Office of Responsible Research Practices
The Ohio State University

Common Rule Revisions

The resources below were developed to help the Ohio State human subjects research community understand the revisions to the Common Rule issued on January 19, 2017 and planned to take effect on January 21, 2019. Please check back often as updates will be made on an ongoing basis.

What the Final Rule Changes Mean for Your Research
Overview Definitions
Continuing Review Exempt Research
Informed Consent Cooperative Research
Lastest news: Delay in Common Rule Revisions Announced

Definitions

Most definitions remain the same; however, there are some important changes and additions. Some important terms are undefined in the regulations, but are clarified in the Final Rule’s preamble. Ohio State has placed the appropriate definitions in HRPP policies. The most significant definition revisions are highlighted below:

Vulnerable: The term has been updated, but not defined in the Final Rule, to reflect that research subject vulnerability should be considered a function of the possibility of coercion or undue influence. IRBs should focus on vulnerability to coercion or undue influence in reference to the subject’s ability to make a decision to participate in research.

Human Subject: Rationale; the definition was revised to replace the reference to “data” with “information or biospecimens.” It also clarifies that an investigator is not conducting human subjects research by merely gathering information or biospecimens but instead when he/she “uses, studies, analyzes, or generates” identifiable private information or “identifiable 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, analyses, or generates identifiable private information or identifiable biospecimens.

Clinical Trial: This is a new term, as the pre-2018 rule did not include a definition.

  • A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Research: The definition did not change; however, four categories of activities were removed from the definition to make clear that they are NOT within the Rule’s jurisdiction, as follows:

  • Scholarly or journalistic activities that focus directly on the specific individuals about whom information are collected
  • Public health surveillance activities (collecting, analyzing, and using data to target public health and disease prevention)
  • Authorized operational activities for national security missions
  • Data collection and analysis that enables the conduct of certain activities carried out as part of the criminal justice system