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."

Undergraduate Students as Investigators

 

Undergraduate students are required to be listed as “Student Investigators” and should never serve as the principal investigator (PI) on a research protocol. Faculty advisors are required to assist students when submitting their protocol to SPARCS as they are the authority responsible for the research. Students should be in continuous contact with the faculty advisors to ensure the requirements for their submission are met. Faculty advisors are listed as the principal investigators as it is the PIs role to provide ongoing oversight over the protocol submission process and research project. If at any point the duty of PI cannot be fulfilled, alternative arrangements should be made, and the Research Compliance office should be notified of the change in PI.

1. Students who are in the process of obtaining an undergraduate degree from William & Mary must always be listed as “Student Investigators” regardless of the type of project.
2. The “Principal Investigator” is required to be the student’s faculty advisor
3. Students may be listed as the “Primary Contact” if they will be the research personnel in charge of managing the study submission

Graduate Students as Investigators

Graduate students may be listed as Co-PIs or Student investigators on protocols depending on their degree program. Students at any level are not allowed to sponsor their own research, and therefore, cannot be listed as the principal investigator. Faculty advisors should assist graduate students as needed, and students should communicate regularly with their advisor about the submission and research.

1. Master’s Level Students

   • Students who are in the process of obtaining a Master’s degree from William & Mary must always be listed as “Student Investigators” regardless of the type of project
   • The “Principal Investigator” is required to be the student’s faculty advisor
   • Students may be listed as the “Primary Contact” if they will be the research personnel in charge of managing the study submission

2. PhD

   • Students who are in the process of obtaining a PhD from William & Mary must always be listed as “Co-Principal Investigators” or “Co-PIs” regardless of the type of project.
   • The “Principal Investigator” is required to be the student’s faculty advisor
   • Students may be listed as the “Primary Contact” if they will be the research personnel in charge of managing the study submission

Roles in SPARCS Submission Form

Table lists all the roles and their abilities within the SPARCS system.

Role	Abilities in System	Certify?
Principal Investigator	Editing Rights Can create additional submissions Included in all study communications Only 1 can be listed	Must certify all submission types
Student Investigator(s) (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
Primary Contact (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
Co-PI(s)	Editing Rights Can create additional submissions  Included in all study communications More than one can be listed	Must certify initial, modification, and incident submissions
All other W&M Study Personnel	Edit 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 number that can be listed	Not required to certify submission

Any questions about this policy should be directed to researchcompliance@wm.edu