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.
- Follow the procedures listed under Submission Process.
- 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