Exempt Review

Criteria for Exemption from IRB Review


Exempt Review: Certain research activities may be exempt from review if approved by the IRB Chair and confirmed in writing to the Principal Investigator. Research may be exempt from review when the only involvement of human subjects in research falls into one of the following categories. For help determining your review category, please see our guide: Is my protocol exempt from IRB review?

Clarification on the Term, “Exempt”

Federal regulations stipulate that certain research activities may be exempt from regulatory requirements of the Common Rule (45 CFR 46), if approved by the IRB Chair and confirmed in writing to the Principal Investigator. These activities must fall into one of the eight predefined Exempt categories set forth by the Office of Human Research Protections (OHRP).

 

Researchers may be misled to believe that “exempt” review means that they do not need to submit a protocol to the IRB. 

However, studies that are categorized as “exempt” are only exempt from federal regulations stipulated in the Common Rule (45 CFR 46). In other words, this type of research is still subject to state, city, and institutional policies. At Teachers College (TC), all human subjects research must be submitted to the IRB for review.

Once a protocol has been determined to be exempt by the TC IRB, it typically is not required to undergo continuing reviews. Principal investigators (PIs) must still alert the IRB of changes to their study by submitting a modification, and must gain approval before implementing changes. The IRB will make a determination if any proposed modifications to a protocol impact an exemption status. Additionally, if an unforeseen event occurs, principal investigators must submit either a protocol deviation or an adverse event, depending on the situation.


 Exempt Review Categories Include:

  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 or the assessment of educators. 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.
  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) Recorded information cannot readily identify the subject (directly or through identifiers linked to the subjects);
    • (ii) Any disclosure of the human subjects’ responses outside of the research would NOT reasonably place 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 is obtained 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, and an IRB conducts a limited IRB review to make a determination.
  3. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal, written responses, including data entry or audiovisual recording if the adult subject prospectively agrees to the intervention and information collection, and at least one of the following criteria is met:
    • (i) Recorded information cannot readily identify the subject (directly or through identifiers linked to the subjects); OR
    • (ii) Any disclosure of the human subjects’ responses outside of the research would NOT reasonably place subjects at risk of criminal or civil liability, or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation
    • 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. 
    • If the research involves deceiving the subjects regarding the nature or purpose 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/she will be unaware of or misled regarding the nature or purpose of the research.
  4. Secondary research for which consent is not required, including research with private information or identifiable biospecimens collected for some other initial activity, if at least one of the following criteria is met:
    • (i) The identifiable private information or identifiable biospecimens are publically available;
    • (ii) The information 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 will not re-identify the subjects;
    • (iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as 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 information collected by or on behalf of a Federal department or agency using government-generated or collected information obtained for non-research activities.
  5. Research and demonstration projects that are conducted or supported by a Federal department or agency, and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs.
    • Each federal department or agency conducting or supporting the research and demonstration projects must publish a list of research and projects covered by this provision prior to research commencing.
  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.
  7. Storage or maintenance for secondary research for which broad consent is required, including storage or maintenance of identifiable private information or identifiable specimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determination.
  8. Secondary research for which broad consent is required, including research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
    • (i) Broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimen was obtained;
    • (ii) Documentation of informed consent or waiver of documentation of consent was obtained;
    • (iii) An IRB conducts a limited IRB review and makes a determination that the research to be conducted is within the scope of broad consent;
    • (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results. 

Note: Federal regulations indicate that certain research is exempt from review. However, under Teachers College's Policy for the Protection of Human Subjects, a research protocol proposing the use of human subjects must be submitted to the IRB to determine if it qualifies for exempt status. Exemptions do not apply to research conducted with pregnant women, prisoners, or vulnerable populations.

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