General Institutional Review Board information

The University Institutional Review Board (IRB) meets twice monthly to review human subject w88 slot that presents greater than minimal risk to participants: on the 2nd and 4th Thursdays. Researchers are advised to submit projects for full board (above minimal risk study activity) review at leastthree weeksin advance of the meeting date for preliminary review to ensure clear and complete submissions to facilitate review at the meeting. Please see schedule for submission deadlines and IRB full board meeting dates.

w88 slot Integrity & Security staff assess each submission in IRBNet for completeness and to determine the requisite level of review.

Completeprojects/packages contain the following:

• Completed Part I Application or Cover Sheet (for new projects only)
• Completed Protocol – Social Behavioral Educational w88 slot and Records w88 slot or Protocol – Biomedical w88 slot; application to request a determination for human subject w88 slot, continuing review, amendments to approved projects, or to use an external IRB; application for emergency or expanded use drug/device or HUD; or problem report form
• Completed supplemental applications as applicable to the w88 slot (e.g., for w88 slot involving vulnerable populations, federal agency support or funding, blood/biological specimens, drugs, or devices)
• All applicable recruitment/consent documents
• All w88 slot instruments, data collection logs, or other materials relevant to the w88 slot
• Applicable committee approvals (e.g., biosafety or radiation safety committees, PRS Committee for VA w88 slot, Renown Clinical w88 slot Department)
• Completed IRB-requested changes or revisions (for follow-up, information requested, or revisions packages only)
• Completed signatures in IRBNet from the Principal Investigator and other signatory officials that may be needed (i.e., Responsible Official, Renown Clinical w88 slot Department, Saint Mary’s Signatory Official).

Projects/packages requiring Full Committee Review must be determined to be complete before these are placed on the agenda for review at a scheduled IRB meeting. Project/packages requiring Administrative, Exempt, or Expedited Review must be determined to be complete before these are forwarded for review. See IRB policy for information about500. Submission Types in IRBNet.

Full Board

• More than minimal risk to participants
• Not covered under other review categories

Example: Interventions involving physical or emotional discomfort or sensitive data

Expedited

• Not greater than minimal risk
• Fits one of the 7 expedited review categories

Example: Collection of biospecimens by noninvasive means, w88 slot with existing documents or records collected for non-w88 slot purposes where participants are identifiable

Exempt

• Less than minimal risk
• Fits one of the 6 exempt categories
• Fits additional Flex Policy* exemption

Example: w88 slot with de-identified records, anonymous surveys

Flex Policy

• For studies that are no greater than minimal risk
• For studies with no federal funding
• Provide equivalent protections to subjects commensurate with risk level