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

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:

• Scholarly/Journalistic activities

• Public Health Surveillance

• Collection/analysis of information/biospecimen/records for/by a criminal justice agency

• Authorized operational activities by an agency for intelligence, homeland security, defense, or national security missions

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.

Now require additional information and elements (when applicable)

• Begin with a concise presentation of the key information that would facilitate comprehension of the intended subject population

• Specific language regarding future research for studies that involves collection of identifiable private information or identifiable specimens

• A statement when specimens may be used for commercial profit

• A statement when clinically relevant research results will be disclosed to subjects

• A statement when whole genome sequencing may be performed

• For the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens, any broad consent must contain all elements and information listed in paragraphs 1 through 7 

• Adequate provisions to protect privacy of subjects / maintain confidentiality of data

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.

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.

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.