New Application:

Research activities in which the involvement of human participants involve no more than minimal risk and falls within one or more of the expedited review categories may be eligible for expedited review.  Expedited reviews are for projects that do not meet the criteria for exempt status, and fall into one 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, non-pregnant adults who weigh at least 110 pounds. For these participants, 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 participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, 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 gumbase 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 including studies of cleared medical devices for new indications.) are not generally eligible for expedited review,
• 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 participants. 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.
• 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 participants. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
• Continuing review of research previously approved by the convened IRB as follows:
  • where (i) the research is permanently closed to the enrollment of new participants; (ii) all participants have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of participants; or
  • where no participants have been enrolled and no additional risks have been identified; or
  • where the remaining research activities are limited to data analysis.

Only the IRB may decide whether the proposed research meets the expedited review criteria requirements. 

Under the expedited review process, the IRB reviewers may take one of the following actions:   

• Approve the research application and decide on the length of time the study is approved (one year or less); the PI is then sent a letter of approval.
• Require additional information or modifications.  The IRB Chairperson or designee will contact the PI  to request the required additional information or modification(s).  The reviewers may decide that one or both of them need to review the additional information or modifications.  If the reviewers are satisfied that the protocol meets the IRB review criteria, the research project is approved for one year or less and a letter of approval is sent to the PI.
• Require a full review of the application.  If the protocol does not fall within one or more of the expedited review categories, the reviewers have concerns about the rights and welfare of the participants, or the additional information or modifications are extensive, the reviewers will forward the application for a full review.  The PI will be notified in writing that a full review is required and will be informed of the reasons for this decision.  Additionally, the PI may be asked to revise the application prior to distribution of the application to the full IRB committee.

Modification Request:
The PI must request approval for any proposed modifications to the research project’s protocol or informed consent or assent forms.  The modifications must be approved by the IRB Chairperson prior to implementation.  If the Chairperson determines that (a) proposed revisions modify participant risk significantly and/or (b) change the basic nature of the research project, the Chairperson will direct the PI to submit an entirely new application for consideration by the Board.

Continuation Request:
Research projects, which are approved under the expedited review process, will require continuation review at a specified interval, which will not exceed one year.  If the PI fails to request a continuation or submit requested information, IRB approval will be terminated on the approval expiration date.  All research activities, including data analysis, must cease, unless the IRB finds it is in the best interest of the individual participants to continue participating in the research interventions or interactions. 

Informing IRB members of Expedited Reviews:
At each regular IRB meeting, the IRB Chairperson will make available to the IRB a list of new research applications, modification requests, and continuation requests that have been submitted or approved through the expedited review process.