Common Rule and Common Rule Changes

The Common Rule is a 1981 rule of ethics regarding biomedical and behavioral research involving human subjects in the United States. The Common Rule is the baseline standard of ethics by which any government-funded research in the U.S. is held. Nearly all U.S. academic institutions hold their researchers to these statements of rights regardless of funding.

Revised Common Rule

In January 2019 the Common Rule revisions went into effect. A tracked changes version of the revised Common Rule is available online (PDF).

UMCIRB and the Revised Common Rule

The UMCIRB has posted a new SOP addressing implementation of the revised Common Rule changes. The UMCIRB’s new SOP titled “Application of Final Common Rule (2018 Requirements): Protection of Human Subjects” is available online (PDF).

Summary of Revised Common Rule Changes

Revised “Human Subject” Definition
  • The definition of “human subject” has been altered to now include identifiable biospecimens. Identifiable biospecimens and identifiable private data are treated the same in the final rule.
Informed Consent Changes
  • Consent forms will need to include an introductory paragraph which provides a clear and easy to understand summary of the key information that will be helpful to a potential participant or their legally authorized representative in the understanding of reasons why they might or might not want to take part in the research. Click here to view samples of a concise summary introductory paragraph (PDF).
  • Overall, there are four new elements of informed consent; one new required element and three new optional (i.e. “if applicable”) elements. These new elements are generally related to the secondary use of data and samples and genomic research.
  • For any clinical trial conducted or supported by a Common Rule department or agency, one consent form must be posted on a publicly available federal website after recruitment closes, and no later than 60 days after the last study visit. The consent form must have been used in enrolling participants in order to satisfy this new provision. Two publicly available federal websites will satisfy the consent form posting requirement including and a docket folder on (Docket ID: HHS-OPHS-2018-0021). More information can be found on the OHRP website.
Revised Exempt Categories
  • The revisions to the Common Rule broaden the types of research that can be reviewed under the exempt categories. For example, secondary research involving identifiable private information that is protected by HIPAA can be reviewed under an exempt category. Currently, this type of research requires review under an expedited category. As has always been the case at ECU, only the IRB may determine what research may be reviewed under the exempt categories.
Continuing Review Requirement Changes
  • Some minimal risk studies will no longer be required to undergo annual continuing review.
Single IRB Requirement for Cooperative Research
  • Changes to the Common Rule mandate the use of a single IRB for multi-site, cooperative studies. This requirement will be effective Jan. 19, 2020.
How do these changes affect you?
  • The revisions to the Common Rule went into effect Jan. 21, 2019 and UMCIRB began reviewing new studies under the revised Common Rule on that date.
  • Remember, the revised Common Rule does not apply to FDA-regulated studies.
  • New document templates have been posted on both the UMCIRB website and within ePIRATE. Be sure to use these new templates for any new studies submitted on or after Jan. 21, 2019.
  • Revised SOPs have been posted on the UMCIRB website.
  • Existing expedited studies approved prior to Jan. 21, 2019 will continue to follow pre-2018 requirements including required renewal at least annually. Upon request by the investigator and after discussion with UMCIRB office, an existing study may be revised to meet the new federal requirements. An amendment would need to be submitted and approved within the electronic IRB submission system to document this transition.
  • Contact UMCIRB with any questions. You are welcome to email us at

UMCIRB Common Rule Revisions Review

The UMCIRB staff has created an overview of the Common Rule revisions. This overview consists of two Power Point presentations which were video recorded so that investigators, key study personnel, and others in the local research community could view them at their convenience. Click below to view the presentations.

Each of the presentations requires a password in order to view them.

  • Common Rule Revisions Overview – Part 1 (password – Mc3JWPy*)
    • Understand the revisions to definitions contained in the Common Rule;
    • Understand the new concept of “limited review” and its application; and
    • Understand the changes to the categories of exempt research contained in the revisions to the Common Rule.
  • Common Rule Revisions Overview – Part 2 (password – Mk4NVym@)
    • Changes to expedited research contained in the revisions to the Common Rule;
    • Changes related to elements of consent and waiver of consent and documentation of consent;
    • Requirements of new local SOP related to the application of the revised Common Rule; and
    • ePIRATE changes related to the revision of the Common Rule

OHRP Education Links

  • OHRP Revised Common Rule Q&As: OHRP has developed a list of common questions about the revised Common Rule with answers. These questions and answers are being made available to the public as an educational resource.
  • OHRP Revised Common Rule Videos: OHRP has produced a set of videos to help IRB personnel, researchers and others in the research community learn about and understand the revised Common Rule. These videos are for educational purposes. Please refer to the text of the Common Rule for a complete and accurate description of the regulatory requirements.

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