IRB Application Categories

I. Exempt Review

II. Exempt Limited Review

III. Expedited Review

IV. Full Review

I. Exempt Review

Under certain circumstances, human subject research activities subject to the IRB may be granted exempt status.  The significance of exempt status, which may be requested by an investigator when submitting an application to an IRB and may be granted by the IRB Chair or designees, is that the research activity is not monitored by the IRB. Assuming the project does not change, it also is not subject to continuing IRB oversight. Exempt status does not, however, lessen the ethical obligations to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct. Thus, depending on the circumstances, researchers performing exempt studies may need to make provisions to obtain informed consent, protect confidentiality, minimize risks, and address problems or complaints.

It is the policy of Siena College IRB that to be deemed exempt, human subjects research activities must be reviewed and determined to fall within one or more of the explicit exemption categories listed in the federal regulations. To be deemed exempt, research activities must be reviewed by the IRB and determined to fall within one or more of the eight exemption categories outlined by federal regulations:  

EXEMPT 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.

EXEMPT 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:

(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, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

EXEMPT CATEGORY 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.

EXEMPT 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 nonresearch 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.

EXEMPT 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.

(i)   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.

(ii)   [Reserved]

EXEMPT 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.

EXEMPT CATEGORY 7.  Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).

EXEMPT CATEGORY 8. Secondary research for which broad consent is required: 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 the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);

(ii)   Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;

(iii)   An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (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.

For guidance in determining the appropriate category for your project, please consult the OHRP decision chart.    

Exempt status does not lessen the ethical obligations to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct. Thus, depending on the circumstances, researchers performing exempt studies may need to make provisions to obtain informed consent, protect confidentiality, and minimize risks. In these situations, an IRB Exempt Review may be appropriate.

IRB Exempt Review Process

Under exempt review process, the review is carried out by the IRB chairperson or by one of the members of the IRB. A typical review may take between 1-2 weeks before a decision is rendered.

 

II. Exempt Limited Review

A limited IRB Review is a type of expedited review process required in the Revised Common Rule.  Its purpose is to ensure privacy/confidentiality protections are in place with exempt research that involves the collection or use of sensitive, identifiable data (exemptions 2, 3 and 8) and, for exemption 7, that "broad consent" was obtained and (if appropriate) documented according to an approved protocol.  For exempt studies involving access to PHI (e.g., from medical records), the required Privacy Board review may be integrated with Limited IRB Review by the same assigned reviewer.

IRB Exempt Limited Review Process

Under an exempt limited review procedure, the review is carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. A typical review may take between 2-3 weeks before a decision is rendered.

III. Expedited Review

An IRB may use the expedited review procedure to review the following:

(1)   Some or all of the research appearing on the list described below, unless the reviewer determines that the study involves more than minimal risk;

(2)   Minor changes in previously approved research during the period for which approval is authorized; or

(3)   Research for which limited IRB review is a condition of exemption under § __.104(d)(2)(iii),(d)(3)(i)(C), and (d)(7) and (8). Expedited review is required for activities that meet the following criteria (see OHRP Chart 8):

  1. Clinical studies of drugs and medical devices;
  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture;
  3. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
  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 involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the DHHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
  6. Collection of data from voice, video, digital, or image recordings made for research purposes.
  7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the DHHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
IRB Expedited Review Process

Under an expedited review procedure, the review is carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. A typical review may take between 2-3 weeks before a decision is rendered.

IV. Full Review

Research that does not qualify for exempt or expedited levels of review must undergo a full IRB review. Research activities that may require a full review include:

  • research placing humans at psychological, physiological, and/or informational risk that is greater than minimal risk
  • research involving sensitive topic areas
  • research that involves the intentional induction of stress (physical or emotional), such as the use of aversive or physically painful stimuli
  • research that involves procedures that might lead to physical injury
  • research that involves interaction with minors (under the age of 18) or other potential vulnerable populations (e.g., prisoners, pregnant women, children)

A full review involves a convened meeting at which the majority of the membership of the IRB are present, including at least one IRB member whose primary concerns are in non-scientific areas.

IRB Full Review Process

Under the full review procedure, this type of review is first determined by the IRB chairperson after careful examination of the application submitted. For the research to be approved, it must receive the approval of a majority of those members present at the meeting. The PI may be requested to attend a full board meeting to discuss the proposal and answer questions posed by the IRB. A typical full review may take between 1-3 months before a decision is rendered. 

Application Submission

Reviewed/Revised: January 2019