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An Overview of the Changes and their Impact

This listing represents an overview of the larger changes to the Common Rule and is not all-inclusive

 

Changes to Activities Determined to be Human Subjects Research

Definition of Human Subjects has changed to include references to biospecimens:

A living individual about whom an investigator conducting research:

 Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; 

                    or

 Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens

 

Definition of Research has changed to include 4 examples of types of activities that in general would not constitute research:

 

New Categories of Exemption and Limited Review

New categories added as well as clarification of existing categories. Certain exemption categories (3, 4, 7 and 8) may now require "limited IRB review" be performed in a similar manner to expedited review.

 

Informed Consent and New Broad Consent

Now require additional information and elements (when applicable)

 

Screening, recruiting, and determining eligibility (exceptions from informed consent)

An IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject (or the subject's legally authorized representative) when either of these conditions are met:

  • The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or

  • The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens

 

A copy of the study’s consent form must be posted on a federal website after the study is closed to recruitment, but no later than 60 days after the last study visit by any subject.

 

Continuing Review Changes

Changes remove the requirement for conducting continuing review of most ongoing research for studies that qualify for review using the expedited process. When continuing review is eliminated, it will be replaced with a check-in procedure.

 

New single IRB Requirements

Effective January 25, 2018, all NIH-funded multi-site studies involving non-exempt human subjects research were required to utilize a single IRB-of-Record (sIRB) for the review of human subject protections. Starting January 20, 2020 this policy will apply to all federally-funded multi-site studies under the Common Rule. Use of Authorization (reliance) agreements required to assure delegation of authority and identification of roles and responsibilities.

 

Note:
  1. Neither the Department of Justice (DOJ), nor the Food and Drug Administration (FDA) have yet adopted the revised Common Rule
  2. The Federal Policy for the Protection of Human Subjects will not affect any state/local laws or regulations, including tribal law passed by the official governing body of an American Indian or Alaska Native tribe.
 

 

 

Last Updated ( Thursday, 17 January 2019 04:15 )