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Guidance for the Definition of Investigators

Conflict of interest disclosures are required of all investigators. The University Individual Financial Conflict of Interest policy defines investigator as the project director or the principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research or scholarly activities conducted in whole or in part under the auspices of the University, which may include for example, collaborators, consultants and/or subaward or subcontract recipients.

"Responsible for the design conduct, or reporting" means that the individual has a sufficient level of responsibility that they could have a meaningful impact on the results of the study. This definition includes individuals who have a substantial role in the research design, in the recruitment and enrollment of subjects, or direct control over the collection and/or analysis of data. However, this definition generally does not apply to individuals who provide limited technical support or those who are in a purely advisory capacity.

The principal investigator is encouraged to consider the roles of all those involved in the project, regardless of job title. Everyone listed will be required to complete conflict of interest screening questionnaires and resolve potential conflicts with the Conflict of Interest Committee prior to engaging in the research.

The principal investigator should consider the following factors when making this evaluation. Individuals involved in any of the following are usually considered to be “responsible for the design, conduct or reporting” of research:

  • Making a substantial contribution to or key decisions about the design of the research
  • Recruiting, enrolling, or consenting research subjects
  • Recording primary study data in a system without quality control mechanisms
  • Independently operating or calibrating laboratory or technical equipment or processes that capture primary study data
  • Analyzing or manipulating data
  • Expected to be an author on publications resulting from the research
  • Presenting research results at conferences, seminars, or in public settings
  • Reporting adverse events to an agency or sponsor
  • Auditing or data monitoring of the study

 

Individuals are generally not considered to be "responsible for the design, conduct or reporting" of research if they are only engaged in one or more of the following:

  • Conducting literature reviews
  • Preparing or editing protocol summaries, consent documents, brochures, questionnaires and other study materials if the scientific decisions are made by other members of the research team
  • Recording study data in a system with quality control mechanisms such as duplicate entry or random data checks
  • Assisting with laboratory or technical equipment or processes under the direction of an investigator
  • Administrative tasks such as scheduling appointments or investigator meetings, or maintaining financial records for the project
Last Updated: 8/9/16