Responsibilities of the Principal Investigator
The person who has the primary responsibility for the conduct of the research is the Principal Investigator (PI). All communications from the IRB Office will be with the project's PI. All forms must be signed by the PI. Students are NOT permitted to be PIs, but are required to have a SRU faculty or staff member supervise the research. Student researchers should be listed as co-investigators.
It is the responsibility of the PI to complete and submit the application materials to the IRB Office in order to maintain his/her project timeline. PI’s are required to inform the IRB Office of any changes to approved research and any adverse events or unanticipated problems.
PI’s are responsible for the following:
Managing the development of the project in accordance with accepted scientific standards
Ensuring the project review of all human participant research by the IRB prior to the initiation of the study
Ensuring that participants in research be apprised of all risks and benefits so that their consent to participate is based on pertinent information
Assuring project adherence to approved research protocols and policies
Ensuring the integrity and safeguarding of all collected data
Remaining aware of, and comply with the policies of the IRB at SRU
Notifying the IRB of any changes made to the protocol and or participant consent process/document
Reporting any potential changes in the risk/benefit ratio that are manifested/discovered during the research process
Meeting the continuing review requirements established by the IRB
Reporting all serious and adverse effects encountered during the investigation to the IRB
Immediately notifying the IRB if a protocol is completed or withdrawn
IRB policies are subject to change. It is the responsibility of all researchers to be familiar with the current IRB policies.
The Role of Co-Investigators and Research Assistants
Co-Investigators are key personnel who have responsibilities similar to that of a PI on research projects. While the PI has ultimate responsibility for the conduct of a research project, the co-investigator(s) is also obligated to ensure the project is conducted in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research.
All co-investigators are required to be listed on the IRB Application Form and also to sign the form as the co-investigator(s). Co-investigators are also required to complete the CITI Online Training Program.
Research Assistants are individuals who are involved on the project, but are not crucial to conducting the research. For example, they can assist in collection and input of data into a database or serve as an aide to the investigators. However, they cannot consent or enroll participants in the research project.
Research Assistants are not required to be listed on the IRB Application Form, nor are they required to complete the CITI Online Training Program.
- The PI is required to submit a complete application packet to the IRB Office for review. Incomplete application packets will be returned.
- Once a complete application packet is received, a protocol file will be created and a protocol-specific number will be assigned.
- All communications with the IRB Office regarding specific protocols must include the protocol number.
- Approved research is required by Federal regulations to be reviewed at least annually. The PI will be contacted by the IRB Office at least one month prior to the expiration date of his/her research. At that time, the PI must complete the Progress/Final Report Form and submit all necessary reports to the IRB Office prior to the expiration date.
- Once a project expires, it will be closed, which means no participants may be enrolled and no data may be collected or analyzed. If the PI desires to continue the research once the protocol has been closed, a new protocol must be submitted to the IRB Office for approval.