» Revised Common Rule

The Federal Policy for Protection of Human Research Subjects, also known as “The Common Rule,” codifies the processes for IRB review and approval of research with human subjects.

The Revised Common Rule will take effect on studies starting on or after January 21, 2019.

Researchers can expect minor changes to review processes, Cayuse IRB forms, and informed consent templates when preparing study submissions. We strongly recommend that you familiarize yourself with the regulatory changes in order to understand how they may or may not impact your current or future human subjects research projects. A summary of the changes are described below:

Exempt Review

  • The Revised Common Rule establishes new exempt categories of research.
    • To qualify for review at the exempt level, the research must not be greater than minimal risk* and must fall into one or more of the exemption categories.
    • *Minimal risk is defined by the federal regulations (45 CFR 46) as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
  • Under some of the new categories, exempt research would be required to undergo limited IRB review, to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.

Expedited Review

  • The expedited categories remain unchanged; however, the requirements of expedited research have been updated. The Revised Common Rule removes the requirement to conduct continuing review of studies that underwent expedited review, have completed study procedures and are merely analyzing study data, or only have observational follow-up in conjunction with standard clinical care.
    • Chapman researchers will be asked to submit research updates every three years, unless the IRB has a documented reason for requesting an annual report. However, researchers must submit to the IRB any modifications to the research protocol (e.g., changes to personnel, protocol amendments, recruitment materials, etc.) and report any adverse events as often as necessary.

Informed Consent 

  • The Revised Common Rule establishes new informed consent criteria regarding the information that must be given to prospective research subjects as part of the informed consent process.
    • “Key information” must be presented at the top of the consent form with sufficient detail so subjects understand why they might or might not want to participate in the research – updated CU informed consent templates will be provided.
  • The Revised Common Rule allows the use of broad consent (e.g., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens.
    • Broad consent will be an optional alternative that an investigator may choose instead of, for example, conducting the research on nonidentified information and nonidentified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study.
    • Whether or not identities are removed, the consent must state:
      • unspecified future research may occur without additional consent;
        or
      • that the information or biospecimens will not be used for future research
  • For clinical trials supported by federal funding, one IRB‐approved consent form used to enroll participants must be posted on publicly available website.
  • Waiver of documentation of consent — new additional exception for subjects for whom signing documents is not the cultural norm

Single IRB Review

  • The Revised Common Rule creates a requirement for institutions engaged in cooperative research to use a single IRB for the portion of the research that takes place within the United States, with certain exceptions.

Research Terms: New/Revised

  • Human subject: a living individual about whom an investigator conducting research obtains
    • (1) information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;
      or
    • (2) uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
  • Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
  • Activities deemed not to be research:
    • Journalistic activities
    • Government functions with separately mandated protections
  • Clinical trial: research study in which human subjects are prospectively assigned to interventions to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
  • Legally Authorized Representative: individual/judicial/body authorized under applicable law to consent on behalf of prospective subject
  • Benign behavioral intervention: interactions that are brief, painless, not physically invasive, not likely to have a significant adverse lasting impact, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing
  • Interaction: communication or interpersonal contact
  • Intervention: physical procedures/environmental manipulations by which information or biospecimen are gathered
  • Private information: information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
  • Identifiable private information: private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
  • Identifiable biospecimen: a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
  • Vulnerable Subjects: vulnerable to coercion/undue influence

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+ - Additional Resources

Office for Human Research Protections (OHRP, 2017 & 2018)

Electronic Code of Federal Regulations (ECFR, 2018)

Public Responsibility in Medicine and Research (PRIM&R, 2017)

 Federal Register (2018)

Collaborative Institutional Training Initiative (CITI, 2017 & 2018)