Revised Common Rule (Human Subject Regulations)

Federal Regulation 45 CFR 46 “Protection of Human Subjects”, referred to as the ‘Common Rule’, is an anchor regulatory text on which investigators and IRBs rely and must comply to protect human subjects in research.

The U.S. Department of Health and Human Services (HHS) issued revisions to the Common Rule, which were originally slated to go into effect on January 19, 2018, but were later delayed until July 19, 2018.

On June 18, 2018, HHS announced that the revisions to the Common Rule will be further delayed until January 21, 2019.

More information will be posted as it becomes available.

The listing of “key changes” are outlined below.  Please also see the “what to expect” section below.

Major Upcoming Regulation Changes (Effective January 21, 2019)

Exemption Categories

  • With additional safeguards in place, some studies using benign behavioral interventions will potentially be eligible for Exempt Review.

Continuing Review

  • Expedited Protocols:  Annual renewals will no longer be required for protocols that were approved under the Expedited Review process (with the exception of FDA regulated studies).  Investigators will now be required to renew their Expedited protocols every 3 years.
  • Expedited and Full Board Protocols:  Continuing review will no longer be required for protocols that have progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

Informed Consent

  • The consent process will need to begin with a concise summary of essential study info that individuals would want to know in order to make an informed decision about participation.
  • The consent form will need to disclose any plans to conduct future research using info and/or biospecimens collected during the research.
  • When applicable, consent form will need to disclose whether: (a) subjects will share in commercial profit; (b) clinically relevant research results will be returned; and (c) research will or might include whole genome sequencing.

Clinical Trials

  • The clinical trial definition has been expanded:  “Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes”.  (This is the same definition used by NIH)
  • Investigators conducting clinical trials will be required to post a copy of their consent form online
  • Learn more about the Clinical Trial Requirements.

Activities No Longer Considered Research

  • Certain activities are no longer considered research and therefore will not require IRB review:
    • Scholarly and journalistic activities that focus directly on specific individuals (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship);
    • Public health surveillance activities conducted by a public health authority.
    • Collection and analysis of information, biospecimens, or records for criminal justice or criminal investigative purposes; and
    • Certain activities in support of intelligence, homeland, security, defense, or other national security missions.

Single IRB-of-Record (sIRB)

  • As of January 25, 2018, all NIH-funded multi-site research must rely on a single IRB-of-Record (sIRB) for review.
  • As of January 19, 2020 all multi-site research that is federally funded—not just NIH-funded—must rely on a single IRB-of Record for review.
  • Learn more about Single IRB Review.

What to Expect

Freeze on New Submissions

The revisions to prepare for all of the new regulatory requirements will require considerable preparation from the Office of Research Integrity (ORI).  To facilitate a smooth transition, there will be a freeze period from January 1, 2019 – January  20, 2019 on all new protocol submissions.

During this freeze period, the IRB Original Form, IRB Amendment Form, IRB Renewal Form, and IRB Event Form will be temporarily disabled in the TOPAZ system. We ask investigators to utilize this time period to work towards finalizing any pending submissions that are currently under review.

The TOPAZ protocol application forms will only be made available to research on a case-by-case basis.  Requests to submit a new application during the freeze period will only be granted in rare cases relating to funding deadlines.

Unless you absolutely need to start your research right away, it would be best for you to wait and submit your protocol on or after January 20th, to avoid confusion during the review and to take advantage of new regulations and procedures that may mean less work for you.  If you are concerned about the timing of a particular submission, please contact ORI staff and we’ll be happy to help you figure out the best way forward.

Pending Submissions

Projects that have been submitted to the IRB, but have not received final approval are considered as “pending”.  All pending submissions need IRB approval by January 15, 2019.  If a pending submission does not receive IRB approval by January 15, 2019, then it will need to be withdrawn and resubmitted on the latest version of the IRB approval form (to comply with the new regulatory requirements).

Unsubmitted Protocols

Investigators with protocols that are in draft form (i.e., have never been submitted to the IRB) will need to submit those applications on or before December 31, 2018.   The Office of Research Integrity will not be accepting submissions that utilize an older version of the IRB application form after this date.

Projects Due for Renewal in January or February 2019

Investigators with protocols expiring during the months of January or February 2019 will need to submit their IRB renewals early to help avoid any lapses in their IRB approvals.

Existing IRB-Approved Projects

All active projects that were previously approved under the Expedited or Full Board review category will gradually be moved under the new regulatory requirements.  This transition will occur at the time of the project’s next amendment or renewal submission.

Note:  Until this transition has occurred, existing active studies will need to continue operating under the old regulatory requirements.

More information will be posted as it becomes available.