Human Research Protection Program

Final Rule Information

 

The “Final Rule”, also called the “Revised Common Rule” and the “2018 Rule”, goes into effect on Monday January 21, 2019.  Explained below are the aspects most likely to impact you.

Background

The Final Rule that updates the current federal regulations at 45 CFR 46, Subpart A - “Federal Policy for the Protection of Human Subjects” (the Common Rule) was published by the U.S. Department of Health and Human Services (HHS) on January 19, 2017 in the Federal Register. The intent behind the revised regulations are to better protect human subjects, facilitate research, remove ambiguity and to reduce regulatory burden.

The most significant changes are changes to definitions, informed consent and waiver regulations, secondary research, and revisions to the process for expedited and exempt studies. Note that some changes in the Final Rule were made for clarity and will not impact how the University of Toledo IRBs review research with human subjects.

Here is a link to the Final Rule.

Revised Definitions (45 CFR 46.102)

Some major changes to definitions include the reference of “biospecimens” in the definition of human subject, the addition of a “clinical trial” definition, and expanding the definition of “research” to clarify activities that are NOT research.

Here is a link to a side by side comparison of the Common Rule definitions versus the Final Rule definitions.

Exempt Research (45 CFR 46.104)

Most of the exempt categories have been revised or are new.  Here is a link to the new exempt categories with changes denoted by red text.

In addition, “limited IRB review” has been added (45 CFR 46.110).  Some research that required expedited review under the Common Rule can be reviewed under the Final Rule via the limited IRB review process.  Limited IRB review is very similar to UT’s current exempt review process. 

IRB Continuing Review

The Final Rule eliminates the requirement for continuing review of all studies that are approved by expedited review, unless the IRB reviewer explicitly justifies why continuing review would enhance protection of human subjects.  Continuing review is also not required when limited IRB review is utilized.

The University of Toledo has chosen to require an accounting of exempt and expedited ongoing research studies.  This consists of completing a simple “check in” process that is further described below.   

Informed Consent Process (45 CFR 46.116 and 46.117)

The Final Rule has added the requirement of (1) a “key information” paragraph at the beginning of the informed consent form, (2) inclusion of a new basic element of consent and (3) three additional elements of consent when applicable.

Also, there is an additional, allowable justification for a waiver of written consent and revised criteria for a waiver of consent.

Please refer to the revised ICF templates that will be/are provided on the UT IRB Biomed and SBE forms web pages.

UT's Transition Process

For existing expedited studies that are approved before January 21, 2019 and for full Board studies that no longer involve subject intervention/interaction, your study will be transitioned to the Final Rule at the time of next regularly scheduled continuing review submission. 

If you submit your study for review before January 21, 2019, but it is not approved until on or after January 21, 2019, your study must comply with all aspects of the Final Rule.

The transition requires that all aspects of the Final Rule be applied, not just evaluation of the need for continuing review.  If you are still enrolling participants at the time of continuing review, please also submit a revised informed consent form with your continuing review submission.

New Process: Annual Reminder and Project Termination

Even when continuing review is not required, the study team must still submit amendment requests and obtain IRB approval of such request before project changes may be implemented, report adverse events, and terminate the study once it is complete.  All exempt studies and expedited studies in which continuing review is not required will be sent an automated email prior to the anniversary approval date for the study.  The IRB does have the authority to assess if continuing review should be instated.  

If the study is completed, you are required to complete the Study Closure xform via IRB Manager.  This form will also be used for all studies.

Additional Resources

 

 

Last Updated: 6/30/19