The SWAU-HSRB has two review categories. 1. STEP 1 - The chairperson of the HSRB will make an initial evaluation & classify the proposal as a.) Exempt or b.) Full Review. a. Exempt from Review: Studies which involve no risk to the subjects. Protocols submitted under this category are screened by the chairperson of the HSRB or a designee. If all application materials are complete and, if found to qualify as "no risk" research, these protocols will be approved without further review. Such protocols will receive a written response within five (5) working days. b. Full Review: All studies involving some risk to the subjects, even if the risk is minimal, or do not meet the criteria for Exempt-from-Review categorization. Such protocols will be reviewed by the entire HSRB- in-session, and must receive approval of the HSRB. Actions taken regarding such protocols may include one of the following four (4): (1) Full Approval (2) Conditional Approval (With monitoring of compliance and any needed revisions.) (3) Request for resubmission (With suggestions for modification) (4) Full Disapproval Protocols requiring Full Review will take up to thirty (30) days for written approval by the HSRB. (NOTE: Written approval for student-projects will be granted within fifteen (15) days.) 2. STEP 2 - The chairperson of the HSRB will notify the principal investigator and faculty advisor, in writing, of the decision regarding the protocol within 30 days of the initial filing of the proposal. RESEARCH INVOLVING HUMAN SUBJECTS CANNOT COMMENCE UNTIL WRITTEN NOTIFICATION HAS BEEN RECEIVED. 3. STEP 3 - HSRB-approval is valid for one calendar-year. In the event that the investigator(s) wishes to continue the research for a longer period of time, a request for an extension of approval must be submitted, no less than 30 days before the expiration date, to the HSRB. |