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When a research protocol is submitted to the IRB, the chair assigns each human subjects research protocol to a specific category of review, depending on the purpose, methods, and risk-to-benefit ratio of that study. The federal regulations detail the three categories of research review: full committee review, exempt review, and expedited review of non-exempt research. This section will describe each category, followed by examples of projects that would be assigned to that category.

Full Committee Review of Non-Exempt Research:

Any research project involving human subjects that poses more than minimal risk to participants must go through full IRB review for approval.

“Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

“Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects."

Minimal risk: "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" (from 45 CFR 46.102(info)).

Certain categories of research automatically require full committee review:

• Research involving vulnerable populations (prisoners, fetuses, pregnant women, children, the seriously ill, or mentally or cognitively compromised adults as subjects.

• Research involving the collection or recording of behavior which, if known 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.

• Research involving the collection of information regarding sensitive aspects of the subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
• Research involving deception (NOTE: research involving minor deception or omission that poses no risk of adverse effects to the participants may qualify for expedited review: see below)

Examples of research that would require full review

o Research on Substance Abuse
o Research on Sexual and Physical Abuse
o Research on Depression and Suicide
o All Research Involving Children and Adolescents
o Research on Sexuality and Gender
o All research involving subjects with diminished capacity
o All institutionalized subjects (e.g., prisoners, state hospital patients)

Expedited Review

To qualify for expedited review (see 45 CFR 46.110), an activity must involve no more than minimal risk, and be found on the list of Expedited Review Categories of Research (see attached)

Expedited research protocols must meet all of the following criteria:

• The research does not include vulnerable populations as participants (minors, prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults)

• The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

• The research does not involve the collection of information regarding sensitive aspects of the subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).

In addition to these categories, continuing research that was originally determined at a full committee meeting to involve minimal risk and where administrative reviewers cannot identify any additional risks to the participants typically qualifies for expedited review.

If the research qualifies for expedited review, it will be examined by an expediting reviewer (either the chair or a designated member of the IRB). Expedited reviews are conducted weekly on a "rolling" basis as applications are submitted. Once all required documents are received, the expediting reviewer will examine your application and issue a decision.
The IRB member conducting the expedited review may exercise all of the authorities of the IRB except that the reviewer may not disapprove the research. The reviewer shall refer any research protocol which the reviewer would have disapproved to the Full IRB for review. The reviewer may also refer other research protocols to the Full IRB whenever the reviewer believes that Full IRB review is warranted.
When the expedited review procedure is used, the IRB chairperson or member(s) conducting the review shall inform IRB members of research protocols which have been approved under the procedure.
At a convened IRB meeting, any member may request that an activity which has been approved under the expedited procedure be reviewed by the IRB in accordance with non-expedited procedures. A vote of the members shall be taken concerning the request and the majority shall decide the issue.

Exempt review status

DHHS Guidelines (45 CFR Part 46.101(define research as exempt from further IRB review when the research involves no risk to the subject, and falls into one of six specific categories (see attached). Research that is considered exempt from full IRB review must still be submitted to the IRB and screened for exempt status. The final determination of level of review will be made by the IRB upon receipt of the application form.

Use the Exempt Review Categories of Research to decide which exemption category might apply to your research. If you don't see a category for your research, expedited or full IRB review is probably required.

Keep in mind that exempt research involves no risk. Therefore, any research that manipulates the participant or the participant’s environment is not exempt. In addition, any survey or interview research with adult subjects that includes sensitive or stressful information or that involves deception is not exempt. Examples of exempt research include:

• No risk survey/interview research with non-vulnerable adult subjects; the use of nonidentifiable laboratory specimens; review of nonidentified existing records; observation of the public behavior of subjects where there is no manipulation of the subject; and some educational testing and classroom activity.

45 CFR 46.101(b) Categories of Exempt Human Subjects Research*

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.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, 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.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under paragraph # 2 (above) if:
• the human subjects are elected or appointed public officials or candidates for public office, or
• federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4. Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or the information is recorded by the investigator in such a manner that the subjects cannot be identified directly or through identifiers linked to the subjects.

5. Research and demonstration projects which are conducted by or subject to the approval of (federal) department or agency heads and which are designed to study, evaluate or otherwise examine: (a) public benefit or service programs, (b) procedures for obtaining benefits or services under those programs, (c) possible changes in or alternatives to those programs or procedures or (d) 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, if:

• wholesome foods without additives are consumed or
• 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.

*Important Notes:
• UCI IRB registration is required for all exempt research.
"Existing" means at the time the research is proposed.
• These exemptions do not apply to research involving prisoners (45 CFR Part 46 Subpart C).
• Exempt, Category 2 does not apply to research with children (45 CFR Part 46 Subpart D) except for research
involving educational tests (cognitive, diagnostic, aptitude, achievement) or observations of public behavior when the researcher(s) do not participate in the activities being observed.

45 CFR 46.110 Categories of Research That May Be Reviewed through an

Expedited Review Procedure

Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
a. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

b. Research on medical devices for which (info) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
a. from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

b. from other adults and children, 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 or 3 ml per kg 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.*

Examples:
• hair and nail clippings in a nondisfiguring manner;
• deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
• permanent teeth if routine patient care indicates a need for extraction;
• excreta and external secretions (including sweat);
• uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing
• gumbase or wax or by applying a dilute citric solution to the tongue;
• placenta removed at delivery;
• amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
• supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is
• accomplished in accordance with accepted prophylactic techniques;
• mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth
• washings;
• sputum collected after saline mist nebulization.
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. 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.)
Examples:
• physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy;
• weighing or testing sensory acuity;
• magnetic resonance imaging;
• electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
• moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS 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 HHS 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.)

8. Continuing review of research previously approved by the convened IRB as follows:
a. where the research is permanently closed to the enrollment of new subjects; all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects; or

b. where no subjects have been enrolled and no additional risks have been
identified; or

c. where the remaining research activities are limited to data analysis.

9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two through eight do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

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