Ethicon Endo-Surgery accepts unsolicited requests from independent researchers
for assistance in the form of technical input (e.g., statistical analyses,
medical writing), funding and/or product to support independent clinical
research activities.
These Investigator-Initiated Study (IIS) proposals receive a
cross-functional scientific, business and health care compliance review. The
proposals are reviewed to ensure that 1) the subjects’ well-being is of
primary importance, 2) Johnson & Johnson Credo-based values are considered in
the design and conduct of the IIS, 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 support of any kind for research involving prospective or
retrospective patient data, etc., fall under the IIS review process. The
process is intended for clinicians who are published, experienced in clinical
research and familiar with the documentation needed to gain approvals by an
institution's IRB or ethics committee that oversees research.
Proposals must describe unique, non-duplicative research of scientific and
business merit. Although approval/non-approval of an individual request for an
IIS from a clinician/institution 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 IIS funding should be in an area of business interest to Ethicon
Endo-Surgery; application must be through the online request application.
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To apply for an IIS Grant involving human subject data, including
prospective/retrospective trials, literature reviews, and database analyses:
Click here
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To apply for an IIS Grant involving cadaver, animal or benchtop testing:
Click here
To be complete, each submission must include:
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A protocol summary of the proposed research. At a minimum, protocols must meet
the criteria for the Independent Review Board (IRB) and include the following
elements:
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Procedures to be included in the study
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Safety and efficacy endpoints
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An analysis plan (Ethicon Endo-Surgery 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 design)
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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.
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A line item budget for the study with suggested payment-based milestones.
Results of an IIS are to be submitted and accepted for publication in a
peer-reviewed journal. It is understood that the final choice of publication
will be partially based on study outcomes.
Research study proposals fall into two categories:
IIS Clinical Studies: Clinical trials, chart reviews, registry, health
economics and outcomes or literature reviews.
IIS Pre-Clinical Studies: Animal studies including in vitro studies, as well
as cadaver, bench top or tissue studies.
All studies including use of cadavers must be held at an Ethicon Endo-Surgery
approved site. For sites not already approved, please allow sufficient lead
time to obtain approval prior to finalizing the agreement. To get approval,
contact 1-800-943-8201 or fundingrequest@eesus.jnj.com.
Animate lab sites require approval by the USDA (U.S. Department of
Agriculture) and IACUC (Institution Animal Care & Use Committee). Ethicon
Endo-Surgery also recommends AAALAC (Association for Assessment and
Accreditation of Laboratory Animal Care International) accreditation of the
research facility. USDA and IACUC approvals need to be in place prior to any
research through animate labs.
DSL# 80-0651
