Federal Guidelines allow certain types of research to be reviewed using "expedited" procedures (see eligibility criteria below). Protocols that are reviewed via an expedited process are evaluated by the same ethical standards and must meet the same approval criteria as those that receive full IRB review. Thus, the same general Application for IRB Review must be submitted when applying for expedited review. However, the review process does not require discussion at a convened IRB meeting.
How is Expedited Review Conducted?
Applications are submitted through the online Compliance Approval Portal (CAP) system, and are reviewed by either the IRB Chair or the IRB Vice-Chair on a rolling basis. The assigned Expedited Reviewer reviews the Application for IRB Review to verify that the Protocol both qualifies for Expedited Review and meets the criteria for IRB Approval.
What Type of Research Qualifies for Expedited Review?
In order to be eligible for expedited review, a research protocol must meet the criteria outlined below. If a study meets these criteria, the investigator may request an expedited review. However, the IRB member conducting the expedited review will make the final determination about whether a study fits the criteria and is eligible for this review mechanism. If a protocol is submitted for expedited review but is not eligible, the investigator must submit additional copies so that the protocol can be reviewed through the Full Board process. To avoid valuable time being lost, investigators are urged to consider carefully whether their project satisfies the criteria for expedited review. If an investigator is uncertain about whether a study is eligible for expedited review, the investigator is welcome to consult with the IRB Chair or Compliance Manager.
In determining whether a project is eligible for review under the Lakeside IRB expedited review procedure, the a) level of risk, b) the nature of the participant population, and c) type of research procedures must be considered.
- Level of Risk
To be eligible for expedited review, research must involve “minimal risk” to participants. Federal regulations define “minimal risk” as follows: “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” (45 CFR 46.102).
In deciding whether to request expedited review, the researcher must make an initial determination that the study involves “minimal risk” to participants. Ultimately, however, the Expedited Reviewer will determine the risk level of the proposed research. If the Expedited Reviewer determines that the Protocol involves greater than minimal risks the Protocol must be reviewed at a Full Board IRB Meeting.
- Nature of Participant Population
Studies using the following populations may not be reviewed under the expedited procedures:
- Mentally Disabled
- Participants with whom the researcher has another relationship which is of a supervisory or authoritarian nature (e.g., administrator-teacher, teacher-student, psychotherapist-client, supervisor-employee, doctor/nurse-patient, professional-client, parole officer-parolee)
- Research Procedures
For minimal risk research, Federal Regulations designate certain categories of research procedures as being eligible for expedited review. According to Federal Regulations, the seven “Expedited Review Categories” listed below represent research procedures which may be reviewed through an expedited process. Minimal risk research involving only the following procedures may qualify for expedited review: (If a project involves any procedures that do not fall in these categories, it does not qualify for expedited review).
Expedited Review Categories
In order for research to be approved via Expedited Review, all research procedures must fall into one or more of the following categories.
Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
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.)
Research on medical devices for which (i) 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:
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
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.
Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring 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 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; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
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: (a) 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; (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; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
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.)
Collection of data from voice, video, digital, or image recordings made for research purposes. NOTE: This refers to recordings that are not in the public domain and that are made for research purposes under an IRB approved research protocol.)
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.
How do I Apply for Expedited Review?
All applications are to be completed through the CAP system. The application includes a section for Investigators to indicate the Review Mechanism they believe their research qualifies for. In order to apply for Expedited Review, an Investigator should select the Expedited Review option.
How long does an Expedited Review take?
Typically the IRB is able to provide Investigators with the review outcome of an Expedited Review within 15 business days of when the Application was submitted for review. Investigators will be sent an email notifying them of the review outcome.
What are the possible outcomes of an Expedited Review?
An IRB member conducting expedited review has the authority to request additional information, to approve a project, to conditionally approve a project and specify conditions of approval, or to table a project for re-review. They do not, however, have the authority to disapprove a project. Expedited reviewers must refer any project which they would have disapproved to the full IRB. They may also refer any project to the full IRB if, in their judgment, full review is warranted.
Although protocols reviewed and approved under the expedited procedure are not generally discussed at convened IRB meetings, all IRB members are advised of research protocols that are approved through the expedited review process. At a convened IRB meeting any IRB member may request that a protocol that has been approved under the expedited procedure be reviewed by the IRB under non-expedited procedures. Investigators should also be aware that certain funding agencies may require that research be reviewed by the full IRB.