Expedited Review

I. Expedited Review Policy

  A. Appointment of Expediting Reviewers

    1. Expedited review may be carried out by the Human Subjects Committee Chairperson or by one or more members of the Committee designated by the Chairperson.

    2. Members so designated must be experienced reviewers, and will usually have served one year or more on the Human Subjects Committee.

  B. Authority of Expediting Reviewers

    1. In reviewing the research, the expediting reviewer may exercise all of the authorities of the Human Subjects Committee, including

      a. approving the use of human subjects in the research, or

      b. requiring modifications in the protocol or consent form (to secure approval).

    2. Exception: The reviewer may not disapprove the research. A research activity may be disapproved only after review in accordance with non-expedited procedures.

II. Application for Expedited Review of Research

  A. Form 112f , the Application for Approval of Activity Involving the Use of Human Subjects, is to be used for research to be reviewed by either expedited or full board review procedures.

  B. The application form should be completed in the same manner and in the same detail for full board review as for expedited review. Consent procedures must be described, and a copy of the consent form OR the subjects' information sheet (description of study where documentation is waived) is to be attached to each copy of Form 112f.

  C. The original plus three copies are required. It should be noted that, if it is determined that the application must have full board review procedures, additional copies will be necessary.

  D. The application should be submitted to the Office of Research, 3227 Cheadle Hall.

III. Disposition of Applications for Expedited Review

  A. The Committee Coordinator will review and identify research that fits the criteria for expedited review, secure approval, request modification or direct it to the next scheduled meeting of the HSC.

  B. Copies of applications approved by expedited procedures will be distributed to the investigator and his/her department. When the investigator is a student, a copy will also be sent to the faculty member responsible for the student's research.

  C. A list of research activities approved through expedited procedures will be included in the agenda for each regular meeting of the Human Subjects Committee. The list shall include the title of the activity, investigator's name and department, and any other relevant information for each such activity not previously listed.

IV. Criteria for Expedited Review of Research

  A. The Human Subjects Committee may use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized (usually, one year from the most recent approval).

  B. The expedited review procedure may be used to review research that involves no more than minimal risk and in which the only involvement of human subjects will be in one or more of the following categories (carried out through standard methods):

     1. Collection of:

      a. hair and nail clippings, in a non-disfiguring manner;

      b. deciduous teeth; and

      c. permanent teeth if patient care indicates a need for extraction.

    2. Collection of excreta and external secretions including:

      a. sweat

      b. uncannulated saliva,

      c. placenta removed at delivery, and

      d. amniotic fluid at the time of rupture of the membrane prior to or during labor.

(NOTE: UCSB Biosafety Committee's regulations concerning the handling of bodily fluids must be followed when using the above and related procedures. Please contact the Biosafety Committee directly for details.)

    3. Recording of data from subjects 18 years of age or older using noninvasive 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 of matter or significant amounts of energy into the subject or an invasion of the subject's privacy.

 It also includes such procedures as:

      a. weighing,

      b. testing sensory acuity,

      c. electrocardiography,

      d. electroencephalography,

      e. thermography,

      f. detection of naturally occurring radioactivity,

      g. diagnostic echography, and

      h. diagnostic electroretinography.

 It does not include exposure to electromagnetic radiation outside the visible range (e.g, 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 and who are in good health and not pregnant. (NOTE: All blood-drawing requires a licensed phlebotomist and adherence to the UCSB Biosafety Committee's regulations concerning the handling of bodily fluids. Please contact the Biosafety Committee directly for details.)

    5. Collection of both supra- 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 the subjects.

    10.Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.