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 April 19, 2018, HHS announced a Notice of Proposed Rulemaking (NPRM) proposing to delay for an additional 6 months the general compliance date for the revisions to the Common Rule.  If the proposed delay is passed, the new compliance date of the revisions to the Common Rule would be January 21, 2019.

More information will be posted as it becomes available.

The listing of “key changes” are outlined below.

Major Upcoming Regulation Changes (Effective July 19, 2018)

Exemption Categories

  • With additional safeguards in place, studies using benign behavioral interventions will potentially be eligible for Exempt Review.
  • With a “Limited IRB Review” of the investigator’s plan to safeguard subjects’ privacy and confidentiality, more studies that previously required Expedited review will 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.