Identifying Investigators & COI Disclosers

Sponsored Project Personnel

IRB Protocol/Personnel

Program Director (PD), Principal Investigator (PI), or Contact PI

Principal Investigator is the individual bearing ultimate responsibility for the design, conduct, reporting, and the management of human research.

Co-Investigator (Co-I), Multiple Principal Investigator (MPI), or Mentor/Advisor

Co-Investigator (Co-I) bears the same rights and responsibilities for the research study as the PI in terms of the design, execution and management of human research; responsible for the proper conduct of the human subject’s research

Key Person (KP)

No IRB equivalent

Conflict of Interest Discloser (COI Discloser)

Responsible Physician is the person responsible for ensuring that all medical procedures that are part of the study will have a suitable physician present during the procedures (as applicable). A responsible physician is required when the study includes medical procedures that the PI is not licensed for.

Advisor is the person who oversees and monitors the conduct of student research by communicating regularly with the Principal Investigator (student researcher) and assists with the resolution of any problems or concerns encountered during the research.

The Advisor also assures that the IRB is notified in the event of an adverse event or unanticipated problem.

Research Staff are study team members who intervene or interact with human subjects and/or access identifiable information for research purposes.

Always an Investigator

Program Director (PD), Principal Investigator (PI), or Contact PI

See expectations on PD/PI Eligibility webpage

Co-Investigator (Co-I), Multiple Principal Investigator (MPI)

May include research scientists, senior research scientists, and senior postdoctoral associates (although this is not common)

Key Person (KP)

Identified as key personnel in the grant application, progress report, or any other report submitted to the sponsor, but is not a PD, PI, Co-I or MPI

Conflict of Interest Discloser (COI Discloser)

Shares in the responsibility for Conducting Research, but is not a PD, PI, Co-I, MPI or KP

Graduate or Postdoc Fellows paid on fellowships

Graduate or Postdoctoral Fellows are considered PIs (or in some cases Co-Is) on their own individual fellowship awards

Sometimes an Investigator

Consider the following when making your determination:

• The degree of independence the individual may have in performing their assigned tasks;
• Whether the individual will be directly involved in the research intervention or consenting or evaluation of human research subjects;
• Will the student/trainee be responsible for Conducting Research without direct oversight from an Investigator;
• Whether the individual will be a collaborator or given authorship credit on a publication related to the Research or present Research findings at a meeting or conference.

Mentor/Advisor* for Graduate or Postdoc Fellows

Oversees and monitors the Conduct of Research of fellows on individual fellowships who are conducting research

*If required in funding announcement, categorize as PD, PI, Co-I, MPI or KP as applicable

Graduate or Postdoc Fellow paid on training grants

Could be referred to as student, postdoc or trainee

Postdoc paid on research grants

In most instances, engage in research under the guidance and mentorship of a PD/PI

Graduate Research Assistants (GRAs)

Typically, in training and conducting research under the guidance and mentorship of a PD/PI

Consultants

Consultants are individuals who generally provide a “fee for service”

Collaborators at UArizona (paid or unpaid)

Typically, do not contribute measurable effort but may be a COI Discloser

Collaborators at outside entity or institution (paid or unpaid)

Typically, a Research Subrecipient

Other Significant Contributors (OSCs)

Typically, included on a proposal with “effort of zero person months” or “as needed” but may still meet the definition of a COI Discloser. In NIH proposals, OSCs who are not a COI Discloser must still submit a biosketch .