IRB-HSR PI Responsibilities

Plans for human research should reflect careful and unhurried consideration on the part of the Investigator, in terms of what questions he/she proposes to answer and the precise methodology needed to obtain those answers.

1. Follow the procedures listed under Submission Process.
2. If your study requires collaboration from another area, it is customary to name a person from that department as a sub-investigator.

YOU ARE RESPONSIBLE FOR ABIDING BY THE INVESTIGATOR'S AGREEMENT.
The points listed in the Investigator's Agreement are as follows:

• That no subjects will be recruited or entered under the protocol until the Investigator has received the signed IRB-HSR Approval Form.
• That any materials used to recruit subjects will be approved by the IRB-HSR prior to use.
• That any modifications of the protocol and/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.
• That any serious deviation from the protocol and/or consent form will be reported promptly to the committee in writing.
• That adverse events that are serious and unexpected will be reported promptly to the IRB-HSR.
• That the continuation status report for this protocol will be completed on request and returned within the time limit stated on the form.
• That if this study involves any funding or resources from an outside source, 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.
• That all subjects will sign a current copy of the consent form that has a non-expired IRB-HSR approval stamp.
• That the IRB-HSR office will be notified within 30 days of a change in the Principal Investigator or of the closure of this study.
• That no personnel will be allowed to work on this protocol until they have completed the IRB-HSR On-line training and the IRB-HSR has been notified.
• That all personnel working on this protocol will follow all IRB-HSR Policies and Procedures as stated on the IRB-HSR Website and on the School of Medicine Clinical Trials Office Website:  http://knowledgelink.healthsystem.virginia.edu/intranet/hes/cto/sops/sop_index.cfm

Revised 10-17-05