Protocol Personnel must be listed on the protocol and must take prerequisite human subjects research training.

Protocol Personnel are Investigators and all researchers who interact (includes intervention and interaction with participants or involvement with the informed consent process) with participants or who obtain or access their identifiable private information.

An Investigator is defined as the Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of funded research, or proposed for such funding, which may include, for example, graduate research assistants, collaborators, or consultants.

 

*All Protocol Personnel must have appropriate human subjects training on file before the protocol may be approved or prior to new personnel beginning work on an existing protocol. 

*Faculty Advisors who oversee student research are also considered Protocol Personnel. 

*See more details from the Office for Human Research Protections about Who are "investigators"? 

TOPAZ Definitions

Primary Investigator (PI)

The PI is the lead researcher who has primary responsibility for the overall design, conduct, and management of the study. This includes ensuring compliance with all regulatory requirements and IRB guidelines, obtaining informed consent, and ensuring the protection of participants. The PI has the ultimate authority and accountability for the research project, including the submission of documents to the IRB and responding to any queries or issues that arise during the study. The PI is typcially a senior researcher with substantial experience and expertise in the area of study.

Co-Investigator (Co-I)

Co-investigators assist the PI in conducting the research. They may take on significant portions of the project, such as specific methodological tasks, data collection, or analysis. While Co-Is support the PI and may have delegated responsibilities, they do not hold the primary accountability for the project. The PI remains ultimately responsible. Co-Is are usually qualified researchers who can independently perform their assigned tasks but operate under the guidance and oversight of the PI.

Key Associate

Key Associates are individuals who play a significant role in the research project but do not have the title or responsibilities of a PI or Co-I. This could include data managers, statisticians, or other specialists who contribute criticial expertise or support. Key Associates do not typically have decision-making authority over the study's design or conduct but provide essential contributions to the project's success. They are selected based on their specialized skills or knowledge that are crucial for the study.

 

Regardless of the three named titles above, all should be listed on the protocol.