561. New Projects: Expedited Review

Updated July 13, 2021

Review of research by the expedited procedure is an alternative to review by the convened IRB for a limited class of research as specified by DHHS. The categories of research that may be reviewed using the expedited review procedure are listed at the end of this policy. For Expedited Review, one or more qualified IRB members are assigned to review a project outside of a convened IRB. In general, requirements and criteria to conduct review using the expedited procedure are identical to those for review by the convened IRB. Research Integrity staff may assign additional reviewers or a consultant if additional expertise is required (for more information, see the Human Research Protection Program (HRPP) Policy Manual for reviewer assignment).

New Project Review Materials

Expedited Reviewers complete a comprehensive review of all documents in the new project submission package (or those flagged for review by Research Integrity staff). The materials available for Expedited Review are the same as those required for Full Committee Review except for documents specific to greater than minimal risk research (e.g., plans for safety reviews). Specifically, the materials include:

  • The full protocol, application, or a protocol summary containing the relevant information to determine whether the proposed research fulfills the criteria for approval.
  • Proposed consent document.
  • Recruitment materials.
  • Topic Specific applications, (e.g., children, prisoners, international, etc.)
  • Permission site letters.

The materials in the submission package are sufficient to ensure the Expedited Reviewer can determine whether the research meets the DHHS regulatory criteria for approval, and any additional requirements under Subparts B, C, and D, other applicable federal agency regulations, and Nevada state law.

See the online HRPP Policy Manual for information about reviewer recommendations and documentation.

Expedited Review Evaluation of New Project Materials

  1. Expedited Reviewers evaluate new project materials submitted for initial review and confirm that:
    1. If the research appears on the list of expedited review categories, it is deemed to be no more than minimal risk;
    2. If research appearing on the expedited review list is greater than minimal risk, the reviewer documents the rationale for this determination and the rationale for review by the convened IRB.
  2. The research does not involve more than minimal risk;
  3. The research represents one or more approvable categories of expedited research, as listed below.
  4. The research does not include activities where identification of the participants or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the participants’ 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.
  5. The project does not involve classified research.
  6. When research involves vulnerable populations, additional safeguards have been included in the study to protect the rights and welfare of these participants.

Expedited Review Actions

The range of IRB Actions for Expedited Review of new projects include Approved, Approved with Conditions, and Deferred. If the Expedited Reviewer determines a project may not be approvable, the project is placed on the agenda for Full Committee Review. Expedited reviewers are prohibited from disapproving research.

Before approving a new project under expedited review procedures, Research Integrity staff or designated IRB member confirms the research meets the criteria for Expedited Review under the DHHS expedited categories and Flex-Exempt under the University IRB Flexibility Policy. Research Integrity staff members are experienced and serve as members of the IRB. The assigned reviewer may determine that the study does not meet the expedited category or determine that the new project should be reviewed as an exempt or scheduled for Full Committee Review at the next convened IRB meeting.

NOTE: Following notification of the expedited review determination, if the researcher disagrees with the recommendations or requested revisions, the project/package may be placed on the agenda for Full Committee Review.

Determining Approval Periods for New Projects

Generally, the approval period for projects approved by Expedited Review is one year. Shorter approval periods are only required when participant risks are determined to be frequent or severe, or greater than minimal risks are not justified by the benefits of the research. Under either of these conditions, the project would not be eligible for Expedited Review.

Expedited Review Criteria

Category 1

Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

  1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (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.)
  2. 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.

Category 2

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 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.

Category 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

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 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.

Category 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 participant or an invasion of the participant’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.

Category 5

Research involving materials (data, documents, records, or specimens) that:

  • have been collected for nonresearch purposes (such as medical treatment or diagnosis), or
  • will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).

(Some research in this category may be exempt from the DHHS regulations for the protection of human participants.)

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.

Category 8

Continuing review of research previously approved by the convened IRB as follows:

  • the research is permanently closed to the enrollment of new participants;
  • all participants have completed all research-related interventions; and 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

Continuing review is not required for research reviewed using the expedited procedure, and the IRB must provide justification for conducting continuing review of research deemed to meet expedited criteria.

Category 9

Continuing review of research, not conducted under an investigational new drug application or investigational device exemption, where categories two (2) through eight (8) 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 identifi