About the LifeScan IIS Program

The LifeScan Investigator-Initiated Study (IIS) Program encourages investigators to pursue and publish original diabetes-related research. LifeScan assists investigators by providing funds, products, or both to eligible studies.

How does the program work?


Investigators submit a study concept to LifeScan. If the concept is approved, investigators are asked to provide the study protocol and other details for additional review. Upon protocol approval, a contract is negotiated and signed. Investigators will receive funding, product, or both based on established milestones defined in the contract.

An IIS program study that has been supported is considered “completed” once the principal investigator (PI) submits a draft manuscript suitable for publication to LifeScan.

 

What is an investigator-initiated study?


An investigator-initiated study is a research effort in which the principal investigator (PI) not only designs and implements the study, but also acts as the study sponsor.

Although the word "sponsor" is commonly used to mean any kind of support, it has a specific meaning for scientific research. The sponsor is the individual (or entity) responsible for understanding and complying with any and all regulatory requirements related to the study. LifeScan cannot act as the sponsor for third-party research studies.

As a study sponsor, the PI is responsible for:

  • Designing the protocol and conducting the scientific investigation
  • Understanding and complying with any and all pertinent laws, regulations, and guidelines
  • Understanding and complying with any and all requirements of institution(s) with which they are associated or in which research will occur
  • Reporting safety data to regulatory authorities, the IRB/IEC, and LifeScan
  • Registering the study on a public Web site, if applicable

When research is being conducted by a group of investigators, it is preferable to have one principal investigator and several sub-investigators.

Under the IIS program, the PI is also responsible for:

  • Disclosing business affiliations
  • Meeting applicable deadlines
  • Submitting quarterly study status updates
  • Informing LifeScan of key study-related milestones or events
    Delivering a draft manuscript of publishable quality upon completion of the study
  • The precise terms of LifeScan support and the responsibilities of the PI are detailed in the IIS agreement.