knowledge of the populations that are the focus of the study. All ad hoc or cultural consultants will have access to the same information in the IRB review process as voting IRB members. However, consultants will not vote on protocols.

No IRB member, including the primary and secondary reviewers, may participate in the review of any project in which the member has a conflict of interest or vote on any project in which the member has a conflict of interest. It is the responsibility of each IRB member to recuse themselves in cases of conflict of interest.

IRB members may consult with the IRB Chair and OSP staff to determine if a conflict of interest exists. OSP staff will ensure that ad hoc or cultural consultants do not have a conflict of interest related to the project under review.

An IRB member makes a motion, another member seconds the motion, and then the convened IRB votes for, against, or abstains from one of the following five actions:

APPROVED. IRB approval indicates the IRB has concluded that the research and consent/assent forms meet the federal criteria for approval. IRB approval verifies that the IRB agrees with the assessment of the protocol and/or specific findings as described in the application. OSP staff process the approval, and the researcher is provided with an approval letter and, if applicable and practicable, stamped informed consent/assent documents.

MINOR REVISIONS and/or ADDITIONAL INFORMATION REQUIRED. This decision indicates that the IRB has approved the protocol pending submission of minor revisions and that the IRB has given the primary reviewer the authority to approve the minor revisions. OSP staff generates an email requesting revisions and returns the submission to the investigator. The investigator responds to the IRB's suggested revisions, making relevant changes in the application and re-submits to the OSP. OSP staff then provides the revised application to the primary reviewer. The reviewer may defer the response to a convened meeting for review by the full IRB, request additional information, or approve the protocol.

TABLED. This decision indicates that the IRB withholds approval pending submission of major revisions and additional information. OSP staff drafts a letter and returns the submission to the investigator, outlining the reasons for tabling the protocol, and includes a description of the revisions or clarifications requested. For some studies, the IRB may appoint one or more members of the IRB to discuss the reasons with the investigator. In cases where the IRB decides to table discussion of an application, the IRB may also vote to invite the researcher requesting approval to a future meeting of the IRB in which the researcher will discuss or answer IRB concerns or questions. OSP will be responsible for extending the invitation to the researcher to attend the meeting and providing a list of the