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Identifying Investigators & COI Disclosers

Investigator Role Mapping

Pursuant to federal regulations, the University of Arizona’s Conflicts of Interest & Commitment Policy requires that Investigators "disclose all sponsored and non-sponsored Research Projects to the Office for Responsible Outside Interests prior to Conducting Research.”

The Program Director, Principal Investigator or Contact PI is responsible for identifying all individuals who are an Investigator on the project. For sponsored research, Investigators should be categorized in one of the below categories in UAccess Research (UAR). This information is integrated from UAR to eDisclosure and Research Certifications are automatically created for individuals listed in the following categories:

  1. The Program Director (PD), Principal Investigator (PI), or Contact PI is an individual who is judged to have the appropriate level of training, skill, authority, and responsibility and is designated by the University of Arizona to direct or co-direct a sponsored project or program. They are responsible and accountable to the University and the   Sponsor for the design, execution, and management of a sponsored project or program, including the submission of all required reports.
  2. A Co-Investigator (Co-I), Multiple Principal Investigator (MPI), or Mentor/Advisor is an individual the PD/PI relies on responsibilities above those of other personnel who make significant contributions to the sponsored project or Co-I does not have overall responsibility and authority for the sponsored project or program like an MPI.
  3. A Key Person (KP) is an individual who is essential to the performance of the sponsored project or program, and who contributes to the scientific design, development, or execution of the project or program in a substantive, measurable way, but who does not have overall responsibility and authority for the sponsored project or program.
  4. A Conflict of Interest Discloser (COI Discloser) is any person, regardless of title or position, included in a proposal, who is responsible for Conducting Research performed by or under the auspices of the University, other than those already included in a Project Director (PD), Co-PD, Principal Investigator (PI), Co-PI, Co-Investigator, or Key Person (KP) role. This may include Postdocs, students, and trainees.

For IRB Protocols: The Human Subjects Protection Program requires protocol personnel submit a Research Certification via eDisclosure for each project they are listed on in eIRB and has mapped IRB protocol roles to the sponsored project personnel categories. The below information can be used to ensure protocol personnel complete Research Certifications:

SPONSORED PROJECT PERSONNEL

IRB PROTOCOLPERSONNEL

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.

 

INVESTIGATOR IDENTIFICATION TABLE

Please note that the following resource table is provided for guidance purposes only. Please contact the Office for Responsible Outside Interests (OROI) at coi@arizona.edu or (520) 626-6406 for assistance with questions.

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 significance of the tasks assigned to the individual with regard to Conducting Research (i.e., making a significant contribution to the research results by participating in the design, development, testing, evaluation, conduct, reporting, review or oversight of the research, or in all of these activities);

· 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.

Research Subrecipients have a different COI disclosure process.  For more information, view the Research Subrecipient webpage or contact OROI at coi@ariozna.edu or 520-626-6406.

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