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Revised Common Rule

In January of 2017, the U.S. Department of Health and Human Services (HHS) published the Final Rule, which is a revised version of the Common Rule (45 CFR 46) first published in 1991 and last amended in 2005. After some delays, the new Final Rule will be implemented with a general compliance date of January 21, 2019. Below you will find a description of the major changes to this Rule, a description of how UTHSC will implement these changes, and links to additional resources.

Note that our revised policies (Standard Operating Procedures), Researcher Tools & Guides, and Board Member Tools & Guides are now posted on their corresponding webpages. Revised consent form templates, required for new project submissions reviewed by the IRB on or after January 21, 2019, were posted on our Consent Forms webpage on December 1, 2018.

On this page, the 1991 Common Rule will be referred to as the “previous Common Rule.” The new version will be referred to as the “revised Common Rule.” Please note that UTHSC will generally follow the revised Common Rule requirements described below for all studies. However, for FDA-regulated studies, FDA regulations will be followed when they are more restrictive than the revised Common Rule, because the FDA has not yet accepted the revised Common Rule changes. See “Implementation at UTHSC: New Studies approved on or after January 21st, 2019” below for more information.

Major Changes to the Regulations

Revised Definitions for “human subject” and “research”

The definitions for “human subject” and “research” were revised as outlined below. All projects that were previously acknowledged to be NHSR will remain Not Human Subjects Research (NHSR). Please note that our NHSR or Exempt Status: Determination policy still states that it is the responsibility of the IRB, not the investigator, to determine whether a project qualifies for NHSR status.

Human subject (45 CFR 46.102(e)(1)) means a living individual about whom an investigator (whether professional or student) conducting research:

  1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens through intervention or interaction with the individual, OR
  2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Research means a systematic investigation, including research development, testing and evaluation, that is designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

The following activities deemed not to be research were added in the revised Common Rule (45 CFR 46.102(l)):

  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.

 

Implementation at UTHSC: New Studies approved on or after January 21, 2019

Existing Studies (approved under the previous Common Rule)
If your study was reviewed BEFORE January 21, 2019 and received initial approval, or approval pending a satisfactory response to administrative provisos, your study was approved under the previous Common Rule. The study will remain regulated under that Rule until it is closed with the UTHSC IRB. This means: 1) You will not be required to revise your study’s consent forms according to the new consent form templates; 2) The new continuing review procedures will not apply to your study; and 3) If your study is exempt, the category under which your study was approved will not change.

 

Resources

Last Published: Jul 29, 2024