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 University 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 integrity and safeguarding of all collected data;
- 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;
- 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- Immediately notifying the IRB if a protocol is completed or withdrawn; and,
- Remaining aware of, and comply with the policies of the IRB at SRU.
IRB policies are subject to change. It is the responsibility of all researchers to be familiar with the current IRB policies.
The PI is required to submit a complete application packet to the IRB Office for review. Incomplete application packets will be returned. It is the responsibility of the PI to submit application packets to the IRB Office in order to maintain his/her project timeline.
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.
There are three levels of review: Exempt, Expedited and Full Board. The PI must decide and checkmark the review level on the IRB Application Form that best pertains to the intended research. The definitions for the review levels are as follows:
- Exempt from Further Review: Exempt from Further Review is defined as no risk to participants and includes research such as anonymous surveys.
- Expedited Review: Expedited Review is defined as minimal risk to participants and includes research such as surveys where participants can be identified.
- Full Board Review: Full Board Review is defined as more than minimal risk to participants. This includes research involving minors or other vulnerable participants as subjects.
Note: Research involving minors, pregnant women, prisoners and the intellectually and physically impaired requires Full Board Review.
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 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.
Forms (to access these files, please right click on the link and choose "save target as")
IRB Application Form
Change to Protocol Form
Adverse Event Form
Informed Assent (parents of minors)
Video/Audiotape Release Form
Retrospective Case Studies
Retrospective case study applications should include the Exempt from Full IRB Review Application Form, consent documents, and CITI training certificates for all investigators.
Retrospective Case Study Application Form