The federal government published on June 19, 2018 the final rule for the Federal Policy for the Protection of Human Subjects, also called The Common Rule. The purpose of the Common Rule is to protect the privacy of people who volunteer to take part in research, while also minimizing the regulatory and administrative burdens for low-risk research studies.
The revised Common Rule was due to take effect on January 19, 2018 but an interim final rule was released on January 17, 2018 putting off the effective date for 6 months until July 19, 2018.
A notice of proposed rulemaking (NPRM) was published on April 20, 2018 seeking comments about delaying the new Common Rule requirements for an additional six months. After evaluating the comments obtained through the notice of proposed rulemaking, the recommendations detailed in the notice of proposed rulemaking were adopted and the compliance date was delayed until January 21, 2019.
There was a note in the final rule acknowledging the timing of the interim final rule, which generated frustration in the regulated community. It is believed that delaying the compliance date for the 2018 requirements whilst allowing the usage of three burden-reducing provisions of the 2018 Requirements provides the regulated community with enough time to prepare.
Regulated entities are going to be required to continue complying with the pre-2018 version of the Common Rule until January 2019. Nevertheless, institutions are allowed to carry out, for particular research studies, three of the burden-reducing guidelines in the 2018 Common Rule from July 19, 2018 to January 19, 2019.
The three provisions are:
- A modified definition of research wherein specific research activities are not covered by the Common Rule anymore, including public health surveillance functions for monitoring the spread of disease
- The removal of the prerequisite for yearly ongoing review regarding particular kinds of research
- The removal of the prerequisite that institutional review boards (IRBs) evaluate grant applications or financing proposals relevant to the research
In cases when those three burden reducing provisions are enforced for research that started during the delay period, complete compliance with the 2018 Common Rule requirements becomes necessary beginning January 21, 2019 until the end of the study.
The Revised Common Rule will allow more secondary studies of EHR data. A number of low-risk research studies, such as observational studies for finding patterns in patient data to improve how medical operations are performed, will be exempted if performed by specific HIPAA-covered entities.
There are also changes in the way consent should be obtained. Vital information regarding a study should be described clearly and concisely in a manner that allows a reasonable individual to know how their information is going to be used. It is additionally possible for broad permission to be obtained, which will help to ensure that biospecimens and patient-reported information are accessible for secondary research.
A new provision is included to help with examining potential research participants to make certain that patients who can likely benefit from new treatment options will find out about those treatment options.