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What You Need to Know About the Revised Common Rule

On January 21, 2019, all new federally funded human subjects research studies must comply with the revisions to the U.S. Department of Health and Human Services (DHHS) human subjects research regulations.  Where research studies are also Food and Drug Administration (FDA) regulated “clinical investigations,” they must also comply with those regulations. The FDA is working on harmonizing its regulations with the revised version of the DHHS regulations. In addition, all research conducted in Maryland must continue to follow the Common Rule. [1]

For purposes of this document, the current DHHS regulations will be referred to as “The Common Rule” and the revised regulations will be referred to as “The Revised Common Rule” .

The three JHU IRBs (SOM, SPH, and Homewood) are working together to revise their policies, procedures, documents, and operational and system infrastructure, in anticipation of the implementation of the Revised Common Rule; each IRB has different operational systems, so there will be some variability in how that implementation is completed.  Investigators should contact the IRB where their research application is submitted for any assistance, or if they have any questions or concerns.

Here’s what you need to know about the Revised Common Rule and impending revisions to JHU IRB procedures:

1.The Revised Common Rule increased the number of Exemption Categories, as well as modifies some of the existing categories. Investigators will still be required to submit their research applications to the appropriate JHU IRB for that IRB’s determination of whether the research is Exempt under the Revised Common Rule. If the research is determined by the IRB to be Exempt, and not subject to the Revised Common Rule, the JHU IRBs will still require the research be conducted in accordance with the principles of the Belmont Report and/or other applicable ethical standards.

2.The IRB applications and templates posted on the JHU IRBs’ websites will change to adapt to the Revised Common Rule.Investigators are responsible for making sure they only use the updated documents posted on the JHU IRBs’ websites after the January 21, 2019 implementation date.

3.Unless your study is also subject to the FDA regulations, under the Revised Common Rule, continuing review is not required for:[2]

  • Research that is eligible for expedited review;
  • Exempt research conditioned on “limited IRB review”;
  • Research that has completed all interventions and now only includes analyzing data, even if the information or biospecimens are identifiable; and
  • Research that has completed all interventions and now only includes accessing follow-up clinical data from clinical care procedures.

Although a Continuing Review is no longer required under these circumstances under the Revised Common Rule, the JHU IRBs have the authority to require JHU investigators to submit on-going Progress Reports to the IRB at intervals suitable for the research protocol or research study activities.

4.Except for certain specific studies that the SPH-IRB has already transitioned, or will transition, to the Revised Common Rule, the JHU IRBs will not transition any studies approved before January 21, 2019 to the Revised Common Rule. Thus, the Common Rule will continue to apply to research applications approved before January 21, 2019, and nothing will change for these studies.[3]Therefore, for Non-Exempt studies, the Principal Investigator must continue to submit Continuing Review applications in accordance with the schedule approved by the IRB, and consent forms will follow current Common Rule requirements.

 

The U.S. Office of Human Research Protections (OHRP) posted FAQs that may be helpful:  https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html.

Refer to 45 CFR 46.109(f), 46.110, and 46.115(a)(8) of the Revised Common Rule for further information.

Except for studies transitioned to the Revised Common Rule by the SPH-IRB.