Human Subjects Research
Do I need approval from the Institutional Review Board (IRB)?
According to 45 CFR 46.102(d), research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. All research activities involving the use of human beings as research subjects (participants) must be reviewed and approved by the Institutional Review Board (IRB).
Human subjects review is designed to protect participants and researchers by ensuring ethical research design and practice. Even though investigators are ultimately responsible for ensuring that the rights and the welfare of human subjects participating in research activities are protected, and that the methods used and information provided to gain subject consent are appropriate to the research, the IRB process assists investigators in this responsibility. For this purpose, investigators may not solicit subject participation or begin data collection until they have received written approval.
IRB Application Review Process
IRB approval is required before research can begin (including recruitment). Studies which qualify for approval under expedited review or exempt status are thoroughly reviewed by the IRB Chair or a member of the IRB committee appointed by the Chair as the applications are received. Protocols determined to require review by the full IRB (i.e., protocols that do not qualify for expedited review or exempt status) will be scheduled for the next regularly scheduled IRB meeting.
The full IRB has a meeting scheduled each month. Proposals requiring full board review are reviewed at the monthly meetings. To be included on the agenda, proposals requiring full board review must be received by 4:30 PM on the last day of the previous month. For example, proposals must be received by 4:30 PM on October 31 to be on the agenda for the November meeting.