Graduate School

Studies that meet the definition of regulated research under the Common Rule may fit within one or more categories of “exempt” research. This does not mean that such studies do not need IRB review. In order for a research study to be deemed "exempt", investigators will need to submit an application to the IRB office, along with study related materials (e.g., consent forms, surveys, questionnaires, interview scripts/outlines, etc.). Please note that this determination of exemption must be made by IRB staff

There are 6 main exemption categories. Each category is below.

Category 1: Research on educational practices, instructional techniques and curricula

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.

Commonly accepted educational settings include any setting where one would go in order to have an educational experience. For example, a public school, an after-school club or program, a Boy or Girl Scout meeting,  a professional development seminar for school district personnel or nurses. This can also include applied learning settings like  on-line educational programs, and internships. Additionally, nontraditional settings may be included in "commonly accepted educational settings." The burden of proof in demonstrating that the proposed research setting qualifies as fitting the category of “established” or “commonly accepted” falls ultimately on the principal investigator

Normal educational practice refers to commonly accepted educational practices. Hence, research involving the use of radically new or innovative practices may not qualify for exemption.

FERPA restrictions may apply and prevent research from qualifying for this exemption. FERPA restricts access to student records without their permission, including grades.

Category 2: Anonymous or non-sensitive research using educational tests, surveys, questionnaires, interviews, focus groups, or observation of public behavior.

This category includes research that only involves interactions using 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.

To qualify under (i) the project must be completely anonymous. To qualify under (ii) the project can be confidential, but the subject matter and questions cannot be sensitive. To see what is considered sensitive, check out our FAQ on the topic. Projects that are not anonymous and collect sensitive information cannot qualify for this exemption.

Category 3: Benign behavioral interventions with adult participants

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:

1. 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;
2. 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
3. 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). [Not applicable at OSU but determination of category 3C may be accepted by OSU if issued by an external institution].

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.

Brief in duration is typically no more than a couple hours for the subjects entire participation across the duration of the project.

Category 4: Secondary analysis of publicly available or de-identified information

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:

1. The identifiable private information or identifiable biospecimens are publicly available;
2. 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;
3. 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
4. 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: Federally supported research designed to examine public benefit or service programs

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 website 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

Taste and food quality evaluation and consumer acceptance studies:

1. If wholesome foods without additives are consumed, or
2. 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.