The Common Rule (45 C.F.R. 46)
Federal regulations at 45 CFR Part 46 govern much of the review process for human subjects research. 45 CFR Part 46, or the “Common Rule” (so called because most federal agencies have adopted the same version of the Rule) was substantially revised in 2018, with changes put into effect in January of 2019. Use this page to learn more about some key review requirements for researchers.
The Categories of Exemption
“Exempt Review” is the “lowest” of the three levels of review available for human subjects research. It does not mean that the project is exempt altogether from IRB review. Rather, it means that the project is exempt from many of the requirements that the IRB must meet for the approval of Expedited and Full Board submissions, largely found at 45 CFR 46.111. Only the IRB makes determinations about exemptions.
Below, you will find detailed information about the exemption categories available at Utah State University. 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.
No exempt project can be greater than minimal risk. Nor can an exemption apply where identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability, or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing. Finally, the involvement of children is prohibited for nearly all categories of exemption.
Exempt Category 1:
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.
Under this exemption category, there can be no likelihood of adverse impact to assessment of an educator. There also can be no likelihood of adverse impact to students’ opportunity to learn required educational content. One application of these revised rules would be 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.
Where such conditions may be present, the research team should seek review under the Expedited review process.
Exempt Category 2:
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;
(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.
Utah State University conducts limited IRB reviews for all of its exempt projects, so the review process is the same for all sub-categories of this exemption.
Children can be included in this category using the public observation procedures, provided there is no interaction or intervention by any member of the research team. Children may also be subjects if the procedures are limited to educational tests as outlined above. Surveys or interviews of children cannot be reviewed as exempt.
Exempt Category 3:
Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
(i) The information obtained 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;
(ii) Any disclosure of the human subjects’ 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 an IRB conducts a limited IRB review.
Prospective Agreement
Data collection can only take place with adult subjects who are 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 national panels). 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. If your study does not allow participants to be alerted to the deception or lack of full information, it simply means that it must be conducted under a different level of review.
Data Collection
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 devices, medical procedures, sensors, passive data collection methods (other than AV recording) etc. would be 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; (2) 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 if the assessments are covered by Exemption #2.
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.
Exempt Category 4:
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.
Data in this category of exemption must be secondary. This means it must all exist because a) it was collected for another, non-research purpose, or b) 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 from the data – 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. This will generally require a HIPAA Waiver of Authorization.
Utah State University’s IRB recognizes that many researchers are conducting important education-based research, which carries its own protective federal measures, akin to the HIPAA protections referenced above. To prevent duplicative regulatory oversight, the USU IRB has created a new, site-specific subsection of this exemption category for data that are protected by FERPA. Researchers who are accessing or using 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. This subsection is not available to federally funded or multi-institutional research.
Exempt Category 5:
Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
Research conducted under this exemption should provide a link in Kuali Protocols to the publicly accessible Federal website referenced above.
Exempt Category #6 reads as follows:
Taste and food quality evaluation and consumer acceptance studies:
(i) If wholesome foods without additives are consumed, or
(ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Single IRB Review
The Revised Common Rule requires Single IRB Review for all federally funded non-exempt projects. The prime recipient of the award is generally the institution where IRB oversight will take place. Many institutions, including Utah State University, will not engage in Single IRB Review for exempt projects. Researchers working within the categories of exemption should seek exemption from their own institutions.
Single IRB Review is implemented through Reliance Agreements (sometimes also called Institutional Authorization Agreements). Utah State University is a member of the SMART IRB collaborative, which streamlines the Reliance Agreement process between member institutions. It does not, however, use the Online Reliance System - all Reliance processes occur in Kuali Protocols. When the other institution does not use SMART IRB, a Reliance Agreement should be requested in Kuali. More information about Reliance Agreement processes, is available on the IRB's Reliance Agreement page.
Informed Consent
The Common Rule outlines both the process and documentation requirements for an effective informed consent process. The Informed Consent page on our website contains templates with all required elements, available for researcher use. The Utah State University IRB does not accept old templates, 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.
Continuing Review (Renewals)
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.
The 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.” This occurs by conducting a continuation review for all Expedited projects which extend their original end date. The original end date will become the continuation review date.
Additionally, each Expedited project will receive a full continuation review in year five, and in at least five year intervals after that.
A Note on Exclusions and Self-Determinations
It is important for researchers to note the core definition of “research” in the 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. 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.
That guidance in its entirety is available for you to view through the Department of Health and Human Services.
The USU IRB continues to make 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.