Changes to the federal rule governing human research (Common Rule) were announced on January 18, 2017 and went into effect January 21, 2019.
The changes to the Common Rule do not apply to FDA-regulated studies.
UMCIRB SOPs, templates, and the ePIRATE electronic IRB submission system have been revised accordingly.
Click on the tab labeled Common Rule Changes in the UMCIRB website for more information about the changes.
Studies submitted on or after January 21, 2019 will be reviewed under the revised Common Rule. Studies approved prior to January 21, 2019 will continue to fall under the pre-2018 Common Rule requirements.
Revised “Human Subject” Definition
The definition of “human subject” has been altered to now include identifiable biospecimens. Identifiable biospecimens and identifiable private information are treated the same in the final rule.
Informed Consent Changes
Consent forms will need to include an introductory paragraph which provides a clear and easy to understand summary of the key information that will be helpful to a potential participant or their legally authorized representative in the understanding of reasons why they might or might not want to take part in the research.
Overall, there are four new elements of informed consent; one new required element and three new optional (i.e. “if applicable”) elements. These new elements are generally related to the secondary use of data and samples and genomic research.
Revised Exempt Categories
The revisions to the Common Rule broaden the types of research that can be reviewed under the exempt categories. For example, secondary research involving identifiable private information that is protected by HIPAA can be reviewed under an exempt category; currently this type of research requires review under an expedited category. As has always been the case at ECU, only the IRB may determine what research may be reviewed under the exempt categories.
Continuing Review Requirement Changes
Some minimal risk studies will no longer be required to undergo annual continuing review.
Single IRB Requirement for Cooperative Research - New
Changes to the common rule mandate the use of a single IRB for multi-site, cooperative studies. This requirement will be effective January 19, 2020.
How do these changes affect you?
The revisions to the Common Rule went into effect January 21, 2019 and UMCIRB has begun reviewing new studies under the revised Common Rule effective 01.21.2019.
New document templates have been posted on both the UMCIRB website and within ePIRATE. Be sure to use these new templates for any new research studies submitted on or after January 21, 2019.
Revised SOPs have been posted on the UMCIRB website.
Existing expedited studies approved prior to January 21, 2019 will continue to follow pre-2018 requirements including required renewal at least annually. Upon request by the investigator and after discussion with the UMCIRB office, an existing study may be revised to meet the new federal requirements. An amendment would need to be submitted and approved within the electronic IRB submission system to document this transition.
Keep our website and the ePIRATE homepage checked for continuing and updated information.
Contact UMCIRB with any questions. You are welcome to email us at UMCIRB@ecu.edu.
Remember, the revised Common Rule does not apply to FDA-regulated studies.
