Exempt Review Form (pdf)
Categories of Research that Fall under Exempt Review:
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 education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Category 2: *Most Common Category for Researchers in the social and behavioral sciences, education, and humanities* 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, but an IRB conducts a limited IRB review to make sure that the researcher implements a plan to protect subjects’ privacy and maintain con¿dentiality.
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:
(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 that the researcher implements a plan to protect subjects’ privacy and maintain con¿dentiality.
*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.
**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.
Category 4: Secondary research for which consent is not required: 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 contact the subjects, and the investigator will not re-identify subjects;
(iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
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.
*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.
Category 6: 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.
Category 7: Storage or maintenance for secondary research for which broad consent is required. This involves the storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use. Secondary use refers to research with materials originally obtained for non-research purposes or for research other than the current research proposal. The IRB must conduct a limited IRB review to determine that 1) broad consent will be properly obtained and records will be kept of which research subjects consent and which research subjects decline to have their information or biospecimens used in secondary research; 2) there is plan to protect subjects’ privacy and maintain con¿dentiality.
Category 8: Secondary research for which broad consent is required. This involves secondary research using identifiable private information or identifiable biospecimens. Secondary use refers to research with materials originally obtained for non-research purposes or for research other than the current research proposal. There are four requirements that must be satisfied to use exemption 8:
(i) Broad consent must have been sought by a prior researcher from the subjects for the secondary research use of their identifiable materials. The prior researcher must have followed IRB protocols for broad consent in a study that received IRB approval, and documented broad consent (kept records of which research subjects consented and which research subjects declined to have their information of biospecimens used in secondary research).
(ii) The prior researcher also obtained informed consent from research subjects following IRB protocol for informed consent in a study that received IRB approval. Informed consent must be documented or the prior researcher must have obtained a waiver of documentation of informed consent.
(iii) An IRB must conduct a limited review to determine that broad consent was properly obtained and that the new research is within the scope of the broad consent. The limited IRB review must also ensure that the researcher implements a plan to protect subjects’ privacy and maintain con¿dentiality.
(iv) Investigators cannot include the return of individual research results to subjects in the study plan. Note that this requirement does not limit an investigator’s ability to abide by any other legal requirement to return individual research results.
Limited IRB Review
Limited IRB review is new process mandated by the revised Common Rule (implemented in January 2019) for certain Exempt categories. Only research in categories #2, #3, #7, and #8 is subject to limited IRB review, as described in the category descriptions above. In a limited IRB review, the IRB does not consider all of the issues that they examine for expedited or full reviews. Rather, they focus only on issues of privacy and confidentiality and/or broad consent. When researchers fill out the Exempt form, they provide the IRB with all of the information necessary for them to conduct a limited IRB review.
Exempt Research with Children
The revised Common Rule (implemented in January 2019) permits research with children (those under the age of eighteen) to be Exempt for certain categories of research. Otherwise such research must undergo Full review.
Exempt categories in which research with children is permitted: Exempt categories 1 & 4-8 can be applied to research with children, while Exempt category 2 (i) and (ii) only applies to children when the research involves educational tests or the observation of public behavior if the investigator(s) do not participate in the activities being observed.
Exempt categories in which research with children is NOT permitted:
Category 2 (iii)--research that includes interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior when data is identifiable
Category 3--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