Investigators are asked to send a completed Human Subjects Review Form A, and an Exempt Review Form B or Expedited Review Form C, if applicable, to the Chair of the IRB seven business days in advance of the published meeting date. If the investigator is a student, the student must have his/her research advisor review and approve the proposal prior to submission to the IRB. The following questions must be addressed in the materials submitted for review:
Who are the investigators, including the faculty supervisor, for student research?
What is the research question and what is its significance/rationale?
When and where will the research be conducted?
Who are the subjects and how will they be recruited and assigned to experimental groups?
What specifically will the subjects be doing in the study? Include a copy or thorough description of the instruments and/or protocol(s).
What level of risk is involved? Use the categories: low or minimal risk, moderate risk, or high risk. If more than minimal risk is involved, a detailed explanation of the prospect of direct benefit to the individual subjects is needed. Moderate risk might include distress or significant fatigue during the task or need for extensive debriefing or explanation due to some deception involved in the research. High risk might include potential danger or more severe levels of distress due to participation in the research.
What procedures will be used for obtaining informed consent? How will subject confidentiality be protected? Include a copy of the consent form (and assent form for subjects under the age of 18).
What procedures will be used to provide feedback and/or debriefing to subjects following completion of their participation in the study?
The Chair of the IRB will review each proposal to determine the appropriate level of review (exempt, expedited, or full board review).
Research proposals that appear to be exempt will be reviewed by the Chair of the IRB or his/her designee. Research proposals meeting one or more of the categories listed on the Exempt Review Form will be exempt from further review and the investigator will be notified within ten business days of receipt of the proposal.
Research proposals not exempt from the review process but meeting one or more of the categories for expedited review will be reviewed by the Chair of the IRB or his/her designee and one additional IRB member. The investigator will be notified within ten business days of receipt of the proposal with one of the following categories of response: approved, approved pending changes, or disapproved (resubmit).
Research proposals requiring full board review will be reviewed and discussed at a regularly scheduled IRB meeting. A majority of IRB members must be present. Research proposals must be approved by a majority of the IRB members present at the meeting. The IRB will respond in writing to the investigator within ten business days of the scheduled meeting with one of the following categories of response: approved, approved pending changes, or disapproved (resubmit).