Appendix C

 

 

Criteria for Expedited Review

 

 

 

 

Research activities in which the risk is minimal and in which the only involvement of human subjects will be in one or more of the categories listed below will be scheduled for expedited review. In this procedure, three members of the IRB review the project and vote for (a) approval, (b) approval pending modifications, or (c) disapproval. If two out of three reviewers vote for disapproval, the project must go to the full board for review. The “Request for IRB Review” form should be used to submit a project for review in the expedited category. Requirements for annual review, informed consent, and informed assent all apply.

 

 The Following Examples Meet the Criteria for Expedited Review:

  1. Collection of hair and nail clippings, in a non- disfiguring manner, deciduous teeth; and permanent teeth of patient care indicated a need for extraction.
  2. Collection of excretal and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
  3. Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input or matter or significant amounts of energy into the subject or an invasion of the subjects’ privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).
  4. collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older who are in good health and not pregnant.
  5. Collection of both supragingivival and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
  6. Voice recordings made for research purposes such as investigations of speech defects.
  7. Moderate exercise by healthy volunteers.
  8. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
  9. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects’ behavior and the research will not involve stress to subjects.
  10. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
Expedited review is granted when three IRB members have studied an abstract of the proposed research and agree that human subjects have been protected. They will inform the Dean of Graduate Studies and Research of their findings, and the approval will be recorded in the minutes of the next IRB Meeting.