Research activities in which the only involvement of human subjects will be in one or more of the exempt categories defined by the Federal regulations will be given an exempt determination, rather than an IRB approval. Exempt studies are so named because they are exempt from some of the Federal regulations. However, they are not exempt from state laws, institutional policies, or requirements for the ethical conduct of research.

  • Research with prisoners cannot be exempt, unless the research is aimed at a broader subject population that incidentally includes prisoners (Subpart C).
  • Children are allowed in categories 1, 4, 5, and 6, however, there are limitations and exclusions under categories 2 and 3 (Subpart D).
  • Studies involving pregnant women, fetuses, and neonates are eligible for exemptions under all categories (Subpart B).

Category

Federal Definition

Conditions and Examples

1

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

a) research on regular and special education instructional strategies, OR

b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. 

This category does NOT apply to studies involving surveys, interviews, questionnaires, or focus groups. However, those activities may be covered under category 2 so long as children (under 18 years old) are excluded from those activities.

A normal educational setting and practice may include a cooking class in a grocery store, professional development workshops or skills development in children’s summer camps, etc. It is not necessary limited to primary and secondary public/private educational settings.

“A study that involves evaluation of radically new instructional strategies or use of random assignment of subjects to different instructional methods is usually not exempt because the methods employed in the studies deviate from normal educational practice” (Prentice & Oki, 2006).

This category may NOT apply to research on physical education on exercises that have been significantly altered or pose a level of risk to participants (Prentice & Oki, 2006).

Studies involving deception will not be considered under this category because deception is not a “normal educational practice.”

2

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, if at least one of the following criteria is met:

i) 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 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, or reputation.

iii) LIMITED IRB REQUIRED. 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 §46.111(a)(7).

This category does NOT apply if the research involves surveys or interviews with minors (under 18 years old).

This category only applies to observations of public behavior involving children if study team members do NOT participate in the activities being observed.

Observations must be of a public behavior and in a public setting. Classrooms and medical settings are not considered public.

If any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation AND the data are completely anonymous, this category may apply. A determination for a higher level of review may be made at the discretion of the OSU IRB on a case-by-case basis.

Limited IRB Review Criteria: The IRB must conduct a limited IRB review and make the determination that when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. 45 CFR 46.111(a)(7).

What is not allowed: Research involving children (except for educational tests or some public observation), the collection of biospecimens, and interventions.

3

i) 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 §46.111(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.

What is not allowed: Children, medical interventions and deception unless a prospective agreement has been obtained.

Benign behavioral interventions must be:

  • brief in duration
  • painless/harmless
  • not physically invasive
  • not likely to have a significant adverse effect on the subjects
  • not likely to make the subjects offended or embarrassed

No deception unless the participant is informed in the prospective agreement that they will be unaware of or misled regarding the true nature or purpose of the research.

4

Secondary research for which consent is not required: 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 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 HIPAA 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).

(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.

What is not allowed: Collection and analysis of protected health information (PHI) and personally identifiable information (PII).

 

 

Must be publicly available (e.g., commercially available specimen or open access data).

 

 

 

 

 

 

 

HIPAA regulations still apply; HIPAA protections include authorization or waiver of authorization; Does not include biospecimens. Only covers “investigator’s use”, sharing is not permitted under this exemption.

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.

A program must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act).

The research or demonstration project must be conducted pursuant to specific statutory authority.

There must be no statutory requirement that the project be reviewed by an IRB.

Must be posted on a Federal Web Site.

Rarely applicable to research at OSU.

6

Taste and food quality evaluation and consumer acceptance studies, if:

a) wholesome foods without additives are consumed, OR

b) 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.

Research under this category must be evaluating taste, food quality, or consumer acceptance. Other types of research involving food will be reviewed under an expedited or full board procedure.