*** Important Recent Development ***
Common Rule Revision
A revised Common Rule , the federal regulation that regulates human research, became effective January 21, 2019. There are three key updates in the new rule that may affect our protocols: 1) changes to the consent process and form, 2) what qualifies for exempt review, and 3) the process for continuing review.
The revised Common Rule was published in the Federal Register by the Office of Human Research Protections (OHRP) on January 19, 2017 and can be found here. The date when your study was (or will be) approved, determines whether you must comply with the Revised Common Rule changes or can continue to follow the Pre-2018 Common Rule, as outlined below:
Approved Before January 21, 2019
Approved January 21, 2019 or After
If your study was approved before January 21, 2019, the Pre-2018 Common Rule regulations will continue to apply to your study.
If the approval date of your study is on, or after, January 21, 2019, you must adhere to the New Revised Common Rule.
A summary of changes that will affect our researchers, for new studies as of January 21, 2019, include:
- Changes to the informed consent process that provides subjects with a better understanding of the research. These changes require that the prospective subjects are given key information that a “reasonable person” would want in order to make the decision to participate, that sufficient detail be provided, and that the form be organized to facilitate understanding.
- New exemption categories and clarification of existing categories.
- Removal of the requirements to conduct continuing review of ongoing studies when the research is eligible for expedited review, limited IRB review, research that has progressed to data analysis only (de-identified and identifiable), or access to follow-up clinical data. We will still require a check-in on an annual basis.
To reiterate, the new guidance applies ONLY to new studies that are reviewed and approved after January 21, 2019. Your existing protocols will continue to be reviewed/renewed and approved per the Regulatory requirements of the pre-2018 Common Rule regulations.
Contact: Ann-Marie Dake, IRB Program Manager, at 925-422-0260.
What is the IRB?
The LLNL Institutional Review Board was established in 1974 to provide institutional assurance that all research activities involving human participants were being conducted under internationally recognized ethical principles, in compliance with U.S. federal regulations, and in adherence to the policies of the U.S. Department of Energy, the U.S. Department of Health and Human Services, the State of California, and Lawrence Livermore National Security, LLC.