Revised Rule Exempt Categories
Below are the mose commonly applied Exempt categories with guidance on their use.
Protected Populations | |||||
Definition | Pregnant Women | Prisoners | Children | Advice | Harvard Requirements |
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. | Yes | Only Incidentally | Yes | A simple way to look at exempt category 1 is that it focuses on “things” – instructional strategies, techniques, curricula –to see if these “things” are effective, do these “things” work? There are two caveats for this exempt category – It must take place in established or commonly accepted educational settings. This does not mean that the research must take place only in schools. For example, an after-school program or a hospital may be settings where education takes place and would found to be acceptable under this category. It must only involve “normal educational practices”. These are viewed as “best practices” or things that would occur regardless if the research was taking place. What would not be considered a normal educational practice is something that would be considered experimental. This is not to say that educational research could never involve an experimental aspect, it is just not meant for exempt level research. | Exempt Consent Script |
Protected Populations | |||||
Definition | Pregnant Women | Prisoners | Children | Advice | Harvard Regulations |
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 | Yes | Only Incidentally | Yes, but only when the research involves educational tests or the observation of public behavior AND if the investigator(s) do not participate in the activities being observed. | As exempt category 1 focused on “things”, exempt category 2 focuses on the person. In the most basic sense, in educational research, the researcher will be gathering information about a person to determine whether an educational aspect is effective. Do test results increase? Do children learn more vocabulary words using method A versus method B? Following the “no surprises” rule, this category may only involve a task if it is part of an educational test and these tests should not be experimental. The term “survey” refers to information collected about individuals through questionnaires or similar procedures (e.g., Current Population Survey conducted by the U.S. Census) The research cannot include interventions in addition to the educational tests, survey or interview procedures, or observation of public behavior. For example, if a research study were to take an educational test in a quiet room or in a room with a moderate level of noise, or to consume a snack (or not) before taking the test, this research would not be exempt under this exemption. For example, reading comprehension tests may direct test takers to read a passage, and a geography test may present test takers with a map and ask them to draw information from that map. Likewise, survey procedures may contain some information that the respondents are asked questions about, which would not be considered distinct interventions. However, research in which the purpose of the research is to see whether respondents answer survey questions differently depending on the gender of the interviewer would not satisfy the conditions of the exemption, because the manipulation of the interviewer would be a distinct intervention. Research involving observation of public behavior does not qualify for this exemption if the investigator intervenes with subjects, for example, by offering them an ostensibly lost wallet to see if they will accept it. | Exempt Consent Script |
(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 §ll.111(a)(7). | Yes | Only Incidentally | No | Exempt Consent Script | |
Protected Populations | |||||
Definition | Pregnant Women | Prisoners | Children | Advice | Harvard Requirements |
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: (A) 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; (B) 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 (C) 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 §ll.111(a)(7).
(ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. | Yes | Only Incidentally | No | Examples of such benign behavioral interventions include having the subjects play an online game, solve puzzles under various noise conditions, or decide how to allocate a nominal amount of received cash between themselves and someone else.
This exemption allows for the intervention to be distinct from the data collection method; for example, a research study comparing test performance of test takers in quiet or noisy surroundings would qualify for this exemption. Also, subjects could be asked to perform cognitive tasks, and audiovisual recording could be used to collect the data, without any educational test, survey or interview procedure occurring, and this research would qualify for this exemption.
If the research involves deceiving the subjects about the nature or purposes of the research, this exemption would not be applicable unless the subject authorizes the deception. For the purpose of this provision, authorized deception would be prospective agreement by the subject to participate in research where the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. | Exempt Content Script |
