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RESPECT FOR PERSONS, BENEFICENCE, AND JUSTICE

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Review Process

There are three categories for review by the IRB: Exempt, Expedited, and Full. Only the IRB Chair gets to make the designation that a project falls into one of these categories. You may be reviewed under one category at the start of your project, and in another during the continuing review process.

Exempt Projects

Exempt Projects include research activities that (1) present no more than minimum risk to human participants, and (2) involve only procedures in one or more of the Exempt Categories are exempt, UNLESS the research involves a protected class:  fetuses, pregnant women, children, human in vitro fertilization, or prisoners (or any combination therein).

  • Exempt projects fall into one of the categories listed below. They contain minimal risk and do not use a protected class as their subjects. (45 CFR 46.101b).
    1. Research conducted involving normal educational practices;
    2. Research involving the use of educational tests, survey, interview, or observation of public behavior, unless:  (i) information can be linked to the participants; and (ii) disclosure of information will place participants at some risk;
    3. Research involving the use of educational tests, survey, interview, or observation of public behavior that is not exempt under (b) above, if participants are elected or appointed public officials or candidates for public office;
    4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information cannot be linked to the participants;
    5. Research and demonstration projects conducted by or subject to the approval of US Government Agencies, and designed to study, evaluate, or otherwise examine public benefit or service programs; and,
    6. Taste and food quality evaluation and consumer acceptance studies that meet safety requirements set forth by government agencies or local laws.

Exempt projects are reviewed by the chair and exempt letters are issued within 5 working days during the academic year.

Expedited Projects

Expedited Projects can involve some medical procedures or discussions of health related issues, research with a protected class, the collection of data from recordings including voice, video or images, or research on individual or group characteristics or behavior using surveys, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

These projects are not considered under the EXEMPT category because they can be considered invasive even if the procedures being used are part of a routine medical exam or routine pedogological practice. Extra care needs to be taken with projects that are deemed expedited because it becomes impossible to shield the participants entirely and their identities may become known. If a proposal is considered under expedited review, two reviewers may be assigned by the chair to review the project or the chair may decide to review and a decision can be expected within 10 working days.

Category 1:  Clinical studies of drugs and medical devices only when (a) the research is on drugs for which an investigational new drug application (21 CFR 312) is not required or (b) the research is on medical devices for which (i) an investigational device exemption application (21 CFR 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.

Category 2:  Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from (a) healthy, non‑pregnant adults who weigh at least 110 pounds for whom (i) the amounts drawn do not exceed 550 ml in an 8 week period and (ii) collection does not occur more frequently than 2 times per week or (b) other adults and children, for whom, considering the age, weight, and health of the participants, and the collection procedures, (i) the amount of blood to be collected does not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and (ii) collection does not occur more frequently than 2 times per week. (Note: Children are defined as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.")

Category 3:  Prospective collection of biological specimens for research purposes by noninvasive means, including, but not limited to: (a) hair and nail clippings, in a non‑disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care  indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and  external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during  labor; (h) supra‑ and sub- gingival 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;  (i) mucosal and skin cells collected by buccal scraping or swab,  skin swab, or mouth washings; and (j) sputum collected after saline mist nebulization.

Category 4:  Collection of data through non‑invasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x‑rays or microwaves. Such procedures include, but are not limited to: (a) physical sensors that are applied either to the surface of the body at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; and (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing  where appropriate given the age, weight, and health of the individual. (Note: Where medical devices are employed, they must be cleared/approved for marketing.)

Category 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).

Category 6:  Collection of data from voice, video, digital, or image recordings made for research purposes.

Category 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.

Full Review

Full review is required for initial applications that are not eligible for exempt or expedited review, initial applications that involve more than minimal risk, revisions that are non-minor changes, renewals of projects that initially required full board and disapproval of a project, regardless of review level. Prior to IRB review at a meeting, a primary review procedure is used for full review projects. It is important to note that while a primary review procedure is used, in order for the research to be approved, a majority of members present at the convened IRB must vote for approval of the research project.

Additionally, the process for IRB full reviews is somewhat different than an exempt or expedited review. Some additional steps are required including:

(a) Research protocols scheduled for review shall be distributed to all members of the IRB prior to the meeting.
(b) The IRB may invite consultants or experts to advise the IRB in its review of a protocol.
(c)  A majority of the membership of the IRB constitutes a quorum and is required in order to convene a meeting for the review.
(d) For a research protocol to be approved, it must receive the approval of a majority of those members present at the convened meeting.
(e)  An IRB member will not participate in the IRB's review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
(f) In cases where research protocols were initially approved under expedited procedures and subsequently reviewed by non-expedited procedures, the decisions reached at the convened meeting shall supersede any decisions made through the expedited review.

In all cases of review, the IRB will notify research investigators and IRB Notification to research investigators and the Associate Provost for Research of its decision. In case of disapproval, the IRB shall provide to the research investigator reasons for disapproval and an opportunity for the research investigator to respond. The IRB shall submit a copy of its decision to the Associate Provost for Research or his/her designee for final approval. The Associate Provost for Research may not approve protocols that have been disapproved by the IRB.

Continuing Review

The IRB is required to perform continuing review or re-evaluations of all approved research studies that extend for the period of a year or more. The purpose of the continuing review is to assure that initial judgments by the researcher and the IRB regarding research results, risk/benefits ratios, and procedures were correct and have not significantly changed. The IRB will inform the researcher of the date for the subsequent review at the time of approval of the initial review in the award letter.
In general, research studies that received approval based on full or expedited reviews will be re-evaluated no later than one (1) year from initiation of research activities.

Research studies that initially received an exempt approval will be reviewed every three (3) years.  Applying for a continuing review involves submitting the Continuing Review Application for Research Involving Human Participants on IRBNet along with any additional required documentation.