Investigator Responsbilities

Principle Investigators must:

• Manage the development of the project in accordance with accepted scientific standards.
• Insure the integrity and safeguarding of all collected data.
• Ensure project review of all human participant research by the University IRB, prior to the initiation of the study.
• Ensure that participants in research be apprised of all risks and benefits so that their consent to participate is based on pertinent information.
• Assure project adherence to approved research protocols and policies.
• Notify the IRB of any changes made to the protocol and or participant consent process/document.
• Report any potential changes in the risk/benefit ratio that are manifested/discovered during the research process.
• Meet the continuing review requirements established by the IRB.
• Report all serious and adverse effects encountered during the investigation to the IRB.
• Immediately notify the IRB if a protocol is completed or withdrawn.
• Remain aware of, and comply with the policies of the IRB at ESU.
• Provide documentation of completion for required educational module for the Protection of Human Subjects.