Can research begin without IRB approval?

Can research begin without IRB approval?

• A. Only with sponsor consent.
• B. No.
• C. Yes.
• D. Only if risk is minimal.

Answer: (B)

Research involving people cannot start until the protocol has been reviewed and approved by an IRB or has an IRB-approved exemption determination. The IRB protects participants by ensuring risks are minimized, informed consent is truly voluntary and understandable, and privacy and data protections are in place. Sponsor consent or agreement does not replace this oversight, and even studies deemed minimal risk must obtain IRB review and an approval or exemption determination before any enrollment or interaction with subjects. If a study proceeds without IRB approval, it is noncompliant and could put participants at risk and compromise the study's integrity.

Research involving people cannot start until the protocol has been reviewed and approved by an IRB or has an IRB-approved exemption determination. The IRB protects participants by ensuring risks are minimized, informed consent is truly voluntary and understandable, and privacy and data protections are in place. Sponsor consent or agreement does not replace this oversight, and even studies deemed minimal risk must obtain IRB review and an approval or exemption determination before any enrollment or interaction with subjects. If a study proceeds without IRB approval, it is noncompliant and could put participants at risk and compromise the study's integrity.