/Institutions/United-States-University/json/2023-2024/Policy-and-Procedure-Manual-local.json

/Institutions/United-States-University/json/2023-2024/Policy-and-Procedure-Manual.json

700-21-Exempt Research Activities

Title:	Exempt Research Activities
Owner:	IRB
Last Update/Revised:	05/01/2024

Policy: Human subject research that is categorized as exempt research is exempt from most of the requirements in the federal regulations for protection of human subjects. Regardless, investigators are expected to adhere to principles of sound research design and ethics.

Exempt research must:

• be no greater than minimal risk (minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests), and
• fit within an exemption category.

For federally funded research, there are 8 exemption categories outlined in 45 CFR 46.104. In relation to federally funded research, the USU IRB utilizes the exemption categories 1-5 but does not utilize categories 6-8.  Category 6 pertains to taste and food studies, which are not permitted at USU. For categories 7 and 8, the USU IRB does not utilize broad consent, thus these categories are not applicable. Categories 1 – 5 are listed below.

Exempt Categories

• 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 - 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:
  • The investigator records the information obtained in such a manner that the identity of the human subjects cannot readily be ascertained, directly or  through identifiers linked to the subjects.
  • 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
  • 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).

• 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:
  • 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;
  • 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
  • the investigator records the information obtained 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).

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, solve puzzles under various noise conditions, or 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 identifiable private information or identifiable biospecimens if at least one of the following criteria is met:
  • the identifiable private information is publicly available;
  • the investigator records information 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;
  • 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
  • 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.

Additional Exempt Categories for Non-Federally Funded Research

In addition to categories 1-5, the USU IRB allows additional exemption categories for research with no federal oversight. The research must meet the following criteria in addition to all specifications of the exemption category:

•  research is not subject to FDA regulations;
•  research is not federally funded;
• research meets the University’s ethical standards governing the conduct of the research, including appropriate provisions for the protection of privacy and confidentiality when identifiable and coded information are used.

The additional exempt categories for non-federally funded research are listed below and designated with the letters A-E.

1. Research involving collecting or studying existing data, documents, records, pathological specimens or diagnostic specimens, where this information is personally identifiable or coded.
2. Research involving the collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
   • From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml [37 Tbsp] in an 8-week period, and collection may not occur more frequently than 2 times per week; OR
   • From other adults, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml [3.4 Tbsp] or 3 ml per kg [0.28 tsp per lb] in an 8-week period, and collection may not occur more frequently than 2 times per week.
3. Prospective collection of biological specimens for research purposes by noninvasive means.
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
5. Research on individual or group characteristics or behavior (including, but not limited to, research or perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, collection of recordings (voice, video, digital, or image), program evaluation, human factors evaluation, or quality assurance methodologies, unless:
   • Information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects, and 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.

The determination of exempt research is made by the IRB Chair or designee. Exemption determinations are recorded and stored in the USU IRB Google Drive on the appropriate document.

If the IRB Chair or designee believes that a study proposal may be eligible for exemption but poses ethical concerns, it will be reviewed accordingly.

All exempt reviews that meet the requirements of a limited IRB review will ensure that, when appropriate, the research plan includes adequate provisions to protect subjects' privacy and to maintain the confidentiality of data. Limited IRB review is a process that is required only for certain exemptions and does not require an IRB to consider all the IRB approval criteria in 45 CFR 46.111. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations, are met.

In addition, the following is required:

• If an exempt study continues past the expiration date, a Continuing Review Form is required for recording purposes.
• Substantive changes to an exempt study must be submitted via an Amendment Form to ensure the study still qualifies for exempt status considering the changes.
• Exempt studies must adhere to the USU IRB reporting requirements for unanticipated problems and deviations.
• Exempt studies must be closed with the IRB once the research activities are complete by submitting a Final Report Form.

Purpose: This policy defines what research may be exempt from IRB oversight and the procedures for determining an exempt status.

Procedures:

1. Exempt Research
   1. The investigator submits an IRB Review Form.
   2. The IRB Chair or designee conducts a review of the research proposal using the appropriate IRB Member Review Checklist. When a category is applicable to the research, the IRB Chair or designee documents the category using the checklist and makes the exempt determination. If the research falls into multiple categories, the one most relevant to the research will be recorded.
   3. All exempt determinations are recorded on the appropriate document in the USU IRB Google Drive and communicated to the investigator (and chair of a doctoral student) via email from IRB@usuniversity.edu.
   4. If the IRB Chair or designee determines the proposal is not eligible for an exempt determination, the submission will move to an expedited review (see 700-22). The IRB Chair or designee will communicate this decision and a timeline to the investigator (and chair of a doctoral student) via email from IRB@usuniversity.edu.

Scope: This policy applies to research conducted at the USU.

Documents and Forms:

IRB Reviewer Checklist (available on IRB Google Drive)

Continuing Review Form

Amendment Form

Final Report Form