April 20, 2018, a notice of proposed rulemaking was published seeking comments about whether the new Common Rule requirements should be delayed for a further six months. After assessing the comments received on the notice of proposed rulemaking, the proposals made in that NPRM have been adopted and the compliance date has now been extended until January 21, 2019.
In the final rule it was noted, “We acknowledge that the timing of the interim final rule was not ideal and led to frustration within the regulated community. We believe that the 2018 NPRM and this final rule to delay the general compliance date for the 2018 Requirements while permitting the use of three burden-reducing provisions of the 2018 Requirements provides the regulated community with sufficient notice about when the 2018 Requirements will go into effect, and when regulated entities will be required to comply with the 2018 Requirements.”
Regulated entities will be required to continue to comply with the pre-2018 version of the Common Rule until the new January 2019 compliance date. However, institutions will be permitted to implement, for certain research studies, three of the burden-reducing principles in the 2018 Common Rule between July 19, 2018 and January 19, 2019, although adoption of those principles is not mandatory.
Those three provisions are:
- A revised definition of research in which certain research activities are no longer covered by the Common Rule – such as public health surveillance activities to monitor the spread of disease
- The elimination of the requirement for annual continuing review with respect to certain categories of research
- The elimination of the requirement that institutional review boards (IRBs) review grant applications or other funding proposals related to the research
If those three principles are implemented for studies initiated during the delay period, full compliance with the 2018 Common Rule requirements is required from January 21, 2019 until the study ends.
The Revised Common Rule will enable more secondary research of EHR data. Certain low-risk studies, such as observational studies to find patterns in patient records that will help to improve how certain medical procedures are performed, will be exempted if conducted by certain HIPAA-covered entities.
Changes are also made to how consent must be obtained. Important information about a study must be explained clearly and concisely in a way that would allow a reasonable person to understand how their data will be used. It is also possible for broad consent to be obtained, which will help to ensure that biospecimens and patient-reported data are made available for secondary research.
A new option is also included to assist with screening potential research participants to help ensure that patients who could potentially benefit from new treatments will be likely to hear about those treatments.