Examples of Options for Management Plans

  • Public disclosure of the financial interests of Investigators in a research sponsor on all publications and in oral presentations.
  • Annual or more frequent report to the COI Committee of status and changes in the relationship and the research.
  • Reformulation/modification of the protocol.
  • Monitoring of research by an independent reviewer(s).
  • Double blind data analysis.
  • Disclosure in informed consent forms and to human subjects who are participating in clinical trials.
  • Informed consent from human subjects obtained by person(s) other than investigator and supervisees.
  • Data analysis and interpretation by independent reviewers or review of raw data and manuscript by an external independent reviewer.
  • Close monitoring of the conduct of the research by an oversight body.
  • Divestiture of relevant personal interests in the research sponsor.
  • Disqualification of the investigator's involvement in all or part of the project.
  • Protection of the academic rights and interests of students/fellows, if any are involved in the project.
  • Severance of the external relationship.

Distinction between the management plans for basic bench research and clinical research involving human subjects should be made.