Possible Outcome of Review - After review, the IRB must take one of the following possible actions:

a. Approve - An approval is granted if the research activity meets the criteria for approval as stated above in Item 4 and no changes are recommended to the research proposal.

b. Approve Pending – CPHS may approve a protocol pending specific non substantive modifications. The Principal Investigator’s response may be reviewed through an expedited procedure.

c. Defer - When the convened board requests substantive modifications or clarifications directly relevant to the criteria of approval stated above in Item 4, IRB approval of the proposed research is deferred to review of the Principal Investigator’s responses by the Full Board.

d. Disapproval: CPHS may disapprove a research proposal if the proposal does not meet the criteria for approval as stated above in Item 4. If the IRB decides to disapprove a research activity, the ORSC staff will include in a written notification a statement of the reasons for the CPHS decision via iRIS and give the investigator an opportunity to respond in person or in writing.