Investigator-Initiated Studies

 

We do accept unsolicited requests from independent researchers for the following:

  • Technical input (statistical analyses, medical writing, etc.).
  • Funding and/or products to support independent research activities.

We give these types of proposals a scientific, business and healthcare compliance review, which takes approximately 90 days from the submission date. The proposals are reviewed to ensure that 1) the subjects' well-being is of primary importance, 2) Our Credo-based values are considered in the design and conduct of the study, 3) the principles of good clinical and/or laboratory practice are applied, 4) product information is relevant, accurate, fair and balanced, 5) cross-cultural differences are taken into account and 6) medical and ethical concerns are raised and vetted.

Requests for research grant support of any kind, including product or financial support, are covered under this review process. If an application is approved, execution of a milestone-based contract is required for disbursement of the grant, and the investigator must publish the study results in a peer-reviewed journal. This application process is intended for clinicians and scientists who are published and experienced in research.

Proposals must describe unique research of scientific and business merit. Although the approval or denial of an individual request does not influence the review of subsequent proposals, reconciliation of any outstanding items from an approved grant must be completed before another can be approved.

Requests for funding must be in an area of business interest to Ethicon Endo-Surgery, Inc. (EES). All applications must be submitted through our website.

Each submission must include: 

  • A protocol summary of the proposed research. At a minimum, protocols must meet the criteria for the Institutional Review Board (IRB), ethics committee or Institutional Animal Care and Use Committee (IACUC)* and include the following elements:
    • Background including scientific rationale with appropriate literature review and references
    • Objective of the study
    • Study design
    • Study population including inclusion and exclusion criteria for subjects
    • Procedures to be included in the study
    • Safety and efficacy endpoints
    • An analysis plan (EES cannot provide internal resources to analyze your data; however, you can be reimbursed for costs incurred for analysis, if contracted. This should be included in your initial study budget).
  • Curriculum vitae (CV) for the primary investigator and any co or sub-investigators. CV should include educational background, current academic appointments, publications and study experience.
  • A line item budget for the study. Applications with budgets incurring >35% institutional overhead expense are not routinely approved and must undergo additional reviews within EES. If reimbursement of study-related travel expenses is desired, include as a budget line item.

To apply for an IIS Grant involving:

  • Human subject data, including prospective/retrospective trials, literature reviews, and database analyses: Click here
  • Cadaver, animal or benchtop testing: Click here.

* For approved applications, appropriate IRB, EC or IACUC oversight of the IIS will be required contractually.
Approval of an IIS application involving the use of cadavers is contingent upon the site being/becoming an EES-approved cadaver site. To apply for this approval, contact 1-800-943-8201 or fundingrequest@eesus.jnj.com.
Consideration of an IIS application for an animate lab to be conducted in the United States is contingent upon the laboratory being USDA (U.S. Department of Agriculture) licensed. When reviewing applications involving animate labs, EES gives preference to research facilities with AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) accreditation.