What qualifies for expedited review?
Protocols that present no more than minimal risk to subjects and include only procedures described in nine specific categories of research (available online at:http://www.hhs.gov/ ohrp/humansubjects/guidance/expedited98.htm) may qualify for expedited review. Expedited review requires all of the same considerations by the IRB as protocols that require full committee review. However, expedited review can be done by one or more designated reviewers.
Protocols that present no more than minimal risk to subjects and include only procedures described in nine specific categories of research (available online at: http://www.hhs.gov/ ohrp/humansubjects/guidance/expedited98.htm) may qualify for expedited review. Expedited review requires all of the same considerations by the IRB as protocols that require full committee review. However, expedited review can be done by one or more designated reviewers.
Protocols that present no more than minimal risk to subjects and include only procedures described in nine specific categories of research (available online at: http://www.hhs.gov/ ohrp/humansubjects/guidance/expedited98.htm) may qualify for expedited review. Expedited review requires all of the same considerations by the IRB as protocols that require full committee review. However, expedited review can be done by one or more designated reviewers. • What changes require approval by the IRB after the protocol is approved? Any proposed change to the protocol procedures (including subject selection, and consent process), consent personnel, documents (including recruitment ads, investigator brochure and/or study instruments) must be submitted to the IRB for review and approval prior to implementation. Any other changes that may affect a participant’s willingness to participate in the study must also be submitted for prospective IRB review. The only time that a change may be implemented wit
