Interpretation of Exempt Categories 1 and 2 as Revised in the 2018 Common RuleSACHRP Recommendations, October 2018
Background
The pre-2018 regulations at 45 CFR 46.101 identify six categories of research that are exempt from the requirements of the policy. These exemptions are described at §46.101(b)(1) - (6). In the 2018 revision to 45 CFR 46, the exemptions have been moved to §46.104(d) and expanded into eight categories. Although categories one and two have retained their original areas of focus, there are modifications to the language that will require the individual making a determination of exemption to consider new factors that may impact the applicability of the exemptions to proposed activities.
SACHRP has been asked to provide input on the interpretation of the revised language as well as on longstanding areas of debate from the original language of the exemptions.
Changes to Exempt Category 1
Exemption 1 with emphasis on differences between pre-2018 rule and 2018 rule:
(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 education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Within the regulated community there is an assumption that the original intent of the category 1 exemption may have been to cover educational settings under the jurisdiction of the US Department of Education (ED), which would typically be afforded the basic privacy protections for educational records that are provided by the Family Educational Rights and Privacy Act of 1974 (FERPA). However, there is no existing guidance that limits the use of the category in this way, and contemporary use of exemption 1 as it appears in the pre-2018 Common Rule has expanded to include anything that could be described as an established or commonly accepted educational setting. In addition to traditional K through 12 and post-secondary settings, use of the exemption has been applied to diverse settings, including professional development seminars, Boy Scout meetings, religious education, drivers education, and educational experiences utilizing various types of training simulators.
The structure of the exemption categories in the 2018 suggests that educational settings under the jurisdiction of ED remains the intended scope of the regulation, regardless of how it has come to be used in practice. Specifically, nearly all other exemptions that deal with private information now have explicit measures to protect such information. Exemption 2, which is largely methodology based, now requires that the information be unidentifiable, or that disclosure does not create risk, or that a limited IRB review ensure confidentiality protections are adequate. The same protections are provided for exemption 3. Exemption 4 provides similar protections by substituting HIPAA or Privacy Act provisions for limited IRB review. Exemptions 7 and 8 rely on broad consent and consequently voluntary and informed participation. Exemption 5 is the only other exemption that will routinely allow access to private information and that provides no implicit or explicit privacy protections. However, exemption 5 is largely a jurisdictional exemption to allow Federal departments and agencies the latitude to evaluate and improve their programs; it contains the requirement that notice be provided of any such exempt research before it is started.
Absent the assumption of FERPA jurisdiction, exemption 1 is the only exemption that contains neither privacy protections nor a requirement for notice or voluntary participation.
Exempt Category 1 Questions for SACHRP:
Q: What are considered “… established or commonly accepted educational settings”…
The consistent interpretation among IRBs is that commonly accepted educational settings can be almost anywhere as long as the setting is one where specific educational offerings normally take place or a setting where one would go in order to have an educational experience. IRBs do not appear to consider the source of funding for proposed research or the applicability of other protections, e.g. FERPA
Examples of settings identified by SACHRP include:
o K-12 schools and college classrooms, after-school programs, preschools, vocational schools, an alternative education programs
o professional development seminar for school district personnel
o soccer practice field
o Scouts meeting
o Medical school
o Religious education settings
o Training simulators (e.g., medical simulators, flight simulators, etc)
Q: What are considered “normal educational practices…”
Normal educational practices are those activities that are routinely used in similar educational settings and/or are considered proven educational practices with the population under study.
Q: The exemption is silent with respect to information collection. Are there any limits on methods or content of data collection?
The educational exemption should not be viewed as a regulatory mechanism for the review of data collection methods or where the content of the collected data would otherwise require non-exempt IRB review. (For example, while the Stanford Prison Experiment took place in an educational setting, the methods utilized in that study would not be appropriate for exemption from IRB review.) Exempt research is commonly understood to involve minimal risk activities, and revised exemption category 1 should not be an exception.
Consistent with other categories of exemption, the content of data collection should be limited to data where 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.
Q: How should IRBs interpret the condition that the normal educational practices studied “are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction”?
It may be difficult to determine what the threshold will be where a proposed activity is likely to have an adverse impact on students’ opportunity to learn required educational content or the assessment of educators who provide instruction. Reviewers / IRBs may need to ask the researcher to provide an initial assessment of the likelihood of the research having such an impact on subjects.
To assess potential issues impacting the opportunity to learn required educational content, reviewers could consider whether the proposed activity requires students to deviate from a curriculum that is aligned with any national or state-level indicators of student achievement (e.g., state end of grade testing) or if the activity will take instructional time away from students. When assessing the impact on the assessment of educators, reviewers may want to ascertain whether participation, or the refusal to participate, in research will be a factor in the assessment of educators. In a similar manner, IRB reviewers may question whether the outcomes of the research will be a factor in the assessment of participating instructors.
Recommendations for Exempt Category 1:
SACHRP recommends that if the intent of the exemption is to cover research that would also be covered by FERPA, this should be made explicit in guidance. In making this determination, OHRP may wish to consider the impact of imposing restrictions on an exempt category that historically has been interpreted broadly, without any well documented issues regarding its use.
SACHRP recommends that OHRP issue guidance that describes any limitations on what may be considered “established or commonly accepted educational settings” and “normal educational practices” for the purpose of the exemption.
SACHRP recommends that OHRP issue guidance to clarify the limits on methods or content of data collection, if any.
Changes to Exempt Category 2
Exemption 2 with emphasis on differences between pre-2018 rule and 2018 rule:
(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 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 to make the determination required by §__.111(a)(7).
Exempt Category 2 Questions for SACHRP:
Q: What sorts of interventions are permissible under this exemption?
This question asks what interventions would be consistent with exemption 2, but the category as written is limited to research that only includes interactions or public observation. Per §46.102(e)(1) and (2), “ intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes” and “ interaction includes communication or interpersonal contact between investigator and subject.”
These definitions suggest that what separates these two categories of activities is the use of “physical procedures.” Exemption 2 covers “educational tests…, survey procedures, interview procedures” and “observations of public behavior.” While the investigator may be actively involved in some of these activities (e.g. interviews), there is no necessary physical contact or “physical procedure” involved.
This exemption does not appear to allow interventions. The category as written is limited to research that only includes interactions or public observation.
Q: When is observation of public behavior without intervention or interaction ever human subjects research?
Observation of public behavior without intervention or interaction can be human subjects research when it satisfies the definitions of human subject and research. Within the framework of this exemption, it is possible that an investigator may be observing individuals in a setting where, while public, there is an expectation of privacy (e.g., public restroom, online group). It is also possible under the exemption that an investigator engaged in public observation would capture information that would allow for the identification of observed individuals, provided that an IRB conducts a limited IRB review to make the determination required by §__.111(a)(7).
Q: How should the addition of “educational advancement” as something that potentially could be damaged be understood?
Examples would be information learned in the study that would disqualify an individual from advancement. For example, in a survey that collects data about academic integrity where respondents indicate whether they have engaged in misconduct (e.g., cheating on exams, plagiarism, etc.), the disclosure of the subjects’ responses outside the research could be damaging to the subjects’ educational advancement.
Q: What is the function of limited IRB review in the context of this exemption?
The function of limited IRB will be to determine whether there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data, given the nature of the information being obtained. Another function would be to look at what identifiers are necessary so that researchers are not gathering more than is needed, thereby decreasing exposure to and impact of breaches of confidentiality.
Q: What is the impact of exemption category 3 (research involving benign behavioral interventions) on the first question.
The immediate impact of the new exemption for benign behavioral interventions on exempt category 2 is not clear. Although the wording of category 2 appears to exclude interventions, it should not present a problem if the activities being reviewed fit one of the categories but are approved under an incorrect category. (This may be a compliance issue, but the severity of the error is not the same as it would be if an activity was determined to be exempt that did not qualify for exemption under any category.)
The addition of exemption 3 to the Common Rule suggests that there are few if any physical procedures that would be acceptable under exemption 2. SACHRP has previously interpreted exemption 3 as a mechanism to extend the coverage of the exemptions to include some interventions with very low risk, and has noted that clinical or medical procedures, such as blood draws, even if low risk, are not included in exemption 3, which is explicitly limited to “behavioral interventions.”
It would be counterintuitive to interpret exemption 2 to include interventions, as defined above, as this would make exemption 3 largely unnecessary, and would undermine any effect that limiting the scope of exemption 3 might have on the scope of exempt research. For example, category 3 does not apply to research involving children. Category 2 does not include the same blanket limitation.
Recommendations for Exempt Category 2:
SACHRP recommends that guidance specify that category 2 cannot serve as the basis for a determination that interventions with research subjects are exempt.
SACHRP recommends that OHRP issue guidance on the use of limited IRB review to support a determination that a proposed activity is exempt under category 2.
Conclusion
Changes to the Common Rule exemption categories, including changes to long-understood categories, have the potential to create confusion among researchers and IRBs. In addition, there is the potential for inconsistency in the application of the categories by the regulated community.
SACHRP recommends that OHRP develop guidance on the application of revised exempt categories 1 and 2, and that the guidance be developed in concert with the other Common Rule departments and agencies that conduct or support research activities that would be covered by these exempt categories.
