HHS common rule changes FAQNew Common Rule – FAQ

Changes to the Common Rule, the principal rule regulating human subjects research, go into effect on July 19, 2018. A number of Pearl IRB policies and procedures will be updated as a result of the changes to the rule. Please note that only studies approved or altered AFTER July 19, 2018 will be governed by the new rule; if necessary, existing studies will need to be amended in order to transition to the new rule.

Investigators will see a number of changes required under the new rule:

Consent forms will now require a concise summary of study activities, risks, and benefits presented to research participants in advance of the body of the consent document. The IRB will not require re-consent, except when other significant changes are made.

Additional elements of informed consent are required to be included in consent forms – these are included in the Pearl IRB consent template documents available to clients.

In requests for waivers to use identifiable data and specimens, the IRB must now find that it would be impracticable to use de-identified data.  The waiver request form has been revised accordingly.

Minimal Risk studies reviewed via the expedited procedure after the new rule goes into effect will no longer require annual continuing review under the new rule, but will require an update be submitted to the IRB every two (2) years.  Remember that the requirement to submit amendments and reportable safety events to the IRB has NOT changed.

The Common Rule regulations are separate from FDA regulations. The FDA regulations have NOT changed, so FDA still requires annual continuing review for FDA-regulated studies, even rare Minimal Risk FDA-regulated studies.

How will the changes to the Common Rule affect NEW submissions to the IRB?

After July 19, 2018, new protocol submissions to Pearl IRB will be required to contain updated consent language that can be found on the IRB website. If a study is approved prior to the July 19, 2018 effective date of the new rule, it will remain on the old rule until its next Continuing Review. At that point, it will transition to the new rule. If a study is approved on or after July 19, 2018, it will automatically be governed by the new rule. Some studies under the new rule may no longer require annual review.

How will the changes to the Common Rule affect my studies?

Existing Full Board Protocols

Protocols that were reviewed by a full board and are open to enrollment or still in an intervention phase will see the fewest changes under the new Common Rule. At the time of the next renewal or significant amendment affecting the informed consent form that occurs after July 19, 2018, you will be requested to update the waiver and consent form to meet the new requirements.

Existing Expedited Protocols

Most studies that were originally expedited by the IRB under the old rule will now be eligible for less frequent review, beginning on July 19, 2018. At the time of the next renewal or significant amendment affecting the informed consent form that occurs after July 19, 2018, you will be requested to update consent form to meet the new requirements. Pearl IRB will require an abbreviated renewal (update) every two (2) years in order to keep the study active.

Existing Exempt Protocols

There will be no changes to these protocols.

Additional requirements for federally funded studies

For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form must be posted to a publicly available Federal website (yet to be specified) after the trial is closed to recruitment and no later than 60 days after the last study visit by any subject.

What do I need to do now?

Look for news and announcements from Pearl IRB. Beginning July 19, 2018, new submissions must comply with the new consent requirements. 

Who can I call if I have questions about a submission or renewal?

info@pearlirb.com