Roles of Students and Other Personnel on IRB Studies/Submissions

Summary

The purpose of this guidance is to explain the roles and responsibilities of both undergraduate and graduate students when submitting protocols to be reviewed by the Institutional Review Board (IRB). This guidance also defines the roles of personnel in SPARCS and who is required to certify submissions.

Full Description

If the research personnel will not be involved as a "lead" investigator on the project (e.g. research assistant), then they should be listed under the question "All other W&M study personnel."

Roles on Protocol Applications

• Principal Investigator (PI): Lead investigator in charge of managing the research project and personnel. The PI must have research rights and permission to serve as PI on research projects. Students can never serve as PIs on research protocols. 
  • Editing rights
  • Can create additional submissions
  • Included in all study communications
  • Only 1 can be listed
  • Must certify all submission types
• Co-Principal Investigator (Co-PI): Faculty or staff member who shares responsibility of the research project with the PI. Students should not be listed as PIs on research protocols. 
  • Editing rights
  • Can create additional submissions
  •  Included in all study communications
  • More than one can be listed
  • Must certify initial, modification, and incident submissions
• Student Investigator: Lead graduate or undergraduate student who is completing a project for a thesis or dissertation project. 
  • Must have their advisor listed as the PI
  • Editing rights
  • Can create additional submissions
  • Included in all study communications
  • More than one can be listed
  • Must certify initial, modification, and incident submissions
• Other W&M Researchers: These are typically individuals in support roles, such as research assistants, data analysts, medical providers, etc. 
  • Editing rights (should not be editing protocol unless listed as Primary Contact, PI, Co-PI, or Student Investigator)
  • Included in all study communications
  • No limit on the number that can be listed
  • Not required to certify submission
• Primary Contacts:
  
  • Can be different from the PI
  • Can be a student
  • Editing rights
  • Can create additional submissions
  • Included in all study communications
  • Only 1 can be listed
  • Only required to certify submissions if they’re the PI, Student Investigator, or Co-PI
• Non-W&M Collaborators: Collaborators not affiliated with W&M but will be engaged in the research project. These individuals would be covered under a reliance agreement, investigator agreement, or exempt review from their home institution. 

Responsibilities for Principal Investigators

PIs are the leaders of the research team and are responsible for oversight and training of research personnel. PIs should ensure that all study personnel comply with William & Mary's policies and procedures. 

When the PI is no longer able to serve as the lead due to illness, administrative leave, or another reason, another researcher must be appointed as the PI. The interim PI must also meet the qualifications required to serve as the PI. 

Serving as a Faculty Mentor

When serving as a faculty mentor to an undergraduate or graduate student, PIs must assist students when submitting their protocol to SPARCS, as they are the authority responsible for the research. In the IRB protocol application, faculty advisors must describe the oversight and training plan in the "PI Assurance" section of the protocol.

When contacting the IRB office, students must always copy their advisor on emails. 

The PI(s) must be in continuous contact with their students to ensure the requirements for their submission are met.