IIS 2017 Priority Areas
Objective endpoints for predicting contact lens comfort
Underlying mechanisms of corneal infiltrative events during contact lens wear
New test methods for measuring visual performance during contact lens wear
(pilot / feasibility studies are preferred)
What is an Investigator-Initiated Study?
An Investigator-Initiated Study (IIS) is a research effort in which the investigator designs and implements the study and the investigator or the institution acts as the study sponsor, not Johnson & Johnson Vision Care, Inc. (JJVCI). As the sponsor, the Investigator assumes all responsibilities for complying with applicable regulatory requirements. IIS may be supported by JJVCI in the form of product, funding, and/or technical input.
What are the responsibilities of the Investigator?
- Designing and conducting the scientific investigation
- Complying with institutional requirements where the study will be conducted and all relevant laws, regulations and guidelines for clinical and pre-clinical research
- Reporting safety data to regulatory authorities and JJVCI as required
- Registering the clinical study on a public website such as www.clinicaltrials.gov, as required
- Providing JJVCI with interim and final research summary reports, a proposed publication plan and a draft manuscript, as applicable.
What is needed for an application?
- A completed IIS Application Form
- A study protocol or proposal that includes, at a minimum, the study objectives, background and rationale, clinical population description and size, study plan, projected study timeline, and amount of product/funding requested
- Investigator Curriculum Vitae (signed and dated)
- Itemized budget (when funding is requested)
How do I submit an application?
JJVCI accepts IIS applications only during the submission windows listed below:
- For 2017 funding – open submissions window from January 01, 2017 through February 28, 2017, with internal review of all received applications in April 2017.
- For 2018 funding – open submissions window from May 01, 2017 through June 30, 2017, with internal review of all received applications in July, 2017.
Please contact the Clinical Research Review Committee (CRRC) Administrator at RA-VISUS-IISRequests@its.jnj.com or call (904) 443-1525 for an Application Package and additional instructions. Once the Application Package has been completed, it should be emailed to the CRRC Administrator, along with documents referenced in the submittal package.
NOTE: The Clinical Research Review Committee of Johnson and Johnson Vision Care, Inc. is located in the United States of America, and therefore requires all application submittals to be made in English.
What is the review process?
All application submittals will be reviewed by JJVCI’s Research & Development to gauge interest in support. All applications of interest will then go through review by the CRRC for additional review/approval, which is a cross-functional team composed of personnel from several departments, including the Regulatory, Clinical & Medical Affairs, and Health Care Compliance (HCC). A decision is based on criteria in the areas of strategic fit with the business plan of JJVCI, investigator research experience, scientific merit, adherence to Good Clinical Practice, etc. You will then be notified of the committee's decision regarding your study proposal.
What happens after my Study Proposal is approved?
You will be notified via e-mail and asked to submit additional study documents for final review. These documents include:
- IIS Research Funding Agreement, provided by JJVCI for signature
- IRB Approval Letter
- IRB-approved Informed Consent
- IRB-approved Full Protocol
Once these documents have been reviewed and approved, agreed-upon funding, product, and/or technical input will be released according to the terms and milestones in the funding agreement. The study cannot commence until final approval is provided by the CRRC.
On completion of the study, you will provide JJVCI with the deliverable noted in the IIS Research Funding Agreement (e.g. final study report, draft manuscript, abstract, etc.)