Revised Common Rule

The federal policies mandating the protection of human subjects are known as the “Common Rule,” and on January 21, 2019, a substantial revision to the Common Rule went into effect. These changes are meant to ease some researcher burden while enhancing the protection of human subjects. These changes apply only to new studies submitted on or after January 21, 2019. Please note: the revised Common Rule does NOT apply to FDA-regulated and Department of Justice studies.

CITI Training & Revised Common Rule

The CITI Program has updated their current modules to reflect the changes to the Common Rule, which will not affect the module assignments required by CSUF IRB. Next time you are due for training, you will see the latest content.

Changes to Definitions of Research

The revised common rule contains a more detailed definition of "research", specifically pointing out certain areas that are NOT "research". So what's not research?

  • Scholarly and journalistic activities focused directly on the specific individuals about whom the information is collected (i.e., oral history).
  • Public health surveillance conducted, supported, requested, ordered, required, or authorized by a public health authority.
  • Collection and analysis of information or biospecimens for a criminal justice agency authorized by law or court order solely for criminal justice or criminal investigative purposes.
  • Authorized activities in support of intelligence, homeland security, defense or other national security interests.

Expedited Review

  • Changes: No continuing review required of expedited research unless the IRB documents a rationale for requiring it.
  • Summary of Expedited Categories (unchanged).

Informed Consent Changes

There are some changes to the process of informed consent. These changes are highlighted on the CSUF informed consent templates. These include:

Informed consent must specifically give prospective participants the information that a reasonable person would want to have in order to make an informed decision about whether to participate. Using this standard, informed consent remains focused on what information a reasonable person would want to have to make an informed choice about participation.

An additional change is that the information needs to be presented in sufficient detail and organized and presented in a way that facilitates an understanding of why one might, or might not, want to participate in the proposed research.

The informed consent needs to include a notice about whether participants' information or biospecimens collected as part of the current research might be stripped of identifiers and used for other research in the future. The purpose of this is to increase transparency by letting participants know that it might happen.

Existing Protocols

Protocols approved under the current regulations will be allowed to continue if no modifications are needed. We may look at these on a case by case basis to transition them to the revised regulations if there is any benefit.

Renewals

Under the revised Common Rule, continuing review/renewal is not required for:

  • Research that is eligible for expedited review (unless the IRB documents a need for continuing review)
  • Exempt research conditioned on limited IRB review,
  • Research that has completed all interventions and now only includes analyzing data, even if the information or biospecimens are identifiable- this includes Full Review applications,
  • Research that has completed all interventions and now only includes accessing follow-up clinical data from clinical care procedures.

Importantly, the IRB can override this default and still choose to require continuing review, as long as the IRB documents the decision and the rationale for this decision.

For CSUF, this means that research classified and approved as exempt (limited IRB review) and expedited will no longer need to be renewed on an annual basis. The initial approval will suffice for the duration of the research unless there is a change to the research (modification/amendment).