There are many different definitions of "key personnel" used by various agencies and organizations. In the context of disclosure of financial conflicts of interest, the important concept is "responsible/responsibility" related to involvement in a research project. The highlighted definitions best capture this notion:

  1. Public Health Service and National Science Foundation Regulations on objectivity in research do not use the term "key personnel" at all. Instead: "Investigator means the principal investigator and any other person who is responsible for the design, conduct or reporting of research funded by PHS, or proposed for such funding".
  2. UC policy: "…it is the policy of the University of California that any Investigator (that is, any University employee responsible for design, conduct or reporting of a sponsored project at the University) may be required to disclose significant personal financial interests related to that project, pursuant to circumstances specified in this policy".
  3. UCLA policy: "Employees with disclosure responsibility include Principal Investigator and Co-Principal Investigators, as well as other University employees who have responsibility for the design, conduct or reporting of the research".
  4. PHS Grant Instructions: "Key personnel as defined as, and should be limited to, individuals who contribute in a substantive way to the scientific development or execution of the project, whether or not salaries are requested…Typically, these individuals have doctoral or other professional degrees although individuals at the masters or baccalaureate level should be included if their involvement meets the definition of key personnel. Consultants should be included only when their level of involvement meets the definition. Individuals providing technical services are not considered key personnel".
  5. UCLA Guidelines regarding application of the policy on Instruction on the Protection of Human Research Subjects by the NIH: "Key personnel is defined as individuals who contribute in a substantive way to the scientific development or execution of the project and are identified as such within the proposal.
  6. NHRPAC definition: "Research staff exercising independent judgment over data gathering, monitoring, analysis and interpretation, and those involved in the informed consent process with research subjects".