Expedited Review Process
Expedited Review Process
An Expedited Review is conducted by RIC and at least 1 experienced IRB member designated by RIC or IRB chairperson to conduct the review. 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 IRB for Full Board Review. The reviewer may also refer other research protocols to the IRB for Full Board Review whenever the reviewer believes it warrants.
Once the review process is complete, a letter will be sent to the researcher notifying him/her of the result of the Expedited Review. The letter will include the specific category of review and expiration date. In addition, at the next convened IRB meeting, RIC will inform IRB members of research protocols, which have undergone an Expedited Review. A vote to approve the studies will be taken. Any member may request a study be reviewed by the IRB in accordance with Full Board Review procedures. A vote of the members shall be taken concerning the request and the majority shall decide the issue.
Ongoing IRB oversight is required for projects that undergo an Expedited Review. Any changes to a study require submission of an Amendment for IRB review and approval prior to implementing changes. Researchers of Expedited studies must submit a Continuing Review (Renewal) prior to the expiration date issued by the IRB. Any occurrence of an Unanticipated or Adverse Event must be promptly reported to the IRB.
Expedited Review Categories
Expedited review is applicable for research activities that involve no more than minimal risk to the human participants and fall into one or more of the nine expedited categories defined by the federal regulations.
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.
- 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)
- un-cannulated 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
- placenta removed at delivery
- amniotic fluid obtained at the time of membrane rupture prior to or during labor
- 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
- mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
- 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.)
- 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.
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).
- 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 category includes materials that were previously collected for either non- research or research purposes, provided that any materials collected for research were not collected for the currently proposed research.
- The phrase “…or will be collected solely for non-research purposes” pertains to the origin of the materials. For example, blood samples that were collected for a clinical test or the results of a course drivenexam given in a history class.
Collection of data from voice, video, digital, or image recordings made for research purposes.
Expedited Review does not apply if identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ 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.
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.
Examples of Commonly Expedited Research
The following types of research are commonly processed under Expedited Review:
- Studies involving the collection of identifiable information in surveys, interviews, or focus groups
- Studies involving collection of hair or saliva samples
- Studies of blood samples from healthy volunteers
- Studies involving the analyses of voice recordings
- Studies of existing pathological specimens or data with patient identifiers
The expedited review procedure cannot be used in the following circumstance:
- Where identification of the participants and/or their responses would reasonably place them 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.