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Human Subjects Review Program

Criteria for Review

Exemption From Further Institutional Review

The federal regulations (45 CFR 46.104) specify the criteria by which a research protocol is eligible for an exemption from institutional review. The following excerpts from the federal regulations define the categories used to determine such exemptions.

  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.
  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 by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to 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 by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to subjects, and the IRB conducts  limited IRB review to make the determination required by 45 CFR 46.111(a)(7).
  3. Research involving benign behavioral interventions in conjuction 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 a least one of the following criteria is met: (i) the information 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 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 by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to subjects, and the IRB conducts  limited IRB review to make the determination required by 45 CFR 46.111(a)(7).
  4. Secondary research uses of identifiable private information or identifiable biospecimens for which consent is not required, 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 investigators does not contact the subjects, and the investgator will not re-identify subjects; (iii) the research involves only information collection and analysis iinvolving the investigator's use of identifiable health information when that use is for the puprpose of "health care operations" or "research" (regulated under 45 CFR 160 and 45 CFR 164, subparts A and E).
  5. "Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to these programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs."
  6. "Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed, or (ii) if 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."

 

Minimal Risk ("Expedited") Review

Minimal Risk Review (sometimes referred to as "Expedited Review") is intended to provide a review for research projects that pose only a minimal amount of risk to subjects. A minimal amount of risk is equivalent to that which would be encountered by an average person in their daily life. Rather than requiring a meeting of the full Human Subjects Review Council, Minimal Risk review is conducted by a subcommittee of its members. Typically, subcommittee members independently review the application materials and forward their recommendations to the HSRC administrator. The proposal is approved if all subcommittee members approve it; otherwise it is referred for "Full Board Review" at a scheduled meeting of the Human Subjects Review Council.

Investigators should consider submitting a research protocol for "Minimal Risk" (i.e., expedited) review only after carefully evaluating whether or not the proposed study meets the criteria for such a review.  According to the Federal regulations, a research protocol qualifies for Minimal Risk (Expedited) review if it involves "no more than minimal risk" as defined by specific categories [see the Expedited Review Categories for more information]. These categories include, but are not limited to:

  • "Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth is patient care indicates a need for extraction."
  • "Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor."
  • "Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice.  This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy.  It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography.  It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves)."
  • "Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant."
  • "Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques."
  • "Voice recordings made for research purposes such as investigations of speech defects." NOTE: In other words, voice recordings in which the information of interest is produced by the process of speaking itself, without regard to what is being said.
  • "Moderate exercise by healthy volunteers."
  • The study of existing data, documents, records, pathological specimens, or diagnostic specimens.  NOTE:  Research of this type is appropriate for expedited review rather than exempt review if there are identifiers linked to the subject, and if data cannot be considered archaeological or historical data.
  • "Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects."  NOTE:  The information gathered under this provision would not be as much personal as situational; such information, were it to become known, would not usually affect the social standing or credibility of the subjects.  NOTE:  The term "manipulate" here should be interpreted to include some behavior that would be considered deceptive outside of the research context.

It is important to remember that it is not the presence of the above activities that qualifies an application for minimal risk review, but the absence of anything beyond such activities. If the study involves any activities that are more intrusive, more personal, or more risky than the above, it is unlikely to qualify for minimal risk review. Instead, such research protocols would receive a full board review at a convened meeting of the Human Subjects Review Council  (HSRC).

 

Full Board Review by the HSRC

Any research protocol that does not fall into one of the other two categories (i.e., "exempt" or "minimal risk") shall be submitted for full board review.  HSRC approval is usually valid for one year and may be amended or modified using the requisite applications forms (e.g., Modification Request).

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