About the Revised Common Rule

The Revised Common Rule came into effect on January 21, 2019. Use this page to learn more about the changes to the Common Rule (45 C.F.R 46) by selecting the topic area you wish to read about!

Please select the Exemption you are interested in learning more about. Exemption categories can be combined within a research project, but for a project to be exempt, all aspects of the project must fall within one (or more) of the exemption categories. As a reminder, no research project carrying greater than minimal risk is permitted to move forward as Exempt.

Exemption #1 reads:

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special instructional strategies, and research on the comparison among instructional techniques, curricula, or classroom management methods.

Interestingly, this is the only exemption that constricted rather than expanded in the Revised Common Rule. There can be no likelihood of adverse impact to assessment of an educator, which is a new requirement. There also can be no likelihood of adverse impact to students’ opportunity to learn required educational content. This new requirement has been expanded upon to mean that students cannot be pulled out of core subjects for research participation, and neither can the educational research itself be likely to negatively impact student learning of those core content areas.

This is not to say that research which might have an adverse impact on those areas cannot be completed, it simply means that it cannot be completed using this exemption. Expedited Review processes are still available to researchers who need to be able to, for example, use core content class time for behavioral interventions, or assess culturally competent ways of teaching that might reflect negatively on an instructor.

The expansion of this category is exciting! The new exemption reads:

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: (i) The information obtained is recorded in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subject; or (ii) Any disclosure of the responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation, or (iii) the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and the IRB conducts a limited IRB review to make required determinations.

In other words, the restriction on only asking about benign topics (with identifiers) is now removed in favor of IRB review to determine that there are adequate privacy and confidentiality safeguards in place for the adult participants in these kinds of studies. Because USU is accredited, we have always completed a limited review of exempt projects, and we will continue to do so to maintain accredited status – this means that functionally, no additional review restrictions will exist for this exemption category, but the kind of work permitted to be done under this exemption is expanded.

Please note that children are still not permitted to be involved under this exemption except in the case of public observation; however, there can be no interaction by the research team. 

The previous exemption regarding public officials has been removed from the regulations all together in favor of a completely new exemption category permitting benign behavioral interventions. This exemption is quite long, and we encourage you to read the full text here. In this section, we will summarize key information regarding what is permitted under this exemption.

Prospective Agreement

Data collection can only take place with adult subjects able to consent for themselves. Please note that several states do not use 18 as the age of majority, so this might be something you need to take into account in your recruitment plan (e.g. use of MTurk participants). The participants must prospectively agree to the specific intervention, although deception (or withholding of full information) is permitted as long as the participant also prospectively agrees to be deceived or to proceeding without full information. As with Exemption 1, this does not mean that deception without prospective agreement is not allowed, it simply means that it must take place under Expedited review.

Data Collection

The exemption is restrictive in terms of the ways data can be collected. Data collection is limited to: verbal or written responses by the subject, data entry by the subject themselves, or observation of the subject including audiovisual recording. No medical devices, medical procedures, sensors, etc. would be permitted under this exemption. Passive data collection devices, such as a FitBit, are not permitted under this exemption.

The Intervention

The intervention itself is limited to one (or a combination) of the following: (1) communication or interpersonal contact with the participant; (b) performance of a cognitive, intellectual, educational, or behavioral task; or (3) manipulation of the subject’s physical, sensory, social, or emotional environment. The examples HHS has given include manipulating a keyboard, doing a puzzle, or the introduction of music during a participant’s regular walking activities. Physical exercise, range of motion activities,  or other physical tasks or manipulations cannot be included under this exemption.

Additionally, the intervention must be brief in duration, harmless, painless, unlikely to have adverse effects on the participant following participation, and unlikely to cause emotional discomfort, offense, or embarrassment. Brief in duration means that the intervention with any given participant will not span more than three hours (separate sessions are okay), and will be contained within a single day. Data collection can be distinct from the intervention in terms of the time permitted: if there is an hour and a half of assessments, followed by a two hour intervention, and then another hour and a half of assessments, the project could be eligible for exemption.

Privacy & Confidentiality

The same restrictions that exist within subsections (i) – (iii) of Exemption 2 also exist here. The data researchers collect must be either anonymous, benign, or the collection and storage procedures must be reviewed and approved by the IRB. 

Previously, this exemption was limited to data that had been collected previously, could not be re-identified, and all existed prior to the filing of the protocol. Now, data needn’t be in existence already as long as it was or will be collected for a non-research purpose. The exemption is a follows:

Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: (i) the identifiable private information or identifiable biospecimens are publicly available; (ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not have contact with the subjects, and the investigator will not re-identify subjects; or (iii) the research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under HIPAA.

While the class of data that can be used for this exemption has expanded, there are some important items to note. For all subsections, the data must be truly secondary. This means it must all exist for another, non-research purpose, or that it was originally collected with the informed consent of the participant for a research study. For data that does not yet exist, if the way the data is being collected in the primary instance is shifted at all for the purposes of research, it does not qualify for this exemption. For (i), the data must be truly publicly available. Any person must be able to access that which a researcher is seeking to access under this exemption. Subsection (ii) requires that the participant’s identity not be able to be readily ascertained – this might involve the use of an honest broker, for example, to provide you with the data. And Subsection (iii) requires that the researcher still follow all HIPAA requirements in obtaining the secondary data, which means that a HIPAA Authorization may still be required even if Informed Consent is not. Much more common will be a required HIPAA Waiver of Authorization, which can only be granted via an Expedited Review process, so expect for this particular exemption to take a little more time than the rest. However, on the whole, this exemption will save significant time for researchers by drastically broadening the type of data eligible for exempted use.

*NEW*: Utah State University recognizes that many researchers are conducting important education-based research, which carries its own protective federal measures. To prevent duplicative regulatory burden, the USU IRB has created a new subsection of this exemption category for data that are protected by FERPA. Researchers who are accessing, using, or disclosing identifiable education records that are still subject to FERPA protections will be able to do so under this exemption category. This requires that the education records be accessed or used either (a) with a valid FERPA Authorization from the parent (K-12) or eligible student (higher education); (b) under one of the exceptions outlined in FERPA; or (c) from the institution’s data custodian, stripped of all identifiers and unable to be re-identified by the research team. This subsection is not available to federally funded research

Exemptions 5 and 6 remain unchanged, except that the federally authorized projects may now be posted online instead of only within the Federal Register.

The Revised Common Rule requires Single IRB Review for all federally funded projects, beginning next year. However, the National Institutes of Health has already implemented its Single IRB Review requirement, and in an effort to avoid duplicative review in all cases, the USU IRB encourages the use of Single IRB Review procedures wherever possible. This means that only one IRB will review a project where there are collaborators at multiple institutions, using what is called a Reliance Agreement, or an Institutional Authorization Agreement. The Utah State University IRB uses SMART IRB whenever possible. To learn more about that process, click on the tab most applicable to your research project.

Except in some extraordinary cases, when a federally funded award involving human subjects research is being granted to USU, the protocol for the work with human subjects will also need to be housed at USU. Researchers should begin to work on their protocol as soon as they learn that their initial scores are in the fundable range, and should submit that protocol to the USU IRB only once the agency has indicated that the funding is likely to be awarded.

As soon as the protocol has been submitted, the collaborator(s) at the external institution(s) (“Relying Institutions”) should reach out to their IRB to determine whether the Reliance Agreement should take place during or after the review process at USU. The USU IRB is willing to engage in Reliance Agreements at any stage in the review process.

If the Relying Institution(s) use SMART IRB, it will be the PI’s responsibility to enter the study into SMART IRB for Reliance. USU researchers can request Investigator Access to SMART IRB at any time – no need to wait until a Reliance Agreement is needed. SMART IRB has several tutorials and online videos available.

If the Relying Institution(s) do not use SMART IRB, the PI should complete USU’s Reliance Agreement template and upload it to the “Submit” section of the protocol. Please provide us with the contact information of the individual at the Relying Institution that we should reach out to.

In all cases, you and your collaborators will be notified once the Reliance Agreement is fully executed. This means that you and your collaborators are free to engage in all activities that have been approved by the USU IRB.

Except in some extraordinary cases, where a federally funded award involving human subjects research is being granted to an institution, the protocol for the work with human subjects will also need to be housed at that institution. The PI where the award will be housed should begin to work on their protocol according to that institution’s procedures for just-in-time reviews.

As soon as the protocol has been submitted, your collaborator at the primary institution (“Reviewing Institution”) should reach out to their IRB to determine whether the Reliance Agreement should take place during or after the review process. The USU IRB is willing to engage in Reliance Agreements at any stage in the review process.

If the Reviewing Institution uses SMART IRB, it will be the Reviewing Institution’s PI’s responsibility to enter the study into SMART IRB for Reliance. USU researchers can request Investigator Access to SMART IRB at any time, but should do it in advance of the PI entering the study into the SMART IRB system. There is no need to wait until a Reliance Agreement is needed for a USU investigator to request that access. SMART IRB has several tutorials and online videos available.

If the Reviewing Institution does not use SMART IRB, the Reviewing Institution PI or the USU PI should complete a Reliance Agreement template (preferably USU’s) and email it to irb@usu.edu. Please provide us with the contact information of the IRB professional at the Reviewing Institution that we will be working with. You are welcome to email both IRBs at the same time in order to permit us to work together on your Reliance request. When the protocol is approved, please send the USU IRB a complete copy of the protocol (including data collection instruments), all informed consent documents, and, if available, recruitment materials.

In all cases, you and your collaborators will be notified once the Reliance Agreement is fully executed. This means that you and your collaborators are free to engage in all activities that have been approved by the Reviewing Institution’s IRB.

USU’s IRB is happy to engage in Reliance Agreements to prevent duplicative review of the same research project. If your colleague already has IRB approval elsewhere, we would encourage you to seek Reliance on that existing approval. Otherwise, you are welcome to seek IRB approval from either institution. In very rare cases, the USU IRB will decline to engage in a Reliance Agreement (for example, the USU IRB feels very strongly that a protocol that was approved as Expedited should have been reviewed by the Convened IRB). In those very rare cases, a protocol will be required here at USU. (At the time of this writing, we have executed over 100 Reliance Agreements and have only once declined to rely on another institution’s review.) To request Reliance, please first determine which IRB you would like to have review your protocol submission. Then, follow the instructions from the two tabs above based on where the review will take place (i.e. the first tab if the review will take place here, the second tab if the review will take place elsewhere).
The institution where the review will take place will need copies of CITI Training Certificates that include the coursework (not just the completion certificate) prior to finalizing a Reliance Agreement. Please provide CITI Training Certificates and Coursework to the IRB where the review will take place for all personnel. The USU IRB is unable to provide you with copies of your training certificate, as your account is with CITI, not the USU IRB. We can assist you with resetting your CITI password, if necessary – please contact Kim Noble at 435.797.1821 or Kimberly.noble@usu.edu for CITI assistance. You can also contact CITI directly at support@citiprogram.org.

Reliance Agreements can only be executed on behalf of faculty. If a student is engaging in a project with a colleague at another institution, that student’s advisor (as well as the student) should be listed on all relevant materials for both IRBs, and the USU advisor is responsible for oversight of the student’s work in all cases, not only when the protocol review takes place here.

Reliance Agreements can only be executed with institutions that have a Federalwide Assurance Number. This means that many international institutions cannot engage in Reliance Agreements with USU’s IRB (and vice versa) and in those cases, a protocol may need to be filed at USU as well as with the international institution. USU’s Federalwide Assurance number is FWA#00003308.

The Revised Common Rule requires several new elements regarding informed consent. The Informed Consent page on our website contains new templates with all of the required elements. Please note that we will not accept the old templates beginning January 22, 2019, as they will be missing several required elements. Your protocol will be returned to you if an old template is used. Researchers are always welcome to develop a completely separate informed consent document, but it must contain all of the required elements of informed consent absent an applicable waiver or alteration.

Under the Revised Common Rule, there are three kinds of projects that will receive annual continuation review:

  • Protocols reviewed by the Convened IRB with ongoing data collection;
  • Protocols that are greater than minimal risk; and
  • Protocols for which the scientific reviewer requested annual continuation review.

And that’s it! This means that almost every Expedited review protocol approved after implementation of the Revised Common Rule will require only an annual check in, rather than a complete annual continuation review. If a PI does not complete their annual check in, the IRB will not accept any new protocols on which they are listed until the check in has been completed.

In place of annual continuation reviews, the Revised Common Rule requires that IRBs establish procedures “to determine which projects need verification from sources other than the investigators that no material changes have occurred since the initial IRB review.” To meet that regulatory mandate, the IRB will select five Expedited protocols each month for routine audits. The protocols will be selected based on the month in which they were originally approved (i.e. only protocols with an initial approval date in June will be eligible for the June audit cycle).

What is happening to expiration dates? You’ll tell us! The research team and the protocol’s scientific reviewer will agree on a date by which active recruitment should be complete, as well as an expiration date for your protocol, prior to the initial approval. Extensions beyond that date will be permitted. If a project is expected to be active for more than five years, it will receive a full continuation review in year five.

What Will the Transition Look Like?

All protocols newly submitted after January 21 will be reviewed under the Revised Common Rule. The most commonly realized change will be that many (formerly) Expedited projects will be eligible for Exempt review, which translates to a decrease in review times by nearly a month on average. For most Expedited approvals under the new framework, annual continuation review will no longer be required. Screening activities will no longer require a waiver of informed consent (meaning less paperwork for you!). HHS has promised revised Expedited review categories, which we expect to be more expansive than they currently are. We think there are a lot of advantages to the Revised Common Rule, and we hope you agree!

A Note on Exclusions and Self-Determinations

Several media and organizational outlets have released false or misleading information regarding certain disciplines (oral history, journalism, biography, literary criticism, legal research, and historical scholarship) falling entirely outside of any oversight by the Revised Common Rule. It is important for researchers to note that the core definition of “research” has not changed in the Revised Common Rule. Research means “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

“Scholarly and journalistic activities… that focus directly on the specific individuals about whom the information is collected” is not research under the federal definition. Those types of activities have never been considered research by the current USU IRB staff. The USU IRB abides by the Department of Health and Human Services guidance on when those activities rise to the level of “research” under 45 CFR 46, which notes that:

[A] significant portion of the activities that are characteristic of these fields fall outside of the category and therefore remain within the scope of 45 CFR 46. Studies using methods such as participant observation and ethnographic studies, in which investigators gather information from individuals in order to understand the beliefs, customs, and practices, not only of those individuals, but also of the community or group to which they belong, would not [be excluded from] 45 CFR 46. The purpose and design of such studies or activities is to reveal something about the community or group – that is, to develop generalizable knowledge. Because the purpose of such studies or activities is not to limit the inquiry to knowledge about the particular individuals being observed, the protections provided by the requirements of 45 CFR part 46, such as the requirement to minimize any harm to the specific individuals from which the information was collected, are appropriate. Such activities would continue to fall within the scope of the definition of “research” under the Revised Common Rule.

You may view that guidance in its entirety here.

The USU IRB continues to make its Non-Human Subjects Research Determinations available to researchers whose work involves scholarly activities where the necessary oversight might not always be clear. We encourage USU researchers to take advantage of that short process, which is typically completed in the same business day as submission. Consistent with longstanding guidance from HHS, the IRB will remain the only source of Exemption determinations.