June 24, 2018
On June 19, 2018, the central government circulated the final law for the Central Policy for the Defense of Human Topics – The Common Rule.
The objective of the Common Rule is to safeguard people who will take part in research, while also decreasing the managerial and regulatory loads for low-risk research.
A modified Common Rule was expected to take effect on January 19, 2018 with an effective conformity date on the same date. Nevertheless, a provisional final rule was issued on January 17, 2018 postponing the effective date for six months – The new conformity date was due to be July 19, 2018.
On April 20, 2018, a notification of planned rulemaking was issued requesting remarks regarding whether the new Common Rule necessities must be postponed for additional six months. After evaluating the remarks received on the notification of suggested rulemaking, the suggestions made in that NPRM have been accepted and the conformity date has now been prolonged until January 21, 2019.
In the final rule, it was noted, “We admit that the timing of the provisional final rule was not perfect and resulted in annoyance within the regulated community. We think that the 2018 NPRM and this final rule to postpone the general conformity date for the 2018 Requirements while allowing the use of three burden-reducing provisions of the 2018 Requirements provides the regulated community with adequate warning concerning when the 2018 Requirements will go into effect, and when regulated units will be required to abide by the 2018 Requirements.”
Regulated units will be needed to carry on to abide by the pre-2018 type of the Common Rule until the new January 2019 compliance date. Nevertheless, organizations will be allowed to apply, for certain research studies, three of the burden-reducing rules in the 2018 Common Rule between July 19, 2018 and January 19, 2019, even though adoption of those principles is not compulsory.
Those three provisions are:
• A reviewed description of research in which specific research activities are no longer protected by the Common Rule – such as public health investigation activities to check the spread of illness
• The removal of the requirement for yearly continuing assessment with respect to specific types of research
• The removal of the requirement that institutional review boards (IRBs) study grant applications or other financing suggestions linked to the research
If those three principles are applied for studies started during the delay period, complete compliance with the 2018 Common Rule requirements is needed from January 21, 2019 until the study finishes.
The Improved Common Rule will enable additional secondary research of EHR data. Specific low-risk studies, such as observational studies to find patterns in patient records that will assist to adjust how specific medical processes are carried out, will be excused if carried out by specific HIPAA-covered units.
Modifications are also made to how approval should be obtained. Important information concerning a study should be described clearly and briefly in a way that would let a reasonable person comprehend how their data will be used. It’s also possible for broad approval to be obtained, which will assist to make sure that bio-specimens and patient-reported data are made accessible for secondary research.
A new alternative is also included to help with screening possible research contributors to assist ensure that patients who might possibly benefit from new cures will be likely to hear about those cures.