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:

  • The informed consent form must begin with "key information.”
  • The continuing review requirement for expedited studies is removed, unless the IRB documents why continuing review is required.
  • More studies will fall in the "exempt" review category, rather than the "expedited" review category.

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.