The Final Rule

What is the background on the Final Rule?

The regulations that govern human subjects research have been in place since 1991. In January 2017, the U.S. Department of Health and Human Services issued revised regulations ("The Final Rule"). The Final Rule's effective date is January 21, 2019.

What did the Final Rule change?

The Final Rule made many changes, but the biggest changes are as follows:

Consent forms must provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate. This requirement is reflected in the consent form template found on our forms page.

The process of grant congruency (the comparison of the IRB application against the grant) has been eliminated.

The Final Rule eliminates the process of annual IRB review called “continuing review” for minimal risk studies. This change affects most research studies at Princeton. Consequently, to manage these records, the IRB will grant three year approval periods for minimal risk studies.

The categories of exempt research were expanded. It is important to note that exempt studies are still human subjects research and require IRB approval before implementation.

Does this mean that exempt studies do not have to be submitted to the IRB?

No. Studies that fall within the "exempt" review category are still human subjects research and must be submitted to the IRB for review.

I've heard that the Final Rule revised the definition of "research." Is this true?

The Rule did not revise the definition of “research,” but defined what is not human subjects research: “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” (not generalizing to other individuals).

Does this mean that oral history, journalism, biography, literary criticism, legal research, and historical scholarship are not human subjects research?

Not necessarily. It is not these particular fields that make the activity not research. Instead, it is the activity's focus on specific individuals without generalizability that makes the activity not research.

What if I'm unsure whether my activity is human subject research?

E-mail a synopsis of the proposed activity (2-3 paragraphs) to the IRB. Please include the following in the synopsis:

  • Study funding
  • Purpose
  • Study procedures
  • Any draft study measurements (survey, questionnaire, and interview guide).

How do I know whether I am in compliance with the Final Rule?

The IRB will review your submission for compliance with the Final Rule.