ABSTRACT
Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the full Board. The IRB will review certain categories of research through an expedited procedure only if the research involves no more than minimal risk to the subjects. Categories of research which may be considered for expedited review include the following:
Minor changes in previously approved research during the period covered by the original approval: a. Where the research is permanently closed to the enrollment of new subjects;
all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects; or
b. Where no subjects have been enrolled and no additional risks have been identified; or
c. Where the remaining research activities are limited to data analysis. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: a. From healthy, non-pregnant adults who weigh at least 110 pounds. For these
subjects, the amounts drawn may not exceed 550 m1 in an 8-week period and collection may not occur more frequently than 2 times per week; or
b. From other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 m1 or 3 m1 per kg in an 8-week period and collection may not occur more frequently than 2 times per week.
