Summary: INSTITUTIONAL REVIEW BOARD FOR HEALTH SCIENCES RESEARCH OF THE UNIVERSITY OF VIRGINIA
Title of Study:
BY SIGNING THIS DOCUMENT, THE INVESTIGATOR AGREES:
1. That no subjects will be recruited or entered under the protocol until the Investigator has received the signed
IRB-HSR Approval form stating the protocol is open to enrollment
2. That any materials used to recruit subjects will be approved by the IRB-HSR prior to use.
3. That any modifications of the protocol or consent form will not be initiated without prior written approval from the
IRB-HSR, except when necessary to eliminate immediate hazards to the subjects.
4. That any serious deviation from the protocol will be reported promptly to the Board in writing.
5. That adverse events that are serious and unexpected will be reported promptly to the Board.
6. That the continuation status report for this protocol will be completed and returned within the time limit stated on
7. That if this study involves any funding or resources from an outside source, or if you will be sharing data outside
of UVA prior to publication that you will contact the Dean's office regarding the need for a contract and letter of
indemnification. If it is determined that either a contract or letter of indemnification is needed, subjects cannot be
enrolled until these documents are complete.
8. That all subjects will sign a copy of the most current consent form that has a non-expired IRB-HSR approval