Hello, I’m Misti Ault Anderson with the HHS Office for Human Research Protections.
I’m going to talk with you today about what’s new with IRB review under the revised Common
Rule, which was published on January 19th, 2017.
The Common Rule was revised with two main goals in mind.
First, to better protect research subjects, and second, to reduce administrative burdens.
In this talk, we’re going to focus on this second goal, and talk about IRB procedures
that are being updated to try to reduce administrative burdens to free up IRB’s time to focus on
higher risk research.
We’re going to talk about: limited IRB review; updating expedited review; eliminating certain
continuing reviews; eliminating the requirements for IRBs to waive informed consent for certain
screening, recruiting, and determining eligibility for perspective subjects; using single IRB
review; and eliminating grant application review.
Some studies that, under the pre-2018 Common Rule, required full IRB review will now, under
the revised Common Rule, be exempt with a limited IRB review that verifies conditions
for certain exemptions to make sure that they are met.
This can be done via the expedited review mechanism.
So, the limited IRB review can be conducted by the IRB chair, or a designated experienced
member.
Also, this procedure will not be required to be re-reviewed every year in a continuing
limited IRB review fashion.
The procedures that can be reviewed under an expedited review mechanism will be updated.
We are now working with other Common Rule agencies to update the expedited review list,
and there will be outreach, and a consultation with the public.
By default, this list, under the revised Common Rule, will include activities that typically
are minimal risk.
So research that appears on the list can undergo an expedited review, unless the reviewer determines
that the study involves more than minimal risk.
In general, under the revised Common Rule, no continuing review will be required for
research that is eligible for expediated review, for exempt research that requires limited
IRB review, or for research that has completed all interventions and only now includes analyzing
data, even if the information or biospecimens are identifiable, or accessing follow-up clinical
data from clinical care procedures.
Importantly, the IRB can override this default and still choose to require continuing review,
as long as that decision is documented.
This is a good time to point out that even without these required continuing reviews,
institutions should be sure to remind investigators that any changes to the research must still
have IRB review and approval before they can be made, unless it’s necessary to eliminate
apparent immediate hazards to the subjects.
The revised Common Rule eliminates the requirement for IRBs to waive informed consent for certain
activities early in research that involve screening, recruiting, and determining eligibility
of perspective subjects.
The IRBs still, of course, must make sure that these activities meet the approval criteria,
including adequate privacy and confidentiality safeguards for the information that is obtained.
The revised Common Rule includes a provision that requires single IRB review for cooperative
research by U.S. institutions in the portion of the research that’s conducted in the
United States.
So this would not apply to foreign institutions or research that’s conducted by U.S. institutions,
but at foreign sites.
Also this would not apply if more than a single IRB were required by law, including tribal
law.
Or, if the Federal department or agency that is conducting or supporting the research determines
that in this particular context, it would not be appropriate to use single IRB review.
The compliance date for this particular provision is different than that for the rest of the
revised rule.
The date for compliance for this provision is January 20, 2020.
This allows extra time for institutions to put mechanisms and policies in place that
will help it comply with this new requirement.
Importantly, the way that you would go about doing this, as an institution, would not change
from the way that many institutions and investigators do it now.
You would need to set up a reliance agreement between the research institutions and the
reviewing IRB.
The relying institution and the IRB, or the organization operating the IRB, must document
the reliance of the institution on the IRB, and it must lay out the responsibilities of
each entity in that agreement.
Formerly, under the pre-2018 Common Rule, this was a requirement for the institution’s
FWA.
Under the revised Common Rule, this is now a regulatory requirement, and it must be part
of the IRB records.
There is flexibility in how to document the reliance agreement, so for example, it can
be done in a written agreement between the institution and the IRB, it can be written
into the language in the protocol of a multi-institutional study, or it can be an institution-wide policy
directive.
Please note that this is required both for nonexempt human subject research, and for
exempt research that requires limited IRB review.
Any sort of IRB review would need to be covered under the reliance agreement.
In addition, IRBs that are not operated by an FWA-holding institution will now, under
the revised Common Rule, be held directly responsible for their compliance, for the
points that they are responsible for.
OHRP will look to the IRBs to make sure that they are compliant with what they are responsible
for.
Other flexibilities that are included in the revised Common Rule, are the elimination of
the requirement to report IRB rosters to OHRP.
So, institutions will no longer need to report all changes to IRB rosters to their department
or agency head, or to OHRP.
This harmonizes with the FDA requirements for maintaining IRB rosters.
Also, the revised Common Rule eliminates the IRBs need to review grant applications.
Please refer to the text of the revised Common Rule, which is available on OHRP’s website,
for a complete and accurate description of the regulatory requirements.
For the information in this presentation, please review the regulations at sections
46.101(a), 46.101(l)(2), 46.103(e), 46.109(f), 46.110, 46.114(b), 46.115(a)(8), 46.115(a)(3),
and 46.116(g).
If you have questions about the revised Common Rule, please send them to us at OHRP@hhs.gov.
You can also find additional information and resources at our website, www.hhs.gov/ohrp.
Thank you for your attention.
We invite you to view the other webinars in this series, and find more information on
the revised Common Rule at our website.