Revised Common Rule

Summary of New Common Rule Changes

On January 19, 2017, the Department of Health and Human Services (HHS), along with 15 other federal agencies, published a final rule revising the Federal Policy for the Protection of Human Subjects, also known as the "Common Rule."ยน This regulation governs clinical research involving human subjects conducted or sponsored by the Federal departments and agencies that have adopted the regulations (16 Common Rule departments and agencies).

 

The revised Common Rule has an effective date of January 19, 2019.

Below is a summary of several key provisions and changes Institutions and Researchers should prepare to comply with by January 19, 2019. The new regulations do not impact studies approved prior to January 19, 2019.

Provisions and changes include:

  • New and Revised Definitions
  • New Exemption Categories Regarding Secondary Research
  • Elimination of Continuing Review
  • Revised Informed Consent Requirements
  • Harmonization with Other Agency Guidance
  • Guidance on Application to Clinical Data Registries
  • Cooperative Research Studies (single IRB)

Exempt vs. Expedited IRB Applications in new Common Rule

In Exempt Research, the process is less rigorous, generally requiring only one IRB reviewer, than an expedited or full IRB committee review. To qualify, research must fall into one or more exempt categories which present the lowest amount of risk to potential subjects. Usually, they involve collection of anonymous or publicly-available data or the implementation of the least potentially harmful research experiments.

 

In Expedited Research, the study falls into one or several federally-defined expedited categories. These categories involve the collection of data in a way that is not anonymous and involves no more than minimal risk to subjects. When the IRB reviewers (usually 2) assigned cannot approve the research under expedited review, the study is referred to a full committee review.

For a summary of new Common Rule Exempt and Expedited categories, click here and here.

Human Subjects v. Non-Human Subjects Research 

The final rule expanded the definition of "human subject" to cover the collection of biospecimens (this does not include non-identified biospecimens). The new definition includes "a living individual about whom an investigator, whether professional or student conducting research:

1. obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens 

or

2. obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." 

 

New Common Rule Forms

As of January 19, 2019, all IRB applications must use new Common Rule Forms for submission. For links to current forms, click here.