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 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;
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
Definition of has changed to include 4 examples of types of activities that in general would not constitute research:
New Categories of and Limited Review
Now require additional information and elements (when applicable)
(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:
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 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.
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