3. Principal Investigators, including those who are also IRB members, may offer information and answer questions about their protocols at a convened meeting, but may not be present during voting (even if this means being unable to continue the meeting because of quorum requirements). 4. Although convened meetings of the IRB are open to the public, materials submitted for review, discussions of protocols, and individual votes are considered confidential and should not be discussed outside of the meeting context. If during an IRB meeting the Chair moves the meeting to executive session then any visitors will be asked to leave the room until the executive session has ended. E. Appeals The PI may appeal the decision of the IRB when a protocol has been disapproved or approved subject to restrictions and mutual agreement cannot be reached as to an acceptable alternative. Upon written notification of appeal from the PI, the IRB shall name an committee of three or more faculty and/or consultants to review the ad hoc protocol a second time. The committee members must be acceptable to both the ad hoc PI and the IRB. The protocol will be reviewed in accordance with the guidelines established herein and the decision of the committee will be referred to the IRB. ad hoc The PI will be promptly notified of actions of the committee and final action by ad-hoc the IRB. Final disapproval of the IRB cannot be overridden by any institutional official. F. Amendments 1. Amendments are categorized into minor changes and significant changes. Minor modification/change - A proposed change in research related activities that does not significantly affect an assessment of the risks and benefits of the study and does not substantially change the specific aims or design of the study. Significant modification/change - A proposed change in research related activities that significantly affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study. Examples of changes to a research study include but are not limited to, the following: Addition or deletion of study team members; Addition of procedures that do not significantly increase risk to subjects, considering the original purpose and study design of the approved study; Removal of research procedures that would thereby reduce the risk to subjects; Addition of non-sensitive questions to unvalidated survey or interview procedures; Addition of or revisions to recruitment materials or strategies; Administrative changes to the approved documents (e.g., correction of spelling, grammatical or typographical errors).
3. Principal Investigators, including those who are also IRB members, may offer information and answer questions about their protocols at a convened meeting, but may not be present during voting (even if this means being unable to continue the meeting because of quorum requirements). 4. Although convened meetings of the IRB are open to the public, materials submitted for review, discussions of protocols, and individual votes are considered confidential and should not be discussed outside of the meeting context. If during an IRB meeting the Chair moves the meeting to executive session then any visitors will be asked to leave the room until the executive session has ended. E. Appeals The PI may appeal the decision of the IRB when a protocol has been disapproved or approved subject to restrictions and mutual agreement cannot be reached as to an acceptable alternative. Upon written notification of appeal from the PI, the IRB shall name an ad hoc committee of three or more faculty and/or consultants to review the protocol a second time. The ad hoc committee members must be acceptable to both the PI and the IRB. The protocol will be reviewed in accordance with the guidelines established herein and the decision of the ad hoc committee will be referred to the IRB. The PI will be promptly notified of actions of the ad-hoc committee and final action by the IRB. Final disapproval of the IRB cannot be overridden by any institutional official. F. Amendments 1. Amendments are categorized into minor changes and significant changes. Minor modification/change - A proposed change in research related activities that does not significantly affect an assessment of the risks and benefits of the study and does not substantially change the specific aims or design of the study. Significant modification/change - A proposed change in research related activities that significantly affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study. Examples of changes to a research study include but are not limited to, the following: Addition or deletion of study team members; Addition of procedures that do not significantly increase risk to subjects, considering the original purpose and study design of the approved study; Removal of research procedures that would thereby reduce the risk to subjects; Addition of non-sensitive questions to unvalidated survey or interview procedures; Addition of or revisions to recruitment materials or strategies; Administrative changes to the approved documents (e.g., correction of spelling, grammatical or typographical errors).
Institutional%20Review%20Board%20Charter.docx