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Revised Common Rule – Information for the UConn Research Community

The Federal Policy for the Protection of Human Subjects (commonly referred to as “the Common Rule”), provides ethically based regulations for the review and conduct of human research studies. On January 21, 2019 changes to the Common rule go into effect. The Department of Health and Human Services (HHS) Office for Human Research protections (OHRP) issued these changes to “better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight” (Federal Register, January 29, 2017).

Among the Common Rule agencies, please note that the U.S. Department of Justice and the U.S. Food and Drug Administration have not adopted the revised regulation at this time.

How does the Revised Common Rule affect my currently approved studies?

Existing Full Board/Greater than Minimal Risk Studies: Studies that were reviewed by a full board and obtained initial approval prior to January 21, 2019 will be required to transition to the revised Common Rule. This will require completion of the transition checklist, and may require updated consent forms or other documents. All existing federally funded studies will be transitioned to the Revised Common Rule at the time of annual continuation, with the goal of transitioning all federally funded studies by February 2020. All other existing studies will be considered for transition to the Revised Common Rule at the time of annual continuation with the goal of transitioning by February 2021.

Existing Expedited/Minimal Risk Studies: Studies that are reviewed by expedited procedures and obtain initial approval prior to January 21, 2019 will be required to transition to the revised Common Rule. This will require completion of the transition checklist, and may require updated consent forms or other documents. All existing federally funded studies will be transitioned to the Revised Common Rule at the time of annual continuation, with the goal of transitioning all federally funded studies by February 2020. All other existing studies will be considered for transition to the Revised Common Rule at the time of annual continuation with the goal of transitioning by February 2021.

Existing Exempt Studies: Studies that received an exemption determination before January 21, 2019 remain under the previous “Common Rule” and will not be affected. As a reminder, studies that receive an exemption determination are exempt from specific regulations and requirements, however are still considered human subject research.

How do these revisions affect my newly submitted studies?

Full Board/Greater than Minimal Risk Studies: Studies that are reviewed by a full board and obtain initial approval on or after January 21, 2019 will be required to comply with the revised Common Rule including new informed consent requirements. The updated consent form template can be found at the following link:

Expedited/Minimal Risk Studies: Studies that are reviewed by expedited review and obtain initial approval on or after January 21, 2019 will be required to comply with the revised Common Rule including new informed consent requirements. The updated consent form template can be found at the following link:

Please note: many studies that previously required expedited review under the Common Rule may now meet the exempt criteria (see below).

Exempt Studies: Studies that are submitted to the IRB requesting an exemption determination on or after January 21, 2019 will be required to comply with the revised Common Rule, which introduces several new categories for exempt review. OHRP provides a helpful overview of the revisions to the exemption categories. Another helpful tool was developed by our UConn Health colleagues.

Note that the UConn IRB is NOT implementing categories 7 and 8 at this time. Like many other IRBs, UConn has determined that the adoption of Broad Consent at this time, may be too burdensome for researchers.

As a reminder, an exemption determination does not mean that the study is not “human subjects research”, but that it is human subjects research that is exempt from specific regulations and requirements.

When will revised application forms be available and when are researchers required to use them?

The new forms will be posted on January 21, 2019. Any new submissions that are submitted after this date must use the new protocol application forms.

In February 2018, the University announced burden reducing provisions including the extension of the approval period for the anticipated time frame of the study. I took advantage of this provision. How will my protocol now be affected after January 21, 2019?

In February 2018, the University allowed for non-federally funded/supported research and non-FDA regulated minimal risk research that qualifies for expedited review to be approved for either the anticipated time frame of the project or one year from the date of approval, whichever is greater. Unless specifically required by the IRB, annual continuing review will no longer be required for this type of research. As the anticipated completion date of the research drew near, investigators could extend the expected completion date if necessary through a request for modification.

How do these revisions change the re-approval (continuing review) process?

The revised Common Rule removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review. Please note, at this time the FDA has not revised its regulation to align with the revised Common Rule. Therefore, FDA regulated expedited and full board studies continue to require continuing review at least annually.

Full Board/Greater than Minimal Risk Studies (Existing and New): Studies that require full board review will continue to require continuing review at least annually.

Expedited/Minimal Risk Studies (Existing): Studies that were reviewed by expedited procedures and obtained initial approval prior to January 21, 2019 will be required to transition to the revised Common Rule. This will require completion of the transition checklist, and may require updated consent forms or other documents. Generally, these studies will no longer require continuing review after transition; however, the IRB reserves the right to require continuing review for some expedited studies at its discretion.

New Expedited/Minimal Risk Studies: Studies that are reviewed by expedited procedures and receive initial approval on or after January 21, 2019 will be evaluated at the time of approval to determine if a continuing review is required. Generally, these studies will no longer require continuing review under the revised Common Rule; however, the IRB reserves the right to require continuing review for some expedited studies at its discretion.

Studies in Data Analysis: Studies (expedited or full board) that are in “Data Analysis” (i.e. have completed subject intervention/interaction and in which activity is limited to either final analysis of identifiable data/biospecimens or involve accessing follow-up clinical data from procedures that subjects undergo as part of clinical care) will also NOT require continuing review.

New and Existing Exempt Studies: Exempt studies do not require continuing review. To assist with understanding the new exempt categories see decision charts created by Guilaine D. Senecal, Office of Research Integrity and Assurance, Cornell University.

How will my existing study be transitioned to oversight under the revised Common Rule?

Existing Federally-funded studies: All existing federally-funded studies will be transitioned to the Revised Common Rule at the time of Annual Continuation, with the goal of transitioning all federally-funded studies by February 2020. This will require completion of the Continuation/Transition Checklist, and may also require updated consent and protocol documents as determined by the Checklist.

All other existing studies: All other existing studies will be considered for transition to the Revised Common Rule at the time of Annual Continuation with the goal of transitioning by February 2021. This will require completion of the Continuation/Transition Checklist, and may also require updated consent and protocol documents as determined by the Checklist.

What steps has the UConn IRB taken to assist stakeholders in the transition to the Revised Common Rule?

  • Revised protocol applications to incorporate the Revised Common Rule
  • Published an updated Consent Template that includes the updated waiver criteria
  • Developed an Initial Review Checklist to assist researchers in meeting the requirements of the Revised Common Rule
  • Developed a Continuation/Transition Checklist to assist researchers in meeting the requirements of the Revised Common Rule

Will InfoEd Change?

For researchers the answer is no, not immediately. The IRB Word document protocol applications will be revised to reflect the revised Common Rule regulations. The online IRB protocol applications will be revised into one Master Application eForm when the InfoEd software is updated. However, IRB staff and IRB members will make greater use of the current capabilities of InfoEd to review protocol submissions in as timely a manner as possible.

What are some of the other changes that may impact my research?

Definition of Research

The definition of research was NOT revised. Instead the regulations now stipulate what activities are NOT research: Please note that the IRB awaits guidance from OHRP with regard to how to operationalize the stipulations. For example, no guidance exists yet for how to define “legal research” referenced in (1).

(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Adoption of NIH definition of a clinical trial

The new Common Rule adopts the NIH definition of a clinical trial. The revised Common Rule includes one additional requirement and that is to post the clinical trial consent form. Specifically, “(1) For each clinical trial conducted or supported by a Federal department or agency, one IRB approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Web site that will be established as a repository for such informed consent forms.” For additional information on this requirement, refer to the OHRP website. The publicly available website has yet to be determined but may be ClinicalTrials.gov.

For more information and case studies of biomedical and social and behavioral science studies that are or are not clinical trials refer to this NIH website.

New definition of participants considered vulnerable

The revised Common Rule changes the definition of a vulnerable population. The new definition states that “individuals that are vulnerable to coercion or undue influence, such as children, prisoners or individuals with impaired decision making capacity, or economically or educationally disadvantaged persons.” You’ll note that pregnant women and “handicapped” were removed and the new definition replaces “mentally disabled” with “individuals with impaired decision-making capacity.”